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  • PTAB · Aug 3, 2026 · IPR2025-00283 · APJ Lilan Ren · IPR · Final written decision

    The Board cancelled claim 11 and granted substitute claims 14–16, finding Petitioner had not shown those claims unpatentable on any asserted ground.

    RulingsFinal written decision
    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted

      “must determine whether the motion to amend meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. Lectrosonics, Paper 15 at 4. In that regard, Patent Owner bears the burden of persuasion to show that: (1) the amendment proposes a reasonable number of substitute claims; (2) the amendment responds to a ground of unpatentability involved in the trial; (3) the amendment does not seek to enlarge the scope of the claims of the patent or introduce new subject matter;” slip op. at 9

    • ExcludeMotion to exclude, deniedDenied

      “In this case, Patent Owner’s expert “Dr. Zhou signed the second declaration, stood behind its contents, and was available for cross-examination.” Paper 35, 4. Petitioner does not dispute this statement. Paper 39, 1. Petitioner does not identify any specific undue prejudice caused by Exhibit 2008. For example, Petitioner argues that “the failure to impress upon a witness that a statement is under oath goes to the heart of its reliability as evidence” and that “as the Board has recognized, hearsay is inherently unreliable” without specifying what statement in Exhibit 2008 lacks reliability. Paper 39, 4. Because Petitioner does not provide specific evidence of undue prejudice, we find Petitioner has suffered no such undue prejudice in this case. See Liquidia, 2021 WL 4860773 at *25. We therefore deny Petitioner’s Motion to Exclude on the basis of lack of authenticity. With regard to the assertion that Exhibit 2008 is hearsay, Petitioner objects to the exhibit because the testimony is based “on other informal and unpublished documents that are hearsay under FRE 802.” Paper 29, 1. Petitioner does not specify what such “informal and unpublished documents” are. See id. Federal Rule of Evidence 703 expressly states, “[a]n expert may base an opinion on fact or data in the case that the expert has been made aware of or personally observed.” The facts or data “need not be deny Petitioner’s Motion to Exclude on the basis of hearsay.” slip op. at 50

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

      “Petitioner’s argument is unpersuasive. Paragraph 59 of the ’503 application describes formula 8-1 but does not support Petitioner’s argument that other unknown formulas may be included in the recited modified heavy chains. Ex. 2003 ¶ 59. Petitioner’s hypothesis that the recited heavy chains may (or may not) encompass unknown formulas is also inapposite to the written description inquiry before us — that is, whether the inventor was in possession of the subject matter recited in claims 14–16 based on the disclosure including formulas 8-1, 8-2, and 8-3. See PowerOasis, 522 F.3d at 1306.” slip op. at 14

