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 .
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.
Current Status of 18/558,351
This Office Action is responsive to the amended claims of 31 October 2023.
Claims 1-14 have been examined on the merits. Claims 1-3, 5-6, 8-9, and 12-14 are currently amended. Claims 4, 7, and 10-11 are original.
Priority
The effective filing date is 6 May 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 31 October 2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 9-11 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.
Claim 9 contains the limitation/word “includes”. This renders the metes and bounds of claim 9 undefined (hence rendering claim 9 indefinite) since the artisan does not know if the limitations following “including” are merely exemplary or are required limitations for the claim.
Examiner recommends revising claim 9 to: -- obtaining crystals further comprises [[includes]] additionally introducing a second crystallization solvent -- to render moot this indefiniteness rejection.
Claims 10-11, which also contain “includes” are similarly rejected as indefinite. The Examiner recommends a similar strategy of using -- further comprises -- in place of “[[includes]]”, as above, to render moot the indefiniteness rejection against claims 10-11.
Conclusion
Claims 9-11 are not presently allowable as written.
Claims 1-8 and 12-14 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates the polymorph of instant claim 1.
The reference MacNEIL (MacNeil, Douglas, et. al. “The role of melanocortins in body weight regulation: opportunities for the treatment of obesity.” European J. of Pharmacology. (2002), Vol. 450, pp. 93-109, provided by Applicants – see IDS of 31 October 2023), discloses the compound:
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(page 101).
However, MacNEIL reference is a close art but not a prior art reference since it does not teach, suggest, or anticipate the polymorphs of the compounds of genus formula I from instant claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D 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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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625