1037-00004 · Solstice Biomedical Devices Ltd · Motions Practice

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DECLARATION OF CHRISTY BAUER IN SUPPORT OF DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT (PRECISIONEDGE™ PE-5000 SERIES)

Filed: April 1, 2025

I. INTRODUCTION AND DECLARANT IDENTIFICATION

1. I, Christy Bauer, declare as follows pursuant to 28 U.S.C. § 1746:

2. I am a Lead Associate in the intellectual Property practice at Calderwood & Harkness LLP, located at 1201 Market Street, Suite 2500, Wilmington, Delaware 19801. Calderwood & Harkness LLP is counsel of record for Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant") in the above-captioned action. I have been actively involved in the representation of Solstice in this matter since the Complaint was filed and have participated in all substantive aspects of the case, including discovery, claim construction proceedings, and expert retention and coordination.

3. I am a member in good standing of the bar of the State of New York and was admitted pro hac vice in this action by Order of this Court dated June 20, 2024, permitting my appearance on behalf of Defendant Solstice Biomedical, Inc.

4. I make this Declaration in support of Defendant Solstice Biomedical, Inc.'s Motion for Summary Judgment of Non-Infringement as to the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) with respect to U.S. Patent No. 9,814,237 ("the '237 Patent") and U.S. Patent No. 10,271,884 ("the '884 Patent").

5. I have personal knowledge of the facts stated herein, or they are based on my review of business records and litigation files maintained by Calderwood & Harkness LLP in the ordinary course of this litigation, identified internally as C&H Matter Number 10294.0017. I have supervised or directly participated in the collection, review, and production of documents, the preparation of claim charts, the coordination of expert discovery, and the review of deposition transcripts relevant to the matters addressed in this Declaration.

6. I am competent to testify to these matters if called upon to do so.

II. BACKGROUND OF THE ACTION

7. On May 9, 2024, Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") filed its Complaint in this Court, alleging that Solstice Biomedical, Inc.'s PrecisionEdge™ line of laparoscopic trocar assemblies infringes three utility patents owned by Apex. The Complaint asserts claims for patent infringement under 35 U.S.C. § 271 and seeks injunctive relief, compensatory damages, enhanced damages for alleged willful infringement, and attorneys' fees.

8. The three patents asserted by Apex in this action (collectively, the "Asserted Patents") are as follows:

(a) U.S. Patent No. 9,814,237 ("the '237 Patent"), titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," which was issued by the United States Patent and Trademark Office on November 14, 2017, and has an expiration date of June 22, 2035;

(b) U.S. Patent No. 10,271,884 ("the '884 Patent"), titled "Retractable Blade Deployment Mechanism for Trocar Systems," which was issued by the United States Patent and Trademark Office on April 30, 2019, and has an expiration date of September 15, 2036; and

(c) U.S. Patent No. 10,932,105 ("the '105 Patent"), titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," which was issued by the United States Patent and Trademark Office on March 2, 2021, and has an expiration date of January 10, 2038.

9. Dr. Raymond Szabo, Vice President of Engineering at Apex, is the named inventor on all three of the Asserted Patents. Each of the Asserted Patents has been assigned to Apex Surgical Innovations, Inc., and Apex has represented in its Complaint and subsequent filings that it holds all right, title, and interest in the Asserted Patents, including the right to sue for infringement.

10. The present Motion for Summary Judgment pertains solely to the PrecisionEdge™ PE-5000 Series, which is Solstice's 5 mm trocar assembly product line. As set forth in Apex's Complaint and its subsequent infringement contentions, Apex has accused the PE-5000 Series of infringing the following claims of the following patents:

(a) Claims 1, 3, 7, and 12 of the '237 Patent; and

(b) Claims 1, 2, 5, 9, and 14 of the '884 Patent.

11. Apex's infringement allegations in this action extend to additional PrecisionEdge™ products beyond the PE-5000 Series, including the PE-12000 Series (12 mm trocar assembly) and the PE-15000 Series (15 mm trocar assembly), as well as allegations of infringement of the '105 Patent. The present motion does not address those additional products or the '105 Patent. Solstice reserves all rights with respect to those products and that patent, including the right to seek summary judgment at a later date.

12. On June 14, 2024, Solstice filed its Answer, Affirmative Defenses, and Counterclaims, denying all allegations of infringement and asserting, among other defenses, non-infringement of the Asserted Patents, invalidity of the Asserted Patents under 35 U.S.C. §§ 102, 103, and 112, and inequitable conduct during prosecution of the Asserted Patents before the United States Patent and Trademark Office.

III. PROCEDURAL HISTORY RELEVANT TO THIS MOTION

13. The Court held an Initial Scheduling Conference on July 2, 2024, at which the parties and the Court discussed the scope and timeline of discovery and other pretrial matters. Thereafter, the Court entered a Scheduling Order establishing deadlines for fact discovery, claim construction proceedings, expert discovery, and dispositive motions.

14. Fact discovery was conducted over the period from July 2024 through January 2025. During this time, the parties exchanged extensive document productions, served written discovery, and conducted depositions of fact witnesses.

15. On September 30, 2024, Solstice produced 48,217 documents in this litigation, bearing Bates numbers SBD-000001 through SBD-048217. This production included, among other materials, technical specifications, engineering drawings, manufacturing records, quality assurance documentation, marketing materials, sales data, and internal communications relating to the design, development, and commercialization of the PrecisionEdge™ product line, including the PE-5000 Series at issue in this motion.

16. On October 7, 2024, Apex produced 31,450 documents in this litigation, bearing Bates numbers APEX-000001 through APEX-031450. Apex's production included, among other materials, the patent prosecution files for the Asserted Patents, internal engineering and design documents, communications relating to the development and commercialization of Apex's own trocar products, prior art references, and documents reflecting Apex's knowledge and understanding of the scope of the Asserted Patents' claims.

17. On October 22, 2024, the parties exchanged their Proposed Claim Constructions and Identification of Extrinsic Evidence pursuant to the Court's Scheduling Order and Local Patent Rule 4.2. The parties identified a total of nine disputed claim terms across the three Asserted Patents. The parties were unable to resolve any of these disputes through the meet-and-confer process required under the Local Patent Rules.

18. On November 4, 2024, the parties filed their Joint Claim Construction Brief pursuant to Local Patent Rule 4.3, setting forth each party's proposed construction for each of the nine disputed terms, supported by intrinsic and extrinsic evidence. Solstice's proposed constructions were supported by, among other things, the claim language, the specifications of the Asserted Patents, the prosecution histories, and the declaration testimony of Dr. Miriam Ostrowski.

19. On November 18, 2024, the Court held a Claim Construction (Markman) Hearing before the Honorable Chief Judge Richard G. Andrews. Both parties presented oral argument on each of the nine disputed claim terms. The hearing lasted approximately four hours and included extensive discussion of the patent specifications, prosecution history, and the extrinsic evidence submitted by both parties.

20. On December 6, 2024, the Court issued its Claim Construction Order, construing all nine disputed claim terms. Of the nine terms construed, five terms were construed in a manner consistent with, or substantially similar to, Solstice's proposed constructions, and four terms were construed in a manner consistent with, or substantially similar to, Apex's proposed constructions. A true and correct copy of the Court's Claim Construction Order is attached hereto as Exhibit 1.

21. Expert discovery opened on January 13, 2025, pursuant to the Court's Scheduling Order. Solstice served the Expert Report of Dr. Miriam Ostrowski on January 27, 2025. Dr. Ostrowski's report addressed both invalidity of the Asserted Patents and, with respect to the PE-5000 Series specifically, the non-infringement of the '237 and '884 Patents under the Court's claim constructions.

