DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the fourth Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 26 September 2025, Applicant amended claims 1, 3, 5, 27, 30, 32, 34, 42-43, and 46. Claims 6-7, 11-13, 15, 17-18, 22, 24-25, 28-29, 31, 35, 37, 40-41, and 45 were cancelled previously by Applicant. Claims 1-5, 8-10, 14, 16, 19-21, 23, 26-27, 30, 32-34, 36, 38-39, 42-44 and 46 are pending and under consideration.
Status of the Rejections
The rejection under 35 U.S.C. 112(b) set forth in the previous Office action (02 July 2025) is maintained against claims 27, 30, 32-34, 36, 38-39, and 42-44 only. It is withdrawn against all other claims in view of Applicant’s recent claim amendments. The examiner acknowledges Applicant’s significant effort to advance prosecution by clarifying many of the claims.
The rejection of claims 5 and 30 under 35 U.S.C. 112(d) set forth in the previous Office action is withdrawn in view of Applicant’s amendments thereto.
The rejection of claims 1-5, 8-10, 14, 16, 19-21, 26-27, 30, 32-34, 36, 38-39, and 43-44 under 35 U.S.C. 103 as being unpatentable over Bellamine (US 2017/0173050 A1) in view of Diorio (US 2017/0354599 A1) is maintained. Applicant’s arguments are considered in paragraphs 35-38 of this Office action. The examiner notes that guidance on advancing prosecution is set forth in paragraph 38.
The rejection of claims 23, 42, and 46 under 35 U.S.C. 103 as being unpatentable over Bellamine (US 2017/0173050 A1) in view of Diorio (US 2017/0354599 A1), as applied above, in view of Shah (US 2012/0315326 A1), Vilallobos (US 2010/0055178 A1), and Cade (US 8,852,631 B2) is maintained.
The provisional rejection of the claims on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 5-8, 11-15, 18-19, 21-26, 29, 31, and 33 of co-pending Application No. 17/765,173 in view of Diorio (US 2017/0354599 A1) is maintained.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 27, 30, 32-34, 36, 38-39, and 42-44 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claim 27, does the weight ratio limitation recited at the end of the claim apply regardless of whether the first option (i.e., “wherein the amino acid is in a form of a solid and the nitrogenous organic is in a form of a solid”) or the second option (i.e., “wherein the protein composition is in a form of a suspension, wherein the creatine or the derivative thereof is in the form of a lipid multiparticulate and the amino acid is in a form of a liquid into which the nitrogenous organic acid is suspended”) is selected? Alternatively, does the weight ratio limitation apply if and only if the second option is selected? This ambiguity renders claim 27 and all claims depending thereon indefinite.
Claim Rejections - 35 U.S.C. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-5, 8-10, 14, 16, 19-21, 26-27, 30, 32-34, 36, 38-39, and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Bellamine (US 2017/0173050 A1) in view of Diorio (US 2017/0354599 A1).
Bellamine is directed to a method for increasing muscle protein synthesis and/or functional strength in mammals by administering a protein building composition. Title/Abstract.
Bellamine discloses that “the protein building composition may comprise an amino acid derivative combined with a nitrogenous organic acid.” Para. [0013]. Bellamine identifies (i) carnitine as the preferred amino acid derivative and (ii) creatine as the preferred nitrogenous acid. Paras. [0013]-[0014], [0016]-[0017], [0067]-[0068], and [0071]-[0072].
Bellamine identifies L-carnitine-L-tartrate as a preferred form of carnitine, which is a salt and, therefore, qualifies as a solid, as does L-carnitine, itself. Para. [0014]. Bellamine identifies creatine monohydrate as a preferred form of creatine, which is a crystalline solid. Pages 30-31 at Table for Sample Nos 1-2; see also paras. [0017] and [0072]. The cited Table discloses that the creatine monohydrate and other constituents (L-carnitine) are in particulate (solid) form.
