2021000877 (P.T.A.B. Dec. 21, 2021)

Bimeda Research & Development Limited

Patent Trials and Appeals BoardDec 21, 2021

2021000877 (P.T.A.B. Dec. 21, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/771,884 04/27/2018 Francisco Javier MOLINS ALBANELL 10255.0006-00000 3766 22852 7590 12/21/2021 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER YOUNG, MICAH PAUL ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 12/21/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): regional-desk@finnegan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte FRANCISCO JAVIER MOLINS ALBANELL, BRENDAN GERARD SMITH, JAMES KENNEDY, and FIONA NÍ CHEARÚIL Appeal 2021-000877 Application 15/771,884 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The Examiner rejected claims 41, 46–48, and 51–60 under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the Examiner’s decision to reject the claims. 1 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies ZOETIS BROOMHILL IP LIMITED, and Zoetis Inc. as the real party in interest. Appeal Br. 3. Appeal 2021-000877 Application 15/771,884 2 STATEMENT OF THE CASE The Examiner rejected claims 41, 46–48, and 51–60 in the Final Office Action under 35 U.S.C. § 103 as obvious in view of Ericson et al. (US 2014/0222067 A1, published Aug. 7, 2014) (“Ericson”), Clarke et al. (US 5,750,591, issued May 12, 1998) (“Clarke”), and Razza et al. (WO 2010/065747 A2, published Jun. 10, 2010) (“Razza”). Final Act. 2. Independent claim 41 is the only independent claim on appeal. The claim is reproduced below: 41. A seal formulation for forming a physical barrier in the teat canal of a non-human animal comprising a polymer in a gel base wherein the polymer is a mixed calcium and sodium salt derivative of a methyl vinyl ether-maleic anhydride copolymer, and wherein the seal formulation further comprises a viscosity enhancing agent that comprises zinc oxide. DISCUSSION The claim is directed to a teat seal formulation comprising a polymer in a gel base. The polymer is a “mixed calcium and sodium salt derivative of a methyl vinyl ether-maleic anhydride copolymer.” The seal formulation also comprises “a viscosity enhancing agent that comprises zinc oxide.” While the claim characterizes the zinc oxide as a “viscosity enhancing agent,” the claim does not require that the seal formulation has its viscosity enhanced by the zinc oxide. As long as zinc oxide is present in the seal formulation, the claim limitation is met because the viscosity enhancing requirement is inherent to the compound and there is no requirement that it be present in an amount effective to enhance the formulation’s viscosity. See In re Papesch, 315 F.2d 381, 391 (CCPA 1963) (“From the standpoint of Appeal 2021-000877 Application 15/771,884 3 patent law, a compound and all of its properties are inseparable; they are one and the same thing.”). The Examiner found that Ericson describes an animal tissue sealant formulation comprising petroleum jelly (a “gel base”) and methyl vinyl ether-maleic anhydride copolymer, the same copolymer recited in claim 41. Final Act. 2–3. The Examiner also found that formulation can comprise zinc oxide, another a required component of the claimed seal formulation. Id. at 3. The Examiner found that Ericson does not disclose that the methyl vinyl ether-maleic anhydride copolymer is a “mixed calcium and sodium salt derivative” as required by the claim, but found that Clarke describes a tissue sealant formulation comprising the “mixed calcium and sodium salt derivative” copolymer. Id. The Examiner also found that Clarke describes a gel base of paraffin wax or petroleum jelly. Id. The Examiner found it would have been obvious to one of ordinary skill in the art to use Clarke’s copolymer and base in Ericson because “they solve the same problem of sealing tissues together with a gel.” Id. The Examiner also found that Razza describes a teat seal formulation, as in claim 41, which is gel based and comprises aluminum stearate and liquid paraffin. Final Act. 3. The Examiner found it would have been obvious to one of ordinary skill in the art to use these compounds in Ericson’s formulation because they solve the same problem of sealing tissues together with a gel.” Id. Appellant argues that the claim requires that the polymer only contains calcium and sodium, but Clarke’s polymer also contains zirconium. Appeal Br. 8. Appellant acknowledges that Clarke describes a reference formulation containing only calcium and sodium, but states that it is only for Appeal 2021-000877 Application 15/771,884 4 the purpose of a comparison and has none of the superior properties of Clarke’s zirconium containing copolymer. Id. at 9. Appellant contends that the skilled worker would not have had a reason “to interchange Ericson’s copolymer with Clarke’s bipartite [calcium/sodium] reference formulation because Clarke itself characterizes that reference formulation as inferior to the zirconium-containing formulation” and would have reasonably expected “that