• Liquidia Technologies, Inc. v. United Therapeutics CorporationSome claims unpatentable
  PTAB · Oct 8, 2021 · IPR2020-00770 · APJ John E Schneider · IPR · Final written decision

  Claims 1–5, 8, and 9 are unpatentable as obvious over Moriarty and Phares; claims 6 and 7 were not shown unpatentable over either asserted ground.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

    “Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). Here, we do not need to define the outer bounds of the term “pharmaceutical batch” because the parties’ dispute over this term centers on the issue of storage stability.7 Patent Owner argues “the correct construction 6 The parties use the terms “purification” and “isolation” interchangeably in the papers. We use the term “isolation” in this Decision. 7 The parties agree on the “pharmaceutical” aspect of the term. We note the ’901 patent defines “pharmaceutically acceptable” as “being useful in preparing a pharmaceutical composition that is generally safe, non-toxic and neither biologically nor otherwise undesirable and includes being useful for veterinary use as well as human pharmaceutical use.” Ex. 1001, 5:27–31.” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner

    “[A]n invention is construed not only in the light of the claims, but also with reference to the file wrapper or prosecution history in the Patent Office.” Graham, 383 U.S. 1, 33. “The prosecution history of a related patent can be relevant if . . . it addresses a limitation in common with the patent in suit.” Advanced Cardiovascular Sys., Inc. v. Medtronic, Inc., 265 F.3d 1294, 1305 (Fed. Cir. 2001); see also Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999) (“When multiple patents derive from the same initial application, the prosecution history regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that contain the same claim limitation.”). Here, the Specification of the ’901 patent includes the same language “crude treprostinil salts can be stored as raw material at ambient temperature” addressed in the prosecution of the parent ’623 application. Ex. 1001, 17:5–6. More importantly, challenged claim 6 recites the same limitation “preparing a pharmaceutical product . . . after storage” the applicant expressly interpreted there. See Ex. 2028, 193. Because “the same claim limitation is at issue, prosecution disclaimer made on the same limitation in an ancestor application will attach,” the applicant’s interpretation of “storing”/“storage” during the prosecution of the ’623 application applies here. See Omega Eng’g, Inc., v. Raytek Corp., 334 F.3d 1314, 1333 (Fed. Cir. 2003). slip op. at 23

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013). Here, step (c) of challenged claim 1 requires “contacting the solution comprising treprostinil from step (b) with a base to form a salt of treprostinil.” Ex. 1001, 17:27–29 (emphasis added). The claim language itself, thus, dictates that the solution formed in step (b), and not treprostinil isolated from step (b), is the starting material for forming a salt in step (c). The Specification of the ’901 patent supports our determination. Indeed, the Specification touts that one of the advantages of the disclosed process is that “the treprostinil salts can be synthesized from the solution of treprostinil without isolation,” because “[t]he impurities carried over from intermediate steps (i.e. alkylation of triol and hydrolysis of benzindene nitrile) are removed during the carbon treatment and the salt formation step.” Ex. 1001, 17:1–11. As a result, we agree with the argument presented in the Patent Owner Response that “claim 1 requires the solution in which treprostinil is formed be used directly in the next salt-forming step without isolating treprostinil in between.” See PO Resp. 11.” slip op. at 27

  • Skill levelSkill level board ownOther

    “pharmaceutical manufacturing.” Id. at 23. We find Patent Owner’s definition of the skill level too narrow. Patent Owner relies on the declaration of Dr. Pinal, who testifies that the ’901 patent is “focused on the production of pharmaceutical compositions and products, on a commercial batch-size scale.” Ex. 2002 ¶ 91; see also id. ¶ 92 (opining that organic and medicinal chemists do not have the “requisite skill set for the large-scale manufacture” of drugs); PO Resp. 24 (arguing an ordinarily skilled artisan is aware of “problems encountered in preparing a commercial-scale pharmaceutical product”).” slip op. at 29

  Patent outcomesUS 9,604,901 mixed
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 9,604,901
• Eis GmbH v. Novoluto GmbHNo claims unpatentable
  PTAB · Sep 23, 2021 · IPR2020-00007 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–3, 5, 7, 8, 11, 14, 15, and 17–26 were not shown unpatentable under the Taylor anticipation or Taylor-based obviousness grounds.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedDenied

    “disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35

  • ExcludeMotion to exclude, deniedDenied

    “5. Conclusion For the reasons set forth above, we deny the portion of Petitioner’s” slip op. at 73

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “7 Petitioner presents argument that the term “pressure field generator” should be construed as a means-plus-function term limited to the following structure: at least one first chamber, at least one second chamber, and at least one connection element. Reply 25–26. As we find that it is not necessary to construe this term to resolve the issues before us, we do not address these arguments presented by Petitioner.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “disclosure of a suction cup “sealingly” receiving the vulva occurs when the vacuum is applied, not before. See Ex. 2034 ¶ 121. We disagree with Petitioner’s conclusion that “Taylor discloses that arm 26 ‘compresses . . . and then expands bellows 160’ after member 156 ‘sealingly’ engages the vulva.” Reply 9. The single statement in Taylor on which Petitioner relies states, with reference to Figure 3 set forth above in Section II.D.1, “[t]he first stimulator 154 includes a suction cup member 156 that conformingly and sealingly receives the upper portion of the vulva.” Ex. 1004, 5:29–31. We agree with Dr. Jensen that this does not support Petitioner’s conclusion that a seal is achieved before the vacuum is applied, and credit Dr. Jensen’s testimony that reads as follows as consistent with Taylor’s disclosure.” slip op. at 35

  Patent outcomesUS 9,849,061 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,849,061
• Fresenius Kabi USA, LLC / Fresenius Kabi Swissbiosim GmbH v. Coherus Biosciences, Inc.Rehearing denied
  PTAB · Jan 27, 2021 · PGR2019-00064 · APJ Christopher G Paulraj · PGR · Rehearing

  The Board denied Petitioner’s rehearing requests, leaving in place denial of institution based on the merits of the written-description and enablement challenges.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. DISCUSSION A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, 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 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).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “Petitioner’s arguments are unpersuasive because our construction of “stable” does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he Board did not construe ‘stable’ to be limited to formulations that are as stable as Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction encompasses the “most” preferred embodiment (e.g., those that do not lose more than 5% of their activity during two years of long-term storage), it also encompasses other embodiments that are considered less preferred but nonetheless within the scope of what is defined to be “stable” in the specification, i.e., compositions that do “not lose more than 20%, or more preferably 15%, or even more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent with the specification, our construction of “stable” encompasses embodiments in which stability is determined by comparison to the commercial formulation of adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis to construe “stable” to be limited to the only most preferred embodiment by requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”).” slip op. at 3

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable

    “These arguments are also unpersuasive. As stated in the Decision: [W]e find that the specification provides a detailed disclosure of the testing used to assess stability (using Humira as the control), and identifies specific ingredients to be included and excluded from the claimed composition, and further identifies the pH that is necessary to achieve the claimed stability. Although there may be certain concentrations of adalimumab or certain types of buffers and sugars that may render the compositions more difficult to stabilize, Petitioner does not explain sufficiently why a POSA would not have known how to adjust or select those ingredients in order to achieve the claimed stable aqueous pharmaceutical composition. Decision 17. As further stated in the Decision: Moreover, even if a POSA would have needed to test whether a particular composition was stable, “[t]he fact that some experimentation is necessary does not preclude enablement; what is required is that the amount of experimentation ‘must not be unduly extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even “a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the invention claimed.” Id. (citing Ex parte Jackson, 217 USPQ 804, 807 (BPAI 1982)). Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of enablement ground for claims 1–12.” slip op. at 5

  • Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable

    “the specification identifies with sufficient clarity each of the ingredients that must be included as part of the claimed composition (i.e., adalimumab, a buffer, polysorbate 80, and a sugar) and further provides a reason to exclude the ingredients that must not be included in theclaimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and sodium chloride). Id. at 13–14. The Decision also explained how one of ordinary skill in the art would recognize that the inventors possessed the claimed invention: Patent Owner identifies teachings in the specification indicating the structural features required for achieving a stable adalimumab composition, which include: 1) avoiding the citrate/phosphate buffer combination in favor of another more stable buffer (such as an acetate buffer); 2) including polysorbate 80 as a stabilizer; 3) removing sodium chloride (NaCl) from the formulation; 4) using a sugar or polyol as the tonicity modifier in place of mannitol/NaCl; and 5) maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60 (citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25). Patent Owner further asserts, and we agree, that the specification “provides working examples that demonstrate comparable or superior stability to the commercial Humira® formulation” and that Petitioner fails to demonstrate why a POSA would doubt that the formulations that demonstrated improved stability relative to Humira would be stable. Id. at 60–61. Id. at 14. Petitioner’s arguments do not persuade us that we committed legal or factual error in making the foregoing determinations. Accordingly, we are not persuaded that we abused our discretion in determining that Petitioner did not satisfy its burden with respect to the lack of written description ground for claims 1–12.” slip op. at 7