22. On February 10, 2025, Apex served the Infringement Expert Report of Dr. Calvin Ng, which set forth Apex's infringement theories as to all accused PrecisionEdge™ products, including the PE-5000 Series, with respect to each of the Asserted Patents.

23. On March 3, 2025, the parties exchanged Rebuttal Expert Reports. Solstice served the Rebuttal Expert Report of Dr. Miriam Ostrowski, which responded to Dr. Ng's infringement opinions as they pertained to the PE-5000 Series and identified errors, unsupported assumptions, and inconsistencies in Dr. Ng's analysis.

IV. THE COURT'S CLAIM CONSTRUCTION ORDER AND ITS RELEVANCE TO THE PE-5000 SERIES

24. I have reviewed the Court's Claim Construction Order dated December 6, 2024, in its entirety. A true and correct copy is attached hereto as Exhibit 1.

25. The Claim Construction Order construed the term "locking seal assembly" as used in Claims 1, 3, 7, and 12 of the '237 Patent, and the term "retractable blade deployment mechanism" as used in Claims 1, 2, 5, 9, and 14 of the '884 Patent, among other terms. The Court's constructions of these two terms are of central importance to Solstice's non-infringement argument with respect to the PE-5000 Series.

26. With respect to the term "locking seal assembly," the Court adopted a construction requiring that the seal assembly include "a mechanical interlock that affirmatively engages and secures the seal in a closed position through positive locking engagement between complementary structural features of the seal housing and the seal element." See Claim Construction Order (Ex. 1) at 12-15. The Court rejected Apex's broader proposed construction that would have encompassed friction-fit or interference-fit seal arrangements. Id. at 14. The Court's construction is consistent with the construction proposed by Solstice and is favorable to Solstice's non-infringement position with respect to the PE-5000 Series, because, as set forth in the accompanying motion papers and the claim charts (Exhibit 7), the PE-5000 Series employs a compression-based elastomeric seal that does not incorporate a mechanical interlock with complementary structural features.

27. With respect to the term "retractable blade deployment mechanism," the Court adopted a construction requiring "a spring-loaded mechanism that deploys the trocar blade from a retracted position to an extended cutting position and automatically retracts the blade to the retracted position upon release of an operator-actuated trigger." See Claim Construction Order (Ex. 1) at 18-21. The Court expressly noted that the prosecution history of the '884 Patent demonstrated that the applicant distinguished the claimed invention over the prior art on the basis of the automatic retraction feature triggered by release of the operator-actuated trigger. Id. at 20. The Court's construction of this term is likewise favorable to Solstice's non-infringement position, because, as demonstrated in the claim charts (Exhibit 8) and the expert report of Dr. Ostrowski (Exhibit 9), the PE-5000 Series blade system utilizes a manually retractable blade that does not automatically retract upon release of a trigger mechanism.

V. AUTHENTICATION OF EXHIBITS

28. In connection with Defendant's Motion for Summary Judgment of Non-Infringement, I am authenticating the exhibits described below, each of which is attached to this Declaration. I have personally reviewed each of these exhibits and can attest to their accuracy and authenticity based on my involvement in this litigation and my review of the records maintained in connection with C&H Matter Number 10294.0017.

Exhibit 1: Claim Construction Order (December 6, 2024)

29. Attached hereto as Exhibit 1 is a true and correct copy of the Court's Claim Construction Order, Dkt. No. 78, entered December 6, 2024, by Chief Judge Richard G. Andrews, construing nine disputed claim terms of the '237 Patent, the '884 Patent, and the '105 Patent. I obtained this copy from the Court's CM/ECF electronic filing system, and it is identical to the Order as entered on the docket in this case.

Exhibit 2: U.S. Patent No. 9,814,237 ("the '237 Patent")

30. Attached hereto as Exhibit 2 is a true and correct copy of U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued by the United States Patent and Trademark Office on November 14, 2017. I obtained this copy from the United States Patent and Trademark Office's online database. The claims of this patent that are asserted against the PE-5000 Series and that are the subject of this motion are Claims 1, 3, 7, and 12.

Exhibit 3: U.S. Patent No. 10,271,884 ("the '884 Patent")

31. Attached hereto as Exhibit 3 is a true and correct copy of U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," issued by the United States Patent and Trademark Office on April 30, 2019. I obtained this copy from the United States Patent and Trademark Office's online database. The claims of this patent that are asserted against the PE-5000 Series and that are the subject of this motion are Claims 1, 2, 5, 9, and 14.

Exhibit 4: Relevant Excerpts from the Prosecution History of the '237 Patent

32. Attached hereto as Exhibit 4 are true and correct copies of excerpts from the prosecution history of U.S. Patent No. 9,814,237, including office actions issued by the United States Patent and Trademark Office, applicant responses submitted on behalf of Apex, and narrowing amendments made to the claims during prosecution. These prosecution history materials were obtained by Apex's patent prosecution counsel, Kendrick & Lau LLP (Dr. Jonathan Kendrick, Lead Partner, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004), and were produced by Apex during fact discovery in this litigation at Bates numbers APEX-004218 through APEX-004897.

33. As set forth more fully in Defendant's memorandum of law filed concurrently herewith, the prosecution history of the '237 Patent is relevant to the non-infringement analysis because it demonstrates that Apex's patent counsel made narrowing amendments and arguments during prosecution that distinguish the claimed "locking seal assembly" from seal arrangements that rely on friction fit, compression fit, or interference fit to maintain the seal in a closed position. These amendments and arguments give rise to prosecution history estoppel, which precludes Apex from asserting infringement under the doctrine of equivalents with respect to the seal mechanism employed in the PE-5000 Series.

Exhibit 5: Relevant Excerpts from the Prosecution History of the '884 Patent

34. Attached hereto as Exhibit 5 are true and correct copies of excerpts from the prosecution history of U.S. Patent No. 10,271,884, including office actions issued by the United States Patent and Trademark Office, applicant responses, and narrowing amendments made to the claims during prosecution. These prosecution history materials were likewise obtained from Apex's patent prosecution counsel at Kendrick & Lau LLP and were produced by Apex in discovery at Bates numbers APEX-006102 through APEX-006789.

35. The prosecution history of the '884 Patent is relevant to the non-infringement analysis because it demonstrates that Apex's patent counsel amended the claims during prosecution to add the automatic retraction limitation and argued to the patent examiner that the automatic retraction feature, triggered specifically by release of an operator-actuated trigger, distinguished the claimed invention over prior art trocar blade mechanisms. These narrowing amendments and arguments are relevant to both literal non-infringement and prosecution history estoppel.

Exhibit 6: PrecisionEdge™ PE-5000 Series Product Specifications and Technical Drawings

36. Attached hereto as Exhibit 6 are true and correct copies of the product specifications and technical drawings for the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), which were produced by Solstice during fact discovery in this litigation at Bates numbers SBD-012445 through SBD-012738. These documents were produced from the files of Solstice's Engineering Department and its Regulatory Affairs Department and are maintained by Solstice in the ordinary course of its business as part of its product design and regulatory compliance documentation.

37. The documents comprising Exhibit 6 describe in detail the design and operation of the PE-5000 Series, including its seal mechanism, blade deployment system, cannula housing, obturator assembly, and overall trocar assembly configuration. These specifications and drawings form the technical basis for the non-infringement claim charts attached as Exhibits 7 and 8 and were relied upon by Dr. Ostrowski in forming her expert opinions.

