- Fresenius-Kabi USA LLC v. Astrazeneca ABInstitution deniedPTAB · Dec 11, 2017 · IPR2017-01910 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because Petitioner failed to show a reasonable likelihood that claims 1, 2, 5, and 9 were obvious over the asserted prior-art combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Principles of Law A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rel[y] on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness, “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 20
- Other 314aDecided for petitioner
“There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. Id. at 9–12. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 6 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits. Nevertheless, we approach this case cognizant that the ’680 patent (at” slip op. at 22
- Skill levelOther
“Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 18; Prelim. Resp. 20. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 19
- Expert testimonyPetitioner expert discountedDecided for patent owner
“experiment in McLeskey that involved powdered—not oil-based— fulvestrant. Prelim. Resp. 50 (citing Pet. 24; Ex. 1014 ¶ 45, 52; Ex. 1008, 707, Fig. 8; Ex. 2002 ¶¶ 93, 161–162). Accordingly, we agree with Patent Owner that this new testimony does not address the Board’s question of in vivo bioavailability, which requires an oil-based fulvestrant formulation. Id. (citing Ex. 1011, 28; Ex. 2162, 28; Ex. 2001 ¶¶ 176, 185, 234–243); see Ex. 1046, 729 (Examiner’s finding that “the unexpected solubility and the bioavailability of using the specific solvent mixture as recited have been demonstrated”). Patent Owner asserts that Petitioner attempts to rewrite the plain disclosure of McLeskey, by raising opinion testimony directed to what the McLeskey authors may have “hoped” to achieve. Prelim. Resp. 18 (citing Pet. 56–57). We agree. As Patent Owner points out, the testimony of Dr. El-Ashry “reverses McLeskey’s conclusion of ‘treatment failure’ . . . and instead claims it was a ‘successful treatment.’” Id. at 5. We accord little weight to the testimony of Dr. El-Ashry, which was executed nearly two decades after McLeskey was published, because it runs counter to the statement of McLeskey within its four corners—“treatment failure,” which was reported at or near the time of the experiments. Ex. 1008, 706.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 6,774,122 - Fresenius-Kabi USA LLC v. Astrazeneca ABInstitution deniedPTAB · Dec 11, 2017 · IPR2017-01912 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 10, 11, 13, or 20 would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’139 Patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denialDenied
“There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. See id. at 9–11. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 6 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits.” slip op. at 22
- Skill levelSkill level board ownDecided for patent owner
“ANALYSIS A. Person of Ordinary Skill in the Art The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 17–18; Prelim. Resp. 20. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 19
- Prior constructionPrior construction adoptedDecided for petitioner
“In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’139 Patent claims should be interpreted in accord with our prior construction. Pet. 18–19; Prelim. Resp. 20. We agree.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 8,466,139 - 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 - Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentablePTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision
Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.
