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 .
Election/Restrictions
Applicant’s election of Group I, claims 2, 6-13, in the reply filed on 9/2/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of:
(i-b) COVID-19;
(ii) trans sodium crocetinate (TSC);
(iii) IV;
(iv-a) treatment of hypoxemia,
in the reply filed on 9/2/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/2/2025.
Claims 6-7, 9, 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/2/2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 103
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) 2, 8, 10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gainer et al. (WO 2015/028411 A1; 2015); in view of Wang et al. (“Comorbidities and multi-organ injuries in the treatment of COVID-19”; the lancet.com; 3/21/2020; Published Online March 9, 2020; https://doi.org/10.1016/S0140-6736(20)30558-4).
Gainer teaches bipolar trans carotenoid salts and their uses (title); these compounds are useful in improving diffusivity of oxygen between red blood cells and body tissues in mammals including humans (abstract). Among the compounds taught are trans sodium crocetinate, TSC (4: 3rd paragraph). TSC has been found to increase the diffusivity of oxygen through liquids (7: 3rd paragraph), by about 30%; TSC increases survival in mammals following hypoxia, increases oxygen consumption following hypoxia, decreases organ damage following hypoxia; the compounds of the invention are useful for treating mammal (including human) diseases/conditions characterized by low oxygen (hypoxia) such as respiratory diseases, and multiple organ failure, among conditions taught (15: 3rd paragraph).
The structure of TSC (1) is depicted on p. 21, 1st compound, and on p. 24:
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Regarding Applicant elected IV administration, Gainer teaches IV administration is advantageous (16: 1st paragraph).
Thus, Gainer teaches a method of treatment of hypoxemia; treating respiratory diseases, including multiple organ failure, by administering Applicant elected TSC, of claim 12 (a bipolar trans carotenoid salt). Gainer does not teach the respiratory disease is Applicant elected COVID-19, which was not known in 2005.
Wang, published online 3/9/2020, teaches comorbidities and multi-organ injuries in the treatment of COVID-19, that potential multi-organ injuries is one cause of death in COIVID-19, and should result in paying attention to potential multi-organ injuries and protection and prevention thereof in treatment of COVID-19.
The skilled artisan, with knowledge of the benefit of TSC in treating hypoxemia, and respiratory diseases, and specifically multiple organ failure, would have found it obvious to administer TSC via IV to a human with COVID-19, reasonably expected to provide added oxygen benefit in a patient with multiple organ failure, rendering the elected embodiment of the claimed method as prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/ Primary Examiner, Art Unit 1614