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 .
All previous objections and rejections not reiterated herein were overcome by amendments to the claims and specifications, filed December 23rd, 2025 have been fully considered and found persuasive. As such the objections and rejections not reiterated herein have been withdrawn.
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.
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Claims 1 – 18 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5, 7 – 12, 14 -18, and 20 of U.S. Patent No. US 11173167 to Rathmacher et. al. (herein after Rathmacher’167).
Rathmacher’167 recites a method for improving muscle function (reference claims 1 and 9; instant claims 13), muscle mass (reference claim 15; instant claims 1 and 21) and muscle strength (reference claim 8; instant claim 7) in an elderly human that is not required to exercise (reference claim 7, 14, and 20; instant claims 1 – 2, 7 – 8, 13 – 14, and 21) the method comprising the steps of administering to said elderly human a composition comprising a combination of from about 0.5g to about 30 g of β-hydroxy-β-methylbutyrate (HMB) and Vitamin D (reference claims 4 – 5, 12 and 18; instant claims 1, 7, 13, and 21) in an amount sufficient to raise blood levels of Vitamin D to at least 30 ng/ml, wherein said combination of HMB and Vitamin D to the elderly human (reference claims 1, 9, and 15; instant claims 1, 7, 13, and 21) is administered. Further reciting that the HMB is selected from the group consisting of its free acid form (instant claims 3, 6, 12, 16, and 18), its salt (instant claims 4 – 5,10 - 11, 15, and 16), its ester and its lactone (reference claims 2, 10, and 16); is a calcium salt (reference claims 3, 11, and 17; instant claims 5, 11 and 17).
While, the claimed invention of Rathmacher’167 fails to explicitly recite an amino acid requirement or non-exercising human; Rathmacher’167 does recite that the elderly humans are not required to exercise. Thus the elderly humans that do not exercise falls within the species of non-exercising humans as recited in the instant application. Moreover, one skilled in the art would have found it obvious to conclude that because amino acids are not taught in the composition, it therefore absent from said composition which is in an amount less than 0.5g. Additionally, both the instant application and Rathmacher’167 direct to methods for improving muscle strength and function through the administration of HMB and Vitamin D.
Therefore, given the overlap in populations receiving the treatment and the treatment method it would be obvious to one of ordinary skill in the art that although the claims at issue are not identical, they are not patentably distinct from each other. Additionally, by not reciting an amino acid requirement, Rathmacher’167 amino acid amount is given the broadest reasonable interpretation of 0 grams of individual amino acid. Since 0 grams is less than 0.5 grams the claimed invention of Rathmacher’167 meets the limitation as being less than 0.5 grams of individual amino acids. Therefore it would be obvious to one of ordinary skill in the art that the method as claimed in instant claim 21 is rendered obvious by Rathmacher’167. Thus the instant application is rendered obvious over reference Rathmacher’167.
Response to Arguments
Applicant's arguments with respect to the see Applicants remarks page 2 – 5, filed December 23rd, 2025, with respect to NSDP rejection of instant claims 1 – 18, and 21 over claims 1 – 5, 7 – 12, 14 -18, and 20 of U.S. Patent No. US 11173167 to Rathmacher et. al. (herein after Rathmacher’167) have been fully considered but they are not persuasive.
Applicant argues that the present application is not in the priority chain of the cited patent (see applicants arguments page 2 paragraphs 4 – 5).
The argument is unpersuasive since double patenting rejections are based on a comparison of the claims in a patent and an application or between two applications which have at least one common inventor, common applicant, and/or are commonly assigned/owned or non-commonly assigned/owned but subject to a joint research agreement as set forth in 35 U.S.C. 102(c) or in pre-AIA 35 U.S.C. 103(c)(2) and (3). (MPEP 1504.06). Since the instant application and the invention share a common applicants, that is John Rathmacher, Shawn Baier, and John Fuller, Jr, as well as a common assigned, that is Metabolic Technologies, an NSDP rejection can be made.
