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 .
DETAILED ACTION
Applicant’s amendment of 14 July 2026, in which claims 21, 30, 34 have been amended, is acknowledged.
Claims 1-42 are pending in the instant application.
Claims 1-16, 23-26, 36-39 are withdrawn, as being drawn to a non-elected invention or to a non-elected species.
Claims 17-22, 27-35, 40-42 are examined herein.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted.
Response to arguments of 14 July 2026
In view of Applicant’s amendment of 14 July 2026, the rejection of claims 22, 35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein withdrawn. Applicant has amended claims 21, 34 to recite a salt cation.
On 14 July 2026, Applicant has amended independent claim 30 to recite that the composition for transdermal supplementation comprises an aqueous gel comprising eucalyptol and menthol in amounts effective to synergistically enhance transdermal penetration and therapeutically effective amounts of: a plurality of medium-chain triglycerides; a plurality of amino acids; a plurality of forms of beta-hydroxybutyrate.
New rejections are made below based on Applicant’s amendment of 14 July 2026.
Applicant’s arguments (Response of 14 July 2026, pages 8-11) against the rejection of claims 17-19, 21-22, 27-32, 34-35, 40-42 under 35 U.S.C. 103 over D’Agostino and Henderson, have been considered.
Applicant argues (page 8) that instant claim 17 recites a plurality of amino acids, while D’Agostino and Herderson only teach carnitine. In response, D’Agostino teaches [0039] that the keto compositions comprise nutritional substrates such as amino acids; nutritional cofactors include carnitine (Applicant’s elected species) that assists in mitochondrial function, and branched chain amino acids leucine, valine, isoleucine. Thus, contrary to Applicant’s argument, D’Agostino is not limited to carnitine, but rather does teach amino acids and does list branched amino acids leucine, valine, isoleucine as components of the formulations of the invention.
Applicant argues (page 9, first two paragraphs) that neither D’Agostino nor Henderson identifies any relationship between the beta-hydroxybutyrate compounds and the amino acids that would have directed a skilled artisan to combine them. This is not persuasive, the prior art already teaches combinations of the instantly claimed components. D’Agostino teaches combinations of sodium beta-hydroxybutyrate, potassium hydroxybutyrate, calcium beta-hydroxybutyrate, or/and magnesium hydroxybutyrate, and at least one medium chain triglyceride, including caprylic acid, and amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine, and Henderson teaches a ketogenic composition comprising medium chain triglycerides comprising caprylic acid, and L-carnitine or a derivative of L-carnitine, and any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate. Thus, all the elements present in the compositions of the instant claims are already present in the prior art by D’Agostino and Henderson.
Applicant argues (page 11) that claim 17 depends upon selecting particular ingredients from broad disclosures. This is not persuasive; the instant claims are not restricted to the elements listed. Rather, the instant claims (“comprising” language) read on the compositions taught by D’Agostino and Henderson.
Applicant’s arguments (page 9, last three paragraphs, page 10) refer to the amendment of 14 July 2026 and to the reference by Jaffe. In response, a new rejection is made below, based on Applicant’s amendment of 14 July 2026.
Applicant argues (page 11-12) that the objective in Buononato is to provide other fumarate salt systems. In response, Buononato is used in the rejection for the specific teaching in [0008], namely that L-carnitine fumarate is a stable salt form of carnitine. Applicant’s elected species is L-carnitine fumarate.
Modified/new rejections are made below, based on Applicant’s amendment of 14 July 2026.
On 13 July 2026, Applicant filed a terminal disclaimer against co-pending U.S. patent applications 18/329,539 and 18/338,310. As a result, the provisional rejections of claims 17-22, 27-35, 40-42 on the ground of nonstatutory double patenting over claims of co-pending U.S. Patent Applications No. 18/329,539 and 18/338,310 are herein withdrawn.
Claims 17-22, 27-35, 40-42 have been examined to the extent they read on the elected species, namely a mixture of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, and magnesium beta-hydroxybutyrate, as the specific mixture/plurality of beta-hydroxybutyrate forms; caprylic acid as the medium chain triglyceride; and L-carnitine fumarate as the amino acid (see reply filed on 22 January 2026), and the following rejections are made below.
Claim objection
Claims 22, 35 are objected to because of the recitation ”comprises an ionic salt having a salt cation”. Clarification of the claim language is required.
Claim Rejections- 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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 interpretation: the term “a plurality” in the claims is interpreted to be two or more.