  Claim construction§ 112 disclosure
  Patents in suitUS 10,155,039
• Rimfrost As. v. Aker Biomarine Antarctic As.All claims unpatentable
  PTAB · Mar 6, 2020 · IPR2018-01730 · APJ John E Schneider · IPR · Final written decision

  Claims 1–20 are unpatentable across the stated anticipation and obviousness grounds; the contingent motion to amend with substitute claims 21–29 is denied because those claims are obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “At institution, we preliminarily adopted Petitioner’s definition of an ordinarily skilled artisan, and determined that the prior art itself was sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. Inst. Dec. 8. We note that Patent Owner states that it “accepts [Petitioner’s] definition of a POSITA.” PO Resp. 15. Accordingly, for this Decision, we adopt Petitioner’s definition, while maintaining that the prior art demonstrates the appropriate level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). Moreover, we have reviewed the credentials of Drs. Tallon and Hoem, and consider each of them to be qualified to provide their opinion on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “Such broadening usages as ‘about’ must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). After considering the parties’ arguments and reviewing the Specification of the ’765 patent, we conclude that Petitioner’s proposed construction is consistent with the intrinsic evidence. Although the ’765 patent does not explicitly address the issue of “about,” the meaning of the term can be discerned from a careful reading of the Specification. Example 8 of the ’765 patent reports the analysis of phospholipid available Krill product. Ex. 1001, col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports the calculated values for the various phospholipids in values to a tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of the table, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent with the approach advanced by Petitioner. IPR2018-00295, Paper 35, 12.3 Similarly here, we find that although the Specification does not explicitly define the term “about,” its meaning may be discerned from the manner by which the Specification refers to reported values for phospholipid profiles of krill oil. Ex. 1001, 32:18–44 (Table 22). In the discussion of the lipids reported in Table 22, the values are rounded to the nearest whole number, not the nearest tenth. Id. at 32:47–52. This is more consistent with the approach advanced by Petitioner than by Patent Owner. Thus, as determined in that Final Written Decision, and for the reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13.” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed

    “We have considered the arguments of the parties and the evidence of record and conclude that claims 5 and 6 are not anticipated by Catchpole. While we agree with Petitioner that Catchpole teaches compositions that can Catchpole discloses a krill oil composition having that amount of acylalkyphospholipids. Catchpole teaches a method of separating lipid materials from a feed material. Ex. 1009, 4. The feed material used in Catchpole may be derived from “terrestrial animals, marine animals, terrestrial plants, marine plants, or micro-organisms such as microalgae, yeast and bacteria. Preferably the feed material is derived from sheep, goat, pig, mouse, water buffalo, camel, yak, horse, donkey, llama, bovine or human.” Id. at 7. Catchpole does not specifically disclose a Krill extract that contains greater than 10% acylalkyphospholipids. The only specific disclosure of the acylalkyphospholipid content of krill oil is in Table 16 discussed above, which discloses an acylalkyphospholipid content of 4.8%, less than the 6% and 7% recited in claims 5 and 6. Based on the foregoing we conclude that claims 5 and 6 are not anticipated by Catchpole. E. Ground 2 - Obviousness Based on Catchpole Combined with Sampalis” slip op. at 17

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013) (citing Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379 (Fed Cir. 1999)). “It is well established that collateral estoppel, also known as issue preclusion, applies in the administrative context.” MaxLinear, Inc. v. CF CRESPE LLC, 880 F.3d 1373, 1376 (Fed. Cir. 2018) (citations omitted); Webpower, Inc. v. WAG (Final Written Decision). The application of collateral estoppel is not limited to patent claims that are identical. Ohio Willow Wood, 735 F.3d at 1342. “Rather, it is the identity of the issues that were litigated that determines whether collateral estoppel should apply. . . . If the differences between the unadjudicated patent claims and the adjudicated patent claims do not materially alter the question of invalidity, collateral estoppel applies.” Id. As our reviewing court has explained, collateral estoppel precludes a party from relitigating an issue if: (1) prior action presents an identical issue; (2) the prior action actually litigated and adjudged that issue; (3) the judgment in that prior action necessarily required determination of the identical issue; and (4) the prior action featured full representation of the estopped party. VirnetX Inc. v. Apple, Inc., 909 F.3d 1375, 1377 (Fed. Cir. 2018) (quoting Stephen Slesinger, Inc. v. Disney Enters., Inc., 702 F.3d 640, 644 (Fed. Cir. 2012)).” slip op. at 21

