During the week of August 6, the Board issued nine decisions in Technology Center 1600, two denying institution of IPR, two Final Written Decisions finding the challenged claims not unpatentable, two Final Written Decisions finding the challenged claims unpatentable, and two terminating inter partes review (“IPR”) proceedings, in whole or in part. The decisions follow.
Denying Institution of Inter Partes Review Proceedings Under 35 U.S.C. § 325(d)
- Hologic, Inc., v. bioMẻrieux, Inc., No. IPR2018-00568 (Decision Entered August 7, 2018). Hologic challenged claims 1–6 of U.S. Patent No. 8,697,352 (“the ’352 Patent”) as obvious in view of two references. bioMẻrieux argued that the Board should deny institution under 35 U.S.C. § 325(d) “because the Examiner considered the same arguments the Petition advances, and Petitioner does not identify any new art or raise any new arguments that should lead the Board to reach a different conclusion.” IPR2018-00568, Paper 9 at 10 (internal quotations omitted). The Board analyzed the six Becton factors in its § 325(d) analysis and, despite the references being neither considered by the Examiner during prosecution nor appearing on the face of the ’352 Patent, concluded that (1) one of the references was similar enough to those before the Examiner during prosecution, and (2) the other reference antedated a version of the same reference considered by the Examiner and did not include any new information relied upon by Hologic in support of its petition. Paper 9 at 11-21 (citing Becton, Dickinson and Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (informative)). The Board also concluded that Hologic’s petition failed to warrant reconsideration of the prior art or arguments before the Examiner. at 18-21. Instead, the Board affirmed that bioMẻrieux had successfully overcome several rounds of prosecution with additional evidence showing the unexpected results associated with the ’352 Patent claims. Id. Accordingly, the Board denied institution of Hologic’s IPR petition. Id. at 22.
- Pfizer, Inc., v. Genentech, Inc., No. IPR2018-00373 (Decision Entered August 2, 2018). In its petition, Pfizer challenged claims 1–18 of U.S. Patent No. 9,795,672 (“the ’672 Patent”) as anticipated, or obvious in view of various combinations of six references. IPR2018-00373, Paper 12 at 4-5. Pfizer argued that the Board should not accord the ’672 Patent its earliest claimed priority date (a provisional patent application) and should rely only on the non-provisional application’s filing date, based on lack of written description support in the earliest application. The Board disagreed with Pfizer regarding the lack of written description and accorded the ’672 Patent its earliest claimed priority date. Based on this decision, the Board denied institution on several anticipation and obviousness grounds because Pfizer failed to show that the relied-upon references were available before the ’672 Patent’s priority date. In response to Pfizer’s arguments that the ’672 Patent claims were anticipated by or obvious in view of two other references, Genentech argued that the references were the same or substantially the same as references previously considered by the USPTO and, as such, the Board should dismiss Pfizer’s petition under 35 U.S.C. § 325(d). The Board agreed and denied institution on these grounds. With respect to a final ground, the Board denied institution because Pfizer relied on a reference that disclosed administration of an agent that, while targeting the same pathway as the agent recited in the ’672 Patent, binds to a different target in a different manner than the agent disclosed in the reference.
