- PTAB · May 9, 2024 · IPR2024-00158 · APJ William V Saindon · IPR · Institution
The Board instituted review of claims 1–4, 7–14, 16, 17, 21, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over Pham and Wu, and granted joinder.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion for Claim 1 Having reviewed the Petition and Preliminary Response, we determine that Petitioner has a reasonable likelihood of success in showing that the subject matter of claim 1 would have been obvious in view of Pham and Wu. E. Conclusion on the Merits of the Petition We have found that the Petition warrants institution based on Petitioner’s showings for claim 1. We have reviewed Patent Owner’s arguments about the other grounds, but they largely rely on the earlier unpersuasive arguments for claim 1. On whole, we determine that Petitioner has shown that the Petition warrants institution.” slip op. at 18
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“FURTHER ORDERED that the Motion for Joinder with IPR2023- 00703 is granted, and Palo Alto Networks, Inc. and Fortinet, Inc. are joined as a party in IPR2023-00703;” slip op. at 27
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on the related district court matters identified above. Opp. Mot. Join 4–12. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”). Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo at 3. Because Petitioner has offered a stipulation like in Sotera, i.e., to “not pursue in the copending district court litigation the specific ground asserted in the petition, or any other ground that was raised or could have been reasonably raised in an IPR (i.e., grounds that could have been raised under §§ 102 or 103 on the basis of prior art patent or printed publications)” (Reply Mot. Join 4–5), we do not discretionarily deny institution under Fintiv.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“factor one necessarily outweighs the other General Plastic factors.”) (Director Review). Patent Owner focuses its analysis on factor 5 and proposed factor 8. Id. at 13–15. As to factor 5, which looks for an explanation of the time between petition filing, we determine that Petitioner sufficiently explained the time between Cisco’s petition and its own when it noted that it merely filed its petition and request for joinder when the statute permitted it. Reply Mot. Join 6 (citing 37 C.F.R. § 42.122(b)). In particular, the statute requires the earlier petition to be instituted before joining a party. 35 U.S.C. § 315(c) (requiring joinder to be to instituted proceedings). Thus, the time elapsed between filings is motivated by the statutory and regulatory procedures. See also 37 C.F.R. § 42.122(b) (requiring the joinder motion to be filed “no later than one month after the institution date of any inter partes review for which joinder is requested”). As to proposed factor 8, we agree with Petitioner that the present situation does not apply. Reply Mot. Join. 6–7; see also Shenzhen, IPR2018-00761, Paper 15, 18–19 (Saindon, concurring) (“There are legitimate reasons why a petition may be filed after [a decision on institution)].”). Proposed factor 8 analyzes situations where a second petitioner strategically waits to file its petition to see what happens to an earlier filed petition. Shenzhen, IPR2018-00898, Paper 9 at 7. If both of the petitioners were sued at or around the same time, but one waits until the other goes first, it can lead to an inference that the delay in filing a different petition was to gain an unfair advantage. Id. at 14 (looking with disfavor on a wait-and-see strategy to use the first petition as a “test case”). That is not the case here, where the second petition is a copycat petition. The Petition here cannot be said to have been filed second in order to glean knowledge from the first petition because it is the same petition. Thus, we do not see this Petition as being a strategic attempt to use Cisco’s petition as a “test case,” and do not consider factor 8 to weigh toward denial. Finally, reviewing factor 6, we do not find that granting Petitioner’s motion to join would cause an undue burden on the Board. Petitioner is serving as an “understudy” and thus, from our perspective, Petitioner’s presence does not change the existing Cisco IPR. Patent Owner argues that if Cisco were to settle then Petitioner would continue the proceeding. Opp. Mot. Join. 15. We do not see this as an undue burden in this situation. Petitioner’s Motion for Joinder serves to lessen our burden (as well as Patent Owner’s) compared to the scenario of it filing its own unique petition. We do not see the present case as similar to the Apple case, in which a copycat joinder petition was denied. See Apple, IPR2020-00854, Paper 9. That case, in our view, turned on the fact that the petitioner had already filed a petition that was denied on the merits. See id. at 4 (“In effect, it would be as if [the petitioner] had brought the second challenge to the patent in the first instance,” and labeling this a “serial attack.”). The situation here is not analogous to the Apple case because this is Petitioner’s only petition against the ’436 patent. The Petition is not a “serial attack” on the ’436 patent, it is merely Petitioner’s statutorily required vehicle to join as a party to an existing petition. Accordingly, we do not find factor 6 to weigh towards denial. Reviewing the General Plastic factors as a whole, including proposed factor 8, we find no factors to weigh toward denial and decline to exercise our discretion to deny institution.” slip op. at 24
