- PTAB · Nov 28, 2017 · IPR2016-01034 · APJ Robert A Pollock · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–3, 5, and 6 unpatentable under Ground IV based on Akinaga and the cited supporting references.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“37 C.F.R. § 42.71(d), which provides in relevant part: 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, an opposition, or a reply.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“UCN-01 alone, and in combination with the DNA damaging agent mitomycin C. See Dec. 27–28; Ex. 1004. Noting that the two compounds had 1) complementary effects in delaying cell cycle progression; and 2) synergistic cytotoxic and antitumor effects, Akinaga expressly suggests the combination of UCN-01 and DNA-damaging agents for cancer chemotherapy. Id. Seynaeve establishes that UCN-01 inhibits multiple tyrosine kinases in human breast cancer cells coincident with promoting cell cycle arrest. Dec. 28–29, 34–35; Ex. 1014. Accordingly, “Seynaeve proposes a link between UCN-01’s inhibitory effects on tyrosine kinases and its inhibitory effects on the cell cycle.” Dec. 29.8 Akinaga further suggests combining a chemotherapeutic DNA damaging agent with UCN-01 because the two compounds cause delays in different stages of the cell cycle and result in synergistic cytotoxic and antitumor effects, whereas Seynaeve examines the effects of UCN-01 on the cell cycle of human carcinoma cells and shows that UCN-01 is a tyrosine kinase inhibitor. See Dec. 37–38. Because both references 8 Considering Seynaeve teachings with respect to UCN-01, we reject Patent Owner’s contention that “there is no evidence from which one can reasonably find that Petitioner carried its burden of proving that people of ordinary skill in the art considered either staurosporine or UCN-01 to be tyrosine kinase inhibitors.” See Reh’g. Req. 6. one of ordinary skill in the art would have found reason to combine their teachings. See id.” slip op. at 4
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Akinaga teaches that UCN-01 inhibits v-src (as does Seynaeve), one of ordinary skill in the art would have no reason to believe that UCN-01 would inhibit its cellular homolog c-src because v-src is “found only in chickens” and “is more difficult to inhibit.” Dec. 28, 32. We instead credited the testimony of Petitioner’s expert, Dr. Eastman that “[b]ecause v-Src and c-Src have similar structures, compounds that inhibit the tyrosine kinase activity of v-Src generally inhibit c-Src as well. Thus, a person of ordinary skill would have understood that an inhibitor of v-Src would also inhibit the c-Src protein present in A431 cells and other human tumors.” Id. at 33 (quoting Ex. 1002 ¶ 202). Dr. Eastman testified that Robinson, for example, showed “that staurosporine, a molecule very similar to UCN-01, inhibited both v-Src and c-Src. . . . Thus, a person of ordinary skill in the art would have recognized that UCN-01 would inhibit tyrosine kinases in both animals and humans.” Id.” slip op. at 5
§ 103 obviousnessPatents in suitUS 7,838,512 - 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 - PTAB · Oct 20, 2017 · IPR2017-01582 · APJ Erica A Franklin · IPR · Institution
The Board dismissed the joinder motion as moot and denied institution because the petition was time-barred under § 315(b).
RulingsInstitution decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“II. ANALYSIS A. The Motion for Joinder is Moot Petitioner seeks joinder with the Mylan IPR. Mot. 1. The Mylan IPR has been terminated based on a settlement between the parties. See IPR2017-00200, Paper 23. Thus, there is no longer a pending proceeding for Petitioner to join. Accordingly, we dismiss the Motion for Joinder as moot.” slip op. at 5
- PTAB / AIA Trials › §315(b) time barInstitution denied time barInstitution denied
“B. The Petition Is Time-Barred Under 35 U.S.C. § 315(b) Section 315(b) bars institution of inter partes review when the petition is filed more than one year after the petitioner is served with a complaint alleging infringement of the patent. 35 U.S.C. § 315(b). The one-year time bar, however, does not apply to a request for joinder. Id. The decision whether to grant joinder is discretionary. Id. at § 315(c).” slip op. at 5
Discretionary denialPatents in suitUS 8,603,514 - Par Pharmaceutical, Inc. / Intelgenx Corp. v. Monosol RX, LLCInstitution deniedPTAB · Oct 20, 2017 · IPR2017-01557 · APJ Erica A Franklin · IPR · Institution
The Board dismissed the joinder motion as moot and denied institution because the petition was time-barred under § 315(b).
