DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
Claims 10-15 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 01/23/2026 are acknowledged. Claims under consideration in the instant office action are claims 10-15.
Applicants' arguments, filed 01/23/2026, have been fully considered and they are deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 10-15 were previously considered allowable subject matter in the Non-Final Rejection, filed 11/14/2025, but upon further search and consideration, the claimed invention is considered anticipated and obvious over the prior art as discussed below. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 10 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chiu et al. (Pharmacokinetics of a novel agent, R667, in patients with emphysema, British Journal of Clinical Pharmacology, 2006, 63:5, pp. 527-533).
Claim Interpretation
The claimed invention is interpreted as drawn towards a composition comprising paloveratene with the intended use of ocular administration, although the claimed invention does not recite any components or structural elements for ocular administration.
Rejection
Chiu et al. teaches the pharmacokinetics of R667, which is a novel retinoid in the treatment of emphysema (see abstract; pg. 528, left column, 1st paragraph). Chiu et al. teaches administering doses of 0.2, 0.5, or 1 mg (pg. 528, right column, 2nd paragraph), and one of ordinary skill in the art would immediately envision a formulation of R667 comprising a pharmaceutically acceptable carrier.
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 nonobviousness.
Claims 11-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chiu et al. (Pharmacokinetics of a novel agent, R667, in patients with emphysema, British Journal of Clinical Pharmacology, 2006, 63:5, pp. 527-533) as applied to claim 10 above, and further in view of DeLong et al. (US 2002/0013294).
The teachings of Chiu et al. are presented above.
Chiu et al. does not teach further comprising a buffer solution, a polyol, an ester, or an oil for ocular administration.
DeLong et al. is drawn towards compositions comprising 2-decarboxy-2-phosphinico prostaglandin derivatives (see abstract). DeLong et al. teaches such compositions further comprising a retinoid (paragraphs 0106, 0113; claim 25). DeLong et al. teaches such compositions further comprising buffer solutions, polyethylene glycol, ethyl oleate, and vegetable oils (paragraphs 0084-0085, 0094). DeLong et al. teaches such compositions formulated for ocular administration (paragraph 0149).
It would have been obvious to one of ordinary skill in the art to formulate a composition further comprising a buffer solution, a polyol, an ester, or an oil for ocular administration, as suggested by DeLong et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since DeLong et al. teaches that retinoids are conventionally formulated with such components, which would be suitable for ocular formulation (paragraphs 0084-0085, 0094, 0149), with a reasonable expectation of success absent evidence of criticality of the particular formulation.
Conclusion
Claims 10-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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