interchanging Clarke’s bipartite reference formulation for Ericson's copolymer would be detrimental to the adhesive properties of Ericson’s primer.” Id. at 12. Furthermore, Appellant asserts that the skilled worker “would further reasonably expect that interchanging Clarke’s bipartite reference formulation for Ericson’s copolymer would likely reduce, not improve, the adhesion of Ericson’s patch to tissue.” Id. Appellant further argues: It is established that, “[i]f a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification.” M.P.E.P. § 2143.01(V) (citing In re Gordon, 733 F.2d 900 (Fed. Cir. 1984)). Appeal Br. 12. Appellant’s argument that it would not have been obvious to the ordinary skilled worker to replace Ericson’s copolymer with Clarke’s reference polymer (the calcium/sodium salt derivative of Ericson’s copolymer) is not persuasive. Appellant’s principal argument relates Clarke’s comparison of the properties of different salts of the same copolymer which is claimed. Table I of Clarke, describing these properties, is reproduced below: Appeal 2021-000877 Application 15/771,884 5 Table I of Clarke shows the test results for a paste adhesive comprising different salts of the polymethyl vinyl ether maleic anhydride copolymer (“Partial Gantrez Salts”; “Gantrez” refers to the copolymer), which is the same copolymer that is claimed. Clarke 4:66–5:2; 8–9. Three different properties were assessed: Hydration, Adhesion, and Cohesion. Clarke compared the copolymer containing zirconium (salts #1 and #2); zirconium, calcium, and sodium (salts #3 and #5); and calcium and sodium (salt #4). The polymer containing calcium and sodium (salt #4) corresponds to the claimed mixed calcium and sodium salt derivative copolymer. Clarke showed that the copolymer containing zirconium/calcium/sodium (salts #3 and #5) had better properties than the copolymer containing calcium and sodium (salt #4). Specifically, while hydration was “Good” for both salts, the zirconium/calcium/sodium salt had better adhesion and cohesion than the calcium/sodium salt. Clarke disclosed: “The test results presented in Table I show the formulation containing the additional 10% zirconium (salt No. 5) tested superior to a prior art sodium and calcium salt described in Example 2.” Clarke 8:47–50. Appeal 2021-000877 Application 15/771,884 6 It is true that the copolymer containing zirconium, calcium, and sodium is superior to the same copolymer containing calcium and sodium in certain of the properties tested by Clarke. But “[a] known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Thus, the fact that the reference calcium/sodium copolymer salt is described as inferior to the zirconium/calcium/sodium containing copolymer salt does not make it unobvious to use it. As explained in In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012), “just because better alternatives exist in the prior art does not mean that an inferior combination is inapt for obviousness purposes.” A “finding that the prior art as a whole suggests the desirability of a particular combination need not be supported by a finding that the prior art suggests that the combination claimed by the patent applicant is the preferred, or most desirable, combination.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004). See also Apple Inc. v. Samsung Electronics Co., Ltd., 816 F.3d 788, 801–802 (Fed. Cir. 2016) (citing Gurley). For these reasons, Appellant’s non- obviousness argument about the inferiority of the polymethyl vinyl ether maleic anhydride copolymer containing only calcium and sodium is not persuasive. Appellant argues that the claimed teat seal formulation is not obvious because it would have been reasonably expected that the calcium and sodium containing polymer would “reduce, not improve, the adhesion of Ericson’s patch to tissue.” Appeal Br. 12. This argument does not persuade us that the Examiner erred. As explained above, even if the calcium/sodium formulation’s adhesion to the Appeal 2021-000877 Application 15/771,884 7 tissue is reduced in comparison to the zirconium containing formulation, it is not unobvious to use an inferior product for its known purpose, which here, is as a tissue sealant. The paste adhesive made using the claimed copolymer containing calcium and sodium is not “inoperable,” but rather had “Good” hydration and “Fair” adhesion and cohesion. Clarke, Table I (cols. 8–9) (reproduced supra at 4). “[A] reference may teach away from a use when that use would render the result inoperable.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1381 (Fed. Cir. 2007). However, we have not been guided to evidence that such copolymer, when employed in Ericson, would be unsuitable as a tissue sealant. The statement in Clarke that its zirconium containing copolymer is superior does not “otherwise discourage”2 the use of the claimed salt derivative because it is actually used in Clarke as a paste adhesive and shown to have adhesive properties (Clarke 8–9, Table I), and Ericson identifies the ability of its patch to adhere to tissue as one of the properties of its patch (Ericson ¶¶ 29, 58, 104). Appellant did not establish that it would be unsatisfactory as a tissue sealant, the purpose for which the copolymer is used in Ericson (Ericson ¶ 2). 