Exhibit 7: Claim Charts Comparing PE-5000 Series to Asserted Claims of the '237 Patent

38. Attached hereto as Exhibit 7 is a true and correct copy of Solstice's Non-Infringement Claim Chart for U.S. Patent No. 9,814,237, which maps Claims 1, 3, 7, and 12 of the '237 Patent against the design and operation of the PrecisionEdge™ PE-5000 Series and identifies, on an element-by-element basis, the claim limitations that are not met by the PE-5000 Series under the Court's claim constructions as set forth in the Claim Construction Order of December 6, 2024 (Exhibit 1).

39. This claim chart was prepared by Calderwood & Harkness LLP. A preliminary version of the claim chart was originally prepared on July 20, 2024, based on Solstice's pre-litigation analysis and the parties' competing proposed claim constructions. The claim chart was subsequently updated following the Court's issuance of the Claim Construction Order on December 6, 2024, to reflect the Court's adopted constructions of all disputed terms. The version attached as Exhibit 7 is the updated version, which accurately reflects the current non-infringement analysis under the controlling claim constructions.

Exhibit 8: Claim Charts Comparing PE-5000 Series to Asserted Claims of the '884 Patent

40. Attached hereto as Exhibit 8 is a true and correct copy of Solstice's Non-Infringement Claim Chart for U.S. Patent No. 10,271,884, which maps Claims 1, 2, 5, 9, and 14 of the '884 Patent against the design and operation of the PrecisionEdge™ PE-5000 Series and identifies the claim limitations that are not met by the PE-5000 under the Court's claim constructions.

41. This claim chart was similarly prepared by Calderwood & Harkness LLP. A preliminary version was originally prepared on July 22, 2024, and the claim chart was updated following the Court's Claim Construction Order of December 6, 2024. The version attached as Exhibit 8 reflects the updated non-infringement analysis under the Court's adopted constructions.

Exhibit 9: Relevant Excerpts from the Expert Report of Dr. Miriam Ostrowski

42. Attached hereto as Exhibit 9 are true and correct copies of excerpts from the Expert Report of Dr. Miriam Ostrowski, Ph.D., the Brinkley Distinguished Professor of Biomedical Engineering at Halford University, Philadelphia, Pennsylvania. Dr. Ostrowski's Expert Report was served on January 27, 2025, on behalf of Defendant Solstice Biomedical, Inc.

43. Dr. Ostrowski was retained by Solstice on August 20, 2024, to provide expert opinions on claim construction, invalidity, and non-infringement of the Asserted Patents. Dr. Ostrowski holds a Ph.D. in Biomedical Engineering from the Massachusetts Institute of Technology and has over twenty-five years of experience in the design and development of minimally invasive surgical instruments, including laparoscopic trocar systems. Her qualifications are set forth in detail in her curriculum vitae, which is appended to her full Expert Report.

44. The excerpts attached as Exhibit 9 address Dr. Ostrowski's expert opinions on why the PE-5000 Series does not satisfy the "locking seal assembly" limitation of the '237 Patent and does not satisfy the "retractable blade deployment mechanism" limitation of the '884 Patent, under the claim constructions adopted by the Court in its December 6, 2024 Order. Dr. Ostrowski's opinions in this regard are based on her independent review and analysis of the PE-5000 Series product specifications and technical drawings (Exhibit 6), the patent claims, specifications, and prosecution histories (Exhibits 2 through 5), the Court's Claim Construction Order (Exhibit 1), and her expertise in the relevant field.

Exhibit 10: Relevant Excerpts from the Expert Report of Dr. Calvin Ng (Apex's Expert)

45. Attached hereto as Exhibit 10 are true and correct copies of excerpts from the Infringement Expert Report of Dr. Calvin Ng, Ph.D., Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware. Dr. Ng's Expert Report was served on February 10, 2025, on behalf of Plaintiff Apex Surgical Innovations, Inc.

46. The excerpts attached as Exhibit 10 include those portions of Dr. Ng's report that specifically address the PE-5000 Series and set forth Apex's infringement contentions with respect to the '237 Patent and the '884 Patent as applied to the PE-5000 Series. I have reviewed these excerpts in detail. Notably, Dr. Ng's report contains several concessions and admissions that are relevant to Solstice's non-infringement position. Specifically, Dr. Ng concedes at paragraph 147 of his report that the PE-5000 Series seal mechanism "does not employ a traditional mechanical interlock" but instead relies on what Dr. Ng characterizes as a "functional equivalent" of a locking seal assembly. Dr. Ng further acknowledges at paragraphs 203-205 of his report that the PE-5000 Series blade retraction is "manually initiated by the operator" rather than being automatically triggered by release of an actuating mechanism, but contends that this distinction is immaterial under the doctrine of equivalents. These concessions are directly relevant to the motion and are addressed in the accompanying memorandum of law.

Exhibit 11: Relevant Excerpts from the Rebuttal Expert Report of Dr. Miriam Ostrowski

47. Attached hereto as Exhibit 11 are true and correct copies of excerpts from the Rebuttal Expert Report of Dr. Miriam Ostrowski, served on March 3, 2025, on behalf of Defendant Solstice Biomedical, Inc. The excerpts attached as Exhibit 11 contain Dr. Ostrowski's responses to Dr. Ng's infringement opinions as they pertain to the PE-5000 Series, including Dr. Ostrowski's analysis of why Dr. Ng's doctrine-of-equivalents theory fails both as a factual matter and because it is barred by prosecution history estoppel.

Exhibit 12: Relevant Excerpts from Apex's Document Production

48. Attached hereto as Exhibit 12 are true and correct copies of documents from Apex's production in this litigation, bearing Bates numbers within the range APEX-000001 through APEX-031450, that are relevant to the non-infringement of the PE-5000 Series. These documents include internal Apex engineering communications, memoranda, and design review notes regarding the scope and intended operation of the claimed "locking seal assembly" and "retractable blade deployment mechanism" as those features were conceived, designed, and disclosed in the patent applications that matured into the '237 and '884 Patents.

49. The documents comprising Exhibit 12 are relevant because they reflect Apex's own contemporaneous understanding of the scope and meaning of the key claim terms at issue in this motion, and they are consistent with the narrower claim constructions adopted by the Court. Among other things, these documents include email communications between Dr. Raymond Szabo and members of Apex's engineering team in which the "locking seal assembly" is described as requiring a "positive mechanical interlock" and the "retractable blade deployment mechanism" is described as featuring "automatic spring-driven retraction upon trigger release." These internal descriptions are consistent with the Court's claim constructions and inconsistent with Apex's broader litigation positions.

Exhibit 13: Relevant Deposition Testimony

50. Attached hereto as Exhibit 13 are true and correct copies of excerpts from depositions taken in this case that are relevant to the non-infringement of the PE-5000 Series. The deposition excerpts include testimony from the following witnesses:

(a) Apex's Rule 30(b)(6) corporate designee, Ms. Karen Holt, Director of Product Development at Apex, whose deposition was taken on December 12, 2024, pursuant to a deposition notice served on November 1, 2024. Ms. Holt testified, among other things, regarding Apex's understanding of the scope of the Asserted Patents' claims, the design and operation of Apex's own trocar products embodying the patented technology, and the distinctions between Apex's patented seal and blade mechanisms and alternative seal and blade designs known in the industry; and

(b) Dr. Raymond Szabo, Vice President of Engineering at Apex and named inventor on the Asserted Patents, whose deposition was taken on December 19, 2024. Dr. Szabo testified regarding the conception and development of the inventions claimed in the '237 and '884 Patents, the prosecution of those patents before the USPTO, and his understanding of the specific claim limitations at issue, including the "locking seal assembly" and the "retractable blade deployment mechanism."

