- Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00972 · APJ David Cotta · IPR · Institution
Instituted IPR of claims 1–23 on all three asserted §103 grounds; Apple showed a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“We typically take courts’ trial schedules at “face value,” and decline Petitioner’s invitation to speculate that the target date for completion of the ITC Investigation will slip as a result of the COVID-19 pandemic. Fintiv, IPR2020-00019, Paper 15 at 13 (informative). Accordingly, for purposes of analyzing this factor, we assume that the ITC Investigation will conclude on October 26, 2022. We also decline Petitioner’s invitation to assume an earlier date for issuance of our FWD. Although we appreciate Petitioner’s willingness to expedite resolution of this case, Patent Owner raises valid concerns that compressing the reply period will also compress the window for taking depositions. Moreover, the statutory due date for our FWD is triggered by the date of our institution decision and is unaffected by the date on which Petitioner files its reply. See 35 U.S.C. § 316(a)(11). Given that our FWD in this case is due seven weeks after the targeted completion of the ITC Investigation, we determine that this factor weighs marginally in favor of exercising our discretion to deny institution.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner shows, based on this preliminary record, where each of the limitations of the challenged claims is taught or suggested by the combination of Shmueli and Osorio. Pet. 11–64. Petitioner’s assertions above are backed by the cited prior art and by the testimony of its declarant, Dr. Chaitman. Id.; see also Ex. 1003 ¶¶ 68–150. On this preliminary record, we determine that Petitioner’s arguments and evidence are sufficient for purposes of institution. We focus our discussion on Patent Owner’s arguments that Petitioner has not sufficiently supported a motivation to combine Shmueli and Osorio and that Shmueli and Osorio do not disclose “key elements” of the independent claims. Prelim. Resp. 30–42.” slip op. at 36
- Skill levelSkill level board ownOther
“As such, Dr. Chaitman would appear to qualify as one of ordinary skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we note that we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., No. 10-CV-1835 JAP TJB, 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary” Ex. 2001 ¶¶ 52–53 (emphasis added).9 Indeed, considering that the claims of the ’941 patent relate to, e.g., “method[s] of cardiac monitoring” to “confirm a presence of the arrhythmia,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. Ex. 1001, 17:1–18. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial. C. Claim Construction” slip op. at 25
- Expert testimonyPetitioner expert creditedOther
“cardiac arrhythmia as opposed some other heart condition. Id. at 31–32. In this respect Patent Owner’s declarant, Dr. Efimov, testifies that Shmueli makes no attempt to define “irregular heart condition” with any specificity, and “one can only speculate” as to its meaning because “numerous conditions can be considered heart irregularities: normal autonomic nervous system control, autonomic dysfunction, heart failure, ischemia, myocardial infarction, heart block, etc.” Ex. 2001 ¶ 69. At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that Shmueli discloses “both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 54 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of the ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, which is “one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. Considering the present record, Petitioner has established sufficiently that one of ordinary skill in the art would have understood Shmueli’s use of “irregular heart condition” as referring to—or at a minimum, encompassing—arrhythmia, and, thus, disclosing the detection of arrhythmia. See Pet. 13–14 (citing, e.g., Ex. 1003 ¶ 54).” slip op. at 37
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,638,941 - Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00971 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–30 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 58 & n.2, (“Trial Practice Guide”).6 We consider the following factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding”: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 5–6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”). In evaluating these factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6. Upon consideration of these factors, we decline to exercise our discretion to deny the Petition. A. Whether the Court Granted a Stay or Evidence Exists That One May Be Granted if a Proceeding is Instituted” slip op. at 10
- Skill levelSkill level board ownOther
“skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary.” Ex. 2001 ¶¶ 52–53 (emphasis added).10 Indeed, considering that the ’731 patent “relates to methods and systems for managing health and disease such as cardiac diseases including arrhythmia and atrial fibrillation,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial.” slip op. at 27
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). At this stage of the proceeding, no term requires construction. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). The parties are, of course, welcome to address the meaning of any relevant claim term at trial. D. Ground 1: Obviousness over Shmueli” slip op. at 29
- Expert testimonyPetitioner expert creditedDecided for petitioner
“At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that, “Shmueli discloses both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 48 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, “which is one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. (citing, Ex. 1016, 6081; Ex. 1020, Abstract, 44:29– 32; Ex. 1011, Abstract; Ex. 1023, 2; Ex. 1047, 320–321; Ex. 1001, 1:40–42; Ex. 1004, 8:11–13, 15:3–5) (alteration in original). Considering the present record, Petitioner has established sufficiently that one of ordinary skill in the art would have understood Shmueli’s use of “irregular heart condition” as referring to—or at a minimum, encompassing—arrhythmia, and, thus, disclosing the detection of arrhythmia. See Pet. 10–12 (citing, e.g., Ex. 1003 ¶ 48).” slip op. at 33
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,595,731 - Apple, Inc. v. Alivecor, Inc.InstitutedPTAB · Dec 8, 2021 · IPR2021-00970 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–20 under the asserted obviousness grounds based on Shmueli and Osorio, with Hu for claims 7–9 and 17–19.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“and merely argues that Petitioner does not rely on Hu to correct the alleged deficiencies of Shmueli–Osorio combination of Ground 1. Prelim. Resp. 42– 43. As discussed above, however, we do not find Petitioner’s arguments with respect to Ground 1 deficient for the purposes of institution. Accordingly, on this record, Petitioner has shown sufficiently that one of ordinary skill in the art would have considered at least one claim of the ’499 patent obvious for the reasons set forth in the Petition.” slip op. at 47
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“grounds, arguments, and/or evidence than the ITC Investigation. Although Patent Owner argues that the prior art cited in the Petition has “already entered the ITC case,” that argument was made before Petitioner narrowed the number of prior art references it intended to rely upon, as required by the ITC’s Order Setting Procedural Schedule. Ex. 2006; Ex. 1057. Currently there does not appear to be any overlap in arguments or evidence between the two proceedings. Moreover, we agree with Petitioner that its stipulation mitigates to some degree concerns of duplicative efforts and possibly conflicting decisions between the Board and the ITC. Indeed, Petitioner’s stipulation echoes the one cited in Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC, which the Board determined weighed “marginally in favor of not exercising discretion to deny institution.” IPR2019-01393, Paper 24 at 16 (PTAB June 16, 2020) (informative). Finally, we agree with Petitioner that this proceeding will likely include claims that are not at issue in the ITC Investigation. We are not persuaded by Patent Owner’s argument that Petitioner has failed to explain why the narrowed set of claims would be substantially different than those challenged in the IPR petition because, based on the ITC’s Order Setting Procedural Schedule, Patent Owner had yet to narrow the number of asserted claims as of the deadline for Petitioner to brief this issue. See Ex. 3001 (email from the Board authorizing the parties to brief discretionary denial issues, setting a deadline of October 25, 2021 for Petitioner to file its” slip op. at 18
- Skill levelSkill level board ownOther
“frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary” Ex. 2001 ¶ ¶ 51–52 (emphasis added). Indeed, considering that the ’499 patent “relates to methods and systems for managing health and disease such as cardiac diseases including arrhythmia and atrial fibrillation,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial.” slip op. at 28
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). Patent Owner notes that claim terms “heart rate sensor” and those relating to “alert” are at issue in the related ITC Investigation but neither party proposes any construction here. See Prelim. Resp. 29 (citing Ex. 2009). At this stage of the instant proceeding no term requires construction. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). The parties are, of course, welcome to address the meaning of any relevant claim term at trial. D. Ground 1: Obviousness over Shmueli and Osorio” slip op. at 29
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,572,499 - PTAB · Nov 18, 2021 · IPR2021-00854 · APJ Wesley B Derrick · IPR · Institution
The Board instituted IPR on claims 1–35 and all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Birnboim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition 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). The Federal Circuit has interpreted the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Thus, based on the information presented, we institute an inter partes review of claims 1–35 of the ’240 patent on all grounds.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that A person of ordinary skill in the art . . . would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid 10 Koller, WO 91/02740, published Mar. 7, 1991. Ex. 1016. 11 Robert E. Farrell, Jr., Ph.D., “RNA Methodologies: A Laboratory Guide for Isolation and Characterization,” (3rd Ed., 2005). Ex. 1026. extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 7 (citing Ex. 1002 ¶ 38). Patent Owner does not dispute Petitioner’s proposed definition at this stage. Prelim. Resp. 7. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’240 patent. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). B. Claim Construction” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Neither Petitioner nor Patent Owner offer any position on the construction of any claim term. See Pet.; Prelim. Resp. 7. On this record, and for purposes of this Decision, we decline to construe any claim terms beyond the limited extent we do so below in our analysis, because it is not necessary to do so in reaching our decision on institution. C. Principles of Law” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“and particularly claim 1. Petitioner provides a detailed analysis of where each element of claim 1 is found in Birnboim. Pet. 13–19. Specifically, Petitioner asserts that Birnboim’s Example 3 discloses an aqueous composition comprising the one or more chaotropes, one or more detergents, one or more reducing agents, one or more chelators, and one or more buffers, as recited in the claim. Id. at 13–18. Petitioner also asserts that “Birnboim’s reagents are present in an amount sufficient to perform the claimed functions.” Id. at 18–23 (heading capitalization normalized and underlining omitted).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,669,240 - PTAB · Nov 12, 2021 · IPR2021-00860 · APJ Robert A Pollock · IPR · Institution
The Board instituted inter partes review of claims 1–20 on all petitioned grounds because Petitioner showed a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Birnboim, Mori, and Farrell, Petitioner provides a detailed analysis of where each claim element is found in the cited references and discusses why one of ordinary skill in the art would have been motivated to combine those elements with a reasonable expectation of success. See e.g., Pet. 34–42 (discussing motivation to combine and reasonable expectation of success with respect to claim 1). For the purpose of institution, we focus on independent claim 1.” slip op. at 17
