- Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Rehearing deniedPTAB · Oct 1, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Rehearing
The Board denied rehearing and maintained its denial of PGR because Petitioner did not show that Perkins and RCSB PDB made claims 1–30 more likely than not unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. LEGAL STANDARD Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). A rehearing request is not an opportunity for the requesting party to reargue its case or merely to express disagreement with the underlying decision. Nor is it an opportunity for the moving party to present new arguments that were not in its original submissions.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Owner’s argument persuasive because Perkins discloses embodiments with “mutations at I182 among a group of 20 other possible locations for modifications,” 13 of which are mutations of specific amino acids that “can be changed to any of the 19 other natural amino acids.” Id. Perkins discloses further that modifications at each of those 20 possible sites can be combined such that “one, two, or more” of the mutations can be made together in other embodiments (Ex. 1006, 17–18), or in other words, “each species [is] combinable to create a vast number of species.” Dec. 35. In addition to the locations of modifications expressly listed in Perkins, Perkins adds yet another option in which “the mutated VSV-G envelope protein is as described in Nikolic et al.” (Ex. 1006, 18), which “describes the crystal structures of VSV G bound to its native LDL-R receptor” that RCSB PDB depicts in entries 5OY9 and 5OYL (Dec. 18). We also considered Dr. Rose’s testimony about the crystal structures depicted in RCSB PDB, namely that a person of ordinary skill in the art would have been motivated to modify Perkins based on the VSV-G crystal structures in the RCSB PDB. Perkins taught that mutations to VSV-G “inhibit binding of VSV-G to the low-density lipoprotein receptor (‘LDL-R’), while preserving the VSV-G protein’s fusogenic function,” and expressly disclosed making a mutation at I182. (See, e.g., Ex. 1005 at 19:29-20:2, 20:29-21:14, 21:16-27; Ex. 1006 at 16.) The VSV-G crystal structures in the RCSB PDB taught that I182 is nearby negatively charged amino acids on the LDL-R. Thus, a person of ordinary skill in the art would have been motivated to incorporate a mutation which negated an interaction with the negatively charged residues in the LDL-R. (Ex. 1005 at 19:29–20:2; Ex. 1006 at 16.) Dec. 37. discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 7
§ 103 obviousnessPatents in suitUS 11,767,366 - Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing deniedPTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing
The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7
Claim construction§ 112 disclosurePatents in suitUS 10,155,039 - PTAB · Jun 30, 2020 · IPR2019-01517 · APJ Jennifer Meyer Chagnon · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show a reasonable likelihood that claims 21–28 and 31 were obvious over Voyksner, Watson, and Rainbow.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“The party challenging a decision in a request for rehearing bears the burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” Id. Upon a request for rehearing, the decision on a petition will be reviewed for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be indicated if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004). III. ANALYSIS” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“precursor of 25-hydroxvitamin D2 having a molecule weight of 412.7 g/mol.” Id. (citing Pet. 27; Ex. 1002 ¶ 57). Petitioner’s arguments explain what a skilled artisan could have done, i.e., select an appropriate precursor ion. However, as discussed in the Decision, the Petition, even when considered along with Dr. Fitzgerald’s testimony, “does not describe specifically why one of ordinary skill in the art would have selected the specific precursor ion” (Dec. 19), when as discussed above, multiple precursors are possible.5 See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“prior art teaches determining the presence or amount of 25-hydroxyvitamin D2 in a sample. However, as discussed in the Decision, claim 21 “requires more than merely determining the presence or amount of 25-hydroxyvitamin D2 in a sample.” Id. at 18. Petitioner does not argue that our interpretation of the plain meaning of claim 21 is incorrect or that we should disregard the step of generating “protonated and dehydrated precursor ion of said 25-hydroxyvitamin D2 with a mass to charge ratio (m/z) of 395.30±0.5.” See id. Accordingly, we are not persuaded