- PTAB · Sep 14, 2022 · IPR2022-00722 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–6 on all petitioned grounds, finding a reasonable likelihood of prevailing on the obviousness challenges, and granted the motion to amend the RPI disclosure.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We disagree with Patent Owner’s argument that Hidaka 1998 and Hidaka 2000 contain substantially the same disclosure as Li. The Petition relies on the sequence alignment in Li Figure 6(a), which compares the amino acid sequences of human and rat uroguanylin along with other uroguanylin and guanylin sequences and a ST sequence from E. coli. See, e.g., Pet. 24–26, 33–34 (citing Ex. 1006, 52 (Fig. 6(a))). As Patent Owner points out, Hidaka 2000 also discloses a sequence alignment showing the sequences of human and rat uroguanylin. Prelim. Resp. 34 (citing Ex. 2009, Fig. 1). However, Li provides additional teachings analyzing the sequence alignment in its Figure 6(a) to identify the residues that are of “particular interest” to the binding of the guanylin receptor (GCC). Ex. 1006, 54 (left column). Among the residues of “particular interest” that Li identifies are the Asp3 in human uroguanlyin and the corresponding glutamic acid residue in rat uroguanylin. Id. Petitioner relies on these teachings in Li for its argument that it would have been obvious to make a “conservative substitution” of glutamic acid for the Asp3 in human uroguanylin, thereby arriving at the peptide of SEQ ID NO:20. See Pet. 26, 34–36. Based on our review, there is no corollary in Hidaka 1998 or Hidaka 2000 to these additional teachings in Li, nor does Patent Owner identify such in its Preliminary Response. Thus, we agree with Petitioner that “Li is not cumulative” of the references that were before the Examiner. See Pet. 56; Reply 2–3 (urging that Li is not cumulative because it “shows the aspartic and glutamic acid residues in the second and third positions and identifies them as important for uroguanylin’s desirable activity level”).” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner has demonstrated a reasonable likelihood that it will prevail in showing that claim 1 is unpatentable. Based on the current record, Petitioner has shown that Currie teaches the amino acid sequence for human uroguanylin and that Currie identifies this peptide as a drug candidate for patients suffering from constipation. Ex. 1005, 1:50–55, 2:20–24. The only difference between SEQ ID. NO:20 in claim 1 and the sequence taught in Currie is the residue at position 3. In Currie’s sequence there is an Asp3, whereas SEQ ID NO:20 has a Glu3. Based on the current record, Petitioner has demonstrated that a POSA would have been motivated to substitute glutamic acid for the Asp3 in Currie’s human uroguanylin sequence, thereby resulting in the peptide of claim 1. In particular, the Petition relies on Dr. Peterson’s testimony that: (1) aspartic acid and glutamic acid are structurally similar such that substituting glutamic acid for aspartic acid would have been regarded as a “conservative substitution,” which was a “primary strategy employed by protein engineers” (Ex. 1002 ¶¶ 73–75); (2) Li teaches that the presence of an acidic residue at position 3 in human uroguanylin is of “particular interest” to the ligand/receptor interaction and its sequence alignment shows that rat uroguanlyin has a glutamic acid at the corresponding position, both of which would suggest substituting glutamic acid for the Asp3 in human uroguanylin (id. ¶¶ 137–152); (3) a POSA would have expected that the peptide resulting from this substitution “would be comparably more protonated than native human uroguanylin . . . in the large intestine and intestinal mucosa” and therefore it would have been reasonably expected to have “improved activity” as compared to the native human uroguanylin (id. ¶¶ 165–170); and (4) a POSA would have understood that another benefit of this substitution would be that it eliminates known sources of aspartimide formation during synthesis (id. ¶¶ 175–179). See Pet. 34–39. On the current record, this evidence, which is largely unrebutted, is sufficient to show that a POSA would have been motivated to substitute glutamic acid for the Asp3 in human uroguanylin and would have had a reasonable expectation of success in doing so.