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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 26, 2026 has been entered.
The amendment filed August 26, 2026 has been entered. Claims 2 and 10 are cancelled and claim 21 was added.
Applicant’s argument filed August 26, 2026 have been fully considered and found not persuasive. The Examiner notes that the present arguments state that the previous response to arguments, “merely stating that arguments were “fully considered but not persuasive,” without addressing their substance, does not satisfy this requirement”. The Examiner draws emphasis to the following statement, which was present in the previous action, and directs towards a full response to arguments below. Maintained rejections and response to arguments are described below.
Claims 1, 3-9, and 11-21 are pending in this application.
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.
Claims 1, 3-9, 11-18, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Geissler (US2014/0080847, cited in previous action) in view of Ferré et al. (J. Caffeine Research, 2013, cited in previous action), Ryu et al (J. Nutr. Sci. Vitaminol., 2001, cited in previous action).
Regarding claims 1, 3, 9, and 11: Geissler teaches a method for increasing muscle strength in a subject, comprising: providing the subject with a composition comprising an effective amount of 1,4-DMPA and caffeine (pg. 2, para. 0013, pg. 4, paras. 0024, 0028). Although increasing muscle function is not explicitly stated in Geissler, increasing muscle strength encompasses increasing muscle function as recited by claim 1. Geissler teaches a method comprising administering an amount of 1,4-DMPA, wherein the amount of 1,4-DMPA is a daily dose ranging from about 5 mg to about 200 mg (pg. 4, para. 0023). The compound 1,4-DMPA can also be combined with another substance as part of a formulation or supplement (pg. 9, para. 0056). Geissler includes paraxanthine or caffeine as one of these substances (pg. 9, para. 0056). Geisler teaches that the inclusion of caffeine in fitness supplements has the benefit of stimulating lipolysis and energy expenditure (pgs. 1-2, para. 0010). In certain embodiments of the invention an amount of 1,4-DMPA in a given composition may range from about 5% to about 20% of the composition by weight, and such compositions may include one or more dietary and/or other ingredients. Possible proportions (or percentages by weight) for these dietary and other ingredients include, for example, about 30% to about 70% caffeine; about 20% to about 50% of one or more other naturally occurring substances; and about 5% to about 15% excipients (pg. 9, para. 0060). Geissler provides an example whereby a composition comprising 1,4-DMPA in an amount of about 30 mg may comprise 1,4-DMPA in an amount corresponding to about 5% of the composition by weight (pg. 9, para. 0060). The disclosure uses caffeine as an example, whereby it can be present in an amount from about 30% to 70% by weight. In this example, the examiner calculated that this amount corresponds to about 180 mg to 420 mg of the composition. Overlapping ranges are prima facie obvious absent evidence showing the claimed ranges to be critical (See MPEP 2144.05). Geissler explicitly describes formulations comprising 1,4-DMPA and 250 mg caffeine (pg. 9, para. 0060, pgs. 12-13, para. 0075).
Geissler does not explicitly teach a method wherein paraxanthine is present in the composition in amount from about 25 mg to about 600 mg or 50 mg to about 400 mg.
However, as discussed above, Geissler suggests that paraxanthine can be used as an alternative to caffeine. Additionally, Ferré teaches that paraxanthine, the main metabolite of caffeine, produces a significantly stronger locomotor activation than caffeine (abstract). Paraxanthine also has less anxiogenic activity and reduced toxicity compared to caffeine (pg. 75, col. 1, para. 1). Ryu teaches that it is known in the art that paraxanthine has the lipolytic effect of caffeine, which has been shown to increase lipid metabolism and decrease muscle glycogen utilization (pg. 144, col. 1, paras. 1-2, pg. 145, col. 1, paras 1-2). As mentioned previously, Geissler teaches the lipolytic behavior warrants its inclusion in supplements for improving fitness or well-being (pgs. 1-2, para. 0010).
Taken together, it would have prima facie obvious to one of ordinary skill in the art to modify Geissler, by substituting caffeine with paraxanthine as suggested, given that it is known in the art that paraxanthine results in stronger locomotor activity and is less toxic as taught by Ferré, and that paraxanthine exhibits favorable properties in supplements as taught by Ryu. One of ordinary skill in the art would have been motivated to do so because in view of the prior art, paraxanthine, a metabolite of caffeine, is demonstrated to exhibit similar properties to caffeine. Given the establishment of caffeine and paraxanthine as possessing similar properties it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)).