  Patent outcomesUS 9,072,752 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,072,752
• Rimfrost As v. Aker Biomarine Antarctic AsAll claims unpatentable
  PTAB · Jan 13, 2020 · IPR2018-01179 · APJ Erica A Franklin · IPR · Final written decision

  Claims 33–61 are unpatentable as obvious across four grounds; the Board denied Patent Owner’s contingent motion to amend claims 75–84 as those substitute claims were also obvious.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “At institution, we preliminarily adopted Petitioner’s definition of an ordinarily skilled artisan, and determined that the prior art itself was sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. Inst. Dec. 9. We note that Patent Owner states that it “accepts [Petitioner’s] definition of a POSITA.” PO Resp. 16. Accordingly, for this Decision, we adopt Petitioner’s definition, while maintaining that the prior art demonstrates the appropriate level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). Moreover, we have reviewed the credentials of Drs. Tallon and Hoem, and consider each of them to be qualified to provide their opinion on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “As noted by Petitioner, the Board construed the phrase “greater than about 5% w/w” as meaning “greater than 4.5% w/w” in a Final Written Decision addressing similar claims of a related patent. Pet. Reply 12. Specifically, in IPR2018-00295, the Board’s analysis of the claim phrase “greater than about 5% w/w” of krill oil in the Final Written Decision reads as follows: Such broadening usages as ‘about’ must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). After considering the parties’ arguments and reviewing the Specification of the ’765 patent, we conclude that Petitioner’s proposed construction is consistent with the intrinsic evidence. Although the ’765 patent does not explicitly address the issue of “about,” the meaning of the term can be discerned from a careful reading of the Specification. Example 8 of the ’765 patent reports the analysis of phospholipid fractions of a product of the invention and a commercially available Krill product. Ex. 1001, col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports the calculated values for the various phospholipids in values to a tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of the table, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent with the approach advanced by Petitioner. IPR2018-00295, Paper 35, 12.10 Similarly here, we find that although the Specification does not explicitly define the term “about,” its meaning may be discerned from the manner by which the Specification refers to reported values for phospholipid profiles of krill oil. Ex. 1001, 32:55–67 (Table 22). In the discussion of the lipids reported in Table 22, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32:47–52. This is more consistent with the approach advanced by Petitioner than by Patent Owner. Thus, as determined in that Final Written Decision, and for the reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13. Similarly, we construe the recitation in claim 33 requiring “greater than about 3% ether phospholipids” as meaning “greater than 2.5% ether phospholipids,” and we construe the recitation in claim 46 of “greater than 4% ether phospholipids” as meaning “greater than 3.5% phospholipids.” Although Petitioner and Patent Owner propose additional claim constructions, we determine that explicit construction of those additional claim terms is not necessary for purposes of this Decision.” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Based upon our review of the arguments, however, it does not appear that those differences between the claims analyzed in IPR2018-00295 and the challenged claims are material to the issue presented by Patent Owner regarding whether a person of ordinary skill in the art would combine ranges for specific lipid components in an extract from references that use different extraction techniques. Indeed, a side-by-side comparison of the argument set forth in Patent Owner’s Response filed in IPR2018-00295 and the Patent Owner’s Response filed here reveals that the same, virtually verbatim, arguments were made in both cases, absent changes in, e.g., citations and referring to Bottino II instead of Frick 1984 as disclosing a “non-selective” Folch extraction of krill. Compare IPR2018-00295, Paper 14, 14–22, with IPR2018-01179, Paper 12, 24–31. In the Final Written Decision, Patent Owner’s arguments, repeated here, were rejected. IPR2018-00295, Paper 35, 34–39. In any event, we do not apply collateral estoppel to this issue, as the parties have not fully briefed their positions in this proceeding. However, we determine that the analysis in the Final Written Decision for IPR2018-00295 regarding whether a skilled artisan would have been motivated to combine ranges for specific lipid components in an extract from references using different, i.e., “selective and non-selective” extraction techniques is applicable here. In particular, for the same reasons discussed in the IPR2018-00295 Final Written Decision, we accord persuasive weight to Dr. Tallon’s testimony that a POSITA would have known that the relative proportions of natural krill and hence the natural krill oil constituents could be varied in predictable ways by applying a single solvent or combination of solvents including super critical fluid extraction to selectively extract specific groups of lipid components based on their different solubility, and by blending these selective extracts in known and predictable ways to produce a desired krill oil composition. Ex. 1006 ¶¶ 104, 106, 110; see IPR2018-00295, Paper 35, 37–39. We note that Dr. Tallon provided similar testimony in IPR2017-00746, Ex. 1006 ¶ 212, which the Board also credited in determining that the claims of the ’877 patent, directed to a method of producing krill oil comprising extracting oil from denatured krill product with a polar solvent, IPR2017- 00746, Paper 23, 47–48, are unpatentable. Indeed, the Federal Circuit affirmed that Final Written Decision and the Board’s finding that “the lipid components of krill oil can be extracted using any number of suitable solvents, that the proportions of the components could be varied in predictable ways, and that the resulting extracts could be blended to produce a final krill oil product.” Aker Biomarine Antarctic, 786 F. App’x at 254. Moreover, as discussed in the IPR2018-00295 Final Written Decision, the ’765 patent, which shares the same Specification as the challenged patent, describes the compositions of the invention as being prepared by “blending the neutral and polar lipid extracts.” IPR2018-00295, Paper 35, 39, Ex. 1001, 12:34–35. As explained there, “[t]he Specification provides no further guidance regarding the blending step but instead relies on the” slip op. at 35

