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
This is a response to Applicant’s communication filed on November 19, 2024. Application No. 18/867,358, filed November 19, 2024, is a 371 of PCT/US2023/022681, filed May 18, 2023, and claims the benefit of U.S. Provisional application No. 63/343,574, filed May 19, 2022. In a preliminary amendment filed November 19, 2024, Applicant cancelled claims 1-112 and added new claims 113-160. Claims 113-160 are pending.
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.
Claims 113-160 are rejected under 35 U.S.C. 103 as being unpatentable over Newman et al., US2021/0247406 A1. Newman teaches a method of treating focal segmental glomerulosclerosis (FSGS) in a subject (see Newman et al., US PG ‘405, Abstract), comprising administering to the subject a therapeutically effective amount of endothelin-1 (ET-1) antagonists, atrasentan (Id., para. [0032]), or a pharmaceutically acceptable salt thereof, wherein the method is characterized by (i) decreasing proteinuria (Id., para. [0020]), and/or (ii) reducing the rate of decline in estimated glomerular filtration rate (eGFR) (Id., para. [0017]), and/or (iii) decreasing renal inflammation and/or fibrosis, (Id., para. [0015]) and/or (iv) delaying the onset of end-stage kidney disease (ESKD) (Id., para. [0019]), and/or (iv) decreasing fatigue, (Id., para. [0021]). In addition, New teaches composition including other agents for treating FSGS. See Id., para. [0046]. The difference between the prior art and present invention is disclosure of the specific characterizations of FSGS, the dosages and administration as well as further subject/patient diagnoses/indications/markers as claimed by the present invention.
Newman teaches that endothelin-1 (ET-1) antagonists such as atrasentan are well known vasodilators; ET-1 is the most potent vasoconstrictor known. (See Id., para. [0027]). Newman presents methods for determining the effectiveness of known ET-1 antagonist in treating FSGS. Accordingly, the elements of characterization, dosages and administration as well as subject diagnosis are disclosed in the prior art specifically, by reference, or are naturally inherent in the treatment of FSGS. See Id., Diagnosis Method, para. [0041]-[0042]; see Id., Pharmaceutical Compositions, para. [0043]-[0058], etc. Accordingly, all the elements of the present invention are disclosed in the prior art.
It would have been obvious to the ordinary artisan at the time of the invention to modify the invention of the prior art to arrive the present invention with a reasonable expectation of success. All the elements of the present invention are disclosed, referenced or are inherent in the prior art. In this case, the present invention combines prior art elements according to known methods to yield predictable results.
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 113-160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, and 9-64 of copending Application No. 17/995,798, (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘798 application are drawn to the same method of treating a form of kidney disease (diabetic kidney disease) as claimed by the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 113-160 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45, 47-49, and 51-74 of copending Application No. 17/363,604, (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘604 application are drawn to the same method of treating a form of kidney disease (IgA nephropathy) as claimed by the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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