Ex Parte SmithDownload PDFPatent Trial and Appeal BoardMar 22, 201611613029 (P.T.A.B. Mar. 22, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111613,029 12/19/2006 127289 7590 03/24/2016 Schmeiser, Olsen & Watts, LLP/RO Schmeiser, Olsen & Watts, LLP 11 Schoen Place, 7th Floor Pittsford, NY 14534 FIRST NAMED INVENTOR Francis X. Smith 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 ATTORNEY DOCKET NO. CONFIRMATION NO. BIOC. l 7348CIP-RO 7077 EXAMINER FAY,ZOHREHA ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 03/24/2016 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): RO 127289@iplawusa.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FRANCIS X. SMITH1 Appeal2014-001428 Application 11/613,029 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FREDMAN and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to ophthalmic and contact lens solutions and methods for using the same, which have been rejected as obvious and for nonstatutory double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The invention relates to a single-part ophthalmic solution, such as a contact lens solution and a method for providing the solution. The solution 1 Appellant identifies the real party in interest as FXS Ventures, LLC (App. Br. 3). Appeal2014-001428 Application 11/613,029 comprises 0.00001 to 10 weight percent of a simple saccharide and at least 0.00001 to 10 weight percent of a preservative. The solution is physiologically compatible with direct contact with corneal tissue and exhibits improved preservative efficacy. Claims 1 and 4-17 are on appeal.2 Claim 1 is illustrative and reads as follows: 1. An ophthalmic solution comprising 0.00001 to 10.0 weight percent of a simple saccharide chosen from the group consisting of: inositol; ribose; triose; tetrose; erythrose; threose; pentose; arabinose; ribulose; xylose; xylulose; lyxose; hexose; allose; altrose; fructose; galactose; glucose; gulose; idose; mannose; sorbose; talose; tagatose; adlose; ketose; heptose; sedoheptulose; and xylitol; at least 0.00001 weight percent of a preservative, and not more than about 0.2 percent by weight chloride; wherein said solution is an aqueous solution effective as a single-part solution; wherein said solution is physiologically compatible with direct contact with corneal tissue. Claims 1and4-16 stand rejected under 35 U.S.C. §103(a) as obvious in view of Asgharian. 3 2 While Appellant discussed claims 11 and 13 separately in his brief, the rejection and arguments presented are the same as those presented for the remaining product claims. We therefore address claims 1 and 4-16 together. 3 Asgharian et al., US 6,139,646, issued Oct. 31, 2000. 2 Appeal2014-001428 Application 11/613,029 Claim 17 stands rejected under 35 U.S.C § 103(a) as obvious in view of Asgharian. Claims 1 and 4-17 stand rejected under the judicially created non- statutory doctrine of obviousness double patenting. I Issue The Examiner has rejected claims 1 and 4-16 as obvious in view of Asgharian. The Examiner finds that Asgharian teaches a contact lens solution of a cationic polymeric preservative and a preservative enhancer comprising glycerin, sorbitol and a propylene glycol (see Ans. 5).. The Examiner finds that Asgharian further teaches that the compositions described therein are "physiologically compatible with the eye" and that its invention includes a stand-alone solution which does not contain an enzyme (see Ans. 7). The Examiner finds that "[i]t would have been obvious to a person skilled in the art, to use the claimed components in a single part composition, considering the prior art, also has all the components of the claimed invention in a single part before being mixed with the enzymic solution." (Ans. 5) Appellant contends that the teachings of Asgharian are directed to an enzyme solution for cleaning and disinfecting contact lenses (see Appeal Br. 6). Appellant contends that the inclusion of an enzyme in the solution renders the solutions incompatible for direct contact with the cornea and therefore Asgharian teaches away from the claimed invention. (Appeal Br. 7-8.) 3 Appeal2014-001428 Application 11/613,029 The issue with respect to this rejection is whether claims 1 and 4-16 are obvious in view of the teachings of Asgharian within the meaning of 3 5 U.S.C. § 103(a). Findings of Fact FF 1. Asgharian teaches that the "disinfecting solution will contain at least one anti-microbial agent ... Preferred polymeric antimicrobial agents include ... polyhexamethylene biguanide" (Asgharian et al., col. 10, 11. 16- 28). Instant claim 12 notes that polyhexamethylene biguanide is a preserving agent. FF2. Asgharian teaches disinfecting contact lens solutions containing tonicity agents including sugars, a cationic polymeric preservative, chelating agents, buffers, and wetting agents (Asgharian, col. 11, 11. 35-60) FF3. Asgharian teaches the preparation of a stand-alone disinfecting solution that is free of enzymes (Asgharian, col. 12, 11. 38-43). FF4. Asgharian teaches that "the multipurpose compositions will be physiologically compatible with the eye" (Asgharian, col. 9, 11. 63-65). Principles of Law A proper § 103 analysis requires "a searching comparison of the claimed invention-including all its limitations-with the teaching of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). "In determining whether the subject matter of a patent claim is obvious, neither 4 Appeal2014-001428 Application 11/613,029 the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under§ 103." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). The "discovery that a claimed composition possesses a property not disclosed for the prior art subject matter, does not by itself defeat a prima facie case." In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990). Analysis The Examiner finds that Asgharian suggests all of the elements of the instant claims. (Ans. 6) The Examiner finds that Asgharian refers to a stand-alone disinfection composition that is physiologically compatible with the eye. (Ans. 7) We find that the Examiner has the better position for claims 1, 11, and 13. Here the claims extend to what is taught by Asgharian and are therefore obvious. KSR Int'! Co., 550 U.S. at 419. We agree that all of the elements required by claims 1, 11, and 13 are suggested in Asgharian for use in disinfecting solutions and that one skilled in the art would have been motivated to use the resulting solution as a single component. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012)(The Federal Circuit found a "strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known ... agent for another.") 5 Appeal2014-001428 Application 11/613,029 Appellant contends that the "instant claims recite a specific list of simple saccharides, none of which are taught by Asgharian" (Appeal Br. 6). We find this argument unpersuasive because Asgharian specifically teaches that the disinfecting solution may comprise tonicity agents that comprise sugars (FF 2). Although Asgarian does not expressly suggest the specific sugars listed in claim 1, it suggests including sugars as tonicity agents (FF), and therefore would have made obvious the common sugars (glucose, fructose, etc.) recited in claim 1. In the instant case, we find that the ordinary artisan taught "sugars" would have reasonably found it obvious to envisage and select the simple saccharides of claim 1. Appellant contends that Asgharian's "enzyme composition would not be suitable for direct eye contact as enzyme solutions are known to those skilled in the art to be harmful to the eye" (Appeal Br. 7). Appellant cites the Jahngen Declaration4 that due "to the extreme dangers of enzyme solutions, such as those disclosed by Asgharian et al., it is not suitable to use an enzyme solution for in-eye applications" (Jahngen Dec. ,-i9).We have considered Appellant's arguments and find them unpersuasive. Asgharian teaches that the recited compositions will be physiologically compatible with the eye, which necessarily includes the cornea (FF 4). In addition, while Asgharian is primarily directed to enzyme containing solutions, Asgharian also teaches the preparation of a stand-alone disinfectant solution which is enzyme free (FF 3). An enzyme free solution would not have the incompatibility problem suggested by Appellant. The "discovery that a 4 Declaration of Dr. Ed Jahngen, dated Mar. 29, 2010. 6 Appeal2014-001428 Application 11/613,029 claimed composition possesses a property not disclosed for the prior art subject matter, does not by itself defeat a prima facie case." In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990). Conclusion of Law We conclude that the Examiner has established that claims 1 and 4- 16 are obvious in view of Asgharian within the meaning of 35 U.S.C. § 103(a). II Issue The Examiner has rejected claim 17 under 35 U.S.C. § 103(a) as obvious in view of Asgharian The Examiner makes no specific finding with respect to the method of claim 1 7. Appellant contends that Asgharian does not disclose a solution that is compatible with direct contact with the eye. In addition, Appellant contends that Asgharian "is silent regarding a method for providing an ophthalmic solution involving the step of contacting the eye with a single-part solution" (Appeal Br. 10.) The issue with respect to this rejection is whether claim 17 is obvious in view of the teachings of Asgharian within the meaning of 35 U.S.C. § 103(a). FF5. Asgharian is silent about applying the disinfecting, enzyme, or combined solutions directly to the eye. 7 Appeal2014-001428 Application 11/613,029 Principles of Law "In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant." "The Patent Office has the initial duty of supplying the factual basis for its rejection." In re Warner, 379 F.2d 1011, 1017 (CCPA 1967); In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). When a prima facie case of obviousness has not been established, the rejection must be reversed. In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988). Analysis In the present case we find that the Examiner has failed to meet his initial duty to supply a factual basis for rejecting claim 17. The Examiner has articulated no factual basis or persuasive reasoning to explain why the disinfecting solution alone, or in combination with the enzyme solution, would have been used for contacting an eye. The Examiner also fails to establish that these solutions would inherently contact the eye during routine use because cleaned contact lenses are routinely washed to remove cleaning solutions prior to insertion into the eye (see App. Br. 9). Since the Examiner has failed to establish a prima facie case of obviousness with respect to claim 17, the rejection must be reversed. In re Fine, 837 F.2d at 1075. Conclusion of Law We conclude that the Examiner has not established that claim 1 7 is obvious in view of Asgharian within the meaning of 35 U.S.C. § 103(a). 8 Appeal2014-001428 Application 11/613,029 III Claims 1 and 4-17 stand provisionally rejected under the judicially created doctrine of nonstatutory double patenting. Applicant has not specifically addressed this rejection on appeal other than to say that "Applicant shall consider filing a terminal disclaimer should corresponding claims be found allowable in either this or the co-pending application." (App. Br. 10). We therefore summarily affirm the obviousness-type double patenting rejection. See Manual of Patent Examining Procedure§ 1205.02 ("If a ground of rejection stated by the examiner is not addressed in the appellant's brief, that ground of rejection will be summarily sustained by the Board."). SUMMARY We affirm the rejection of claims 1 and 4-16 and reverse the rejection of claim 17 under Section 103(a) and affirm the rejection of claims 1 and 4-17 under nonstatutory double patenting. 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. § l.136(a). AFFIRMED 9 Copy with citationCopy as parenthetical citation