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,566,612 - PTAB · May 9, 2024 · IPR2024-00099 · APJ William V Saindon · IPR · Institution
The Board instituted review of claims 1–4, 7–14, 16, 17, 21, and 22 on all asserted grounds and granted joinder to IPR2023-00673.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 314(b) and 37 C.F.R. § 42.4(a). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons provided below, we determine that Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’436 patent is unpatentable, we institute an inter partes review. 37 C.F.R. § 42.108(a) (2023).” slip op. at 2
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“compressed, or use security protocols, then the packets transit the packet engine. Pet. 41–42 (citing Ex. 1004 ¶¶ 49, 51, 53). Patent Owner argues that only the SA parameter association task in Pham may be offloaded. Prelim. Resp. 26–27 (citing Ex. 1004 ¶¶ 38, 51). Patent Owner’s argument here implies that the filtering function remains at the ingress processor and that some packets will be filtered and never reach the packet engine. See id. (citing, e.g., Ex. 1004 ¶ 38); Ex. 1004 ¶ 38 (“In the preferred embodiments of the present invention, the ingress processors 30, 34 are tasked with filtering and routing functions . . . .”). The statement Patent Owner relies on is not in the same section as the one Petitioner relies on. In other words, it does not appear on this record that we can limit the disclosure of paragraph 51 based on the statements in paragraph 38. On this record, we are not persuaded that only the SA parameter association task can be offloaded. As Pham notes, tasks can be moved between processors to perform load balancing. Ex. 1004 ¶ 54. We see no disclosure that prevents certain tasks from being load balanced or otherwise tasked to the security processor.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“find them persuasive on this record. Id. at 32–33. At a high level, Patent Owner’s arguments are that Petitioner’s modification to Pham would “increase[] complexity and resources.” Id. at 33. On this record, this argument is unpersuasive because even if the addition of Wu’s intrusion detection system was somehow more complex, the reason to combine it is to gain certain beneficial features. See, e.g., Pet. 30–31. Patent Owner’s arguments do not show that the alleged increase in complexity would somehow dissuade a person of ordinary skill in the art from including these beneficial features. See, e.g., Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016) (“[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”) (alteration in original); Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine”).” slip op. at 17
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“based on the related district court matters identified above. Opp. Mot. Join 4–12. Our analysis under Fintiv is guided by the USPTO Director’s Memorandum issued on June 21, 2022, titled “Interim Procedure for Discretionary Denials in AIA Post Grant Proceedings with Parallel District Court Litigation” (“Director’s Memo”). Pursuant to the Director’s Memo, we “will not discretionarily deny institution . . . where a petitioner presents a [Sotera] stipulation.” Director’s Memo at 3. Because Petitioner has offered a stipulation like in Sotera, i.e., to “not pursue in the copending district court litigation the specific ground asserted in the petition, or any other ground that was raised or could have been reasonably raised in an IPR (i.e., grounds that could have been raised under §§ 102 or 103 on the basis of prior art patent or printed publications)” (Reply Mot. Join 4–5), we do not discretionarily deny institution under Fintiv.” slip op. at 21
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,685,436 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe 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 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - Apple Inc. / LG Electronics, Inc. et al. v. Gesture Technology Partners, LLCSome claims unpatentablePTAB · Dec 5, 2022 · IPR2022-00362 · APJ Patrick R Scanlon · IPR · Final written decision