that we overlooked Petitioner’s arguments. Further, we agree with Patent Owner that the Petition lacks sufficient explanation of why a person of ordinary skill in the art “would have chosen to [specifically] investigate 25-hydroxyvitamin D2 using Voyksner’s methods in the first place, particularly since Voyksner only discusses ‘dihydroxyvitamin D3’ for the purposes of evaluating the orientation of certain mass spectrometry equipment.” Opp. 5 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362–63 (Fed. Cir. 2016) (noting that it is error to accept general knowledge in the art without evidence on the record for limitations that are “not evidently and indisputably within the common knowledge of those skilled in the art”) (emphasis in original)).” slip op. at 9
§ 103 obviousnessPatents in suitUS 7,972,867 - Genome & Company v. The University Of ChicagoRehearing deniedPTAB · Jan 9, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Rehearing
The Board denied the Patent Owner’s rehearing request, leaving institution in place for claims 1–29 because the Board found no abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Owner’s argument. As we noted in our Decision, the issue of whether undue experimentation is required to practice the claimed invention is evaluated using the factors outlined in In re Wands, a fact based inquiry. Dec. 8. Our conclusion for purposes of institution that undue experimentation would be required to practice the claimed invention was based, not only on Dr. Braun’s statement to that effect, but on the detailed analysis presented by Petitioner and Dr. Braun of all of the Wands factors as supported by the evidence of record. Dec. 14–15. show that the experimentation required was other than routine and found it unpersuasive at the institution stage of the proceeding. Id. Patent Owner’s argument was based on the premise that Dr. Braun’s opinion regarding nonenablement was based on the number of experiments and not whether the experiments were routine. Prelim. Resp. 2–4. This argument ignores the fact that our consideration of Dr. Braun’s opinion was based on an analysis of all of the Wands factors, a fact based inquiry that includes analyzing the minimal guidance presented in the Specification and the unpredictability of cancer treatments and unpredictable nature of CPIS, and not merely the number of experiments required. Id. at 15; Ex. 1002 ¶ 166; In re Morsa, 713 F.3d 104, 109 (Fed. Cir. 2013) (“Enablement is a question of law based on underlying factual findings.”). Although we acknowledge Patent Owner’s argument in support of its position that the claimed subject matter is enabled, we remind Patent Owner that, for purposes of deciding whether to institute a post-grant review, we view a genuine issue of material fact in the light most favorable to the petitioner. 37 C.F.R. § 42.208(c). As Patent Owner offered attorney argument concerning enablement based on the current record, we resolved the parties’ dispute regarding enablement for which Petitioner offered Dr. Braun’s opinion as supported by evidence of record in favor of Petitioner.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for petitioner
“Patent Owner contends that we should reconsider our decision to institute to avoid having Patent Owner address Petitioner’s legally insufficient enablement challenge. Reh’g. Req. 6–9. Patent Owner further contends that we should exercise our discretion and deny the Petition to help maintain the integrity of the patent system and promote fairness. Id. We have considered Patent Owner’s new arguments and are not persuaded. Those arguments were not previously raised in the Preliminary Response, and a request for rehearing is not the proper vehicle to set forth new argument.” slip op. at 5
NonePatents in suitUS 9,855,302 - Hologic, Inc. v. Biomérieux, Inc.Rehearing deniedPTAB · Jan 31, 2019 · IPR2018-00569 · APJ Kristi L R Sawert · IPR · Rehearing
The Board denied Hologic’s rehearing request, leaving in place the denial of institution under § 325(d) for claims 1–6.