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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/2026 has been entered.
Election/Restrictions
Claims 2-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 10 and 22-24 have been examined on the merits.
Claim Rejections - 35 USC § 102 and 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
RE: Rejection of claims 10, 22, and 24 under 35 U.S.C. 102(a)(1)/102(a)(2) as
being anticipated by Bortz; as well as claims 10 and 22-24 over Bortz in view of Pannerec et al.
Traversal of rejections is based on Bortz allegedly requiring the use of two or more nutrients (i.e., not vitamin B12 alone) and being not enabled for administering adenosylcobalamin to treat, reduce the incidence of, and/or reduce the severity of a mitochondria-related disease or condition. Referring to the newly submitted Exhibits A, B, and C, applicant argues that challenges in treating metabolic syndrome are well-known to a skilled artisan and Bortz’s disclosure is allegedly insufficient to enable treatment of metabolic syndrome using adenosylcobalamin. Applicant further asserts that there would be no motivation for a person with ordinary skill in the art to combine the teachings of Pannerec et al. and Bortz.
Applicant’s traversal and Exhibits A-C have been fully considered but are found unpersuasive.
First, Bortz provides several embodiments of disclosed method and is not limited to using at two or more of the disclosed nutrients. The pharmaceutical composition being administered can comprise essential fatty acids, a cobalamin binding protein, choline, vitamin B12, OR combinations thereof (emphasis added; par. [0114]), which indicates that said pharmaceutical composition can comprise one of these nutrients as the sole component. Bortz also explicitly states that “The composition of the present disclosure can include specific amounts of vitamin B12, or oral administration, alone…” (par. [0056]). It is therefore respectfully submitted that one of the embodiments taught by Bortz entails orally administering a composition containing vitamin B12 only. And as discussed in the last office action, even if the cited prior art requires at least two nutrients in the pharmaceutical composition, the claims of the instant application do not prohibit administering other substances.
Second, although treatment of metabolic syndrome is indeed challenging as illustrated by the submitted Exhibits, it does not negate Bortz’s teachings despite not providing experimental evidence that the disclosed pharmaceutical composition is particularly effective in treating metabolic syndrome. According to MPEP § 2121, “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation”, and that when a cited prior art anticipates or makes obvious all elements of the claimed invention, it is presumed to be operable. Moreover, Botz teaches that vitamin B12 plays a crucial role in metabolism because it is an essential cofactor for enzymes that convert nutrients like fats and carbohydrates into cellular energy, it is involved in the methylation of homocysteine to methionine (which is the key substrate of the main methyl donor, S-adenosyl methionine, in single carbon metabolism), and it facilitates regulation of homocysteine thereby lowering oxidative stress and inflammation (par. [0065]-[0068], [0073]). Given the disclosed mechanism of action and teachings regarding how vitamin B12 can be used for oral administration, the cited prior art is considered to provide sufficient information for one with ordinary skill in the art to practice the claimed invention.
Lastly, a nutrient such as vitamin B12 can be provided by administering the nutrient itself or a source of said nutrient. Pannerec et al. is cited in the obviousness rejections to show support that the latter means is known in the art. Like Bortz, Pannerec et al. is directed to therapeutic use of compositions comprising vitamin B12. Although Pannerec et al. specifically aims to treat sarcopenia and frailty, it should be noted that these conditions are associated with metabolic syndrome since they are considered mitochondria-related disorders, characterized by mitochondrial dysfunction and reduced energy production. Thus contrary to applicant’s argument, a person with ordinary skill in the art would have reason to look at Pannerec et al. and apply its teachings to Bortz.
The rejections of record have therefore been maintained.
Maintained rejections
Claims 10, 22, and 24 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Bortz (Pub. No. US 2018/0161299 A1).
Bortz provides a pharmaceutical composition for mammalian consumption as well as a method of using said pharmaceutical composition. The pharmaceutical composition comprises essential fatty acids, cobalamin binding protein, vitamin B12 or a synthetic form thereof, and/or choline (Abstract; par. [0114]).
Vitamin B12 is a key vitamin in the normal functioning of every cell in the body and is involved in the metabolism of every cell including fatty acid metabolism (par. [0065]-[0068]). The form of vitamin B12 in the disclosed pharmaceutical composition can be selected from the group consisting of cyanocobalamin, methylcobalamin, hydroxocobalamin, and/or adenosylcobalamin (par. [0065]). It can be present in the amount of about 1 µg to about 9,000 µg (par. [0008]). In various exemplary embodiments, vitamin B12 amounts to 2.2-2.6 µg to 6.0-6.4 µg in the disclosed composition (par. [0102]).
To use the pharmaceutical composition, Bortz teaches administering to a subject in need thereof an effective amount of a combination of essential fatty acids, cobalamin binding protein, vitamin B12 or a synthetic form thereof, and/or choline (i.e., the disclosed pharmaceutical composition) in order to prevent and/or treat a condition like metabolic syndrome (par. [0103], [0114]; claims 17-18). One route for administration of the pharmaceutical composition is oral administration (par. [0099]).
Bortz’s method reads on the instant application’s method as follows:
Regarding claims 10 and 24: orally administering to a subject in need thereof an effective amount of the disclosed pharmaceutical composition comprising vitamin B12 or a synthetic form thereof (par. [0099]), wherein the vitamin B12 can be in the form of adenosylcobalamin (par. [0065]), is equivalent to “orally administering to an individual in need thereof an effective amount of adenosylcobalamin”.