Final Written Decisions of Inter Partes Review Proceedings
- Rimfrost AS, v. Aker Biomarine Antarctic AS, IPR2017-00745 (Final Written Decision Entered August 10, 2018). In the petition, Rimfrost challenged claims 1–20 of U.S. Patent No. 9,078,905 (“the ’905 Patent”) on five grounds of obviousness based on the references of (i) Catchpole and Sampalis, (ii) Catchpole, Sampalis, and Randolph, (iii) Catchpole, Sampalis, and Fricke 1984, (iv) Catchpole, Sampalis, Fricke 1984, and Bottino, and (v) Catchpole, Sampalis, and Bottino. IPR2017-00745, Paper 24 at 7-8. The ’905 Patent relates to “extracts from Arctic krill, small shrimp-like animals, that include bioactive fatty acids. In particular, the ’905 Patent discloses krill oil compositions having high levels of astaxanthin, phospholipids, includ[ing] enriched quantifies of ether phospholipids, and omega-3 fatty acids.” Id. at 3 (internal citations omitted). The independent claim at issue relates to an “encapsulated krill oil” that contains “an effective amount of krill oil … comprising from about 3% to about 15% w/w ether phospholipids.” Id. at 7.The Board credited the testimony of Petitioner’s expert, Dr. Tallon, and noted the admissions of Patent Owner’s expert Dr. Hoem, in concluding that claims 1-20 of the ’905 Patent are unpatentable. According to the Board, “we credit Dr. Tallon’s testimony that an ordinarily skilled artisan would have had a reasonable expectation of success in combining Catchpole and Sampalis to arrive at the claimed invention because the prior art discloses that the lipid components identified in the claims of the ’905 Patent are the natural lipid components in the krill oil that can be extracted using any number of suitable solvents, and that the relative proportions of those lipid components can also be varied in a predictable way by applying a combination of solvents with different polarity to selectively concentrate groups of compounds based on their different solubility.” Paper 24 at 42-43 (internal citations omitted). The Board supported its finding by noting that “an ordinary skilled artisan would not have relied on the ether phospholipid levels reported by Fricke 1986 [which was used as evidence regarding the detailed protocols and methods used by Fricke 1984] in view of the limitations of the [degradation product-based] method of ether phospholipid quantification employed by Fricke 1986.” Id. at 40. The Board pointed to Dr. Hoem being named as co-author on a paper that “touts the superiority of 31P NMR relative to other analytical techniques [such as those employed by Fricke 1986].” Id. at 39. Accordingly, the Board “credit[ed] Dr. Tallon’s testimony that the ether lipid content values reported by Fricke [1986] are lower than the range of typical ether lipid content seen in krill … which demonstrates that Fricke [1986]’s analysis is indeed non-representative.” Id. at 40. The Board also concluded that “an ordinary skilled artisan would have had a reason to include Bottino in the combination because Bottino discloses the levels of fatty acids, and in particular, the levels of omega-3 fatty acids, present in krill oil.” Id. at 61.Accordingly, in its Final Written Decision, the Board determined Petitioner demonstrated that claims 1–20 are unpatentable.Rimfrost AS filed a second petition (see IPR2017-00747) alleging the ’905 Patent is obvious in view of various combinations of five references, some of which were relied upon by Rimfrost in IPR 2017-00745. In its Final Written Decision entered on August 10, 2018, the Board relied upon Rimfrost’s arguments that 31P NMR is the superior method to quantify phospholipids when deciding that claims 1-20 of the ’905 Patent had not been shown to be unpatentable. IPR 2017-00745, Paper 24 at 26-29. Notably, Rimfrost failed to cite any references which used 31P NMR to determine quantities of phospholipids that it alleged were disclosed in its combination of references. According to the Board, “Petitioner [Rimfrost] does not adequately explain how the results obtained by Tanaka [using a non-NMR-based quantification method] compare to results acquired using other methods, such as 31P NMR, or why an ordinarily skilled artisan would have relied on Tanaka when NMR analysis of krill oil ether phospholipid levels were available.” Id. at 27-28.
- Rimfrost AS, v. Aker Biomarine Antarctic AS, IPR2017-00746 (Final Written Decision Entered August 10, 2018). In the petition, Rimfrost challenged claims 1–19 of U.S. Patent No. 9,028,877 (“the ’877 Patent”) on four grounds of obviousness based on the references of (i) Breivik, Catchpole, and Fricke 1984, (ii) Breivik, Catchpole, Fricke 1984, and Bottino (iii) Breivik, Catchpole, Fricke 1984, and Sampalis I, and (iv) Breivik, Catchpole, Fricke 1984, and Sampalis II. IPR2017-00746, Paper 23 at 8-9. The ’877 Patent relates to “extracts from Arctic krill, small shrimp-like animals, that include bioactive fatty acids such as astaxanthin, phospholipids, includ[ing] enriched quantifies of ether phospholipids, and omega-3 fatty acids.” Id. at 3 (internal citations omitted). In particular, the ’877 Patent includes “methods for processing freshly caught kill at the site of capture and preferably on board a ship … [where] oil can be extracted by an optional selection of nonpolar and polar solvent including use of supercritical carbon dioxide.” Id. at 4. The independent claims at issue relate to a method of producing krill oil which includes the steps of providing and treating krill “to denature lipases and phospholipases … to provide a denatured krill product” having certain amounts of ether, non-ether, and total phospholipids as well as certain amounts of triglycerides. Id. at 7. According to the independent