51. The deposition excerpts attached as Exhibit 13 include testimony that is consistent with the Court's claim constructions and that further supports Solstice's non-infringement position with respect to the PE-5000 Series.

VI. STATEMENT REGARDING THE ACCUSED PE-5000 SERIES PRODUCTS

52. The PrecisionEdge™ PE-5000 Series is Solstice Biomedical, Inc.'s 5 mm trocar assembly product line, designed and marketed for use in minimally invasive laparoscopic surgery. The PE-5000 Series was first commercially introduced in the United States in February 2021 and has been continuously sold and distributed throughout the United States since that date. The PE-5000 Series is manufactured at Solstice's facility in West Chester, Pennsylvania, and is cleared for marketing by the U.S. Food and Drug Administration under 510(k) clearance.

53. Based on my review of the technical specifications and engineering drawings for the PE-5000 Series (Exhibit 6), the Court's Claim Construction Order (Exhibit 1), and the non-infringement claim charts prepared by Calderwood & Harkness LLP (Exhibits 7 and 8), as well as my review of the expert reports of Dr. Ostrowski (Exhibits 9 and 11), the PE-5000 Series does not practice every element of the asserted claims of the '237 Patent or the '884 Patent.

54. Specifically, with respect to the '237 Patent, the PE-5000 Series seal mechanism operates differently from the "locking seal assembly" as that term was construed by the Court in the Claim Construction Order. As detailed in the claim charts (Exhibit 7) and Dr. Ostrowski's expert report (Exhibit 9), the PE-5000 Series employs a compression-based elastomeric seal that maintains instrument sealing through radial compression forces generated by the elastomeric material rather than through a mechanical interlock between complementary structural features. The PE-5000 Series seal does not incorporate the positive locking engagement between complementary structural features of a seal housing and a seal element that the Court's construction requires.

55. With respect to the '884 Patent, the PE-5000 Series blade system does not employ a "retractable blade deployment mechanism" as that term was construed in the Court's December 6, 2024 Order. As detailed in the claim charts (Exhibit 8) and Dr. Ostrowski's expert report (Exhibit 9), the PE-5000 Series utilizes a blade deployment system in which the blade is manually extended by the operator through forward sliding motion of an actuator and is manually retracted by the operator through rearward sliding motion of the same actuator. The PE-5000 Series blade does not automatically retract to the retracted position upon release of an operator-actuated trigger, as the Court's construction requires. Rather, the blade remains in whatever position the operator has placed it until the operator affirmatively moves the actuator in the opposite direction.

56. Based on the foregoing, the PE-5000 Series lacks at least two independent limitations of the asserted claims: the "locking seal assembly" limitation of the '237 Patent and the "retractable blade deployment mechanism" limitation of the '884 Patent. Failure to satisfy even a single claim limitation is sufficient to establish non-infringement.

57. For informational context, I note that the combined U.S. sales of all accused PrecisionEdge™ products — including the PE-5000 Series, the PE-12000 Series, and the PE-15000 Series — from the initial commercial launch in 2021 through the third quarter of 2024 totaled approximately $74.6 million. These sales break down by fiscal year as follows: FY 2021 sales of approximately $12.1 million; FY 2022 sales of approximately $17.8 million; FY 2023 sales of approximately $22.4 million; and FY 2024 sales through September 30, 2024, of approximately $22.3 million. The PE-5000 Series represents a subset of these figures. The foregoing sales data is based on business records produced by Solstice during fact discovery and is provided solely for context regarding the scope of this litigation.

VII. NO GENUINE DISPUTE OF MATERIAL FACT

58. Based on my review of the complete record in this case — including Apex's own document production (Exhibit 12), the deposition testimony of Apex's witnesses (Exhibit 13), the expert reports of both Dr. Ostrowski (Exhibits 9 and 11) and Dr. Ng (Exhibit 10), the Asserted Patents and their prosecution histories (Exhibits 2 through 5), the technical specifications and drawings for the PE-5000 Series (Exhibit 6), the non-infringement claim charts (Exhibits 7 and 8), and the Court's Claim Construction Order (Exhibit 1) — there is no genuine dispute of material fact regarding the non-infringement of the PE-5000 Series with respect to the '237 Patent (Claims 1, 3, 7, and 12) and the '884 Patent (Claims 1, 2, 5, 9, and 14).

59. The undisputed facts, viewed in their totality and in the light most favorable to the non-moving party, establish that the PrecisionEdge™ PE-5000 Series does not meet the "locking seal assembly" limitation of the asserted claims of the '237 Patent and does not meet the "retractable blade deployment mechanism" limitation of the asserted claims of the '884 Patent, as those terms have been construed by this Court. Apex's own expert, Dr. Ng, has conceded that the PE-5000 Series does not literally practice these limitations but relies instead on a doctrine-of-equivalents theory that is foreclosed by prosecution history estoppel, as detailed in the accompanying memorandum of law. The record thus establishes that Defendant Solstice Biomedical, Inc. is entitled to summary judgment of non-infringement as to the PE-5000 Series.

VIII. CONCLUSION AND SIGNATURE

I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct.

Executed on April 1, 2025, at Wilmington, Delaware.

________________________________________

Christy Bauer

Christy Bauer, Lead Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201

Email: cbauer@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

EXHIBIT LIST

CERTIFICATE OF SERVICE

I hereby certify that on April 1, 2025, a true and correct copy of the foregoing Declaration of Christy Bauer in Support of Defendant Solstice Biomedical, Inc.'s Motion for Summary Judgment of Non-Infringement (PrecisionEdge™ PE-5000 Series), together with all exhibits attached thereto, was served upon counsel for Plaintiff via the Court's CM/ECF electronic filing system, which will send notification of such filing to all counsel of record, including:

Victoria Stanton, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, DE 19801 vstanton@htblaw.com

Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, DE 19801 dloomis@htblaw.com

________________________________________

Christy Bauer

Christy Bauer, Lead Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201

Email: cbauer@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

APEX SURGICAL INNOVATIONS, INC.,

Plaintiff,

SOLSTICE BIOMEDICAL, INC.,

Defendant.

Exhibit No.	Description
1	Claim Construction Order, dated December 6, 2024 (Dkt. No. 78)
2	U.S. Patent No. 9,814,237, "Locking Seal Assembly for Minimally Invasive Surgical Access Device"
3	U.S. Patent No. 10,271,884, "Retractable Blade Deployment Mechanism for Trocar Systems"
4	Prosecution History Excerpts — U.S. Patent No. 9,814,237 (APEX-004218 through APEX-004897)
5	Prosecution History Excerpts — U.S. Patent No. 10,271,884 (APEX-006102 through APEX-006789)
6	PrecisionEdge™ PE-5000 Series Product Specifications and Technical Drawings (SBD-012445 through SBD-012738)
7	Non-Infringement Claim Chart — U.S. Patent No. 9,814,237, Claims 1, 3, 7, and 12 vs. PE-5000 Series
8	Non-Infringement Claim Chart — U.S. Patent No. 10,271,884, Claims 1, 2, 5, 9, and 14 vs. PE-5000 Series
9	Excerpts from Expert Report of Dr. Miriam Ostrowski (January 27, 2025)
10	Excerpts from Infringement Expert Report of Dr. Calvin Ng (February 10, 2025)
11	Excerpts from Rebuttal Expert Report of Dr. Miriam Ostrowski (March 3, 2025)
12	Excerpts from Apex Document Production (selected documents within APEX-000001 through APEX-031450)
13	Excerpts from Deposition Testimony (Karen Holt, Dec. 12, 2024; Dr. Raymond Szabo, Dec. 19, 2024)

