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 Application
The Office Action is in response to the application filed May 21, 2024. Amended claims 2-25 are being examined on the merits herein.
Specification Objection – Title
Applicant is reminded of the proper content of the title of the invention. The title of the invention should be brief, but technically accurate and descriptive, preferably from two to seven words. See 37 CFR 1.72(a) and MPEP § 606. The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests identifying the compounds of Formula I as a method of mTOR enhancement.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following applications and patents.
US Patents:
US 12195463 B2- claims 1-14
US 12195462 B2- claims 1-37
US 11957791 B2- claims 1-17
US 12465570 B2- claims 1-22
US 11844757 B2- claims 1-22
US 11427587 B2-claims 1-14
US 11773095 B2-claims 1-10 and 17-21
US 12,023,331- claims 1-26
US 12173004 B2-claims 1, 2, and 10-24
US 10844061 B2-claims 1-8
US Patents (provisionally rejected because the patentably indistinct claims have not in fact been patented):
18/847,121 (US 20250101029 A1)-claims 1-11
18/703,145 (US 20240415832 A1)-claims 1-24
19/317,053 (US 20260053748 A1)-claims 1-24
18/320,173 (US 20230372336 A1) – claims 1-23
17/832,282 (US 2022/0296591)- 1,2, 5, 8-19, and 21
19/239,540 (US 20250312340 A1)- claims 17-21, 23, 24, and 27-40
US 20210093634 A1- claims
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a method of enhancing mTOR signaling comprising administering a compound of Formula I. The copending and patented claims above teach compounds of Formula I, but are silent on the mechanism of action, that is enhancing mTOR signaling. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). >In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id.< See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited patents and applications.
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 2, 8-15, 17-19, 21, and 23-24 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, by way of example, claim 2 recites the broad recitation mTOR, and the claim also recites “(e.g., mTORC1)…”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Similarly, claims 8-15, 17-19, 21, and 23-24 recite a broad limitation followed by a narrower statement of the range/limitation.
Amending the claims by deleting the terms (e.g., … or i.e., …) would obviate the rejection.
Conclusion
Claims 2-25 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR JAVANMARD whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