Claims 1–3, 5–10, and 12–17 are unpatentable over Numazaki and Nonaka; claims 4, 11, and 18 were not shown unpatentable because the evidence did not establish the sensors were fixed relative to each other.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“After institution, LG Electronics, Inc. and LG Electronics U.S.A., Inc. filed a petition and a motion for joinder to this proceeding. IPR2022-00092, Papers 1, 3. We granted the motion for joinder, and IPR2022-00092 was joined with this proceeding and dismissed. Paper 12, 11–12. In addition, Google LLC filed a petition and a motion for joinder to this proceeding. IPR2022-00362, Papers 2, 3. We granted the additional motion for joinder, and IPR2022-00362 was joined with this proceeding and dismissed. Paper 16, 5–6. Consequently, Apple Inc., LG Electronics, Inc., LG Electronics U.S.A., Inc., and Google LLC are joined in this proceeding.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person having ordinary skill in the art “would have had at least a bachelor’s degree in electrical engineering or equivalent with at least one year of experience in the field of human computer interaction,” and “[a]dditional education or experience might substitute for the above requirements.” Pet. 5–6 (citing Ex. 1003 ¶¶ 29–31). Patent Owner does not dispute Petitioner’s definition for the purposes of its Response. PO Resp. 5. Based on our review of the record before us, we determine 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 adopt Petitioner’s definition.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“C. Claim Construction In inter partes reviews, the Board interprets claim language using the district-court-type standard, as described in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See 37 C.F.R. § 42.100(b). Under that standard, we generally give claim terms their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history. See Phillips, 415 F.3d at 1313–14. Although extrinsic evidence, when available, may also be useful when construing claim terms under this standard, extrinsic evidence should be considered in the context of the intrinsic evidence. See id. at 1317–19. capture command causes the digital camera to store an image to memory” in claim 1, “capturing an image to the digital camera in response to . . . the image capture command” in claim 8, and “correlate the gesture detected . . . with an image capture function and subsequently capture an image using the digital camera” in claim 13. Pet. 8. Specifically, Petitioner asserts that these phrases “should be construed broadly enough to encompass capturing/storing video or still images,” and provides reasons supporting its assertion. Id. at 8–10. Patent Owner does not contest Petitioner’s proposed claim constructions. PO Resp. 5. We agree with Petitioner’s supporting reasoning and accordingly adopt Petitioner’s proposed claim constructions.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find that Petitioner’s Reply argument is not beyond the proper scope of a reply because it directly responds to Patent Owner’s argument that Petitioner does not explain how elements from both the third and fifth embodiments would accessed by the reflected light extraction unit and whether these elements would operate simultaneously or at different times. Moreover, Petitioner’s Reply argument elaborates on the contentions in the Petition that the gesture recognition would be implemented as a means of allowing the user to initiate the fifth videoconferencing functionality. Pet. 31; see Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F. 3d, 919, 925 (Fed. Cir. 2019) (“Parties are not barred from elaborating on their arguments on issues previously raised.”). Accordingly, we find that the Petition adequately explains how the reflected light extraction unit would be accessed by both the third embodiment’s shape interpretation unit 333 and the fifth embodiment’s extraction unit 353. We particularly credit Dr. Bederson’s uncontroverted testimony that “it would be well within the capabilities of a [person having ordinary skill in the art] to utilize the same output by two separate processing blocks to implement the proposed combination,” and one of ordinary skill in the art “would understand there are no technical barriers to arranging multiple distinct processing units that separately process the same output of a single unit.” See Ex. 1018 ¶ 9.” slip op. at 24
Patent outcomesUS 8,878,949 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,878,949 - Apple Inc. / LG Electronics, Inc. et al. v. Gesture Technology Partners, LLCSome claims unpatentablePTAB · Dec 5, 2022 · IPR2021-00921 · APJ Patrick R Scanlon · IPR · Final written decision
Claims 1–3, 5–10, and 12–17 are unpatentable as obvious over Numazaki and Nonaka; claims 4, 11, and 18 were not shown unpatentable.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find that Petitioner’s Reply argument is not beyond the proper scope of a reply because it directly responds to Patent Owner’s argument that Petitioner does not explain how elements from both the third and fifth embodiments would accessed by the reflected light extraction unit and whether these elements would operate simultaneously or at different times. Moreover, Petitioner’s Reply argument elaborates on the contentions in the Petition that the gesture recognition would be implemented as a means of allowing the user to initiate the fifth videoconferencing functionality. Pet. 31; see Chamberlain Grp., Inc. v. One World Techs., Inc., 944 F. 3d, 919, 925 (Fed. Cir. 2019) (“Parties are not barred from elaborating on their arguments on issues previously raised.”). Accordingly, we find that the Petition adequately explains how the reflected light extraction unit would be accessed by both the third embodiment’s shape interpretation unit 333 and the fifth embodiment’s extraction unit 353. We particularly credit Dr. Bederson’s uncontroverted testimony that “it would be well within the capabilities of a [person having ordinary skill in the art] to utilize the same output by two separate processing blocks to implement the proposed combination,” and one of ordinary skill in the art “would understand there are no technical barriers to arranging multiple distinct processing units that separately process the same output of a single unit.” See Ex. 1018 ¶ 9.” slip op. at 24
