- Watson Laboratories, Inc. v. United Therapeutics, Corp.Rehearing deniedPTAB · Jun 19, 2018 · IPR2017-01622 · APJ David Cotta · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, concluding it had not shown an abuse of discretion in instituting review on all challenged claims and grounds.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing has the burden of showing the decision should be modified, which includes specifically identifying all matters the party believes we misapprehended or overlooked. 37 C.F.R. § 42.71(d).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“requiring institution on each prior art ground, the statute permits review ‘only on the basis of prior art consisting of patents and printed publications.’” Req. Reh’g. 4 (citing 35 U.S.C. § 311(b)). Patent Owner then asserts that Grounds 2 and 3 fail to meet this statutory requirement because they rely on documents that do not constitute prior art. We have addressed the deficiencies regarding those grounds in the Institution Decision. Our determination to proceed on all grounds is based upon the policy set forth in the above-mentioned Office 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
- BurdenDecided for patent owner
“requiring institution on each prior art ground, the statute permits review ‘only on the basis of prior art consisting of patents and printed publications.’” Req. Reh’g. 4 (citing 35 U.S.C. § 311(b)). Patent Owner then asserts that Grounds 2 and 3 fail to meet this statutory requirement because they rely on documents that do not constitute prior art. We have addressed the deficiencies regarding those grounds in the Institution Decision. Our determination to proceed on all grounds is based upon the policy set forth in the above-mentioned Office 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
NonePatents in suitUS 9,339,507 - Watson Laboratories, Inc. v. United Therapeutics, Corp.Rehearing deniedPTAB · Jun 19, 2018 · IPR2017-01621 · APJ David Cotta · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving in place institution on all challenged claims and grounds under the SAS-related Office Guidance.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be found if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing has the burden of showing the decision should be modified, which includes specifically identifying all matters the party believes we misapprehended or overlooked. 37 C.F.R. § 42.71(d).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Our decision to modify our original institution decision to include all challenged grounds was based not just on SAS, but also on Office policy, as reflected in the April 26, 2018, Guidance on the Impact of SAS on AIA Trial Proceedings. The Federal Circuit has recently embraced the approach set forth in the Guidance, explaining: Equal treatment of claims and grounds for institution purposes has pervasive support in SAS. Although 35 U.S.C. § 318(a), the primary statutory ground of decision, speaks only of deciding all challenged and added “claim[s],” the Supreme Court spoke more broadly when considering other aspects of the statutory regime, and it did so repeatedly. The Court wrote that “the petitioner is master of its complaint and normally entitled to judgment on all of the claims it raises.” SAS, 138 S.Ct. at 1355. It said that § 312 contemplates a review “guided by a petition describing ‘each claim challenged’ and ‘the grounds on which the challenge to each claim is based,’” and it added that the Director does not “get[ ] to define the contours of the proceeding.” Id. The Court also said that § 314’s language “indicates a binary choice—either institute review or don’t.” Id. It further reasoned that “[n]othing suggests the Director enjoys a license to depart from the petition and institute a different inter partes review of his own design” and that “Congress didn’t choose to pursue” a statute that “allows the Director to institute proceedings on a claim-by-claim and ground-by-ground basis” as in ex parte reexamination. Id. at 1356 (emphasis in original). And the Court concluded that “the petitioner’s petition, not the Director’s discretion, is supposed to guide the life of the litigation,” id., and the “petitioner’s contentions ... define the scope of the litigation all the way from institution through to conclusion,” id. at 1357. We read those and other similar portions of 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, and we have seen no basis for a contrary understanding of the statute in light of SAS.” slip op. at 4