Regarding claim 4: Geissler teaches wherein the composition can further comprise one or more compounds selected from the list consisting of: caffeine, theophylline, phenethylamine, arginine, tyrosine, creatine, beta-alanine. More generally, other substances include, without limitation, antioxidants, minerals, and amino acids (pg. 2, para. 0013).
Regarding claims 5 and 12: Geissler teaches wherein the composition is substantially free of caffeine. (caffeine is optional, pg. 2, para. 0013).
Regarding claims 6 and 13: Geissler teaches wherein the composition is substantially free of caffeine, and tyrosine (pg. 2, para. 0013). Geissler does not explicitly state wherein the composition is substantially free of taurine and 1-methylxanthine. Since Geissler does not teach the inclusion of these substances, it is prima facie obvious to formulate without them.
Regarding claims 7 and 14: Geissler teaches wherein the composition is administered in conjunction with exercise and strength training activities (pg. 4, para. 0028, pg. 5, para. 0031, pg. 12, para. 0074). Although a strength training regimen is not explicitly stated in Geissler, exercise and strength training activities encompasses a strength training regimen as recited by claim 7.
Regarding claim 8, 15-16, 21: Geissler does not teach a method of administering a composition of paraxanthine wherein muscle function is increased from about 10-20%, muscle strength is increased from about 10-25%, muscle size in increased from about 10-20% and relative to a subject receiving a control composition without paraxanthine.
However, Geissler provides a method of measuring strength output, power, local muscular endurance, and percentage of muscle mass (pg. 14, paras. 0084-0086). According to the instant specification, a composition comprising 100 mg of paraxanthine resulted in the claimed increase (pg. 23 para. 072, pgs. 26-27, para. 084). The composition made obvious over Geissler and Ferré can comprise greater than 100 mg of paraxanthine. Thus, the phrases “wherein muscle function is increased from about 10-20%”, “muscle strength is increased from about 10-25%”, “muscle size in increased from about 10-20%” are expected properties of the composition. As discussed above, the prior art makes obvious the claimed method of administering an effective amount of paraxanthine in order to increase muscle function. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)). Therefore, the result of increasing muscle function, strength and size as claimed, necessarily flows as a result of the prior art teaching administration of the composition to the same patient population, absent evidence to the contrary.
Regarding claim 17: As discussed above, Geissler teaches the limitations of claims 1-16, but does not teach a method wherein nitric oxide (NO) signaling is increased from about 90-100 % relative to a subject receiving a control composition without paraxanthine.
However, Ferré teaches a method wherein administering a composition of paraxanthine results in increased nitric oxide (NO) signaling (pg. 74, fig. 1, pg. 75, cols. 1-2, bridging para.). According to the instant specification, a composition comprising 100 mg of paraxanthine resulted in the claimed increase (pg. 23 para. 072, pgs. 27, para. 085). The composition made obvious over Geissler and Ferré can comprise greater than 100 mg of paraxanthine. With the evidence provided by Ferré, the phrase “wherein nitric oxide (NO) signaling is increased from about 90-100%” is an expected property of the composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)). Therefore, the result of increasing nitric-oxide signaling as claimed, necessarily flows as a result of the prior art teaching administration of the composition to the same patient population, absent evidence to the contrary.
Regarding claim 18: As discussed above, Geissler and Ferré teach the limitations of claims 1, 3-9, and 11-17, but do not teach a method wherein muscle glycogen levels are increased from about 10- 30% relative to a subject receiving a control composition without paraxanthine.
However, Ryu teaches that it is known in the art that paraxanthine has the lipolytic effect of caffeine, which has been shown to increase lipid metabolism and decrease muscle glycogen utilization (pg. 144, col. 1, paras. 1-2, pg. 145, col. 1, paras 1-2). The composition made obvious over Geissler and Ferré can comprise greater than 100 mg of paraxanthine.
