Ivan Nunez et al.

Patent Trials and Appeals Board

Feb 9, 2022

2021000380 (P.T.A.B. Feb. 9, 2022)

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. 13/480,651 05/25/2012 Ivan Nunez P05310 9015 23702 7590 02/09/2022 Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 EXAMINER SALAMON, PETER A ART UNIT PAPER NUMBER 1759 NOTIFICATION DATE DELIVERY MODE 02/09/2022 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): patents@bausch.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte IVAN NUNEZ and JENNIFER HUNT Appeal 2021-000380 Application 13/480,651 Technology Center 1700 Before JEFFREY T. SMITH, KAREN M. HASTINGS, and JANE E. INGLESE, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1-39. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. The appealed invention relates to a method of making a substantially fully polymerized UV blocking hydrogel lens comprising polymerizing a 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Bausch & Lomb Incorporated. (App. Br. 1.) Appeal 2021-000380 Application 13/480,651 2 monomer mixture of at least N-vinylpyrrolidone (NVP) and one other comonomer and a Bis O- hydroxy benzophenone. (Spec. ¶ 1.) Appellants (see App. Br., generally) request review of the following rejections: I. Claims 1-39 rejected under 35 U.S.C. §103(a) as unpatentable over the combination of Awasthi (US 2011/0009658Al, pub. Jan. 13, 2011) and Brown-Skrobot (US 2005/0079096A1, pub. Apr. 14, 2005). II. Claims 1-6, 9-14, 18-26, and 28-33 rejected 35 U.S.C. §103(a) over the combination of Zhang WIPO (W0 2011/037897A2, pub. Mar. 31, 2011) and of Brown-Skrobot. III. Claims 7 and 8 rejected 35 U.S.C. §103(a) over the combination of Zhang, Brown-Skrobot and Nueraji (US 2010/0304163A1, pub. Dec. 2, 2010). IV. Claims 15-17 rejected 35 U.S.C. §103(a) over the combination of Zhang, Brown-Skrobot and Kunzler (US 5,270,418, pub. Dec 14. 1993). OPINION This is the second time rejected claims based on this application have come before us for adjudication over the same prior art references. Claim 1 differs from our prior appeal in that the limitation describing the amount of Bis O-hydroxybenzophenone has been added. Claim 1 on appeal states: 1. A method of making a substantially fully polymerized UV blocking hydrogel lens comprising: polymerizing a monomer reaction mixture of at least NVP and one other comonomer and from about 1 to about 2 wt% of a free-radical polymerizable, substituted or Appeal 2021-000380 Application 13/480,651 3 unsubstituted, Bis O-hydroxybenzophenone to provide a substantially fully polymerized hydrogel ophthalmic device. Claims Appendix to App. Br. 22 We incorporate the findings and discussions presented in our prior decision on appeal for Application 13/480,651, Appeal 2018-000837, mailed November 2, 2018 (“Prior Decision”) and the Decision on Rehearing mailed February 1, 2019. We affirm the appealed rejections for the reasons presented in our prior decisions and those by the Examiner in the Final Action and the Answer. We add the following. Appellant’s arguments in rebuttal to the appealed rejections are substantially the same as the arguments presented in the prior appeal. (Compare March 12, 2015 App. Br. with May 5, 2020 App. Br.). Appellant repeats the arguments that the combination of Brown-Skrobot with either Awasthi or Zhang does not necessarily teach essentially the same process and materials as required by the claimed invention. Appellant argues while each reference may disclose separate elements which may be employed in the presently claimed invention, the combination of Brown-Skrobot with either Awasthi or Zhang does not reasonably teach specifically selecting a Bis O-hydroxy benzophenone for use in the materials and method of Awasthi or Zhang, as Brown-Skrobot rather teaches that benzotriazole UV blocking agents are most preferred for the materials thereof. The issue of whether the cited prior art renders obvious the selection of Bis O-hydroxy benzophenone for use in the materials and method of Awasthi and Zhang has been previously addressed in this record in the Prior Decision. Furthermore, Appellant’s arguments lacks persuasive merit for the reasons expressed by the Examiner in the Final Action and Answer. Appeal 2021-000380 Application 13/480,651 4 A person of ordinary skill in the art would have reasonably expected that the monomer mix utilized in a method of making a polymerized hydrogel lens may include UV-absorbing agents such as those known in the contact lens art. Brown-Skrobot discloses in the contact lens art it is known to incorporate a UV blocking agents such as 1,3-Bis(4-benzoyl-3- hydroxyphenoxy)-2-propyl methacrylate. (Brown-Skrobot ¶ 50.) While Brown-Skrobot also describes other suitable UV blocking agents, this disclosure does not detract from the disclosure that Bis O-hydroxy benzophenone is known for use as a UV blocking agent for formation of hydrogel lens. Appellant argues the Examiner has failed to properly consider the evidence of non-obviousness. (Appeal Br. 8-10.) Appellant argues the amendment to claim 1 specifically defining the Bis O-hydroxy benzophenone is present an amount from about 1 to about 2 wt% establishes the