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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 of RCE on July 31, 2025 and amendment after final filed on July 31, 2025 has been entered. Claims 1-23 and 47-49 were canceled, claim 24 was amended and claims 24-46 are pending in the instant application.
The restriction requirement is deemed proper and made FINAL in the previous office action. Claims 24-46 are examined on the merits of this office action.
Withdrawn Rejections or Objections
The rejection of claims 24-46 under 35 U.S.C. 103 as being unpatentable over Gardiner (WO 200128356, cited in Applicant’s IDS) as evidenced by Rai (J Food Sci Technol. 2016 Aug 30;53(9):3381–3394) in view of McKinley-Barnard (Journal of the International Society of Sports Nutrition (2015) 12:27, cited in Applicant’s IDS), Mumfitnessblog (http://munfitnessblog.com/how-much-weight-should-you-lift-to-build-muscles-and-strength/, published 2011, cited previously) and RalphRoberts (https://ralphrobertspersonaltrainer.com/why-separate-workouts-into-upper-body-and-lower-body-days, published on 2015, cited previously) is withdrawn in view of amendment of the claims filed July 31, 2025.
New Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24-46 are rejected under 35 U.S.C. 103 as being unpatentable over McKinley-Barnard (Journal of the International Society of Sports Nutrition (2015) 12:27, cited in Applicant’s IDS) in view of Gardiner (WO 200128356, cited in Applicant’s IDS), Mumfitnessblog (http://munfitnessblog.com/how-much-weight-should-you-lift-to-build-muscles-and-strength/, published 2011, cited previously) and RalphRoberts (https://ralphrobertspersonaltrainer.com/why-separate-workouts-into-upper-body-and-lower-body-days, published on 2015, cited previously).
McKinley-Barnard teaches administering L-citrulline and glutathione (GSH) to human subjects undergoing resistance exercise (see page 2 right column into page 3). Specifically, McKinley-Barnard teaches participants orally ingested 2 g/day L-citrulline and 200 mg/day GSH for seven consecutive days (see page 3, “Supplementation Protocol”). McKinley-Barnard further teaches administering the supplementation in conjunction with a resistance exercise program performed at approximately 70–75% of the participant’s estimated 1-repetition maximum (1-RM) (see page 3, “Resistance Exercise Protocol,” describing 5–10 warm-up repetitions followed by 3–5 repetitions at ~70–75% 1-RM).
McKinley-Barnard additionally teaches that supplementation and resistance exercise occur during the same time period (page 3, blood draw schedule and Figure 1), and that performance is measured using 1-RM elbow flexor strength testing (page 3, “Assessment of elbow flexor muscle strength”). McKinley-Barnard teaches resulting physiological improvements including increased biomarkers of nitric oxide synthesis such as NOx, nitrite, and cGMP following supplementation combined with resistance exercise (pages 4–6 and Figures 2–8).
However, McKinley-Barnard is silent to (a) a four-day-per-week resistance training routine; (b) training for a total period of four weeks; or (c) measuring muscle mass using a body composition device.
However, Gardiner teaches administering supplementation in conjunction with resistance training over a multi-week duration (≥4 weeks) and evaluating the effects of the program by measuring body composition using dual-energy X-ray absorptiometry (DEXA), which is a recognized body composition meter (see Example 4, page 13, lines 1-18). Gardiner further teaches that the supplementation and resistance program enhances nitric-oxide-related pathways and contributes to improvements in muscle size and strength (see “summary of the invention”, lines 17-20), similar to the effects reported in McKinley-Barnard.
Mumfitnessblog teaches that 1 RM which stands for 1 Repetition Maximum weight. One RM is the heaviest weight you are able to lift properly on a workout if you do only one repetition. Most weight training programs recommend a weight that is between 70% and 85% of your 1 RM. Once you find that weight, you should do 8 to 10 repetitions for each set with 3 sets (see page 3, “To build Muscle”).
RalphRoberts teaches a structured resistance training program utilizing an upper/lower body split performed four days per week, wherein two training days target upper-body muscle groups (e.g., Monday/Thursday) and two training days target lower-body muscle groups (e.g., Tuesday/Friday). RalphRoberts further teaches that such four-day resistance training splits are standard routines used to improve muscle strength and mass while preventing overtraining (see all of pages 1-4).
