DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 11/13/2025 wherein claims 1 and 3 have been amended, claims 5-8 have been cancelled and claims 9-10 have been added.
Claims 1, 3, 9 and 10 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 11/13/2025 overcomes the rejection of claim 1, 3 and 5-8 made under 35 USC 102(a)(1) over Ohkawa et al. (US2003/0211132), evidenced by Palm et al. (J Undergraduate Chemistry Research, 2010) and Merriam Webster:intragastric. This rejection has been withdrawn as Ohkawa does not disclose a composition in the form of a tablet, capsule or lozenge wherein the light isotope is in the form of a sulfate or citrate salt. It is noted that claims 5-8 have been cancelled
Applicant’s amendments filed 11/13/2025 overcomes the rejection of claims 1, 3 and 5-8 made under 35 USC 102(a)(1) over Turnland et al. (AM J Clin Nutr, 2005, 81, 822-888). This rejection has been withdrawn as Turnland does not disclose their composition as being in the form of a tablet, capsule or lozenge. It is noted that claims 5-8 have been cancelled.
Applicant’s amendments filed 11/13/2025 overcomes the rejection of claims 1, 3 and 5-8 made under 35 USC 103 over Bad’in et al. (RU2101982; translation provided) in view Turnland et al. (Am J Clin Nutr, 2005, 81, 822-888), evidenced by Merriam-Webster: intragastric. This rejection has been withdrawn as Bad’in does not teach their composition as being in the form of a tablet, capsule or lozenge. It is noted that claims 5-8 have been cancelled
New Rejections, Necessitated by Amendment
Claim Rejections - 35 USC § 102
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.
Claims 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bad’in et al. (RU2101982; translation provided; of record).
Bad’in is directed to a curative food material comprising at least one component enriched by adding light stable isotopes such as Cu-63, Ca-40 and Ni-58 (see page 5). Combinations of two or more of the light stable isotopes would be well within the purview of an ordinarily skilled person as Bad’in states that their composition is to comprise “at least one” light stable isotopes (see instant claims 9 and 10). By nature of the light isotope being enriched it would necessarily result in a composition enriched to exceed its natural isotopic ratio.
Administration of the light isotope enriched food product is taught to be preventative nutrition and intended to treat certain diseases which may benefit from administration of light isotopes (see pages 1 and 3). For instance, it is taught that the copper light isotope increases the efficiency of the enzymes based on it and thus affects the improvement of the body’s vital functions (see page 3). The light isotopes are to be purified/isolated from other isotopes via centrifugation (see page 4). Thus, the method of administering Bad’in’s composition would result in the treatment of degenerative disease.
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 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 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.
Claims 1, 3, 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bad’in et al. (RU2101982; translation provided; of record) in view of Turnland et al. (Am J Clin Nutr, 2005, 81, 822-888; of record) and Ohkawa (US 2003/0211132; of record).
Bad’in is directed to a curative food material comprising at least one component enriched by adding light stable isotopes such as Cu-63, Ca-40 and Ni-58 (see page 5). Combinations of these isotopes would be well within the purview of an ordinarily skilled person (see instant claims 9 and 10). The light isotope may be presented as a metal salt such as citrate (see page 5). Methods of administering the light isotope compositions are envisaged such as by administering as a food (see page 2). The food material used to deliver the light isotope is considered to be ‘pharmaceutically acceptable excipients’ as require by instant claims 1 and 3. Administration of the light isotope enriched food product is taught to be preventative nutrition and intended to treat certain diseases which may benefit from administration of light isotopes (see pages 1 and 3). For instance, it is taught that the copper light isotope increases the efficiency of the enzymes based on it and thus affects the improvement of the body’s vital functions (see page 3). The light isotopes are to be purified/isolated from other isotopes via centrifugation (see page 4).
Bad’in fails to teach the Cu-63 enriched copper being at least about 95.16% Cu-63, the Ni-58 enriched nickel being 90.4% Ni-58 and/or the Ca-40 enriched calcium being 98.9% Ca-40.
Turnland teaches administering copper enriched with the light isotope Cu-63 to subjects by means of light isotope enriched liquid wherein the copper is in the form of a sulfate salt (see page 823) so as to determine the biological fate of copper post consumption. The copper is enriched to 99.89% Cu-63 (see page 824) (see instant claims 1 and 3). It is taught that modulating the copper administered to a subject is important in controlling conditions such as Wilson disease, childhood cirrhosis and biliary cirrhosis (see page 827). The conditions described by Turnland are understood to broadly read on ‘degenerative disease’ as recited by the claims 1 and 6. Thus, it would have been obvious to modify Bad’in’s teaching such that their composition/method included Cu-63 enriched copper contain at least 95.6% Cu-63 given that a) Turnland teaches that Cu-63 can be enriched to 99.89% and b) Bad’in desires to enrich light isotopes in the teaching and so using the purest source of the light isotope to achieve that enrichment would have been an obvious and desirable modification. See MPEP 2143(I)(A) which states that combining prior art elements according to known methods to yield predictable results is indicative of obviousness.
Bad’in fails to teach the form of the composition as being a tablet, a capsule or a lozenge.
Ohkawa, like Bad’in, is directed to a nutritional supplement for providing light isotope K-39 by reducing the naturally occurring radioactive potassium isotope K-40 resulting such that the product is substantially free of the K-40 isotope. Removing K-40 from the food product results in a product that is free of the potassium isotope responsible for emitting harmful ionizing radiation. The net result of removing K-40 from the food product is a food product that comprises potassium that is essentially entirely K-39 (see [0010] and claim 1). Ohkawa states that their product is free of K-40 and can contain only K-39 (see [0018]). A composition according to Ohkawa would comprise the K-39 isotope is enriched to an amount of at least 97.9% of the potassium source as a composition comprising K-39 as the only potassium source would result in K-39 being 100% of the potassium source (see instant claims 1 and 3).
The K-39 enriched food product of Ohkawa may be in the form of a liquid (see [0012, 0013]) or a tablet (see claim 7) (see instant claims 1 and 3). It is noted that these generic compositions, e.g. liquid product, a drink, mineral tablet, would necessarily include pharmaceutically acceptable excipients (see instant claims 1 and 3).
Regarding the form of Bad’in’s light isotope nutritional supplement, it would have been obvious to modify the teaching such that the composition took the form of a tablet. The use of a known technique (e.g. providing a light isotope as a tableted dosage form) to improve similar products (Bad’in’s generic light isotope nutritional composition) in the same way is supportive of obviousness. See MPEP 2143(I)(C).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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