Claims 17-22, 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. (US 2014/0350105, cited in PTO-892 of 16 April 2026) and Henderson (US 2008/0287372, cited in PTO-892 of 16 April 2026), in further view of Buononato (US 2003/0171417, cited in PTO-892 of 16 April 2026).
D’Agostino teaches a composition comprising ([0033], claim 1)
at least one beta-hydroxybutyrate compound, wherein the beta-hydroxybutyrate compound comprises one or more of: a beta-hydroxybutyrate salt comprising, for example, sodium beta-hydroxybutyrate, potassium beta- hydroxybutyrate, calcium beta- hydroxybutyrate, magnesium beta-hydroxybutyrate, as in instant claims 21, 22; or a salt mixture further comprising beta-hydroxy butyrate sodium salt, beta- hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta- hydroxy butyrate magnesium salt or combination thereof; and
at least one medium chain fatty acid or ester thereof [0033], such as medium chain triglyceride [0037], including caprylic acid, as in instant claims 18.
The ketone precursor beta-hydroxybutyrate compounds are administered at between 2 g and 50 g, or between 10 grams and 20 grams [0033].
The at least one medium chain triglyceride is administered at between 5 g and 50 g [0037].
D’Agostino teaches [0039] that the ketone precursors are preferably ingested along with nutritional substrates such as, for example, amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine that assists in mitochondrial function.
D’Agostino teaches (claim 15) a composition comprising
at least one beta-hydroxybutyrate (BHB) compound which is sodium salt of beta-hydroxybutyrate and potassium salt of beta-hydroxybutyrate, as in instant claims 21, 22, and
at least one medium chain triglyceride (MCT),
wherein the at least one MCT and BHB salt mixture is present at a ratio of 1:1.
D’Agostino teaches [0040] that the BHB/MCT composition is used as brain tonic, or anti-aging supplement. A combination BHB/MCT is administered in a range 1:1 to 1:2 mixture to elevate blood ketone to a level that would be considered nutritional ketosis.
D’Agostino teaches [0041] that the preferred route of administration of the mixture of beta-hydroxybutyrate salts and MCT oil is oral, delivered for example as a tablet/ingestible pill, as in instant claim 17.
D’Agostino teaches that the compositions of the invention can be used as an adjunct to a ketogenic diet [0040]; further, ketone supplementation results in greater mental clarity, improvement in cognitive performance [0010].
D’Agostino does not teach that the medium chain triglycerides are present in the composition at 0.1 to 2 grams, as in instant claim 27, that the amino acids are at 0.1 to 1 grams, as in instant claim 28, and that the beta-hydroxybutyrate forms are at a concentration of 10-40% of the composition, as in instant claim 29.
D’Agostino does not teach that carnitine is provided in the form of L-carnitine fumarate, as in instant claim 20.
Henderson (US 2008/0287372) teaches a composition for oral administration capable of elevating ketone body concentrations in a mammal (ketogenic), comprising medium chain triglycerides (MCT) for treatment of age-associated memory impairment/cognitive decline [0015].
Henderson teaches [0034] that the MCT contains greater than 95% C8 at R1, R2, R3 in chemical formula [0033], which is consistent with the medium chain triglycerides comprising caprylic acid, as in instant claims 18.
Henderson teaches [0050] co-administration of a composition comprising at least one compound capable of elevating ketone body concentrations, such as MCT and L-carnitine or a derivative of L-carnitine.
Henderson teaches that MCT is combined with L-carnitine at doses required to increase the utilization of MCT.
Henderson exemplifies a composition for oral supplementation comprising [0119] MCT 0.1-50 g, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 27, 28.
Henderson exemplifies [0121] a composition for oral supplementation as tablet/ingestible pill (as in instant claim 17) comprising MCT 0.1-1000 mg tablet, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 27, 28.
Henderson further teaches [0056] that ketone body precursor compounds appropriate for the present invention include any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate.
Henderson teaches that compositions of the invention are in the form of, for example, ingestible tablet/pill, or parenteral solution (claim 24).
Henderson does not exemplify a composition comprising a plurality of forms of beta-hydroxybutyrate, added to a plurality of MCT and a plurality of amino acids, as in the instant claims.
Henderson does not specifically teach that carnitine is provided in the composition in the form of L-carnitine fumarate, as in instant claim 20.