RulingsFinal written decision- BurdenNot shown unpatentable
“In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7
- Skill levelOther
“We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29
Patent outcomesUS 6,667,061 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,667,061 - 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 - Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. et al. v. Rosetta-Wireless CorporationRehearing deniedPTAB · Oct 20, 2017 · IPR2016-00622 · APJ John A Hudalla · IPR · Rehearing
The Board denied Rosetta’s rehearing request, finding it had not shown the Board overlooked or misapprehended its § 318(a) and constitutional arguments.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“should be modified, which includes specifically identifying all matters the party believes we misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. See 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Constitutional / APA (Arthrex, Oil States, due process)Not reached
“property right. Req. Reh’g 4–5. Thus, Rosetta contends “[i]nter partes review is an adjudicatory proceeding which, as in this case, may result in extinguishment of a patentee’s property rights by action of the Board and without the right to trial by jury.” Id. at 3. According to Rosetta, this violates the Seventh Amendment and Article III of the Constitution. Id. Rosetta cites to a pending case before the U.S. Supreme Court that has taken up this issue. Id. (citing Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC, 137 S. Ct. 2239 (2017)). Accordingly, Rosetta asks us to vacate our Final Written Decision. Id. at 6. Rosetta never made arguments during trial about the purported unconstitutionality of inter partes review. Nor does Rosetta’s request for rehearing attempt to identify such arguments in the trial record. As such, we could not have misapprehended or overlooked this issue.” slip op. at 4
NonePatents in suitUS 7,149,511 - Smith & Nephew, Inc. v. Conformis, Inc.Institution deniedPTAB · Sep 12, 2017 · IPR2017-00984 · APJ James A Worth · IPR · Institution
The Board denied institution after finding no reasonable likelihood that claims 1–25, 28, 29, 32–46, and 50–64 were unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 shows that 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. § 42.108. For the reasons set forth below, we determine that Petitioner has not demonstrated a reasonable likelihood that claims 1–25, 28, 29, 32–46, and 50–64 are unpatentable. Accordingly, we do not institute an inter partes review of claims 1–25, 28, 29, 32–46, and 50–64 of the ’827 patent based on the grounds asserted in the petitions.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“As to “references the osteophyte,” Petitioner states that the ’827 patent does not define the term “reference,” but argues the broadest reasonable construction of the limitation includes “at least a patient-specific surface that engages or avoids an osteophyte.” Id. Patent Owner does not address this issue directly in this proceeding. For purposes of this Decision, we determine that the broadest reasonable construction of the “references the osteophyte” limitation includes a patient specific surface that “engages or avoids the osteophyte,” consistent with the embodiments of Figures 32 and 33 of the ’827 patent. We note that dependent claims 2 and 3 use the phrase “not engage” with respect to a “second osteophyte.” Ex. 1001, 119:30, 119:36–37 (claims 2, 3). Nevertheless, dependent claims 4 and 5 require that the patient-specific surface “substantially engage[s]” an osteophyte (id. at 119:41–46), and therefore the principle of claim differentiation indicates that independent claim 1 has a broader scope than dependent claims 4 and 5.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“The next question is whether referencing osteophytes is the “natural result flowing from” Radermacher’s technique, under the aforementioned Oelrich test, or whether it otherwise would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes. Petitioner argues that it would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes because (1) such a template would be a negative of the “natural (i.e. not pre-treated) surface”; (2) referencing any osteophyte would, in some cases, aid in alignment because the unique structure of the osteophyte would help ensure that the template was placed in the proper position; and (3) it would eliminate the need to pre-treat the joint to remove the osteophyte in a preliminary surgical step, thus reducing surgical time and improving patient safety. Pet. 30 (citing, e.g., Ex. 1003, 10, 12; Ex. 1002 ¶¶ 116–117).” slip op. at 14
- BurdenNot shown unpatentable
“Thus, the prior art relied upon in the asserted ground does not disclose referencing an osteophyte, expressly or inherently. Additionally, Petitioner does not provide adequate evidence that it would have been obvious to apply the technique of Radermacher in patients with osteophytes to engage (or avoid or reference) the osteophyte, as opposed to performing an alternate technique, such as first removing the osteophytes. In particular, Petitioner has not provided adequate evidence of a reasonable likelihood of success of applying Radermacher’s technique to a bone surface with osteophytes beyond unsupported and conclusory assertions thereof. For these reasons, we determine that Petitioner has not demonstrated a reasonable likelihood that the combination of Radermacher and Alexander renders obvious independent claim 1. Accordingly, we determine that Petitioner has failed to establish a reasonable likelihood that it would prevail in its assertion that independent claim 1, or dependent claims 2–13, 32, 38, and 44–46, are unpatentable as obvious over Radermacher and Alexander.5” slip op. at 17
Claim construction§ 103 obviousnessPatents in suitUS 8,657,827 - Smith & Nephew, Inc. v. Conformis, Inc.Institution deniedPTAB · Sep 12, 2017 · IPR2017-00983 · APJ James A Worth · IPR · Institution
The Board denied both petitions and instituted no trial, finding no reasonable likelihood that claims 1–25, 28, 29, 32–46, or 50–64 were unpatentable on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 shows that 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. § 42.108. For the reasons set forth below, we determine that Petitioner has not demonstrated a reasonable likelihood that claims 1–25, 28, 29, 32–46, and 50–64 are unpatentable. Accordingly, we do not institute an inter partes review of claims 1–25, 28, 29, 32–46, and 50–64 of the ’827 patent based on the grounds asserted in the petitions.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see Cuozzo Speed Techs. v. Lee, LLC, 136 S. Ct. 2131, 2142–46 (2016). Under that standard, and absent any special definitions, we 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 construe claim terms only as relevant to the parties’ contentions and only to the extent necessary to resolve the issues in dispute. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Petitioner requests a construction of the term “references the osteophyte.” Pet. 17–18. Patent Owner does not propose construction of any terms. As to “references the osteophyte,” Petitioner states that the ’827 patent does not define the term “reference,” but argues the broadest reasonable construction of the limitation includes “at least a patient-specific surface that engages or avoids an osteophyte.” Id. Patent Owner does not address this issue directly in this proceeding. For purposes of this Decision, we determine that the broadest reasonable construction of the “references the osteophyte” limitation includes a patient specific surface that “engages or avoids the osteophyte,” consistent with the embodiments of Figures 32 and 33 of the ’827 patent. We note that dependent claims 2 and 3 use the phrase “not engage” with respect to a “second osteophyte.” Ex. 1001, 119:30, 119:36–37 (claims 2, 3). Nevertheless, dependent claims 4 and 5 require that the patient-specific surface “substantially engage[s]” an osteophyte (id. at 119:41–46), and therefore the principle of claim differentiation indicates that independent claim 1 has a broader scope than dependent claims 4 and 5.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“The next question is whether referencing osteophytes is the “natural result flowing from” Radermacher’s technique, under the aforementioned Oelrich test, or whether it otherwise would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes. Petitioner argues that it would have been obvious to apply Radermacher’s technique to a bone surface with osteophytes because (1) such a template would be a negative of the “natural (i.e. not pre-treated) surface”; (2) referencing any osteophyte would, in some cases, aid in alignment because the unique structure of the osteophyte would help ensure that the template was placed in the proper position; and (3) it would eliminate the need to pre-treat the joint to remove the osteophyte in a preliminary surgical step, thus reducing surgical time and improving patient safety. Pet. 30 (citing, e.g., Ex. 1003, 10, 12; Ex. 1002 ¶¶ 116–117).” slip op. at 14
Claim construction§ 103 obviousnessPatents in suitUS 8,657,827 - 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 - Innopharma Licensing, LLC v. Astrazeneca ABInstitution deniedPTAB · Aug 30, 2017 · IPR2017-00904 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 1, 2, 5, and 9 would have been obvious over the asserted references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that 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; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’122 Patent. A.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Decided for petitioner
“There is no doubt that the Petition was prepared using our prior Mylan Decision as a roadmap in an attempt to cure deficiencies that led to our denial of trial in the Mylan IPR. Id. at 9–11. The Petition repeatedly refers to our Mylan Decision, and is structured to address deficiencies that we identified in the record of the prior proceeding. See id. passim. Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 5 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and a different patent (the related ’680 patent). Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits.” slip op. at 22
- Skill levelSkill level board ownOther
“Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 17; Prelim. Resp. 18. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 19
- Prior constructionPrior construction adoptedDecided for petitioner
“In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’122 Patent claims should be interpreted in accord with our prior construction. Pet. 18–19; Prelim. Resp. 18–19. For the reasons set forth in the Mylan Decision, we agree. See Ex. 1011, 16–18. C.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites KSRPatents in suitUS 6,774,122
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.