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
The amendment to the claims filed after non-final office action on April 7, 2026 is acknowledged. Claim 24 was amended, claims 1-23, 35-37, and 47-49 were canceled and claims 24-34, 38-46 are pending in the instant application. The restriction was deemed proper and made final previous office action.
Claims 24-34 and 38-46 are examined on the merits of this office action.
Maintained/Revised 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 24-34, 38-46 are/remain 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, 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 claim 24, administering the supplement of McKinley-Barnard in view of Gardiner daily for four weeks meets the limitations of a period of 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 claims 39-40, 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 role 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 that McKinley-Barnard does not disclose supplementation and resistance exercise occurring during the same period. IN particular, Applicant argues that McKinley Barnard teaches administered L-citrulline and GSH for seven days and resistance occurred only after supplementation. Therefore McKinely Barnard does not disclose a resistance workout program administered during supplementation, resistance workout throughout the supplementation or supplementation for at least 28 days with concurrent resistance training. Applicant’s arguments have been fully considered but not found persuasive. MPEP 2145 states “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).” In the instance case, the rejection does not rely upon McKinley-Barnard for teaching the entire training protocol. McKinley Barnard is relied upon for administering L-citrulline and glutathione, administering them in connection with resistance training, dosage amounts, intensity and NO enhancement associated with resistance exercise. Gardiner is relied upon for multi week training, supplementation during a prolonged training period, body composition measurement. RalphRoberts is relied upon for four day per week upper/lower split training. Accordingly, Applicant attacks McKinley-Barnard individually rather than the combination actually relied upon for the rejection.
Applicant argues that McKinely Barnard teaches only NO biomarkers, not muscle mass. In particular, applicant argues that McKinley Barnard measures NOx markers, cGMP, nitrite and strength but does not measure muscle mass or muscle mass ratio. Applicant’s arguments have been fully considered but not found persuasive. The rejection does not rely upon McKinely-Barnard as teaching muscle mass measurements. Mckinley Barnard teaches the exact supplementation combination, enhanced nitric oxide signaling and improved physiological responses to resistance exercise. Gardiner teaches muscle size improvements, strength improvements and body composition assessment. One of ordinary skill would have reasonably expected that the physiological benefits taught by McKinley-Barnard would contribute to the muscle adaptations associated with the multi-week training regiment taught by Gardiner.
Applicant argues that Gardiner requires a source of amino acids, in particular a nitric oxide enhancer and amino acid source. Applicant argues that amino acids are required by Gardiner, Gardiner would not motivate omission of amino acids and Gardiner teaches away from the claimed invention. Applicants arguments have been fully considered but not found persuasive. The rejection does not rely upon Gardiner for teaching the claimed supplementation composition. Rather, McKinley-Barnard teaches administration of citrulline and glutathione, while Gardiner is relied upon for teaching that enhancement of nitric oxide related pathways in conjunction with a multi-week resistance training program is associated with improvements in muscle size, muscle strength, and body composition. Gardiner’s disclosure of embodiments utilizing amino acid supplementation does not constitute a teaching away from the proposed combination because Gardiner does not criticize, discredit, or otherwise discourage the use of nitric oxide enhancing compositions absent additional amino acid supplementation. Instead, Gardiner teaches that nitric oxide enhancement is beneficial for promoting physiological adaptations associated with resistance training. Therefore, one of ordinary skill in the art would have reasonably expected the nitric-oxide-enhancing citrulline/glutathione regimen taught by McKinley-Barnard to likewise be beneficial when utilized in the multi-week resistance training program taught by Gardiner.
Applicant argues Gardiner does not disclose citrulline and glutathione and is silent to citrulline and glutathione. Applicants arguments have been fully considered but not found persuasive. The rejection relies on Mckinley Barnard for citrulline and glutathione and Gardiner for duration, body composition, assessment and muscle size outcomes. A reference need not disclose every claimed feature.
Applicant argues Gardiner would require additional amino acids beyond citrulline and GSH. Applicant argues that Gardiner and Mckinley Barnard would arrive at citrulline, GSH and amino acids. Therefore the proposed combination would not yield the claimed invention. Applicants arguments have been fully considered but not found persuasive. The rejection does not require incorporating of every feature disclosed in Gardiner. A reference is relied upon only for what it teaches. The rejection relies upon Gardiner for multi week resistance training, body week composition assessment and muscle size outcomes. The rejection does not rely upon Gardiner’s amino acid disclosure. Applicant improperly argues against bodily incorporation (see MPEP707.07). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues nitric oxide production alone does not increase muscle mass and Gardiner requires amino acids for NO enhancement. Applicants arguments have been fully considered but not found persuasive. The rejection does not assert that NO alone increases muscle mass. Rather, Mckinley-Barnard teaches enhanced NO signaling during resistance exercise. Gardiner teaches muscle size and strength improvements associated with NO promoting supplementation during training. Furthermore, resistance training itself is known to increase muscle mass. Thus, the rejection relies upon the combined teachings of the references.
Applicant argues the references do not directly disclose increasing muscle mass ratio (muscle mass to body weight). Applicants arguments have been fully considered but not found persuasive. Direct disclosure is not required under 35 U.S.C. 103. The issue is wither the claimed subject matter as a whole would have been obvious. The cited references collectively teaches the claimed supplementation, the claimed training duration, the claimed exercise intensity, the claimed workout frequents/duration and body composition assessment. Thus, combining known elements according to know methods to obtain predictable results is obvious under KSR (See MPEP2143). Nevertheless, 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.
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.
Applicant argues that they unexpectedly discover amino acids are unnecessary and that they are not required in combination with GSH and citrulline. Applicants arguments have been fully considered but not found persuasive. Applicants have not shown criticality of excluding amino acids, comparative data versus amino acid containing formulations and unexpected superiority relative to the closest prior art.
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.
Applicant argues that figure 1A demonstrates unexpected results. Figure 1A shows placebo had 0 kg gain, Cit-malate had 0.1 kg gain, GSH-Cit had .75 kg gain. Applicants arguments have been fully considered but not found persuasive. McKinley-Barnard already teaches the exact citrulline GSH combination, McKinley-Barnard teaches superior physiological responses from the combination and Gardiner teaches that NO-promoting supplementation with resistance training improves muscle size and strength. Accordingly, the in creased muscle mass represents the type of adaptation that one of ordinary skill would have expected from the combined teachings. Figure 1A does not establish critcaility or excluding amino acids, unexpected superiority over the closest prior or synergy relative to all relevant prior art combinations. 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.
Applicant argues that MumFitnessBlog and RalphRoberts do not cure the deficiencies. Applicant further argues that the workout references merely teach 70-80% 1RM and upper lower split and do not cure the deficiencies in Mckinley-Barnard or Gardiner. Applicants arguments have been fully considered but not found persuasive. The references are relied upon for precisely the above stated limitations. The rejection does not rely on them for supplementation teachings. Therefore, Applicants arguments is directed at features for which those references were not cited for teaching.
Applicant argues that the combined references would not lead to the claimed method. Applicants arguments have been fully considered but not found persuasive. The references collectively teach citrulline/GSH, resistance exercise, 70-80% 1RM, multi-week training, body composition assessment, upper/lower training split and four training days per week. The claimed variables (dose, duration, intensity, timing and frequency) constitute known result effective variables. Selection and optimization of such variables would have been within ordinary skill. Accordingly, the rejection under 35 U.S.C. 103 is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ERINNE R DABKOWSKI/ Primary Examiner, Art Unit 1654
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