Bellamine discloses: “Creatine may be administered in a dosage from about 5 to 15,000 milligrams per day, such as from about 5 to about 10,000 milligrams per day, such as from about 50 milligrams to about 5,000 milligrams per day. The dosage, for instance, can be greater than about 100 milligrams per day, such as greater than about 500 milligrams per day, such as greater than about 1,000 milligrams per day, such as greater than about 1,250 milligrams per day.” (Emphasis added) Para. [0082]. The italicized ranges are each overlapped by the corresponding range of “less than about 500 mg” recited in claims 1 and 27 of the present application. Therefore, the claimed range is prima facie obvious. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Regarding the ratio range of “about 10:1 to about 1:3” recited in claims 1 and 27, Bellamine does not disclose that range with sufficient specificity to anticipate the claims. MPEP § 2131.03(II). Nevertheless, Bellamine discloses: “The weight ratio between the amino acid derivative and the organic acid, on the other hand, can generally be from about 1:10 to about 5:1, such as from about 1:1 to about 1:5, such as from about 1:1 to about 1:3.” Para. [0078]. The foregoing disclosure is sufficient to render Applicant’s claimed ratio ranges prima facie obvious. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Bellamine is silent regarding whether the carnitine and/or creatine can be in lipid multiparticulate form. As explained below, Diorio compensates for this deficiency.
Diorio is directed to lipid multiparticulate (LMP) formulations.
Diorio teaches: “LMPs are advantageous active agent forms because they are amenable for use in scaling dosage forms according to the weight of an individual animal, including humans, in need of treatment by simply scaling the mass of particles in the dosage form to comport with the animal's weight. They are further advantageous since they allow the incorporation of a large quantity of active into a simple dosage form such as a capsule. Multiparticulates also have numerous therapeutic advantages over other dosage forms, especially when taken orally, including (1) improved dispersal in the gastrointestinal (GI) tract, (2) relatively rapid and reproducible passage from the stomach, (3) more uniform GI tract transit time, and (4) reduced inter- and intra-patient variability.” (Emphasis added) Para. [0038].
Diorio teaches that (i) the active agent can preferably be a small molecule having a molecular weight of 2000 Daltons or less and (ii) that the LMP can contain one or more active agents. Para. [0020].
The LMP comprises a matrix, the continuous phase of which is composed of the low flow point and high flow point excipients and the discontinuous phase of which comprises the active agent. Paras. [0004], [0022], [0039]; see also claims 1 and 11. Additionally, the LMPs have a mean diameter ranging from 40 μm to 3000 μm. Paras. [0003]-[0005] and [0037]; see also claims 1 and 11.
Before the effective filing date of the claimed invention, the teachings of Diorio would have motivated a person having ordinary skill in the art to modify Bellamine by formulating the small molecules carnitine and/or creatine as LMPs, in an effort to (i) improve the dispersal thereof in the gastrointestinal (GI) tract, (ii) achieve relatively rapid and reproducible passage from the stomach, (iii) provide more uniform GI tract transit time, and/or (iv) reduce inter- and intra-patient variability, following oral administration. Therefore, claims 1-3, 8, 14, 16, 27, 34, 36, and 43-44 are prima facie obvious.
Regarding claims 4 and 5, Bellamine discloses that protein building composition can be administered as a suspension. Para. [0085].
Regarding claims 9 and 38, Diorio teaches that the LMPs can comprise from 1 wt% to 60 wt% of the active agent. Paras. [0004], [0040]; see also claim 5. This teaching is sufficient to render Applicant’s claimed range prima facie obvious. MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Regarding claims 10 and 39, Diorio teaches stearyl alcohol, stearic acid, and waxes as preferred high flow point excipients (paras. [0029]-[0031]) and corresponding concentrations of 2-30 wt% (para. [0039]). MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Regarding claim 19, Bellamine discloses oral administration. Para. [0085].