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

    “Having considered the amended limitations of the substitute claims, and incorporating our analysis and conclusions regarding for the reiterated arguments regarding a motivation to combine and reasonable expectation of success from our discussion of the original claims, we conclude that the preponderance of the evidence demonstrates that substitute claims 75–82 are unpatentable as obvious over the combination of Yoshitomi, Catchpole, Bottino II, Sampalis I, Randolph, Sampalis II, and NKO; substitute claim 83 is unpatentable as obvious over the combination of Yoshitomi, Catchpole, Bottino II, Sampalis I, Fricke, Randolph, Sampalis II, and NKO; and substitute claim 84 is unpatentable as obvious over Yoshitomi, Catchpole, Bottino II, Sampalis I, Sampalis II, Randolph, and NKO. Accordingly, Patent Owner’s contingent Motion to Amend is denied. of this issue here is consistent with what was decided in that Final Written Decision. CONCLUSION For the foregoing reasons, we conclude that Petitioner has established by a preponderance of the evidence that claims 33–38, 40–43, 46–49, 51–52, 55–58, and 60 are unpatentable as obvious over Breivik II, Catchpole, Bottino II, and Sampalis I; claim 39 is unpatentable as obvious over Breivik II, Catchpole, Bottino II, Sampalis I, and Sampalis II; claims 44, 50, 53, and 59 are unpatentable as obvious over Breivik II, Catchpole, Bottino II, Sampalis I, and Fricke; and claims 45, 54, and 61 are unpatentable as obvious over Breivik II, Catchpole, Bottino II, Sampalis I, and Randolph. Additionally, we deny Patent Owner’s contingent Motion to Amend. V. ORDER Accordingly, it is hereby: ORDERED that based on a preponderance of the evidence, claims 33–61 of the ’453 patent are unpatentable; FURTHER ORDERED, Patent Owner’s Motion to Amend is denied;” slip op. at 51

