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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 9/9/2025 is acknowledged.
Claims 26-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/9/2025.
Current Status of 17/963,929
This Office Action is responsive to the claims of 9/9/2025.
Claims 1-25 have been examined on the merits.
Priority
This application is a continuation of abandoned Application 16/367,209, which also claims priority to US provisional applications 62/648,870 and 62/650,594. There are also family member patents (US1115449 and US11633354) and US application 18/117,328.
This application find support from abandoned Application 16/367,209. Therefore, the effective filing date is 3/27/2019.
Information Disclosure Statement
The information disclosure statement s (IDS), submitted on 10/31/2025 and 11/08/2022, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-25 are 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 1, and all claims depending therefrom, is indefinite for the recitation of “the pH of the composition is 4.2 to 4.4” because one of ordinary skill in the art would not be able to reasonably determine its metes and bounds in regards to the ‘dosage form’ (i.e. ‘a capsule, a cachet, a pill, a tablet, an effervescent tablet, a powder, a granule, a pellet, a bead, a particle, a troche, a lozenge’ or ‘a gel’) as recited by instant claim 1 and/or the ‘solid composition’ as recited by instant claim 2. The present specification discloses that the ‘pH’ is a property/functional limitation of a liquid composition (see paras. [0044] of pg. 14; and [0048] of pg. 15). Thus, the metes and bounds of claim 1 are unclear and thus indefinite. Dependent claims 2 and 4-14 do not resolve the rationale underpinning this rejection and are also rejected for the same reason.
In the present instance, claim 2 recites the broad recitation ‘a solid composition’, and the claim also recites that is must be all of the following: ‘a dietary supplement, a component of a dietary supplement, and a component of a fortified food’. The narrowing of the composition (the second limitation) is not indefinite; however, the claim says the solid composition must be all of the options of the second quoted limitation (which it can not be). Thus, the metes and bounds of the claim is unclear and therefore, indefinite. Dependent claims 7, 8, and 14 do not resolve the rationale underpinning this rejection and are also rejected for the same reason.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 4, and 23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites the “composition of claim 1, wherein the composition is a solid composition and is a dietary supplement, a component of a dietary supplement, and a component of a fortified food”. Claim 1 for which claim 2 depends recites the “composition is in a dosage form selected from the group consisting of: a capsule, a cachet, a pill, a tablet, an effervescent tablet, a powder, a granule, a pellet, a bead, a particle, a troche, a lozenge, a gel, a liquid, a suspension, a solution, an elixir, and a syrup”. Claim 1 says the composition can be a gel, liquid, suspension, elixir, or a syrup. However, Claim 2 says it must be a solid composition. Thus, claim 2 fails to further limit the subject matter of the claim upon which it depends.
Claim 1 recite the limitation of the molar ratio of the creatine compound to of the creatinine compound is 1:1 to 1:1.7. Claim 4 (which depends on claim 1) recites the limitation of “the weight of the creatinine compound is 50%-200% the weight of the creatine compound”. Claim 4 now allows for a 1:0.5 or a 1:2 ratio. Thus, claim 4 fails to further limit the subject matter of the claim upon which it depends.
Claim 23 does not depend on any claim, but might be attempting to be dependent on claim 20 (given claim construction and the “of 20”). Thus, claim 23 fails to further limit the subject matter since it does not properly depend on a claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-8, and 11-23 are rejected under 35 U.S.C. 102(a) as being anticipated by HOWARD (US6524611B2).
HOWARD anticipates a composition for human consumption, comprising creatine and a quantity of creatinine sufficient to render the creatine therein substantially stable when presented in an aqueous medium (ref Claim 1).
HOWARD anticipates the composition having a mole ratio of creatinine to creatine from 1:10 to 10:1. A 1:1 and 1:1.7 molar ratio of creatine to creatinine falls within the reference’s range. This anticipates claims 11-12.
HOWARD also anticipates a pH of the composition is 4.2 to 4.4 (this range falls between the reference’s range of 4.0 to 6.5 in ref claim 6). HOWARD anticipates a method of preparing this composition by providing solid creatine and solid creatinine (instant claimed the creatinine compound/anhydrous creatinine and the creatine compound/anhydrous creatine of claim 1); mixing the two solids so as to provide a resulting composition which, when dissolved in aqueous solution, provides a composition in which there is sufficient creatinine to render the creatine substantially stable (ref Claims 27 and 35). HOWARD anticipates an aqueous medium to be a drink (summary of invention).