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“The Board determined that these factors weighed in favor of denying institution because, inter alia: the Examiner considered the same prior art or prior art cumulative to Petitioner’s prior art during prosecution, id. at 12–13; the Examiner thoroughly considered the patentability of the ’352 patent’s claims over the lengthy period of prosecution, id. at 13–15; Petitioner’s arguments were substantially the same as the findings the Examiner made with respect to prior-art reference Montagnier, which is a strong (if not stronger) reference than the prior art Petitioner asserted in these Petitions for inter partes review, id. at 15–18; Petitioner failed to address §325(d) in the Petition, id. at 18; and Petitioner failed to persuade the Board that the Examiner erred in relying on the unexpected results shown in the Laayoun Declaration, id. at 18–21; see also id. at 21–22 (weighing the factors). As to the final finding, the Board considered Petitioner’s argument that the Laayoun Declaration is not persuasive evidence of non-obviousness because the Declaration compares the claimed invention to Bell’s prior-art primers, rather than Backus’s “closest prior art” primers. Id. at 20–21. The Board explained that Petitioner bears the burden to prove unpatentability in an inter partes review, and had failed, in this case, to provide “some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers.” Id. at 21. The Board noted that the Examiner was aware of Backus, but nevertheless “accepted Bell as the closest prior art.” Id. The Board “decline[d] to revisit that decision,” because “Petitioner d[id] not persuade us that the Examiner erred in accepting that evidence as showing unexpected results.” Id. at 21–22.” slip op. at 4
Discretionary denialPatents in suitUS 8,697,352 - Hologic, Inc. v. Biomérieux, Inc.Rehearing deniedPTAB · Jan 31, 2019 · IPR2018-00568 · APJ Kristi L R Sawert · IPR · Rehearing
The Board denied Hologic’s rehearing request, leaving in place the § 325(d) denial of institution for claims 1–6 because Hologic did not show the Board abused its discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters it believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“The Board determined that these factors weighed in favor of denying institution because, inter alia: the Examiner considered the same prior art or prior art cumulative to Petitioner’s prior art during prosecution, id. at 12–13; the Examiner thoroughly considered the patentability of the ’352 patent’s claims over the lengthy period of prosecution, id. at 13–15; Petitioner’s arguments were substantially the same as the findings the Examiner made with respect to prior-art reference Montagnier, which is a strong (if not stronger) reference than the prior art Petitioner asserted in these Petitions for inter partes review, id. at 15–18; Petitioner failed to address §325(d) in the Petition, id. at 18; and Petitioner failed to persuade the Board that the Examiner erred in relying on the unexpected results shown in the Laayoun Declaration, id. at 18–21; see also id. at 21–22 (weighing the factors). As to the final finding, the Board considered Petitioner’s argument that the Laayoun Declaration is not persuasive evidence of non-obviousness because the Declaration compares the claimed invention to Bell’s prior-art primers, rather than Backus’s “closest prior art” primers. Id. at 20–21. The Board explained that Petitioner bears the burden to prove unpatentability in an inter partes review, and had failed, in this case, to provide “some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers.” Id. at 21. The Board noted that the Examiner was aware of Backus, but nevertheless “accepted Bell as the closest prior art.” Id. The Board “decline[d] to revisit that decision,” because “Petitioner d[id] not persuade us that the Examiner erred in accepting that evidence as showing unexpected results.” Id. at 21–22.” slip op. at 4
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for patent owner
“Here, Petitioner attempted to show that Bell is not the closest prior art by presenting schematics comparing the nucleotide sequences of Backus’s primers to Bell’s primers and repeating Dr. Linnen’s statements that he considered the Backus primer set “closer” to the claimed primer set than the Bell primer set. Pet. 52–54 (citing Ex. 1020 ¶¶ 317–327). But neither Petitioner nor Dr. Linnen attempted to explain—or present any evidence— that Backus’s primers would have achieved the same results as the claimed primers. See Instit. Dec. 21. Put differently, Petitioner’s bare assertions failed to establish a reasonable likelihood that Patentee’s unexpected results would have been any different when compared to Backus. See Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006) (calling patent challenger Unilever’s argument that patentee Kao’s unexpected results were not compared to the closest prior art “not sustainable”: “Even if we were to conclude that Gangadharan was clearly the closest prior art, Unilever has not demonstrated, or even alleged, that Gangadharan achieved [the unexpected results] reported by Kao. . . . In the absence of such an allegation, any error made by the trial court in using Gueret for its comparison would be harmless.”). Third, we note that Petitioner’s case appears to rely on an overly