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DECLARATION OF CHRISTY BAUER IN SUPPORT OF DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT (PRECISIONEDGE™ PE-5000 SERIES)
Filed: April 1, 2025
I. INTRODUCTION AND DECLARANT IDENTIFICATION
1. I, Christy Bauer, declare as follows pursuant to 28 U.S.C. § 1746:
2. I am a Lead Associate in the intellectual Property practice at Calderwood & Harkness LLP, located at 1201 Market Street, Suite 2500, Wilmington, Delaware 19801. Calderwood & Harkness LLP is counsel of record for Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant") in the above-captioned action. I have been actively involved in the representation of Solstice in this matter since the Complaint was filed and have participated in all substantive aspects of the case, including discovery, claim construction proceedings, and expert retention and coordination.
3. I am a member in good standing of the bar of the State of New York and was admitted pro hac vice in this action by Order of this Court dated June 20, 2024, permitting my appearance on behalf of Defendant Solstice Biomedical, Inc.
4. I make this Declaration in support of Defendant Solstice Biomedical, Inc.'s Motion for Summary Judgment of Non-Infringement as to the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) with respect to U.S. Patent No. 9,814,237 ("the '237 Patent") and U.S. Patent No. 10,271,884 ("the '884 Patent").
5. I have personal knowledge of the facts stated herein, or they are based on my review of business records and litigation files maintained by Calderwood & Harkness LLP in the ordinary course of this litigation, identified internally as C&H Matter Number 10294.0017. I have supervised or directly participated in the collection, review, and production of documents, the preparation of claim charts, the coordination of expert discovery, and the review of deposition transcripts relevant to the matters addressed in this Declaration.
6. I am competent to testify to these matters if called upon to do so.
II. BACKGROUND OF THE ACTION
7. On May 9, 2024, Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") filed its Complaint in this Court, alleging that Solstice Biomedical, Inc.'s PrecisionEdge™ line of laparoscopic trocar assemblies infringes three utility patents owned by Apex. The Complaint asserts claims for patent infringement under 35 U.S.C. § 271 and seeks injunctive relief, compensatory damages, enhanced damages for alleged willful infringement, and attorneys' fees.
8. The three patents asserted by Apex in this action (collectively, the "Asserted Patents") are as follows:
(a) U.S. Patent No. 9,814,237 ("the '237 Patent"), titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," which was issued by the United States Patent and Trademark Office on November 14, 2017, and has an expiration date of June 22, 2035;
(b) U.S. Patent No. 10,271,884 ("the '884 Patent"), titled "Retractable Blade Deployment Mechanism for Trocar Systems," which was issued by the United States Patent and Trademark Office on April 30, 2019, and has an expiration date of September 15, 2036; and
(c) U.S. Patent No. 10,932,105 ("the '105 Patent"), titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," which was issued by the United States Patent and Trademark Office on March 2, 2021, and has an expiration date of January 10, 2038.
9. Dr. Raymond Szabo, Vice President of Engineering at Apex, is the named inventor on all three of the Asserted Patents. Each of the Asserted Patents has been assigned to Apex Surgical Innovations, Inc., and Apex has represented in its Complaint and subsequent filings that it holds all right, title, and interest in the Asserted Patents, including the right to sue for infringement.
10. The present Motion for Summary Judgment pertains solely to the PrecisionEdge™ PE-5000 Series, which is Solstice's 5 mm trocar assembly product line. As set forth in Apex's Complaint and its subsequent infringement contentions, Apex has accused the PE-5000 Series of infringing the following claims of the following patents:
(a) Claims 1, 3, 7, and 12 of the '237 Patent; and
(b) Claims 1, 2, 5, 9, and 14 of the '884 Patent.
11. Apex's infringement allegations in this action extend to additional PrecisionEdge™ products beyond the PE-5000 Series, including the PE-12000 Series (12 mm trocar assembly) and the PE-15000 Series (15 mm trocar assembly), as well as allegations of infringement of the '105 Patent. The present motion does not address those additional products or the '105 Patent. Solstice reserves all rights with respect to those products and that patent, including the right to seek summary judgment at a later date.
12. On June 14, 2024, Solstice filed its Answer, Affirmative Defenses, and Counterclaims, denying all allegations of infringement and asserting, among other defenses, non-infringement of the Asserted Patents, invalidity of the Asserted Patents under 35 U.S.C. §§ 102, 103, and 112, and inequitable conduct during prosecution of the Asserted Patents before the United States Patent and Trademark Office.
III. PROCEDURAL HISTORY RELEVANT TO THIS MOTION
13. The Court held an Initial Scheduling Conference on July 2, 2024, at which the parties and the Court discussed the scope and timeline of discovery and other pretrial matters. Thereafter, the Court entered a Scheduling Order establishing deadlines for fact discovery, claim construction proceedings, expert discovery, and dispositive motions.
14. Fact discovery was conducted over the period from July 2024 through January 2025. During this time, the parties exchanged extensive document productions, served written discovery, and conducted depositions of fact witnesses.
15. On September 30, 2024, Solstice produced 48,217 documents in this litigation, bearing Bates numbers SBD-000001 through SBD-048217. This production included, among other materials, technical specifications, engineering drawings, manufacturing records, quality assurance documentation, marketing materials, sales data, and internal communications relating to the design, development, and commercialization of the PrecisionEdge™ product line, including the PE-5000 Series at issue in this motion.
16. On October 7, 2024, Apex produced 31,450 documents in this litigation, bearing Bates numbers APEX-000001 through APEX-031450. Apex's production included, among other materials, the patent prosecution files for the Asserted Patents, internal engineering and design documents, communications relating to the development and commercialization of Apex's own trocar products, prior art references, and documents reflecting Apex's knowledge and understanding of the scope of the Asserted Patents' claims.
17. On October 22, 2024, the parties exchanged their Proposed Claim Constructions and Identification of Extrinsic Evidence pursuant to the Court's Scheduling Order and Local Patent Rule 4.2. The parties identified a total of nine disputed claim terms across the three Asserted Patents. The parties were unable to resolve any of these disputes through the meet-and-confer process required under the Local Patent Rules.
18. On November 4, 2024, the parties filed their Joint Claim Construction Brief pursuant to Local Patent Rule 4.3, setting forth each party's proposed construction for each of the nine disputed terms, supported by intrinsic and extrinsic evidence. Solstice's proposed constructions were supported by, among other things, the claim language, the specifications of the Asserted Patents, the prosecution histories, and the declaration testimony of Dr. Miriam Ostrowski.
19. On November 18, 2024, the Court held a Claim Construction (Markman) Hearing before the Honorable Chief Judge Richard G. Andrews. Both parties presented oral argument on each of the nine disputed claim terms. The hearing lasted approximately four hours and included extensive discussion of the patent specifications, prosecution history, and the extrinsic evidence submitted by both parties.
20. On December 6, 2024, the Court issued its Claim Construction Order, construing all nine disputed claim terms. Of the nine terms construed, five terms were construed in a manner consistent with, or substantially similar to, Solstice's proposed constructions, and four terms were construed in a manner consistent with, or substantially similar to, Apex's proposed constructions. A true and correct copy of the Court's Claim Construction Order is attached hereto as Exhibit 1.
