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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/11/2026 has been entered.
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 05/11/2026.
Claims 1, 4-11, 13-14, 16-21, and 25-35 have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/11/2026 is 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 5/11/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to 102 rejection over SONG, this rejection is withdrawn. Claim 16 has been amended to human subjects.
In regard to the obviousness rejection (Section IIA in the remarks), this rejection is maintained. Applicants remarks with Examiner’s reply is summarized below:
Applicants argue that not every dose is scalable with the coeffect recited by NAIR.
Without supporting data or another explicit teaching from a reference (disavowing this kind of dose conversation for paraxanthine), Examiner takes this statement as opinion.
FDA recites that when scaling from animal models to humans scaling based on body weight may be more appropriate. Additionally the NOAEL should occur at a similar mg/kg dose across species.
The lethal dose of caffeine for rats has been estimated to be 150-265 mg/kg; while, the lethal dose of caffeine for humans has been estimated to be 150-200 mg/kg.
From applicants on admission, these NOAEL ranges overlap/are similar (premising scaling from animal models to humans scaling based on body weight).
Applicants submit that the dose disclosed by SONG is 15 mg of paraxanthine per kg, which would mean a dose of 900 mg of paraxanthine.
Examiner disagrees. SONG’s dose is for a rat, which is why the dosage convert was done.
Applicants submit that Examiner failed to articulate a reason as to why NAIR would be obvious to a practitioner when FDA guidance suggests otherwise.
NAIR teaches that “Allometric scaling is generally used to convert doses among the species and is not preferred within species” (Conclusion). This is enough of a reason to use NAIR’s teaching. FDA also uses Allometric scaling (page 16).
In regard to the to the obviousness rejection (Section ii in the remarks page 9), this rejection is maintained. Applicants submit that the dependent claims depend on base claim 1 and incorporate all limitations that this rejection should be withdrawn. This rejection is maintained for the reasons stated above.
In regard to the obviousness rejection (section iii and iv in remarks on page 10), this rejection is maintained. Applicants submit that the doses used on the MSG-obese rats from SONG do not align with the instantly claimed dose range. This rejection is maintained for the reasons stated above.
In regard to the obviousness rejection (section v in remarks on page 11-12), this rejection is maintained. Applicants submit that the doses used on the MSG-obese rats from SONG do not align with the instantly claimed dose range. This rejection is maintained for the reasons stated above.
In regard to the obviousness rejection (section vi in remarks on page 12), this rejection is maintained. Applicants submit that the doses from SONG do not align with the instantly claimed dose range. This rejection is maintained for the reasons stated above.
In regard to the obviousness rejection (section vii in remarks on page 12), this rejection is maintained. Applicants submit that the doses from SONG do not align with the instantly claimed dose range. This rejection is maintained for the reasons stated above.
In regard to the obviousness rejection (section viii in remarks on page 12), this rejection is maintained. Applicants submit that the doses from SONG do not align with the instantly claimed dose range. This rejection is maintained for the reasons stated above.
Applicants also submit remarks about the properties recited in the instant claims which they submit that are not inherent to the methods. Applicants submit that Examiner has not provided evidence or technical reasoning demonstrating that the specific weight loss and fat loss results observed in rats necessarily translates to humans at the dosages claimed.
As discussed in (for example) paragraph 32, 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).
Song teaches the active method of administering paraxanthine as part of a method of promoting weight and fat loss. If the properties of paraxanthine, such as increasing swagger, are suprising or unexpected, please show data supporting this.
Without evidence to the contrary, chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition cannot have mutually exclusive properties.
In regard to the obviousness rejection over SONG as evidenced by Konopelniuk in view of Hoffman, in view of Amazon, Gustin, Nair and Mandal (section C in the remarks), this rejection is maintained. Applicants submit that the doses from SONG do not align with the instantly claimed dose range. This rejection is maintained for the reasons stated above.
Applicants submit that it is nonsensical to combine an appetite suppressant with a fat or the suggestion to eat fat-rich foods (page 17 of Remarks). This was not the basis or motivation used in the 103 (see page 11 of the Final rejection of 2/10/2026).
Applicants submit that the teachings of Hoffman are speculative and would not have been a teaching that yohimbine is a weight loss supplement (page 18 of Remarks). Examiner disagrees and provides an additional reference confirming this. Kucio (Kucio et al., “Does yohimbine act as a slimming drug?”, Isr J Med Sci., October 1991) teaches that “Yohimbine significantly increased the mean weight loss in patients on a low-energy diet” (abstract).
Applicants amended claims 26, 30, and 32 to remove “Garcinia cambogia”.
Applicants submit that it would not have been obvious to combine 3 weight loss supplements together (page 19 of Remarks). Applicants have not addressed the underlying rationale (e.g. Kerkhoven logic) underpinning the rejection.
In regard to the obviousness rejection over SONG and Gustin (section v in the remarks page 20), this rejection is maintained. Applicants submit that the teachings of Hoffman are speculative and would not have been a teaching that yohimbine is a weight loss supplement (page 18 of Remarks). Examiner disagrees and provides an additional reference confirming this. Kucio (Kucio et al., “Does yohimbine act as a slimming drug?”, Isr J Med Sci., October 1991) teaches that “Yohimbine significantly increased the mean weight loss in patients on a low-energy diet” (abstract).
In regard to the double patenting rejection, rejections cannot be held in abeyance. This rejection is maintained.
Response to Amendment
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 (Kucio et al., “Does yohimbine act as a slimming drug?”, Isr J Med Sci., October 1991) and Li (Li and Ji, “Ginseng and Obseity”, J Ginseng Res, January 10, 2017) 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.
Kucio teaches that “Yohimbine significantly increased the mean weight loss in patients on a low-energy diet” (abstract). This teaches a species from claim 5, 26, and 30.
Li teaches ginseng has been shown to have an antiobesity effect (abstract).
GUSTIN, HOFFMAN, Kucio and Li 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 Ginseng. Paraxanthine (Song pages 1 and 5), Yohimbine (HOFFMAN background and page 3 and Kucio), and Ginseng (Li abstract) are known compounds used in weight loss supplements. The artisan would expect by adding Paraxanthine, yohimbine, and Ginseng 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 Ginseng) 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 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 as written.
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
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