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Based on the current record, Petitioner has demonstrated that a POSA would have been motivated to substitute glutamic acid for the Asp3 in Currie’s human uroguanylin sequence, thereby resulting in the peptide of claim 1. In particular, the Petition relies on Dr. Peterson’s testimony that: (1) aspartic acid and glutamic acid are structurally similar such that substituting glutamic acid for aspartic acid would have been regarded as a “conservative substitution,” which was a “primary strategy employed by protein engineers” (Ex. 1002 ¶¶ 73–75); (2) Li teaches that the presence of an acidic residue at position 3 in human uroguanylin is of “particular interest” to the ligand/receptor interaction and its sequence alignment shows that rat uroguanlyin has a glutamic acid at the corresponding position, both of which would suggest substituting glutamic acid for the Asp3 in human uroguanylin (id. ¶¶ 137–152); (3) a POSA would have expected that the peptide resulting from this substitution “would be comparably more protonated than native human uroguanylin . . . in the large intestine and intestinal mucosa” and therefore it would have been reasonably expected to have “improved activity” as compared to the native human uroguanylin (id. ¶¶ 165–170); and (4) a POSA would have understood that another benefit of this substitution would be that it eliminates known sources of aspartimide formation during synthesis (id. ¶¶ 175–179). See Pet. 34–39. On the current record, this evidence, which is largely unrebutted, is sufficient to show that a POSA would have been motivated to substitute glutamic acid for the Asp3 in human uroguanylin and would have had a reasonable expectation of success in doing so.” slip op. at 19
- Skill levelSkill level petitioner adoptedDecided for petitioner
“At this stage in the proceeding, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record. Accordingly, we apply this description in our analysis herein.” slip op. at 13
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 7,041,786 - PTAB · May 31, 2022 · IPR2022-00403 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–33, finding a reasonable likelihood of success on the Pioneer Hi-Bred anticipation ground and the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Advanced Bionics9 sets out a two-part framework for analyzing these factors. In the first part, we consider factors (a), (b), and (d) to determine whether the art and arguments presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, 8–10. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office,” then we move on to the second part of the analysis to determine “whether the petitioner has demonstrated a material error by the Office” in view of factors (c), (e), and (f). Id.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“On balance, the record before us does not support either party’s view as to the proximity of the district court’s trial date to the projected deadline for our final written decision. Accordingly, this factor is neutral.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claims 1 and 19, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown that Table 8 of Pioneer Hi-Bred discloses a synthetic CRISPR crRNA molecule having one or more 2’-O-methyl modifications in its guide sequence (i.e., SEQ ID No: 66 and SEQ ID No: 68). See, e.g., Pet. 26–30. Petitioner also demonstrates sufficiently for institution that Pioneer Hi-Bred discloses a tracrRNA segment complementary to a stem sequence of the crRNA. Id. at 19–25. Petitioner points to Pioneer Hi-Bred’s disclosure that “the modified gRNAs such as those described in [] Tables 7 and 8 can be used to edit cells, e.g., maize cells,” (see id. at 26) thus demonstrating sufficiently for institution that Pioneer Hi-Bred discloses that the modified crRNAs in Table 8 have guide RNA functionality in a CRIPSR-Cas system.” slip op. at 25
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’034 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 11 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 20
Claim constructionDiscretionary denialcites KSR · GrahamPatents in suitUS 10,900,034 - PTAB · May 31, 2022 · IPR2022-00402 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–30, finding a reasonable likelihood of success on the anticipation challenge and all asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Petitioner has shown that Pioneer Hi-Bred discloses examples of synthetic guide RNA and crRNA molecules having the recited modifications at their 3’ and 5’ ends. See Pet. 20–24 (referring to Table 8 of Ex. 1006). That disclosure undermines the Applicant’s arguments during prosecution that: (1) “a skilled person would not modify a CRISPR guide RNA or crRNA at the particularly claimed positions,” and (2) the reference to “‘securing or steadying the structure’ of RNA in [Zhang] relates to secondary structure” as opposed to “modifications at the claimed positions,” i.e. within five nucleotides from one or both of the ends. Ex. 1002, 783. Both of these arguments were credited by the Examiner as reasons for withdrawing the rejection over Zhang. Id. at 783–784. Thus, Petitioner has sufficiently shown that the Examiner materially erred by not recognizing the relevance of Pioneer Hi-Bred’s disclosure and in particular the crRNA examples in Table 