2 A teaching away requires a reference to actually criticize, discredit, or otherwise discourage the claimed solution. See Fulton, 391 F.3d at 1201 (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”). Appeal 2021-000877 Application 15/771,884 8 Evidence of nonobviousness Appellant argues that the Specification discloses “that not only embodiments of the polymer of claim 41 itself but also the combination of embodiments of that polymer with zinc oxide exhibit advantageous properties that are not taught or suggested by the cited references. Appeal Br. 15. Appellant points the statement in the Specification that the “Gantrez MS-955 polymer,” which corresponds to the sodium and calcium salt derivative of methyl vinyl ether-maleic anhydride copolymer of claim 41, “lightly crosslinks the structure through ion bridges to reduce its solubility and increase its cohesive strength and viscoelasticity. Id. (quoting from Spec. 6:23–25). As a consequence, Appellants argue the material has “excellent wet adhesive strength” and “long lasting hold.” Appeal Br. 15 (quoting from Spec. 7:1–2). We address these arguments below. Synergistic mixture Appellant argues that the Specification discloses experiments showing that “the combination of the polymer and zinc oxide yields a ‘synergistic mixture’ that forms ‘the foundation of a superior teat seal.’ See Specification at p. 18, 11. 19-26.” Appeal Br. 16. Appellant argues that the cited references do not describe this synergistic effect. Id. The portion of the Specification discussed by Appellant discloses: The ratio of active (Gantrez/Zinc Oxide) to the TS [teat seal] Base appears to be very important in achieving a good seal. Lowering the Gantrez concentration may lead to loss in the bio- adhesive nature of the formulation. In addition the use of TS base works well at low concentrations when used as emollient, however, increasing the amount beyond 50% leads to a greasy or oilier paste. This in turn will have a negative effect on bio- adhesive nature of the seal. Appeal 2021-000877 Application 15/771,884 9 The introduction of ZnO led to a successful teat seal. ZnO appears to react with Gantrez giving a swollen structure on removal. The degree of swelling itself may be cause for excellent teat seal. Following irradiation at 7 kGy the viscosity of Formulation C with Zinc Oxide increased at both 20 and 37 degrees Celsius. This is indicative of chemical binding /crosslinking of the Zinc Oxide and Gantrez and potentially is the foundation of a superior teat seal. Spec. 18:10–21. The disclosure reproduced above identifies the ratio between the copolymer/zinc oxide to the TS (teat seal) base as “very important in achieving a good seal.” Spec. 18:10-11. The claim, however, is not limited to specific ratio between these copolymer and zinc. In addition to this, the Specification in this disclosure states that the “degree of swelling” may be the cause of the excellent seal. Spec. 18: 16–17. The claim, however, does not require any specific degree of swelling. The claim, therefore, is not limited to a specific ratio or degree of swelling that are said to give the good and excellent teat seal. See CollegeNet, Inc. v. ApplyYourself, Inc., 418 F.3d 1225, 1231 (Fed. Cir. 2005) (holding that “[i]n examining the specification for proper context” it is improper to “import limitations from the specification into the claims”). The Specification also states that the “foundation of a superior teat seal” may be achieved, but this is accomplished using irradiation 7 kGy. Spec. 18: 19–21. The claim, however, does not require irradiation. The Specification concludes: “From the trial described above, the synergistic mixture of the Gantrez based polymer [the same polymer which is claimed] with the Zinc Oxide shows promise.” Spec. 18: 25–26. We Appeal 2021-000877 Application 15/771,884 10 understand the “trial described above” to correspond to at least the disclosure describing the ratio between the copolymer/zinc oxide to the TS base and the degrees of swelling as factors controlling the quality of the teat seal. In sum, Appellant’s argument is not commensurate with the scope of the claim. While superiority of the sealant may be achieved under certain conditions, these conditions are not claimed. The claim does not recite the values asserted to be synergistic; the claim scope includes embodiments for which there is no evidence of synergy. Specifically, Appellant did not provide evidence that other embodiments outside the values said to be important in achieving a good teat seal, etc., would also achieve synergy. As explained in In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011), an appellant must “provide[] an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner” in order