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 .
Application Status
Claim 1, 3, 5-7, 10-17, 19, 22-27 and new claim 28 are under examination.
Claim 2, 4, 8-9, 18 and 20-21 are cancelled.
Claim 1, 3, 5-7, 10-17, 19 and 22-28 are rejected.
Withdrawn Rejections
The 112, second paragraph rejections over claim 24-27 as set forth in previous office action have been withdrawn in light of Applicant’s amendments.
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.
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.
Claim(s) 1, 3, 5-7, 10-17, 19, 22-24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Rinsch et al. (US 9,962,366) in view of Hamill et al. (WO 2018/118957 A1).
Regarding claim 1, 3, 5, 7, 19 and 23, when reading the preamble in the context of the entire claim, the recitation “…improving and/or enhancing at least one bone benefit selected from the group consisting of bone mineralization, bone strength, bone mass, and bone mineral density…” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble, wherein the limitations with respect to the “the individual” in claim 7; and 23 are considered within the preamble of claim 1, does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Rinsch et al. (Rinsch) discloses a method of administering of a composition in an effective amounts (‘366, col. 146, ln. 1-27) for treatment in autophagy in bone (‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47). Rinsch discloses the method comprising the administering the composition to an animal (individual) (‘366, col. 74, ln. 25-29; ln. 40-43), wherein the composition comprising urolithin (autophagy-inducing compound) (‘366, col. 138, ln. 9-28) and spermidine (autophagy-inducing compound).
With respect to the new limitation of “at least two anabolic amnio acids”, Rinsch discloses the composition comprising one or more agent useful for mitochondrial disorder, wherein the one or more agents includes L-arginine (anabolic amino acid) (‘366, col. 141, ln. 43-49) in effective amounts (‘366, col. 146, ln. 1-27; col. 150, ln. 8-47). Additionally, Hamill et al. (Hamill) discloses method of administering (‘957, pg. 19, ln. 23-27) a composition comprising at least four different amino acids entities (‘957, pg. 1, ln. 26-27; pg. 3, ln. 7-8) for disorder including decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27) and bone weakness disease (‘957, pg. 22, ln. 13). Hamill discloses in some embodiments the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, and L-Glutamine (‘957, pg. 17, ln. 16-24) in the composition.
Rinsch and Hamill are of the same field of endeavor of administering a composition comprising amino acids entities (anabolic amino acids) for disorder including decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47). It would have been obvious to one of ordinary skill in the art to be motivated to use Hamill’s the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, L-Glutamine (‘957, pg. 17, ln. 16-24) in Rinsch’s method for treating decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47) as taught by Hamill.
With respect to claim 5, modified Rinsch discloses the effective amounts (‘366, col. 146, ln. 1-27; col. 150, ln. 8-47). Modified Rinsch uses like materials in a like manner as claimed, it would therefore be expected that the composition will have same characteristics claimed, particularly to activate mTOR in the animal (individual). With respect to claim 7 and 23, the animal (individual) is aging (‘366, col. 20, ln. 35-64). Modified Rinsch discloses osteoarthritis, bone disease (‘366, col. 20, ln. 35-64). As noted, the limitations with respect to the “the individual” in claim 7 and 23 are considered within the preamble of claim 1, does not provide any distinct definition of any of the claimed invention’s limitations.
Regarding claim 6, modified Rinsch discloses the administering of the composition in the effective amounts (‘366, col. 146, ln. 1-27) for treatment in autophagy in bone (‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47).
Regarding claim 10, 11, 14, 24 and 26, Hamill discloses in some embodiments the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, L-Glutamine (‘957, pg. 17, ln. 16-24) in the composition. Rinsch and Hamill are of the same field of endeavor of administering a composition comprising amino acids entities (anabolic amino acids) for disorder including decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47). It would have been obvious to one of ordinary skill in the art to be motivated to use Hamill’s the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, L-Glutamine (‘957, pg. 17, ln. 16-24) in Rinsch’s method for treating decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47) as taught by Hamill. Modified Rinsch discloses whey-based cysteine supplements, wherein the whey-based cysteine is known as a hydrolyzed protein.
Regarding claim 12, 13 and 22, modified Rinsch discloses the L-arginine (anabolic amino acid) (‘366, col. 141, ln. 43-49), which is a free form amino acids. Ritsch’s L-arginine is considered multiple particles of the L-arginine (anabolic amino acid), hence meets limitation of a mixture of multiple particles of the L-arginine (anabolic amino acid).
Regarding claim 15, modified Rinsch does not explicitly the protein has a formulation as cited; however it is well known in the art to obtain a desired molecular weight of a protein for intended use in a consumable product. It would have been obvious to one of ordinary skill in the art to be motivate to use known molecular weight including the cited weight in modified Rinsch for a desired application in the composition, absent a showing of unexpected results.