claims, the steps of providing and treating krill are “performed on a ship.” Id.The Patent Owner challenged whether “an ordinary skilled artisan would have had reason for, and a reasonable success in” combining the references in the manner alleged by Petitioner. The Board credited “Dr. Tallon’s testimony that an ordinarily skilled artisan would have had a reasonable expectation of success in combining Breivik, Catchpole, and Fricke 1984 to arrive at the claimed invention because the lipid components described in the claims of the ’877 Patent are the natural lipid components in the krill oil that can be extracted using any number of suitable solvents, and that the relative proportions of those lipid components can also be varied in a predictable way by applying a combination of solvents with different polarity to selectively concentrate groups of compounds based on their different solubility and by blending these selective extracts in known and predictable ways to produce a desired krill oil composition.” Paper 23 at 47-48 (internal quotations omitted). With respect to Bottino, Patent Owner “contends that Bottino’s oil would contain ether phospholipid levels similar to those reported in Fricke 1986”; however, according to the Board, this contention is unsupported by evidence in the record and does not defeat reliance on the reference. Id. at 49-50.Patent Owner contended “that an ordinarily skilled artisan would have sought to avoid using krill oil extracts having high ether phospholipid levels as a dietary supplement”; however, the Board dismissed these arguments in view of commercial realities at the time of Patent Owner’s invention. Id. at 59-60. The Board noted that “the record is devoid of evidence suggesting any concern relating to potential harm from the ether phospholipids present in NKO [i.e., Neptune Krill Oil], or any other commercially available prior art krill oil extract. To the contrary, the evidence of record demonstrates that NKO was generally recognized as safe.” Id. at 60. In response to Petitioner’s reliance upon Sampalis II, Patent Owner contended that an ordinary skilled artisan would not have combined this reference with the others “because there is no scientific basis to combine ranges for lipid components of oils produced by different methods and from different starting to produce a single defined oil.” Id. at 63. The Board disagreed and found that “an ordinarily skilled artisan would have had reason for, and a reasonable expectation of success in” combining these references because “each disclose that the phospholipids have been implicated in conferring numerous health benefits and that Sampalis II further teaches that krill … is a useful starting material for obtaining a phospholipid rich extract.” Id. at 63-64 (internal citations omitted).As above, the Board supported its finding with reference to Fricke 1986, which was used as evidence regarding the detailed protocols and methods used by Fricke 1984. The Board also pointed to Dr. Hoem being named as co-author on a paper that “touts the superiority of 31P NMR relative to other analytical techniques [such as those employed by Fricke 1986].” Id. at 43. Accordingly, the Board concluded “that Fricke [1986]’s analysis is indeed non-representative.” Id. The Board also concluded that “an ordinary skilled artisan would have had a reason to include Bottino in the combination because Bottino discloses the levels of fatty acids, and in particular, the levels of omega-3 fatty acids, present in krill oil.” Id. at 50.Accordingly, in its Final Written Decision, the Board determined Petitioner demonstrated that claims 1–19 are unpatentable.Rimfrost AS filed a second petition (see IPR2017-00748) alleging the ’877 Patent is obvious in view of various combinations of seven references, some of which were relied upon by Rimfrost in IPR 2017-00745 and -00746. The Board entered its Final Written Decision on August 10, 2018, and arrived at similar conclusions regarding the superiority of 31P NMR as it did in its Final Written Decision in IPR2017-00747. According to the Board, “[t]he absence of evidence sufficient to establish the reliability of Tanaka I is of particular importance where, as here, Petitioner and its declarant … go to great lengths both to tout the superiority of a quantification technique different from that used by Tanaka I – NMR – as well as to disparage the accuracy of other degradation-based analyses – namely, that used by Fricke 1986.” IPR2017-00748, Paper 24 at 28.
Termination of Inter Partes Review Proceedings Under 35 U.S.C. § 317(a)
- Taro Pharmaceuticals U.S.A., Inc., v. Apotex Technologies, Inc., No. IPR2017-01449 (Judgment Entered August 7, 2018). With the Board’s prior authorization, Taro and Apotex filed a Joint Motion to terminate the IPR proceeding under 35 U.S.C. § 317(a), a copy of a settlement agreement, and a Joint Request to treat the same as business confidential information, to be kept separate from the file of the patent at issue. Accordingly, the Board entered Judgment to Terminate the Proceeding without rendering a final written decision. Id.; see also 37 C.F.R. § 42.72.
- Breckenridge Pharmaceutical, Inc. v. Novartis Pharmaceuticals Corp., IPR2017-01592 (Judgment Entered August 8, 2018). Breckenridge and Novartis complied with 35 U.S.C. § 317(a) by filing a Joint Motion to terminate the IPR proceeding, a copy of a settlement agreement, and a Joint Request to treat the same as business confidential information. However, rather than terminate the entire proceeding, the Board entered the Judgment to Terminate only with respect to Breckenridge and Novartis; due to an earlier grant of a motion for joinder, the IPR will continue with Petitioner West-Ward.