evidence of unexpected result is commensurate in scope with the claimed invention. (App. Br. 9-10.) Appellant further argues the Examiner’s position “that Applicant’s arguments as to non-obviousness are not commensurate with the scope of claim 1 since the claim ‘does not recite benzotriazole and mono O- hydroxybenzophenone’(or similar language)” is inappropriate. (Reply Br. 2; Final Act 42-43, Ans. 15.) We do not agree. The Examiner’s comment is in response to Appellant’s description of the evidence in Tables 1 and 5 which is reproduced below: The evidence as shown in Tables 1 and 5 more particularly demonstrate increasing the concentration of the benzotriazole UV absorbing agent SA Monomer benzotriazole UV blocker in Comparative Examples 1-5 (in which all other Appeal 2021-000380 Application 13/480,651 5 component concentrations remain essentially constant) results in decreasing water content in the hydrated formed lens, evidencing a decrease in the hydrophilic polymer content after extraction due to incomplete cure of the NVP monomer due to presence of the benzotriazole UV blocker (as this is essentially the only component varied in these examples). Comparative Examples 12 and 13 (see Table 3) demonstrate a similar decrease in water content with increase in concentration of BPA-1, i.e., a mono O-hydroxybenzophenone. (Appeal Br. 9.) It appears Appellant is relying on embodiments not encompassed by the claimed invention or representative of the closest prior art to establish the alleged unexpected results. Appellant’s reliance upon and discussion of benzotriazoles and mono O-hydroxybenzophenones is unclear because these compounds are not representative of the claimed invention or the teachings of Brown-Skrobot which expressly teaches “benzophenones, such as, 1,3- bis(4-benzoyl-3-hydroxyphenoxy)-2-propyl)(meth)acrylate” suitable as blocking agents. (Brown-Skrobot ¶ 50.) The Examiner properly determined that Appellant has failed to demonstrate that the data from the discussed comparative examples establish that the inventive examples exhibit unexpected results. (Ans. 15.) The burden of demonstrating unexpected results rests on the party asserting them, and “it is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). “Mere improvement in properties does not always suffice to show unexpected results.” In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). “[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Appeal 2021-000380 Application 13/480,651 6 Baxter-Travenol Labs., 952 F.2d 388,392 (Fed. Cir. 1991). The Examiner asserted that Appellant has not established the acceptable % water content (WC) that provides the alleged unexpected results. Specifically the Examiner noted: [T]he Comparative Examples 1-5 in Table 5 of Appellants’ specification have % water content (WC) in the range of 37.0-51.5 which overlaps the %WC of the Inventive Examples 4, 7, and 9 which has a range of 43.9-45.1 as shown in Table 3. (Final Act. 44; Ans. 15.) … Appellants has insufficiently demonstrated criticality for wt% concentration as recited in claim 1 because a sufficient number of tests outside the claimed range of from about 1 to about 2 wt% have not been demonstrated to show criticality of the claimed range. (Final Act. 45; Ans. 16.) The Examiner further noted: [A]lthough Inventive Examples 4 and 7 produced advancing contact angles of 33 and 31 respectively which are smaller than the advancing contact angles of Comparative Examples 4-5 and 12-13 (having advancing contact angles of 81, 84, 61, 108 respectively), however this is inconclusive because Comparative Example 10 (uses benzotriazole as UV blocker) in Table 3 shows advancing contact angle (33) and % WC (43.1) which are comparable to the range of the mentioned Inventive Examples. (Final Act. 44; Ans. 17.) Appellant failed to specifically address the Examiner’s concerns regarding the data in the Appeal or Reply Briefs. Appellant has failed to articulate how the evidence relating to the water content and wettability (advancing contact angle)-that have significant overlap with the comparative examples-establishes unexpected results for the the claimed invention. Appellant has failed to explain how the data in the Specification Appeal 2021-000380 Application 13/480,651 7 exemplifies the added claim limitation defining the Bis O- hydroxybenzophenone is present an amount from about 1 to about 2 wt% establishes unexpected results. Appellant has also failed to explain that the content of Bis O-hydroxybenzophenone in the amount from about 1 to about 2 wt% is necessary to achieve unexpected results. We sustain the Examiner’s rejections under 35 U.S.C. § 103(a) for the reasons presented in our prior decisions, the reasons the Examiner presents and the reasons presented above. DECISION SUMMARY The Examiner’s rejections are affirmed. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-39 103(a) Awasthi, Brown- Skrobot, 1-39 1-6, 9-14, 18-26, 28- 33 103(a) Zhang, Brown- Skrobot, 1-6, 9-14, 18-26, 28- 33 7, 8 103(a) Zhang, Brown- Skrobot, Nueraji 7, 8 15-17 103(a) Zhang, Brown- Skrobot, and Kunzler 15-17 Overall Outcome 1-39 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED