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 .
Claim Status
Claims 9-17, 19-21, and 24 are pending.
Claim 9, 21, and 24 are currently amended.
Claims 1-8, 18, and 22 were cancelled.
Claim 16 is withdrawn.
Claims 9-15, 17, 19-21, and 24 have been examined.
Priority
This application is a 371 of PCT/US2015/054862 filed on 10/09/2015,
PCT/US2015/054862 has PRO of 62062015 filed on 10/09/2014.
A metal chelator is first described in PCT/US2015/054862; thus, the prior art date of claims 15-17 is the effective filing date of PCT/US2015/054862 on 10/09/2015.
Withdrawn Objection and Rejection
All objection and Rejections of record are withdrawn because the cited prior art did not the compound of teach 7-keto dehydroepiandrosterone (7- keto DHEA).
New Ground of Rejection
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
1. Claims 9-10, 13-15, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lane (WO2004/093824 A2, previously cited 7/5/2024) in view of Hastings et al. (US 6,368,617 B1).
Claim 9 is drawn to a method for reducing heavy metal toxicity in a biological system in need thereof, comprising contacting said biological system with a composition comprising (a) L-cystine, (b) selenium source, (c) dehydroepiandrosterone (7-keto DHEA) and (d) the composition not including ethylenediaminetetraacetic acid (EDTA).
The preamble “for reducing heavy metal toxicity in a biological system” is an intended use of the composition. Prior art references teaching a method of administering a composition satisfying the limitations (a)-(d) read on claim 9.
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Lane teaches a method of providing nutritional supplementation to a patient in need (p7, para 2). Lane teaches the use of the composition comprising cystine and selenium to promote healing after surgery, burns, and chelates heavy metals (p12, 2nd last para) as well as protects against infection and promotes the immune system (p13, para 2) including glutamine supplements (p12, para 2), reading on contacting a biological system of a patient for reducing heavy metal toxicity. Lane shows nutritional supplementation composition comprising (a) L-cystine, and (b) a selenium source without EDTA as follows (p9, Table IIA.), reading on the limitations (a), (b), and (d) in claims 9. Lane teaches the composition further comprising coenzyme Q10 acting as an antioxidant to neutralize cell damaging molecules known as free radicals (P11, last para).
Lane did not teach the composition further comprising dehydroepiandrosterone (7- keto DHEA) to enhance the immune system.
Hastings et al. teach a dietary supplement comprising 7-keto dehydroepiandosterone (7-keto DHEA) and other ingredients for delivering antioxidants (e.g., coenzyme Q10 at Col 3, line 38-50) for retarding damage at the cellular level caused by the presence of free radicals and for promoting physiological health (Abstract). Hastings et al. further teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65). Because Hastings et al. teach beneficially combining 7-keto DHEA with an antioxidant of coenzyme Q10 (Col 3, line 38-50) in a dietary supplement comprising for retarding damage caused by free radicals and promoting physiological health and immune enhancement, one of ordinary skill in the art would have found it obvious to beneficially add Hastings’s 7-keto dehydroepiandosterone (7-keto DHEA) to Lane’s nutritional supplementation for reducing heavy metal toxicity, retarding damage caused by free radicals, and/or promoting the immune system against infection as taught by Lane in view of Hastings et al.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Lane’s nutritional supplement composition with Hastings’s teaching of adding 7-keto dehydroepiandosterone (7-keto DHEA) to a dietary supplement because (a) Lane teaches a method of providing nutritional supplementation comprising cystine, glutamine, coenzyme Q10, and selenium to a patient in need (p9, Table IIA) to chelate heavy metals (p12, 2nd last para) as well as to protect against infection and promote the immune system (p13, para 2) and (b) Hastings et al. teach beneficially combining 7-keto DHEA with an antioxidant of coenzyme Q10 (Col 3, line 38-50) in a dietary supplement comprising for retarding damage caused by free radicals and promoting physiological health and immune enhancement. The combination would have reasonable expectation of success because both references teach a dietary supplement comprising coenzyme Q10 as an antioxidant to neutralize free radicals and enhance immunity.
With respect to claim 10, Lane teaches a nutritional supplement comprising L-Cystine and L-Glutamine (p12, para 2), L-Glutamine reading on a glutamate source.
With respect to claim 13, Lane teaches the nutritional supplement for health of women and men (p4, para 3; p5, last para), reading on an organism.
With respect to claims 14-15, Lane teaches the use of the composition to promote healing after surgery and burns, chelates heavy metals, reading on a metal chelator, (p12, 2nd last para).
