- Hengdian Group Dmegc Magnetics Co., Ltd. / Zhejiang Innuovo Magnetics Co., Ltd. et al. v. Hitachi Metals, Ltd.Rehearing deniedPTAB · Dec 21, 2017 · IPR2017-01313 · APJ Jo-Anne M Kokoski · IPR · Rehearing
The Board denied Petitioner’s rehearing request and left in place its § 325(d) denial of institution for claims 1–8 because materially the same prior art had been considered by the Office.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A request for rehearing must identify specifically all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. 37 C.F.R. § 42.71(d). Additionally, Petitioner, as the party challenging the Decision, has the burden of showing it should be modified. Id. When rehearing a decision on a petition, the Board will review the decision for an abuse of discretion. See 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.” Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004) (citing In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000)).” slip op. at 3
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner
“As an initial matter, we note that Petitioner states that, for purposes of its Request, it “do[es] not argue Uchida and Uchida II are not materially the same.” Req. Reh’g 3. Because we have discretion to reject a petition if “the same or substantially the same prior art or arguments previously were presented to the Office,” see 35 U.S.C. § 325(d) (emphasis added), Petitioner has not established that we abused our discretion in denying the Petition. Given that Uchida (asserted here) and Uchida II (previously presented to the Office) are “materially the same,” substantially the same prior art was previously before the Office. Indeed, the presence of Uchida in the Petition and the materially-identical Uchida II in the prosecution history alone is a sufficient basis to exercise our discretion under Section 325(d).” slip op. at 3
Discretionary denialPatents in suitUS 6,527,874 - Facebook, Inc. / Instagram, LLC v. Skky, LLCRehearing deniedPTAB · Nov 27, 2017 · CBM2017-00002 · APJ William V Saindon · CBM · Rehearing
The Board denied rehearing, finding no abuse of discretion in denying CBM institution because the patent, after disclaimer, lacked a claim requiring financial activity.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs 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). The party requesting rehearing bears the burden of showing an abuse of discretion, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 3
- Adverse judgmentAdverse judgmentOther
“CBM patent review of claims 1–14 of the ’870 patent under Section 18 of the Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284, 329 (2011) (“AIA”). Patent Owner, Skky, LLC, filed a Preliminary Response. Paper 8 (“Prelim. Resp.”). With its Preliminary Response, Patent Owner provided evidence (Ex. 2001) that it filed with the Office a statutory disclaimer of claims 1–7 and 9 of the ’870 patent pursuant to 37 C.F.R. § 1.321(a). Prelim. Resp. 2 (citing Ex. 2001). After the Preliminary Response, Petitioner filed a Preliminary Reply to Patent Owner’s Preliminary Response, as authorized by the panel pursuant an e-mail request by Petitioner, to address the consequences of Patent Owner’s disclaimer of claims 1–7 and 9. Paper 9 (“Pet. Prelim. Reply”). In response to the” slip op. at 2
NonePatents in suitUS 9,203,870 - Facebook, Inc. / Instagram, LLC v. Skky, LLCRehearing deniedPTAB · Nov 9, 2017 · CBM2017-00003 · APJ Karl D Easthom · CBM · Rehearing
The Board denied Facebook and Instagram’s rehearing request, maintaining that the patent was ineligible for CBM review because no existing challenged claim required financial activity.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “An abuse of discretion occurs 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). The party requesting rehearing bears the burden of showing an abuse of discretion, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“only for a patent that is a covered business method patent.” (Emphasis added). A patent is eligible for CBM review if it has at least one claim directed to a covered business method. Transitional Program for Covered Business Method Patents—Definitions of Covered Business Method Patent and Technological Invention; Final Rule, 77 Fed. Reg. 48,734, 48,736 (Response to Comment 8).” slip op. at 4
- Adverse judgmentOther
“Pet.”) requesting covered business method (“CBM”) patent review of claims 1–7 of the ’810 patent under Section 18 of the Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284, 329 (2011) (“AIA”). Patent Owner, Skky, LLC, filed a Preliminary Response. Paper 6 (“Prelim. Resp.”). With its Preliminary Response, Patent Owner provided evidence (Ex. 2001) that it filed with the Office a statutory disclaimer of claim 5 of the ’810 patent pursuant to 37 C.F.R. § 1.321(a). Prelim. Resp. 2 (citing Ex. 2001). After the Preliminary Response, Petitioner filed a Preliminary Reply to Patent Owner’s Preliminary Response, as authorized by the panel pursuant an e-mail request by Petitioner, to address the consequences of Patent Owner’s disclaimer of claim 5. Paper 7 (“Pet. Prelim. Reply”). In slip op. at 2
NonePatents in suitUS 9,219,810 - Facebook, Inc. / Instagram, LLC v. Skky, LLCRehearing deniedPTAB · Nov 9, 2017 · CBM2017-00006 · APJ Karl D Easthom · CBM · Rehearing