RulingsInstitution decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, deniedDenied
“II. ANALYSIS A. The Motion for Joinder is Moot Petitioner seeks joinder with the Mylan IPR. Mot. 1. The Mylan IPR has been terminated based on a settlement between the parties. See IPR2017-00200, Paper 23. Thus, there is no longer a pending proceeding for Petitioner to join. Accordingly, we dismiss the Motion for Joinder as moot.” slip op. at 5
- PTAB / AIA Trials › §315(b) time barInstitution denied time barInstitution denied
“is filed more than one year after the petitioner is served with a complaint alleging infringement of the patent. 35 U.S.C. § 315(b). The one-year time bar, however, does not apply to a request for joinder. Id. The decision whether to grant joinder is discretionary. Id. at § 315(c). Petitioner admits that Patent Owner filed a complaint alleging infringement of the ’514 patent against Petitioner on April 4, 2014. Mot. 2 (explaining that a complaint alleging infringement of the ’514 patent against Par Pharmaceutical, Inc. and Intelgenx Corp., LLC was filed on April 4, 1 R. Ilango et al., In-Vitro studies on Buccal strips of Glibenclamide using Chitosan, 59 INDIAN J. PHARM. SCI. 232–35 (1997). Ex. 1005 (“Ilango”). 2 Patent Application Publication No. WO 00/42992 by Li-Lan Chen et al., published July27, 2000. Ex. 1006 (“Chen”). 2014). Petitioner was served with that complaint on April 7, 2014, more than one year before it filed its Petition. See Ex. 2003 (Par Proof of Service); Ex. 2004 (Intelgenx Proof of Service). Despite the late filing, Petitioner asserts as its grounds for standing that “under 37 C.F.R. § 42.104(a), if the simultaneous motion for joinder is granted, the ’514 patent is available for inter partes review.” Pet. 20. As discussed above, Petitioner’s Motion for Joinder is dismissed as moot because there is no instituted inter partes review for Petitioner to join. Thus, the Petition is statutorily barred, and no inter partes review may be instituted. 35 U.S.C. § 315(b).” slip op. at 5
Discretionary denialPatents in suitUS 8,603,514 - Incyte Corporation v. Concert Pharmaceuticals, Inc.Institution deniedPTAB · Oct 19, 2017 · IPR2017-01256 · APJ Tina E Hulse · IPR · Institution
The Board denied institution on claims 1–15 because Petitioner did not show a reasonable likelihood of proving anticipation by Rodgers or obviousness over either asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a); see also 37 C.F.R. § 42.4(a) (stating Director has delegated institution authority to Board). Upon considering the Petition and Preliminary Response, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of claims 1–15 of the ’149 patent. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“15, 2012, would have had a “master’s degree or a Ph.D. in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, physical organic chemistry or a related discipline,” or a lesser degree with more experience.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). Anticipation may arise where a reference describes a “definite and limited class,” and a person of ordinary skill in the art would “at once envisage each member of this limited class.” In re Petering, 301 F.2d 676, 681 (CCPA 1962).” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,249,149 - Mylan Laboratories Limited v. Aventis Pharma S.A.All claims unpatentablePTAB · Sep 21, 2017 · IPR2016-00712 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–5 and 7–30 are unpatentable; the contingent motion to amend claims 27–30 with substitute claims 31–34 is denied.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“unpatentable. Therefore, we address Patent Owner’s contingent motion to enter proposed substitute claims 31–34. MTA 1, App. (claims 31–34). For the reasons that follow, Patent Owner’s motion is denied.” slip op. at 66
- ExcludeMotion to exclude, deniedDenied
“McSorley’s Declaration in connection with Exhibits 1089 or 1090 to support our decision. Therefore, Patent Owner’s Motion to Exclude Exhibits 1089 and 1090 is denied as moot.” slip op. at 81
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“e. Conclusion When we balance Petitioner’s strong evidence of obviousness against” slip op. at 52
