- Avita Medical Limited v. Renovacare Sciences Corp.Institution deniedPTAB · Dec 18, 2017 · IPR2017-01243 · APJ Bart A Gerstenblith · IPR · Institution
The Board denied institution on all grounds, finding the petition relied on the same or substantially the same prior art previously considered by the Office.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“Our discretion pursuant to § 325(d) involves a balance between several competing interests. “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, are the interests of giving petitioner 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.” slip op. at 5
Discretionary denialPatents in suitUS 9,610,430 - 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 - Icon Health & Fitness, Inc. v. Nautilus, Inc.Rehearing deniedPTAB · Oct 27, 2017 · IPR2017-00495 · APJ Bart A Gerstenblith · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution because Petitioner did not show a reasonable likelihood of prevailing on any challenge to claims 1–16.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Pursuant to 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or reply. See 37 C.F.R. § 42.71(d).” slip op. at 3
NonePatents in suitUS 8,323,155 - Icon Health & Fitness, Inc. v. Nautilus, Inc.Rehearing deniedPTAB · Oct 27, 2017 · IPR2017-00493 · APJ Bart A Gerstenblith · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution because the Petition failed to identify corresponding structure and show the prior art disclosed the same or equivalent structures.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Pursuant to 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous We did not undertake an analysis to determine whether the equivalent structure was shown in the prior art because Petitioner failed to do so in the first instance: “By not identifying a corresponding structure, material, or acts in the ’542 patent specification, Petitioner does not show where that structure, material, or acts or its equivalent is disclosed by Maresh-I.” Dec. 18 (citing 37 C.F.R. § 42.104(b)(4) (“The petition must specify where each element of the claim is found in the prior art . . . relied upon.”)). conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or reply. See 37 C.F.R. § 42.71(d).” slip op. at 3
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“In particular, we first construed “right means,” “left means,” “second end portion support,” “first support,” “second support,” “first member,” and “second member” as invoking § 112, ¶ 6, because none of the terms has a sufficiently definite meaning as a name for structure. Dec. 7–15. Second, with respect to independent claims 1, 46, 75, and 86, we found that Petitioner did not identify corresponding structure, material, or acts in the specification for performing each of the recited functions. See id. at 17–18 (discussing Maresh-I), 19–21 (discussing Stearns). With respect to independent claims 91, 94, 97, and 100, we found that even if we accepted Petitioner’s identification of the alleged corresponding structure, material, or acts, Petitioner’s analysis failed to show that the prior art structures were the same or equivalent. Id. at 18 (discussing Maresh-I), 20–21 (discussing Stearns). Rather, Petitioner’s analysis focused entirely on the functional language of these claim elements without identifying and addressing the corresponding structure. Id. at 18 (discussing Maresh-I), 20–21 (discussing Stearns).1” slip op. at 2
- BurdenNot shown unpatentable
“We disagree. Petitioner did not do either. First, Petitioner did not identify any portion of the specification describing corresponding structure in the Petition. Second, there is no mention of tracks or swing arms in the discussion of Maresh-I and Stearns at pages 14, 15, and 40 of the Petition, let alone any argument that the structures identified in either reference are equivalent. See Pet. 14, 15, 40. Accordingly, we did not misapprehend or overlook whether Petitioner complied with these requirements for means-plus-function claim terms; Petitioner did not. Petitioner’s Alleged Analysis and Evidence Regarding the Same or Equivalent Structures” slip op. at 7
Claim constructionPatents in suitUS 7,341,542 - Icon Health & Fitness, Inc. v. Nautilus, Inc.Rehearing deniedPTAB · Oct 27, 2017 · IPR2017-00494 · APJ Bart A Gerstenblith · IPR · Rehearing
The Board denied rehearing, leaving in place its denial of institution because the Petition did not explain how the prior-art structures were the same as or equivalent to the claimed structures.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or reply. See 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
“focuses on the functional language of these claim limitations and fails to explain how the structures of Maresh-I and Stearns are the same as, or equivalent to, those identified in the ’219 patent. Dec. 15–16. For example, Petitioner’s discussion of Maresh-I equates the claimed “first means” and “second means” with Maresh-I’s “radially displaced pins of cranks 760,” but fails to make any argument explaining how these are the same or equivalent structures. See Pet. 13–14. Petitioner also points to paragraphs 37 and 90 of Mr. Ganaja’s declaration where he testifies that Maresh-I’s radially displaced pins are crank arms and that a connection between rollers 2023 and cranks 2020 is the crank arm in Stearns. Req. Reh’g 5–6 (discussing Ex. 1006 ¶ 37), 6 (discussing Ex. 1006 ¶ 90). There is no question that Mr. Ganaja’s testimony in these paragraphs addresses the issues that we found lacking in the Petition. The problem for Petitioner, however, is that the Petition itself did not include these arguments equating the structures as Mr. Ganaja did. Citing to these paragraphs of Mr. Ganaja’s declaration without providing any explanation of the significance thereof in the Petition itself is insufficient. See 37 C.F.R. § 42.6(3) (“Arguments must not be incorporated by reference from one document into another document.”). See also DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”).” slip op. at 4
