DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 135-154 are currently pending.
Priority
This application is a CON of 16/441,894 (06/14/2019 ABN)
16/441,894 is a CON of 16/148,731 (10/01/2018 ABN)
16/148,731 is a CON of 15/590,107 (05/09/2017 ABN)
15/590,107 is a CON of 14/129,648 (04/09/2014 ABN)
14/129,648 is a 371 of PCT/US2012/033571 (04/13/2012)
which claims benefit of 61/502,588 (06/29/2011).
Claim Interpretation
Independent claims 135, 149, and 151 have the language “consisting essentially of” without a clear indication as to how this limits the basic and novel characteristics of the claimed invention. As stated in MPEP 2111.03 III:
For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (“PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.”). See also AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41, 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003) (Applicant’s statement in the specification that “silicon contents in the coating metal should not exceed about 0.5% by weight” along with a discussion of the deleterious effects of silicon provided basis to conclude that silicon in excess of 0.5% by weight would materially alter the basic and novel properties of the invention. Thus, “consisting essentially of” as recited in the preamble was interpreted to permit no more than 0.5% by weight of silicon in the aluminum coating.); In re Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ 893, 895-96 (CCPA 1963). If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. & Inter. 1989) (“Although ‘consisting essentially of’ is typically used and defined in the context of compositions of matter, we find nothing intrinsically wrong with the use of such language as a modifier of method steps. . . [rendering] the claim open only for the inclusion of steps which do not materially affect the basic and novel characteristics of the claimed method. To determine the steps included versus excluded the claim must be read in light of the specification. . . . [I]t is an applicant’s burden to establish that a step practiced in a prior art method is excluded from his claims by ‘consisting essentially of’ language.”).
Applicant has not provided any description or explanation as to how the prior art is excluded, thus Applicant has not met their “burden to establish that a step practiced in a prior art method is excluded from his claims by ‘consisting essentially of’ language.” In addition, Applicant has not pointed to and Examiner could not locate a “clear indication in the specification or claims of what the basic and novel characteristics actually are,” thus “consisting essentially of” is construed as equivalent to “comprising” as per MPEP 2111.03.
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.
Claims 138-139 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 138 recites the language “wherein the method provides the benefits of diet or exercise”, which does not provide a clear indication of the scope of the claim both because of the unclear “provides the benefits of” and how the method steps are limited by the language. The language also does not set forth well-defined boundaries of the invention and only states a problem solved or a result obtained. Furthermore, one of ordinary skill in the art would not know from the claim terms what structure or steps are encompassed by the claim. Thus, the language is ambiguous as to the metes and bounds of the claim. Thus, the claim and those that depend therefrom are indefinite.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 135-154 are rejected under 35 U.S.C. 103(a) as being unpatentable over Milburn et al. (US20060229265) in view of Alvarez et al. (US 20140065099, priority to 2011-02-15).
Milburn teaches methods of treating disease, including increasing the lifespan of a cell, by administering the sirtuin-modulating compound nicotinamide riboside (“NR”) (Title, Abstract, [0007]; [0181][-0182]; [0205]) in combination with piceatannol ([0339]) orally ([0461]-[0463]).
Regarding claim 135, Milburn does not specifically teach “increasing cellular NAD+”
Alvarez teaches increasing cellular NAD+ by administering NR (claim 11: “A method of increasing the concentration of NAD+ within the mitochondria comprising contacting mitrocondria with nicotinamide riboside (NR).”).
One of ordinary skill in the art following the teaching of Milburn would have considered formulating an oral composition of NR and piceatannol as the combination was suggested by Milburn. In addition, one of ordinary skill in the art would have known from Alvarez that the administration would increase cellular NAD+. Thus, one of ordinary skill in the art would have reasonably considered selecting NR and testing combinations with agents known to have the desired effect such as picatannol as specifically suggested and arrive at the claimed invention. One of ordinary skill in the art would have had a reasonable expectation of success because Milburn and Alvarez teach that combinations with NR are sirtuin modulators and known to increase NAD. In addition, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Like in Kerkhoven, both compounds are taught as useful for treating disease and increasing the lifespan of a cell such that one of ordinary skill in the art would combine them for the same purpose and arrive at the claimed invention.
Regarding claim 136-137, 141, 148, wherein the composition is a food supplement, a component of a multi-vitamin, or formulated as a capsule, Alvarez demonstrated administration as a food supplement in Example 1 ([0100]) and “Oral compositions” with “an edible carrier” ([0090]) which reasonably suggests administration as a food supplement or a multi-vitamin or a “capsule” ([0090]) to one of ordinary skill in the art such that they would arrive at the claimed invention.
Regarding claims 138-139, wherein the method provides the benefits of diet or exercise or preventing various conditions, Milburn teaches the combination treats obesity (Abstract).
Regarding claims 140, 142-147, Milburn teaches treatment of coronary heart disease, osteoporosis ([0198]).
Regarding claim 149 to a method of increasing mitochondrial function of a cell in a subject, as with claim 135 Milburn in view of Alvarez renders the claim obvious also because Alvarez specifically teaches the same method of increasing mitochondrial function (claim 12, [0191]).
Regarding claim 150, wherein the composition is a food supplement, a component of a multi-vitamin, or formulated as a capsule, Alvarez demonstrated administration as a food supplement in Example 1 ([0100]) and “Oral compositions” with “an edible carrier” ([0090]) which reasonably suggests administration as a food supplement or a multi-vitamin or a “capsule” ([0090]) to one of ordinary skill in the art such that they would arrive at the claimed invention.
Regarding claims 151-152 to a composition, as with claim 135 Milburn in view of Alvarez renders the claim obvious because formulating the composition would be required to perform the obvious method including with a carrier.
Regarding claim 153-154 to a method of increasing sirtuin activity in a cell, Milburn teaches the same method (Title, Abstract, [0007]; [0181][-0182]; [0205]) and as with claims 151-152 would have been obvious to one of ordinary skill in the art.
Thus, the claims are rendered prima facie obvious.
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 135-154 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9597347. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method of treating disorders in a subject by administering NR and in view of Milburn et al. (US20060229265) in view of Alvarez et al. (US 20140065099, priority to 2011-02-15) as detailed above renders the instant claims prima facie obvious.
Conclusion
The claims are not in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached on 9am - 6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
Prosecution Insights