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 and the species
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in the reply filed on 4/13/26 is acknowledged.
Claims 3-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/13/26.
The species
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were not found in the prior art and therefore, the search was expanded.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue et al. (J. Med. Chem. 1998, 41, 1745-1748).
Xue et al. (J. Med. Chem. 1998, 41, 1745-1748) teaches of the cyclic inhibitors of matrix metalloproteinases
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(title; abstract; Scheme 2; p1747, Conclusion) which anticipates R = -NHR’ and R’ = C1-C6 alkyl of the instant claims.
SE205 has excellent water solubility (13 mg/mL) which makes it an attractive prototypical molecule for in vivo studies (p1747, right column, first paragraph) wherein the water anticipates the pharmaceutically acceptable carrier of the instant claims.
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.
Claim(s) 1,2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xue et al. (US 6,281,352B1).
Xue et al. (US 6,281,352B1) discloses inhibitors of metalloproteinases and pharmaceutical compositions comprising such compounds and a pharmaceutical carrier used for the treatment of inflammatory diseases (abstract; column 22, lines 31-45; column 200, lines 41-52; column 201, lines 39+).
The compounds comprise novel hydroxamic acids and carboxylic acids and derivatives (column 4, lines 10-26 and 40-55), such as
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(column 58, lines 55-65) wherein R2 comprises CONH-cyclopentyl, CONMe2, CONEt2, etc. (table 1) that encompass the compounds of the instant claims when R is –NHR’ or –NR’R’ and R’ is C3-C7 cycloalkyl or C1-C6 alkyl.
The pharmaceutical carrier encompasses the pharmaceutical carrier of the instant claims.
Xue et al. further discloses a pharmaceutical kit comprising a container, instructions, inserts, labels, etc. (column 206, lines 5-17) that encompasses the kit of the instant claims.
Claim(s) 1,2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xue et al. (J. Med. Chem. 1998, 41, 1745-1748) in view of Xue et al. (US 6,281,352B1).
Xue et al. (J. Med. Chem. 1998, 41, 1745-1748) discloses the cyclic inhibitors of matrix metalloproteinases
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as well as that stated above.
Xue et al. (J. Med. Chem. 1998, 41, 1745-1748) does not disclose a kit.
Xue et al. (US 6,281,352B1) discloses that stated above.
At the time of the invention it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to include the compounds of Xue et al. (J. Med. Chem. 1998, 41, 1745-1748) in kits comprising instructions as Xue et al. (US 6,281,352B1) discloses analogous compounds provided in kits to provide instructions and/or guidelines for administration for the advantage of use of the compounds in treatment of a subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1,2 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,286,251B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the U.S. Patent No. 11,286,251B2 comprises compounds, such as
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,
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, etc. that encompass the compounds of the instant claims when R is -NHR1; R1 is
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, etc.; R3 is F,
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, etc.
The U.S. Patent No. 11,286,251B2 comprises a kit comprising an applicator and instructions that encompasses the kit of the instant claims comprising an applicator and instructions.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The
examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA J PERREIRA/Examiner, Art Unit 1618
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