With respect to claim 19, Lane teaches Cystine supplementation also is useful for promoting chelates heavy metals (p12, 2nd last para). Although Lane does not specify heavy metals are xenobiotic heavy metal, it would be obvious to use the nutritional supplement taught by Lane in view of Hastings et al. to treat xenobiotic heavy metal toxicity as Lane teaches free radical destroyers and works best for Cystine in conjunction with Selenium and Vitamin E, regardless of the source of heavy metal toxicity.
With respect to claim 21, Lane teaches coenzyme Q10 (synonym of ubiquinone) in the nutritional supplement acts as an antioxidant to neutralize cell damaging molecules known as free radicals (p11, last para).
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
2. Claims 9-10, 13-15, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lane (WO2004/093824 A2, previously cited 7/5/2024) in view of Hastings et al. (US 6,368,617 B1) as applied to claims 9-10, 13-15, 19, 21 and further in view of Fischer et al. (Analyst. January 1998; 123:55–58, previously cited 11/6/2023).
Claim 17 is directed to a chelator for heavy metal toxicity.
Lane teaches a method administering a nutritional supplement comprising a heavy metal chelator for reducing heavy metal toxicity (p12, 2nd last para).
Lane in view of Hastings et al. did not specify a claimed heavy metal chelator.
Fischer et al. teach the use of chelating agents to modify lead uptake and lead toxicity
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(p55, col 1, Abstract). Fischer et al. show the chelating agent of EGTA and others can reduce lead-induced cytotoxicity with higher cell survival rate compared to lead/Pb alone (p56, Fig 2 shown as follows; p56, col 2, Discussion). Because Fischer et al. demonstrate EGTA is effective to reduce lead-induced toxicity in a dose-dependent manner, one of ordinary skill in the art would have found it obvious to beneficially add Fischer’s lead chelating agent (e.g., EGTA) to the antioxidant composition taught by Lane in view of Hastings et al. to chelate lead and reduce lead-induced toxicity, reading on claim 17.
With respect to claims 14-15 and 19-20, Fischer et al. suggest the use of a composition comprising a lead chelating agent (e.g., EGTA) to reduce xenobiotic lead-induced toxicity (p56, Fig 2; p56, col 2, Discussion). Applicant elected heavy metal species of lead in the interview dated 3/27/2019.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Lane in view of Hastings et al. with (ii) Fischer’s lead chelating agents because (a) Lane in view of Hastings et al. teach a method of administering a nutritional supplement comprising antioxidants to promote healing after surgery and burns, and chelates heavy metals (p12, 2nd last para) and (b) Fischer et al. show lead chelating agent of EGTA is effective to reduce lead-induced toxicity at a dose-dependent manner (p56, Fig 2). The combination would have reasonable expectation of success because both Lane and Fischer et al. teach the use of a composition to chelate heavy metals.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
3. Claims 9-10, 11-12, 13-15, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Hastings et al. as applied to claims 9-10, 13-15, 19, 21 and further in view of Crum (US 2005/0202521 A1, previously cited 7/25/2022) and Yeh et al. (Journal of Functional Foods I. 2009: 23-32, previously cited 7/25/2022).
Claim 11 is drawn to selenium source is selenocysteine or selenomethionine.
Claim 12 is drawn to the composition further comprises a metallothionein or a fragment thereof.
Lane in view of Hastings et al. teach a method of administering an antioxidant composition comprising selenium for reducing heavy metal toxicity in a patient as applied to claims 9-10, 13-15, 19, and 21.
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Lane in view of Hastings et al. do not specify (i) the selenium source as selenocysteine or selenomethionine or (ii) the composition further comprising a metallothionein or a fragment thereof.
Crum teaches a composition for antioxidant therapy [Abstract, 0012, 0136], including heavy metal-induced nephrotoxicity [0003]. Crum shows an antioxidant composition comprising cystine, glutamic acid, and a selenium source of selenium methionine above [0332], reading on claim 11.
