DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 (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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 114, 115, 122, 123, 125, 126, 128-137 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bialonska et al (J. Agric. Food Chem 2009, 57, 10181-10186) in view of Eisenberg et al (Nature Cell Biology, 2009, 11(11), 1305-1314).
Bialonska teaches health benefits of Pomegranate metabolites Urolithins A, B and C specifically their antioxidant activity (Table 1, page 10183). Bialonska teaches that cellular injury caused by oxidative stress has been associated with aging and various other clinical conditions.
While Biolinska teaches Urolithins as having antioxidant properties, there is no teaching directed to combination of spermidine and urolithins.
Eisenberg teaches activity of spermidine in induction of autophagy and promotion of longevity (abstract).
Since autophagy, longevity and reduction in oxidative stress are all processes that are desired for healthy aging, a skilled artisan would have found it obvious to prepare a composition comprising urolithins (including Urolithin A) and spermidine and administer to a subject in need of improvement in longevity and healthy aging with an expectation that the composition would find utility in promoting healthy aging in a subject by reducing oxidative stress and improving autophagy. The combination renders obvious the currently claimed method because it renders obvious administration of the claimed combination (Urolithin A and spermidine) to the claimed subject population (subjects in need of improvement in autophagy).
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 114, 115, 122, 123, 125, 126, 128-137 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,020,373 in view of Chen et al (Aging Cell, 2011, 10(5) 908-911; abstract).
Claims of the ‘373 patent are directed to a method of improving autophagy comprising administering Urolithin A.
Claims of the ‘373 patent do not recite a composition comprising urolithin A and an additional compound selected from rapamycin, resveratrol metformin and spermidine. However, in the summary, Chen teaches that rapamycin, resveratrol metformin and spermidine are longevity promoting compounds. A person of ordinary skill in the art would have fount is obvious to combine urolithin A with rapamycin, resveratrol metformin or spermidine and administer the composition in the method of the ‘373 patent. Improvement in autophagy by urolithin A promotes longevity. Since the other 4 compounds also promote longevity, the combination is obvious because all the components promote the same effect. It would be obvious to prepare a composition comprising all of the components to be administered. Notably, spermidine is described in Chen as autophagy promoter.
Claims 114, 115, 122, 123, 125, 126, 128-137 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,931,336 in view of Chen et al (Aging Cell, 2011, 10(5) 908-911; abstract).
Claims of the ‘336 patent are directed to a method of treating negative consequences linked to aging comprising administering Urolithin A.
Claims of the ‘373 patent do not recite a composition comprising urolithin A and an additional compound selected from rapamycin, resveratrol metformin and spermidine. However, in the summary, Chen teaches that spermidine is a longevity promoting compound. A person of ordinary skill in the art would have fount is obvious to combine urolithin A with spermidine and administer the composition in the method of the ‘373 patent. Treatment of negative consequences due to aging and promoting longevity refer to the same activity which is delaying death. Since the other 4 compounds also promote longevity, the combination is obvious because all the components promote the same effect. It would be obvious to prepare a composition comprising all of the components to be administered.
Claims 114, 115, 122, 123, 125, 126, 128-137 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,576,065). Claims of the ‘065 patent are directed to a composition comprising urolithin A and spermidine (claim 1) formulated for administration to subjects (claims 3-16). A skilled artisan would have found it obvious to administer the claimed composition to a subject. The current claims limit the subject population to those in need of improvement or increase in autophagy. Any human subject would benefit from improvement in autophagy, therefore administration of the composition to any human subject would meet the limitations of current claims. Furthermore, the description of ‘065 patent describes administration of the claimed composition to human subjects. It would be obvious to practice a method of administering the composition of ‘065 to human subjects because it is the sole use described in the spesification.
Claims 114, 115, 122, 123, 125, 126, 128-137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 132-137 of copending Application No. 18/205,305 (reference application) in view of Chen et al (Aging Cell, 2011, 10(5) 908-911; abstract). Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 132 of the ‘305 application are directed to a method of treating a skin inflammation comprising administration of Urolithin A and at least one other agent wherein the treatment improves autophagy. Chen teaches that spermidine improved autophagy. It would have been obvious for a person skilled in the art to prepare a single composition comprising Urolithin A and spermidine and to administer the resulting composition to a subject, thereby arriving at the currently claimed invention. Since both Urolithin A and spermidine are described in the art as improving autophagy, there is expectation that the combination will also achieve the result of the ‘305 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 114, 115, 122, 123, 125, 126, 128-137 are pending
Claims 114, 115, 122, 123, 125, 126, 128-137 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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