DETAILED ACTION
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 .
Current Status of 18 / 877765
Claims 1-23 filed 2024 December 20 are pending. As a result of the improper multiply dependent claims 5-21, claims 1-4, 22, and 23 are examined on the merits.
Claims 5-21 are objected to under 37 CFR 1.75(c) as being in improper form because they are improper multiple dependent claims. Claims 5-21 are dependent on claim 4, a properly dependent claim. Claims 5-21 are improper because claim 5 is a multiply-dependent claim. See MPEP § 608.01(n). Accordingly, claims 5-21 have not been further treated on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2025 November 25 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BAZAN (WO 2009/058815, published 2009 May 7). Bazan describes a combination of a lipoxin and neuroprotection D1 (page 7, paragraph [0018]-[0019]; page 6, paragraph [0013]). In neuroprotection D1, the following examined definitions apply: R1 is CO2H; and R2-R5 are each H.
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This combination can be used in an implantable device (page 9, paragraphs [0023] and [0025]; claims 6 and 10-12) or in a controlled delivery form (page 10, paragraphs [0028]-[0030]). The composition can be administered ocularly (abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived 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(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 1 and 2 are rejected under 35 U.S.C. 103(a) as being unpatentable over SCIAVOLINO (WO 2019/108605, published 2019 June 6).
Determining the scope and contents of the prior art
Sciavolino describes compounds 36-40 (pages 80-81). Each of these compounds is a pharmaceutically acceptable salt of PDX. In PDX, the following examined definitions apply: R1 is CO2H; and R2-R5 are each H. Example 19 describes that RvE1-Mg-di-lysinate has a controlled release profile when given orally (pages 108-110, paragraphs [390]-[392]). Table 5 shows the prepared compounds are alternative embodiments to one another as active agents (pages 76-83).
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Ascertaining the differences between the prior art and the claims at issue
Sciavolini does not explicitly describe the administration of a PDX pharmaceutical salt administered.
Resolving the level of ordinary skill in the pertinent art
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in preparation of compounds of the elected group).
Considering objective evidence present in the application indicating obviousness or nonobviousness
Sciavolini shows that RvE1-Mg-di-lysinate has a controlled release profile when given orally. Based on the idea that each of the compounds of table 5 are each alternative embodiments to one another as active agents, substitution of RvE1-Mg-di-lysinate with any one of compounds 36-40 as an active agent has a reasonable expectation of success. Based on example 2, each of compounds 36-40 would be expected to have a similar controlled release profile as RvE1-Mg-di-lysinate.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Conclusion
Claims 1 and 2 are not allowed. Claims 22 and 23 are free of the prior art of record.
Claims 3 and 4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Bazan does not describe that a pharmaceutical composition contains an excipient or that the excipient is a polymer.
The following is a statement of reasons for the indication of allowable subject matter: Bazan (WO 2009/058815, published 2009 May 7) does not describe a composition comprising a tri-block or penta-block polymer prepared by dissolving in propylene glycol or ethanol.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 8:00 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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