- Hamilton Beach Brands, Inc. v. F’Real Food, LLCRehearing deniedPTAB · Apr 25, 2018 · IPR2017-00765 · APJ Lora M Green · IPR · Rehearing
The Board denied Hamilton Beach’s rehearing request and maintained its denial of institution, citing follow-on petition concerns and its discretion under §§ 314(a) and 325(d).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the decision for an abuse of discretion. See 37 C.F.R § 42.71(c). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial 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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with those principles in mind.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner
“The Board has discretion not to institute an inter partes review. 35 U.S.C. § 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“the PTO is permitted, but never compelled, to institute an IPR proceeding”); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). When exercising that discretion, the Board may take into account whether “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d); see Conopco, Inc. v. The Proctor & Gamble Co., Case IPR2014-00628, slip op. 5– 10 (PTAB October 20, 2014) (Paper 21) (declining to institute because substantially the same arguments previously were presented to the Board). The issue of whether substantially the same arguments were raised previously in IPR2016-01105 arises in the present case. In addition, when determining whether to exercise our discretion not to institute a trial proceeding under 35 U.S.C. § 314(a), we seek to balance the equities between the parties, i.e., Petitioner’s desire to be heard against Patent Owner’s interest in avoiding harassment through repeated challenges. 5 Exhibit 1002 in IPR2016-01105. 6 U.S. Patent Publication No. 2002/0189460 A1, filed April 11, 2002, published December 19, 2002, to Brown et al. (“Brown”). Exhibit 1003 in IPR2016-01105. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (post-grant proceedings conducted under the AIA “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). In circumstances such as the present case, the Board considers the potential inequity of a petitioner filing serial attacks against the same claims of a patent, while benefiting from patent owner’s arguments and/or the Board’s decision in prior cases. See, e.g., Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426 slip op. at 12–16 (PTAB June 22, 2017) (Paper 17) (citing Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-00034, slip op. at 6–11 (PTAB April 13, 2017) (Paper 9); Baker Hughes Inc. v. LiquidPower Specialty Prods., Inc., Case IPR2016-01896, slip op. at 9–11 (PTAB March 31, 2017) (Paper 10); Duk San Neolux Co., Ltd. v. Idemitsu Kosan Co., Ltd., Case IPR2017-00197, slip op. at 4–11 (PTAB March 31, 2017) (Paper 10); NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 8 (PTAB May 4, 2016) (Paper 9); Toyota Motor Corp. v. Cellport Sys., Inc., Case IPR2015- 01423, slip op. at 8 (PTAB Oct. 28, 2015) (Paper 7)); see also Conopco, Case IPR2014-00628, slip op. at 11–12. Therefore, we must balance the parties’ competing interests when determining whether to exercise our discretion and decline to institute. Id.” slip op. at 5
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDecided for patent owner
“An important reason for denying institution in the instant proceeding was that Petitioner had the advantage of Patent Owner’s preliminary response in IPR2016-01105, as well as the claim construction and analysis set forth in the decision denying institution in that proceeding. That is, Petitioner had the benefit of that information in crafting the challenges set forth in the instant proceeding, and, thus, was able to address Patent Owner’s arguments made in its preliminary response in IPR2016-01105, as well as address the concerns of the Board set forth in the decision denying institution in IPR2016-01105. Consideration of these factors is consistent with the principles set forth in General Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-01357, 15−19 (PTAB Sept. 6, 2017) (Paper 19) (“General Plastics”) (designated precedential Oct. 18, 2017) (setting forth a non-exhaustive list of factors to be considered in determining whether to institute a follow-on petition, including whether the same petitioner previously filed a petition directed to the same claims of the same patent, and whether, at the time of filing of the second petition, the petitioner already received the patent owner’s preliminary response to the first petition or received the Board’s decision on whether to institute review in the first petition). We noted further that Sato “was published nearly 30 years ago,” and Karkos issued on December 26, 2000. Dec. 11. We determined that Petitioner had not established that those references were not available to Petitioner when it filed the petition in IPR2016-01105. Id. We declined to provide a second chance merely because Petitioner’s “highly experienced searchers” did not find those references before the filing of the petition in IPR2015-01105. Id. (citing Pet. 6). That determination was another factor that informed our decision to exercise our discretion and decline to institute inter partes review in the instant proceeding. See, e.g., General Plastics at 16 (noting that other factors to be considered in granting a follow-on petition are whether at the time of filing of the first petition petitioner knew of the prior art asserted in the second petition or should have known of it, and whether the petitioner provides adequate explanation for the time elapsed between the filings of multiple petitions directed to the same claims of the same patent). Finally, we noted that we were “troubled by the implications of Petitioner’s overarching premise – that it is cost-effective and appropriate to wait for a claim construction and institution decision by the Board, and then launch a follow-on patent challenge in reliance on additional references that challenge the same patent claims already addressed by the Board.” Dec. 13 (citing Pet. 7‒8). As noted in the Decision denying institution, however, “[s]uch tactics increase the costs to Patent Owner and impose unnecessary demands on the finite resources of the Board.” Id.; see, e.g., General Plastics at 16 (noting another factor to be considered is the finite resources of the Board).” slip op. at 7