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“On the current record, we determine that the merits of Petitioner’s anticipation ground appear to be particularly strong for the independent claims and for those dependent claims where Petitioner’s arguments are similarly premised on the crRNA examples in Table 8 being anticipatory without any further modification. See infra § V.E (explaining that, on the current record, Petitioner has shown that Pioneer Hi-Bred Table 8 discloses presumptively-enabled examples that read on claims 1 and 12 as well as a number of the dependent claims). Accordingly, we find that this factor weighs strongly against exercising discretion to deny institution. G. Weighing of Fintiv Factors Considering the Fintiv factors as part of a holistic analysis of the factors discussed above, we are not persuaded that the interests of the efficiency and integrity of the system would be served by invoking our authority under 35 U.S.C. § 314(a) to deny institution of a potentially meritorious Petition. Accordingly, we do not exercise our discretion to deny institution under § 314(a).” slip op. at 18
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Neither party identifies any claim term for construction. Pet. 17; Prelim. Resp. 35. We agree that no formal claim construction is necessary at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor 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 21
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,337,001 - Rimfrost As v. Aker Biomarine Antarctic AsAll claims unpatentablePTAB · Apr 6, 2022 · IPR2020-01533 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1–19 are unpatentable as obvious over the combined prior art, considered with the knowledge of a person of ordinary skill in the art.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Neither Patent Owner nor Dr. Jaczynski disputes Petitioner’s definition of a person of ordinary skill in the art. Ex. 2015 ¶ 8 (“For purposes of this proceeding, I will accept [Petitioner’s] definition of a [person of ordinary skill in the art].”). Upon review of the ’046 patent and the prior art of record, we find Petitioner’s uncontested definition reasonable and supported by the evidence of record. Accordingly, we adopt this definition of one of ordinary skill in the art for purposes of this Decision.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Upon review of the parties’ arguments and supporting evidence, we determine that no terms of the ’046 patent require construction in order to resolve the disputes in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting 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 9
- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“Collateral estoppel protects a party from having to litigate issues that have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013). In the context of patent claims, collateral estoppel applies “[i]f the differences between the unadjudicated patent claims and adjudicated patent claims do not materially alter the question of invalidity.” Id. Petitioner points to no prior decision of the Board where the issue of whether it would have been obvious to denature a krill product and then store it for 1 to 36 months before extraction was at issue. Moreover, to demonstrate that the added limitation would have been obvious, Petitioner relies heavily on the disclosures of Budziński, which was not at issue or analyzed in the prior proceedings. Pet. 39. Accordingly, Petitioner has not demonstrated that collateral estoppel applies to any issue in this proceeding. slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Breivik II’s disclosures would have understood that extraction of fresh krill is preferable over stored krill products, and that extraction should be performed on the fishing vessel as opposed to on land. PO Resp. 53. On this record, we agree with Patent Owner that Breivik II teaches or suggests a successful method of immediately processing and extracting fresh caught krill on-board a fishing vessel. We also agree that Breivik II suggests that its disclosed method may have advantages over conventional krill oil extraction processes. The disclosed advantages to immediately denaturing and extracting krill oil discussed in Breivik II, however, are only “expected,” not definitive, and we are directed to no disclosure in Breivik II to suggest that extraction from a stored, denatured krill meal was unlikely to result in a useful krill oil. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (noting that the case law “does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art in order to provide motivation for the current invention”); In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (explaining that a reference teaches away when it suggest that a particular course of action “is unlikely to be productive of the result sought by the applicant,” and that “[a] known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product of the same use”). Moreover, although, as noted in Breivik II, oxidation and enzymatic hydrolysis are of particular concern during krill processing procedures, Petitioner and Dr. Tallon persuasively demonstrate that the denatured and “stable” krill meal of Budziński was not subject to significant enzymatic hydrolysis or deterioration of krill lipid antioxidants, such as astaxanthin. Ex. 1006 ¶¶ 172, 421, 434; Ex. 1086 ¶¶ 50–51; see also Ex. 1010, 822–823 (Fricke disclosing storing denatured krill products for a period of time before extraction with a polar solvent). As such, we are not persuaded that Breivik II would have taught away from, or otherwise discouraged, one of ordinary skill in the art from extracting krill oil from a denatured and stable krill meal that has been stored from between 1 and 36 months. Patent Owner further argues that, consistent with Breivik II’s disclosures, Budziński instructs that krill should be “processed as soon as possible after capture” and that “[t]he only way to meet this requirement is to install processing facilities on-board the vessel.” PO Resp. 51 (citing Ex. 1008, 25). The required processing of Budziński, however, is to denature the problematic krill enzymes, not to extract krill oil. Ex. 1008, 25. And, once the krill products are denatured, Petitioner persuasively demonstrates that krill oil extraction could be successfully performed either on-board a vessel or on land after a storage period of up to 13 months. In view of the foregoing, we find that Breivik II and Budziński do not teach away from, or counsel against, extracting krill oil from a krill meal that had been denatured and stored for 1 to 36 months.” slip op. at 26
Patent outcomesUS 9,816,046 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,816,046 - New World Medical, Inc. v. The Regents Of The University Of CaliforniaAll claims unpatentablePTAB · Mar 11, 2022 · IPR2021-00066 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–11 are unpatentable: claims 1–11 are anticipated by Quintana and obvious over Quintana; the Board did not reach the Jacobi ground.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Patent Owner filed a motion to exclude evidence (Paper 38); Petitioner opposed (Paper 41); and Patent Owner filed a reply in support of its motion (Paper 43). Petitioner also filed a motion to exclude evidence (Paper 39); Patent Owner opposed (Paper 40); and Petitioner filed a reply in support of its motion (Paper 42). We addressed (and denied) the parties’ motions to exclude in Paper 49.” slip op. at 3
- Expert testimonyPetitioner expert creditedPatent owner expert discountedOther
“We “conclude[d] that the better course is to have a complete record of the evidence,” and, therefore, denied Petitioner’s Motion, but also explained that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance thereon ventures into areas the witness has conceded he either does not understand or has inadequately analyzed,” we would accord it little weight, as distinguished “from that relating to Dr. Condon’s technical expertise in, for example, anatomy, eye surgery, and his own reading of evidence.” Order 13. Therefore, it is through this lens that we consider and analyze Dr. Condon’s testimony here.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 22 (citing Ex. 1003 ¶ 24). On page 18 of our Institution Decision, we provisionally accepted Petitioner’s proposed definition, which was not opposed by Patent Owner, and is consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’544 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). As Patent Owner expressly agrees with our analysis, we apply Petitioner’s proposed definition here. See PO Resp. 11, n.4. C.” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“1. “A device useable to create an opening in the trabecular meshwork of the eye” Independent claim 1 is directed to “[a] device useable to create an opening in the trabecular meshwork of the eye” and having a “foot member . . . advanceable, tip first, through Schlemm’s Canal to facilitate performance of a surgical procedure using the surgical instrument.” Ex. 1001, 23:4–5, 23:18–20. As an initial matter, we consider the preamble of claim 1 limiting here because a device that “create[s] an opening in the trabecular meshwork” recites or, at a minimum, implies, “essential structure or steps” required for the insertion and advancement of the instrument through Schlemm’s Canal as set forth in [1.d]. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).8” slip op. at 26
Patent outcomesUS 9,999,544 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,999,544 - Janssen Biotech, Inc. v. The United States Of America, As Represented By The Secretary, Department Of Health & Human ServicesInstitution deniedPTAB · Mar 2, 2022 · IPR2021-01484 · APJ Robert A Pollock · IPR · Institution