NonePatents in suitUS 9,358,240 - Merck Sharp & Dohme Corp. v. Pfizer Inc.Rehearing deniedPTAB · May 4, 2018 · IPR2017-02138 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Pfizer’s rehearing request, leaving institution of review on claims 11–15 and 20–37 unchanged because the petition made a threshold showing that Pfizer 2012 was publicly accessible.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“ServiceNow, Inc. v. Hewlett–Packard Co., Case IPR2015–00707, slip op. at 2 (PTAB August 26, 2015) (Paper 12, 2) (Crumbley, APJ, dissenting) (citations omitted). For the reasons set forth below, we determine that that Petitioner has made a threshold showing that Pfizer 2012 is a printed publication.” slip op. at 7
§ 102 anticipationPatents in suitUS 9,492,559 - Incyte Corporation v. Concert Pharmaceuticals, Inc.Rehearing grantedPTAB · Apr 9, 2018 · IPR2017-01256 · APJ Tina E Hulse · IPR · Rehearing
The Board granted Incyte’s rehearing request and instituted review of claims 1–15 on Ground 3, finding it had applied overly restrictive standards for lead compound analysis and combining references.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, 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. When rehearing a decision on a petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if an unreasonable judgment is made in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Having considered the Request for Rehearing, the current record, and our Decision denying institution, we are persuaded that we applied an overly restrictive standard for the lead compound analysis and for the reason to combine the cited references. See Reh’g Req. 2–12. Accordingly, we grant Petitioner’s Request for Rehearing and concurrently issue a decision granting institution on Ground 3. Paper 14.” slip op. at 3
NonePatents in suitUS 9,249,149 - Apotex Inc. / Apotex Corp. et al. v. Osi Pharmaceuticals LLCRehearing deniedPTAB · Mar 5, 2018 · IPR2016-01284 · APJ Lora M Green · IPR · Rehearing
The Board denied the Patent Owner’s rehearing request and left intact its determination that claims 44–46 and 53 are unpatentable as obvious over Schnur combined with OSI’s 10-K or Gibbs.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a final written decision the Board reviews the decision to determine whether we misapprehended or overlooked a matter. See 37 C.F.R. § 42.71(d). Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial 1 Schnur et al., U.S. Patent No. 5,747,498, issued May 5, 1998 (Ex. 1009) (“Schnur”). 2 Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the Fiscal Year Ended September 30, 1998, Commission File Number 0-15190, OSI Pharmaceuticals, Inc. (Ex. 1011) (“OSI’s 10-K”). 3 J.B. Gibbs, “Anticancer Drug Targets: Growth Factors and Growth Factor Signaling,” 105 J. CLIN. INV. 9‒13 (2000) (Ex. 1010) (“Gibbs”). Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “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); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s arguments with these principles in mind.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for petitioner
“In declining to adopt Petitioner’s definition of skill of the ordinary artisan, we noted that the claims encompassed cancers other than non-small cell lung cancer, and, thus, found that “the ordinary artisan would be a medical oncologist who would hold an M.D. degree and would have completed several years of practice in the field of oncology.” FWD 9. We did not just rely on Dr. Bunn’s testimony as to the level of skill on the ordinary artisan, however, but noted that “the level of ordinary skill in the art in this proceeding is reflected by the prior art of record.” Id. (citing Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)). In defining the level of ordinary skill, we also stated: [D]uring oral hearing, counsel for both parties opined that the outcome of the obviousness analysis would be the same under either parties’ definition of the ordinary artisan. Tr. 22:3‒8, 37:9‒11. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition of the ordinary artisan. FWD 9.” slip op. at 5
- Expert testimonyPetitioner expert creditedDecided for petitioner
“weight in determining whether the Gibbs reference was referring to CP- 358,774 when referring to “good anti-cancer activity” and “an acceptable therapeutic index,” we cited the Gibbs reference itself, which explicitly discloses: The EGF receptor is also the target for the development of inhibitors of the intracellular tyrosine kinase domain. ZD-1839 and CP-358,774, competitive inhibitors of ATP binding to the receptor’s active site, are currently in clinical trials (12, 13). Their mechanism of action has led to some concern about safety, given the variety and physiological significance of protein kinases and other enzymes that bind ATP. However, these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. Id. at 39 (quoting Ex. 1010, 10). That is, Gibbs refers to two compounds, ZD-1839 and CP-358,774, and refers to compounds in the plural in stating that the compounds have anticancer