During the week of August 13, the Board issued one decision in Technology Center 1600, which denied institution of inter partes review. The decision is as follows:
Hologic, Inc. v. bioMérieux, Inc., No. IPR2018-00569 (Decision Entered August 10, 2018). In ground 1 of its petition, Hologic challenged claims 1–6 of U.S. Patent No. 8,697,352 (“the ’352 patent”) as obvious based on references by Backus, Sooknanan, and Myers. In ground 2, Hologic challenged claims 1-6 of the ’352 patent as obvious based on references by Bell, Sooknanan, and Myers. bioMérieux argued that the Board should exercise its discretion under 35 U.S.C. § 325(d) to deny institution because “the Examiner considered the same arguments the Petition advances” and Hologic did “not identify any new art or raise any new arguments that should lead the Board to reach a different conclusion.” IPR2018-00569, Paper 9 at 13 (informative). The Board reviewed the non-exclusive factors laid out in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, slip op. at 17–18 (Paper 8, Dec. 15, 2017), and concluded that on balance, the factors supported exercising the Board’s discretion to deny institution. The Board concluded that, while the Examiner did not consider the Sooknanan reference during prosecution, and Sooknanan is not listed on the face of the patent, substantially similar prior art references were considered during prosecution. IPR2018-00569, Paper 9 at 16. The Board observed that the Examiner expressly considered the primary references on which Petitioner based its grounds for unpatentability. Id. at 26. Moreover, Petitioner made arguments that were “substantially similar to the findings the Examiner made to reject the claims, and that the patent applicants overcame with evidence.” Id. Accordingly, the Board exercised its discretion to deny institution under § 325(d).
During the week of August 20, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600, both denying institution of inter partes review. A summary of the decisions follows:
Catalent Pharma Solutions, Inc. (“Catalent”) v. Patheon Softgels Inc. (“Patheon”), IPR2018-00421 (Decision Denying Institution Entered August 13, 2018).
In its petition, Catalent challenged claims 1-38 of U.S. Patent No. 9,693,978 (“the ’978 patent”) on anticipation and obviousness grounds. The ’978 patent is directed to oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules.
A key determination concerned claim construction of the term “about 5% lactic acid by weight of the fill material.” Catalent argued that the term “about 5%” should encompass between 2% to 8%. During prosecution, Patheon narrowed the scope of the claims from “lactic acid in an amount from about 0.2 to about 1.0 mole equivalents per mole of naproxen salt” to exclude a broader amount of lactic acid and recite “about 5% lactic acid by weight of the fill material.” The Board agreed with Patheon that the term “about 5%” should be given its ordinary meaning of “approximately 5%” and declined to adopt Catalent’s proposed construction, concluding that such a determination would improperly broaden the scope of the claims.
Catalent challenged the claims as anticipated and/or obvious based on references by Chen, Kim, and Schoenhard. The Board found that Catalent failed to establish that arriving at the claimed amount of lactic acid would have been a routine matter of choice and that Catalent’s expert relied on improper assumptions. In particular, Catalent’s expert chose a specific capsule size and shape and a specific amount of active agent for the basis of his contentions, but failed to adequately explain why that specific capsule was selected from numerous other conventional combinations. The Board determined that Catalent “appear[ed] to have arbitrarily selected dosages and capsule sizes so as to achieve the desired result of 5%[] lactic acid by weight of the fill material.” IPR2018-00421, Paper 9 at 24. Furthermore, Catalent’s expert erroneously referenced a capsule size that was impractical for human consumption. The Board found that “the unexplained picking-and-choosing activity” of Catalent’s analysis to reach their conclusions amounted to improper hindsight. Id. at 15. The Board further found that Catalent failed to establish that lactic acid would be a simple substitution for other acids, like citric acids, or that the amounts of each would be the same. Id. 17-19.
The Board concluded that Catalent failed to establish a reasonable likelihood of prevailing on any of the challenged claims of the ’978 patent and therefore denied institution of inter partes review.
Catalent Pharma Solutions, Inc. (“Catalent”) v. Patheon Softgels Inc. (“Patheon”), IPR2018-00422(Decision Denying Institution Entered August 13, 2018).
In another petition, Catalent challenged claims 1-19 of U.S. Patent No. 9,693,979 (“the ’979 patent”) on anticipation and obviousness grounds. The ’979 patent, like the ’978 patent discussed above, is directed to oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. The same references and similar grounds of unpatentability were presented by Catalent as were presented in its petition in IPR2018-00421.