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“We agree with Patent Owner that the Petition does not establish sufficiently that Numazaki’s unit 102 and camera 351 are fixed relative to one another. Without more, the mere fact that unit 102 and camera 351 are arranged in parallel and have overlapping fields of view does not establish that the structures are fixed. At the oral hearing, counsel for Petitioner indicated that Petitioner’s position was not an inherency argument but relied on Dr. Bederson’s analysis and interpretation of Numazaki’s fifth embodiment. Tr. 17:7–15. The Petition, however, does not reference any such analysis in connection with the subject matter of claims 4, 11, and 18. 27–28 of the Petition, which pertain to limitation 1[(a)]) discuss the overlapping fields of view but not assert that overlapping fields of view require the structures to be fixed with respect to one another. For the foregoing reasons, we determine that Petitioner has not shown by a preponderance of the evidence that the combination of Numazaki and Nonaka renders obvious claims 4, 11, or 18. 6. Dependent Claims 2, 3, 5–7, 9, 10, 12, and 14–17 Petitioner provides reasonable and detailed explanations, supported by the testimony of Dr. Bederson, indicating where in the references the limitations of claims 2, 3, 5–7, 9, 10, 12, and 14–17 are disclosed. Pet. 33– 43, 44, 47, 49. Further, Patent Owner offers no arguments particularly directed to these dependent claims. PO Resp. 22, 25, 28. We have considered the evidence and arguments of record and determine that Petitioner has demonstrated by a preponderance of the evidence that the combination of Numazaki and Nonaka renders obvious claims 2, 3, 5–7, 9, 10, 12, and 14–17 for the reasons discussed in the Petition and as supported by the testimony of Dr. Bederson.” slip op. at 34
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“After institution, LG Electronics, Inc. and LG Electronics U.S.A., Inc. filed a petition and a motion for joinder to this proceeding. IPR2022-00092, Papers 1, 3. We granted the motion for joinder, and IPR2022-00092 was joined with this proceeding and dismissed. Paper 12, 11–12. In addition, Google LLC filed a petition and a motion for joinder to this proceeding. IPR2022-00362, Papers 2, 3. We granted the additional motion for joinder, and IPR2022-00362 was joined with this proceeding and dismissed. Paper 16, 5–6. Consequently, Apple Inc., LG Electronics, Inc., LG Electronics U.S.A., Inc., and Google LLC are joined in this proceeding.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had at least a bachelor’s degree in electrical engineering or equivalent with at least one year of experience in the field of human computer interaction,” and “[a]dditional education or experience might substitute for the above requirements.” Pet. 5–6 (citing Ex. 1003 ¶¶ 29–31). Patent Owner does not dispute Petitioner’s definition for the purposes of its Response. PO Resp. 5. Based on our review of the record before us, we determine 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 adopt Petitioner’s definition. slip op. at 8
Patent outcomesUS 8,878,949 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,878,949 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentablePTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3
- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14
Patent outcomesUS 6,407,213 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,407,213 - Skechers USA, Inc. v. Adidas AGNo claims unpatentablePTAB · Apr 25, 2018 · IPR2017-00127 · APJ Josiah C Cocks · IPR · Final written decision