Applicant argues that the examiner NSDP analysis improperly treats the composition as the invention and that the method of administrating HMB and Vitamin D produces a statistically significant improvement in strength without reliance on exercise of amino acid supplements (see applicants arguments page 2 paragraph 6 and page 3 paragraph 1).
This argument is unpersuasive since it falls along the lines of unexpected results; however, any differences between the claimed invention and the prior art, may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected).(MPEP 716.02). Now while the invention of Rathmacher’167 is not prior art, applicant still has the burden on demonstrating or explaining greater than expected results (MPEP716.02(b)).
Applicant argues that the claimed population and required therapeutic success define a different invention (see applicants arguments page 3 paragraph 4).
However, as pointed out in the rejection conflicting patent Rathmacher’167 recites that the elderly population is not required to exercise and thus would inherently have individuals who do not or cannot exercise. Thus the populations of patients in the instant application overlaps with the populations of the conflicting patent Rathmacher’167.
Discussion of the prior art
The instant claims 1 – 18, and 21 direct to a method of increasing muscle mass of a non-exercising human in need thereof comprising the steps of administering to said human a combination of from about 0.5 g to about 30 g of acid (HMB) and Vitamin D in an amount sufficient to raise blood levels of Vitamin D to at least 30 ng/ml, wherein upon said administration of said combination HMB and Vitamin D to the animal, said muscle mass is increased in amount similar to that achieved by an exercising human that does not consume HMB (claim 1); a method of increasing strength of a non-exercising human in need thereof comprising the steps of administering to said human a combination of β-methylbutyric acid (HMB) from about 0.5 g to about 30 g and Vitamin D in an amount sufficient to raise blood levels of Vitamin D to at least 30 ng/ml, wherein the human does not engage in a formal exercise program during the administration period, and wherein administration of said combination HMB and Vitamin D results in a statistically significant increase in muscle strength relative to a non-exercising population not receiving HMB (claim 7); a method of improving muscle function of a non-exercising human in need thereof comprising the steps of administering to said human a combination of β- hydroxy-β-methylbutyric acid (HMB) from about 0.5 g to about 30 g and Vitamin D in an amount sufficient to raise blood levels of Vitamin D to at least 30 ng/ml, wherein the human does not engage in a formal exercise program during the administration period and wherein upon said administration of the combination of HMB and Vitamin D results in a statistically significant imrpov4ement in composite measures of muscle function relative to non-exercising population not receiving HMB (claim 13); and a method of increasing muscle mass in a non-exercising human in need thereof comprising the steps of administering to said human a combination of β- hydroxy-β-methylbutyric acid (HMB) from about 0.5 g to about 30 g and Vitamin D in an amount sufficient to raise blood levels of Vitamin D to at least 30 ng/ml, wherein the human does not engage in a formal exercise program during the administration period and wherein upon said administration of the combination of HMB and Vitamin D to the human wherein the composition contains less than 0.5 grams if any individual amino acids and wherein the administration of the composition results in a statically significant increase in muscle mass relative to a non-exercising group receiving HMB (claim 21).
The closest prior art of US Patent No. US 8, 815, 280 B2 to Rathmacher et al. (herein after Rathmacher’280; cited in the office action mailed October 9th, 2024) teach a composition comprising β-hydroxy-β-methylbutyrate (HMB) and Vitamin D, and methods of using the composition to improve muscle mass (claim 1), strength (claims 7 and 21), or functionality (claim 13) (column 1 lines 11 – 15). Moreover, Rathmacher’280 teach that compositions comprising HMB and amino acids, more specifically arginine and lysine have been used in the prior art to increase lean mass in non-exercising, elderly population over a year-long study (column 2 lines 62 – 64).
However, Rathmacher’280 fails to explicitly teach the limitation of the administration of the composition to non-exercising humans. Moreover as pointed out in Applicants arguments (page 6 paragraphs 1 and 4 – 5), populations that did not exercising performed unexpectedly better in the Get up test at 12 months (Figure 4A), and Handgrip strength (Figure 5A). Thus the prior art of Rathmacher’280 fails to anticipate or render obvious the method of the instant applications.
Conclusion
Claims 1 – 18 and 21 are rejected.
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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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682