- Innoscience (Zhuhai) Technology Company, Ltd / Innoscience America, Inc. v. Efficient Power Conversion CorporationAll claims unpatentablePTAB · Mar 18, 2025 · IPR2023-01381 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1–3 and 7–9 are unpatentable as obvious over Uemoto and Smith; the motion to amend is granted, and proposed substitute claims 13 and 14 are not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In order to determine whether an invention would have been obvious at the time the application was filed, we consider the level of ordinary skill in the pertinent art. Graham, 383 U.S. at 17. In assessing the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (quotation omitted). Petitioner contends a person of ordinary skill in the art “would have possessed at least a four-year degree in electrical engineering, chemical engineering, physics, or material science, or a closely related field, and at least two years of experience in semiconductor device design or fabrication, including the processing of semiconductor materials, analysis of device operation, or the development of new device topologies.” Pet. 5–6. Petitioner contends “[a]dditional education could substitute for professional experience and vice versa.” Id. at 6. Patent Owner contends that a person of ordinary skill in the art would have had “at least a four-year degree in electrical engineering, physics, material science, or a closely related field, and three years of professional work experience in the epitaxial growth, design, and fabrication of semiconductor electronic devices, including those of GaN.” PO Resp. 7 (citing Ex. 2009 ¶ 82). Upon review of the evidence of record and the parties’ arguments, we adopt Petitioner’s definition of the person of ordinary skill in the art as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). We note, however, that the conclusions reached in this Decision would be the same under either proposed definition of the ordinarily skilled artisan. See Ex. 2009 ¶ 83 (Dr. Schubert testifying that his opinions would be the same under either proposed definition); Ex. 1033 ¶ 9 (Dr. Shealy testifying that the differences in proposed definitions of the ordinarily skilled artisan “would not change the outcome of the invalidity analysis in any material manner”); PO Resp. 7; Pet. Reply 1.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“compensated GaN layer above the barrier layer, and a gate contact above the compensated GaN layer.” Ex. 1001, 5:12–18. Petitioner contends the term “compensated” indicates that the step of compensating the GaN layer has already occurred, such that the term “compensated GaN layer” should be construed as a “‘[d]oped GaN layer formed with a step to passivate its impurities’ which is a ‘product-by-process’ limitation.”5 Pet. 12–14. And, because compensation with hydrogen was the “critical step” distinguishing the claims from the prior art, and because hydrogenation in as-grown III-nitride materials had been well known for over a decade by 2009, Petitioner contends “compensated” “cannot be interpreted as mere hydrogen presence in as-grown material, a well-known property of doped GaN.” Id. at 15. Patent Owner contends “compensated GaN material” should be construed as “a semiconductor GaN gate material in which one type of impurity (for example, donor) cancels the electrical effects of the other type of impurity (for example, acceptor).” PO Resp. 11 (citing Ex. 2009 ¶ 92) (emphasis added). Patent Owner contends this construction is consistent with the IEEE dictionary, which defines “compensated semiconductor” as 5 Given that product-by-process steps in a device claim are not entitled to patentable weight, Petitioner contends “the prior art only need show a material with passivated impurities to show unpatentability, not the step to achieve it.” Pet. 15–16. “[a] semiconductor in which one type of impurity or imperfection (for example, donor) partially cancels the electric effects of the other type of impurity or imperfection (for example, acceptor).” PO Resp. 14 (quoting Ex. 2004). Patent Owner contends its construction is also consistent with the written description of the ’294 patent, which explains that a compensated GaN material is part of the gate and includes a p-type impurity that imparts an electrical effect (i.e., conductivity), as well as a second impurity, e.g., hydrogen, that partially cancels the electrical effect of the p-type impurity, rendering the layer semi-insulating. Id. at 14–15 (citing Ex. 1001, 3:10–13, 3:43–45). On this record, we construe “compensated GaN layer” as “a GaN layer in which one type of impurity (for example, donor) partially cancels the electric effects of the other type of impurity (for example, acceptor).” This is consistent with the disclosures of the ’294 patent, the IEEE dictionary definition, and the construction ultimately adopted by the ITC. Ex. 2004, 3; Ex. 1049, 16–17 (ITC construing “compensated GaN layer” to mean “a GaN layer in which one type of impurity partially cancels the electrical effects of another type of impurity”); Ex. 1001, 3:43–45 (explaining that the compensated GaN layer of the ’294 patent is formed through the “passivation of a p-type impurity using hydrogen”). For the reasons set forth below, however, we decline to construe “compensated GaN layer” as a product-by-process claim term (as asserted by Petitioner), or to limit the compensated GaN layer to a gate material (as asserted by Patent Owner).” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner
“There are two exceptions to the general rule that we apply the ordinary and customary meaning of a claim term: (1) when a patentee sets out a definition and acts as his own lexicographer, or (2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution. See Thorner, 669 F.3d at 1365. The standards for lexicography and disclaimer, however, are “exacting.” Id. at 1366. There is no argument that the patentees acted as their own lexicographer to redefine the term “compensated GaN layer.” With respect to disavowal, a “patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Thorner, 669 F.3d at 1366 (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002)). As noted by Patent Owner, the title of the ’294 patent is, in part, “Compensated Gate MISFET” and much of the discussion of the ’294 patent is of a compensated GaN layer that is directly below the gate contact and above a barrier layer and operates in conjunction with the gate contact to control the on/off state of the transistor. PO Resp. 12–14. We are presented with insufficient argument or evidence to conclude, however, that these disclosures rise to the level of a disclaimer. For example, although the title of the ’294 patent is directed to a “Compensated Gate MISFET,” claim 1 is more broadly directed to “[a] column III Nitride transistor.” Ex. 1001, 5:12, code (54). Nor are we directed to an expression or statement of manifest exclusion in the ’294 patent that would serve to disclaim any “compensated GaN layer” that is not directly below the gate and/or that does not function in concert with the gate electrode to control the on/off state of the transistor. See Thorner, 669 F.3d at 1366. With respect to the stated goals of the invention, as noted by Patent Owner, one of the primary purposes of the compensated GaN layer of the ’294 patent is to reduce gate leakage and gate capacitance. Ex. 1001, 2:13– 19, 3:18–21 (“[U]sing a compensated semiconductor layer 38 leads to low gate leakage during device operation.”). We cannot use the goals of the invention, however, to rewrite the claims or insert terms that are not present. See Thorner, 669 F.3d at 1366. Moreover, the prior art of record indicates that a compensated GaN layer that is below the gate contact and above a barrier layer, but not part of the active gate structure, may also “decrease the leakage current between the gate and the drain.” Ex. 1006 ¶¶ 44 (“Even when a positive bias of 5 V or higher is applied to the gate electrode, no significant gate-leakage current is observed.”), 61. As such, evidence of record suggests that a person of ordinary skill in the art would have understood that one of the primary goals disclosed in the ’294 patent is achieved regardless of whether the compensated GaN layer is part of the gate, or simply in close vicinity to the gate. In view of the foregoing, we are not persuaded that the written description of the ’294 patent indicates that the “compensated GaN layer” must be part of the gate structure.” slip op. at 17
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“To be probative, Patent Owner must prove there is a nexus between the presented evidence and the merits of the claimed invention. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). A rebuttable presumption of nexus applies when the “patentee shows that the asserted evidence is tied to a specific product and that the product ‘is the invention disclosed and claimed.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Demaco, 851 F.2d at 1392). “That is, presuming nexus is appropriate ‘when the patentee shows that the asserted objective evidence is tied to a specific product and that product embodies the claimed features, and is coextensive with them.’” Id. (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). If the praise is not limited to the features of the claimed invention, the patent owner may still prove nexus “by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Id. at 1373–74 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Patent Owner contends that the compensated gate of the ’294 patent “was a breakthrough invention and resulted in the first commercially viable enhancement-mode GaN transistor.” PO Resp. 60 (citing Ex. 2009 ¶¶ 192– 193, 197; Ex. 2021). Patent Owner further contends that this achievement required the counter-intuitive use of a compensated gate material in the gate structure, and represented “a technological leap that laid the foundation for viable enhancement-mode GaN transistors.” Id. at 61–62. For this achievement, Patent Owner contends the inventor, Dr. Alex Lidow, received the 2015 