Claims 1–30 were not shown unpatentable under §103 because the proposed prior-art modifications lacked adequate support and rational underpinning.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“The basis of disagreement boils down to an evaluation of a skilled artisan’s experience. In that respect, Petitioner urges that the artisan generally has “substantial experience in the structural design of flexible elements and plastic polymers,” whereas Patent Owner characterizes the experience as directed to “biomechanical systems.” The ’079 patent is clearly directed to matters of shoe construction, and takes note, for instance, of the desirability of “cushioning and biomechanically supporting the foot.” Ex. 1001, 1:27–29. It is also apparent that an overarching focus of the ’079 patent is concern with “balance” and “support” of a “foot against misorientations such as pronation and supination (i.e. a tilting movement of the forefoot part to the medial and the lateral side, respectively).” Id. at 2:34–39. Such concerns, in our view, go beyond general experience in the design of flexible elements and plastic polymers. In that regard, we credit the testimony of Patent Owner’s declarant, Dr. Hinrichs, that a person of ordinary skill in the art would have experience with biomechanical systems, such as shoes. See Ex. 2001 ¶¶ 14–15. We have considered the respective opinions of the parties when it comes to the level of ordinary skill in the art. In reaching our decision as to the merits of this proceeding, for the reasons discussed above, we are persuaded by Patent Owner’s evidence as to the ordinary skill of an artisan.” slip op. at 12
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“substantial dissection and modification of Luthi ’202’s Figure 17. That dissection is premised on Mr. Ganaja’s assessment of what a person of ordinary skill in the art would take from the record at hand. Yet, in our view, neither Mr. Ganaja nor Petitioner explains adequately how the teachings of the prior art would have led one down the path that they advocate. For instance, it is decidedly unclear from the record that any “longitudinal groove” as advanced in Petitioner’s annotated illustrations of Luthi ’202’s Figure 17 reproduced herein exists in the configuration proposed by Petitioner. Although Petitioner and Mr. Ganaja postulate that it does exist, Luthi ’202’s teachings are less than determinative in that respect. We credit the testimony of Dr. Hinrichs and Dr. Luthi, that no such groove or “gap” exists as proposed by Petitioner. PO Resp. 21–25 (citing Ex. 2001 ¶¶ 32–35, 42–43; Ex. 2005 ¶¶ 6, 8–13).” slip op. at 22
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We observe that Patent Owner relies on content of the ’079 patent at column 11, lines 31–34 to support the meaning of “leaf spring[s]” and “leaf spring element[s]” that it advances. That portion of the ’079 patent describes embodiments of the invention appearing in Figures 19 to 25. Referencing particular leaf spring elements 22 and 23 of those embodiments, the ’079 patent states that “[t]ypically the restoring force exerts a force that has a component orthogonal to the sole plate (e.g., for cushioning) and a component parallel to the sole in the rearward direction (e.g., for acceleration).” Ex. 1001, 11:31–34. While that language mirrors the meaning of “leaf spring[s]” and “leaf spring element[s]” proposed by Patent Owner, we discern that the noted clause also begins with the term “[t]ypically.” That leaf spring elements may “typically” include a component parallel to the sole in the rearward direction does not lend itself to the conclusion that a “leaf spring” necessarily includes such a component. Rather, it conveys the opposite. In that respect, the plain understanding of the pertinent content of the ’079 patent is that, while, perhaps, not typical, the ’079 patent contemplates other component arrangements, logically including those in which the parallel component is not in the rearward direction.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“substantial dissection and modification of Luthi ’202’s Figure 17. That dissection is premised on Mr. Ganaja’s assessment of what a person of ordinary skill in the art would take from the record at hand. Yet, in our view, neither Mr. Ganaja nor Petitioner explains adequately how the teachings of the prior art would have led one down the path that they advocate. For instance, it is decidedly unclear from the record that any “longitudinal groove” as advanced in Petitioner’s annotated illustrations of Luthi ’202’s Figure 17 reproduced herein exists in the configuration proposed by Petitioner. Although Petitioner and Mr. Ganaja postulate that it does exist, Luthi ’202’s teachings are less than determinative in that respect. We credit the testimony of Dr. Hinrichs and Dr. Luthi, that no such groove or “gap” exists as proposed by Petitioner. PO Resp. 21–25 (citing Ex. 2001 ¶¶ 32–35, 42–43; Ex. 2005 ¶¶ 6, 8–13). Moreover, even if such groove does exist, neither Petitioner nor Mr. Ganaja adequately explains why the presence of such groove would create at least two leaf springs or leaf spring elements that are “integrally joined to form a single end not directly connected to the sole plate,” as required by all the claims involved in this proceeding. We agree with, and credit, the testimony of Dr. Hinrichs that “Luthi ’202 consistently discloses that the strut elements run the entire width of the shoe.” Ex. 2001 ¶ 32 (citing Ex. 1005, 3:47–50 (“the strut elements 22 extend substantially from the medial edge of the lateral edge of lower plate 26 . . .”)). In extending the entire width of the shoe, strut elements 22 (and 222) are more appropriately viewed as a single element (e.g., a spring element) rather than multiple spring elements that come together integrally. Petitioner and Mr. Ganaja also inadequately