Prosecution Insights
Last updated: April 19, 2026
Application No. 18/011,430

METHODS, COMPOSITIONS, AND PROPHYLACTICS FOR TREATING, AMELIORATING, OR PREVENTING CORONAVIRUS DISEASE (COVID-19)

Non-Final OA §103§112
Filed
Dec 19, 2022
Examiner
BOWERS, ERIN M
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Research Foundation for the State University of New York
OA Round
1 (Non-Final)
55%
Grant Probability
Moderate
1-2
OA Rounds
3y 8m
To Grant
66%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allow Rate
292 granted / 534 resolved
-5.3% vs TC avg
Moderate +11% lift
Without
With
+11.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
47 currently pending
Career history
581
Total Applications
across all art units

Statute-Specific Performance

§101
7.1%
-32.9% vs TC avg
§103
43.4%
+3.4% vs TC avg
§102
10.5%
-29.5% vs TC avg
§112
23.9%
-16.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 534 resolved cases

Office Action

§103 §112
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 without traverse of the invention of Group I, claims 1-13, and the species of SEQ ID NO.: 4 in the reply filed on 08/25/2025 is acknowledged. Upon further search and consideration, the Examiner has rejoined the species of SEQ ID NO.: 2 with the elected species of SEQ ID NO.: 4 for the genus of “variant ACE2 sequence.” Claim Status The amendment of 08/25/2025 has been entered. Claims 1-20 are pending in this US patent application. Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/25/2025. Claims 1-13 are currently under examination and were examined on their merits. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-7 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph , as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites a recombinant variant of a parent ACE2 comprising a plurality of deletions from M1-Q18 and from E56-F805, wherein said variant has increased stability, increased spike protein binding activity, and/or increased COVID-19 treatment performance benefit compared to the parent ACE2. Applicant’s specification has not provided any information regarding the link between the recited deletions, which are incredibly broad in scope, and the recited functions. Given the breadth of the structural genus and the lack of a structure/function relationship disclosed in the instant specification, along with the recited functions pertaining to a novel virus that had existed for less than a year at the time of filing of the parent case (06/19/2020), the small number of particular species disclosed that do have the recited functions are insufficient to provide written description for the entirety of the above-listed claims. Therefore, claims 1-7 and 11 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. 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 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. Claims 1, 5, and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al ., ACS Nano 14 : 5143-5147 (2020; published April 14, 2020) . Han teaches simulated peptides that bind with the spike protein of SARS-CoV-2, including a peptide consisting of residues 21-55 of human ACE2 (page 5144, left column, paragraphs 3-4; cf. claims 1, 5, 7-1 3 ; the Examiner notes that human ACE2 is the sequence of SEQ ID NO.: 1, as recited in instant claim 11, and instant SEQ ID NO.: 2 consists of residues 19-55 of SEQ ID NO.: 1; as such, the entire peptide sequence of Han is found within SEQ ID NO.: 2 and also contains deletions of residues 19-20 [a plurality] as recited in instant claim 5 ; additionally, the only amino acids in Han’s peptide sequence are also contained within SEQ ID NO.: 4, and so Han’s sequence “consists of amino acids selected from…SEQ ID NO.: 4” as recited in instant claim 12 ). The proposed peptides could be used as inhaled therapeutics for topical lung delivery, providing an efficient way to combat COVID-19 (page 5144, left column, paragraph 2). However, Han does not teach actually producing the simulated peptides. While Han does not teach actually producing the simulated peptides, it would have been obvious to one of ordinary skill in the art to produce the peptides of Han, including the peptide representing residues 21-55 of ACE2, it would have been obvious to one of ordinary skill in the art to do so because Han suggests that these peptides could be used as inhaled therapeutics for topical lung delivery. One of ordinary skill in the art would have a reasonable expectation that making the peptides of Han as suggested by Han would successfully result in the production of a small peptide that is capable of binding to the SARS-CoV-2 spike protein. Therefore, claims 1, 5, and 7-13 are rendered obvious by Han and are rejected under 35 U.S.C. 103. Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al ., ACS Nano 14 : 5143-5147 (2020; published April 14, 2020), in view of Forood et al ., Proc. Nat’l . Acad. Sci. USA 90 : 838-842 (1993). As discussed above, claims 1, 5, and 7-13 are rendered obvious by Han. However, Han does not teach the addition of arginine to the short ACE2 peptide. Forood teaches that capping alpha-helices at the carboxy terminus with arginine improves the stability of the alpha-helix (see entire document, including page 840, left column, paragraph 2; cf. claims 2-3 and 6). While Han does not teach the addition of an arginine residue to the carboxy terminus of the alpha-helical ACE2 peptide, it would have been obvious to one of ordinary skill in the art to do so because Forood teaches that adding arginine to the carboxy termini of alpha-helices improves their stability. While Han and Forood do not teach the addition of at least two arginine residues as recited in instant claim 4, one of ordinary skill in the art would have been motivated to do so to further improve the stability of the alpha-helix structure. One of ordinary skill in the art would have a reasonable expectation that adding the arginine of Forood to the ACE2 alpha-helical peptide of Han would successfully result in the improved stability of the alpha-helix structure of the peptide and, thus, its improved binding to the SARS-CoV-2 spike protein. Therefore, claims 1-13 are rendered obvious by Han in view of Forood and are rejected under 35 U.S.C. 103. T he Supreme Court has acknowledged: When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable vari a tion … 103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obviou s unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions …… the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added). 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. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Enter examiner's name" \* MERGEFORMAT Erin M. Bowers , whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2897 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT Monday-Friday, 7:30-5:00 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Sharmila Landau , can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-0614 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Erin M. Bowers/ Primary Examiner, Art Unit 1653 12/12 /2025
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Prosecution Timeline

Dec 19, 2022
Application Filed
Dec 12, 2025
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
55%
Grant Probability
66%
With Interview (+11.2%)
3y 8m
Median Time to Grant
Low
PTA Risk
Based on 534 resolved cases by this examiner. Grant probability derived from career allow rate.

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