For the same reasons as in IPR2018-00421, the Board denied institution of Catalent’s petition in IPR2018-00422. Accordingly, no trial was instituted against the claims of the ’979 patent.
The Patent Trial and Appeal Board issued two decisions in TC 1600 during the week of August 27-31, 2018. The first decision denied institution of an IPR petition filed by Hologic Inc. (Hologic) against bioMérieux, Inc. (bioMérieux). The second decision denied institution of a PGR petition filed by Rimfrost AS (Rimfrost) against Aker Biomarine Antarctic AS (Aker). The decisions are as follows:
Hologic Inc. v. bioMérieux, Inc., No. IPR2018-00566 (Decision Entered August 24, 2018).
In this Petition, Hologic challenged U.S. Patent No. 9,074,262 (“the ’262 patent”) on an obviousness ground based, on references by Sooknanan and Myers published in 1995 (“the 1995 Myers”). The ’262 patent relates to methods for diagnosing HIV-1 infections via amplification and detection of HIV-1 nucleic acid. The challenged claims recite amplification methods using a first primer of SEQ ID NO: 1 and a second primer of SEQ ID NO: 5. bioMérieux filed a preliminary response to the Petition. The Board exercised its discretion to deny the Petition under 35 U.S.C. § 325(d) because Hologic presented prior art arguments substantially similar to the rejections bioMérieux overcame in the prosecution of the ’262 patent. Specifically, the Board concluded that although Sooknanan was not before the Examiner, Hologic relied on Sooknanan for the same teachings that the Examiner considered admitted and well-known during prosecution. Additionally, the Examiner considered a version of Myers published in 1996 (“the 1996 Myers”) and not the 1995 Myers reference relied upon by Hologic. Nevertheless, the Board found the two versions of Myers substantively the same because both versions provided identical sequences relevant to the claimed invention, and the prior art teachings bioMérieux overcame in the prosecution were as strong as, if not stronger than, that in the 1995 Myers reference.
A similar decision involving the same parties was issued on August 10, 2018, which was discussed in our blog post https://www.1600ptab.com/2018/08/ptab-round-up-week-of-august-13-17-2018/#more-2957.
Rimfrost AS v. Aker Biomarine Antarctic AS, No. PGR2018-00033 (Decision Entered August 29, 2018).
In this Petition, Rimfrost challenged U.S. Patent No. 9,644,170 (“the ’170 patent”) on (1) enablement and written description grounds; (2) subject matter eligibility grounds; (3) an anticipation ground based on a parent application of the ’170 patent that matured into U.S. Patent No. 9,034,338 (the ’388 Application); and (4) obviousness grounds based on Bruheim, Neptune’s GRAS, Sampalis, Randolph, and Bottino. Aker filed a preliminary response to the Petition alleging that Rimfrost failed to establish that the ’170 patent contains or contained at least one claim with an effective filing date no earlier than March 16, 2013, as required to be eligible for a post grant review [America Invents Act, Sec. 3(n)(1)]. The Board agreed with Aker and denied the Petition.
The ’170 patent relates to encapsulated krill oil with specific lipid components. Rimfrost alleged that claim limitations related to the amount of (1) ether phospholipids (3% to 15% w/w of sake krill oil), (2) astaxanthin esters (greater than about 100 mg/kg of krill oil), and (3) trimethylamine (less than 1 mg/kg of krill oil) failed to satisfy the enablement and written description requirements of 35 U.S.C. § 112(a) and were not supported by the prior filed applications. The first two limitations were recited in the issued claims, and the third limitation was recited in the original claims. The Board agreed with Aker that the specification of the ’170 patent provided specific disclosure of the limitations at issue and, therefore, the limitations satisfied the written description requirement. Furthermore, the Board agreed with Aker and concluded that (1) the limitations related to ether phospholipids and astaxanthin esters were enabled because blending specific amounts of various lipid components to create a krill oil composition would be within the ability of a POSITA; and (2) a POSITA would know how to remove odor causing agents such as trimethylamine from krill oil at the time of the invention, based on the guidance provided in the specification and the Sampalis reference Aker relied on. The ’170 patent is a continuation of the ’388 Application that was filed March 28, 2008. Therefore, the Board concluded that Rimfrost failed to demonstrate that the ’170 patent contains or contained at least one claim that is not entitled to a priority date before of March 16, 2013.