It would have been obvious before the effective filing date of the claimed invention to modify the supplementation and exercise regimen of McKinley-Barnard to incorporate the structured multi-week resistance training protocol taught in Gardiner. One of ordinary skill in the art would have been motivated to do so because both references address improving physiological outcomes associated with resistance training, including improvements in muscle strength, muscle size, and nitric-oxide-mediated exercise response, and both identify nitric oxide signaling as a biological mechanism contributing to training adaptation. McKinley-Barnard demonstrates that co-administration of L-citrulline and glutathione enhances nitric-oxide biomarkers and exercise performance in response to resistance activity, while Gardiner teaches that meaningful and measurable changes in muscle composition and strength occur when supplementation is paired with a structured, multi-week progressive resistance training program, rather than a single acute training session.
A person of ordinary skill in the art would have recognized that replacing the resistance protocol in McKinley-Barnard with the longer-term program of Gardiner and RalphRoberts represents routine optimization of a known parameter—namely, the duration and frequency of resistance training—and would predictably result in improved or more measurable muscular outcomes. Such design choice reflects a predictable variation of known methods and falls within the reasoning permitted under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), which states that combining familiar elements according to known methods to achieve predictable results is obvious. This rationale is further supported by MPEP § 2143(I)(B) (predictable results rationale) and MPEP § 2144.05 (routine optimization).
Accordingly, there would have been a reasonable expectation of success in applying the multi-week structured resistance protocol of Gardiner to the supplementation framework of McKinley-Barnard, because both references operate in the same field of exercise science, rely on the same biological mechanism (nitric-oxide-mediated exercise enhancement), and seek the same outcome—improved muscle performance and adaptation resulting from resistance training.
Furthermore, it would have been obvious to perform the resistance training protocol of McKinley-Barnard and Gardiner 70-80% of 1-RM to achieve optimal muscle building. One of ordinary skill in the art would have been motivated to do so given that Mumfitnessblog teaches that a weight that is between 70% and 85% of your 1 RM is recommended for building muscle in most weight training programs. There is a reasonable expectation of success given that McKinley-Barnard teaches a protocol wherein the 3 sets of 15 repetitions were typically 70–75 % of 1RM and Mumfitnessblog teaches between 70% and 85% of your 1 RM is recommended for building muscle.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to incorporate the four-day resistance-training split routine taught by RalphRoberts into the combined teachings of McKinley-Barnard, Gardiner and MumFitness. One of ordinary skill in the art would have been motivated to do so because RalphRoberts teaches that a four-day upper/lower body split is a commonly used and effective resistance-training format for improving muscle size, strength, and training efficiency while balancing recovery. This scheduling approach aligns with the same training objectives and goals described in McKinley-Barnard and Gardiner and is presented as a standard, accepted method for structuring resistance training exercise programs.
The modification of the exercise protocol to adopt a known four-day training split represents a predictable refinement of an existing regimen and constitutes routine optimization of a known design parameter (training frequency), as described in MPEP § 2144.05. Under the reasoning of KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), combining familiar elements according to known methods to achieve predictable results is obvious where the improvement is no more than the predictable use of prior-art elements according to their established functions. Because RalphRoberts describes a widely accepted and routinely implemented scheduling format used to achieve the same muscular performance benefits sought in McKinley-Barnard and Gardiner, there would have been a reasonable expectation of success in applying the four-day split structure to the supplementation-and-exercise method.
Regarding claims 25-27, McKinley-Barnard teaches administering 2 grams of L-citrulline in a day to the subject thus meeting the limitations of about 2 grams/day or more (see “Methods”).
Regarding claims 28-30, McKinley-Barnard teaches administering 200 mg of GSH in a day to the subject thus meeting the limitations of about 200 mg/day or more (see Methods).
Regarding claims 31-34, the ratio taught by McKinley-Barnard is 2000 mg L-Cit/200mg GSH which is a ratio of about 10:1.
Regarding claims 35-37, administering the supplement of McKinley-Barnard in view of Gardiner daily for four weeks meets the limitations of a period of at least 14, at least 21 and at least 28 days.
Regarding claim 38, Claim 38 recites that the daily resistance workout comprises at least 8 repetitions. McKinley-Barnard teaches resistance exercise performed in sets of 5–10 repetitions targeting the elbow flexors, which includes ≥8 repetitions (see Methods). Gardiner likewise teaches sets of 4–10 repetitions in a structured resistance training program, and MumFitness Blog/RalphRoberts demonstrate that repetition schemes in the 6–12 range are commonly used and in four-day hypertrophy-focused routines.
