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 .
Current Status of 17/701,349
Some of the rejections of record have been maintained below.
This Office Action is responsive to the amended claims of 10/10/2025.
Claims 1-11, 13-14, 16-22, and 25-35 have been examined.
Election/Restrictions
Applicants elected a) yohimbine and catechins; b) L-carnitine and taurine; c) alpha-GPC; and d) Garcinia cambogia.
Examiner had searched a) yohimbine; b) L-carnitine; c) alpha-GPC; and d) Garcinia cambogia as “Applicants’ elected species”. The Markush Search has not been extended.
Priority
This application claims priority to US provisional 63/164,220, filed 3/22/2021.
The instant claims find support from the US provisional application. Therefore, the effective filing date is 3/22/2021.
There is also a PCT/US22/21384.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/14/2025 and 10/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicants’ claim amendments and Remarks of 10/10/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
The anticipatory rejections for independent claims 1, 13, and 21 (and their respective dependent claims) are withdrawn because applicants amended claims 1, 13, and 21. Claims 22-23 are now canceled.
The anticipatory rejection for claim 16 is maintained. Song does not have to explicitly disclose the effect of paraxanthine on swagger; properties of chemicals (increasing swagger) are inherent to their compounds. See paragraph 22 of the Nonfinal Rejection of 4/10/2025.
In regard to the 103 rejection over SONG as evidenced by Konopelniuk, this rejection is maintained and updated below. Applicants have not addressed the substance of the obviousness rejection, and instead have relied on claim amendments, which are obvious. The claims have been amended to narrow the dosage and to administer the composition to a human. NAIR (cited below) teaches a simple practice guide for dose conversion between animals and humans and teaches to convert a rat dose (in mg/kg) to a human equivalent dose (in mg/kg), one multiplies the animal dose by 0.162. So the rat dose of paraxanthine (15mg/mg) taught by Song would have a human equivalent dose of 15mg/kg *0.162= 2.43 mg/kg. Assuming a 60 kg human, this would be a dose of 145.8 mg (which would fall within the instant range). Furthermore, paraxanthine is a major known metabolite of caffeine and is known to be administered to humans (as part of caffeine) (Mandal page 1).
In regard to the double patenting rejection, this rejection is maintained. Rejections cannot be held in abeyance.
Response to Amendments
Claim Rejections - 35 USC § 102- Maintained
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.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by: SONG (Song et al., “Effect of Paraxanthine on Body Fat Reduction and Insulin Sensitivity in Monosodiun Glutamate-Obese Rats”, Journal of Yeungnam Medical Science, 2007) as evidenced by Konopelniuk (Konopelniuk et al., “The correction of the metabolic parameters of msg-induced obesity in rats by 2-[4-(benzyloxy) phenoxy] acetic acid”, Journal of Nutrition and Intermediary Metabolism, September 2018).
Song anticipates that 15mg/kg of paraxanthine is administered to rats (abstract). Song anticipates that the body fat mas of the paraxanthine treated rats was decreased about 29.6% in the MSG-obese and 6.3% in the normal rats compared with the control rats during 15 days (results).
Song does not say how much their rats weighed, but as evidenced by another paper written by Konopelniuk, which also has MSG-obese rats, weighed them at about .3-.4kg (3 results and discussion). It is calculated that about .3kg *15mg/kg = 4.5 mg of paraxanthine was administered.
Additionally, Song’s rats were not administered caffeine.
Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical composition, paraxanthine, and its properties are inseparable. See MPEP 2112.01 (II).
This anticipates claim 16.
Claim Rejections - 35 USC § 103- Due to amendment
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.
Claims 1-4, 6-9, 11, 13-14, 16-18, 20-21, 25, 27-29, 31, 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over SONG (Song et al., “Effect of Paraxanthine on Body Fat Reduction and Insulin Sensitivity in Monosodiun Glutamate-Obese Rats”, Journal of Yeungnam Medical Science, 2007) as evidenced by Konopelniuk (Konopelniuk et al., “The correction of the metabolic parameters of msg-induced obesity in rats by 2-[4-(benzyloxy) phenoxy] acetic acid”, Journal of Nutrition and Intermediary Metabolism, September 2018) in view of NAIR (Nair and Jacob, “A simple practice guide for dose conversion between animals and human”, J Basic Clin Pharm., March 2016) and as evidenced by Mandal (Dr. Ananya Mandal, “Caffeine Pharmacology”, News Medical, June 19, 2023).
