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 .
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.
Response to Amendment
The amendment filed February 3, 2026 has been entered. Claims 1-6, 8-9, and 12 have been amended and claims 7 and 11 have been cancelled. Applicant’s amendments to the claims have overcome the objections to the claims and specifications, the 112(b) rejections, and the 112(d) rejection of claim 11 previously set forth in the Non-Final Office Action mailed October 8, 2025. Applicants cancellation of claims 7 and 11 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed February 3, 2026 were fully considered but they were not persuasive. Maintained/modified rejections and new rejections necessitated by Applicant’s amendment are addressed below.
Claims 1-6, 8-10, and 12 are pending in this application.
Claim Interpretation
Claim 1 recites “wherein (A) is covalently bonded (B) through (C), and wherein the amide or ester linker is formed between a carboxylic acid group of (B) and an amino or hydroxyl group of (A). The examiner notes that so long as the structure between the groups possess amide/ester functionalities between them, it is not necessary that the individual components possess the claimed groups.
Maintained/New Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1: Claim 1 recites various groups for A, B, and C, and describes connectivity to arrive at the claimed compound. However the recitation of specific compounds and connectivity utilizing groups that are not present in the specific compounds renders the scope of the claim unclear. For example, Claim 1 recites that A is bonded to B through C using a carboxylic acid group of B, however, 4-guanidino-benzamide does not have a carboxylic acid group and is listed as a B compound. Claim 1 also that A is bonded to C using an amino or hydroxyl group of A recites 2H-chromen-6-yl or pyrimidine as an A species, which do not specifically have a hydroxyl group. Thus, the scope is unclear, and a person of ordinary skill would be unable to ascertain the metes and bounds of the invention, rendering claim 1 indefinite. The Examiner suggests utilizing chemical structures to demonstrate bond connections or possible compounds that are encompassed by the claim.
Regarding claim 2 and 5-6: Claim 2 recites inter alia, “The compound of claim 1, comprising (A) a nucleoside analogue moiety; (B) a guanidine analogue moiety; and (C) an amide linker according to formula RH11….” and then recites the structure of RH11. The phrase “(C) an amide linker according to formula RH11” renders the claim indefinite because it is unclear whether the claim is stating that all three groups are present in the compound RH11, or that RH11 is solely the amide linker also comprises (A) and (B). Additionally, the claim utilizes the phrase “comprising” which is open ended, but appears to be directed towards a specific compound (i.e. RH11). It is unclear what additional elements are present in RH11. For examination purposes the claim will be interpreted wherein claim 2 is limited to specifically compound RH11. Claims 5-6 which depend from claim 2 are similarly rejected. The examiner suggests amending the claim in such a way that claim 2 is directed towards solely compound RH11, similar to instant claims 3-4.
Maintained/Modified Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 5-6: Claims 5-6 recite limitations of compound 2 by describing compound activity, (i.e. “wherein the compound exhibits”). However, these characteristics are necessarily present in claim 2 drawn to the specific compound as a compounds properties cannot be separated from the compound itself. Thus, claims 5-6 fail to limit claim 2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained Claim Rejections - 35 USC § 102
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.
(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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seither (WO 2010/089391, cited in previous action).
Regarding claim 1: Seither teaches the following compound which comprises a pyrimidine, an amide linker, 4-guanidinobenzamide:
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(pg. 18, compound 1.52).
Claims 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by LV (CN1401634, cited in previous action).
Claim 1: LV teaches the following the following compound which comprises a pyrimidine, an amide linker, 4-guanidinobenzamide:
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wherein R is
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(original document, pg. 8, top of page, pg. 9, compound 22).
Allowable Subject Matter
Claims 8-10 and 12 are allowed.
Claims 3-4 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4, 8-10, and 12: The closest prior art is Burns (WO 2022/265964, cited on PTO-892). Burns teaches nucleoside analogs and compositions for the treatment of SARS-CoV-2 infection (abstract). Sars teaches the specific compound
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(pg. 84, compound 85). Burns does not teach incorporation of the guanidine or pyrimidine moieties as represented by claimed compounds RH13 and R11 in the instant claims. Thus, it would be improper hindsight to suggest a person of ordinary skill in the art would have the motivation to modify the compound in such a way as to arrive at the claimed compounds. A person of ordinary skill would lack the requisite motivation to do so as there is no teaching or suggestion such modification would be beneficial in any way.
Regarding claim 3: The closest prior art is Hamoda (Frontiers in Pharmacology, 2021, cited on PTO-892). Hamoda teaches sponge derived compounds that poses anti-SARS-Cov-2 from the ocean (abstract) Hamoda teaches coumarin compounds such as
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and guanidino containing compounds such as
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possess anti-SARS-2 activity (pg. 4, figure 2). Hamoda does not teach the compound recited by instant claim 3. Thus, it would be improper hindsight to suggest a person of ordinary skill in the art would have the motivation to combine certain features of the compounds in such a way as to arrive at the claimed compound. A person of ordinary skill would lack the requisite motivation to do so as there is no teaching or suggestion such modification would be beneficial in any way.
Response to Arguments
Applicant’s arguments filed February 3, 2026 with respect to claim 1 have been fully considered but they are not persuasive.
On pages 10-11 of Applicant’s response, Applicant argues the newly amended claims clearly specify connectivity’s and moieties which exclude the compound of Seither (bridging para.). On page 11 of Applicant’s response, Applicant argues that Seither compound comprises a pyrimidine moiety, but now requires specific structural connectivity wherein the pyrimidine moiety is covalently bound to the guanidine or 2-amino pyrimidine moiety B through an amide or ester linker.
However, Seither teaches the following compound:
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wherein the boxed section is a pyrimidine moiety possessing an amino group, which connects through amide bond with a 4-guanidino benzoic acid/amide species. Given that the phrase “pyrimidine” is not necessarily limiting, the compound of Seither anticipated claim 1. The requirement of connection through a carboxylic acid is not necessary so long as the compound possesses a final structure that is claimed.
On page 12 of Applicant’s response, Applicant argues the newly amended claims clearly specify connectivity’s and moieties which exclude the compound of LV (paras. 2-3).
However, LV teaches the following the following compound which comprises a pyrimidine, an amide linker, 4-guanidinobenzamide:
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wherein R is
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(original document, pg. 8, top of page, pg. 9, compound 22). The requirement of connection through a carboxylic acid is not necessary so long as the compound possesses a final structure that is claimed.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 112 and 102 rejections are maintained for reason of record and foregoing discussion.
Conclusion
Claims 8-10 and 12 are allowed in this action.
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 SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693