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 .
The following application has been transferred from previous examiner Knight to the present examiner.
New claims 15-32 are pending and examined on the merits as drawn, post-amendment, to a method of treating any lung disease resulting from exposure to a virus e.g. COVID-19, with a therapeutically effective amount of aviptadil.
Restriction/Election: Withdrawn based on the amendments.
Claim Rejections - 35 USC § 103 - Obviousness
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 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 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020247665 (Emory University) in view of WO 2014173759 (Ascendis Pharma).
Merely by example in the crowded arts that surrounded treatments directed to COVID-19 and especially lung sequalae therefrom:
Regarding instant claims 15-18, 21-23, 25, 27, 29-30, and 32, WO ‘665 teach the use of aviptadil (Relief Therapeutics) for the use of treating COVID-19 (abstract, page 2), including lung infections therefrom (e.g. page 1-2). While not per se teaching “post-viral infection syndrome” such would have been prima facie obvious as symptoms (lung) linger long after the infection has transpired.
Regarding instant claims 19, 20, 24, 26, 28, and 31, WO ‘759 teach the pharmaceutical compositions comprising combination of molecules including aviptadil (page 109, line 7) and alpha-lipoic acid (page 144, line 1).
Standard carriers are routine optimization within the pharmaceutical field depending on the route and desired treatment.
Concentrations, amounts, dosages, and routes of administration are result effective variables standardly employed by routine optimization absent evidence of criticality thereof.
Thus, based on the combination of WO ‘665 and ‘759, the instantly claimed invention would have been prima facie obvious to arrive at, as employing known agents in the field of COVID-19 therapy aimed at targeting lung sequalae and the choice of concentrations and/or amounts thereof routine optimization by PHOSITA absent evidence of secondary considerations of unexpected results based on specific compositions versus valid controls.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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