Song teaches that 15mg/kg of paraxanthine is administered to rats (abstract). Song teaches that the body fat mas of the paraxanthine treated rats was decreased about 29.6% in the MSG-obese and 6.3% in the normal rats compared with the control rats during 15 days (results). This is understood being a method of promoting weight loss (claim 1) and promoting fat loss (claim 21).
Song does not say how much their rats weighed, but as evidenced by another paper written by Konopelniuk, which also has MSG-obese rats, weighed them at about .3-.4kg (3 results and discussion). It is calculated that about .3kg *15mg/kg = 4.5 mg of paraxanthine was administered.
Additionally, Song’s rats were not administered caffeine.
Song does not teach giving paraxanthine to humans or a human dose of paraxanthine.
NAIR teaches a simple practice guide for dose conversion between animals and humans and teaches to convert a rat dose (in mg/kg) to a human equivalent dose (in mg/kg), one multiplies the animal dose by 0.162 (table 1). So the rat dose of paraxanthine (15mg/mg) taught by Song would have a human equivalent dose of 15mg/kg *0.162= 2.43 mg/kg. Assuming a 60 kg human, this would be a dose of 145.8 mg (which would fall within the instant range). This help teach a dosage between 50 and 400 mg of paraxanthine (of claims 1, 13, 16-18, and 21).
NAIR is silent to whether paraxanthine can be administered to humans.
Mandal is relied upon for the beneficial teaching that paraxanthine is a major known metabolite of caffeine and is known to be administered to humans (as part of caffeine) (Mandal page 1).
Song teaches an animal model. An artisan would have found it obvious to take the teachings from an animal model and administer the same compound to a human. Additionally, paraxanthine is a known metabolite of caffeine and is commonly in humans (who drink caffeinated drinks like coffee).
Because Paraxanthine is safe to administer to humans, the artisan would have found it obvious to use Song’s teachings (methods of promoting weight loss (claim 1) and promoting fat loss (claim 21)) and the artisan would have been motivated to administer paraxanthine to humans.
Furthermore, the artisan would have found it obvious to optimize the dosage of paraxanthine in order to administer it to humans. NAIR teaches a simple practice guide for dose conversion between animals and humans and teaches to convert a rat dose (in mg/kg) to a human equivalent dose (in mg/kg), one multiplies the animal dose by 0.162 (table 1). So the rat dose of paraxanthine (15mg/mg) taught by Song would have a human equivalent dose of 15mg/kg *0.162= 2.43 mg/kg. Assuming a 60 kg human, this would be a dose of 145.8 mg (which would fall within the instant range). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)A. Examiner has reviewed the instant specification and claims and has not found evidence that the dosage is critical. Thus, the artisan would be motivated and expected to optimize the dosage of paraxanthine. This teaches a dosage between 50 and 400 mg of paraxanthine (of claims 1, 13, 16-18, and 21).
Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition, paraxanthine, and its properties are inseparable. See MPEP 2112.01 (II).
Furthermore, the claimed compound (paraxanthine) is administered to the claimed patient population (anyone and/or any animal). Claims 4, 6, 7, 8, 9, 11, 13, 14, 16, 20, 21, 25, 27, 28, 29, 31, 33, 34, and 35 appear to be a property of the compound; thus administration of the compound will necessarily maintain/accomplish properties described in these claims. Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This teaches claims 4, 6, 7, 8, 9, 11, 13, 14, 16-18, 20, 21, 25, 27, 28, 29, 31, 33, 34, and 35.
