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 .
Status of the Claims
Claims 1, 5, 7-9, 11-14 and 16-22 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/24/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections – Withdrawn
The prior claim objection to claim 7 is withdrawn in response to Applicant’s amendment of claim 7.
Claim Rejections - 35 USC § 112(b) – Withdrawn
The prior rejection of claims 1, 4-5, 8-9, 11-14 and 17-22 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in response to Applicant’s amendment of claim 1 and cancellation of claim 4.
Claim Rejections - 35 USC § 112(b)
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.
Claim 16 is 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.
Claim 16 is drawn to a group of specific compounds but does not illustrate or articulate what are the specific compounds being claimed. MPEP § 2173.05(s) states the following:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Compounds to be claimed in claim 16 must each be incorporated into the claim by drawing or by their chemical names. Since the compounds can be incorporated by name, it is not the case that there is no practical way to define the invention in words.
Claim Rejections - 35 USC § 102 – Withdrawn
The prior rejection of claims 1, 4, 8 and 14 under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1790524-36-5 (Chemical Abstracts Service, registry number 1790524-36-5, originally entered on 28Jun2015 by Aurora Fine Chemicals)1, is withdrawn in response to Applicant’s amendment of claim 1.
The prior rejection of claims 1, 7-9, 14 and 17 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Feng (WO 2011/050245 A1)2 is withdrawn in response to Applicant’s traverse. As noted by Applicant, claim 1 includes heterocycloalkyl groups for R2, but does not include heteroaryl groups as eligible for the R2 position.
The prior rejection of claims 1, 7-8 and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Karaluka (Karaluka, et al.; Organic & Biomolecular Chemistry, v13, pp10888-10894; 2015)3 is withdrawn in response to Applicant’s amendment of claim 1.
Claim Rejections - 35 USC § 102 – Necessitated by Amendment
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 and 7-8 are anticipated by CAS 1936652-89-9.
Claims 1 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1936652-89-9 (Chemical Abstracts Services, registry number 1936652-89-9, originally entered on 22Jun2016 by FCH Group).
Claim 1 is directed to a genus of bicyclic heterocyclic compounds and their pharmaceutically acceptable salts, bearing a carboxamide group and having additional substitutions and/or limitations, as shown in the table below. CAS 1936652-89-9 discloses a compound4 that anticipates the instant genus, as shown below:
Claim Number(s) of Instant Application
Instant Application
CAS 1936652-89-9
1
PNG
media_image1.png
272
350
media_image1.png
Greyscale
wherein:
PNG
media_image2.png
144
338
media_image2.png
Greyscale
Thus, claim 1 is anticipated by the disclosure of CAS 1936652-89-9.
Claims 7-8 further limit the genus of claim 1, each to a narrower genus that is met by the compound disclosed by CAS 1936652-89-9.
Thus, claims 7-8 are anticipated by the disclosure of CAS 1936652-89-9.
Claims 1 and 7-8 are anticipated by Moraski.
Claims 1 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moraski (Moraski, et al.; Bioorganic & Medicinal Chemistry Letters, v24, pp3493-3498; 2014).
Claim 1 is directed to a genus of bicyclic heterocyclic compounds and their pharmaceutically acceptable salts, bearing a carboxamide group and having additional substitutions and/or limitations, as shown in the table below. Moraski discloses a compound5 that anticipates the instant genus, as shown below:
Claim Number(s) of Instant Application
Instant Application
Moraski
1
PNG
media_image1.png
272
350
media_image1.png
Greyscale
wherein:
PNG
media_image3.png
178
238
media_image3.png
Greyscale
Thus, claim 1 is anticipated by the disclosure of Moraski.
Claims 7-8 further limit the genus of claim 1, each to a narrower genus that is met by the compound disclosed by Moraski.
Thus, claims 7-8 are anticipated by the disclosure of Moraski.
Claim Rejections - 35 USC § 103 – Withdrawn
The prior rejection of claims 1, 11 and 17-18 under 35 U.S.C. 103 as being unpatentable over Yang (WO 2011/049987 A2) in view of Brown (Brown; Bioisosteres in Medicinal Chemistry, Wiley-VCH, 2012) is withdrawn in response to Applicant’s amendment of claim 1.
Double Patenting - Withdrawn
The prior rejection of claims 1, 7 and 17 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,323,000 B2 in view of Brown (Brown; Bioisosteres in Medicinal Chemistry, Wiley-VCH, 2012) is withdrawn in response to Applicant’s amendment of claim 1.
Claims Free of the Prior Art
Claims 5, 9, 11-14 and 17-22 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 12/18/2023.
2 Cited in Applicant’s Information Disclosure Statement dated 12/18/2023.
3 Cited in Applicant’s Information Disclosure Statement dated 12/18/2023.
4 7-Bromo-N-(phenylmethyl)-1H-indazole-3-carboxamide.
5 N-benzyl-6-methyl-1H-indazole-3-carboxamide