- Eis GmbH v. Novoluto GmbHRehearing grantedPTAB · Jun 17, 2020 · IPR2019-01302 · APJ John E Schneider · IPR · Rehearing
Granted rehearing and instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 is unpatentable over Guan, Lee, and Hovland.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“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 addressed previously in a motion, an opposition, or a reply. Id. 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 occurs if the decision (1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015). With this in mind, we address the arguments presented by Petitioner in turn.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Request for Rehearing and conclude there are genuine issues of material fact about the teachings of Guan that warrant institution and resolution at trial.” slip op. at 2
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner contends that Guan is non-analogous art in that it is not related to stimulation of the clitoris. Prelim. Resp. 59. Patent Owner also contends that there is no motivation to combine the teachings of Lee and Guan. Id. at 60–63. Patent Owner argues that one skilled in the art would not consider using the indirect stimulator of Guan in the dildo of Lee as it would require a modification of Lee beyond a simple substitution of elements. Id.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“Petitioner has also provided a reasonable motivation to combine the teachings of Lee and Guan. Lee comprises a dildo with an extension which directly stimulates the clitoris, a body part. Ex. 1006, Fig. 1; Ex. 1002, ¶¶ 72, 134–137. Guan discloses an apparatus, which indirectly stimulates a body part. Ex. 1007, 3; Ex. 1002 ¶ 137. Given the teaching in the art of the problems with direct stimulation versus indirect stimulation, we agree on this record with Dr. Prisco that one skilled in the art would have had a reason to substitute the indirect stimulation device of Guan for the direct intensive and is best decided on a full record. Cf. Monark Knitting Mach, Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 886 (Fed. Cir. 1998) (determining that issues of fact concerning secondary considerations precluded grant of summary judgment) reasonable expectation of success. Ex. 1002 ¶¶ 132–137.” slip op. at 6
§ 103 obviousnessPatents in suitUS 9,937,097 - 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 - 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 - Spectrum Brands, Inc. / Unikey Technologies, Inc. v. Assa Abloy ABSome claims unpatentablePTAB · Jan 12, 2017 · IPR2015-01562 · APJ Christopher G Paulraj · IPR · Final written decision
Claims 1, 3, 5, 9–16, 22, 23, 26, 29, and 30 are unpatentable as obvious over Nielsen; claims 7 and 21 were not shown unpatentable over Nielsen and Karkas.
RulingsFinal written decision- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“separate Petition for inter partes review, challenging claims 1, 3, 5, 7, 9–16, 21–23, 26, 29, and 30 of the ’374 patent based on similar grounds to those presented by Spectrum. See IPR2016-00686, Paper 2. We instituted inter partes review based on UniKey’s Petition to the extent that the grounds set forth therein are consistent with the basis for our institution of this proceeding, and joined UniKey as a Petitioner to this proceeding. See Paper 29 (instituting inter partes review based on UniKey’s Petition and joining UniKey as a Petitioner to IPR2015-01562). As a condition of UniKey’s joinder, the parties submitted a joint stipulation setting forth the parameters of UniKey’s participation in this proceeding, including the requirement that “UniKey will not have any right to separate or additional briefing, discovery, or speaking time for the duration of the contest involving [the ’374 patent], through termination of the joined proceedings and through any related appeal.” Paper 27, 1. UniKey also filed a statement “withdraw[ing] all grounds and arguments presented in IPR2016-00686 to the extent that they differ from the Panel’s ground for institution in IPR2015-01562.” Paper 32.2” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“the Specification of the patent in which they appear. See 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2146 (2016). Under the broadest reasonable construction standard, claim terms are presumed to have their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification . . . when [it] expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004). “Although an inventor is indeed free to define the specific terms used to describe his or her invention, this must be done with reasonable clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine, for purpose of this Final Written Decision, that no terms in the challenged claims require express construction. See, e.g., 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 11
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Dr. Villasenor insofar as the relevant field for the ’374 patent is more accurately defined as “electronic control access systems” rather than merely “security systems” (id. ¶ 41), but otherwise find no meaningful difference between the level of ordinary skill in the art proposed by the parties’ experts. We also recognize that the level of skill in the art is reflected in the prior art references themselves, which focus on mobile-phone based electronic access systems, and take that into consideration in our analysis. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). As such, we determine that a person of ordinary skill in the art would have least an undergraduate degree in computer science or electrical engineering and one year of experience in electronic control access systems.” slip op. at 15
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“step 1a. As recognized by Petitioners, the Federal Circuit has observed that “[u]nless the steps of a method actually recite an order, the steps are not ordinarily construed to require one.” Reply 10–11 (quoting Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1369 (Fed. Cir. 2003)). In this case, however, the plain language of claim 1 requires “storing . . . a first set of credential data,” “receiving . . . a credential update,” and “in response to receiving the credential update, . . . replacing the first set of credential data with a second set of credential data that is different from the first set of credential data.” Ex. 1001, 12:35–45. Thus, we agree that “[l]ogic compels the conclusion that step 1b follows step 1a, because the controller’s receipt of a ‘credential update’ associated with ‘different’ data would follow the first set of credential data previously stored at the controller.” PO Resp. 21. See Mformation Techs., Inc. v. Research In Motion Ltd., 764 F.3d 1392, 1398–99 (Fed. Cir. 2014) (“[A] claim requires an ordering of steps when the claim language, as a matter of logic or grammar, requires that the steps be performed in the order written, or the specification directly or implicitly requires an order of steps.” (internal quotation marks omitted)). With reference to Figure 3, Nielsen teaches that “[i]n the initial step 381, the access right owner 352 defines the access rights to be granted, possibly including a list of possible access right grantees,” that “[i]n step 382, the access right owner 352 authorizes the administrator 351 to generate and assign access keys,” that “[b]y means of an access code management system, the administrator in step 383 transforms the access right definition into a set of electronic access codes,” and that “[i]n step 384, the access codes and other related data are stored.” Ex. 1002 ¶ 132. Thus, we agree with Patent Owner that “the relied upon steps of Nielsen teach a process that differs from the steps recited in claim 1” insofar as Figure 3 shows the “receiving” step(s) performed before the “storing” step 384. PO Resp. 25. Specifically, that Figure 3 of Nielsen does not show that the process is iterative. Nonetheless, we find that Nielsen suggests a process wherein access codes (i.e., “credential data”) that are stored in the access code management system are periodically replaced with new and different access codes (i.e., a “credential update”). See Ex. 1002 ¶ 128 (“[T]he access code may be transmitted periodically, in order to replace the access codes on a lock control unit and the corresponding electronic key . . . .”). The same paragraph of Nielsen also indicates that “[t]he access code management system 211 generates and administers the access codes as described in connection with FIGS. 3 and 9a-b.” Id. Thus, we determine that the skilled artisan would have found it obvious to initially store access codes, and thereafter repeat the process described in the flow chart of Figure 3 in order to replace previously stored access codes. As explained by Dr. Green, the purpose of Nielsen periodically replacing previous access codes “is to improve the security of the system,” such as in the situation when codes are invalidated if misused or lost. See Ex. 1004 ¶ 29. Nielsen explicitly references Figure 3 when referencing how the access code management system administers access codes (Ex. 1002 ¶ 128), thereby providing a suggestion and motivation to modify Nielsen’s teachings so as to repeat the process of Figure 3 when replacing previously stored access codes in order to improve security.” slip op. at 18
Patent outcomesUS 8,150,374 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,150,374
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.