Buononato (US 2003/0171417) teaches the advantages of using L-carnitine fumarate as a form of L-carnitine in pharmaceutical compositions.
Buononato teaches [0008] that l-carnitine fumarate is very stable and non-hygroscopic, without provoking gastrointestinal side effects. It was developed to overcome complex problems of storage and processing due to L-carnitine inner salt hygroscopicity.
It would have been obvious to combine the teachings of D’Agostino and Henderson to arrive at the instant invention. The person of ordinary skill in the art would have co-administered beta-hydroxybutyrate salts as plurality of forms of beta-hydroxybutyrate, together with medium chain triglycerides and a plurality of amino acids including carnitine, because
D’Agostino teaches a composition used as brain tonic, or anti-aging supplement, comprising ketone precursors as a mixture/combination of sodium beta-hydroxybutyrate, potassium hydroxybutyrate, calcium beta-hydroxybutyrate, or/and magnesium hydroxybutyrate, and at least one medium chain triglyceride, including caprylic acid,
where the ketone precursors are ingested along with amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine,
and Henderson teaches a ketogenic composition for treatment of age-associated memory impairment/cognitive decline, comprising medium chain triglycerides comprising caprylic acid,
and L-carnitine or a derivative of L-carnitine, where the composition may further include any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate.
Thus, the person of ordinary skill in the art would have co-administered in a composition the salts of beta-hydroxybutyrate taught by D’Agostino with the MCT comprising caprylic acid and amino acids such as carnitine taught by Henderson to a subject in need of a brain tonic/anti-aging supplement to treat age-related cognitive decline, with the expectation that said co-administration/composition is ketogenic and is therapeutically effective to treat age-related cognitive decline.
Regarding claims 27-29, the person of ordinary skill in the art would have prepared a ketogenic composition by combining BHB/MCT in a range 1:1 to 1:2, as taught by D’Agostino, and would have used the relative amounts/ratio of MCT and L-carnitine or derivative thereof in the composition taught by Henderson, MCT 0.1-1000 mg, L-carnitine 250-500 mg, with the expectation that the resulting composition maintains ketogenic properties and is effective to treat age-related cognitive decline.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). MPEP 2144.05.
It is well within the skill of the art to determine the effective amount within a range through routine experimentation. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
Regarding claim 20, the person of ordinary skill in the art would have used L-carnitine fumarate as a form of carnitine in the composition, because Buononato teaches the advantages of using L-carnitine fumarate as a form of L-carnitine in pharmaceutical compositions, namely L-carnitine fumarate is very stable and non-hygroscopic. Thus, the person of ordinary skill in the art would have used L-carnitine fumarate as a form of carnitine in the composition, with the expectation of better stability and better humidity resistance over other forms of L-carnitine salts.
As such, claims 17-22, 27-29 are rejected as prima facie obvious.
Claims 30-32, 34-35, 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. (US 2014/0350105, cited in PTO-892 of 16 April 2026) and Henderson (US 2008/0287372, cited in PTO-892 of 16 April 2026), in view of Beal et al. (US 2021/0338613, cited in PTO-892) and Koch et al. (US 2009/0169601, cited in PTO-892).
D’Agostino teaches a composition comprising ([0033], claim 1)
at least one beta-hydroxybutyrate compound, wherein the beta-hydroxybutyrate compound comprises one or more of: a beta-hydroxybutyrate salt comprising, for example, sodium beta-hydroxybutyrate, potassium beta- hydroxybutyrate, calcium beta- hydroxybutyrate, magnesium beta-hydroxybutyrate, as in instant claims 34, 35; or a salt mixture further comprising beta-hydroxy butyrate sodium salt, beta- hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta- hydroxy butyrate magnesium salt or combination thereof; and
at least one medium chain fatty acid or ester thereof [0033], such as medium chain triglyceride [0037], including caprylic acid, as in instant claims 31.
The ketone precursor beta-hydroxybutyrate compounds are administered at between 2 g and 50 g, or between 10 grams and 20 grams [0033].
The at least one medium chain triglyceride is administered at between 5 g and 50 g [0037].
D’Agostino teaches [0039] that the ketone precursors are administered along with, for example, amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine that assists in mitochondrial function.
D’Agostino teaches (claim 15) a composition comprising
at least one beta-hydroxybutyrate (BHB) compound which is sodium salt of beta-hydroxybutyrate and potassium salt of beta-hydroxybutyrate, as in instant claims 34, 35, and
at least one medium chain triglyceride (MCT),
wherein the at least one MCT and BHB salt mixture is present at a ratio of 1:1.
D’Agostino teaches [0040] that the BHB/MCT composition is used as brain tonic, or anti-aging supplement. A combination BHB/MCT is administered in a range 1:1 to 1:2 mixture to elevate blood ketone to a level that would be considered nutritional ketosis.
D’Agostino teaches that the compositions of the invention can be used as an adjunct to a ketogenic diet [0040]; further, ketone supplementation results in greater mental clarity, improvement in cognitive performance [0010].
D’Agostino does not teach that the medium chain triglycerides are present in the composition at 0.1 to 2 grams, as in instant claim 40, that the amino acids are at 0.1 to 1 grams, as in instant claim 41, and that the beta-hydroxybutyrate forms are at a concentration of 10-40% of the composition, as in instant claim 42.
Henderson (US 2008/0287372) teaches a composition for oral administration capable of elevating ketone body concentrations in a mammal (ketogenic), comprising medium chain triglycerides (MCT) for treatment of age-associated memory impairment/cognitive decline [0015].
Henderson teaches [0034] that the MCT contains greater than 95% C8 at R1, R2, R3 in chemical formula [0033], which is consistent with the medium chain triglycerides comprising caprylic acid, as in instant claim 31.
Henderson teaches [0050] co-administration of a composition comprising at least one compound capable of elevating ketone body concentrations, such as MCT and L-carnitine or a derivative of L-carnitine.
Henderson teaches that MCT is combined with L-carnitine at doses required to increase the utilization of MCT.
Henderson exemplifies a composition for oral supplementation comprising [0119] MCT 0.1-50 g, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 40, 41.
Henderson exemplifies [0121] a composition for oral supplementation as tablet/ingestible pill (as in instant claim 17) comprising MCT 0.1-1000 mg tablet, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 40, 41.
Henderson further teaches [0056] that ketone body precursor compounds appropriate for the present invention include any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate.
Henderson teaches that compositions of the invention are in the form of, for example, ingestible tablet/pill, or parenteral solution (claim 24).
Henderson does not specifically teach that the composition is for transdermal supplementation, as in instant claims 40-42.
Henderson does not exemplify a composition comprising a plurality of forms of beta-hydroxybutyrate, added to a plurality of MCT and a plurality of amino acids, as in the instant claims.
D’Agostino and Henderson do not teach that the composition is for transdermal supplementation, as in instant claims 30-32, 34-35, 40-42.
Beal (US 2021/0338613) teaches that [0005] ketosis can be generated by introducing exogenous ketone bodies via oral supplementation, or by topical delivery (Example 1, page 11).
Beal teaches formulations for transdermal administration comprising [0009] a ketone component such as beta-hydroxybutyrate [0025] and a penetration enhancer. Thus, Beal implicitly teaches that the ketone bodies are sparingly skill permeable and the addition of the skin penetration component is needed for their transdermal delivery. The formulations are gel-like [0047] and contain water (Tables 1-6), thus an aqueous gel.
Beal exemplifies (Tables 1-6) topical formulations comprising sodium 3-hydroxybutyrate and menthol. Beal teaches (Example 4) that the topically delivered ketones using the formulations of the invention (Table 4) enhance cognitive performance. The formulations may further contain carnitine [0078].
Beal teaches that menthol has skin penetration properties [0064].
Koch et al. (US 2009/0169601) teaches a transdermal therapeutic system for administering sparingly skin permeable pharmaceutical active substances, where the active substance is present in a penetration enhancer system comprising terpenes such as menthol [0029], or eucalyptol [0031], and medium-chain triglycerides of caprylic acid.
Koch specifically teaches (Example 6) a skin penetration enhancer comprising eucalyptol and menthol (Table 2, Example 6), which increases skin permeation rates for drugs in a transdermal therapeutic system.
Koch exemplifies (Examples 1, 2, 5, 7, claim 14) a transdermal therapeutic system containing eucalyptol and medium-chain triglycerides of caprylic acid as skin penetration enhancer.