- Other 314aInstitution denied discretionary otherDecided for patent owner
“The Board has discretion not to institute an inter partes review. 35 U.S.C. § 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“the PTO is permitted, but never compelled, to institute an IPR proceeding”); see also 37 C.F.R. § 42.108(a) (“When instituting inter partes review, the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). When exercising that discretion, the Board may take into account whether “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d); see Conopco, Inc. v. The Proctor & Gamble Co., Case IPR2014-00628, slip op. 5– 10 (PTAB October 20, 2014) (Paper 21) (declining to institute because substantially the same arguments previously were presented to the Board). The issue of whether substantially the same arguments were raised previously in IPR2016-01105 arises in the present case. In addition, when determining whether to exercise our discretion not to institute a trial proceeding under 35 U.S.C. § 314(a), we seek to balance the equities between the parties, i.e., Petitioner’s desire to be heard against Patent Owner’s interest in avoiding harassment through repeated challenges. 5 Exhibit 1002 in IPR2016-01105. 6 U.S. Patent Publication No. 2002/0189460 A1, filed April 11, 2002, published December 19, 2002, to Brown et al. (“Brown”). Exhibit 1003 in IPR2016-01105. See H.R. Rep. No. 112-98, pt.1, at 48 (2011) (post-grant proceedings conducted under the AIA “are not to be used as tools for harassment or a means to prevent market entry through repeated litigation and administrative attacks on the validity of a patent. Doing so would frustrate the purpose of the section as providing quick and cost effective alternatives to litigation.”). In circumstances such as the present case, the Board considers the potential inequity of a petitioner filing serial attacks against the same claims of a patent, while benefiting from patent owner’s arguments and/or the Board’s decision in prior cases. See, e.g., Nautilus Hyosung Inc. v. Diebold, Inc., Case IPR2017-00426 slip op. at 12–16 (PTAB June 22, 2017) (Paper 17) (citing Xactware Sols., Inc. v. Eagle View Techs., Inc., Case IPR2017-00034, slip op. at 6–11 (PTAB April 13, 2017) (Paper 9); Baker Hughes Inc. v. LiquidPower Specialty Prods., Inc., Case IPR2016-01896, slip op. at 9–11 (PTAB March 31, 2017) (Paper 10); Duk San Neolux Co., Ltd. v. Idemitsu Kosan Co., Ltd., Case IPR2017-00197, slip op. at 4–11 (PTAB March 31, 2017) (Paper 10); NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 8 (PTAB May 4, 2016) (Paper 9); Toyota Motor Corp. v. Cellport Sys., Inc., Case IPR2015- 01423, slip op. at 8 (PTAB Oct. 28, 2015) (Paper 7)); see also Conopco, Case IPR2014-00628, slip op. at 11–12. Therefore, we must balance the parties’ competing interests when determining whether to exercise our discretion and decline to institute. Id.” slip op. at 5
Discretionary denialPatents in suitUS 7,520,658 - 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 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Feb 8, 2018 · IPR2016-01412 · APJ Christopher G Paulraj · IPR · Final written decision
Claims 1–13 and 16–19 are unpatentable as obvious over Palermo, Joshi, and Handbook, and over Oshlack, Joshi, Handbook, and Doyon.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 15 (citing Ex.1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 24 (citing Ex. 2001 ¶¶ 74–75). We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We find Petitioner’s proposed construction to be more persuasive based on the ’376 patent specification. In particular, the specification defines “unsuitable for injection” “to mean that one would have substantial difficulty injecting the dosage form (e.g., due to pain upon administration or difficulty pushing the dosage form through a syringe) due to the viscosity imparted on the dosage form, thereby reducing the potential for abuse of the opioid analgesic from the dosage form.” Ex. 1001, 3:15–20. Additionally, in an example concerning the formation of a gel at different concentrations, the specification characterizes certain solutions as “THICK (10 cP to 60 cP): Although a syringe can be filled with this solution, it was hard to do.” Id. at 32:8–24, Table 3. Thus, the specification teaches that a viscosity of at least 10 cP is difficult to pull into a syringe or administer parenterally (via injection). Patent Owner does not address these teachings of the specification. We, therefore, determine that the broadest reasonable interpretation of “unsuitable for parenteral administration” and “unsuitable to pull into an insulin syringe” encompasses a gelling agent that imparts a viscosity of at least 10 cP.” slip op. at 10
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“articulated a four-factor test in determining whether collateral estoppel attaches: “(1) the identity of the issues in a prior proceeding; (2) the issues were actually litigated; (3) the determination of the issues was necessary to the resulting judgment; and (4) the party defending against preclusion had a full and fair opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). Collateral estoppel can attach in proceedings before the Office for identical issues that were addressed with respect to a different patent during prior district court litigation. See In re Arunachalam, No. 2016-1607, 2017 WL 4387224, at *2–4 (Fed. Cir. Oct. 3, 2017) (“In light of Dr. Arunachalam’s previous opportunity to litigate the validity of the asserted claims of the ’500 Patent, which contain the [same] terms . . . , we see no reason to allow her to appeal the patentability of the challenged claims of the ’556 Patent, which also contain the same critical terms.”). All four factors for collateral estoppel are met here. With regard to the first factor, the issue of Joshi’s status as prior art is identical for both proceedings. The ’376 patent is part of the same chain of continuity as the ’888 patent, and both patents share the same specification and claim priority to the same non-provisional application filed August 6, 2002 and provisional application filed August 6, 2001. As such, to the extent Joshi qualifies as prior art to the ’888 patent, it would also qualify as prior art to the ’376 patent.” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateWritten description inadequateNot shown unpatentable
“Although the statements above encompass “mixtures” of HPMC and PEO among a myriad of other possibilities for the gelling agent, we find no basis to conclude that the inventors of the ’376 patent were in possession of the specifically claimed formulation from such a broad disclosure.11 The 10 The April 25th draft application is heavily redacted and we thus cannot discern what other materials were specifically contemplated as “thickening agents” by that time. See Ex. 2091, 5. However, given the nature and amount of the redactions and Patent Owner’s assertion that the draft application ultimately led to the filing of the ’534 provisional with the broad disclosure set forth above, we find it reasonable to conclude that additional materials were included in the draft application. Moreover, the draft application was forwarded as part of an email from Patent Owner’s attorney, which “[e]nclosed the latest draft of the tamper resistant application.” Ex. 2091. As such, there is no evidence to suggest that the list of thickening agents included as part of the draft application originated from the inventors as opposed to patent counsel. 11 We recognize that the same broad disclosure with a “laundry list” of possible gelling agents is found in the specification of the ’376 patent. See Federal Circuit has held that such “laundry list” disclosures are insufficient to satisfy the written description requirement when there is no further guidance (“blazemarks”) provided about which species or combination of species included as part of the list may be selected to arrive at the claimed invention. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Not having specifically named or mentioned the combination in any manner, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967); see also Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“To satisfy the written description requirement, the disclosure in each application must ‘reasonably convey[ ]’ to those skilled in the art that as of the claimed priority date the inventor was in possession of the later claimed subject matter.”) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Other evidence of record further supports our conclusion that the inventors of the ’376 patent had not conceived of or reduced to practice the claimed formulation prior to Joshi’s August 30, 2001 filing date. In his Declaration, inventor Benjamin Oshlack attests that Patent Owner’s laboratory scientists focused on “testing the syringeability of various concentration solutions of pectin, sodium alginate, and sodium acrylate, as well as combinations of pectin and sodium alginate” between January 4 and Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. 17, 2001. Ex. 2081 ¶ 22. Additionally, Mr. Oshlack attests that the scientists had evaluated “xanthan gum, carrageenan, and locust bean gum (and combinations thereof) as gelling agents, between April 5 and 12, 2001.” Id. ¶ 23. None of the laboratory notebook excerpts proffered by Patent Owner mention a combination of HPMC and PEO as gelling agents to be used in an oxycodone formulation. Exs. 2087–2090. Consistent with the testing actually done, the working examples set forth in the ’534 provisional (as well as in the ’376 patent) focus on xantham gum, pectin, microcrystalline cellulose, and hydroxyethlcellulose as the gelling agents. See Ex. 1026, 44– 49 (Examples 1–5). We find, therefore, that the inventors did not particularly consider either PEO or HPMC, let alone both PEO and HPMC in combination, when evaluating possible gelling agents for an abuse-deterrent formulation of oxycodone. Accordingly, because we find that the ’376 patent is not entitled to a filing date earlier than August 6, 2002, we further determine that Joshi qualifies as § 102(e) prior art as of that date. Having determined that Joshi qualifies as prior art, we turn to the merits of Petitioner’s patentability challenges.” slip op. at 21
Patent outcomesUS 9,034,376 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 9,034,376 - 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 · IPR2016-01102 · APJ Christopher L Crumbley · IPR · Rehearing
Petitioners’ rehearing requests concerning joinder of claim 7 were dismissed as moot because claim 1 was not proven unpatentable and claim 7’s grounds depended on claim 1.
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 · IPR2016-01059 · 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 - 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 - 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 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Nov 8, 2017 · IPR2016-01027 · APJ Christopher G Paulraj · IPR · Final written decision
Claim 1 is unpatentable as obvious over McGinity, Joshi, and Palermo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 24 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 26. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner
“iv. “core matrix” The parties agree that the broadest reasonable construction of “core matrix” is “a blended mixture having: (a) PEO having a molecular weight of from about 300,000 to about 5,000,000 daltons, (b) magnesium stearate, and (c) oxycodone or a pharmaceutically acceptable salt of oxycodone.” Ex. 3001. We adopt that agreed-upon construction for purposes of this Decision. v.” slip op. at 14
Patent outcomesUS 9,060,976 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,060,976
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.