The Board denied institution of IPR challenging claims 1–9, 13, 17, and 19 as obvious over Milone and Kalled under § 103, exercising discretion under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 8–10 (Feb. 13, 2020) (“Advanced Bionics”) (precedential), the Board addresses § 325(d) applying a “two-part framework.” In the first part of the framework, we ask whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments 8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. 22 previously were presented to the Office. Advanced Bionics at 8. Factors (a), (b), and (d) of Becton, Dickinson come into play under this first part of the framework. Id. at 8–10. If either condition of the framework’s first part is met (e.g., substantially the same art is presented), we move to part two of the framework, asking “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. at 8. Factors (c), (e), and (f) of Becton, Dickinson fall within part two of the framework. Id. at 10 (“[F]actors (c), (e), and (f) relate to whether the petitioner has demonstrated material error by the Office.”). Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9. “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9 (“If reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.”). B.” slip op. at 22
- Skill levelSkill level patent owner adoptedOther
“Patent Owner does not dispute Petitioner’s proposed definition, but states that the person of ordinary skill in the art would “[t]ypically” . . . have had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors.” Prelim. Resp. 44 (citing Ex. 2001 ¶ 20). According to Patent Owner, the ordinarily skilled artisan “would have had knowledge of the scientific literature and have skills relating to chimeric T cell receptors and methods of using such receptors” and “may have worked as part of a multidisciplinary team” and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist. See id. at 43–44. Considering the record before us, both parties present reasonable definitions of one of ordinary skill in the art. For the purpose of this proceeding, we consider one of ordinary skill in the art as having had an M.D. or a Ph.D. in immunology, biochemistry, cell biology, molecular biology, or a related discipline, with at least two years of experience in conducting laboratory research on chimeric T cell receptors and/or the use of CAR-T immunotherapy. Consistent with Patent Owner’s proposed definition, the ordinarily skilled artisan may have worked as part of a 20 multidisciplinary team and been able to draw on the specialized skills of, for example, an immunologist, and/or a clinical oncologist.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for patent owner
“We do not find Petitioner’s argument persuasive for the reasons set forth on pages 34–40 of the Preliminary Response. Most particularly, we note that the phrase “[a] chimeric antigen receptor (CAR)” occurs solely in the preamble of independent claim 24. Terms in a preamble, however, are not generally construed as limiting. See Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). More specifically, “when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention,” the preamble is not considered a limitation. Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). In the present case, we find it plausible—if not likely—that the Examiner gave no weight to the terms in the preamble of claim 24 such that the remaining language did not expressly or implicitly require either a 32 transmembrane domain, or a “T-cell activation moiety” specific to CAR constructs. The Examiner appears to have recognized, however, that CAR constructs differ from Kalled’s antibodies at least in having a transmembrane domain as expressly recited in claims 29 and 30. See Ex. 2005, 605, 745–749 (allowing amended claims). This view is underscored by the Examiner’s decision not to reject claims 34 and 38 as anticipated by Kalled. See Ex. 2005, 604. Notably, claims 34 and 38 recite SEQ ID Nos 4–12, each of which encodes a complete CAR construct and, thus, implicitly includes a transmembrane domain. See id. at 589 (claiming a CAR comprising the amino acid sequence of SEQ ID Nos: 4–12 (claim 34) or a nucleic acid encoding the same (claim 38)); Ex. 1001, 9:49–53; Ex. 2001 ¶ 92.12” slip op. at 32
Claim constructionDiscretionary denialcites GrahamPatents in suitUS 9,765,342 - Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentablePTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision
Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” Ruschig, 379 F.2d at 995.” slip op. at 34
Patent outcomesUS 9,693,961 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites NautilusPatents in suitUS 9,693,961
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.