to “establish that the evidence is commensurate with [the] scope of the claims.” Appellant did not explain how the results alleging synergy with certain compositions are sufficient “to ascertain a trend in the exemplified data which would allow [one having ordinary skill in the art] to reasonably extend the probative value thereof” to different compositions with different amounts of the components. In re Kollman, 595 F.2d 48, 56 (CCPA 1979). For this reason, the results in the Specification do not establish that the full scope of the claim would provide a synergistic seal formulation as asserted by Appellant. Appeal 2021-000877 Application 15/771,884 11 Viscosity and ease of administration Appellant also directs attention to the experiments described in the Specification which varied “both the composition and the concentrations of the various constituents in order to determine their effect on both viscosity and ease of administration (compression testing).” Spec. 18:30–32. The gel base was also varied (liquid paraffin or 1-Oleoyl-rac-glycerol). Id. The data in shown in Table 11 of the Specification. Spec. 19. Eight compositions, numbered A–H, were tested for viscosity and max load/force. Each comprised Gantrez MS955, which is the claimed mixed calcium and sodium salt derivative of the methyl vinyl ether-maleic anhydride copolymer. The max load/force is the injection force required to expel or express the composition. There are four general groups in Table 11: 1) Gantrez MS955, zinc oxide, liquid paraffin (compositions A, D, E, H) (differing by the amount of each of these components present in the composition). 2) Gantrez MS955, zirconium oxide, liquid paraffin (composition B). 3) Gantrez MS955, titanium dioxide, liquid paraffin (compositions C) 4) Gantrez MS955, zinc oxide, 1-Oleoyl rac-glycerol (compositions F, G) (differing by the amount of each of these components present in the composition). The Specification compares compositions A, B, and C, each which have the same amount of polymer (Gantrez MS955), metal oxide, liquid paraffin (25, 25, 49.5, respectively), but differ in the type of metal oxide (zinc oxide, zirconium oxide, or titanium dioxide, respectively). The Specification discloses that “in spite of Titanium Dioxide and Zinc Oxide Appeal 2021-000877 Application 15/771,884 12 yielding a viscosity of 140 and 413 Pa.s respectively, the Zinc Oxide formulation was substantially easier to express.” Spec. 19:11-13. The Specification further discloses that the use of “1-Oleoyl rac- glycerol in place of the liquid paraffin [compositions G and H] resulted in change in viscosity from 413 to 23 Pa.s.” but “the formulation was substantially harder to express.” Spec. 19:14–Spec. 20:1. “The higher the Zinc Oxide concentration in the 1-Oleoyl-rac-glycerol based systems the harder the formulations were to express.” Spec. 20:2–3. Appellant’s first point is that viscosity and difficulty to expel a composition are not correlated with each other. Spec. 20:6–7. The Specification shows that compositions with zinc oxide and paraffin (the gel base) can achieve higher viscosities, but still are easy to expel in contrast to compositions with different metal oxides of zirconium and titanium. This is shown in the portion of Table 11 copied below: Table 11 shows one concentration of each of the copolymer, metal oxide, and gel base. Only one gel base was tested, liquid paraffin. To the extent that the result is unobvious because one of ordinary skill in the art would not have known that using the specific combination of components in composition A would retain a higher viscosity while still being easy to expel, in contrast to the two other metal oxides in compositions B and C, Appeal 2021-000877 Application 15/771,884 13 Appellant has not established that using different concentrations of metal oxide and gel base, and a different gel base other than liquid paraffin, would achieve the same result. The data in Table 11 does not support the full scope of the claim, which is not limited to specific amounts of the polymer, zinc oxide, and liquid paraffin. The statement in the Specification that “the Zinc Oxide formulation was substantially easier to express” is only with respect to the specifically tested composition (“the Zinc oxide formulation”) and the claim is not limited to such composition. Spec. 19:11-13. Appellant has not explained how the results achieved by these specifically tested amounts show that amounts outside these would have same result. See Kao, 639 F.3d at 1068; Kollman, 595 F.2d at 56. In fact, a different gel base, 1-Oleoyl-rac-glycerol, did not achieve as high viscosities as did compositions using liquid paraffin. For example, Table 11 shows that the viscosity and load force of compositions A and F, differing only in the type of gel base, had very different viscosities and ease of expression: Composition A and F, differing only in the type of gel base, had about the same ease of expression (35.38, 38.86), but more than a ten-fold difference