With the evidence provided by Ryu, the phrase “wherein muscle glycogen levels are increased from about 10- 30%” is an expected property of the composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer (See MPEP 2112 (I)). Therefore, the result of increasing muscle glycogen levels as claimed, necessarily flows as a result of the prior art teaching administration of the composition to the same patient population, absent evidence to the contrary.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Geissler (US2014/0080847, cited in previous action) in view of Ferré et al. (J. Caffeine Research, 2013, cited in previous action), and Ryu et al (J. Nutr. Sci. Vitaminol., 2001, cited in previous action) and Zemel (US2018/0105498, cited in previous action).
Regarding claims 19-20: Geissler teaches a method for increasing muscle strength in a subject, comprising: providing the subject with a composition comprising an effective amount of 1,4-DMPA and caffeine (pg. 2, para. 0013, pg. 4, paras. 0024, 0028). Geissler teaches a method comprising administering an amount of 1,4-DMPA, wherein the amount of 1,4-DMPA is a daily dose ranging from about 5 mg to about 200 mg (pg. 4, para. 0023). The compound 1,4-DMPA can also be combined with another substance as part of a formulation or supplement (pg. 9, para. 0056). Geissler includes paraxanthine or caffeine as one of these substances (pg. 9, para. 0056). Geisler teaches that the inclusion of caffeine in fitness supplements has the benefit of stimulating lipolysis and energy expenditure (pgs. 1-2, para. 0010). In certain embodiments of the invention an amount of 1,4-DMPA in a given composition may range from about 5% to about 20% of the composition by weight, and such compositions may include one or more dietary and/or other ingredients. Possible proportions (or percentages by weight) for these dietary and other ingredients include, for example, about 30% to about 70% caffeine; about 20% to about 50% of one or more other naturally occurring substances; and about 5% to about 15% excipients (pg. 9, para. 0060). Geissler provides an example whereby a composition comprising 1,4-DMPA in an amount of about 30 mg may comprise 1,4-DMPA in an amount corresponding to about 5% of the composition by weight (pg. 9, para. 0060). The disclosure uses caffeine as an example, whereby it can be present in an amount from about 30% to 70% by weight. In this example, the examiner calculated that this amount corresponds to about 180 mg to 420 mg of the composition. Overlapping ranges are prima facie obvious absent evidence showing the claimed ranges to be critical (See MPEP 2144.05). Geissler explicitly describes formulations comprising 1,4-DMPA and 250 mg caffeine (pg. 9, para. 0060, pgs. 12-13, para. 0075).
Geissler does not teach a method of administering an effective amount of paraxanthine for treating or preventing muscle atrophy in a subject, wherein said subject has been diagnosed with, or is at risk of developing, sarcopenia or cachexia. Geissler does not teach wherein paraxanthine is present in the composition in amount from about 25 mg to about 600 mg or 50 mg to about 400 mg.
However, as discussed above, Geissler explicitly describes formulations comprising 1,4-DMPA and 250 mg caffeine (pg. 9, para. 0060, pgs. 12-13, para. 0075) and Geissler suggests that paraxanthine can be used as an alternative to caffeine. Ferré teaches that paraxanthine, the main metabolite of caffeine, produces a significantly stronger locomotor activation than caffeine (abstract). Paraxanthine also has less anxiogenic activity and reduced toxicity compared to caffeine (pg. 75, col. 1, para. 1). Ryu teaches that it is known in the art that paraxanthine has the lipolytic effect of caffeine, which has been shown to increase lipid metabolism and decrease muscle glycogen utilization (pg. 144, col. 1, paras. 1-2, pg. 145, col. 1, paras 1-2). As mentioned previously, Geissler teaches the lipolytic behavior warrants its inclusion in supplements for improving fitness or well-being (pgs. 1-2, para. 0010). Zemel teaches that it is known in the art that a composition containing PDE inhibitor can be administered to treat a subject with muscle wasting or cachexia (pg. 34, para. 0286, pg. 41, para. 0363, pg. 43, para. 0381). Paraxanthine is listed as a possible PDE inhibitor (pg. 43, para. 0381).