mechanical application of the “closest prior art.” See Reh’g Req. 6–12. Although unexpected results must be shown to be unexpected compared to the closest prior art, the Federal Circuit has warned against applying that requirement “so rigidly as to require [patentee] to identify and focus on just one prior art product when multiple, similar” products “existed or were described in the prior art.” Tris Pharma, Inc. v. Actavis Labs. FL, Inc., 2019 WL 254418, at *7 (Fed. Cir. Jan. 16, 2019). Thus, as we stated in the Institution Decision, we decline to revisit the Examiner’s decision to accept the Laayoun Declaration absent some persuasive evidence that the claimed primers would not have been unexpectedly better than Backus’s primers. Instit. Dec. 21.” slip op. at 8
§ 103 obviousnessDiscretionary denialPatents in suitUS 8,697,352 - Coherus Biosciences, Inc. v. Hoffmann-Laroche Inc.Rehearing deniedPTAB · Jul 13, 2018 · IPR2017-02066 · APJ Wesley B Derrick · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution because Petitioner did not consistently define the claimed hinge or show an abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW 37 C.F.R. § 42.71(d) provides that: A party dissatisfied with a decision . . . may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply. See also Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“matters in construing the claims does not address our reasoning set forth in the decision. Contrary to Petitioner’s contentions, we did not construe the claims to be limited to fusion proteins comprising a hinge having the full amino acid sequence encoded by the corresponding hinge exon, including three cysteine residues. Although we did construe the claims to exclude “any protein with less than all of the amino acid sequence of the hinge domain of human IgG (or IgG1) immunoglobulin heavy chain, even if functional,” see Dec. 7, we could not discern from Petitioner’s discussion of the claims and the art any consistent demarcation in the amino acid sequence of human IgG (or IgG1) concerning where the first domain ends and the hinge domain begins. As we explained, the phrase “all of the domains of the constant region . . . other than the first domain of said constant region” leaves unsettled “where in the constant region the divide lies between the first domain of the constant region and the hinge domain.” Dec. 7–8. What is settled, however, is that the ordinary and customary meaning of the terms in the phrase requires that all constant region amino acid sequence that is not part of the first domain must be included in the fusion protein. Id. at 7. As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained:” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
Claim constructionPatents in suitUS 8,063,182 - Coherus Biosciences, Inc. v. Hoffmann-Laroche Inc.Rehearing deniedPTAB · Jul 13, 2018 · IPR2017-01916 · APJ Wesley B Derrick · IPR · Rehearing
The Board denied rehearing, leaving in place the denial of institution for claims 1–36 of the ’182 patent and claims 1–10 of the ’522 patent because Petitioner did not show an abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW 37 C.F.R. § 42.71(d) provides that: A party dissatisfied with a decision . . . may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply. See also Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
- BurdenDecided for patent owner
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
NonePatents in suitUS 8,163,522 - Guardant Health, Inc. v. Foundation Medicine, Inc.Rehearing deniedPTAB · Nov 8, 2017 · IPR2017-01170 · APJ Richard J Smith · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving instituted review of claims 65, 66, 72, 73, 75–77, and 80–85 based on its reasonable-likelihood determination.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“DISCUSSION When rehearing a decision on petition, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“According to the ’830 patent, the term “bait” is defined as including “a nucleic acid molecule . . . which can hybridize to (e.g., be complementary to), and thereby allow capture of a target nucleic acid.” Ex. 1001, 28:47–50. Patent Owner acknowledges that “both primers and baits hybridize to a complementary portion of the target nucleic acid.” Req. Reh’g. 3 (citing Prelim. Resp. 30). However, Patent Owner does not explain or otherwise persuasively address why the subject nucleic acids in Shah are not included within that definition of “bait.” We did not overlook Patent Owner’s explanation of why, in its view, “primers” are not “baits.” Rather, at this stage of the proceeding, we found such explanation unpersuasive as we stated in the Decision. Dec. 13. (stating “we are not persuaded that the definition of the term ‘bait,’ as set forth in the ’830 patent, does not include primers”). Moreover, because we did not overlook Patent Owner’s explanation, we find no basis to reconsider the disclosures of Shah.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successDecided for petitioner