It would have been obvious before the effective filing date of the claimed invention to select ≥8 repetitions because all cited references operate within the same recognized resistance training rep range. One of ordinary skill would have been motivated to do so to promote muscle growth and performance, as taught across the references. Selecting a specific repetition count within an already-taught functional range is a routine optimization of a result-effective variable, consistent with KSR v. Teleflex, 550 U.S. 398 (2007) and MPEP § 2144.05, and would have been expected to yield predictable results. Accordingly, there would have been a reasonable expectation of success in using ≥8 repetitions within the combined protocol.
Regarding claim 40, While Mckinley Barnard teaches administering L-citrulline and glutathione prior to and immediately before the resistance exercise, Gardiner teaches administering a nitric oxide promoting composition immediately after exercise to maximize physiological benefit (see page 10, line 34). Gardiner explains that nitric oxide plays an essential roll in post exercise recovery via vasodilation and blood flow (see background paragraph 2 of Gardiner). Thus, Gardiner teaches the limitation requiring administration immediately after the workout which one of ordinary skill in the art would recognize an hour or less. Nevertheless, it would have been obvious before the effective filing date of the claimed invention to modify the administration timing in McKinley-Barnard to include administering the composition immediately after exercise as taught by Gardiner. One of ordinary skill in the art would have been motivated to do so because both references address nitric oxide mediated enhancement of exercise outcomes, and Gardiner specifically teaches that nitric oxide plays an essential role in post exercise recovery by promoting vasodilation and increased blood flow, which supports delivery of nutrients and oxygen to muscle following exercise. Applying Gardiner’s post exercise dosing strategy would therefore be expected to improve or optimize the supplementation effect described in Mckinley-Barnard. Furthermore, adjusting the timing of administration is considered routine optimization of a known result effective variable (see MPEP 2144.05).
Regarding the functional limitations in claims 41-43, “wherein the ratio of muscle mass to total body weight is increased by about 0.3% or more” (claim 41); wherein the ratio of muscle mass to total body weight is increased by about 0.6% or more (claim 42); and wherein the ratio of muscle mass to total body weight is increased by about 1% or more (claim 43); McKinley-Barnard in view of Gardiner, Mumfitnessblog and RalphRoberts teach the same method of the instant claims including administering the same composition (with the same effective amounts) and in conjunction with a resistance workout program, thus, the result oriented effects listed in instant claim 41-43 will inherently be achieved as a result of practicing the method of McKinley-Barnard in view Gardiner, mumsfitnessblog and Ralphroberts.
Regarding claim 44, McKinley-Barnard teaches administering a composition comprising both GSH and L-citrulline and thus would meet the limitation of concurrently, given they would both be in the same nutritional supplement (see “methods”, lines 6-8).
Regarding claim 45, McKinley-Barnard teaches oral administration (“Methods”, orally ingest).
Regarding claim 46, the citrulline of McKinley-Barnard is L-citrulline (see page 3, “Supplementation Protocol, line 5).
Regarding the limitations of administering the supplement one hour prior to resistance exercise found in claim 39, McKinley-Barnard teaches administering L-Citrulline and GSH one hour prior to resistance exercise (see Figure 1). As stated above, it would have been obvious to optimize the timing of when the supplement was administered (prior to or after exercise) to achieve optimal nitric oxide enhancement with exercise. The timing of administering the NO enhancing supplement is considered a result-effective variable.
The MPEP states the following: 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Therefore, It would have been obvious to optimize the timing of when the supplement was administered (prior to or after exercise) to achieve optimal nitric oxide enhancement with exercise. There is a motivation to optimize since it is normal desire of scientists or artisans to improve upon what is already generally known with a reasonable expectation that optimization would at least work the same.
Regarding the amount of weeks (four weeks) resistance training found in instant claim 24, the duration of treatment/resistance training protocol is clearly a result effective variable (i.e. the longer your train, the greater chances of achieving the desired result). It would have been obvious to optimize the duration of training for the method of McKinley Barnard, Gardiner, Mumfitnessblog and RalphRoberts in combination with the nitric oxide supplementation to achieve optimal strength and lean mass. Nevertheless, Gardiner additionally teaches protocols of 4 weeks of training with supplementation and showed improvement in mass and strength (see Example 6).