in viscosity. Appeal 2021-000877 Application 15/771,884 14 An additional comparison between compositions G and H show that the gel base makes a difference in the viscosity and ease of expression. A portion of Table 11 showing compositions G and H is copied below: Composition G and H are show in Table 11 above. G has 1-Oleoyl- rac-glycerol as the gel base; H has liquid paraffin as the gel base. The Specification does not provide a direct comparison of the same amount of 1- Oleoyl-rac-glycerol present in composition G to the same amount of liquid paraffin; the closest comparison is composition H (30.8 versus 40). Between these two compositions, there is a large difference in viscosity (1450 for liquid paraffin but only 92.68 for 1-Oleoyl-rac-glycerol) and ease of expression (64.22 for liquid paraffin and 113.01 for 1-Oleoyl-rac-glycerol). In sum, the results overall with respect to the gel base show that the type of gel base makes a difference in achieving a composition with high viscosity and which is also easy to express. The claim, however, is not limited to a specific gel base and therefore the results are not commensurate with the full scope of the claim. Appellant points the disclosure in the Specification of the mechanism as to why zinc oxide provides an improved viscosity as compared to the other metal oxides: “In contrast, Zinc Oxide yielded a viscosity of 413 Pa.s and this is a result of chemical interactions with the Gantrez, which Appeal 2021-000877 Application 15/771,884 15 subsequently progressed to crosslinking within the formulation; thus increasing the viscosity.” Spec. 20:11–13. However, using a different gel, 1- Oleoyl-rac-glycerol, in combination with zinc oxide did not result in increased viscosity as indicated by compositions F and G discussed above. Thus, it is evident that such improvement requires a specific gel base at specific component concentrations. Neither of these conditions are claimed. For the foregoing reasons, the obviousness rejection of claim 41 is affirmed. Claims 66–48, 51, and 54–60 were not separately argued and fall with claim 41. 37 C.F.R. § 41.37(c)(1)(iv). Claims 52, 53 Appellant provides separate argument for claims 52 and 53. The claims are reproduced below: 52. A seal formulation as claimed in claim 41 wherein the seal formulation contains from 5% to 25% of the viscosity enhancing agent. 53. A seal formulation as claimed in claim 41 wherein the seal formulation contains from 5% to 20% of the viscosity enhancing agent. The Examiner cited paragraph 76 of Ericson as disclosing a range of 8–12%, meeting the claim limitations. Final Act. 3. Appellant argues that the Examiner’s assertion is erroneous because “Paragraph [0076] of Ericson in fact pertains to an ‘oil compound’ (e.g., eugenol) that is present in about 8 wt. % to about 12 wt. %, not to zinc oxide present in those amounts.” Appeal Br. 14. Appellant’s argument does not persuasively demonstrate error in the Examiner’s rejection. Appeal 2021-000877 Application 15/771,884 16 Claims 52 and 53 recite that the seal formulation of claim 41 contains “from 5% to 25% of the viscosity enhancing agent” and “from 5% to 20% of the viscosity enhancing agent,” respectively. Claim 41 specifically recites that “the seal formulation further comprises a viscosity enhancing agent that comprises zinc oxide,” indicating that zinc oxide is present in the agent but that the agent is open to other components. The viscosity enhancing agent includes zinc oxide, but it is not solely made of zinc oxide. Therefore, claims 52 and 53 do not require the zinc oxide, alone, to be present in the claimed amounts. Appellant’s interpretation of the claim to require that the viscosity enhancing agent is only zinc oxide improperly narrows the scope of the claim. Ericson discloses in paragraph 76 (as cited by the Examiner) that in “certain embodiments, the primer region includes the oil compound (e.g., eugenol) in an amount of from about 5 wt% to about 15 wt%, or in an amount of from about 8 wt % to about 12 wt %.” The primer can comprise Gantrez MS-95 (the claimed co-polymer) as an adhesive (Ericson ¶ 66) and zinc oxide (Ericson ¶ 73). The primer can also comprises an oil (Ericson ¶¶ 71, 74). Appellant did not establish that the oil described in Ericson as present in the primer is not a viscosity enhancing agent as required by claims 52 and 53. The range of the oil in Ericson of about 8–12 wt% falls within the range recited in claims 52 and 53. It is well established that, when there is a range disclosed in the prior art, and the claimed invention overlaps or falls within that range, as there is here, there is a presumption of obviousness. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Appeal 2021-000877 Application 15/771,884 17 For the foregoing reasons, the obviousness rejection of claims 52 and 53 is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 41, 46–48, 51–60 103 Ericson, Clarke, Razza 41, 46–48, 51–60 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).