explain why combination of Luthi ’202’s teachings with those of either Luthi ’800 or Chan would result in the above-noted “central cavity” as a part of the directional element of Luthi ’202’s Figure 17. Although Luthi ’800 and Chan may show spaces or cavities in components of their shoes, there appear substantial differences in the designs of those shoes, and in particular the cushioning aspects, as compared with Luthi ’202’s Figure 17. We credit Dr. Hinrichs’s and Dr. Luthi’s testimony that the presence of such a cavity as shown in Luthi ’800 and Chan would prove detrimental to the medial-lateral stability of Luthi ’202’s shoe, and specifically the directional element of such a shoe that is depicted in Luthi ’202’s Figure 17. See Ex. 2001 ¶ 42; Ex. 2005 ¶¶ 11–13. To that end, we also find inadequate Petitioner’s general position that combining the teachings of Luthi ’202, Luthi ’800, and Chan would result simply in a “combination of familiar elements according to known methods that would yield predictable results,” and “well within the knowledge and skill of persons of ordinary skill in the art . . .” Pet. 35. We are not persuaded that any such combination would yield the “predictable results” advanced by Petitioner, or that “well within the knowledge and skill” of an artisan cited by Petitioner constitutes rational underpinning to support an obviousness conclusion. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (An assertion of unpatentability based on “obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)” slip op. at 22
Patent outcomesUS 9,339,079 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,339,079 - Skechers USA, Inc. v. Adidas AGNo claims unpatentablePTAB · Apr 25, 2018 · IPR2017-00125 · APJ Josiah C Cocks · IPR · Final written decision
Claims 20–32 were not shown unpatentable under §103 because the proposed modifications to Luthi ’202 were unsupported and relied on hindsight.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“artisan’s experience. In that respect, Petitioner urges that the artisan generally has “substantial experience in the structural design of flexible elements and plastic polymers,” whereas Patent Owner characterizes the experience as directed to “biomechanical systems.” The ’285 patent is clearly directed to matters of shoe construction, and takes note, for instance, of the desirability of “cushioning and biomechanically supporting the foot.” Ex. 1001, 1:19–21. It is also apparent that an overarching focus of the ’285 patent is concern with “balance” and “support” of a “foot against misorientations such as pronation and supination (i.e. a tilting movement of the forefoot part to the medial and the lateral side, respectively.” Id. at 2:28– 31. Such concerns, in our view, go beyond general experience in the design of flexible elements and plastic polymers. In that regard, we credit the testimony of Patent Owner’s declarant, Dr. Hinrichs, that a person of ordinary skill in the art would have experience with biomechanical systems, such as shoes. See Ex. 2001 ¶¶ 14–15. In crediting Dr. Hinrichs’s assessment of the level of ordinary skill in the art we observe that, although Petitioner makes reference to the testimony of its declarant Mr. Ganaja (see Pet. 6 (citing 1002 ¶¶ 39–43)), Mr. Ganaja makes no evaluation of his own in that testimony in connection with the level of ordinary skill. We have considered the respective opinions of the parties when it comes to the level of ordinary skill in the art. In reaching our decision as to the merits of this proceeding, for the reasons discussed above, we are persuaded by Patent Owner’s evidence as to the ordinary skill of an artisan.” slip op. at 10
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“substantial dissection and modification of Luthi ’202’s Figure 17. That dissection is premised on Mr. Ganaja’s assessment of what a person of ordinary skill in the art would take from the record at hand. Yet, in our view, neither Mr. Ganaja nor Petitioner explains adequately how the teachings of the prior art would have led one down the path that they advocate. For instance, it is decidedly unclear from the record that any “longitudinal groove” as advanced in Petitioner’s annotated illustrations of Luthi ’202’s Figure 17 reproduced herein exists in the configuration proposed by Petitioner. Although Petitioner and Mr. Ganaja postulate that it does exist, Luthi ’202’s teachings are less than determinative in that respect. We credit the testimony of Dr. Hinrichs and Dr. Luthi, that no such groove or “gap” exists as proposed by Petitioner. PO Resp. 18–21 (citing Ex. 2001 ¶¶ 32–35, 42–43; Ex. 2005 ¶¶ 8 and 11–13). Moreover, even if such groove does exist, neither Petitioner nor Mr. Ganaja adequately explains why the presence of such groove would create at least two leaf springs or leaf spring elements that “come together integrally to form a single end not directly connected to the sole plate,” as required by all the claims involved in this proceeding. We agree with, and credit, the testimony of Dr. Hinrichs that “Luthi ’202 consistently disclosed that the strut elements run the entire width of the shoe.” Ex. 2001 ¶ 32 (citing Ex. 1005, 3:47–50 (“the strut elements 22 extend substantially from the medial edge of the lateral edge of lower plate 26 . . .”)). In extending the entire width of the shoe, strut elements 22 (and 222) are more appropriately viewed as a single element (e.g., a spring element) rather than multiple spring elements that come together integrally.