Taken together, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Geissler with the teachings of Zemel. A person of ordinary skill would have been motivated to combine the method taught by Geissler with the teachings of Zemel, whereby the composition of paraxanthine is administered to a subject suffering from muscle atrophy or cachexia, in order to increase muscle strength or muscle size in the subject. A person of ordinary skill would recognize the therapeutic benefit of administering a supplement to improve muscle mass to a subject suffering from atrophy or cachexia.
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 1, 3-6, 9, and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 13, and 16 of copending Application No. 17/794,729 (US 2023/0072854, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1 and 3 in the instant application recite administering a composition of paraxanthine for increasing muscle function. Claims 10 and 13 in the copending application recite administering a composition of paraxanthine, in the recited amounts, for increasing physical performance. Although increasing muscle function is not explicitly claimed in the copending application, improving physical performance encompasses on increasing muscle function as claimed in the instant application.
Claims 4-6 in the instant application recite administering a composition of paraxanthine that further comprises isoleucine, leucine, and valine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, creatine, arginine, cysteine, glutamine, glycine, proline, carnitine, creatinol, beta-alanine, ATP, protein, peptides, and beta-hydroxy beta-methylbutyrate, and is substantially free of caffeine, taurine, tyrosine, and 1-methylxantine. Claims 1, 2, and 16 in the copending application recite that the composition can contain tryptophan, and caffeine is optional.
Claims 9 and 11 in the instant application recite administering a composition of paraxanthine for increasing muscle strength and/or muscle size. Claims 10 and 13 in the copending application recite administering a composition of paraxanthine, in the recited amounts, for improving physical performance. Although increasing muscle strength is not explicitly claimed in the copending application, improving physical performance reads on increasing muscle strength as claimed in the instant application
Claims 12-13 in the instant application recite administering a composition of paraxanthine that is substantially free of caffeine, taurine, tyrosine, and 1-methylxanthine. Claims 1, 2, and 16 in the copending application recite a composition whereby the inclusion of tyrosine, taurine and caffeine is optional. The copending application does not explicitly state the composition is substantially free of 1-methylxanthine. However, the copending application does not teach the inclusion of these substances, therefore it is prima facie obvious to formulate without them.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-9, and 11-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 17, 18 of copending application No. 17/794,729 (US 2023/0072854, cited in previous action) in view of Geissler (US2014/0080847, cited in previous action), Ferré et al. (J. Caffeine Research, 2013, cited in previous action), Ryu et al (J. Nutr. Sci. Vitaminol., 2001, cited in previous action) and Zemel (US2018/0105498, cited in previous action):
As discussed above, claims 1, 3-6 and 9, 11-13 were made obvious over the copending application.
Claims 7-8, 4-16, 21 in the instant application recite a method wherein the composition of paraxanthine is administered in conjunction with a strength training regimen relative to a subject receiving a control composition without paraxanthine and wherein muscle function is increased by from about 10% to about 20%, muscle strength is increased from about 10% to about 20%, and muscle size is increased from about 10-20% relative to a subject receiving a control composition without paraxanthine. Claim 10 in the copending application recite administering a composition of paraxanthine for increasing physical performance in a subject, but does not state wherein the composition is administered in conjunction with a strength training regimen, and wherein muscle function, strength and size is increased relative to a subject receiving a control composition without paraxanthine. However, as discussed above with the teachings of Geissler, it is obvious to administer the composition in conjunction with a strength training regimen. Furthermore, the phrases “wherein muscle function is increased from about 10-20%”, “muscle strength is increased from about 10-25%”, “muscle size in increased from about 10-20%” are expected properties of the composition. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the copending application with the teachings of Geissler. Therefore, one of ordinary skill in the art would have been motivated to implement the strength training regimen taught by Geissler with administration of the composition of paraxanthine in the copending application for the purpose of increasing muscle function, strength, and size in order to improve muscle function in a subject.
Claim 17 in the instant application recites a method of administering the composition of paraxanthine wherein nitric oxide (NO) signaling is increased from about 90-100% relative to a subject receiving a control composition without paraxanthine. Claim 10 in the copending application recite administering a composition of paraxanthine for increasing physical performance in a subject, but does not state that nitric oxide (NO) signaling is increased from about 90-100%. However, as discussed above with the teachings of Ferré, the phrase “wherein nitric oxide (NO) signaling is increased from about 90-100 %” is an expected property of the composition. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the copending application with the teachings of Ferré. Therefore, one of ordinary skill in the art would have been motivated to administer the composition of paraxanthine in the copending application with the purpose of increasing nitric oxide signaling from about 90-100% as taught by Ferré in order to improve muscle function in a subject.
