DETAILED ACTION
This action is in response to Applicant’s submission dated November 17, 2023, in which Applicant canceled claims 2, 4, 8-14, 16-21, 23-26, 30, 32-33, 35-36, 38-47, 49, 51-56, 58-60, 62-64, 66, 68-122, and 124-135, and amended claims 3, 5-7, 15, 22, 27-29, 31, 34, 37, 48, 50, 57, 61, 65, 67, and 123.
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Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The references contained in the IDS dated December 12, 2024 and November 17, 2023 are made of record.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 48, and 67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chong, US 2003/0211163. Chong teaches a method of treating an infection or infestation in a subject in need thereof (a method of treating PV in a mammal by administering a therapeutically effective amount of the combination of one or more antiviral agent compounds and one or more COX-2 inhibitor compounds para. [0007]; Claim 1) comprising contacting one or more sites on or around one or both eyes, ocular adnexa, or combination thereof, of the subject (A combination therapy for treating PV includes administering to a mammal an antiviral agent and a COX-2 selective inhibitor, para. [0059]; In therapeutic use for treating, or combating, viral infections in a mammal… the pharmaceutical composition including the antiviral agent(s) and the COX-2 inhibitor(s) can be administered… parenterally, topically, para. [0362]; Examples of parenteral administrations are… intraocular, para. [0363]; topical administrations include the treatment of infectious areas or organs readily accessible by local application, such as, for example, eyes, para. [0364]) with a composition comprising 5-fluorouracil, or salt thereof (the antiviral agent is an antineoplastic agent… antineoplastic agents are highly effective against a broad spectrum of papillomavirus…. The antineoplastic agent is 5-fluorouracil, para. [0068]).
Regarding claim 48, Chong discloses a method according to claim 1, wherein the composition comprises polyethylene glycol, glycerin, polyethylene glycol, or a combination thereof (The compounds may be dissolved in… polyethylene glycol, propylene glycol, para. [0355]; Carriers for the topical administration of the compounds of this invention include… propylene glycol, para. [0385]).
Regarding claim 48, Chong discloses a pharmaceutical composition (a pharmaceutical composition including one or more antiviral agent compounds and one or more COX-2 inhibitor compounds, para. [0006], comprising 5-fluorouracil or a salt thereof (A combination therapy for treating PV includes administering to a mammal an antiviral agent and a COX-2 selective inhibitor, para. [0059]; the antiviral agent is an antineoplastic agent…. Antineoplastic agents are highly effective against a broad spectrum of papillomavirus…. The antineoplastic agent is 5-fluroruracil, par. [0068]), wherein the composition is suitable for administration to the cornea, skin around the eye, lacrimal apparatus, or a combination thereof (In therapeutic use for treating, or combating, viral infections in a mammal… the pharmaceutical composition including the antiviral agent(s) and the COX-2 inhibitor(s) can be administered… parenterally, topically, para. [0362]; Examples of parenteral administrations are… intraocular, para. [0363]; Topical administrations include the treatment of infectious areas or organs readily accessibly by local application, such as, for example, eyes, para. [0364].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Determining the scope and contents of the prior art.
Claims 1 and 3 are rejected under 35 U.S.C. § 103 as being unpatentable over Chong, US 2003/0211163 in view of CMI Research Management, LLC, WO 2015/105905.
Ascertaining the difference between the prior art and the claims at issue.
Chong discloses the method according to claim 1, but fails to explicitly teach wherein the infection or infestation comprises Demodex. WO 2015/105905 is in the field of treating demodectic mange (Title) and discloses wherein the infections or infestation comprises Demodex (the use of thymus extract compositions… for treating inflammatory conditions related to the presence of mammalian parasites and/or viral infections, and in more particular veterinary aspects to treating demodectic mange… in the veterinary setting…. Combination or adjunctive therapies are also encompassed using at least one additional… anti-viral agent, pg. 1, lines 5-12; the inventive Thyrex compositions are used in combination with administering of at least one additional… antiviral agent, pg. 6, lines 26-28).
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here. It would have been obvious to one of ordinary skill in the art at the time that the invention was made to modify the method of Chong by a condition as taught by WO 2015/105905 for the purpose of providing adjunctive therapies for persistent or difficult to treat demodicosis (WO 2015/105905, Abstract; pg. 3, lines 13-14).
Claim Objections
Claims 5-7, 15, 22, 27-29, 31, 34, 37, 50, 57, 61, 65, and 123 are objected to as being dependent upon rejected independent claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
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