activity. See id. Thus, we found that “the clear inference [of the Gibbs reference] is that erlotinib has anti-cancer activity against non-small cell lung cancer.” Id. In that regard, we credited the testimony of Dr. Giaccone, noting that Dr. Giaccone testified that the statement in Gibbs “is a pretty strong and precise statement saying, there is activity in non-small cell lung cancer patients.” Ex. 2020, 115:12‒20. In addition, Dr. Giaccone testified further that statement by Dr. Gibbs would have been based on the information he had at the time, and that as Dr. Gibbs was a reputable pharmacologist, and as the statement was made in “a peer-reviewed journal of high impact,” he would have trusted that Dr. Gibbs “was saying something very important.” Ex. 2020, 115:12‒20. Id.” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“In finding that Patent Owner’s evidence of long-felt need was weak, however, we noted that “[a]ll types of objective evidence of nonobviousness must be shown to have a nexus to the claimed invention.” Id. at 42‒43 (citing In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus 4 Moyer et al., Induction of Apoptosis and Cell Cycle Arrest by CP-358,774, an Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinase. 57 CANCER RESEARCH 4838‒4848 (1997) (Ex. 1016) (“Moyer”). generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need)). In particular, we stated that the challenged claims were not limited to the treatment of patients with non-small cell lung cancer, but included treatment of mammals, and that the challenged claims did not require a clinical effect. Id. at 43. In addition, we noted that Patent Owner acknowledged in its Response that “the FDA required it to change its label as it is only effective in treating approximately 10% of patients with non-small cell lung cancer.” Id. Therefore, our finding that the evidence of long-felt need is weak relied primarily on a lack of nexus. Id. at 42. To the extent we relied on the testimony of Dr. Giaccone that erlotinib was only approved for treatment of subset of non-small cell lung cancer, that testimony is supported by Patent Owner’s admission that “Tarceva is currently approved for the treatment of a subset of NSCLC patients,” as well as the evidence that Patent Owner relied upon to support that statement. PO Response 12 (citing Ex. 2030, 1; Ex. 2021 ¶¶ 41, 102‒107; Ex. 2023 ¶ 7).” slip op. at 12
§ 103 obviousnessPatents in suitUS 6,900,221 - Taro Pharmaceuticals U.S.A., Inc. v. Apotex Technologies, Inc.Rehearing deniedPTAB · Jan 11, 2018 · IPR2017-01446 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review because the record showed a reasonable likelihood of inherent anticipation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable standard for a request for rehearing is set forth in 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. Patent Owner “submits that the evidence of record fails to show that” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“THRESHOLD – The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 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. As also noted in the decision on institution, we have considered both the Petition and Patent Owner Preliminary Response, and determined that the information presented in the Petition demonstrates that there is a reasonable likelihood that Petitioner would prevail with respect to the challenged claims. Dec. 2. Therefore, we applied the correct threshold standard for instituting the inter partes review.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundOther
“We agree with Patent Owner on the legal standard for inherency. As we acknowledged in our Decision, “[i]nherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).” Dec. 14. However, we remain persuaded at this stage of the proceeding on the current factual record based on Hoffbrand 1998 and the Mehta Declaration, that Petitioner established a “reasonable likelihood” that Hoffbrand 1998 necessarily disclosed treatment of patients with “an iron overload condition of the heart” with a therapeutically effective amount of deferiprone. See Dec. 16–20; 35 U.S.C. § 314(a). Patent Owner does not identify a definition of the phrase “iron overload condition of the heart” in the ’328 patent Specification that distinguishes the claimed patient population from Hoffbrand’s disclosure of “10 patients [that] had a liver iron content above 15.0 mg/g dry weight, ie, falling within the range that has been associated with cardiac disease.” Ex. 1007, 297. The reasonable understanding of Hoffbrand’s teaching of this association between liver iron content and cardiac disease is that all ten patients with the elevated iron levels also necessarily fell into the spectrum of having “an iron overload condition of the heart.” Indeed, Patent Owner’s Declarants do not rebut Hoffbrand’s teaching that liver iron content above 15.0 mg/g identifies patients with cardiac disease, and, therefore, with “an iron overload condition of the heart.” Dr. Coates simply notes that Hoffbrand 1998 reports five treated “patients suffered fatal complications. . . . Four of the five reported fatalities resulted from congestive heart failure.” Ex. 2001 ¶ 37. Cf. Pennell Decl. Ex. 2003 ¶ 37. That statement supports the position that Hoffbrand 1998 treated patients who inherently had an ultimately fatal “iron overload condition of the heart” with 75 mg of deferiprone, acknowledged by claim 15 of the ’328 patent as a therapeutically effective amount. Ex. 1007, 295; Ex. 1001, 28:33–37. We recognize that Dr. Pennell stated that “a patient with a liver iron content above 15 mg/g dry weight is at risk of developing cardiac disease not that such liver iron content definitely establishes cardiac disease.” Ex. 2003 ¶¶ 50–51, citing Exhibits 2007, 2015, and 2016. The Exhibits cited by Dr. Pennell do not identify evidence showing a single patient with a liver iron content that exceeds 15.0 mg/g but failed to display an “iron overload condition of the heart.” See Ex. 2003 ¶ 51. Exhibit 2007 states “while whole liver iron levels >15 mg/g dry weight . . . have been shown to predict patients at highest risk of cardiac death, it is not known how these variables relate to cardiac iron deposition.” Ex. 2007, 1. No specific patient data is provided in Exhibit 2007 comparing liver iron levels of particular patients with “iron overload.” See id. Similarly, Exhibits 2015 and 2016 also do not identify any patients with elevated liver iron content >15 mg/g dry weight with normal cardiac iron levels. Therefore, the evidence currently of record in Hoffbrand 1998,” slip op. at 3
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Regarding the second argument, Dr. Mehta relied upon specific facts within the Olivieri Abstract 1995 itself to support the conclusion that “lower TRT values indicate cardiac disease due to iron overload. Ex. 1010 (Olivieri Abstract 1995).” Ex. 1002 ¶ 75. In particular, Olivieri Abstract 1995 states “MRI demonstrates changes consistent with reduction in cardiac iron in L1 [deferiprone]-treated pts, in who baseline T2 relaxation time (TRT of 23.9±6.4 msec (normal >32) has increased to 32.4±9.3msec.” Ex. 1010. Olivieri Abstract 1995’s identification of the value of “32” as normal for TRT levels with lower values such as “23.9±6.4” as associated with elevated cardiac iron levels that require treatment with deferiprone, provides factual support for Dr. Mehta’s conclusion that patients with these lower TRT values inherently have “an iron overload condition of the heart.” See Ex. 1002 ¶ 75.” slip op. at 6
§ 102 anticipationPatents in suitUS 7,049,328 - PTAB · Jan 11, 2018 · IPR2016-01059 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable and no separate unpatentability ground was advanced for claim 7.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01103 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable, leaving no basis to find dependent claim 7 separately unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedOther
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - Roquette Freres, S.A. v. Tate & Lyle Ingredients Americas LLCRehearing deniedPTAB · Dec 19, 2017 · IPR2017-01506 · APJ Grace Karaffa Obermann · IPR · Rehearing
The Board denied rehearing, leaving claim 4 in the instituted trial because it had not overlooked the digestibility limitation or the concurrent decision.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We did not overlook the digestibility limitation in claim 4. Nor did we overlook the decision that we entered concurrently in IPR1507. On the contrary, having determined that Petitioner met the threshold for review of claim 1 of the ’436 patent (Dec. 10), we ordered (as permitted by our authorizing statute) “that trial shall proceed on all other claims challenged as anticipated” or obvious over Shah (Ex. 1008). Id. at 10 (citing 35 U.S.C. § 314(a)), 11 (for obviousness grounds based on Shah). We specifically included those other claims in the trial “without reaching any preliminary findings or conclusions on the merits.” Id. at 10. We pointed out that doing so serves our mission of securing the just, speedy, and efficient resolution of the parties’ dispute. Id. (citing 37 C.F.R. §§ 42.1(b), 42. 108). That action was not inconsistent with any finding in the decision declining to institute trial in IPR1507. Nor does it establish that we overlooked or misapprehended any matter in the Decision entered in this proceeding.” slip op. at 2
NonePatents in suitUS 7,608,436 - 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
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.