The Board denied rehearing and maintained its denial of CBM institution because, after the statutory disclaimers, no challenged claim required a financial activity.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“proceeding only for a patent that is a covered business method patent.” (Emphases added). In other words, the decision at the time of institution is based upon on what “is a covered business method patent,” id. (emphasis added), instead of what was “a covered business method patent” prior to the disclaimer. See also AIA § 18(d)(1) (using the present tense “claims”); 37 C.F.R. § 42.207(e) (when a patent owner files a statutory disclaimer, “[n]o post-grant review will be instituted based on disclaimed claims”). Petitioner’s proposed rule would require the Director to institute a CBM patent review “for a patent that is [not] a covered business method patent,” contrary to AIA § 18(a)(1)(E).” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“284 (2011) (“AIA”) created a transitional program for the Board to conduct post-grant reviews of a limited set of patents designated as “covered business method patents.” AIA § 18(a). The AIA defines a “covered business method patent” as “a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service.” Id. § 18(d)(1). Thus, in order to institute a CBM review proceeding, the statute requires a patent that claims a particular type of method or apparatus. See Secure Axcess, LLC v. PNC Bank Nat’l Ass’n, 848 F.3d 1370, 1381 (Fed. Cir. 2017) (“Necessarily, the statutory definition of a CBM patent requires that the patent have a claim that contains, however phrased, a financial activity element.” (emphasis added)); Unwired Planet, LLC v. Google Inc., 841 F.3d 1376, 1382 (Fed. Cir. 2016) (CBM patents “are limited to those with claims that are directed to methods and apparatuses of particular types and with particular uses ‘in the practice, administration, or management of a financial product or service’” (emphasis added)); Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1340 (Fed. Cir. 2016) (citing previous Board decisions that “properly focuse[d] on the claim language at issue” (emphasis added)). Under AIA § 18(a)(1)(E), “[t]he Director may institute a transitional proceeding only for a patent that is a covered business method patent.” (Emphases added). In other words, the decision at the time of institution is based upon on what “is a covered business method patent,” id. (emphasis added), instead of what was “a covered business method patent” prior to the disclaimer. See also AIA § 18(d)(1) (using the present tense “claims”); 37 C.F.R. § 42.207(e) (when a patent owner files a statutory disclaimer, “[n]o post-grant review will be instituted based on disclaimed claims”). Petitioner’s proposed rule would require the Director to institute a CBM patent review “for a patent that is [not] a covered business method patent,” contrary to AIA § 18(a)(1)(E).” slip op. at 5
NonePatents in suitUS 9,215,310 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Nov 8, 2017 · IPR2016-01028 · APJ Christopher G Paulraj · IPR · Final written decision
Claim 1 is unpatentable as obvious over Palermo, the Handbook, and McGinity, and also over McGinity, Joshi, Bastin, and the PDR.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 22–23 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 25. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the broadest reasonable construction of “PEG applied onto the core matrix” is a “PEG coating of the core matrix.” Petitioner’s proposed construction would read “applied onto the core matrix” (emphasis added) out of the claim, which we decline to do. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006) (noting that claim language “should not [be] treated as meaningless”).” slip op. at 14
Patent outcomesUS 9,060,976 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,060,976 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Nov 8, 2017 · IPR2016-01027 · APJ Christopher G Paulraj · IPR · Final written decision
Claim 1 is unpatentable as obvious over McGinity, Joshi, and Palermo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 24 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 26. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner
“iv. “core matrix” The parties agree that the broadest reasonable construction of “core matrix” is “a blended mixture having: (a) PEO having a molecular weight of from about 300,000 to about 5,000,000 daltons, (b) magnesium stearate, and (c) oxycodone or a pharmaceutically acceptable salt of oxycodone.” Ex. 3001. We adopt that agreed-upon construction for purposes of this Decision. v.” slip op. at 14