SEMI Award. Id. at 60 (citing Ex. 2021). Upon review of Patent Owner’s evidence and the parties’ arguments, we find that Patent Owner’s objective indicia evidence is entitled to little, if any, weight. The evidence of praise relied upon by Patent Owner is not clearly linked to the claimed invention or any particular product having each of the claimed features of the ’294 patent. Ex. 2021. For example, the 2015 SEMI award was provided to Dr. Lidow “for commercialization of GaN power devices.” Id. An article explaining the award indicates that “high cost” previously “limited [the] commercial success” of GaN technologies, but Dr. Lidow was able to overcome these issues, “from resolving packaging limitations to establishing a low-cost supply chain,” “through persistence.” Id. This praise is not demonstrably linked to the claimed invention or any particular device, and does not mention the use of a compensated gate, or any other relevant feature recited in the claims. In view of the foregoing, we determine that Patent Owner’s objective evidence of non-obviousness is entitled to little, if any, weight.” slip op. at 20
Patent outcomesUS 8,350,294 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,350,294 - PTAB · Oct 11, 2024 · IPR2024-00771 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted IPR on claims 1–6 of the ’195 patent on all asserted grounds and granted Texas Instruments’ motion to join the Cirrus IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Because the Preliminary Response in the instant case includes arguments pertaining to the sufficiency of the asserted prior art references, which were not raised in the preliminary response in the Cirrus IPR, we briefly address below the patentability of the challenged claims.” slip op. at 6
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“II. TIMELINESS OF THE PETITION UNDER 35 U.S.C. § 315(B) Pursuant to 35 U.S.C. § 315(b), “[a]n inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” Patent Owner argues that the Petition is untimely under 35 U.S.C. § 315(b) because Petitioner is in privity with time-barred entities. Prelim. Resp. 10– 30. However, 35 U.S.C. § 315(b) also provides that the one-year time bar “shall not apply to a request for joinder under subsection (c).” See also 37 C.F.R. § 42.122(b). Because the Petition is accompanied by a timely request for joinder (Paper 2) to the instituted proceeding (IPR2024-00017), which we grant as further discussed below, Patent Owner’s argument that the Petition is time-barred under 35 U.S.C. § 315(b) is moot, irrespective of whether Petitioner is in privity with time-barred entities.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“B. Whether to Join Petitioner as a Party to the Cirrus IPR Joinder may be authorized when warranted, but the decision to grant joinder is discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. A motion for joinder should (1) set forth reasons why joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; (3) explain what impact (if any) joinder would have on the trial schedule for the existing review; and (4) address specifically how briefing and discovery may be simplified. See, e.g., Kyocera Corp. v. Softview LLC, IPR2013- 00004, Paper 15 (PTAB April 24, 2013). As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). As an initial matter, we find the Motion for Joinder meets the timing requirements of 37 C.F.R. § 42.122(b) because Petitioner filed it on April 4, 2024, no later than one month after the Cirrus IPR was instituted on May 1, 2024.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“5. “Aid the Movement of Minority Carriers” Patent Owner argues that the Petition fails to show that the applied prior art references disclose the claim limitations “requiring ‘aid the movement of minority carriers,’” as twice recited in claim 1. Prelim. Resp. 8. Patent Owner summarizes this dispute as follows: The challenged patent discloses and claims a semiconductor device with (among other things) a “drift layer having a graded concentration of dopants . . . [and] further having a first static unidirectional electric drift field to aid the movement of minority carriers.”[] The Petition should not be instituted, because (among other deficiencies) it fails to show that the prior art discloses the “aid the movement of minority carriers” claim limitation. Rather than pointing to anything in the prior art that would teach this claim limitation, the Petition assumes that any “graded concentration of dopants” would necessarily “aid the movement of minority carriers.” The Petition contains no analysis explaining why the “graded concentration of dopants” in the prior art meet the “aid the movement of minority carriers” limitation, apart from the fact that they are “graded concentration of dopants.” In other words, Petitioner reads the “aid the movement of minority carriers” limitation out of the claims completely. Id. at 1–2. Patent Owner includes additional details in support of its view that the asserted prior art fails to establish obviousness of the “aid carrier movement” limitations of claim 1. Prelim. Resp. 1–10.” slip op. at 8
