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 .
Detailed Action
Claims 1, 4-5, 8, 11-12, 14 and 17-21 are pending and now evaluated on its merits.
Priority
This application is a continuation of application 17/055,459, filed 11/30/2020 and application 18/347,674, filed 07/06/2023, which claims domestic benefit to U.S. provisional application 62/671,753, dated 05/15/2018.
Information Disclosure Statement
The information disclosure statement (IDS) dated 2/27/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claim 4 is objected to because the structures of ring D have a substitution wherein rind D according to claim 1 is a phenyl or pyridinyl.
Claim Interpretation
Examiner for prior art purposes is interpreting the above claim 4 objection of ring D as a phenyl or pyridinyl with an attached R2 group as identified in claim 1.
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 12 and 14 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.
Regarding claims 12 and 14, the phrase "n is 0 or 1" renders the claim indefinite because claims 12 and 14 are dependent on claim 1 which recites “n is 1, 2, 3, 4, or 5”. Thus, a limitation of n as zero is rendered indefinite.
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.
Claims 1, 4-5, 8, 11-12 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (U.S. Patent No. 7179831) in view of Patani et al. Bioisosterism: A Rational Approach in Drug Design, Chem Rev; May 1996, Pages 3147-3176.
Regarding claims 1, 4-5, 8, 11-12 and 19-21, Yang teaches compounds for the treatment of Human macrophage elastase (MMP-12) mediated diseases of emphysema, fibrotic disease, arthritis, and chronic obstruction pulmonary disease comprising administration of formula (IV)
PNG
media_image1.png
124
311
media_image1.png
Greyscale
with a suitable pharmaceutical diluents, excipients, or carriers (relevant to claims 19-21) (Pg. 3-4). Of particular embodiments Yang teaches the above compound wherein R is
PNG
media_image2.png
224
180
media_image2.png
Greyscale
The teaching of Yang corresponds with instant claims of R1, R4, R5 as H, Ring C as phenyl, X as S, Y as O, Z as CH2, ring D as a phenyl, R2 as a methyl (relevant to claims 4-5).
Yang fails to teach ring B as a thiophenyl or oxazolyl.
Patani teaches the replacement of O and S as bioisoteres of heteroatoms structures that resulted in similar activity of the compounds (Figure 36-37, Tables 27-28).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have developed compound
PNG
media_image1.png
124
311
media_image1.png
Greyscale
taught by Yang to treat an MMP-12 disease, wherein the furan is replaced with a thiophenyl. One would have been motivated to do so from the teachings of Patani of substituting a Sulphur atom with an Oxygen atom on a heterocyclic structure would yield similar activity. There is a reasonable expectation of treating an MMP-12 mediated disease by administrating the compound
PNG
media_image1.png
124
311
media_image1.png
Greyscale
taught by Yang wherein the furan is replaced with a thiophenyl.
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, 5, 8, 11-12 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 11-12 and 19 of U.S. Patent No. 11739080. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 5, 11-12 and 19 of U.S. ‘080 anticipates and is obvious to claims 1, 5, 8, 11-12 and 19 of claimed invention for a compound of formula (I)
PNG
media_image3.png
139
368
media_image3.png
Greyscale
PNG
media_image4.png
385
628
media_image4.png
Greyscale
PNG
media_image5.png
58
168
media_image5.png
Greyscale
.
Allowable Subject Matter
Claims 17-18 are free of the arts. The prior art of Yang fails to teach the compounds recited in independent claim 17, in particular the compounds with ring B as oxazolyl and ring D as a pyridinyl.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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, Kortney Klinkel can be reached at 571-270-5239. 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.
MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights