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 Group I (claims 1 – 2, and 4 – 7) drawn to a compound having one of the following formulae:
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; wherein L, M, Y, Y1, Z, R1-18 and X1-4 are defined and the species election of 7-(trifluoromethyl)benzo[b]thieno[2,3-f][1,4]oxazepin-10(9H)-one with the chemical structure of
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in the reply filed on January 29th, 2026 is acknowledged.
Claims 8 – 19, and 21 – 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method for preventing and/or treating a viral infection), there being no allowable generic or linking claim. Additionally, claims 4, and 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 January 29th, 2026.
Hence claims 1 – 2, 5, and 7 are being examined on the merits herein.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 and 7 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.
Claim 1 recites a compound having one of the following formulae:
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; wherein L, M, Y, Y1, Z, R1-14, and 16 - 18 and X1-4 are defined. However, claim 1 does not define within the claim what R15 is which renders claim 1 indefinite. While the instant specification defines what structural limitation for R15 can be (see applicants specification page 31 paragraph 0078) one of ordinary skill in the art wouldn’t know if the embodiments in the instant application are exclusive or inclusive. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of what a compound of formula III would be. Therefore, given the uncertainty around the structural limitation for R15 claim 1 is rejected under 35 U.S.C. 112(b). Additionally, claim 7 is included in the rejection for being dependent on claim 1 and failing to address the deficiency.
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).
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.
Conclusion
Claims 1 – 2, 5, and 7 are rejected.
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