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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2020/066243, filed 12/18/2020, which claims the priority benefit of PRO Application No. 63/125,937, filed 12/15/2020, PRO Application No. 63/121,721, filed 12/04/2020, PRO Application No. 62/952,161, filed 12/20/2019, and PRO Application No. 62/952,097, filed 12/20/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/21/2022, 08/01/2023, 06/13/2024, 01/28/2025, and 10/13/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election without traverse of Group I, (claims 1, 125, 157, 227, 269-270, 279, 284, 290, 295-296, 305, 310, 316, 414, 420, 422, 424, 430, 431, 433) in the reply filed 10/13/2025 is acknowledged.
Applicants' election without traverse of species of compound 28 (below) in the reply filed 10/13/2025 is acknowledged.
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Applicant’s elected species makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration.
Given the elected species has been found free of the prior art, examination has been expanded to the species of 5-(7-Cyclopentyl-3-hydroxynaphthalen-2-yl)-1,1-dioxo-1,2,5-thiadiazolidin-3-one (below), which is taught by Barnes (WO 2007/067615 A2).
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Thus, It has been determined that the scope instantly claimed is not patentable.
Status of the Application
Claims 1, 125, 157, 227, 269-270, 279, 284, 290, 295-296, 305, 310, 316, 414, 420, 422, 424, 430-431, 433-436, 440-441, 444-445 and 447-448 are pending. Claims 2-124, 126-156, 158-226, 228-268, 271-278, 280-283, 285-289, 291-294, 297-304, 306-309, 311-315, 317-413, 415-419, 421, 423, 425-429, 432, 437-439, 442-443, 446, and 449-450 have been cancelled. Claims 434-436, 440-441, 444-445, and 447-448 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 270, 279, 284, 290, 295-296, 305, 310, 316, 420 and 422, have been withdrawn from further consideration as being drawn to a non-elected species. Claims 1, 125, 157, 227, 269, 414, 424, 430, 431, and 433 are examined herein insofar as they read on the elected invention and species.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show clear structural definition of compounds and functional groups as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification (523 pages) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: There are multiple instances of structure drawing throughout the specification which are unclear and difficult to determine what applicant intends to be understood by reader, for example structure
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(specification page 50). See MPEP 608.01(f).
Appropriate correction is required.
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 414, 430 and 431 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.
Claims 414 and 430 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: functional groups and intended atoms in compound structures cited in instant claims, for example
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(claim 414). Because the quality of the chemical structures lacks clarity to the extent that a skilled artisan would not be able to determine the metes and bounds of the claims, claims 414 and 430 are rejected as indefinite. Applicants may wish to consider filing a new claim set where the figures are presented more clearly.
The limitations of claim 431 refer to a compound selected from “Table I or Table 2” (sic) however, neither Table 1 nor Table 2 is provided in the claims and must be referenced/located in the specification which is an improper incorporation by reference as the claim is currently written. See MPEP 2173.05(s). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
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.
Claims 1, 430 and 433 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Barnes (WO 2007/067615 A2).
With regard to instant claims 1 and 433, Barnes discloses the compound of example 22 as 5-(7-Cyclopentyl-3-hydroxynaphthalen-2-yl)-1,1-dioxo-1,2,5-thiadiazolidin-3-one, CAS RN 941304-89-8 (page 67-68). Barnes example 22 satisfies the structural limitations of applicants compound of formula I of claim 1 where R1, R3 and Rx are H and R2 is a C3-C6 cycloalkyl. The limitations of claim 433 wherein a pharmaceutical composition comprises a compound of instant claim 1 is also satisfied by the teaching of Barnes example 22.
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Applicants formula I (Left) Barnes example 22 (right)
With regard to instant claim 30, Barnes discloses the compound of example 4 as 5-(7-Ethyl-3-hydroxynaphthalen-2-yl)-1,1-dioxo-1,2,5-thiadiazolidin-3-one, CAS RN 941304-19-4 (page 51). Barnes example 4 satisfies the structural limitations of applicants compound of formula I of claim 430 where R1, R3 and Rx are H and R2 is a C1-C3 alkyl.
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Applicants formula I (Left) Barnes example 4 (right)
Allowable Subject Matter
Claims 125, 157, 227, 269, and 424 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.
Conclusion
Claims 1, 414, 430-431, and 433 are rejected. Claims 125, 157, 227, 269, and 424 are objected to.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623