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 1-20 are under examination.
Claim 1-20 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/02/2024, 12/23/2024, 10/28/2025 and 04/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 3 and 4 are objected to because of the following informalities: claim 3 and 4 recite the same limitations to claim 1 . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the phrase “the anabolic amino acid in an amount approximately equal to or greater than an amount of the anabolic amino acid…” is confusing. It is not clear what Applicant intend for the comparison of amount of the anabolic amino acid based upon itself. The claim is indefinite.
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) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Offord-Cavin et al. (CN 1602159, Machine Translation English) in view of Moore et al. (US 8,968,791 B2).
When reading the preamble in the context of the entire claim, the recitation “…of improving and/or enhancing at least one of bone mineralization, bone strength, bone mass, and bone mineral density in an individual in need thereof.…” 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 5, 7, 8 and 9 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.
Regarding claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 18, 19 and 20, Offord-Cavin et al. (Offord-Cavin) discloses a method for improving bone regeneration including bone mineral density and bone mass comprising administering to an individual a food composition(‘159, pg. 3, ln. 5th – 11th paragraph), wherein the composition comprising plant extract including thymol (autophagy-inducing compounds) (‘159, pg. 3, 12th – 14th paragraph) and free amino acids mixture (‘159, pg. 4, 7th paragraph).
Offord-Cavin does not explicitly discloses the free amino acids mixture as anabolic amino acids. However, Moore et al. (Moore) discloses a dietary supplement to promote bone growth and repair (‘791, col. 2, ln. 48-51), wherein the supplement comprising several amino acids includes leucine, isoleucine, arginine and glutamine (anabolic amino acids) (‘791, col. 7, ln. 65-67; col. 8, ln. 1-8). Moore and Offord-Cavin are of the same field of endeavor of promoting bone growth. It would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to use Moore’s several amino acids includes leucine, isoleucine, arginine and glutamine (anabolic amino acids) (‘791, col. 7, ln. 65-67; col. 8, ln. 1-8) in Offord-Cavin’s composition to promote bone growth and repair as taught by Moore (‘791, col. 2, ln. 48-51). With respect to claim 5 and 6, modified Offord-Cavin discloses the administering in effective amount of the composition (‘159, pg. 2, 2nd paragraph). Modified Offord-Cavin 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 or induce autophagy in bone in the individual. With respect to claim 7, 8, and 9, the individual with bone disease (‘159, pg. 2, 2nd- 3rd paragraph). As noted, the limitations with respect to the “the individual” in claim 7, 8 and 9 are considered within the preamble of claim 1, does not provide any distinct definition of any of the claimed invention’s limitations. With respect to claim 18, modified Offord-Cavin discloses the several amino acids includes leucine, isoleucine, arginine and glutamine (anabolic amino acids) (‘791, col. 7, ln. 65-67; col. 8, ln. 1-8), and considered to encompass the limitation.
With respect to claim 19 and 20, Moore’s several amino acids includes valine, proline, glycine, cysteine (autophagy-inducing amino acids) (‘791, col. 7, ln. 65-67; col. 8, ln. 1-8).
Regarding claim 10, 11, 12, 13 and 14, modified Offord-Cavin discloses the composition comprising protein (‘159, pg. 4, 7th paragraph) including animal protein. Moore and Offord-Cavin are of the same field of endeavor of promoting bone growth. It would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to use Moore’s several amino acids includes leucine, isoleucine, arginine and glutamine (anabolic amino acids) (‘791, col. 7, ln. 65-67; col. 8, ln. 1-8) in Offord-Cavin’s composition to promote bone growth and repair as taught by Moore (‘791, col. 2, ln. 48-51). With respect to claim 11, the protein comprising milk protein (‘159, pg. 4, 7th paragraph). With respect to claim 13 and 14, modified Offord-Cavin discloses the protein comprising casein, wherein the casein is known as a hydrolyzed protein.
Regarding claim 15, modified Offord-Cavin does not explicitly disclose 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 Offord-Cavin for a desired application in the composition, absent a showing of unexpected results.
Regarding claim 16, modified Offord-Cavin discloses the composition comprising fat and carbohydrate source (‘159, pg. 4, 8th-9th paragraph).
Regarding claim 17, modified Offord-Cavin discloses the administrating the composition by enteral administration (‘159, pg. 4, 11th paragraph).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 5-7, 10-17, 22-24, 26 and 29 of co-pending Application No. 17/686,054 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims recites method of improving and/or enhancing at least one of bone benefits comprising administering to an individual a composition of anabolic amino acids and thymol as recited in claims 1-, 3, 5-7, 10-17, 22-24, 26 and 29 of co-pending Application No. 17/686,054.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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/HONG T YOO/Primary Examiner, Art Unit 1792
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