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 .
Priority
The present application claims priority to the application, 63/359,406, with effective filing date of 8 July 2022.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction Requirement filed, 30 January 2026.
Applicant’s election without traverse of Group I and
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in the reply filed on 30 January 2026 is acknowledged.
Claim 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group (Group II: claims 12-16), there being no allowable generic or linking claim. Claim 3-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 3-8 specify other compounds of Formula (I). Election was made without traverse in the reply filed on 30 January 2026.
Information Disclosure Statement
The Information Disclosure Statement filed on 6 July 2023 and the references cited therein have been considered, unless indicated otherwise
Claim Objections
1. Claim 1 is objected to because of the following informalities: “W” is defined as the term, “C,” which should be replaced with “CH.” In the specification, Applicant defines “W” as “CH,” and none of the compounds taught are further substituted ([0007]; [0008]; [0050] – [0057]).
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
2. Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Cragoe (U.S. Patent No. 4,070,539, issued 24 Jan 1978).
Cragoe teaches a new class of compounds: [1-oxo-2-halo(or hydrogen)indanyloxy]alkanoic acids via alkanoylphenoxyalkanoic acids (column 1, lines 10-12; column 7, lines 1-5 and 46-47). Cragoe specifically teaches the compound, [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid, which is
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(column 11, lines 24-25).
Regarding claim 1, Cragoe teaches [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid, which is
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(column 11, lines 24-25).
Regarding claim 2, Cragoe teaches [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid, which is
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(column 11, lines 24-25).
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.
3. Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Cragoe (U.S. Patent No. 4,070,539, issued 24 Jan 1978) in view of Patel (Int. J. Mol. Sci., 2020, 21(8224), 1-21) as evidenced by Power Thesaurus (“Synonyms for Pharmaceutical Composition,” Power Thesaurus, 2026, < https://www.powerthesaurus.org/pharmaceutical_composition/synonyms>, accessed 25 Feb 2026).
Cragoe (U.S. Patent No. 4,070,539, issued 24 Jan 1978) is applied as discussed in the 35 U.S.C. 102 rejection above.
The Examiner notes the relevant teachings with respect to claims 1-2 set forth above and are incorporated herein by reference.
Additional relevant teachings set forth below.
Cragoe teaches [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid, which is
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(column 11, lines 24-25).
Regarding claim 9, Cragoe fails to teach a composition of [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid.
Patel teaches the roles of pharmaceutical compositions and excipients in drug metabolism (abstract; page 4, paragraphs 4 and 5), as evidenced by Power Thesaurus. Power Thesaurus teaches that the term, pharmaceutical formulations, is a synonym for pharmaceutical compositions (terms #9 and #14).
It would have been prima facie obvious to one or ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the compound of Cragoe with the compositions of Patel to develop a composition of [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid (Formula II) to arrive at instant claim 9. One of ordinary skill would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Cragoe teaches [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid, which is
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,
-Patel teaches that the pharmacokinetics (absorption, distribution, metabolism, and elimination) of active pharmaceutical ingredients are possibly altered because of their transport and metabolism modulation from incorporated excipients (abstract),
-Patel teaches that most popular route for drug delivery is oral administration because of pain avoidance, ease of ingestion, patient compliance and versatility of drug candidates (page 1, paragraph 1),
-Patel teaches that poor bioavailability of oral formulation is a limiting factor that can alter efficacy and therapeutic effect (page 1, paragraph 1),
-Patel teaches that addition of commonly-used pharmaceutical excipients can be a potential solution to these problems (page 4, paragraph 4),
-Patel teaches that pharmaceutical excipients are ingredients other than the active pharmaceutical ingredient (API) present in a finished pharmaceutical drug formulation and that excipients are frequently used as lubricants, diluent, binders, flavorings, coating and coloring agents for the formulation (page 4, paragraph 4),
-Patel teaches that addition of pharmaceutical excipients in drug formulations have gained attention which can alter the pharmacokinetics of drugs, resulting in improved bioavailability (page 4, paragraph 5), and
-Patel teaches a review of the current literature and evaluates the effect of different pharmaceutical excipients on metabolic enzymes (page 4, paragraph 5).
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a composition of [2,3-dichloro-4-(2-methylenebutyryl)phenoxy]acetic acid.
Regarding claim 10, Patel teaches a pharmaceutical composition (page 4, paragraphs 4 and 5), as evidenced by Power Thesaurus. Power Thesaurus teaches that the term, pharmaceutical formulations, is a synonym for pharmaceutical compositions (terms #9 and #14).
Regarding claim 11, Patel teaches a composition comprises a pharmaceutically excipient, diluent, and vehicle (page 4, paragraph 4).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622