Yeh et al. teach Metallothionein (MT) is a primary antioxidant enzyme involved in the metabolism and detoxification of heavy metal (Abstract; p25, col 2, Metallothioneins and chemoprevention). Thus, one of ordinary skill in the art would have found it obvious to add Metallothionein (MT) as an antioxidant enzyme in the antioxidant composition taught by Lane in view of Hastings et al. for the same purpose of making an antioxidant composition, reading on claim 12.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Lane in view of Hastings et al. with (ii) Crum’s selenium source because (a) Lane in view of Hastings et al. teach a method of administering an antioxidant composition comprising cystine and selenium for reducing heavy metal toxicity in a patient, (b) Crum teaches a beneficial combination of cystine and selenium methionine in a composition [0332] for antioxidant therapy [Abstract, 0012, 0136] including heavy metal-induced nephrotoxicity [0003]. The combination would have reasonable expectation of success because both Lane and Crum teach the use of a composition comprising cystine and selenium for reducing heavy metal induced toxicity.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Lane in view of Hastings et al. of Crum with (ii) Yeh’s Metallothionein because (a) Lane in view of Hastings et al. of Crum teach a method of administering an antioxidant composition to reduce heavy metal toxicity and (b) Yeh et al. teach Metallothionein (MT) is a primary antioxidant enzyme involved in the metabolism and detoxification of heavy metal (Abstract; p25, col 2, Metallothioneins and chemoprevention). The combination would have reasonable expectation of success because all Lane, Crum, and Yeh teach reduction of heavy metal toxicity.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
4. Claims 9-10, 13-15, 19, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Hastings et al. as applied to claims 9-10, 13-15, 19, 21 and further in view of Zeana (Abstract of Rom J Intern Med. 1999 Jan-Mar;37(1):91-7, previously cited 4/16/2025).
Claim 24 is drawn to the composition further comprising magnesium orotate
Lane in view of Hastings et al. teach a method of administering an antioxidant composition toa patient for reducing heavy metal toxicity in a patient as applied to claims 9-10, 13-15, 19, and 21.
Lane in view of Hastings et al. do not teach the composition further comprising magnesium orotate.
Zeana teaches magnesium orotate in myocardial and neuronal protection. Zeana teaches aggressive factors mainly act by free radicals injury and increase in cytosolic calcium level. Magnesium orotate molecule includes two synergic protective components: orotic acid and magnesium. Moreover, the orotic acid behaves as a transporter, carrying magnesium into the cells. The antioxidation protective effect of the orotic acid is mainly due to the pirimidinic bases that favor and increased synthesis of enzymes which act as free radical scavengers. Because (a) Lane teaches coenzyme Q10 (synonym of ubiquinone) acts as an antioxidant to neutralize cell damaging molecules known as free radicals (p11, last para) and selenium is a part of antioxidant enzymes important for heart function (p16, para 1) in a nutritional supplement for women and men, and (b) Zeana teaches magnesium orotate molecule beneficially includes two synergic protective components: orotic acid and magnesium to increase synthesis of enzymes which act as free radical scavengers for myocardial (heart muscle) and neuronal protection (Abstract), one of ordinary skill in the art would have found it obvious to beneficially combine Zeana’s magnesium orotate with Lane’s antioxidant of coenzyme Q10 (synonym of ubiquinone) and selenium as a part of antioxidant enzymes beneficial for heart function in a nutritional supplement and for the body health of both women and men (p4, para 3; p5, last para), reading on claim 24.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to beneficially combine (i) the nutritional supplement taught by Lane in view of Hastings et al. with (ii) Zeana’s magnesium orotate because (a) Lane in view of Hastings et al. teach a nutritional supplement comprising antioxidants of coenzyme Q10 and selenium (a part of antioxidant enzymes) for health of women and men (See Lane p4, para 3; p5, last para), and (b) Zeana teaches magnesium orotate molecule includes two synergic protective components: orotic acid and magnesium able to increase synthesis of free radical scavenger enzymes with antioxidant activity (Abstract). The combination would have reasonable expectation of success because both references teach magnesium is beneficial for human health (Lane p4, para 3; p5, last para and Zeana’s abstract).
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
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 9-10, 11-12, 13-15, 19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1of U.S. Patent No. 12,220,393 B2 (the ‘393 patent) in view of Lane (WO2004/093824 A2, previously cited 7/5/2024) in view of Lane, Hastings et al. Crum, and Yeh et al.
Claim 1 of the ‘393 patent disclosed a composition comprising L-cystine, a glutamate source selected from the group consisting of glutamine and glutamic acid, and a selenium source.
Claim 1 of the ‘393 patent did not disclose the composition further comprising dehydroepiandrosterone (7-keto DHEA) for reducing heavy metal toxicity.
The relevancy of Lane in view of Hastings et al., Crum, and Yeh et al. as applied to claims 9-10, 11-12, 13-15, 19, and 21 described above not repeated here.
Because Lane in view of Hastings et al., Crum, and Yeh et al. teach beneficially combine L-cystine, glutamate source (glutamate/glutamine), and a selenium source without EDTA as taught by claim 1 of the ‘393 patent with Hastings’s 7-keto dehydroepiandosterone (7-keto DHEA) to chelate/reduce heavy metal toxicity and promote the immune system against infection, one of ordinary skill in the art would have found it obvious to beneficially combine the composition in claim 1 of the ‘393 patent with Lane I in view of Hastings et al., Crum and Yeh et al.