“We did not overlook and/or misapprehend Patent Owner’s argument. We expressly addressed that argument with respect to bait sets (i) and (ii) by stating that “we find that choosing bait sets that select somatic mutations that appear at a frequency of about 5% or less and at a frequency of about 10% or higher is taught or suggested by the combined teachings of Levin and Shah.” Dec. 17 (emphasis added); see also Dec. 20 (“Having considered the arguments and evidence, we are persuaded at this stage of the proceeding that Petitioner has sufficiently shown that the limitations of claim 65 are taught or suggested by, or would have been obvious in view of, the combined teachings of Levin and Shah.”). Moreover, contrary to Patent Owner’s argument, the fact that the Decision may not recite the words “used together” does not indicate that we overlooked and/or misapprehended Patent Owner’s argument. See Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017) (stating “this court has said on multiple occasions that failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it”) (citing cases).” slip op. at 5
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Decided for petitioner
“We did not overlook and/or misapprehend Patent Owner’s argument; rather, we considered it and found it unpersuasive. See Dec. 13 (stating “on this record, we find that Levin’s disclosure of multiple baits would include multiple bait sets”). In particular, we found that Levin teaches the use of multiple bait sets, not one bait set as argued by Patent Owner. See id. Furthermore, Patent Owner’s argument that all of the baits in Levin were “designed in precisely the same way” was based on Levin’s statement that “[b]aits were designed in a tiling fashion with minimal overlap to span the entire protein-coding region of each transcript.” See Prelim. Resp. 28 (citing Ex. 1010, 2). However, that statement suggests the design of multiple different baits that would include multiple different bait sets.” slip op. at 6
Claim construction§ 103 obviousnessPatents in suitUS 9,340,830 - Merial, Inc. v. Sergeant’S Pet Care Products, Inc.Rehearing deniedPTAB · Aug 3, 2017 · IPR2016-00798 · APJ Susan L C Mitchell · IPR · Rehearing
The Board denied Merial’s rehearing request, leaving institution denied for claims 1–22 because the evidence did not show that the prior art suggested the claimed cyphenothrin concentration.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party requesting rehearing bears the burden of showing that the decision should be modified. 37 C.F.R. § 42.71(d). The party must identify specifically all matters we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. Id. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3 For the foregoing reasons, Petitioner has not demonstrated that we abused our discretion in denying institution of an inter partes proceeding in this case. Consequently, Petitioner’s Request for Rehearing is denied.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We considered this evidence of Dr. Clark’s testimony concerning the teachings of Sirinyan and Garden in making our Decision on Institution and found it insufficient to institute an inter partes proceeding. See Dec. 9–14. First, besides citing to references that indicate that cyphenothrin may exhibit Type I and Type II characteristics, Dr. Clark offers no other evidence that one of skill in the art would apply such knowledge to the teachings of Sirinyan to reasonably expect that the lower concentration range for α-cyanopyrethroids disclosed generally in Sirinyan would be effective for cyphenothrin. See Ex. 1002 ¶¶ 51, 60–67; 37 C.F.R. 42.65(a). We also noted in our Decision on Institution that “Sirinyan describes how not all pyrethroids are found to work with fipronil at the same concentrations,” which would indicate that a lower concentration than that explicitly provided for cyphenothrin may not be effective. Dec. 12. We also noted Sirinyan’s specifically disclosed lower concentration range for α-cyanopyrethroids specifically included α-cypermethrin, which is consistent with Garden’s examples using α-cypermethrin, not cyphenothrin, effectively at lower concentrations. Id. at 12–13. We did not misapprehend or overlook Petitioner’s evidence; we simply found it insufficient.3” slip op. at 5
§ 103 obviousnessPatents in suitUS 8,614,244
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.