21. Expert discovery opened on January 13, 2025, pursuant to the Court's Scheduling Order. Solstice served the Expert Report of Dr. Miriam Ostrowski on January 27, 2025. Dr. Ostrowski's report addressed both invalidity of the Asserted Patents and, with respect to the PE-5000 Series specifically, the non-infringement of the '237 and '884 Patents under the Court's claim constructions.
22. On February 10, 2025, Apex served the Infringement Expert Report of Dr. Calvin Ng, which set forth Apex's infringement theories as to all accused PrecisionEdge™ products, including the PE-5000 Series, with respect to each of the Asserted Patents.
23. On March 3, 2025, the parties exchanged Rebuttal Expert Reports. Solstice served the Rebuttal Expert Report of Dr. Miriam Ostrowski, which responded to Dr. Ng's infringement opinions as they pertained to the PE-5000 Series and identified errors, unsupported assumptions, and inconsistencies in Dr. Ng's analysis.
IV. THE COURT'S CLAIM CONSTRUCTION ORDER AND ITS RELEVANCE TO THE PE-5000 SERIES
24. I have reviewed the Court's Claim Construction Order dated December 6, 2024, in its entirety. A true and correct copy is attached hereto as Exhibit 1.
25. The Claim Construction Order construed the term "locking seal assembly" as used in Claims 1, 3, 7, and 12 of the '237 Patent, and the term "retractable blade deployment mechanism" as used in Claims 1, 2, 5, 9, and 14 of the '884 Patent, among other terms. The Court's constructions of these two terms are of central importance to Solstice's non-infringement argument with respect to the PE-5000 Series.
26. With respect to the term "locking seal assembly," the Court adopted a construction requiring that the seal assembly include "a mechanical interlock that affirmatively engages and secures the seal in a closed position through positive locking engagement between complementary structural features of the seal housing and the seal element." See Claim Construction Order (Ex. 1) at 12-15. The Court rejected Apex's broader proposed construction that would have encompassed friction-fit or interference-fit seal arrangements. Id. at 14. The Court's construction is consistent with the construction proposed by Solstice and is favorable to Solstice's non-infringement position with respect to the PE-5000 Series, because, as set forth in the accompanying motion papers and the claim charts (Exhibit 7), the PE-5000 Series employs a compression-based elastomeric seal that does not incorporate a mechanical interlock with complementary structural features.
27. With respect to the term "retractable blade deployment mechanism," the Court adopted a construction requiring "a spring-loaded mechanism that deploys the trocar blade from a retracted position to an extended cutting position and automatically retracts the blade to the retracted position upon release of an operator-actuated trigger." See Claim Construction Order (Ex. 1) at 18-21. The Court expressly noted that the prosecution history of the '884 Patent demonstrated that the applicant distinguished the claimed invention over the prior art on the basis of the automatic retraction feature triggered by release of the operator-actuated trigger. Id. at 20. The Court's construction of this term is likewise favorable to Solstice's non-infringement position, because, as demonstrated in the claim charts (Exhibit 8) and the expert report of Dr. Ostrowski (Exhibit 9), the PE-5000 Series blade system utilizes a manually retractable blade that does not automatically retract upon release of a trigger mechanism.
V. AUTHENTICATION OF EXHIBITS
28. In connection with Defendant's Motion for Summary Judgment of Non-Infringement, I am authenticating the exhibits described below, each of which is attached to this Declaration. I have personally reviewed each of these exhibits and can attest to their accuracy and authenticity based on my involvement in this litigation and my review of the records maintained in connection with C&H Matter Number 10294.0017.
Exhibit 1: Claim Construction Order (December 6, 2024)
29. Attached hereto as Exhibit 1 is a true and correct copy of the Court's Claim Construction Order, Dkt. No. 78, entered December 6, 2024, by Chief Judge Richard G. Andrews, construing nine disputed claim terms of the '237 Patent, the '884 Patent, and the '105 Patent. I obtained this copy from the Court's CM/ECF electronic filing system, and it is identical to the Order as entered on the docket in this case.
Exhibit 2: U.S. Patent No. 9,814,237 ("the '237 Patent")
30. Attached hereto as Exhibit 2 is a true and correct copy of U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued by the United States Patent and Trademark Office on November 14, 2017. I obtained this copy from the United States Patent and Trademark Office's online database. The claims of this patent that are asserted against the PE-5000 Series and that are the subject of this motion are Claims 1, 3, 7, and 12.
Exhibit 3: U.S. Patent No. 10,271,884 ("the '884 Patent")
31. Attached hereto as Exhibit 3 is a true and correct copy of U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," issued by the United States Patent and Trademark Office on April 30, 2019. I obtained this copy from the United States Patent and Trademark Office's online database. The claims of this patent that are asserted against the PE-5000 Series and that are the subject of this motion are Claims 1, 2, 5, 9, and 14.
Exhibit 4: Relevant Excerpts from the Prosecution History of the '237 Patent
32. Attached hereto as Exhibit 4 are true and correct copies of excerpts from the prosecution history of U.S. Patent No. 9,814,237, including office actions issued by the United States Patent and Trademark Office, applicant responses submitted on behalf of Apex, and narrowing amendments made to the claims during prosecution. These prosecution history materials were obtained by Apex's patent prosecution counsel, Kendrick & Lau LLP (Dr. Jonathan Kendrick, Lead Partner, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004), and were produced by Apex during fact discovery in this litigation at Bates numbers APEX-004218 through APEX-004897.
33. As set forth more fully in Defendant's memorandum of law filed concurrently herewith, the prosecution history of the '237 Patent is relevant to the non-infringement analysis because it demonstrates that Apex's patent counsel made narrowing amendments and arguments during prosecution that distinguish the claimed "locking seal assembly" from seal arrangements that rely on friction fit, compression fit, or interference fit to maintain the seal in a closed position. These amendments and arguments give rise to prosecution history estoppel, which precludes Apex from asserting infringement under the doctrine of equivalents with respect to the seal mechanism employed in the PE-5000 Series.
Exhibit 5: Relevant Excerpts from the Prosecution History of the '884 Patent
34. Attached hereto as Exhibit 5 are true and correct copies of excerpts from the prosecution history of U.S. Patent No. 10,271,884, including office actions issued by the United States Patent and Trademark Office, applicant responses, and narrowing amendments made to the claims during prosecution. These prosecution history materials were likewise obtained from Apex's patent prosecution counsel at Kendrick & Lau LLP and were produced by Apex in discovery at Bates numbers APEX-006102 through APEX-006789.
35. The prosecution history of the '884 Patent is relevant to the non-infringement analysis because it demonstrates that Apex's patent counsel amended the claims during prosecution to add the automatic retraction limitation and argued to the patent examiner that the automatic retraction feature, triggered specifically by release of an operator-actuated trigger, distinguished the claimed invention over prior art trocar blade mechanisms. These narrowing amendments and arguments are relevant to both literal non-infringement and prosecution history estoppel.
Exhibit 6: PrecisionEdge™ PE-5000 Series Product Specifications and Technical Drawings
36. Attached hereto as Exhibit 6 are true and correct copies of the product specifications and technical drawings for the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), which were produced by Solstice during fact discovery in this litigation at Bates numbers SBD-012445 through SBD-012738. These documents were produced from the files of Solstice's Engineering Department and its Regulatory Affairs Department and are maintained by Solstice in the ordinary course of its business as part of its product design and regulatory compliance documentation.