Performing the method to prevent and/or treat a condition such as metabolic syndrome (par. [0114]; claims 17-18) satisfies “wherein the mitochondria-related disease or condition is selected from the group consisting of reduced metabolic rate, metabolic syndrome…”.
Bortz therefore anticipates claims 10 and 24.
Regarding claim 22: the disclosed vitamin B12 amounts of about 1-9,000 µg such as 2.2-2.6 µg to 6.0-6.4 µg in the exemplary embodiments of the disclosed pharmaceutical composition (par. [0103]), which can be taken daily (par. [0115]), fulfills “wherein the amount of adenosylcobalamin is from 1 µg to 2000 µg per day”.
Claim 10 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bortz (Pub. No. US 2018/0161299 A1) in view of Pannerec et al. (Pub. No. WO 2017/108419 A1).
Bortz’s teachings are set forth above and applied herein. Bortz is found to anticipate claims 10, 22, and 24.
The method of Bortz is comparable to the claim below:
Regarding claim 23: the adenosylcobalamin in the method of claim 10 is further required to be “in the form of a probiotic supplement comprising adenosylcobalamin- producing bacteria”.
Bortz is different from the instant claim in that it does not teach having adenosylcobalamin-producing bacteria in the disclosed pharmaceutical composition.
Nonetheless, it is known in the art that certain bacteria produce vitamin B12 like adenosylcobalamin and that such bacteria can be incorporated in a composition to provide vitamin B12. Pannerec et al., for example, teaches treating conditions characterized by age-related decline in muscle function and muscle mass like sarcopenia and frailty by orally administering a supplement comprising vitamin B12 or vitamin B12-producing bacteria (lines 14-15, page 6; lines 1-3 and 8-16, page 20). One with ordinary skill in the art would have thus incorporated vitamin B12-producing bacteria in the composition used in Bortz’s method of treatment and predict that a vitamin B12 like adenosylcobalamin would be successfully delivered when the composition it is a part of is orally administered to the patient.
Claim 23 is thus obvious over Bortz in view of Pannerec et al..
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.
RE: Double patenting rejections over US 10,758,560
Arguments against the double patenting rejections were not presented. Applicant states that a terminal disclaimer is premature at this stage of the prosecution and will consider the double patenting rejections when the claims are in condition for allowance.
Since none of the claims allowable, the rejections of record have been maintained.
Maintained rejections
Claims 10, 22, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,758,560 in view of Bortz (Pub. No. US 2018/0161299 A1); and claim 23 is rejected as being unpatentable over claims 1-6 of U.S. Patent No. 10,758,560 in view of Bortz (Pub. No. US 2018/0161299 A1) and Pannerec et al. (Pub. No. WO 2017/108419 A1).
The U.S. patent is directed to a method of maintaining or increasing muscle function and/or mass in an ageing subject over thirty years old, as well as a method of treating sarcopenia or frailty. Both methods comprise administering neuregulin-1 (NRG1) comprising the amino acid sequence of SEQ. ID. NO. 6 to the ageing subject.
Although the claims at issue are not identical, they are not patentably distinct from each other because the U.S. patent’s methods can further comprise administering vitamin B12 to said subject, wherein the vitamin B12 can be at least one of adenosylcobalamin or methylcobalamin. The embodiment of administering NRG1 and adenosylcobalamin to an ageing subject in order to treat frailty is analogous to the instant application’s method, which is directed to treating, reducing an incidence of, and/or reducing severity of a mitochondrial-related disease or condition including pre-frailty. Pre-frailty is a condition or state of high risk for development of frailty and characterized by weakness and slowness. One with ordinary skill in the art would have recognized that a treatment for frailty would be suitable for treatment of pre-frailty. Moreover, Borz teaches that administering a vitamin B12 like adenosylcobalamin in the amount of about 1-9,000 µg is useful for treating metabolic syndrome. It would have been obvious to perform the U.S. patent’s method by administering said amount of adenosylcobalamin to treat pre-frailty and metabolic syndrome.
Thus, claims 10, 22, and 24 are obvious over U.S. 10,758,560 in view of Bortz.
The U.S. patent differs from claim 23 in that it does not disclose the daily amount of adenosylcobalamin, nor that adenosylcobalamin is provided in the form of adenosylcobalamin-producing bacteria.
However, these limitations are obvious over Pannerec et al.. Pannerec et al. teaches orally administering vitamin B12 like adesnosylcobalamin in the amount of 250-1000 µg per day to treat frailty or age-related decline in muscle function and mass. Furthermore, Pannerec et al. teaches that the vitamin B12 can be given as a probiotic supplement comprising vitamin B12-producing bacteria. Accordingly, a person with ordinary skill in the art before the effective filing date of the claimed invention would have orally administered adenosylcobalamin in said amount and/or would have provided adenosylcobalamin in the form of a probiotic supplement comprising vitamin B12-producing bacteria to the subject. It can be predicted that such modification to the U.S. patent’s method would treat or reduce incidence/severity of pre-frailty and metabolic syndrome.
Claim 23 is therefore obvious over U.S. 10,758,560 in view of Bortz and Pannerec et al..
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651