Claims 1, 4-11, 13-14, 16, 19-21, 25-31, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over: SONG (Song et al., “Effect of Paraxanthine on Body Fat Reduction and Insulin Sensitivity in Monosodiun Glutamate-Obese Rats”, Journal of Yeungnam Medical Science, 2007) as evidenced by Konopelniuk (Konopelniuk et al., “The correction of the metabolic parameters of msg-induced obesity in rats by 2-[4-(benzyloxy) phenoxy] acetic acid”, Journal of Nutrition and Intermediary Metabolism, September 2018) in view of HOFFMAN (Hoffman et al., “Thermogenic effect of an acute ingestion of a weight loss supplement”, Journal of international Society of Sports Nutrition, January 6, 2009), and in view of AMAZON (“Garcinia Cambogia Weight Loss Pills”, Amazon, Date First Available: April 11, 2016) in view of GUSTIN (Dr. Anthony Gustin and Lorenz Mac, “Alpha-GPC: 4 Enhancing and performance Benefits”, Perfect Keto, January 18, 2019) in view of NAIR (Nair and Jacob, “A simple practice guide for dose conversion between animals and human”, J Basic Clin Pharm., March 2016) and as evidenced by Mandal (Dr. Ananya Mandal, “Caffeine Pharmacology”, News Medical, June 19, 2023).
Song in view of NAIR and as evidenced Mandal teaches claims 1, 4, 6, 7, 8, 9, 11, 13, 14, 16-18, 20, 21, 25, 27, 28, 29, 31, 33, 34, and 35 above.
Song, NAIR, and Mandal do not teach the additional compounds.
GUSTIN teaches that Alpha-GPC can be taken to increase fat burning (page 1). GUSTIN also teaches that Alpha-GPC can deepen ketosis (page 2). This helps teach claim 19.
HOFFMAN teaches a supplement containing yohimbine (page 3 supplement) used as a wight loss supplement (background). This helps teach the elected species (yohimbine) from claims 5 and 26.
AMAZON teaches a supplement of Garcinia cambogia used as an appetite suppressant, fat burner, and weight loss supplement (page 1). This teaches the elected species of Garcinia cambogia from claim 5, 10, 26, and 30.
GUSTIN, HOFFMAN, AMAZON each teach additional compounds required by the dependent claims but do not teach paraxanthine.
The artisan would have found it obvious to combine paraxanthine, yohimbine, and Garcinia cambogia. Paraxanthine (Song pages 1 and 5), Yohimbine (HOFFMAN background and page 3), and Garcinia cambogia (AMAZON page 1) are known compounds used in weight loss supplements. The artisan would expect by adding Paraxanthine, yohimbine, and Garcinia cambogia to result in a functional weight loss supplement. It is prima facie obvious to combine one weight loss supplement (Paraxanthine) with three other weight loss supplements (Yohimbine, and Garcinia cambogia) in order to form a composition to be used for the very same purpose (weight loss). This teaches claims 1, 5, 10, 21, 26, and 30.
The artisan would have found it obvious to combine paraxanthine, and alpha-GPC. Paraxanthine (Song page 1) and alpha-GPC (GUSTIN pages 1-2) are known compounds used in weight loss and fat loss supplements. The examiner understands fat loss as a specific type of weight loss. The artisan would expect by adding Paraxanthine and alpha-GPC to result in a functional weight loss supplement. It is prima facie obvious to combine one weight loss supplement (Paraxanthine) with another weight loss supplement (alpha-GPC) in order to form a composition to be used for the very same purpose (weight loss). This helps teach claims 13, and 19.
Double Patenting- Maintained
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 1, 4, 7, and 10 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 18, 19, 20 and 22 of co-pending Application No. 17/875,368 (reference application). The instant claims of 02/20/2024 and the reference claims of 10/11/2022 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and reference claims are drawn to the same method.
Reference claim 18, drawn to a method of promoting weight loss in a subject by providing the subject with a composition of about 2 mg to 800 mg of paraxanthine, anticipates instant claim 1.
Reference claim 19, drawn to weight loss being promoted through inducing thermogenesis, anticipates instant claim 4, drawn to the same.
Reference claim 20, drawn to an additional compound such as Garcinia cambogia and yohimbine, anticipates instant claim 10, drawn to the same.
Reference claim 22, drawn to the weight loss is promoted through enhancing lipolysis, anticipates instant claim 7, drawn to the same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625