37. The documents comprising Exhibit 6 describe in detail the design and operation of the PE-5000 Series, including its seal mechanism, blade deployment system, cannula housing, obturator assembly, and overall trocar assembly configuration. These specifications and drawings form the technical basis for the non-infringement claim charts attached as Exhibits 7 and 8 and were relied upon by Dr. Ostrowski in forming her expert opinions.
Exhibit 7: Claim Charts Comparing PE-5000 Series to Asserted Claims of the '237 Patent
38. Attached hereto as Exhibit 7 is a true and correct copy of Solstice's Non-Infringement Claim Chart for U.S. Patent No. 9,814,237, which maps Claims 1, 3, 7, and 12 of the '237 Patent against the design and operation of the PrecisionEdge™ PE-5000 Series and identifies, on an element-by-element basis, the claim limitations that are not met by the PE-5000 Series under the Court's claim constructions as set forth in the Claim Construction Order of December 6, 2024 (Exhibit 1).
39. This claim chart was prepared by Calderwood & Harkness LLP. A preliminary version of the claim chart was originally prepared on July 20, 2024, based on Solstice's pre-litigation analysis and the parties' competing proposed claim constructions. The claim chart was subsequently updated following the Court's issuance of the Claim Construction Order on December 6, 2024, to reflect the Court's adopted constructions of all disputed terms. The version attached as Exhibit 7 is the updated version, which accurately reflects the current non-infringement analysis under the controlling claim constructions.
Exhibit 8: Claim Charts Comparing PE-5000 Series to Asserted Claims of the '884 Patent
40. Attached hereto as Exhibit 8 is a true and correct copy of Solstice's Non-Infringement Claim Chart for U.S. Patent No. 10,271,884, which maps Claims 1, 2, 5, 9, and 14 of the '884 Patent against the design and operation of the PrecisionEdge™ PE-5000 Series and identifies the claim limitations that are not met by the PE-5000 under the Court's claim constructions.
41. This claim chart was similarly prepared by Calderwood & Harkness LLP. A preliminary version was originally prepared on July 22, 2024, and the claim chart was updated following the Court's Claim Construction Order of December 6, 2024. The version attached as Exhibit 8 reflects the updated non-infringement analysis under the Court's adopted constructions.
Exhibit 9: Relevant Excerpts from the Expert Report of Dr. Miriam Ostrowski
42. Attached hereto as Exhibit 9 are true and correct copies of excerpts from the Expert Report of Dr. Miriam Ostrowski, Ph.D., the Brinkley Distinguished Professor of Biomedical Engineering at Halford University, Philadelphia, Pennsylvania. Dr. Ostrowski's Expert Report was served on January 27, 2025, on behalf of Defendant Solstice Biomedical, Inc.
43. Dr. Ostrowski was retained by Solstice on August 20, 2024, to provide expert opinions on claim construction, invalidity, and non-infringement of the Asserted Patents. Dr. Ostrowski holds a Ph.D. in Biomedical Engineering from the Massachusetts Institute of Technology and has over twenty-five years of experience in the design and development of minimally invasive surgical instruments, including laparoscopic trocar systems. Her qualifications are set forth in detail in her curriculum vitae, which is appended to her full Expert Report.
44. The excerpts attached as Exhibit 9 address Dr. Ostrowski's expert opinions on why the PE-5000 Series does not satisfy the "locking seal assembly" limitation of the '237 Patent and does not satisfy the "retractable blade deployment mechanism" limitation of the '884 Patent, under the claim constructions adopted by the Court in its December 6, 2024 Order. Dr. Ostrowski's opinions in this regard are based on her independent review and analysis of the PE-5000 Series product specifications and technical drawings (Exhibit 6), the patent claims, specifications, and prosecution histories (Exhibits 2 through 5), the Court's Claim Construction Order (Exhibit 1), and her expertise in the relevant field.
Exhibit 10: Relevant Excerpts from the Expert Report of Dr. Calvin Ng (Apex's Expert)
45. Attached hereto as Exhibit 10 are true and correct copies of excerpts from the Infringement Expert Report of Dr. Calvin Ng, Ph.D., Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware. Dr. Ng's Expert Report was served on February 10, 2025, on behalf of Plaintiff Apex Surgical Innovations, Inc.
46. The excerpts attached as Exhibit 10 include those portions of Dr. Ng's report that specifically address the PE-5000 Series and set forth Apex's infringement contentions with respect to the '237 Patent and the '884 Patent as applied to the PE-5000 Series. I have reviewed these excerpts in detail. Notably, Dr. Ng's report contains several concessions and admissions that are relevant to Solstice's non-infringement position. Specifically, Dr. Ng concedes at paragraph 147 of his report that the PE-5000 Series seal mechanism "does not employ a traditional mechanical interlock" but instead relies on what Dr. Ng characterizes as a "functional equivalent" of a locking seal assembly. Dr. Ng further acknowledges at paragraphs 203-205 of his report that the PE-5000 Series blade retraction is "manually initiated by the operator" rather than being automatically triggered by release of an actuating mechanism, but contends that this distinction is immaterial under the doctrine of equivalents. These concessions are directly relevant to the motion and are addressed in the accompanying memorandum of law.
Exhibit 11: Relevant Excerpts from the Rebuttal Expert Report of Dr. Miriam Ostrowski
47. Attached hereto as Exhibit 11 are true and correct copies of excerpts from the Rebuttal Expert Report of Dr. Miriam Ostrowski, served on March 3, 2025, on behalf of Defendant Solstice Biomedical, Inc. The excerpts attached as Exhibit 11 contain Dr. Ostrowski's responses to Dr. Ng's infringement opinions as they pertain to the PE-5000 Series, including Dr. Ostrowski's analysis of why Dr. Ng's doctrine-of-equivalents theory fails both as a factual matter and because it is barred by prosecution history estoppel.
Exhibit 12: Relevant Excerpts from Apex's Document Production
48. Attached hereto as Exhibit 12 are true and correct copies of documents from Apex's production in this litigation, bearing Bates numbers within the range APEX-000001 through APEX-031450, that are relevant to the non-infringement of the PE-5000 Series. These documents include internal Apex engineering communications, memoranda, and design review notes regarding the scope and intended operation of the claimed "locking seal assembly" and "retractable blade deployment mechanism" as those features were conceived, designed, and disclosed in the patent applications that matured into the '237 and '884 Patents.
49. The documents comprising Exhibit 12 are relevant because they reflect Apex's own contemporaneous understanding of the scope and meaning of the key claim terms at issue in this motion, and they are consistent with the narrower claim constructions adopted by the Court. Among other things, these documents include email communications between Dr. Raymond Szabo and members of Apex's engineering team in which the "locking seal assembly" is described as requiring a "positive mechanical interlock" and the "retractable blade deployment mechanism" is described as featuring "automatic spring-driven retraction upon trigger release." These internal descriptions are consistent with the Court's claim constructions and inconsistent with Apex's broader litigation positions.
Exhibit 13: Relevant Deposition Testimony
50. Attached hereto as Exhibit 13 are true and correct copies of excerpts from depositions taken in this case that are relevant to the non-infringement of the PE-5000 Series. The deposition excerpts include testimony from the following witnesses:
(a) Apex's Rule 30(b)(6) corporate designee, Ms. Karen Holt, Director of Product Development at Apex, whose deposition was taken on December 12, 2024, pursuant to a deposition notice served on November 1, 2024. Ms. Holt testified, among other things, regarding Apex's understanding of the scope of the Asserted Patents' claims, the design and operation of Apex's own trocar products embodying the patented technology, and the distinctions between Apex's patented seal and blade mechanisms and alternative seal and blade designs known in the industry; and