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable

      “These arguments in the Sur-Reply are unpersuasive to show a lack of enablement first and foremost because the arguments do not specifically provide evidence showing that any purported experimentation is undue. See Sur-Reply 2–8 (asserting, but without providing evidence under any specific Wands factors, that the examples and guidance in the specification do not extend to the broad scope of all antibodies); see Wands, 858 F.2d at 737. We again emphasize that the analysis of undue experimentation does not necessarily require every Wands factor to be explicitly addressed but the analysis must be based on “weighing many factual considerations” depending on the nature of the invention and underlying art. Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013). The assertion that the claim scope is broad alone does not suffice to show a lack of enablement based on the record before us. Moreover, as we note supra, Petitioner’s claim scope argument is based on the false premise that the scope of claims 14–16 is as broad as the claim term “antibody” without taking into account all other claim elements. For example, Petitioner does not disagree with Patent Owner’s statement that “[t]he ’675 Patent’s specification discloses the structural modification site, the chemistry used to modify that residue, and working examples demonstrating the modification” (Reply 2), but asserts only that “[t]he disclosure of SSFI that only binds to IgG1 Fc domains (SEQ ID NO:1) is . . . . inconsistent with the expansive scope of the claims.” Sur-Reply 5. Petitioner’s argument that the claims encompass proteins that lack a lysine reside at a 248 position improperly excludes from the claim language the “lysine residue at 248 position . . . [as] determined by the EU numbering system” that claims 14–16 require. As Dr. Zhou testifies, “each proposed lysine residue at position 248 (EU numbering) is covalently modified with a specific attachment with a terminal bio-orthogonal click-chemistry functional group. The specification describes targeted transfer of a chemical functional group to lysine 248” and when claims 14–16 are considered in their entirety, which includes all claim elements, “[a] POSA would understand the claim itself to limit the modified antibodies to those with lysine at position 248.” Ex. 2004 ¶ 48; Ex. 2008 ¶ 47. We also note that Patent Owner states “a POSA would understand that the phrase ‘one or more modified heavy chain’ encompasses antibodies within typical DAR distributions (i.e., fractional numbers) rather than requiring a distinct process for producing antibodies bearing modified heavy chains in exact integers.” Reply 2–3. Moreover, Patent Owner states that PepTalk Presentation demonstrates that “a POSA would understand antibody conjugation products to exist as mixtures rather than discrete whole number species” because PepTalk Presentation “presents DAR values as non-integer measurements, i.e. DARs of 1.8 and 1.9 reflecting such distributions.” Id. at 3 (citing Ex. 1007, 28). According to Patent Owner, “preparations having an average DAR of approximately 1.8 (commonly referred to in practice as ‘DAR2’) may reflect typical reaction distributions in which some antibodies contain two modified heavy chains while others contain fewer.” Id. at 3 (citing Ex. 2008 ¶ 46). Petitioner does not rebut these statements. See Sur-Reply 2–8. Based on the foregoing, the evidence before us does not show any” slip op. at 27

    Patent outcomesUS 11,896,675 not shown unpatentable
    § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,896,675
  • PTAB · May 11, 2026 · PGR2025-00013 · APJ Alyssa A Finamore · PGR · Final written decision

    Claims 1–16 and 18 were not shown unpatentable because the asserted prior art did not establish the claimed quick-connect system during reciprocation, and Clark was not analogous art.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A. Level of Ordinary Skill in the Art The level of ordinary skill in the art is “a prism or lens” through which we view the prior art and the claimed invention. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art may reflect the level of ordinary skill in the art. Id.” slip op. at 8

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “During oral argument, Petitioner confirmed it would not object to the Board adopting the construction that Petitioner proposes in the district court litigation. JUDGE MARSCHALL: I think the Petitioner wouldn’t object if we adopted the construction that Petitioner proposed in the district court, especially the “designed to” construction, correct? MR. BERG: No. We wouldn’t object to that. And we think that our Petition is on all fours with that construction. Tr. 81:12–16. As Petitioner does not object to adopting its construction from the district court litigation, we construe claim element 1[e] in accordance with Petitioner’s construction from the district court litigation.” slip op. at 11

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

      “The invention, a reciprocating massage device, is in a predictable field, namely the electro-mechanical arts. Also, there is no evidence that the recited quick-connect system is complex, even considering Patent Owner’s alleged understanding of it. Rather, Dr. Pratt testifies that many different types of connectors, whether they require alignment or not, were known. Ex. 1002 ¶¶ 54–58. Given the predictability of the electro-mechanical arts and lack of complexity of the recited quick-connect system, a low level of detail is required to satisfy the written description requirement. See RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., 92 F.4th 1085, 1090 (Fed. Cir. 2024) (“Given the predictability of electro-mechanical inventions such as the one at issue here, and the lack of complexity of the particular claim limitation at issue—i.e., reciting the length of a heating member—‘a lower level of detail is required to satisfy the written description requirement than for unpredictable arts.’” (quoting Hologic, Inc. v. Smith & Nephew, Inc., 884 F.3d 1357, 1361 (Fed. Cir. 2018)). In view of the low level of detail required to satisfy the written description requirement, Petitioner has not persuaded us that the Specification’s example of a quick-connect system configured to secure the massaging head as the piston reciprocates fails to provide sufficient written description support for the “quick-connect system” recited in independent claims 1 and 18.” slip op. at 14

    • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteNot shown unpatentable

      “Contrary to Petitioner’s assertion, the Specification provides guidance as to what amount of deviation from a perfect cylinder is still “substantially cylindrical.” The Specification describes: Quick-connect system 600 includes a piston 602 that has a hollow-end bore 608 for receiving the shaft 621 of a massaging head 620. Located within the bore 608 of piston 602 is a cylindrical seat 604. Cylindrical seat 604 retains a magnet 606. Magnet 606 is illustrated with its north pole located flush with the seat and facing toward the opening in bore 608. Massaging head 620 includes a shaft 621 having a cylindrical pocket 622 at the distal end. Located within the cylindrical pocket 622 is a magnet 624. Magnet 624 is positioned so that its south pole is located at the distal end of shaft 621. Accordingly, when the shaft 621 of massaging head 620 is slid into opening in bore 608, the magnets 606 and 624 are attracted to one another and magnetically hold massaging head 620 firmly in place. Ex. 1001, 6:57–7:3. In view of the description of quick-connect system 600, the Specification sets forth a standard for ascertaining whether the bore and the seat located within the bore are “substantially cylindrical.” To wit, the bore and the seat within the bore are “substantially cylindrical” when the massaging head and magnet are respectively received therein so that the magnet in the seat and the magnet in the pocket of the massaging head can magnetically hold the massaging head firmly in place. Furthermore, Dr. Pratt testifies that “[m]agnetic connectors comprise a magnet on at least one of the two objects to be joined. These types of connectors are ubiquitous even today for driving threaded fasteners.” Ex. 1002 ¶ 56. Dr. Pratt also testifies that a POSITA would understand how to take into account certain variances, like runout. Ex. 2033, 25:3–17. Dr. Pratt’s testimony shows that magnetic connectors are well known and that a POSITA would be able to determine whether the bore and the seat within the bore were “substantially cylindrical” for a secure connection of the massaging head. In view of the foregoing, Petitioner has not persuaded us that the claim term “substantially cylindrical” recited in claims 13–16 fails to inform, with reasonable certainty, the shapes of the bore and the structure within the bore. Petitioner has not proven, by a preponderance of the evidence, that any of claims 13–16 are unpatentable under 35 U.S.C. § 112(b) as indefinite.” slip op. at 19

    Patent outcomesUS 11,938,082 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · Nautilus
    Patents in suitUS 11,938,082
  • PTAB · Oct 31, 2025 · IPR2024-00777 · APJ Jameson Lee · IPR · Final written decision

    Claims 16–27 were not shown unpatentable because Petitioner failed to account for limitations 16[b] and 16[i] and their counterparts across the asserted obviousness grounds.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner proposes that a person of ordinary skill in the art “would have a Bachelor of Science degree in Electrical Engineering, Computer Engineering, Computer Science, Human Computer Interaction, or a related technical field, with at least one year of experience working in the field of user interfaces and/or content management.” PO Resp. 11 (citing Ex. 2040 ¶ 53). The Decision on Institution adopted Petitioner’s proposed level of ordinary skill in the art. Inst. Dec. 10. We find Patent Owner’s stated level to be less precise than that proposed by Petitioner in that the modifier “at least” used by Patent owner imposes no upper bound on the amount of experience possessed by one of ordinary skill in the art. Also, Patent Owner states: “The difference between the Board’s definition and Patent Owner’s (EX2040. ¶53) does not change the arguments set forth herein.” PO Resp. 11. Thus, we continue to adopt Petitioner’s stated level of ordinary skill in the art.4 4 All of our findings and conclusions would still be the same, however, had we applied Patent Owner’s articulation of the level of ordinary skill in the art.” slip op. at 8