This anticipates claims 1, 3, 11-12.
HOWARD anticipates a composition that takes the form of a dry powder (refers to instant claimed the composition is in a dosage form of a powder of claim 1; and instant claims 2 and 7) comprising 149 g of creatine monohydrate (refers to instant claimed the creatine compound/a hydrate of creatine of claim 1, and at least 2g of claim 13), 113 g of creatinine, and 1.8 g of vitamin premix (vitamin E 3.4 mg, vitamin C 16.2 mg, thiamin 0.3 mg, riboflavin 0.4 mg, niacin 5 mg, vitamin B6 0.4 mg, Focalin 85 μg, vitamin B12 0.9 μg, Biotin 0.18 mg and pantothenic acid 2.2 mg) (refers to instant claim 8); and it is dissolved in water (Example 6 on col. 16). The amounts of creatine monohydrate and creatinine (i.e. 113g/149g =0.758 or 75.8%) anticipates the limitation ‘the weight of the creatinine compound is 5%-800% the weight of the creatine compound’ of instant claim 1 and instant claim 4.
This anticipates claims 1, 2, 4, 7-8, and 13.
HOWARD anticipates that HOWARD’s composition can be put into gel like aloe gel or a semi-liquid foodstuff like yogurt (col 5). This anticipates claims 14-15, and 20-22.
HOWARD is silent on the storage and decomposition properties of the composition. However, the storage and decomposition properties of a chemical composition are an inherent property. See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical products, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. The composition of HOWARD is identical to the instant composition. Furthermore, the decomposition and storage of HOWARD’s composition would occur identically to the instant composition. This anticipates claims 16-19.
HOWARD anticipates additionally including a preservatives (col 7). This anticipates claim 23.
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) 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over HOWARD (US6524611B2) in view of GALVAN ((Journal of the International Society of Sports Nutrition, 2016, 13(12), pp. 1-24; cited in IDS filed 11/08/2022)
Claim(s) 1-4, 7-8, and 11-23 are taught above.
HOWARD teaches that caffeine can be added (col 7). HOWARD teaches that the term "creatine" as used herein is intended to encompass all bioavailable derivatives of creatine, such as creatine monohydrate, phosphocreatine, and other salts of creatine (col 3). This helps teach other salts of creatine.
HOWARD anticipates a range of creatine (for liquids per 100g) from 1.5g to 24g of creatine (col 8). This helps teach claims 5-6, 9-10 and 24-25.
HOWARD does not teach creatine nitrate explicitly.
GALVIN teaches that creatine nitrate has similar performance benefits as creatine monohydrate without any safety concern at the same concentration (see pg. 1, conclusion section; and pg. 23, left col., lines 3-9).
It would have been obvious for a person of ordinary skill in the art to substitute the creatine monohydrate (from HOWARD) with the creatine nitrate. An artisan would have been motivated to do so because of GALVIN’s performance benefits. This teaches claims 5 and helps teach claims 6, 9-10.
The artisan would be expected to optimize the amount of caffeine, creatine, and creatinine in the composition of HOWARD in the normal course of dose tailoring (col 3 and 8). See MPEP 2144.05(II): “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”. Neither the specification nor the claims indicate the ranges of amount of caffeine, creatine, and creatinine are critical. This teaches claims 5-6, 9-10 and 24-25.
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 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11633354. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims use a composition which teaches the instant compound claims.
Reference claim 18, drawn to a method of improving the oral bioavailability of creatine, the method comprising administering to a human subject a composition comprising an effective amount of creatine and creatinine, wherein the molar ratio of the effective amount of creatine and creatinine is 1:1 to 1:1.7 and the pH of the composition is 4.2 to 4.4, teaches instant claim 1, drawn to a composition of creatine and creatinine with the same molar ratio and pH. ‘354’s specification Col 3 also teaches the dosage forms of the instant claim 1. ‘354’s specification Col 4 also teaches the instant types of creatine and creatinine.
An artisan would have found it obvious and expected to use all the teaches in ‘354 to arrive at the instant composition.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625