(b) Dr. Raymond Szabo, Vice President of Engineering at Apex and named inventor on the Asserted Patents, whose deposition was taken on December 19, 2024. Dr. Szabo testified regarding the conception and development of the inventions claimed in the '237 and '884 Patents, the prosecution of those patents before the USPTO, and his understanding of the specific claim limitations at issue, including the "locking seal assembly" and the "retractable blade deployment mechanism."
51. The deposition excerpts attached as Exhibit 13 include testimony that is consistent with the Court's claim constructions and that further supports Solstice's non-infringement position with respect to the PE-5000 Series.
VI. STATEMENT REGARDING THE ACCUSED PE-5000 SERIES PRODUCTS
52. The PrecisionEdge™ PE-5000 Series is Solstice Biomedical, Inc.'s 5 mm trocar assembly product line, designed and marketed for use in minimally invasive laparoscopic surgery. The PE-5000 Series was first commercially introduced in the United States in February 2021 and has been continuously sold and distributed throughout the United States since that date. The PE-5000 Series is manufactured at Solstice's facility in West Chester, Pennsylvania, and is cleared for marketing by the U.S. Food and Drug Administration under 510(k) clearance.
53. Based on my review of the technical specifications and engineering drawings for the PE-5000 Series (Exhibit 6), the Court's Claim Construction Order (Exhibit 1), and the non-infringement claim charts prepared by Calderwood & Harkness LLP (Exhibits 7 and 8), as well as my review of the expert reports of Dr. Ostrowski (Exhibits 9 and 11), the PE-5000 Series does not practice every element of the asserted claims of the '237 Patent or the '884 Patent.
54. Specifically, with respect to the '237 Patent, the PE-5000 Series seal mechanism operates differently from the "locking seal assembly" as that term was construed by the Court in the Claim Construction Order. As detailed in the claim charts (Exhibit 7) and Dr. Ostrowski's expert report (Exhibit 9), the PE-5000 Series employs a compression-based elastomeric seal that maintains instrument sealing through radial compression forces generated by the elastomeric material rather than through a mechanical interlock between complementary structural features. The PE-5000 Series seal does not incorporate the positive locking engagement between complementary structural features of a seal housing and a seal element that the Court's construction requires.
55. With respect to the '884 Patent, the PE-5000 Series blade system does not employ a "retractable blade deployment mechanism" as that term was construed in the Court's December 6, 2024 Order. As detailed in the claim charts (Exhibit 8) and Dr. Ostrowski's expert report (Exhibit 9), the PE-5000 Series utilizes a blade deployment system in which the blade is manually extended by the operator through forward sliding motion of an actuator and is manually retracted by the operator through rearward sliding motion of the same actuator. The PE-5000 Series blade does not automatically retract to the retracted position upon release of an operator-actuated trigger, as the Court's construction requires. Rather, the blade remains in whatever position the operator has placed it until the operator affirmatively moves the actuator in the opposite direction.
56. Based on the foregoing, the PE-5000 Series lacks at least two independent limitations of the asserted claims: the "locking seal assembly" limitation of the '237 Patent and the "retractable blade deployment mechanism" limitation of the '884 Patent. Failure to satisfy even a single claim limitation is sufficient to establish non-infringement.
57. For informational context, I note that the combined U.S. sales of all accused PrecisionEdge™ products — including the PE-5000 Series, the PE-12000 Series, and the PE-15000 Series — from the initial commercial launch in 2021 through the third quarter of 2024 totaled approximately $74.6 million. These sales break down by fiscal year as follows: FY 2021 sales of approximately $12.1 million; FY 2022 sales of approximately $17.8 million; FY 2023 sales of approximately $22.4 million; and FY 2024 sales through September 30, 2024, of approximately $22.3 million. The PE-5000 Series represents a subset of these figures. The foregoing sales data is based on business records produced by Solstice during fact discovery and is provided solely for context regarding the scope of this litigation.
VII. NO GENUINE DISPUTE OF MATERIAL FACT
58. Based on my review of the complete record in this case — including Apex's own document production (Exhibit 12), the deposition testimony of Apex's witnesses (Exhibit 13), the expert reports of both Dr. Ostrowski (Exhibits 9 and 11) and Dr. Ng (Exhibit 10), the Asserted Patents and their prosecution histories (Exhibits 2 through 5), the technical specifications and drawings for the PE-5000 Series (Exhibit 6), the non-infringement claim charts (Exhibits 7 and 8), and the Court's Claim Construction Order (Exhibit 1) — there is no genuine dispute of material fact regarding the non-infringement of the PE-5000 Series with respect to the '237 Patent (Claims 1, 3, 7, and 12) and the '884 Patent (Claims 1, 2, 5, 9, and 14).
59. The undisputed facts, viewed in their totality and in the light most favorable to the non-moving party, establish that the PrecisionEdge™ PE-5000 Series does not meet the "locking seal assembly" limitation of the asserted claims of the '237 Patent and does not meet the "retractable blade deployment mechanism" limitation of the asserted claims of the '884 Patent, as those terms have been construed by this Court. Apex's own expert, Dr. Ng, has conceded that the PE-5000 Series does not literally practice these limitations but relies instead on a doctrine-of-equivalents theory that is foreclosed by prosecution history estoppel, as detailed in the accompanying memorandum of law. The record thus establishes that Defendant Solstice Biomedical, Inc. is entitled to summary judgment of non-infringement as to the PE-5000 Series.
VIII. CONCLUSION AND SIGNATURE
I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct.
Executed on April 1, 2025, at Wilmington, Delaware.
________________________________________
Christy Bauer
Christy Bauer, Lead Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201
Email: cbauer@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
EXHIBIT LIST
CERTIFICATE OF SERVICE
I hereby certify that on April 1, 2025, a true and correct copy of the foregoing Declaration of Christy Bauer in Support of Defendant Solstice Biomedical, Inc.'s Motion for Summary Judgment of Non-Infringement (PrecisionEdge™ PE-5000 Series), together with all exhibits attached thereto, was served upon counsel for Plaintiff via the Court's CM/ECF electronic filing system, which will send notification of such filing to all counsel of record, including:
Victoria Stanton, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, DE 19801 vstanton@htblaw.com
Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, DE 19801 dloomis@htblaw.com
________________________________________
Christy Bauer
Christy Bauer, Lead Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201
Email: cbauer@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
APEX SURGICAL INNOVATIONS, INC.,
Plaintiff, | Civil Action No. 1:24-cv-00587-RGA
v.
SOLSTICE BIOMEDICAL, INC.,
Defendant.
Exhibit No. | Description
1 | Claim Construction Order, dated December 6, 2024 (Dkt. No. 78)
2 | U.S. Patent No. 9,814,237, "Locking Seal Assembly for Minimally Invasive Surgical Access Device"
3 | U.S. Patent No. 10,271,884, "Retractable Blade Deployment Mechanism for Trocar Systems"
4 | Prosecution History Excerpts — U.S. Patent No. 9,814,237 (APEX-004218 through APEX-004897)
5 | Prosecution History Excerpts — U.S. Patent No. 10,271,884 (APEX-006102 through APEX-006789)
6 | PrecisionEdge™ PE-5000 Series Product Specifications and Technical Drawings (SBD-012445 through SBD-012738)
7 | Non-Infringement Claim Chart — U.S. Patent No. 9,814,237, Claims 1, 3, 7, and 12 vs. PE-5000 Series
8 | Non-Infringement Claim Chart — U.S. Patent No. 10,271,884, Claims 1, 2, 5, 9, and 14 vs. PE-5000 Series
9 | Excerpts from Expert Report of Dr. Miriam Ostrowski (January 27, 2025)
10 | Excerpts from Infringement Expert Report of Dr. Calvin Ng (February 10, 2025)
11 | Excerpts from Rebuttal Expert Report of Dr. Miriam Ostrowski (March 3, 2025)
12 | Excerpts from Apex Document Production (selected documents within APEX-000001 through APEX-031450)
13 | Excerpts from Deposition Testimony (Karen Holt, Dec. 12, 2024; Dr. Raymond Szabo, Dec. 19, 2024)