  Patent outcomesUS 9,375,453 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,375,453
• Rimfrost As v. Aker Biomarine Antarctic AsAll claims unpatentable
  PTAB · Jan 13, 2020 · IPR2018-01178 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–32 are unpatentable as obvious over the stated reference combinations; the contingent motion to amend substitute claims 62–74 is denied because those claims are unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “At institution, we preliminarily adopted Petitioner’s definition of an ordinarily skilled artisan, and determined that the prior art itself was sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. Inst. Dec. 9. We note that Patent Owner states that it “accepts [Petitioner’s] definition of a POSITA.” PO Resp. 16. Accordingly, for this Decision, we adopt Petitioner’s definition, while maintaining that the prior art demonstrates the appropriate level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect appropriate level of ordinary skill in art). Moreover, we have reviewed the credentials of Drs. Tallon and Hoem, and consider each of them to be qualified to provide their opinion on the level of skill and the knowledge of a person of ordinary skill in the art at the time of the invention.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “As noted by Petitioner, the Board construed the phrase “greater than about 5% w/w” as meaning “greater than 4.5% w/w” in a Final Written Decision addressing similar claims of a related patent. Pet. Reply 12. Specifically, in IPR2018-00295, the Board’s analysis of the claim phrase “greater than about 5% w/w” of krill oil in the Final Written Decision reads as follows: Such broadening usages as ‘about’ must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996). After considering the parties’ arguments and reviewing the Specification of the ’765 patent, we conclude that Petitioner’s proposed construction is consistent with the intrinsic evidence. Although the ’765 patent does not explicitly address the issue of “about,” the meaning of the term can be discerned from a careful reading of the Specification. Example 8 of the ’765 patent reports the analysis of phospholipid fractions of a product of the invention and a commercially available Krill product. Ex. 1001, col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports the calculated values for the various phospholipids in values to a tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of the table, the values are rounded to the nearest whole number, not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent with the approach advanced by Petitioner. IPR2018-00295, Paper 35, 12.10 Similarly here, we find that although the Specification does not explicitly define the term “about,” its meaning may be discerned from the manner by which the Specification refers to reported values for phospholipid profiles of krill oil. Ex. 1001, 32:55–67 (Table 22). In the discussion of the lipids reported in Table 22, the values are rounded to the nearest whole number, not the nearest tenth. Id. at 32:47–52. This is more consistent with the approach advanced by Petitioner than by Patent Owner. Thus, as determined in that Final Written Decision, and for the reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13. Similarly, we construe the recitation in claim 1 requiring “greater than about 3% ether phospholipids” as meaning “greater than 2.5% ether phospholipids,” and we construe the recitation in claim 14 of “greater than 4% ether phospholipids” as meaning “greater than 3.5% phospholipids.”” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Based on those prior art teachings, Petitioner asserts that the ordinarily skilled artisan also would have had a “reasonable expectation of producing a polar krill oil having the percentage of constituents as recited in the claims.” Id. at 53. Likewise, Dr. Tallon testifies that a person of ordinary skill in the art “would have known that the relative proportions of the natural krill and hence the natural krill oil constituents could be varied in predictable ways by applying a single solvent or combination of solvents . . . to selectively extract specific groups of lipid components . . . , and by blending these selective extracts in known and predictable ways to produce a desired krill oil composition,” indicating that an ordinarily skilled artisan would have had a reason to combine the teachings of the cited references and a reasonable expectation of success in doing so in a manner that yields the claimed invention. Ex. 1006 ¶ 104. Based on our review of the record as a whole, we determine that a preponderance of the evidence supports Petitioner’s contention that an ordinarily skilled artisan would have had reason to combine the teachings of Breivik II, Catchpole, Bottino II, and Sampalis I, with a reasonable expectation of successfully arriving at the inventions of claims 1–3, 5–10, 12, 14–17, 19–20, 23–26, 28, and 30–32. Next, we address Patent Owner’s arguments and Petitioner’s assertion of collateral estoppel.” slip op. at 30

  • BurdenUnpatentable

    “Based on the foregoing, we conclude that Petitioner has established by a preponderance of the evidence that claims 1–3, 5–10, 12, 14–17, 19–20, 23–26, 28, and 30–32 are unpatentable over the combined teachings of Breivik II, Catchpole, Bottino II, and Sampalis I. F. Obviousness of Remaining Grounds Based upon Combinations including Breivik II, Catchpole, Bottino II and Sampalis I Each of the three remaining grounds rely upon similar combinations of Breivik II, Catchpole, Bottino II, and Sampalis I, as set forth in the ground analyzed above, in Section II. E. Pet. 7, 56–66. The remaining grounds combine additional references to address various limitations of dependent claims 4, 11, 13, 18, 21, 22, 27, and 29. Id. Patent Owner challenges those additional grounds only by relying on its arguments presented with respect to the ground based upon Breivik II, Catchpole, Bottino II, and Sampalis I. PO Resp. 33–35. According to Patent Owner, the additional references relied upon in the remaining grounds do not “cure the deficiencies noted above for the core four references.” Id. We have considered the combined teachings of the cited references for each of the remaining grounds, along with Petitioner’s arguments and Dr. Tallon’s testimony and, based on the record as a whole, we determine that Petitioner has established by a preponderance of the evidence that claims 4, 11, 13, 18, 21, 22, 27, and 29 are unpatentable over those combined teachings for the reasons discussed herein regarding the combination of Breivik II, Catchpole, Bottino II, and Sampalis I, and based upon Petitioner’s additional evidence and arguments in each of the remaining grounds, which we adopt as our own. See Pet. 56–66; Ex. 1006 ¶¶ 439–457.” slip op. at 37

  Patent outcomesUS 9,375,453 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,375,453

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.