Claim 18 in the instant application recites a method of administering the composition of paraxanthine wherein muscle glycogen levels are increased from about 10-30% relative to a subject receiving a control composition without paraxanthine. Claim 10 in the copending application recite administering a composition of paraxanthine for increasing physical performance in a subject, but does not state that muscle glycogen levels are increased from about 10- 30% relative to a subject receiving a control composition without paraxanthine. However, as discussed above with Ryu, the phrase “wherein muscle glycogen levels are increased from about 10-30%” is an expected property of the composition. Therefore, the composition claimed and the composition of the prior art are expected to have the same properties, absent evidence to the contrary. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the copending application with the teachings of Ryu. Therefore, one of ordinary skill in the art would have been motivated to administer the composition of paraxanthine taught by the copending application with the purpose of increasing muscle glycogen levels from about 10-30% as taught by Ryu in order to improve muscle function in a subject.
Claims 19-20 in the instant application recite a method of treating or preventing muscle atrophy in a subject, wherein the subject has been diagnosed with, or is at risk of developing, sarcopenia or cachexia, comprising administering to the subject and effective amount of paraxanthine. Claim 17-18 in the copending application recite a method treating a condition in a subject in need thereof, comprising administering to the subject a composition of paraxanthine, but fail to specify treating a subject with muscle atrophy or has been diagnosed with sarcopenia or cachexia. However, Zemel teaches that it is known in the art that a composition containing paraxanthine can be administered to treat a subject with muscle wasting or cachexia (pg. 34, para. 0286, pg. 41, para. 0363, pg. 43, para. 0381). Therefore, claims 19-20 are obvious as discussed above. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the copending application with the teachings of Zemel. Therefore, one of ordinary skill in the art would have been motivated to administer the composition of paraxanthine taught by the copending application to subjects suffering from cachexia as taught by Zemel in order to improve muscle function.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed August 26th, 2026 have been fully considered but they are not persuasive.
On pages 5-6 of Applicant’s response, Applicant argues that Geissler does not teach the relationship between caffeine (or paraxanthine) and its impact on muscle (bridging para.). Applicant argues Geisler does not provide motivation for the selection of caffeine and caffeine is one of many ingredients that can be combined with 1,4-DMPA (bridging para.). Applicant argues that the office has not demonstrated that replacing caffeine with paraxanthine would improve muscle function either, and both a reason to make the selection and a reasonable expectation of success are required to support an obviousness rejection.
However, one of ordinary skill in the art upon reading the reference would be motivated to select caffeine out of the list as Geissler explicitly describes formulations comprising 1,4-DMPA and 250 mg caffeine (pg. 9, para. 0060, pgs. 12-13, para. 0075). Geissler teaches the individual upon receiving this supplement experiences improved physical performance (pg. 1, para. 0074). Geissler teaches a method for increasing muscle strength in a subject, comprising: providing the subject with a composition comprising an effective amount of 1,4-DMPA and caffeine (pg. 2, para. 0013, pg. 4, paras. 0024, 0028). Although many additional possible ingredients are listed, a person of ordinary skill in the art upon reading the reference would directed to a composition comprising caffeine as it is disclosed within specific embodiments of the invention. Given that Geissler teaches a method of administering a formulation for the purpose of increasing muscle function (i.e. muscle strength), wherein caffeine is present in an effective amount, the ability of caffeine to improve function separately than 1,4-DMPA is necessarily present in the composition. This applies to the replacement of caffeine with paraxanthine taught to be a less toxic alternative caffeine with similar properties. Additionally, Geisler recognizes the ability of caffeine to stimulate lipolysis and energy expenditure, which as discussed above relates to improvement in fitness (pgs. 1-2, para. 0010). Ryu verifies that paraxanthine effectively mimics the lipolytic ability of caffeine (pg. 144, col. 1, paras. 1-2, pg. 145, col. 1, paras 1-2). Thus, even though Geisler does not explicitly relate the effects of caffeine on muscle function, a person of ordinary skill would be capable of substituting caffeine with paraxanthine with a reasonable expectation of success, as they are known to have similar properties and arrive at the claimed invention, since a purpose of the composition of Geisler is for improving muscle function.