Patent outcomesUS 9,060,976 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,060,976 - Hengdian Group Dmegc Magnetics Co., Ltd. / Zhejiang Innuovo Magnetics Co., Ltd. et al. v. Hitachi Metals, Ltd.Institution deniedPTAB · Nov 6, 2017 · IPR2017-01313 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board denied institution for claims 1–8 under § 325(d), finding the petition relied on substantially the same prior art or arguments previously considered by the Office.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“the same prior art and arguments as those previously presented to the Office, we now decide whether to exercise our discretion to deny institution under § 325(d). Our discretion under § 325(d) involves a balance between several competing interests. See Neil Ziegman, N.P.Z., Inc. v. Stephens, Case IPR2015-01860, slip op. at 12–13 (PTAB Feb. 24, 2016) (Paper 11). “On the one hand, there are the interests in conserving the resources of the Office and granting patent owners repose on issues and prior art that have been considered previously.” Fox Factory, Inc. v. SRAM, LLC, Case IPR2016- 01876, slip op. at 7 (PTAB Apr. 3, 2017) (Paper 8). “On the other hand, there are the interests of giving petitioners the opportunity to be heard and correcting any errors by the Office in allowing a patent—in the case of an inter partes review—over prior art patents and printed publications.” Id. For the following reasons, we deny the Petition. The disclosures of the primary references asserted by Petitioner were previously presented to, and considered by, the Office. Specifically, the disclosures in Uchida and Kaneko II upon which Petitioner relies were presented to the Office in Uchida II and Kaneko III, both of which were considered by the Office during prosecution of the ’104 application. Petitioner is thus asking the Board to readjudicate the Office’s previous decision on substantially the same issues, without providing any arguments distinguishing the Examiner’s prior consideration of Uchida II and Kaneko III, or any compelling reason why we should re-evaluate substantially the same prior art as that presented during prosecution and considered by the Examiner. Moreover, although we acknowledge that Petitioner has a direct interest in pursuing the instant Petition, we also acknowledge the burden and expense to Patent Owner in having to defend the ’874 patent based on substantially the same prior art or arguments already considered by the Office. We are not persuaded that adjudicating disputes on already-considered issues is an efficient use of Board or party resources. See Unified Patents Inc. v. John L. Berman, Case IPR2016-01571, slip. op. at 12 (PTAB Dec. 14, 2016) (Paper 10) (informative); see also Cultec, Inc. v. StormTech LLC, Case IPR2017-00777 (PTAB Aug. 22, 2017) (Paper 7) (informative) (denying institution of inter partes review under § 325(d) because the same or substantially the same prior art or arguments previously were presented to the Office during prosecution); Hospira, Inc. v. Genentech, Inc., Case IPR2017-00739 (PTAB July 27, 2017) (Paper 16) (informative) (denying institution of inter partes review under § 325(d) because the Office already decided the dispositive issue of whether the asserted references qualified as prior art with respect to the challenged patent); Juniper Networks, Inc. v. Mobile Telecomm’ns Techs., LLC, Case IPR2017-00642, slip op. at 13 (PTAB July 27, 2017) (Paper 24) (finding that “the Examiner was aware of the contents of [the” slip op. at 15
Discretionary denialPatents in suitUS 6,527,874 - Baker Hughes, A GE Company, LLC (F/K/A Baker Hughes Incorporated) v. Liquidpower Specialty Products Inc. (F/K/A Lubrizol Specialty Products, Inc.)All claims unpatentablePTAB · Nov 1, 2017 · IPR2016-00734 · APJ Michelle N Ankenbrand · IPR · Final written decision
Claims 1–11 are unpatentable: claims 1, 3, 4, 6, 7, and 11 as anticipated by Eaton; claims 1–7 and 11 as obvious over Eaton and Strausz; claims 8–10 as obvious over Eaton, Strausz, and Naiman.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Eaton discloses that a different size flow loop—not dilution—was utilized to achieve turbulent flow of the Bow River crude oil. Ex. 1002, 14:40–42 (“The 1" flow loop was used to test the . . . BOW RIVER crude oil[], which [is] so viscous that [it] do[es] not generate turbulent flow in a ¼" flow loop.”); see id. at 14:42–55 (describing the flow loop test procedure).11 We decline to credit Dr. Dunn’s testimony over Eaton’s explicit disclosure. Accordingly, we determine that Petitioner establishes, by a preponderance of the evidence, that Eaton discloses the API gravity limitation.” slip op. at 27
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Eaton discloses that a different size flow loop—not dilution—was utilized to achieve turbulent flow of the Bow River crude oil. Ex. 1002, 14:40–42 (“The 1" flow loop was used to test the . . . BOW RIVER crude oil[], which [is] so viscous that [it] do[es] not generate turbulent flow in a ¼" flow loop.”); see id. at 14:42–55 (describing the flow loop test procedure).11 We decline to credit Dr. Dunn’s testimony over Eaton’s explicit disclosure. Accordingly, we determine that Petitioner establishes, by a preponderance of the evidence, that Eaton discloses the API gravity limitation.” slip op. at 27
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“persuaded by Petitioner’s argument and Dr. Epps’s testimony that the combination of Eaton and Strausz suggests drag reducing polymers having the solubility parameter limitation, because the solubility parameter limitation merely states what one of ordinary skill already knew and would have applied—that the drag reducing polymer must be soluble in the liquid hydrocarbon. See Pet. 41; Ex. 1005 ¶ 32. We also credit Dr. Epps’s testimony setting forth how one of ordinary skill in the art, knowing the target solubility parameter of the liquid hydrocarbon (e.g., for Bow River crude oil, a range of 17.1–19.6 MPa1/2), would have consulted the literature or used calculations to determine which of Eaton’s homopolymers or copolymers would provide a solubility parameter within the target range, and then used Eaton’s disclosed methods to prepare that polymer or polymers. Ex. 1005 ¶¶ 81–92 (citing Ex. 1002, 9:8–18; Ex. 1003, 465–467; Ex. 1007, VII-686, VII-707; Ex. 1012, 1025; Ex. 1037, 252–253). Accordingly, Petitioner establishes, by a preponderance of the evidence, that the combined teachings of Eaton and Strausz disclose the solubility parameter limitation of the challenged claims.” slip op. at 45