    • Prior constructionPrior construction adoptedDecided for patent owner

      “In its Reply, Petitioner does not assert that the district court’s construction is incorrect. We agree with Patent Owner that the district court’s construction is better than Petitioner’s proposed construction, because for reasons indicated by Patent Owner, which are not disputed by Petitioner, settings in the computer, e.g., dedicated folders for each user are the user profiles, rather than simply data alone of any kind. Further, when asked about the appropriateness of the district court’s construction, counsel for Petitioner expressed that Petitioner has no objection to the Board’s adopting the district court’s construction for “user profile”: JUDGE LEE: So, you’d be fine with just going with the District Court’s construction? MR. HEINTZ: Yes, Your Honor. Tr. 15:22–24. For the foregoing reasons, we adopt the district court’s construction for “user profile,” i.e., “a collection of settings and information associated with a user.”” slip op. at 13

    • BurdenNot shown unpatentable

      “PO Resp. 30–31 (Figure 26 omitted). In its Reply, Petitioner still does not provide an articulated reason for placing user profile selection buttons, labeled with user names, within Horn’s panes 2601 or 2602. Reply 12–14. Although Horn does describe personalized profile, Petitioner points to no disclosure of Horn as to how a user would have selected his or her own profile from among a plurality of user profiles. Petitioner presents no reason for placing these user profile selection buttons, labeled with user names, gleaned from or suggested by Baumgartner, within either pane 2601 or pane 2602 in Horn’s workspace view. Further, pane 2602 contains “a list of all collections defined by MFS and the user,” and pane 2601 lists the source examined by the user to create his or her collections. Ex. 1005, 19:41–46. That disclosure suggests the contents of panes 2601 and 2602 are tied to one particular user. No rational basis is articulated by Petitioner to place user profile selection buttons within these panes which appear to be in the profile space of one user. For the foregoing reasons, Petitioner has not adequately accounted for limitation 16[b].” slip op. at 22

    • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

      “The test for sufficiency of a written description under 35 U.S.C. § 112 is whether the earlier application’s disclosure “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The specification must “clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Id. The Court of Appeals for the Federal Circuit has explained: One shows that one is “in possession” of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious. Id. (“[T]he applicant must also convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.”) (emphasis in original). One does that by such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention. Although the exact terms need not be used in haec verba, see Eiselstein v. Frank, 52 F.3d 1035, 1038, 34 USPQ2d 1467, 1470 (Fed.Cir.1995) (“[T]he prior application need not describe the claimed subject matter in exactly the same terms as used in the claims. . . .”), the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient. Lockwood v. American Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997).” slip op. at 31

    Patent outcomesUS 11,017,815 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 11,017,815
  • PTAB · Jul 10, 2024 · IPR2023-00319 · APJ Brent M Dougal · IPR · Final written decision

    Claims 5, 15, and 25 were not shown unpatentable because Barsoum supports their priority date, and neither Barsoum nor ATSC327 qualifies as prior art.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner

      “Petitioner does not sufficiently explain why claim 5 requires this type of optimization, or why this would be required in order for Barsoum to provide written description support for the claim. Claim 5 does not expressly require optimization of phase considerations and Petitioner does not argue for a claim construction that would include such a requirement.” slip op. at 17

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “(3) Conclusion – Written Description In view of the above, we find that either disclosure in Barsoum identified by Patent Owner satisfies the written description requirement. 2. 35 U.S.C. § 103 As noted previously, Petitioner argues that dependent claims 5, 15, and 25 are obvious over the combination of Barsoum and ATSC327. Pet. 67–79. Having determined the Barsoum provides written description support for claims 5, 15, and 25, Barsoum cannot be prior art under 35 U.S.C. §102(a)(1) as asserted by Petitioner. Pet. 2; 35 U.S.C. § 102(a)(1) (requiring that “the claimed invention was patented . . . before the effective filing date of the claimed invention). Furthermore, having determined that the ’700 patent is entitled to an effective filing date of Barsoum ’777, which is June 5, 2008, the asserted March 2019 date of ATSC327 does not qualify it as prior art to the ’700 patent. Thus, the Petition does not establish by a preponderance of the evidence that claims 5, 15, and 25 are obvious over the combination of Barsoum and ATSC327.” slip op. at 22