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,421,195 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.Rehearing grantedPTAB · Aug 10, 2023 · PGR2022-00023 · APJ Jeffrey N Fredman · PGR · Rehearing
On Patent Owner’s rehearing request, the Board held claim 25 unpatentable under § 112(a) because it depends from claim 14, which lacks written description support.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“We therefore agree with Petitioner that we overlooked the correct dependency of claim 25. Claim 25, as a claim dependent from claim 14, lacks written descriptive support because claim 25 fails to cure the absence of descriptive support for claim 14.” slip op. at 4
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“In the Final Written Decision, we determined that claim 14 lacked descriptive support. We noted that Claim 14, in particular, recites a GDC-0199 dosing regimen “compris[ing] a dose of 20 mg per day for one week, a dose of 50 mg per day for one week, a dose of 100 mg per day for one week, a dose of 200 mg of GDC-0199 per day for one week, and a dose of 400 mg per day.” Unlike for claim 1, such disclosure is not found in a single example, but results from picking and choosing three separate selections from column 24. “The written description requirement is not met when, as here, the specification provides at best disparate disclosures that an artisan might have been able to combine in order to make the claimed invention.” Flash-Control, LLC v. Intel Corp., 2021 WL 2944592 *4 (Fed. Cir. 2021) (citing Ariad, 598 F.3d at 1352.)” slip op. at 3
§ 112 disclosurePatents in suitUS 10,993,942 - 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 - Saudi Arabian Oil Company v. SK Innovation Co., Ltd.All claims unpatentablePTAB · May 9, 2019 · IPR2018-00159 · APJ Monté T Squire · IPR · Final written decision
Claim 2 was held unpatentable as anticipated by Novomer 1; the contingent motion to amend was granted, substituting claim 5.
RulingsFinal written decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Applying the standard set forth in 35 U.S.C. § 314(a), which requires demonstration of a reasonable likelihood that Petitioner would prevail with respect to at least one challenged claim, we granted Petitioner’s request and instituted an inter partes review for challenged claim 2. Paper 9 (“Institution Dec.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner agrees with Petitioner’s assessment regarding the level of ordinary skill in the art. Mot. Amend 7. We determine the level of ordinary skill proposed by Petitioner is consistent with the ’979 patent and the asserted prior art, and we adopt that level in construing and deciding the patentability of claim 2.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In the Institution Decision, we determined that the phrase “A poly(alkylene carbonate) represented by Formula 10” did not require construction at that stage. Institution Dec. 9; see also id. at 7 (citing Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only terms which are in controversy need be construed and only to the extent necessary to resolve the controversy)). Neither party has argued post-institution that this phrase of claim 2 needs be construed. See PO Resp. 2; Pet. Reply 1–3. We conclude that no further construction of this phrase is necessary.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In the Institution Decision, we agreed with Petitioner that the variable construction of the phrase “each independently” is the broadest reasonable interpretation in light of the specification, and construed the phrase to mean that “each variable R81, R82, R83, and R84 is independent from one instance to another throughout the polymer.” Institution Dec. 13–14. Based on that construction, we also determined in the Institution Decision that claim 2 encompasses the following genera: (1) “Genus A,” which includes a poly(ethylene glycol) chain transfer agent flanked by poly(ethylene carbonate) chains (Pet. 24); (2) “Genus B,” which includes a poly(propylene glycol) chain transfer agent flanked by poly(propylene carbonate) chains (id. at 25–26); (3) “Genus C,” which includes a poly(propylene glycol) chain transfer agent flanked by poly(ethylene carbonate) chains (id. at 26); and (4) “Genus D,” which includes a poly(ethylene glycol) chain transfer agent flanked by poly(propylene carbonate) chains (id. at 27). Institution Dec. 12–13. Neither party opposes adopting the variable construction of the phrase “each independently” and the determination that, under the variable construction, claim 2 encompasses Genus A, Genus B, Genus C, and Genus D. PO Resp. 2; Pet. Reply 1–3. We maintain the variable construction of the phrase “each independently” on the complete record.” slip op. at 11
Patent outcomesUS 9,023,979 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,023,979 - 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
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