It would have been obvious to combine the teachings of D’Agostino and Henderson to arrive at the instant invention. The person of ordinary skill in the art would have co-administered beta-hydroxybutyrate salts as plurality of forms of beta-hydroxybutyrate, together with medium chain triglycerides and a plurality of amino acids including carnitine, because
D’Agostino teaches a composition used as brain tonic, or anti-aging supplement, comprising ketone precursors as a mixture/combination of sodium beta-hydroxybutyrate, potassium hydroxybutyrate, calcium beta-hydroxybutyrate, or/and magnesium hydroxybutyrate, and at least one medium chain triglyceride, including caprylic acid,
where the ketone precursors are ingested along with amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine,
and Henderson teaches a ketogenic composition for treatment of age-associated memory impairment/cognitive decline, comprising medium chain triglycerides comprising caprylic acid,
and L-carnitine or a derivative of L-carnitine, where the composition may further include any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate.
Thus, the person of ordinary skill in the art would have co-administered in a composition the salts of beta-hydroxybutyrate taught by D’Agostino with the MCT comprising caprylic acid and amino acids such as carnitine taught by Henderson to a subject in need of a brain tonic/anti-aging supplement to treat age-related cognitive decline, with the expectation that said co-administration/composition is ketogenic and is therapeutically effective to treat age-related cognitive decline.
Regarding claims 40-42, the person of ordinary skill in the art would have prepared a ketogenic composition by combining BHB/MCT in a range 1:1 to 1:2, as taught by D’Agostino, and would have used the relative amounts/ratio of MCT and L-carnitine or derivative thereof in the composition taught by Henderson, MCT 0.1-1000 mg, L-carnitine 250-500 mg, with the expectation that the resulting composition maintains ketogenic properties and is effective to treat age-related cognitive decline.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). MPEP 2144.05.
It is well within the skill of the art to determine the effective amount within a range through routine experimentation. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
The person of ordinary skill in the art would have prepared the composition for transdermal supplementation, because Beal teaches that ketosis can be generated by introducing exogenous ketone bodies via oral supplementation, or by transdermal delivery, and Beal teaches
ketogenic compositions for transdermal administration in the form of an aqueous gel comprising a ketone component such as beta-hydroxybutyrate and a penetration enhancer which comprises menthol, topically delivered to enhance cognitive performance.
Further, the person of ordinary skill in the art would have selected menthol and eucalyptol as penetration enhancer in a transdermal composition comprising a ketone component such as beta-hydroxybutyrate, because Koch teaches skin penetration enhancer comprising eucalyptol and menthol, effective to increase skin permeation for sparingly skin permeable pharmaceutical active substances, and Koch also teaches transdermal therapeutic system containing eucalyptol and medium-chain triglycerides of caprylic acid as skin penetration enhancer.
Thus, the person of ordinary skill in the art would have used the penetration enhancers taught by Koch comprising eucalyptol and menthol, to improve skin permeation of ketone components in transdermal formulations, with a reasonable expectation of success.
As such, claims 30-32, 34-35, 40-42 are rejected as prima facie obvious.
Claims 30, 33 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. (US 2014/0350105) and Henderson (US 2008/0287372), in view of Beal et al. (US 2021/0338613, cited in PTO-892) and Koch et al. (US 2009/0169601, cited in PTO-892), as applied to claim 30 above, in further view of Buononato (US 2003/0171417, cited in PTO-892 of 16 April 2026).
D’Agostino and Henderson, Beal and Koch are as above.
D’Agostino and Henderson do not specifically teach that carnitine is provided in the composition in the form of L-carnitine fumarate, as in instant claim 33.
Buononato (US 2003/0171417) teaches the advantages of using L-carnitine fumarate as a form of L-carnitine in pharmaceutical compositions.
Buononato teaches [0008] that l-carnitine fumarate is very stable and non-hygroscopic, without provoking gastrointestinal side effects. It was developed to overcome complex problems of storage and processing due to L-carnitine inner salt hygroscopicity.
Regarding claim 33, the person of ordinary skill in the art would have used L-carnitine fumarate as a form of carnitine in the composition, because Buononato teaches the advantages of using L-carnitine fumarate as a form of L-carnitine in pharmaceutical compositions, namely L-carnitine fumarate is very stable and non-hygroscopic. Thus, the person of ordinary skill in the art would have used L-carnitine fumarate as a form of carnitine in the composition, with the expectation of better stability and better humidity resistance over other forms of L-carnitine salts.
As such, claims 30, 33 are rejected as prima facie obvious.
Conclusion
Claims 17-22, 27-35, 40-42 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/IRINA NEAGU/ Primary Examiner, Art Unit 1629
Prosecution Insights