Response to Applicant’s Arguments
Applicant argues “ Applicant respectfully submits that the previously pending claims are unobvious over Gardiner et al., as evidenced by Rai et al., in view of McKinley-Barnard et al., MunFitnessBlog, and RalphRoberts. However, in an effort to expedite prosecution and without acquiescing to any rejections, Applicant has amended claim 24, upon which claims 25-46 are dependent, to recite that the method of increasing a ratio of muscle mass to total body weight in a person consists of administering citrulline or a salt thereof, glutathione or a salt thereof, and optionally one or more additives selected from pharmaceutically acceptable carriers, solubilizers, surfactants, stabilizers, thickeners, lubricants, preservatives, dyes, sweeteners, flavorings, acidulants, electrolytes, and vitamins, provided that the additives do not include an amino acid, in conjunction with a resistance workout program to a person, as defined by the pending claims. Thus, each of the pending claims requires, inter alia, administering only (a) citrulline or a salt thereof and (b) glutathione [GSH] or a salt thereof, optionally in combination with (c) one or more additives selected from pharmaceutically acceptable carriers, solubilizers, surfactants, stabilizers, thickeners, lubricants, preservatives, dyes, sweeteners, flavorings, acidulants, electrolytes, and vitamins, provided that no amino acids other than those provided by citrulline or a salt thereof and GSH or a salt therefore administered in conjunction with the resistance workout program. In other words, the pending claims have been amended to exclude administration of a source of amino acids, other than those provided by citrulline or a salt thereof and GSH or a salt thereof, in conjunction with the claimed resistance workout program.
As acknowledged by the Office, Gardiner et al. (the primary reference) discloses a method for increasing muscle mass and/or strength of an individual comprising administering a food supplement comprising (1) a substance that increases nitric oxide production in the body and (2) a source of amino acids. In other words, Gardiner et al. discloses that both (1) a substance that increases nitric oxide production in the body and (2) a source of amino acids are required for increasing muscle mass and/or strength of an individual.
As further acknowledged by the Office, Gardiner et al. does not disclose that the dietary supplement for increasing nitric oxide production in the body comprises citrulline and glutathione. The Office relies on McKinley-Barnard et al. for its disclosure that "the combination of L-citrulline and GSH increases the levels of cGMP, nitrite, and NOx" (McKinley-Barnard et al. at "Conclusions" - see also Office Action at paragraph bridging pages 12 and 13). In that respect, Fig. 8 of McKinley-Barnard et al. shows that the effect of increasing NOx concentration was not confirmed for GSH alone, but rather was only confirmed for the combination of citrulline and GSH. In other words, McKinley-Barnard et al. discloses that the combination of citrulline and GSH, i.e., not GSH alone, is considered the substance that increases nitric oxide production in the body.
In view of the foregoing, if a person of ordinary skill in the art were to have combined the disclosures of Gardiner et al. and McKinley-Barnard et al. in the manner suggested by the Office, the person of ordinary skill in the art would not have arrive at the claimed invention, which excludes the administration of a source of amino acids, other than those provided by citrulline or a salt thereof and GSH or a salt thereof, in conjunction with the resistance workout program. Rather, a person of ordinary skill in the art, upon reading the disclosures of Gardiner et al. and McKinley-Barnard et al., would have been motivated to administer a food supplement comprising (1) a combination of citrulline and GSH (i.e., the substance that increases nitric oxide production in the body) and (2) a source of amino acids to increase muscle mass and/or strength of an individual.
Such a method is different from the claimed method, which consists of administering only (a) citrulline or a salt thereof, (b) GSH or a salt thereof, and (c) optionally one or more additives, provided that the additives do not include an amino acid, in conjunction with the resistance workout program, as defined by pending claims as amended herein. Applicants argue that a person of ordinary skill in the art would not have been motivated to combine the cited references in the manner suggested by the Office to administer only (a) citrulline or a salt thereof and (b) glutathione or a salt thereof, optionally in combination with (c) one or more additives selected from pharmaceutically acceptable carriers, solubilizers, surfactants, stabilizers, thickeners, lubricants, preservatives, dyes, sweeteners, flavorings, acidulants, electrolytes, and vitamins, provided that the additives do not include an amino acid, in conjunction with a 4 day per week resistance training program comprising two upper and two lower extremity workouts per week for a total of 4 weeks, as required by the pending claims.
Applicants arguments have been fully considered but not found persuasive. Applicant argues that the prior art does not teach or suggest the claimed method because Gardiner allegedly requires administering both a nitric oxide increasing substance and a source of amino acids, whereas McKinley Barnard purportedly teaches only the combination of citrulline and glutathione. Applicants asserts that a person of ordinary skill in the art would not have modified Gardiner with McKinley Barnard to exclude additional amino acids and arrive at the presently claimed composition. As noted in the updated rejection, the office action has restructured the prior art analysis such that McKinley Barnard now serves as the primary reference, rather than Gardiner. McKinley Barnard teaches administering a composition consisting of L-citrulline and glutathione in conjunction with resistance exercise and demonstrates increased nitric oxide related physiological effects resulting from the combination. Thus, contrary to Applicants position, the core composition recited in the amended claims (i.e. citrulline and glutathione without additional amino acids) is expressly taught in the primary reference (McKinley-Barnard).
Gardiner, along with MumFitness Blog and RalphRoberts, is now applied as a secondary and tertiary references for the exercise regiment features, duration, repetition structure, and training frequency. These references collectively teach standardized resistance training protocols, multi-week implementation schedules, and body composition based measurement, all of which align with the claimed method steps. As explained under the revised rejection, it would have been obvious before the effective filing date of the claimed invention for a person of ordinary skill in the art to apply the multi-week resistance training system of Gardiner, supported by routine exercise programming teachings in MumFitness Blog and RalphRoberts, to the method disclosed in McKinley Barnard in order to optimize nitric oxide mediated training adaptation.
Under KSR Int’l Co. v. Teleflex, 550 U.S. 398 (2007), the substitution or combination of known elements to achieve predictable improvements is considered obvious where, as here, all references pursue the same objective, improving strength and training response through nitric-oxide linked supplementation and resistance exercise. Because each reference is directed to the same field of exercise supplementation and resistance-training physiology, a person of ordinary skill in the art would have had a reasonable expectation of success in combining their teachings. Applicant has not provided evidence of criticality or unexpected results sufficient to overcome the rejection under MPEP §§ 2143 and 2145.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to modify the supplementation and exercise regimen of McKinley-Barnard to incorporate the structured multi-week resistance training protocol taught in Gardiner. One of ordinary skill in the art would have been motivated to do so because both references address improving physiological outcomes associated with resistance training, including improvements in muscle strength, muscle size, and nitric-oxide-mediated exercise response, and both identify nitric oxide signaling as a biological mechanism contributing to training adaptation. McKinley-Barnard demonstrates that co-administration of L-citrulline and glutathione enhances nitric-oxide biomarkers and exercise performance in response to resistance activity, while Gardiner teaches that meaningful and measurable changes in muscle composition and strength occur when supplementation is paired with a structured, multi-week progressive resistance training program, rather than a single acute training session.
A person of ordinary skill in the art would have recognized that replacing the resistance protocol in McKinley-Barnard with the longer-term program of Gardiner and RalphRoberts represents routine optimization of a known parameter—namely, the duration and frequency of resistance training—and would predictably result in improved or more measurable muscular outcomes. Such design choice reflects a predictable variation of known methods and falls within the reasoning permitted under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), which states that combining familiar elements according to known methods to achieve predictable results is obvious. This rationale is further supported by MPEP § 2143(I)(B) (predictable results rationale) and MPEP § 2144.05 (routine optimization).
Accordingly, there would have been a reasonable expectation of success in applying the multi-week structured resistance protocol of Gardiner to the supplementation framework of McKinley-Barnard, because both references operate in the same field of exercise science, rely on the same biological mechanism (nitric-oxide-mediated exercise enhancement), and seek the same outcome—improved muscle performance and adaptation resulting from resistance training.
Furthermore, it would have been obvious to perform the resistance training protocol of McKinley-Barnard and Gardiner 70-80% of 1-RM to achieve optimal muscle building. One of ordinary skill in the art would have been motivated to do so given that Mumfitnessblog teaches that a weight that is between 70% and 85% of your 1 RM is recommended for building muscle in most weight training programs. There is a reasonable expectation of success given that McKinley-Barnard teaches a protocol wherein the 3 sets of 15 repetitions were typically 70–75 % of 1RM and Mumfitnessblog teaches between 70% and 85% of your 1 RM is recommended for building muscle.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to incorporate the four-day resistance-training split routine taught by RalphRoberts into the combined teachings of McKinley-Barnard, Gardiner and MumFitness. One of ordinary skill in the art would have been motivated to do so because RalphRoberts teaches that a four-day upper/lower body split is a commonly used and effective resistance-training format for improving muscle size, strength, and training efficiency while balancing recovery. This scheduling approach aligns with the same training objectives and goals described in McKinley-Barnard and Gardiner and is presented as a standard, accepted method for structuring resistance training exercise programs.