Regarding claim 20, Bellamine discloses: “The mammal treated in accordance with the present disclosure can comprise any suitable mammal. For instance, the mammal may be human or canine.” (Emphasis added) Para. [0089].
Regarding claim 21, Applicant is referred to paragraph [0102] of Bellamine, which discloses various excipients.
Regarding claim 26, Applicant is referred to paragraphs [0093]-[0094] of Bellamine, which discloses an increase in mTOR expression.
Regarding claims 30, 32 and 33, Bellamine discloses that protein building composition can be administered as a liquid or powder. Para. [0085]. Bellamine discloses that the protein building composition can comprise citric acid and/or sodium citrate, both of which qualify as pH-adjusting agents.
Response to Applicant’s Arguments
The following remarks are provided in reply to the arguments raised by Applicant on pages 10-11 of the Reply filed 26 September 2025:
Sample 2 of Table 3 of Bellamine discloses a 1:2 weight ratio of carnitine to creatine. Para. [0118]. Therefore, Applicant’s argument set forth on page 11 of the Reply is not persuasive.
None of Applicant’s method claims include a dosing frequency or similar temporal limitation, such as “daily” or “per day.” Consequently, the method claims are open to multiple or repeated administrations of the recited formulation within any given time frame. It follows that the synergistic effects asserted by Applicant, which are seemingly dependent on creatine doses of 500 mg or less, are not commensurate in scope with the claimed method. MPEP § 716.02(d) (“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’”). Accordingly, Applicant’s argument set forth on page 10 of the Reply is not persuasive.
The examiner recommends that Applicant explore focusing the claims on a formulation and corresponding method that combines and incorporates all the limitations of both claim 30 and 42. Applicant is cautioned that this is not an offer for allowance because a further search and further consideration would be necessary to determine compliance with 35 U.S.C. 112(b), 35 U.S.C. 102, and 35 U.S.C. 103.
* * *
Claims 23, 42, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Bellamine (US 2017/0173050 A1) in view of Diorio (US 2017/0354599 A1), as applied above to claims 1-5, 8-10, 14, 16, 19-21, 26-27, 30, 32-34, 36, 38-39, and 43-44, in view of Shah (US 2012/0315326 A1), Vilallobos (US 2010/0055178 A1), and Cade (US 8,852,631 B2).
Although Bellamine discloses that the protein building composition can be orally administered in the form of a capsule (paras. [0060], [0066], and [0085]), Bellamine is silent as to which types of capsules are suitable. It follows that Bellamine does not satisfy claims 23, 42 and 46, which require a enteric capsule. As explained below, the following three references compensate for this deficiency: Shah, Vilallobos, and Cade.
Shah is directed to “[e]nteric coated multiparticulate compositions that use a L-carnitine compound an active ingredient.” Abstract.
Shah teaches that “[s]ince L-carnitine and the derivatives ALCAR [acetyl L-carnitine] and propionyl-L-carnitine can cause various side effects such as upset stomach, nausea and vomiting, it is desirable to administer L-carnitine, ALCAR, or propionyl-L-carnitine in a manner that minimizes the manifestation of these side effects.” Para. [0005].
Shah teaches it is advantageous for L-carnitine to released into the intestines, as opposed to the stomach, thereby preventing the undesirable side effects or reduced efficacy of L-carnitine that may result otherwise. (Emphasis added) Paras. [0021]-[0022].
Vilallobos is directed to an “enteric-coated creatine pharmaceutical formulation.” Abstract.
Vilallobos teaches: “The main problem with all existing creatine supplementation is the ability to deliver creatine in a usable form by the human body. Current delivery systems do not protect the degradation of creatine, which breaks down rapidly to creatinine in acidic environments like the stomach. Creatinine is a toxic byproduct of creatine. It is believed that the main reason for complaints resulting from creatine consumption, namely, stomach cramps, edema, and dehydration, are caused by the body’s defense to this toxic compound.” (Emphasis added) Para. [0010].