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Taylor, Petitioner asserts that A person of ordinary skill in the art (“POSA”) would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 10 citing Ex. 1002, ¶¶34–35. Patent Owner presently does not dispute Petitioner’s proposed definition. Prelim. Resp. 6. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’256 patent. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionPlain and ordinary meaningDecided for petitioner
“According to Petitioner, we should apply the plain and ordinary meaning of “stock solution” as meaning “a formulated supply of solution for future use,” which, in the context of the instant claims, refers to “the aqueous composition before it is mixed with a sample.” Pet. 8 (citing Ex. 1029; Ex. 1002 ¶ 38). Patent Owner neither contests Petitioner’s definition of “stock solution” nor requests that we construe any other claim term, but reserves its right to do so. Prelim. Resp. 7. At this stage of the proceeding, we apply the plain and ordinary meaning of “stock” solution as Petitioner proposes. In section II.D.4, below, we note that Patent Owner implicitly relies on narrow constructions of “kills pathogens” and “without degrading nucleic acids.” As these terms may be critical to our final determination but have not been briefed by either party, we provisionally apply their plain and ordinary meaning. D. Ground 1: Obviousness in View of Birnboim, Mori, and Farrell” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner provides reasoned bases for why one of ordinary skill in the art would have combined the cited references to arrive at the claimed invention. See Pet. 34–42 (citations omitted). Summarizing its arguments, Petitioner concludes that one of ordinary skill in the art would have been motivated to prepare solutions comprising a chaotrope, a detergent, a reducing agent, a chelator, a shortchain alkanol, and a buffer (with the associated acid and base) at a pH of 5–7 with a reasonable expectation that, when combined with a biological sample, the solution would denature proteins, inactivate nucleases, and kill pathogens, all without degrading nucleic acids of the sample. Ex. 1002, ¶151. The POSA would have been motivated to use Mori’s surfactants or defoaming agents along with Farrell’s nuclease-free water in Birnboim’s stock solution and would have had a reasonable expectation of success in doing so. Ex. 1002, ¶¶137–152.” slip op. at 19
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,683,256 - Boehringer Ingelheim Pharmaceuticals, Inc. v. Genentech, Inc.Rehearing deniedPTAB · Jul 9, 2018 · IPR2017-02032 · APJ Zhenyu Yang · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, upholding institution on all challenged claims and all petition grounds under SAS and the Office’s Guidance.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Our decision to proceed on all grounds is based upon the policy set forth in the Guidance, in view of SAS, along with our determination that Petitioner has shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim in the petition. Regarding that determination, Patent Owner has not persuaded us that we have misapprehended or overlooked any matters. See 37 C.F.R. § 42.71(d).” slip op. at 5
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institution decision left claim 72 unchallenged. Paper 21, 1, 3. After Petitioner filed its rehearing request, the Supreme Court held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., 138 S. Ct. at 1359. In addition, the Office’s Guidance instructs that “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”8 See Guidance. As a result, we granted Petitioner’s rehearing request and instituted trial on all of 8 The Federal Circuit appears to have embraced the approach set forth in the Guidance. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (reading “the SAS opinion as interpreting the statute to require a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). the challenged claims and all of the grounds presented in the Petition. Paper 23, 5.” slip op. at 4
NonePatents in suitUS 6,407,213 - 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 - Par Pharmaceutical, Inc. v. Novartis AGRehearing deniedPTAB · Jun 30, 2016 · IPR2016-00084 · APJ Christopher L Crumbley · IPR · Rehearing
The Board denied Novartis’s rehearing request, leaving institution in place for claims 1–3 and 8–10 because it had not abused its discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“review trial, the Board “will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “An abuse of discretion occurs where the decision is based on an erroneous interpretation of the law, on factual findings that are not supported by substantial evidence, or represents an unreasonable judgment in weighing relevant factors.” Lacavera v. Dudas, 441 F.3d 1380, 1383 (Fed. Cir. 2006) (citing Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005)). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he 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.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We did not overlook this argument in reaching our decision to institute trial. While Novartis’ argument raises an issue of fact to be considered at trial, it does not directly refute the testimony of Par’s expert, Dr. Jorgensen, who relies on Lemke’s Table 16-1 for a slightly different purpose. Dr. Jorgensen testifies that a person of ordinary skill in the art would understand, based on Lemke, that alcohol, phenol, amine, carboxylic acid, ester, and amide groups have the greatest solubilizing potential in a polyfunctional molecule. Ex. 1003 ¶ 83. Because, according to Dr. Jorgensen, some of these groups have known drawbacks, he concluded that a person of ordinary skill in the art seeking to improve solubility would have had reason to modify rapamycin to add amino, hydroxyl, or carboxylate groups. Id. ¶¶ 83–84. Contrary to Novartis’ argument, Dr. Jorgensen did not rely on the exact figures of Table 16-1; this may be appropriate, given the fact that Lemke reports the figures as “predictions.” Ex. 1008, 115. The parties will have the opportunity to explore this issue further during trial.” slip op. at 4
NonePatents in suitUS 5,665,772
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.