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 .
Status of the Claims
Claims 1-2, 5, 12, and 15-30 are pending. Claims 3-4, 6-11, and 13-14 were canceled, claims 1, 5, 12, 15-16, 18and 27-29 were amended, and claim 30 was added in the response filed March 20, 2026.
Claims 16-27 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of the species SEQ ID NO: 1 in the reply filed on November 5, 2025, is acknowledged. The elected species was searched and prior art was found. The search and examination was not extended in accordance with MPEP § 803.02.
Claims 15 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Both claims 15 and 29 as amended require search and consideration of non-elected species.
In summary, claims 1-2, 5, 12, and 15-30 are pending and claims 15-29 are withdrawn.
Claim Objections - withdrawn
The objection to claims 11-15 and 28 under 37 CFR 1.75(c) is withdrawn in view of the amendment filed March 20, 2026.
Claim Rejections - 35 USC § 101 - withdrawn
The rejection of claims 1-6 and 8-10 under 35 U.S.C. 101 is withdrawn in view of the amendment filed March 20, 2026.
Claim Rejections - 35 USC § 112 - withdrawn
The rejection of claims 1-5 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amendment filed March 20, 2026.
Claim Rejections - 35 USC § 102 - withdrawn
The rejection of claims 1 and 3-6 under 35 U.S.C. 102(a)(1) as being anticipated by Düzgüneş et al. is withdrawn in view of the amendment filed March 20, 2026.
The rejection of claims 1 and 3-6 under 35 U.S.C. 102(a)(1) as being anticipated by Maiti is withdrawn in view of the amendment filed March 20, 2026.
The rejection of claims 1-6 and 8-9 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Pincus et al. is withdrawn in view of the amendment filed March 20, 2026.
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.
Claims 1-2, 5, 12, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pincus et al. (WO 2021/258002 A2, published 23 December 2021, effective filing date 19 June 2020) in view of Düzgüneş et al. (NPL U, PTO-892 12/23/2025).
Determining the scope and contents of the prior art.
Pincus et al. teach a composition for treating viral infection caused by the coronavirus SARS-CoV-2 comprising a peptide SEQ ID NO: 2, which is derived from the wild-type ACE2 receptor and which binds to the receptor binding domain of the spike protein of SARS-CoV-2 (para. [0025]-[0026], [0028], [0030], [0092], [0142]). The peptide SEQ ID NO: 2 of Pincus et al. is 37 amino acids in length and comprises instant SEQ ID NO: 1 at positions 1 to 31. Pincus et al. also teach SEQ ID NO: 3, which is a fragment of SEQ ID NO:2 and of instant SEQ ID NO: 1. A comparison of these peptides is as follows:
Instant SEQ ID NO: 1(ACE2 19-49) STIEEQAKTFLDKFNHEAEDLFYQSSLASWN Pincus SEQ ID NO: 2 (ACE2 19-55) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNIT
Pincus SEQ ID NO: 3 (ACE2 22-42) EEQAKTFLDKFNHEAEDLFYQ
Pincus et al. teach that the composition may be delivered by a pulmonary route or intranasal route to treat or prevent SARS-CoV-2 infection (para. [0116]-[0123], [0129]; Figures 1-2). Pincus et al. teach that the composition may be incorporated into personal protection equipment to prevent SARS-CoV-2 infection (para. [0128]-[0129]; Figure 3). Pincus et al. teach that the peptide may be fused to a molecular tag, such as a histidine tag, for chelation to metal ions (para. [0130]-[0136]; Figures 4-5).
Ascertaining the differences between the prior art and the claims at issue.
Pincus et al. does not teach a peptide consisting of instant SEQ ID NO: 1.
Resolving the level of ordinary skill in the pertinent art.
Pincus et al. teach that the viral spike proteins S1 and S2 bind to one a-helical domain of ACE2, the a-helix 1, or a1, domain on the amino terminal end of the protein including amino acid residues 19- 55 (para [0028]). Pincus et al. teach that the structure of the a1 helical domain appears to be unchanged whether bound to the RBD of the spike protein, or not bound to the RBD of the spike protein: superposition of the a1 domain (residues 22-45) of Covid-2-bound ACE2 and free ACE2 results in a root mean square deviation (RMSD)Å of only 0.58 Å, showing that the conformation of the a1 domain is fixed and stable (para [0028]).
Pincus et al. teach that the disclosed peptides, including SEQ ID NO: 2, can be modified by substitution, deletion, and/or insertion at up to 5 or up to 10 positions (para. [0111]), especially by deletion of the amino acids corresponding to residues S19 to I21 and N49 to T55 in ACE2 (claim 5).
Düzgüneş et al. teach peptide inhibitors of membrane fusion involved in infection by influenza virus, HIV-1, MERS and SARS coronaviruses, hepatitis viruses, paramyxoviruses, flaviviruses, herpesviruses and filoviruses (abstract). Düzgüneş et al. teach in section 7.4 that peptides derived from the wild-type receptor for hepatitis C virus, claudin, bind to the virus and inhibit viral fusion and infection. “An 18-amino acid peptide derived from the N-terminus of claudin-1 inhibits a late step during viral entry, most likely after the binding step, with an IC50 of 2.1 µM. The peptide, designated as CL58, is not cytotoxic at concentrations about 100-fold higher than the IC50. Slightly shorter peptides have much higher IC50s, and slightly longer peptides have slightly higher IC50s, highlighting the importance of peptide length in the design of inhibitors.” Therefore, the prior art establishes that peptide length is a result-effective variable for viral entry inhibition.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The specification fails to provide a comparison between a peptide consisting of SEQ ID NO: 1 and the closest prior art, SEQ ID NO: 2 of Pincus et al. which is 37 amino acid residues in length comprising instant SEQ ID NO: 1 at positions 1-31. Therefore, there is no evidence on record that the claimed peptide has unexpected properties.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate deletion mutants of SEQ ID NO: 2 taught by Pincus et al., including a peptide consisting of instant SEQ ID NO: 1. The rationale for obviousness is "obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP § 2143.01(E)). The relevant findings for this rationale are as follows.