The modification of the exercise protocol to adopt a known four-day training split represents a predictable refinement of an existing regimen and constitutes routine optimization of a known design parameter (training frequency), as described in MPEP § 2144.05. Under the reasoning of KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), combining familiar elements according to known methods to achieve predictable results is obvious where the improvement is no more than the predictable use of prior-art elements according to their established functions. Because RalphRoberts describes a widely accepted and routinely implemented scheduling format used to achieve the same muscular performance benefits sought in McKinley-Barnard and Gardiner, there would have been a reasonable expectation of success in applying the four-day split structure to the supplementation-and-exercise method.
Applicants further argue that “Applicant has unexpectedly discovered that such an administration in conjunction with the resistance workout program, as defined by the pending claims, is sufficient to increase the ratio of muscle mass to total body weight in a person. In other words, Applicant has unexpectedly discovered that "a source of amino acids", other than those provided by citrulline or a salt thereof and GSH or a salt thereof, is not required to increase the ratio of muscle mass to total body weight in a person.”
Applicant’s arguments have been fully considered but not found persuasive. As noted in the revised rejection, McKinley-Barnard, now the primary reference, expressly teaches administering only the combination of L-citrulline and glutathione, without requiring or relying on any additional amino acid supplementation or amino-acid-containing additive. Thus, the claimed exclusion of other amino acids does not represent a departure from, or unexpected performance relative to, the closest prior art. It merely recites what McKinley-Barnard already practices.
Furthermore, the core active supplementation ingredients (citrulline and glutathione) remain unchanged and are themselves amino-acid-based molecules recognized to play roles in nitric-oxide synthesis, vasodilation, recovery, and muscle protein synthesis. Excluding optional additional amino acids constitutes a routine formulation choice and falls under routine optimization of known result-effective variables, consistent with KSR v. Teleflex, 550 U.S. 398 (2007) and MPEP § 2144.05.
Finally, applicant has not provided evidence meeting the standard for unexpected results under MPEP § 716.02, such as comparative data demonstrating a difference between supplementation with citrulline+glutathione versus supplementation that includes additional amino acids. Attorney argument alone is insufficient to establish unexpected results (In re Best, 562 F.2d 1252 (CCPA 1977); In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)). Applicants do not point to any specific data regarding unexpected results in this response. However, as stated in the previous office action, McKinley-Barnard teaches “In the present study, L-citrulline + GSH showed an improvement in cGMP activity suggesting that this outcome could likely play a role in muscle protein synthesis and muscle performance when combined with resistance training” (see Discussion, paragraph 0008). Thus, it is not unexpected that increasing NO and cGMP levels with resistance training would increase protein synthesis and muscle mass. Furthermore, Applicants have not shown any comparison between a non-trained control and placebo trained group to determine the effects of the training protocol. Furthermore, Figure 1B does not show any statistically significant differences between groups (it is not indicated and the standard error bars are overlapping). MPEP 716.02 states “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Furthermore, at 8 weeks, the data seems variable and there does not appear to be any statistically significant changes between the groups.
Regarding the data in Figure 2, again there is no statistical significance indicated between groups. Furthermore, Placebo does appear to have 28% of the subjects whom do have a consistent increase in muscle mass at both 4 and 8 weeks which is contradictory to Applicant’s arguments above stating that there is loss of muscle mass in the placebo group because of the “overtraining”. Nevertheless, MPEP 716.02 states “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Regarding figures 3A-3D, there is no differentiation between groups with regards to 1-RM at the different time points. Thus, this data only confirms improvement of 1-RM/muscle mass over time which is not unexpected. Regarding Figures 3E-3F there is no significant changes in 1-RM/muscle mass whereas 3G is indicated to be a significant increase in 1-RM/muscle mass (in pounds) with GSH +CIT. Applicants specification states “a statistically significant correlation between muscle mass and strength was observed in subjects administered L-citrulline and GSH” (see paragraph 0080). However, it is unclear how this correlation is unexpected given that one would expect with an increase in muscle mass there would be an increase in strength especially in with eight weeks of training. Furthermore, any assertions of unexpected results should be commensurate in scope of the claims (see 716.02 (d)). In the instant case, claim 24 does not require any specific amounts of citrulline or GSH that would be commensurate in scope with the unexpected results. For all of the reasons stated above, the rejection is maintained.
Conclusion
No claims are allowed.
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/ERINNE R DABKOWSKI/ Examiner, Art Unit 1654