On page 6 of Applicant’s response, Applicant argues that the open transition phrase comprising does not require the composition be free of 1,4-DMPA, but does not remove the limitations that are present within the claim (para. 3). Applicant argues that claim 1 does not merely require that paraxanthine be present somewhere in a composition that increases muscle function, but that it recites a method for increasing muscle function in which the subject is provided a composition comprising an effective amount of paraxanthine (para. 4). Applicant argues that the phrase “effective amount” is tied to the claimed therapeutic purpose supplies the metric by which effectiveness is determined. On pages 6-7 of Applicant’s response, Applicant argues the permissibility of additional 1,4-DMPA does not permit the Office to substitute 1,4-DMPA’s activity for the claimed effectiveness of paraxanthine and does not establish that the proposed composition is present in an effective amount to increase muscle function as claim 1 requires (bridging para.). Applicant argues treating DMPAs effect as sufficient would reduce effective amount of paraxanthine to merely, “an amount of paraxanthine” contrary to the claim language described above.
However, wherein Geissler teaches 250 mg of caffeine in the composition, and it would have been obvious to replace caffeine with paraxanthine in view of the prior art, a person of ordinary skill in the art would utilize 250 mg of paraxanthine, which according to the instant claims is necessarily an effective amount. Thus the therapeutic effect claimed and observed by Applicant, necessarily flows as a result of practicing the method rendered obvious (i.e. increasing muscle strength/function, especially given the method of Geissler is directed to improving muscle strength in a subject. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Recognition of another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious (See MPEP 2145 (II)).
On page 7 of Applicant’s response, Applicant argues inherency may not be established by probability or possibility, the disputed property must be shown to necessarily flow from the references teachings, there is no composition in Geissler in which caffeine’s presence is shown to produce or correlate with a muscle related outcome (para. 2). Applicant argues that absent such a showing, the property relied upon is not necessarily present, and is at most a possibility (para. 2).
However, as discussed above, the therapeutic effect claimed and observed by Applicant, necessarily flows as a result of practicing the method rendered obvious (i.e. increasing muscle strength/function, especially given the method of Geissler is directed to improving muscle strength in a subject. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Recognition of another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious (See MPEP 2145 (II)).
On page 7 of Applicants’ response, Applicant argues the office has identified no motivation for selecting caffeine among is numerous optional co-ingredients for any purpose relevant to the claims (last para.). Applicant argues the lipolytic/energy-expenditure properties motivate caffeine’s inclusion in a composition directed to weight loss or energy expenditure, not muscle function/strength/size as is actually claimed. A motivation directed to a different physiological endpoint does not supply a motivation to select, or substitute an ingredient for the distinct endpoints recited in claims 1 and 9.
However, as discussed above, one of ordinary skill in the art upon reading the reference would be motivated to select caffeine out of the list as Geissler explicitly describes formulations comprising 1,4-DMPA and 250 mg caffeine (pg. 9, para. 0060, pgs. 12-13, para. 0075). Geissler teaches the individual upon receiving this supplement experiences improved physical performance (pg. 1, para. 0074). Replacement with paraxanthine would yield a less toxic composition with similar pharmacodynamic effects as the composition of Geissler (improving muscle function), absent evidence to the contrary.
On page 8 of Applicant’s response, Applicant argues the “known equivalents” rationale for substituting caffeine with paraxanthine requires the prior art recognize the interchangeability of two elements for the specific purpose at hand, not merely that the elements are similar or interchangeable for some other purpose (para. 1). Applicant argues Ferres teachings concern nitric-oxide mediated dopaminergic neurotransmission governing locomotor behavior in the brain which does not have a mechanism related to muscle strength/size/function (para. 1). Applicant argues Ryu’s teachings concern lipid metabolism and glycogen utilization during exercise, not muscle strength, size, or function (para. 1). Neither reference establishes caffeine and paraxanthine are recognized in the art as interchangeable for improving muscle function (para. 1).
