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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed May 28th, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Election/Restrictions
Claims 1 – 2, 4 – 19, and 21 – 22 are currently pending in the application. However, due to a restriction requirement, claims 4, 6, 8 – 19, and 21 – 22 are withdrawn from further consideration.
Hence claims 1 – 2, 5, and 7 are being examined on the merits herein.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 – 2, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spain Patent Application ES 518427 A1 to Saleta et. al. (herein after Saleta’427; cited IDS dated April 14th, 2025).
Regarding claims 1 – 2, and 5, Saleta’427 teach compound 13 of the structure
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(claims 1 – 2, and 5) (page 3 Table III Entry 13) that was prepared from recrystallization from ethyl acetate (page 5 line 1). Moreover, Saleta’427 teach compounds of this disclosure as potential therapeutics (page 2 lines 1 – 3).
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.
Claim 7 is are rejected under 35 U.S.C. 103 as being unpatentable over Spain Patent Application ES 518427 A1 to Saleta et. al. (herein after Saleta’427; cited IDS dated April 14th, 2025) as applied to claims 1 – 2, and 5 above, and further in view of Danish et. al. ((2016), Various Techniques of Bioavailability enhancement: A review, Journal pf Drug Delivery and Therapeutics, 6, 34 – 41; cited in Office Action dated March 9th, 2026).
The teaching of Saleta’427 as they relate to claims 1, from which claim 7 depend, is given previously in this office action and are fully incorporated here.
While, the prior art of Saleta’427 does teach that the compounds of the disclosure are potential therapeutics, the prior art does not to explicitly teach a pharmaceutical composition comprising prior art compound 13 and a pharmaceutically acceptable carrier (claim 7).
Nevertheless, Danish et. al. teach that bioavailability is one of the important pharmacokinetic properties of drugs which are used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation (page 34 column 1 paragraph 1). Additionally, Danish et. al. teach that if the drug is administered through other routes (such as oral), its bioavailability decreases because of incomplete absorption or first pass metabolism (page 34 column 1 paragraph 1). Moreover, Danish et. al. teach that the therapeutic efficacy of a drug depends upon the ability of the dosage form to deliver the active drug to the site of action at a rate and amount which is sufficient to show the desired pharmacological response (page 34 column 1 paragraph 2). Furthermore, Danish et. al. teach that the oral route is the most suitable and commonly used route of drug delivery due to its ease of administration, high patient compliance, cost-effectiveness, no sterility issues and flexibility in the design of dosage form (page 34 column 2 paragraph 2).
Danish et. al. teach that the solubility of a poorly water soluble drug can be increased by the addition of a water miscible solvent in which the drug has good solubility known as cosolvents which is one of the most widely used techniques due to its simplicity (page 35 column 2 paragraph 5). Moreover, Danish et. al. teach that examples of solvents used in co-solvent mixtures are PEG 300, propylene glycol or ethanol (page 35 column 2 paragraph 6). Furthermore, Danish et. al. teach that co-solvent formulations of poorly soluble drugs can be administered orally and parentally (page 35 column 2 paragraph 6).
Therefore, it would have been obvious before the effective filing date of the instant application to modify the invention of Saleta’427, in view of Danish et. al. that is for a pharmaceutical composition comprising a co-solvent such as PEG300,propylene glycol or ethanol for a pharmaceutical composition. One of ordinary skill in the art would have been motivated to make this modification in order to orally administer the compound. One of ordinary skill in the art would have had a reasonable expectation of success because the addition of a co-solvent is a widely used technique which is simple.
Response to Arguments
Applicant's arguments filed May 28th, 2026 have been fully considered but they are not persuasive.
Applicant argues that claim 1 has been amended to include the limitation, wherein the compound or pharmaceutically acceptable salt thereof binds to an interface of a SARS-Co V-1 or SARS-Co V-2 spike protein receptor binding domain (RBD) and a host cell ACE-2 receptor.” See Applicant’s arguments page 12 paragraph 4. As such, applicant argues that the prior art rejection should be withdrawn since the prior art of record does not teach the newly added limitation. See Applicant’s arguments page 13 paragraphs 1 – 2.
The examiner contends that the inclusion of the above limitation fails to overcome the obvious rejection in view of Saleta’427. Specifically, Saleta’427 taught compound 13 of the structure
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which in a compound species that anticipates all of the structural features recited in claims 1 – 2, and 5 that would contribute to this compounds pharmaceutical properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 (I). Furthermore, "products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01(II). Thus, since prior art compound 13 is identical to species elected by applicant and recites in claims 1 – 2, and 5. Prior art compound 13 would inherently be able to bind to an interface of a SARS-Co V-1 or SARS-Co V-2 spike protein receptor binding domain (RBD) and a host cell ACE-2 receptor.
Conclusion
Claims 1 – 2, 5, and 7 are rejected.
THIS ACTION IS MADE FINAL. 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 DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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