Vilallobos teaches: “The known oral creatine supplements are dissolved in acidic solutions having a pH range from 3-6 and more importantly, the pH of the stomach is even lower. Research has shown that at these pH levels, the rate of conversion of creatine to creatinine is almost instantaneous.” Para. [0011].
Cade is directed to acid-resistant hard pharmaceutical capsules for oral administration of pharmaceuticals and dietary supplements to humans. Abstract.
Cade teaches: “Pharmaceutical capsules are widely used in the pharmaceutical field as oral dosage forms for administration to humans and animals. In this context, it is often desirable that the capsules be acid resistant in order to remain intact in the stomach of patients and do not release the encapsulated content therein. Acid resistant capsules are thus useful for the administration of substances instable in an acid environment or substances, like NSAIDs, that are associated with serious gastric side-effects.” Column 1, lines 31-39.
Cade teaches: “The capsules of the invention are obtained by aqueous compositions comprising a water-soluble film-forming polymer and gellan gum in a mutual weight ratio of 4 to 15 weight parts of gellan gum for 100 weight parts of film-forming polymer.” Abstract. Cade identifies HPMC (hydroxypropyl methylcellulose) as the preferred film-forming polymer. Column 4, lines 19-35; column 7 at Table 1; and column 8 at claim 1.
Cade teaches: “The hard capsules of the invention do not leak at pH 1.2 in a USP-30 simulated gastric fluid for at least 1 hour, confirming the acid-resistant performance.” (Emphasis added) Column 5, lines 38-40; column 7 at Table 2; and column 8 at claim 1.
Cade teaches that “[i]n a preferred embodiment, a hard capsule shell of the invention as defined above is filled with one or more acid-instable substances and/or one or more substances associated with gastric side effects in humans and/or animals.” Column 6, lines 44-47.
Cade teaches that the hard capsules disclosed therein qualify as “enteric release hard capsules”. Column 8, lines 25-31.
Before the effective filing date of the claimed invention, the teachings of Shah, Vilallobos, and Cade would have motivated a person having ordinary skill in the art to simply load the protein building composition disclosed in Bellamine into the acid-resistant hard capsules of Cade, in an effort to (i) reduce the undesirable side effects (e.g., nausea) caused by release of carnitine and creatine in the stomach, while (ii) protecting the carnitine and creatine from acid-catalyzed degradation or conversion in the low pH of the stomach. Therefore, claims 23, 42, and 46 are prima facie obvious.
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1-5, 8-10, 14, 16, 19-21, 23, 26-27, 30, 32-34, 36, 38-39, 42-44, and 46 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 5-8, 11-15, 18-19, 21-26, 29, 31 and 33 of co-pending Application No. 17/765,173 (as amended on 11 August 2025) in view of Diorio (US 2017/0354599 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: The conflicting claims require that the carnitine/creatine protein-building composition is contained in an enteric hard capsule but are silent regarding whether the carnitine and/or creatine can be formulated as lipid multiparticulates (LMPs). Consequently, they do not satisfy all the present claims. The teachings of Diorio are discussed above, in the rejections under 35 U.S.C. 103. That discussion is incorporated by reference into this double patenting rejection. Diorio compensates for the deficiency in the conflicting claims by providing motivation to select LMPs, to effort to (i) improve the dispersal thereof in the gastrointestinal (GI) tract, (ii) achieve relatively rapid and reproducible passage from the stomach, (iii) provide more uniform GI tract transit time, and/or (iv) reduce inter- and intra-patient variability, following oral administration. MPEP § 2144.07 (the selection of a known material based on its suitability for its intended use can support a prima facie obviousness determination). This is a provisional non-statutory double patenting rejection because the conflicting claims have not yet been patented.
Conclusion
Claims 1-5, 8-10, 14, 16, 19-21, 23, 26-27, 30, 32-34, 36, 38-39, 42-44, and 46 are rejected.
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
09 January 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611