- BurdenDecided for patent owner
“focuses on the functional language of these claim limitations and fails to explain how the structures of Maresh-I and Stearns are the same as, or equivalent to, those identified in the ’219 patent. Dec. 15–16. For example, Petitioner’s discussion of Maresh-I equates the claimed “first means” and “second means” with Maresh-I’s “radially displaced pins of cranks 760,” but fails to make any argument explaining how these are the same or equivalent structures. See Pet. 13–14. Petitioner also points to paragraphs 37 and 90 of Mr. Ganaja’s declaration where he testifies that Maresh-I’s radially displaced pins are crank arms and that a connection between rollers 2023 and cranks 2020 is the crank arm in Stearns. Req. Reh’g 5–6 (discussing Ex. 1006 ¶ 37), 6 (discussing Ex. 1006 ¶ 90). There is no question that Mr. Ganaja’s testimony in these paragraphs addresses the issues that we found lacking in the Petition. The problem for Petitioner, however, is that the Petition itself did not include these arguments equating the structures as Mr. Ganaja did. Citing to these paragraphs of Mr. Ganaja’s declaration without providing any explanation of the significance thereof in the Petition itself is insufficient. See 37 C.F.R. § 42.6(3) (“Arguments must not be incorporated by reference from one document into another document.”). See also DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”). Accordingly, we did not misapprehend or overlook discussion in the Petition regarding these structures.” slip op. at 4
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner
“In particular, we first construed “first means” and “second means” as invoking § 112, ¶ 6, as proposed by Petitioner and Patent Owner. Dec. 9. Second, we found that even if we accepted Petitioner’s identification of the alleged corresponding structure, material, or acts, Petitioner’s analysis failed to show that the prior art structures were the same or equivalent. Id. at 15– 16 (discussing Maresh-I and Stearns). Rather, Petitioner’s analysis focused entirely on the functional language of these claim elements without addressing the corresponding structure. Id.” slip op. at 2
Claim constructionPatents in suitUS 7,632,219 - Icon Health & Fitness, Inc. v. Nautilus, Inc.Rehearing deniedPTAB · Oct 27, 2017 · IPR2017-00490 · APJ Bart A Gerstenblith · IPR · Rehearing
The Board denied rehearing, finding no overlooked or misapprehended matter in its § 112, ¶ 6 construction and its determination that Petitioner’s prior-art analysis was deficient.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW Pursuant to 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus., Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). The request must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or reply. See 37 C.F.R. § 42.71(d).” slip op. at 3
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for patent owner
“In particular, we first construed “second portion support” as invoking § 112, ¶ 6, because it did not have a sufficiently definite meaning as a name for structure. Dec. 7–10. Second, we found that Petitioner did not identify corresponding structure, material, or acts in the specification for performing the recited function of guiding the second portions of the right and left foot engagement members to follow a forward-rearward reciprocating motion in response to the user moving the user’s feet with striding steps during the striding exercise as the right and left crank arms reciprocally lift and lower the first portions of the right and left foot engagement members. Id. at 11–12 (quoting Ex. 1001, 22:65–23:4). Third, we determined that Petitioner’s analysis was deficient because it did not identify where the same structure, material, or acts or their equivalents were found in the prior art.1 Id. at 12–13.” slip op. at 2
- BurdenNot shown unpatentable
“§ 112, ¶ 6, because it did not have a sufficiently definite meaning as a name for structure. Dec. 7–10. Second, we found that Petitioner did not identify corresponding structure, material, or acts in the specification for performing the recited function of guiding the second portions of the right and left foot engagement members to follow a forward-rearward reciprocating motion in response to the user moving the user’s feet with striding steps during the striding exercise as the right and left crank arms reciprocally lift and lower the first portions of the right and left foot engagement members. Id. at 11–12 (quoting Ex. 1001, 22:65–23:4). Third, we determined that Petitioner’s analysis was deficient because it did not identify where the same structure, material, or acts or their equivalents were found in the prior art.1 Id. at 12–13.” slip op. at 2
Claim constructionPatents in suitUS 6,689,019 - 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
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.