    • Adverse judgmentAdverse judgmentOther

      “1 Claims 2, 3, 12, 13, 22, and 23, though challenged by Petitioner, were disclaimed by Patent Owner after trial was instituted. Ex. 2024. 2 The Petitioner Sur-reply was authorized in view of our authorization for Patent Owner to file declarant testimony with the Patent Owner Sur-reply.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We are persuaded that Petitioner’s proposal is consistent with the problems and solutions in the ’700 patent and prior art of record. We also find that Dr. Caire’s statement of a “Ph.D.,” “and possibly some years of work after Ph.D.” is consistent with Petitioner’s statement that the level of skill includes “[s]uperior education” to “compensate for a deficiency in work experience.” The complexity of the evidence of record emphasizes the importance of “at least two years of experience . . . including the use of constellations in transmitting signals between devices” or “[s]uperior education” in the same area. We adopt Petitioner’s definition of the level of skill as discussed above.” slip op. at 9

    Patent outcomesUS 10,693,700 not shown unpatentable
    § 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 10,693,700
  • PTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision

    The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner

      “d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32

    Patent outcomesUS 11,110,087 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,110,087
  • PTAB · Apr 11, 2024 · PGR2023-00003 · APJ William A Capp · PGR · Final written decision

    The Board held claims 1–5 not unpatentable; Petitioner failed to prove its asserted §101, §102, §103, and §112 grounds, including indefiniteness and written-description challenges.

    RulingsFinal written decision
    • BurdenNot shown unpatentable

      “prevail, Petitioner bears the burden to demonstrate that the challenged claims are unpatentable. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). This burden never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). The standard of proof is preponderance of the evidence. 35 U.S.C. § 326(e); 37 C.F.R. § 42.1(d). We have jurisdiction under 35 U.S.C. § 6.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A. Level of Ordinary Skill Petitioner’s expert, Mr. Serra testifies that he is familiar with the” slip op. at 45

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

      “process of claim 1. The first principal decision is the selection of a known liner design from a library that is made at the beginning of the design process. The second principal decision is made at the conclusion of the design process where a “final liner design” emerges after hole shapes produced by modified liners converge toward the desired hole shape. A person of ordinary skill in the art, having read claim 1 in context, would understand that the term “optimized” in the claim refers to the hole shape of the known liner design that is selected from among the known liner designs in the library during the selection step of the claim. A person of ordinary skill in the art would similarly understand that the design that is chosen in the initial selection process is “optimized” with respect to the population of known liner designs in the library as opposed to being “optimized” relative to liner designs produced during the later varying and modelling steps of the design process.” slip op. at 26

    • Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteNot shown unpatentable

      “Accordingly, Petitioner has not shown that claims 1–5 of the ’039” slip op. at 22

    Patent outcomesUS 11,215,039 not shown unpatentable
    Claim construction§ 101 eligibility§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Bilski · Phillips · Markman · Nautilus
    Patents in suitUS 11,215,039
  • PTAB · Feb 6, 2023 · PGR2021-00103 · APJ Patrick R Scanlon · PGR · Final written decision

