DETAILED ACTION
This action is in response to Applicant’s submission dated July 6, 2023, in which Applicant amended the specification to correct clerical errors.
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 .
Information Disclosure Statement
The references contained in the IDS dated June 27, 2023 are made of record.
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 92 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 92 is inconsistent with general principles of chemistry regarding valency in that it should be -C(=O)-Rc3. The Rc4 is superfluous and needs to be deleted from the claim to comply with valency requirement of carbon. The anticipation rejection, infra, assumes this correction.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 87-106 are rejected over claims 162-181 of co-pending Application No. 18/259,716, which published as US 2024/0108633. Specifically, dependent claim 165 of co-pending '716, which is drawn to a method of preventing or treating a cutaneous disease or disorder (i.e. a skin disease or disorder) associated with an antitumor agent comprising administering a JAK inhibitor such as compound I-2, which is delgocitinib (JT-052) anticipates instant claims 87-93. Additionally, dependent claims 172 (renders instant claims 94-95 obvious), 173 (renders instant claim 99 obvious), 174 (renders instant claim 100 obvious), 175 (renders instant claim 101 obvious), 176 (renders instant claim 102 obvious), 177 (renders instant claims 97-98 and 103 obvious), 178 (renders instant claims 94-96 obvious), 179 (renders instant claim 104 obvious), 180 (renders instant claim 105 obvious), and 181 (renders instant claim 106 obvious) of co-pending '716 render instant claims obvious as indicated in the aforementioned parentheticals, because the cited conflicting claims recite the same limitations as the cited instant claims or a sub-genus thereof. Moreover, it would have been obvious to administer any of the specific JAK inhibitors recited in dependent claim 165 of co-pending '716 in the method of claims 172-181 of co-pending '716 with a reasonable expectation of success to achieve the function these compounds are indicated as being suitable.
This obviousness-type double patenting rejection is provisional because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932