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“column 11, lines 23–26 to support the meaning of “leaf spring[s]” and “leaf spring element[s]” that it advances. That portion of the ’285 patent describes embodiments of the invention appearing in Figures 19 to 25. Referencing particular leaf spring elements 22 and 23 of those embodiments, the ’285 patent states that “[t]ypically the restoring force exerts a force that has a component orthogonal to the sole plate (e.g., for cushioning) and a component parallel to the sole in the rearward direction (e.g., for acceleration).” Ex. 1001, 11:23–26. While that language mirrors the meaning of “leaf spring[s]” and “leaf spring element[s]” proposed by Patent Owner, we discern that the noted clause also begins with the term “[t]ypically.” That leaf spring elements may “typically” include a component parallel to the sole in the rearward direction does not lend itself to the conclusion that a “leaf spring” or “leaf spring element” necessarily includes such a component. Rather, it conveys the opposite. In that respect, the plain understanding of the pertinent content of the ’285 patent is that, while, perhaps, not typical, the ’285 patent contemplates other component arrangements, logically including those in which the parallel component is not in the rearward direction. Indeed, our above-noted understanding is also consistent with other embodiments described in the ’285 patent. For instance, embodiments depicted in Figures 13–16 show elements 23 extending in a forward direction with respect to the sole. The elements 23 of those figures are described as “leaf spring elements.” Id. at 10:15–50. Moreover, the ‘285 patent makes explicit that those leaf spring elements “are either forwardly or rearwardly directed.” Id. at 10:49–50. Patent Owner’s position that the claimed “leaf springs” or “leaf spring elements” require a parallel component extending in the rearward direction is inconsistent with these particular figures and the accompanying description in the ’285 patent. To that end, Patent Owner does not explain persuasively why the meaning of the term “leaf spring” encompasses only a parallel component in the rearward direction, yet the ’285 patent clearly provides that leaf springs may also have components that extend in the forward direction. Accordingly, for the foregoing reasons, we again conclude that “leaf spring[s]” and “leaf spring element[s]” mean “a flexible member that deflects and provides a restoring force with an orthogonal and a parallel component in response to a load applied to the sole.” We discern that it is unnecessary to construe expressly any other claim term of the ’285 patent. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“substantial dissection and modification of Luthi ’202’s Figure 17. That dissection is premised on Mr. Ganaja’s assessment of what a person of ordinary skill in the art would take from the record at hand. Yet, in our view, neither Mr. Ganaja nor Petitioner explains adequately how the teachings of the prior art would have led one down the path that they advocate. For instance, it is decidedly unclear from the record that any “longitudinal groove” as advanced in Petitioner’s annotated illustrations of Luthi ’202’s Figure 17 reproduced herein exists in the configuration proposed by Petitioner. Although Petitioner and Mr. Ganaja postulate that it does exist, Luthi ’202’s teachings are less than determinative in that respect. We credit the testimony of Dr. Hinrichs and Dr. Luthi, that no such groove or “gap” exists as proposed by Petitioner. PO Resp. 18–21 (citing Ex. 2001 ¶¶ 32–35, 42–43; Ex. 2005 ¶¶ 8 and 11–13). Moreover, even if such groove does exist, neither Petitioner nor Mr. Ganaja adequately explains why the presence of such groove would create at least two leaf springs or leaf spring elements that “come together integrally to form a single end not directly connected to the sole plate,” as required by all the claims involved in this proceeding. We agree with, and credit, the testimony of Dr. Hinrichs that “Luthi ’202 consistently disclosed that the strut elements run the entire width of the shoe.” Ex. 2001 ¶ 32 (citing Ex. 1005, 3:47–50 (“the strut elements 22 extend substantially from the medial edge of the lateral edge of lower plate 26 . . .”)). In extending the entire width of the shoe, strut elements 22 (and 222) are more appropriately viewed as a single element (e.g., a spring element) rather than multiple spring elements that come together integrally.” slip op. at 20