    Claims 1–28 were not shown unpatentable on any asserted ground; the Board found the prior art failed to establish key limitations and rejected the enablement and indefiniteness challenges.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In reply, Petitioner argues that the ’764 patent’s control system is not complex as there are no detailed algorithms, logic, or software. Pet. Reply 4. Instead, the control system merely raises or lowers power of the pumps in accordance with the demand HHP of the job design. Id. (citing Ex. 1036, 97:15–98:18, 98:21–99:25, 100:1–101:25, 102:2–7, 115:4–9, 115:24–116:4, 116:17–22; Ex. 1001, 5:2–6, 6:36–7:7, 10:4–64). According to Petitioner, this “rudimentary control concept” does not necessitate the higher skill level proposed by Patent Owner. Id. Petitioner further notes that Dr. Adnan testifies that “a mechanical engineer who has worked in the industry developing programming and control systems could fall within this definition,” and the person of ordinary skill in the art “is ‘just a specifier.’” Id. (quoting Ex. 2003 ¶ 22; Ex. 1036, 161:21–164:18). Based on our review of the record before us, particularly the ’764 patent’s description and Dr. Adnan’s testimony, we agree with Petitioner that the ordinary level of skill in the art does not require the high level of specialized knowledge of control systems suggested by Patent Owner. Moreover, we find that Petitioner’s stated level of ordinary skill in the art is reasonable because it is consistent with the evidence of record, including the asserted prior art. Accordingly, for the purposes of this Decision, we apply Petitioner’s definition, although our conclusions with respect to obviousness would be the same if we were to apply Patent Owner’s definition.” slip op. at 9

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Based on the full record, we are not persuaded that Mr. Marscher is unqualified to serve as an expert in this proceeding. As noted above, a person of ordinary skill in the art is not required to have been a fracturing operator. Patent Owner’s proposed definition does not even require experience as a fracturing operator. See PO Resp. 20–21. Furthermore, Mr. Marscher testifies that he has extensive experience developing pumps for fracturing applications. Ex. 2027, 6:24–8:7. Mr. Marscher also testifies that he has experience with control systems relating to pumps and pumps units. Id. at 212:19–23. This testimony, as well as his declaration and curriculum vitae, show that Mr. Marscher has extensive education and experience in relevant fields. Ex. 1003 ¶¶ 8–17; Ex. 1004. Accordingly, we are not persuaded that Mr. Marscher’s qualifications or experience provide reason to discount the weight associated with Mr. Marscher’s testimony.” slip op. at 10

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “In its Reply, Petitioner argues that the maximum power output value is the pump unit’s highest HHP output and one of ordinary skill in the art would have understood this value is the pump unit’s output power in intermittent duty. Pet. Reply 2–3 (citing Ex. 1003 ¶¶ 71–72, 123–124; Pet. 9–10; Ex. 1036, 64:17–67:13, 119:17–120:11, 124:7–24, 198:9–200:9, 221:8–222:15). However, even if Petitioner is correct that the “maximum power output value” is near or equivalent to a pump unit’s output power in intermittent duty, we are still not persuaded that the term “maximum intermittent power” should be tied to the “maximum power output value,” in conflict with the definition provided in the Specification. Petitioner also argues that Patent Owner’s proposed construction is indefinite. Pet. Reply 3. For the reasons discussed below (see supra § II.I.1), we determine that Petitioner has not shown by a preponderance of the evidence that the term “maximum intermittent power,” as defined in the Specification, is indefinite. Thus, based on the complete record before us, we maintain our prior construction of “maximum intermittent power” for this Final Written Decision.” slip op. at 13

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “3. Additional Terms We determine that we need not expressly construe any other claim terms to resolve the parties’ disputes because doing so would have no effect on the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 13

    Patent outcomesUS 10,815,764 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,815,764
  • PTAB · Jan 9, 2023 · IPR2021-01189 · APJ Hyun J Jung · IPR · Final written decision

    Claims 1–13 were not shown unpatentable because MacDonald was not prior art and the petition failed to establish anticipation or obviousness; the contingent motion to amend was dismissed as moot.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedOther

      “The full record makes clear that the parties do not dispute the portion of Petitioner’s proposed level of ordinary skill regarding education and years of experience. Compare Pet. 14–15, with PO Resp. 3. Patent Owner acknowledges that the analysis does not depend on whether Petitioner’s proposed level of ordinary skill or Patent Owner’s proposal is adopted. See PO Resp. 3–4; Ex. 2003 ¶ 34 (testifying that Patent Owner’s declarant has an understanding of the capabilities of one of ordinary skill in the art irrespective of which proposed skill level is adopted), ¶ 35. The parties’ proposals are consistent with the factors of GPAC, the disclosure of the ’728 patent, and the prior art of record. Ex. 1012 ¶ 71 (testifying that Petitioner’s proposed level of ordinary skill is based on considering the factors of GPAC); Ex. 2003 ¶ 32 (testifying that Patent Owner’s proposed level of ordinary skill is based on the ’728 patent); GPAC, 57 F.3d at 1579. In view of the above, we see no reason to disturb our preliminary determination regarding the level of ordinary skill in the art. Thus, we maintain and reaffirm that one of ordinary skill in the art would have had “(1) a bachelor’s degree in mechanical engineering or a similar field that includes thermal sciences; and (2) at least two years of industrial experience on the design and evaluation of thermal management of electronic systems and heat pipes/TGPs.” Pet. 14–15; Ex. 1012 ¶ 71; Ex. 2003 ¶ 35. We agree with Patent Owner that the analysis would not be affected by adopting Patent Owner’s proposed level of ordinary skill in the art. PO Resp. 3–4; Ex. 2003 ¶ 35.” slip op. at 13

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “Petitioner contends that “the ordinary and customary meaning of the term ‘pitch’ in [c]laim 9 encompasses the definition of ‘pitch’ given in [c]laim 1—‘a distance from a center of one microfabricated structure to a center of a next neighboring microfabricated structure.’” Pet. 15. No claim term was interpreted expressly for our Institution Decision. Inst. Dec. 10. Patent Owner does not propose expressly any interpretation for any claim term. See generally PO Resp. Patent Owner, however, states that “claim 1 of the ’728 Patent expressly defines the claimed ‘pitch’ of the microfabricated structures as being ‘a distance from a center of one microfabricated structure to a center of a next neighboring microstructure.’” Id. at 12 (citing Ex. 1001, 14:45–48). Patent Owner notes that “[c]laim 9 does not include this particular definition, but the Board apparently applied the definition of the ‘pitch’ limitation in claim 1 to claim 9, as did Petitioner.” Id. “Patent Owner does not dispute or disagree with this.” Id. Based on the full record and because the parties do not dispute it, we apply the definition of pitch in claim 1 to the recited pitch of claim 9. Also, based on the full record, we determine that no other claim term requires express interpretation. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms that . . . are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 14

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateNot shown unpatentable

      “Petitioner appears to be seeking verbatim support, when, as argued by Patent Owner, the Specification does not need to provide exact or verbatim support to meet the written description requirement. See Pet. 20; PO Resp. 32. One of ordinary skill in the art would have immediately discerned that 5–500 microns is well within 2–1500 microns calculated by Petitioner using the parent applications’ claim 2. See Pet. 21–22; PO Resp. 16–17; Ex. 2003 ¶ 47. The numerical differences between the derived and claimed ranges do not address sufficiently why one of ordinary skill in the art would not discern the claimed range. See Pet. 20. As determined above, the disclosure would allow one of ordinary skill in the art to recognize that the claimed “distance from a center of one microfabricated structure to a center of a next neighboring microfabricated structure” has a range of values, such as the 2– 1500 microns calculated by Petitioner. See id. at 22. The numerical differences between the calculated ranges and the claimed ranges alone fail to show that the ordinarily skilled artisan would not have discerned the claimed range of 5–500 microns from the range of 2–1500 microns.” slip op. at 42

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “Patent Owner responds that “[b]ecause MacDonald does not qualify as prior art against the claims of the ‘728 Patent, Petitioner has failed to show that the challenged claims of the ‘728 Patent . . . would have been obvious over MacDonald in view of Ding.” PO Resp. 40. No reply arguments are presented specifically for the obviousness challenge. See generally Pet. Reply; PO Sur-reply. For the reasons given above, we agree with Patent Owner that MacDonald is not prior art to the ’728 patent. PO Resp. 39. Accordingly, based on the full record, Petitioner fails to show by a preponderance of the evidence that MacDonald and Ding would have rendered obvious claims 2, 3, and 7.” slip op. at 51