(1) At the relevant time, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem. In the instant case, Pincus et al. teaches there is a need to develop compositions for treating SARS-CoV-2 and COVID-19, including the development of inhibitors of viral entry derived from ACE2 peptide fragments (para. [0001]-[0007]). Therefore, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem.
(2) There had been a finite number of identified, predictable potential solutions to the recognized need or problem. Pincus et al. teach that SEQ ID NO: 2, which corresponds to ACE2 positions 19-55, blocks SARS-CoV-2 entry into host cells (Examples, para. [0142]). Pincus et al. suggest that the peptide can be modified by up to 10 deletions (para. [0111]), specifically by deleting the positions corresponding to S19 to I21 and N49 to T55 in ACE2 (claim 5). The subgenus of peptide fragments encompassed by this teaching of Pincus et al. wherein SEQ ID NO: 2 is modified by deletion at positions corresponding to S19 to I21 and N49 to T55 include:
(ACE2 19-55) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNIT
(ACE2 19-54) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNI
(ACE2 19-53) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTN
(ACE2 19-52) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNT
(ACE2 19-51) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYN
(ACE2 19-50) STIEEQAKTFLDKFNHEAEDLFYQSSLASWNY
(ACE2 19-49) STIEEQAKTFLDKFNHEAEDLFYQSSLASWN
(ACE2 20-55) TIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNIT
(ACE2 20-54) TIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNI
(ACE2 20-53) TIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTN
(ACE2 20-52) TIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNT
(ACE2 20-51) TIEEQAKTFLDKFNHEAEDLFYQSSLASWNYN
(ACE2 20-50) TIEEQAKTFLDKFNHEAEDLFYQSSLASWNY
(ACE2 20-49) TIEEQAKTFLDKFNHEAEDLFYQSSLASWN
(ACE2 21-55) IEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNIT
(ACE2 21-54) IEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNI
(ACE2 21-53) IEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTN
(ACE2 21-52) IEEQAKTFLDKFNHEAEDLFYQSSLASWNYNT
(ACE2 21-51) IEEQAKTFLDKFNHEAEDLFYQSSLASWNYN
(ACE2 21-50) IEEQAKTFLDKFNHEAEDLFYQSSLASWNY
(ACE2 21-49) IEEQAKTFLDKFNHEAEDLFYQSSLASWN
This list of options includes instant SEQ ID NO: 1(ACE2 19-49) STIEEQAKTFLDKFNHEAEDLFYQSSLASWN. The number of peptides in this list of deletion mutants, 21, is comparable to the number the courts held as a finite in Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007) (the court rejected the notion that unpredictability could be equated with nonobviousness here, because there were only a finite number (53) of pharmaceutically acceptable salts to be tested for improved properties). Therefore, there had been a finite number of identified, predictable potential solutions to the recognized need or problem.
(3) One of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. One of ordinary skill in the art would expect that the length of peptide could impact function because Pincus et al. teach this fact in para. [0111] and claim 5. In addition, Pincus et al. teach that SEQ ID NO: 3, a fragment of SEQ ID NO: 2, is active (para. [0142]). In addition, Düzgüneş et al. teach the importance of peptide length in the design of viral entry inhibitors. In other words, the prior art establishes that peptide length is a result-effective variable for viral entry inhibition, providing further motivation to vary the peptide length in the pursuit of new viral entry inhibitors. Therefore, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.
(4) Whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. The specification fails to provide a comparison between a peptide consisting of SEQ ID NO: 1 and the closest prior art, SEQ ID NO: 2 of Pincus et al. which is 37 amino acid residues in length comprising instant SEQ ID NO: 1 at positions 1-31. Therefore, there is no evidence on record that the claimed peptide has unexpected properties.
The rationale to support a conclusion that a peptide consisting of SEQ ID NO: 1 would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use said SEQ ID NO: 1 in all the applications taught by Pincus et al. including delivery by a pulmonary route or intranasal route to treat or prevent SARS-CoV-2 infection (para. [0116]-[0123], [0129]; Figures 1-2), incorporation into personal protection equipment to prevent SARS-CoV-2 infection (para. [0128]-[0129]; Figure 3), and fusion to a molecular tag, such as a histidine tag, for chelation to metal ions (para. [0130]-[0136]; Figures 4-5). Fusion to a molecular tag such as a histidine tag satisfies the requirement in claim 1 that the peptide is fused to another peptide domain.
Therefore, claims 1 and 30 are obvious over the cited art.
Regarding claim 2, Pincus et al. teach delivery by a pulmonary route or intranasal route to treat or prevent SARS-CoV-2 infection (para. [0116]-[0123], [0129]; Figures 1-2).
Regarding claim 5, Pincus et al. teach a composition for treating viral infection caused by the coronavirus SARS-CoV-2 comprising a peptide SEQ ID NO: 2, which is derived from the wild-type ACE2 receptor and which binds to the receptor binding domain of the spike protein of SARS-CoV-2 (para. [0025]-[0026], [0028], [0030], [0092], [0142]).
Regarding claim 12, MPEP § 2144.06(I) states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). In the instant case, it would have been obvious to combine the peptide consisting of SEQ ID NO: 1 obvious over Pincus et al. with the additional peptides taught by Pincus et al. because both were taught to be useful for the same purpose of binding to the receptor binding domain of the spike protein of SARS-CoV-2 (para. [0025]-[0026], [0028], [0030], [0092], [0142]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654
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