Patent outcomesUS 9,345,285 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,345,285 - Hospira, Inc. v. Genentech, Inc.Rehearing grantedPTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 7,846,441 - Mylan Pharmaceuticals Inc. / Mylan Laboratories Limited v. Ucb Pharma GmbHNo claims unpatentablePTAB · Jul 19, 2017 · IPR2016-00517 · APJ Robert A Pollock · IPR · Final written decision
Claims 1, 3, 4, and 6–8 were held not unpatentable because Petitioner did not prove either obviousness ground by a preponderance of the evidence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“For the purpose of this decision, we accept Petitioner’s undisputed contention that: [a] person of ordinary skill in the art would have a Ph.D. in chemistry, medicinal chemistry, pharmacology, or a related field, and at least one year of industrial exposure to drug discovery, drug design, and synthesis. In lieu of an advanced degree, the individual may have additional years of industry experience, including, for example, in drug discovery, drug synthesis, and structure-activity work. Pet. 6 (citing Ex. 1003 ¶ 20); see Prelim. Resp. 9; PO Resp. 6. Based on our review of the ’772 patent, the types of problems and solutions described in the ’772 patent and cited prior art, we adopt Petitioner’s definition of a person of ordinary skill in the art at the time of the claimed invention. We note that the applied prior art also reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner submits that the “claims in the ʼ772 patent are presumed to take on their ordinary and customary meaning based on the broadest reasonable interpretation of the claim language.” Pet. 6. Patent Owner “does not dispute Petitioner’s position that no claim terms require construction, which the Board also accepted for purposes of institution.” PO Resp. 7 (citing Pet. 6; Inst. Dec. 7). In our Decision on Institution, we determined that “for purposes of this Decision, none of the terms in the challenged claims require express construction at this time.” Inst. Dec. 7. As in the Decision on Institution, we apply the broadest reasonable interpretation standard here, and see no reason to construe explicitly any claim term. B. Principles of Law” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Petitioner, however, fails to point to any evidence that 5-HMT is metabolized through the CYP2D6 pathway, or that administering 5-HMT would have resulted in the same risks of drug interaction and adverse effects that Petitioner contends are the result of administering tolterodine. See Pet. 22–24 (describing alleged problems associated with tolterodine, not 5 HMT); Ex. 1003 ¶¶ 95–100 (Dr. Patterson’s testimony regarding the drawbacks of tolterodine). Indeed, such an argument appears to undermine Petitioner’s position, discussed in Section III.D.1 supra, that one of ordinary skill in the art would have selected 5-HMT as a lead compound over tolterodine to avoid the CYP2D6 metabolic pathway, and Dr. Patterson’s testimony that the prior art collectively “indicated to a skilled drug designer interested in overactive bladder treatment that 5-HMT would avoid the issues associated with dosing [] tolterodine.” Ex. 1003 ¶ 101. Petitioner’s argument also is contradicted by Dr. Patterson’s testimony that “5-HMT is not metabolized by both CYP2D6 and CYP3A4, but only by CYP3A4.” Id. ¶ 111; see also Ex. 1010, 289 (Postlind indicating that 5-HMT is not a CYP2D6 substrate).” slip op. at 25
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Following our weighing of the experts’ testimony, we find that Dr. Roush’s testimony better addresses the issue at hand and we credit that testimony over Dr. Patterson’s testimony. Dr. Patterson opines generally that the “presence of two hydroxyl groups around the left most aromatic ring (shown above in blue) would have created a product likely to have decreased oral bioavailability compared to tolterodine because of its hydrophilicity and thus lower than acceptable lipophilicity” (Ex. 1003 ¶ 112), and that it “would [have been] a matter of routine experimentation” to confirm that 5-HMT could have significantly less bioavailability than its parent, tolterodine” (Ex. 1003 ¶ 115). Dr. Patterson, however, did not perform any experiments to confirm 5-HMT’s oral bioavailability, and cites to no further evidence to support his opinions. See Ex. 2022 ¶ 92; compare Brynne (Ex.1011) discussed supra § III.C.2. Dr. Roush, on the other hand, conducts an analysis of the compound under the “Rule of 5” to determine that “5-HMT does not meet a single factor, much less two, of the rule” thus teaching the skilled artisan “away from concluding that 5-HMT had an oral absorption problem.” PO Resp. 26– 27 (citing Ex. 2022 ¶¶ 56–58, 87, 92). At oral hearing, Patent Owner restated that the analysis under the Rule of 5 indicates that 5-HMT was “not even close to being a problem . . . for all four of these properties, 5-HMT says there’s no red flags; there’s no problem,” and that “Dr. Patterson admitted in his deposition, 5-HMT does not violate the Rule of Five.” Tr. 67:35–68:3; 68:17–21; see Ex. 2020 180:14–181:14.” slip op. at 31
Patent outcomesUS 7,985,772 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,985,772
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.