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“of ordinary skill in the art would have a reason to combine the teachings of Eaton and Strausz and, in making that combination, a person of ordinary skill would have had a reasonable expectation of success at achieving a drag reducing polymer meeting the limitations of claims 1–7 and 11. That does not end our inquiry, however, because Patent Owner presents arguments and evidence regarding objective indicia of nonobviousness that we must consider before reaching our conclusion on obviousness. WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016). We consider those arguments and evidence below.” slip op. at 57
Patent outcomesUS 8,022,118 unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,022,118 - Hospira, Inc. v. Genentech, Inc.Rehearing grantedPTAB · Oct 26, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Rehearing
The Board granted Hospira’s rehearing request and instituted review of claims 1–14 for obviousness over Baselga ’94 and Baselga ’96.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“recites “in the absence of an anthracycline derivative.” In the Petition and the Preliminary Response, neither party proposed a construction for that term. Patent Owner, however, argues that “[e]ven if a person of ordinary skill would have chosen to combine an anti-ErbB2 antibody and a taxoid, there is no reason an ordinarily skilled artisan would have avoided anthracyclines as part of that treatment.” Prelim. Resp. 52 (emphasis added). In our Decision denying institution, we agreed with Patent Owner, stating that evidence of the record is “insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans.” Dec. 10 (emphasis added). In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation “in the absence of an anthracycline derivative” as requiring “avoidance” of an anthracycline derivative. Reh’g Req. 6. According to Petitioner, this term “is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative.” Id. at 5. After reconsidering the current record, we find Petitioner’s argument persuasive. In particular, because Baselga ’94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation “in the absence of an anthracycline derivative.” Cf. Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants”).” slip op. at 17
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In sum, Petitioner has presented sufficient evidence, for purposes of instituting trial, to show that in considering prior therapy received, an ordinary artisan would have been motivated to treat patients with ErbB2- overexpressing breast cancer by administering a combination of an anti- ErbB2 antibody and a taxoid, and “in the absence of an anthracycline derivative.”” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner, however, points to other evidence to show that prior art teaches an ordinary artisan to combine an anti-ErbB2 antibody with a taxoid. Specifically, Petitioner refers to Baselga ʼ94 for teaching that, in mouse xenografts, “individual treatment with either anti-HER2 4D5 or paclitaxel alone resulted in 35% growth inhibition whereas the combination ‘resulted in a major antitumor activity with 93% inhibition of growth’ without increasing toxicity.” Id. at 45 (citing Ex. 1005 at 4). Similarly, Baselga ’96, citing Baselga ’94, teaches that “[i]n preclinical studies, both in vitro and in xenografts, rhuMAb HER2 markedly potentiated the antitumor effects of several chemotherapeutic agents, including … paclitaxel without increasing their toxicity.” Id. at 44 (quoting Ex. 1004, 15). Based on these teachings, we are persuaded that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“Patent Owner argues that Exhibit 2029, which states that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol,” teaches away from the claimed combination therapy. Prelim. Resp. 51 (citing Ex. 2029,5 1362). We are not persuaded on this record. In an obviousness inquiry, we must analyze the prior art as a whole, and not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (explaining that the question is “whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination”). Other evidence of record shows paclitaxel had been approved for treating breast cancer (see, e.g., Ex. 1025, 10), demonstrates synergy of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1005, 4; Ex. 1004, 15), and suggests clinical trials of the combination therapy (see, e.g., Ex. 1005, 4; Ex. 1004, 15). Weighing all evidence of record, we are not persuaded that prior art as a whole teaches away from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers.” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 7,846,441 - 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
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.