    Patent outcomesUS 10,309,728 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,309,728
  • PTAB · Sep 9, 2021 · PGR2020-00037 · APJ Julia Heaney · PGR · Final written decision

    Claims 1–10, 14–28, 32–38, 51, 52, 55–57, 59, 64–72, and 76–82 were not shown unpatentable for indefiniteness or obviousness over Hiltzik, Clontz WIPO, and Clontz SAE.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedOther

      “art include “(1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field.” Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Petitioner argues a person of ordinary skill in the art at the time of the invention “would possess at least a B.S. in chemistry or chemical or mechanical engineering and would have at least one year of experience working on control of automotive evaporative emissions,” and “would also understand the chemistry and physics associated with the phenomena of fuel vapor adsorption, desorption, and diffusion.” Pet. 28 (citing Ex. 1003 ¶ 17). Patent Owner does not dispute the level of ordinary skill in the art. We adopt Petitioner’s definition of the level of ordinary skill in the art because it is consistent with the ’553 patent and the asserted prior art.” slip op. at 11

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and standards that confirm persons of ordinary skill in the art understood that gravimetric and volumetric measurement techniques would provide consistent results when proper experimental protocols are followed and the instruments’ accuracy and precision are taken into consideration. See Ex. 2022 ¶¶ 88–91, 119–127. This evidence is essentially unrebutted by Petitioner. We find that the evidence submitted by Patent Owner as to the gravimetric and volumetric measurement techniques demonstrates that they were well established in the art as comparable methods of measuring adsorption capacity, and accordingly, not a basis for determining claim” slip op. at 16

    • ExcludeMotion to exclude, grantedGranted in part

      “Exhibit 2027. Paper 57 (“Pet. Mot.”). We do not discuss or cite Exhibit 2080 or paragraph 39 of Exhibit 2027 in this Decision, and consideration of them played no part in our determinations set forth herein. Because their presence in the record would not affect our analysis in this Decision, we dismiss as moot Petitioner’s motion with respect to these exhibits. B. Patent Owner’s Motion to Exclude Patent Owner filed a motion to exclude Exhibits 1015–1016, 1023– 1025, 1032, 1038–1039, 1042 (certain paragraphs), 1044, 1046–1049, and 1052–1054. Paper 56 (“PO Mot.”). Patent Owner groups these exhibits into four categories, which we apply in discussing the motion below. 1. Patent Owner moves to exclude Exhibits 1015 and 1046 as “irrelevant determinations from other adjudicative bodies regarding different patents.” PO Mot. 1. We do not discuss or cite these exhibits in this Decision, and have not considered them in reaching our decision herein. Because the presence of these exhibits in the record would not affect our analysis in this Decision, we dismiss as moot Patent Owner’s motion with respect to these exhibits. 2. Patent Owner moves to exclude Exhibits 1023, 1024, 1025,” slip op. at 46

    • Disclosure Requirements (§112) › Definiteness (Nautilus)Written description adequateNot shown unpatentable

      “Petitioner has not shown by a preponderance of the evidence that the gravimetric and volumetric methods provide fundamentally different measurements of adsorption capacity. Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and” slip op. at 16

    Patent outcomesUS 10,323,553 not shown unpatentable
    § 103 obviousness§ 112 disclosurecites KSR · Graham · Nautilus
    Patents in suitUS 10,323,553
  • Illumina, Inc. v. Natera, Inc.No claims unpatentable
    PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableReasonable expectation not foundNot shown unpatentable

      “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

    • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

      “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

    • ExcludeMotion to exclude, deniedDenied

      “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

    • Strike new argumentNew argument disregardedDecided for patent owner

      “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

    Patent outcomesUS 8,682,592 not shown unpatentable
    Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
    Patents in suitUS 8,682,592
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