Thus, claim 1 of the ‘393 patent in view of Lane, Hastings et al., Crum, and Yeh et al. are obvious to the instant claims 9-10, 11-12, 13-15, 19, and 21.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
Claims 9-11, 13-15, 19, 21, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of copending Application No. 18/839,218 (the ‘218 application, 8/16/2024) in view of Lane, Hastings et al., and Zeana.
Claims 1 and 13 of the ‘218 application disclosed a composition comprising glycine, L-glutamine, L-cystine, coenzyme Q10, and selenomethionine.
Claims 1 and 13 of the ‘218 application did not disclose the composition further comprising dehydroepiandrosterone (7-keto DHEA).
The relevancy of Lane in view of Hastings et al. and Zeana as applied to claims 9-10, 13-15, 19, 21, and 24 described above not repeated here.
Because Lane in view of Hastings et al. and Zeana teach beneficially combine L-cystine, glutamate source (glutamate/glutamine), and a selenium source without EDTA as taught by claims 1 and 13 of the ‘218 application with Hastings’s 7-keto dehydroepiandosterone (7-keto DHEA) to chelate/reduce heavy metal toxicity and promote the immune system against infection, one of ordinary skill in the art would have found it obvious to beneficially combine the composition taught by claims 1 and 13 of the ‘218 application with Lane in view of Hastings et al., and Zeana.
Thus, claims 1 and 13 of the ‘218 application in view of Lane, Hastings et al. and Zeana are obvious to the instant claims 9-10, 13-15, 19, and 24.
Claims 1 and 13 of the ‘218 application disclosed the selenium source as selenomethionine, satisfying the instant claim 11.
Claims 1 and 13 of the ‘218 application disclosed the composition comprising coenzyme Q10 (a synonym of ubiquinone), further satisfying the instant claim 21.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
Claims 9-11, 13-15, 19, 21, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of copending Application No. 18/839,218 (the ‘218 application, 8/16/2024) in view of Lane, Hastings et al., and Zeana.
Claims 1 and 12 of the ‘225 application disclosed a composition comprising glycine, L-glutamine, L-cystine, coenzyme Q10, and selenomethionine.
Claims 1 and 12 of the ‘225 application did not disclose the composition further comprising dehydroepiandrosterone (7-keto DHEA).
Because Lane in view of Hastings et al. and Zeana teach beneficially combine L-cystine, glutamate source (glutamate/glutamine), and a selenium source without EDTA as taught by claims 1 and 12 of the ‘225 application with Hastings’s 7-keto dehydroepiandosterone (7-keto DHEA) to chelate/reduce heavy metal toxicity and promote the immune system against infection, one of ordinary skill in the art would have found it obvious to beneficially combine the composition taught by claims 1 and 12 of the ‘225 application with Lane in view of Hastings et al., and Zeana.
Thus, claims 1 and 12 of the ‘225 application in view of Lane and Zeana are obvious to the instant claims 9-10, 13-15, 19, 21-22, and 24.
Claims 1 and 12 of the ‘225 application disclosed the selenium source as selenomethionine, satisfying the instant claim 11.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
Claims 9-11, 13-15, 19, 21, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 18/002,880 (the ‘880 application, 12/22/2022) in view of Lane, Hastings et al., and Zeana.
Claims 1 and 11 of the ‘880 application disclosed a composition comprising a glycine, an L-glutamate source, L-cystine, L-seleno-methionine and coenzyme Q10 (CoQ10).
Claims 1 and 11 of the ‘880 application did not disclose the composition further comprising dehydroepiandrosterone (7-keto DHEA).
Because Lane in view of Hastings et al. and Zeana teach beneficially combine L-cystine, glutamate source (glutamate/glutamine), and a selenium source without EDTA as taught by claims 1 and 11 of the ‘880 application with Hastings’s 7-keto dehydroepiandosterone (7-keto DHEA) to chelate/reduce heavy metal toxicity and promote the immune system against infection, one of ordinary skill in the art would have found it obvious to beneficially combine the composition taught by claims 1 and 11 of the ‘880 application with Lane in view of Hastings et al., and Zeana.
Thus, claims 1 and 11 of the ‘880 application in view of Lane, Hastings et al., and Zeana are obvious to the instant claims 9-10, 13-15, 19, 21, and 24.
Claim 11 of the ‘880 application disclosed the selenium source as selenomethionine, satisfying the instant claim 11.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive because the argument does not apply to the new ground of rejection based on Lane in view of Hastings et al. described above. In particular, Hastings et al. teach 7-keto DHEA having therapeutic applications in immune modulation, immune enhancement through T-cell upregulation known in the art (Col 1, line 55-65).
Conclusion
No claim is allowed.
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 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.
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/J.L/Examiner, Art Unit 1658 30-December-2025
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654