Regarding claim 16, modified Rinsch discloses the composition comprising vegetable oil (fat source) (‘366, col. 145, ln. 26-29) and corn starch (carbohydrate source) (‘366, col. 145, ln. 18).
Regarding claim 17, modified Rinsch discloses the administering of the composition by oral (‘366, col. 144, ln. 45).
Claim(s) 25, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Rinsch et al. (US 9,962,366) in view of Hamill et al. (WO 2018/118957 A1) as applied to claim above, and further in view of Clayton (WO 02/47492 A2).
Regarding claim 25, 27 and 28, modified Rinsch discloses the claimed invention as discussed above. As, Hamill discloses in some embodiments the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, L-Glutamine (‘957, pg. 17, ln. 16-24) in the composition. Rinsch and Hamill are of the same field of endeavor of administering a composition comprising amino acids entities (anabolic amino acids) for disorder including decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47). It would have been obvious to one of ordinary skill in the art to be motivated to use Hamill’s the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, L-Glutamine (‘957, pg. 17, ln. 16-24) in Rinsch’s method for treating decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47) as taught by Hamill. Modified Rinsch discloses whey-based cysteine supplements, wherein the whey-based cysteine is known as a hydrolyzed protein.
Modified Rinsch does not disclose thymol in the composition. However, Clayton discloses a health promoting composition for mitochandhal function (‘493, pg. 8, ln. 27-32 – pg. 9, ln. 3-4) includes thymol. Clayton and Rinsch are of the same field of endeavor of promoting mitochandhal function. It would have been obvious to one of ordinary skill in the art to be motivated to use Clayton’s thymol in Rinsch to provide a desired health benefit for promoting mitochandhal function (‘493, pg. 8, ln. 27-32 – pg. 9, ln. 3-4) as taught by Clayton.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive.
Applicant asserts “…Firstly, the teachings of Rinsch and Hamill are incompatible with one another. Hamill teaches that the composition comprising at least four amino acids is effective for "treating physiological symptoms selected from immobilisation, malnutrition, fasting, aging, autophagy " This is further clarified in Table 4, row 1…wherein it is stated that administering the composition of Hamill to a subject is expected to decrease the subject's myoglobin levels, resulting in reduced autophagy and reduced muscle breakdown. The skilled person reading Hamill is therefore taught that a composition comprising at least four amino acids can be used to reduce autophagy in an individual. In contrast, Rinsch primarily teaches a method to achieve the opposite effect, i.e. increase autophagy in an individual. The methods taught in these two references are therefore incompatible with each other as they aim to achieve opposing outcomes. The skilled person will therefore be disincentivised from using Hamill's composition comprising at least four different amino acid entitles in Rinsch's method for increasing autophagy. Secondly, Applicant submits that even if the skilled person were to somehow overlook this incompatibility, it is simply not obvious to combine these references as they belong to different technical fields and are directed towards solving different problems…”.
Applicant’s remarks are not convincing. Hamill’s Table 4, row 1 discloses the opposite of Applicant’s argument; wherein Table 4 disclose a “down” is a “decrease” of the composition suggest a reduction of the autophagy. In other words, Hamill’s composition comprising the least four amino acids when down in amount would suggest a reduction autophagy. There is no disclosure in Table 4 wherein Hamill’s composition comprising the least four amino acids in “up” amount would provide a reduction of autophagy.
It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Rinsch and Hamill are of the same field of endeavor of administering a composition comprising amino acids entities (anabolic amino acids) for disorder including decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47). It would have been obvious to one of ordinary skill in the art to be motivated to use Hamill’s the least four different amino acids entities (anabolic amino acids) including L-Leucine, L-Isoleucine, L-Valine, L-Glutamine (‘957, pg. 17, ln. 16-24) in Rinsch’s method for treating decreased mitochondrial biogenesis (‘957, pg. 5, ln. 27; ‘366, col. 141, ln. 43-46)) and bone weakness disease (‘957, pg. 22, ln. 13; ‘366, col. 29, Table 1, ln. 20; col. 150, ln. 8-47) as taught by Hamill.
Applicant asserts “…New and unexpected results are provided by the present claims as
detailed in the experimental data set forth in Example 3 of the specification. Example 3 assesses the effect of an amino acid mix comprising anabolic amino acids (specifically isoleucine and leucine), as well as other amino acids (valine, proline, glycine, lysine, and cysteine), both in the absence and presence of the autophagy-inducing compound, thymol…”.
Applicant’s remarks are not persuasive. The new and unexpected results as detailed in the experimental data set forth in Example 3 of the specification does not commensurate claim wherein the composition of Example 3, with specific amounts % and specific amino acids [00187] for new and unexpected results, hence Applicant’s argument is not convincing. It is noted the instant claims are broad without specific amounts % and specific amino acids.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/HONG T YOO/Primary Examiner, Art Unit 1792