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 .
Current Status of 18 / 528215
Claims 1-3 filed 2023 December 4 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities: the issued status of parent application 17 / 104771 should be properly noted within the CROSS-REFERENCE to RELATED APPLICATIONS section.
The text
“This application is a continuation of U.S. Application No. 17/104,771, filed November 25, 2020, which is a divisional of U.S. 16/443,298, filed June 17, 2019, now U.S. 10,980,784, which claims the benefit of U.S. Provisional App. No 62/68 5,666 filed on June 15, 2018, the contents of each are hereby incorporated by reference.”
should be amended to
--This application is a continuation of U.S. Application No. 17/104,771, filed November 25, 2020, now U.S. 11,944,605, which is a divisional of U.S. 16/443,298, filed June 17, 2019, now U.S. 10,980,784, which claims the benefit of U.S. Provisional App. No 62/68 5,666 filed on June 15, 2018, the contents of each are hereby incorporated by reference.--
Appropriate correction is required.
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 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 nonstatutory 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 nonstatutory 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 1 and 2 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10980784. Although the claims at issue are not identical, they are not patentably distinct from each other because the first compound of claim 2 of US 10980784 is encompassed by examined claims 1 and 2. Variable R1 of US 10980784 is (CH2CH2O)-CH2CH2OH in this compound.
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Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 11944605. Although the claims at issue are not identical, they are not patentably distinct from each other because compound I-29 is encompassed by examined claims 1 and 2. Compound I-29 is the same compound as the recited compound in examined claims 1 and 2.
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Even though claims 1 and 14 are drawn to a method of using a compound I-29, because applicants have possession of this compound (columns 87-88 of US 11944605).
Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company states the following:
Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see U.S. Patent No. SUN PHARMACEUTICAL v. ELI LILLY 85,563,165 (“’165 patent”), at [57], col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 l.49-col.108 l.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
When US 11944605 is combined with Sun, non-statutory double patenting is present because US 11944605 shows possession of a compound that is embraced by examined claims 1 and 2.
Conclusion
Claims 3 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: GRINFELD (Tetrahedron Letters, 1994, 35 (37), 6835-6838, cited in 2024 May 14 IDS) describes compounds 2a-c (page 6835). Compounds 2a and 2b do not anticipate or render obvious a compound of examined claims 1-3 because an O-[CH2CH2OH, CH2CH(OH)CH2OH, or CH2CH2OCH2CH2OCH2CH2OMe) is attached to the rapamycin ring. Compound I-90 of claim requires that the cyclohexyl ring be substituted with an OCH2CH2OMe group not an OMe group.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699