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 office action is in response to applicant’s communication filed on 9/17/26.
Claims 1-15, 19, 24-25 and 37-38 are pending in this application.
Applicant's election of Group I, claims 1-15, without traverse, in the reply filed on 9/17/26 is acknowledged. Thus claims 19, 24-25 and 37-38 are withdrawn from consideration being drawn to the non-elected invention.
Applicant’s election of the following compound (Example 2.2) is acknowledged herewith:
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Claims 1-2, 5, 8 and 10-15 read on applicant's elected species. Claims 3-4, 6-7 and 9 do not read on the elected species. The elected species has a phenyl ring A, a pyridyl ring B, a pyrimidinyl ring C, and no -CD3 group.
Applicant’s elected species above is found allowable.
Thus the new species to be examined is the following:
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Thus, additionally, claims 3-4, 6-7 and 9 are hereby withdrawn from consideration being non-readable on the new and elected species. The search has not been extended to determine the patentability of the other species encompassed by the claims.
As a result, claims 1-2, 5, 8 and 10-15 are being examined in this Office Action. Claims 3-4, 6-7, 9, 19, 24-25 and 37-38 are withdrawn.
Priority
The applicant claims benefit as follows:
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Objections
Claims 1 are objected to because of the following informalities:
a) In the definition of R1, "or" appears before "5- to 10-membered heteroaryl" in the middle of the list.
b) In the definition of R1, "S(O)R1a" should read "-S(O)R1a" with the hyphen.
c) In the definition of R1a, "or" should be inserted before "two R1a groups taken together".
d) In the definition of R6, "N(R6a1)C(O)N(R6a1)2" should read "-N(R6a1)C(O)N(R6a1)2" with the hyphen.
e) In the definition of R6c1 and R6c2, the parentheses in "-N(R6d1)(S(O)(R6d1)" are not balanced.
f) In the definition of R6d1, a comma is missing in "heterocyclyl aryl".
Claim 13 is objected to because it recites "or a pharmaceutically acceptable salt thereof" twice.
Claim 10 is 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.
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.
Claim 13 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 13 refers to "Table I" of the specification.
Incorporation by reference to a table is permitted only in exceptional circumstances where there is no practical way to define the invention in words. See MPEP § 2173.05(s); Ex parte Fressola, 27 USPQ2d 1608 (Bd. Pat. App. & Inter. 1993). Here, the compounds can be recited by name or structure. Appropriate correction is required.
Reference to applicant’s specification refers to applicant’s PGPub: US 20250051309
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to include all the limitations of the claim upon which it depends. Claim 10 requires ring C to be a 5- to 10-membered heteroaryl. Claim 11 recites phenyl (the second ring shown) for ring C. Phenyl is not a heteroaryl. Applicant may cancel the claim, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements. Appropriate correction is required.
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 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 the AIA 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5, 8 and 14-15 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Kasai et al. (US 20150018363, pub date 1/15/2015).
Kasai exemplifies the following compound, 4-((1RS,2RS)-2-(4-chlorophenyl)cyclopropyl)-1-(2-cyclopropyl-1-methyl-1H-benzimidazol-6-yl)pyridin-2(1H)-one. The structure is shown below twice. (page 146, Table 1, Example 253; page 95, paragraphs [1670]-[1678]):
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This compound reads on applicant's compound of Formula I, when:
Ring A = phenyl (C6 aryl);
R1 = Cl;
p = 1;
L = bond;
q = 0;
R2 = H;
X = CR3;
R3 = H;
R4 = H
Ring B = benzimidazolyl (9-membered heteroaryl);
R5 = methyl;
n = 1
Ring C = cyclopropyl (C3 cycloalkyl);
m = 0
Kasai teaches that its compounds are formulated as a pharmaceutical composition with a pharmacologically acceptable carrier, such as an excipient. (paragraphs [0547]-[0549]) This meets claim 14.
Kasai also teaches that its compounds are used with a concomitant drug, such as an anti-obesity agent or a therapeutic agent for diabetes. (paragraph [0569]) This includes a single preparation of both. (paragraph [0584]) This meets claim 15.
Therefore these claims are fully met.
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 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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kasai et al. (US 20150018363, pub date 1/15/2015).
Claim 12 requires m to be 1, 2 or 3. Thus ring C must bear at least one R6.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kasai exemplifies Example 253, as set forth above and also shown below. (page 146, Table 1) It reads on Formula I with ring C = cyclopropyl and m = 0.
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Kasai also teaches that the group at the 2-position of the benzimidazole (R3) may be a C3-10 cycloalkyl substituted by a C1-6 alkyl, and that alkyl may have a hydroxy group. (paragraphs [0014]-[0017]) Kasai exemplifies a 2-methylcyclopropyl group (Example 90, page 57) and a 2-(2-hydroxypropan-2-yl)cyclopropyl group (Example 81, Table 1) at this position.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Kasai is deficient in the sense that Example 253 has an unsubstituted cyclopropyl (m = 0), and not a substituted cyclopropyl (m = 1).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Therefore, it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the cyclopropyl of Example 253 with a 2-methylcyclopropyl or 2-(2-hydroxypropan-2-yl)cyclopropyl group. Kasai teaches these groups at the same position, in the same compound series, for the same use (MCH receptor antagonists).
The resulting compound reads on claim 12. In that compound, ring C = cyclopropyl and m = 1. R6 = C1-6 alkyl, or C1-6 alkyl substituted with -OR6b2 where R6b2 = H.
Note that an express suggestion to substitute one equivalent for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Also, replacing H with methyl is a homolog change, and homologs are prima facie obvious. See In re Wilder, 563 F.2d 457, 195 USPQ 426; MPEP § 2144.09. The applicant does not show any unusual and/or unexpected results.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER C SAWYER/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