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73(a) regarding the patentability of the challenged claims. In this case, the claimed treatment method, administering a 20 to 25 mg/m2 dose of cabazitaxel in combination with prednisone to docetaxel-refractory metastatic prostate cancer patients, was disclosed more than one year before the earliest effective filing date to which the ’592 patent might be entitled.4 Therefore, for the reasons that follow and based on our review of the complete trial record, we determine Petitioner has shown by a preponderance of the evidence that claims 1–5 and 7–30 of the ’592 patent are unpatentable. We further determine that Patent Owner’s Contingent Motion to Amend claims 27–30 is denied.” slip op. at 4
Patent outcomesUS 8,927,592 unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,927,592 - Osi Pharmaceuticals, LLC / Genentech, Inc. v. Arch Development Corp.All claims unpatentablePTAB · Sep 11, 2017 · IPR2016-01034 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–3, 5, and 6 are unpatentable: claims 1–3, 5, and 6 as obvious over Akinaga, Seynaeve, Friedman, and Tam; claim 6 also over Honma.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art as of the effective filing date of the ’512 patent, “would have held an M.D. or Ph.D. in molecular biology, biochemistry, pharmacology, or a related field and have had several years of experience working in cancer research.” Pet. 17 (citing Ex. 1002 ¶ 19); PO Resp. 4. This level of ordinary skill is consistent with the prior art asserted in the Petition. See Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 779 n.2 (Fed. Cir. 1983) (indicating that the prior art itself may reflect the appropriate level of ordinary skill in the art). Accordingly, we adopt the parties’ definition for the purpose of this Decision. C.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Plain and ordinary meaningTerm construed board ownDecided for patent owner
“which defines a “therapeutically effective amount” as “an amount of a DNA damaging agent and tyrosine kinase inhibitor that, when administered to an animal in combination, is effective to kill cells within the animal.” Id. at 5. The challenged claims, however, use “therapeutically effective amount” in a context different from the express definition set forth in the Specification. As noted by Petitioner, the definition at column 4, lines 16 to 19 of the Specification refers to “a combined amount of the DNA damaging agent and the tyrosine kinase inhibitor, while the claims require that only the tyrosine kinase inhibitor be administered in a ‘therapeutically effective amount.’” See Pet. 20.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Specification suggest that the inventors contemplated the induction of a differentiation pathway. See Ex. 2011 ¶ 4. To the contrary, and as discussed above in Section 1(C), the Specification focuses on the use of DNA damaging agents in combination with tyrosine kinase inhibitors to force damaged cells to override the G2 arrest checkpoint and enter mitosis before completing DNA repairs. See, e.g., Ex. 1001, 3:46–48 (“By preventing delays in G2, cells will enter mitosis before the DNA is repaired and therefore the daughter cells will likely die.”). Accordingly, we agree with Patent Owner that, in light of the Specification, one of ordinary skill in the art would not understand the terms “enhanc[ing] cell death” and “enhancing apoptosis” to encompass the a process by which cancer cells are differentiated, become mortal, and, subsequently, “live out their days and die.” See Pet. 29; Ex. 1002, ¶ 127.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“The parties agree that the preamble of each challenged claim, as well as the “thereby” clause of claims 1–3 (“thereby improving chemotherapeutic intervention”), are non-limiting. Pet. 17–18, 21–22; Prelim. Resp. 5, 8; Ex. 2001, 15. On the present record, we adopt the parties’ proposed Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (instructing that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). D.” slip op. at 16
Patent outcomesUS 7,838,512 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,838,512 - Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution deniedPTAB · Sep 7, 2017 · IPR2017-01009 · APJ Michelle N Ankenbrand · IPR · Institution
The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show a reasonable likelihood of proving obviousness over the cited combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“that, as of November 30, 2007, a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 22–23 (citing Ex. 1302 ¶¶ 62–63). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 13 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner proposes that we construe the phrase “does not comprise a buffering system.” Pet. 23–24. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding (see Prelim. Resp. 13), neither party identifies a dispute that turns on the meaning of the phrase “does not comprise a buffering system.” See generally Pet.; Prelim. Resp. Thus, we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“buffer system of the 2003 HUMIRA formulation based on Fransson’s teachings, we find that Fransson neither discloses nor suggests removing the buffer system from a formulation. To the contrary, as Patent Owner points out, Fransson describes all of its formulations as including a buffer. Prelim. Resp. 33–34. Specifically, Fransson states that the tested formulations “were prepared by mixing disodium phosphate, monosodium phosphate, and sodium chloride in water for injection to give isotonic solutions of different pH and buffer concentration. hIGF-I was added to some of the solutions by ultrafiltration.” Ex. 1304, 1012–13. Petitioner does not explain adequately how that express teaching of buffered formulations, with no disclosure of any tested formulations without a buffer, would have prompted the ordinary artisan to eliminate buffer from the 2003 HUMIRA formulation. Moreover, in summarizing the results of its study, Fransson explains that although an intermediate phosphate buffer concentration of 10 mM resulted in less injection pain than a higher buffer concentration of 50 mM, further reducing the phosphate buffer concentration to 5 mM “did not reduce pain further.” Id. at 1014. In other words, Fransson teaches that reducing the buffer concentration below a particular threshold concentration provides no additional pain reducing benefit. That disclosure fails to support Petitioner’s assertion, and Dr. Radtke’s testimony (Ex. 1302 ¶ 86), that Fransson would have prompted the skilled artisan to eliminate Humira’s buffer system to reduce injection site pain.” slip op. at 14
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 9,085,619 - Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution deniedPTAB · Sep 7, 2017 · IPR2017-01008 · APJ Michelle N Ankenbrand · IPR · Institution
The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show a reasonable likelihood that either asserted §103 combination would succeed.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art. Petitioner contends that, as of November 30, 2007, a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 22 (citing Ex. 1202 ¶ 64). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 15 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner proposes that we construe the phrase “does not comprise a buffering system.” Pet. 22–23. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding (see Prelim. Resp. 15), neither party identifies a dispute that turns on the meaning of the phrase “does not comprise a buffering system.” See generally Pet.; Prelim. Resp. Thus, we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“buffer system of the 2003 HUMIRA formulation based on Fransson’s teachings, we find that Fransson neither discloses nor suggests removing the buffer system from a formulation. To the contrary, as Patent Owner points out, Fransson describes all of its formulations as including a buffer. Prelim. Resp. 33–34. Specifically, Fransson states that the tested formulations “were prepared by mixing disodium phosphate, monosodium phosphate, and sodium chloride in water for injection to give isotonic solutions of different pH and buffer concentration. hIGF-I was added to some of the solutions by ultrafiltration.” Ex. 1219, 1012–13. Petitioner does not explain adequately how that express teaching of buffered formulations, with no disclosure of any tested formulations without a buffer, would have led the ordinary artisan to eliminate buffer from the 2003 HUMIRA formulation.” slip op. at 16
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 9,085,619 - Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.Institution deniedPTAB · Sep 7, 2017 · IPR2017-00823 · APJ Tina E Hulse · IPR · Institution
The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show Gokarn ’011 anticipated them.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear” slip op. at 9
- Skill levelSkill level petitioner adoptedOther
“skill in the art of pharmaceutical antibody formulation would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline) with at least two years of experience preparing formulations of proteins suitable for therapeutic use. Pet. 20 (citing Ex. 1102 ¶¶ 61–62). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. Prelim. Resp. 10. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
Claim construction§ 102 anticipationPatents in suitUS 9,085,619
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.