However, Geissler teaches inclusion of caffeine stimulates lipolysis and energy expenditure (pgs. 1-2, para. 0010). Geissler suggests that paraxanthine can be used as an alternative to caffeine. Additionally, Ferré teaches that paraxanthine, the main metabolite of caffeine, produces a significantly stronger locomotor activation than caffeine (abstract). Paraxanthine also has less anxiogenic activity and reduced toxicity compared to caffeine (pg. 75, col. 1, para. 1). Ryu teaches that it is known in the art that paraxanthine has the lipolytic effect of caffeine, which has been shown to increase lipid metabolism and decrease muscle glycogen utilization (pg. 144, col. 1, paras. 1-2, pg. 145, col. 1, paras 1-2). There is no requirement that paraxanthine/caffeine is explicitly taught to possess these properties to render the present claims obvious. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant (See MPEP 2144 (IV)). Geissler is directed towards a composition for improving muscle function comprising caffeine wherein paraxanthine is a suitable alternative. Whereas a person of ordinary skill in the art would find caffeine and paraxanthine to be considered equivalents, a person of ordinary skill would be capable of substituting one for another with a reasonable expectation of success. As discussed previously, the art recognizes the lipolytic ability of caffeine, useful in fitness supplements, is also a property of paraxanthine, a less-toxic caffeine metabolite. Thus, a person of ordinary skill would have had a reasonable expectation of success in providing a composition of Geissler for improving muscle function comprising paraxanthine instead of caffeine, given their similar properties with the added benefit of being less-toxic.
On page 8 of Applicant’s response, Applicant summarizes the arguments presented above and suggests that similarly the dependent claims are not rendered obvious as argued above (paras. 2-3).
See response to arguments above.
On page 9 of Applicant’s response, Applicant argues that Geissler does not describe any role of paraxanthine in muscle function and the same applies for muscle atrophy (para. 1). Applicant argues Zemel argues many compounds to be used in conjunction with biguanides to affect sirtuin function and PDE inhibitors are presented only as one of several optional sirtuin pathway activators and paraxanthine appears solely as one of seven compounds in an undifferentiated boilerplate list (para. 1). Applicant argues Zemel supplies no reason to select paraxanthine specifically has any bearing on muscle atrophy at all (para. 1). Applicant argues selecting an untested compound from an unranked list for a use the reference attributes to a different mechanism relies on improper hindsight (para. 1).
However, the Examiner notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (See MPEP 2145 (IV)). As discussed above, it would have been obvious to replace caffeine in the composition of Geissler with paraxanthine as a less toxic, suitable alternative through the teachings of Ferré. Geissler is directed towards methods of increasing muscle mass (pg. 4, para. 0024, pg. 10, para. 0062). Zemel teaches that it is known in the art that a composition containing PDE inhibitor can be administered to treat a subject with muscle wasting or cachexia (pg. 34, para. 0286, pg. 41, para. 0363, pg. 43, para. 0381). Paraxanthine, as well as caffeine are listed as a possible PDE inhibitor (pg. 43, para. 0381). Given that through the teachings of Geissler and Farre it would have been obvious to administer a composition comprising paraxanthine for increasing muscle mass, and paraxanthine is a known in the art as a PDE inhibitor which are useful for treating cachexia and muscle wasting (atrophy), one of ordinary skill would recognize that the composition of Geissler (for increasing muscle mass) would be beneficial in the treatment of these disorders.
On page 10 of Applicant’s response Applicant argues in light of the arguments presented above, the double patenting rejections should also be withdrawn (para. 1).
See response to arguments above.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Magkos (Critical Reviews in Food Science and Nutrition, 2005, cited on PTO-892) suggests use of paraxanthanine in the same dose of caffeine results in similar pharmacodynamic actions as caffeine (pg. 543, col. 1, para. 1).
Davis (Sports Med, 2009, cited on PTO-892) suggests paraxanthine can stimulate resting skeletal muscle for forceful output of muscle contractions (pg. 821, cols. 1-2, bridging para.).
Fujiwara (PLOS ONE, 2014, cited on PTO-892) teaches paraxanthine levels are lower in cancer cachexic patients (pg. 1, abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMUEL L GALSTER/Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
Prosecution Insights