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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The instant claims are directed to beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
The instant specification only discloses D-1,3-butanediol.
The instant specification is silent as to R-1,3-butanediol and S-1,3-butanediol.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The same rationale applies to dependent claims 8-12 being duplicates of dependent claims 2-6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30 and 37 of copending Application No. 18/298,851 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims 30 and 37 of the copending Application No. 18/298,851 are directed to the foodstuff comprising “enantiomerically pure (D)-1,3-butanediol, or wherein the 1,3-butanediol is enriched with respect to (D)-1,3-butanediol” (i.e. R-1,3-butanediol). It is noted that a beverage reads on foodstuff. It is further noted that the instant claims recite the phrase “comprising” . "Comprising" is an open-ended transition term that means "including but not limited to". Hence, the instant claims may further include all components of independent claims of the copenidng application such as ß-hydroxybutyric acid salts; a ketone ester; and ß-hydroxbutyric acid.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 11,760,963. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims of U.S. Patent No. 11,760,963 are directed to a beverage comprising water and at least 0.5 percent by volume D-1,3-butanediol and no, or substantially no, L-1,3-butanediol, the beverage further optionally comprising one or more additives selected from the group consisting of D ethyl 3-hydroxybutyrate; D beta hydroxybutyrate salts; D beta hydroxybutyrate, D 1,3-butanediol monoester; 3-hydroxy-, 3-ethoxy-l-methyl-3-oxopropyl ester; D hydroxybutyric acid; ethanol; and combinations thereof.
Hence, the claims in both instant application and U.S. Patent No. 11,760,963 read on a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/578,476 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims 1-10 of the copending Application No. 19/578,476 are directed to a composition for parenteral or topical delivery comprising 1,3 butanediol, enantiomerically enriched in its R enantiomer, and water. 1,3 butanediol, enantiomerically enriched in its R enantiomer reads on “R-1,3-butanediol and no, or substantially no, S-1,3-butanediol”. The beverage reads on composition. Hence, the claims in both applications read on a composition (beverage) comprising water, and at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 19/544,257 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol. Claim 18 of the copending Application No. 19/544,257 is directed to a foodstuff comprising R-1,3-butanediol. It is noted that a beverage reads on foodstuff. It is further noted that the instant claims recite the phrase “comprising” . "Comprising" is an open-ended transition term that means "including but not limited to". Hence, the instant claims may further include all components of independent claim 1 of the co-pending application such as D-ß-hydroxybutyric acid and at least one D-ß- hydroxybutyrate salt.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 23-25 of copending Application No. 18/678,629 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims 21 and 23-25 of copending Application No. 18/678,629 are directed to a foodstuff comprising a mixture of ß-hydroxybutyric acid and 1,3- butanediol, wherein the ß-hydroxybutyric acid and 1,3-butanediol are each enriched in their D isomers, and-wherein the ß-hydroxybutyric acid and 1,3-butanediol are present in a molar ratio of 5:4, and wherein the foodstuff is free of medium chain fatty acids and esters thereof.
It is noted that a beverage reads on foodstuff. It is further noted that the instant claims recite the phrase “comprising” . "Comprising" is an open-ended transition term that means "including but not limited to". Hence, the instant claims may further include all components of claims of the co-pending application such as ß-hydroxybutyric acid. “1,3-butanediol are each enriched in their D isomers” read on “R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol”.
Hence, the claims in both applications read on a foodstuff (beverage) comprising water and R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12/703,842. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims of U.S. Patent No. 12/703,842 are directed to a fruit flavored beverage comprising water and at least 0.5 percent by volume D-1,3-butanediol and no, or substantially no, L-1,3-butanediol, wherein the beverage comprises a fruit flavor, and wherein the beverage further optionally comprises one or more additives selected from the group consisting of D-ethyl 3-hydroxybutyrate; D-beta hydroxybutyrate salts; D-beta hydroxybutyrate, D-1,3-butanediol monoester; 3-hydroxy-, 3-ethoxy-1-methyl-3-oxopropyl ester; D-hydroxybutyric acid; ethanol; and combinations thereof.
It is noted that D-1,3-butanediol reads on R-1,3-butanediol and S-1,3-butanediol reads on L-1,3-butanediol.
Hence, the claims in both instant application and U.S. Patent No. US 12/703,842 read on a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/534,368 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are directed to a beverage comprising water, D-beta hydroxybutyrate, at least 0.5 percent by volume R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol. The claims 18 of the copending Application No. 19/534,368 are directed to a beverage comprising R-1,3-butanediol and water. Hence, the claims in both applications are directed to a beverage comprising R-1,3-butanediol and water.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over D'Agostino et al (US 20140350105 A1) in view of Clarke et al (Oral 28-day and developmental toxicity studies of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate).
In regard to claims 1 and 7, D'Agostino et a discloses a ready-to-drink liquid, comprising 1,3-butanediol ([0041], [0033], claim 2) and a beta-hydroxybutyrate salt ([0033], [0070], [0071]).
D'Agostino et a discloses that 1,3-butanediol is one of available sources of β-hydroxybutyrate ketone. In regard to the presence of beta-hydroxybutyrate salt and 1,3-butanediol as hydroxybutyrate ketone source and the amount of hydroxybutyrate ketone sources in claims 4-5 and 10-11, D'Agostino et a discloses:
[0033] As such, a composition of ketone precursors is disclosed which comprises at least one medium chain fatty acid, or an ester thereof such as a medium chain triglyceride, and a .beta.-hydroxybutyrate ketone source or precursor. There are numerous sources of ketones and ketogenic precursors. Nonlimiting examples of the beta-hydroxybutyrate compound include beta-hydroxybutyrate salts such as sodium beta-hydroxybutyrate and arginine beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, citrulline beta-hydroxybutyrate, beta-hydroxy butyrate sodium salt, beta-hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta-hydroxy butyrate magnesium salt, or a combination of salts. Nonlimiting examples of combinations of beta-hydroxybutyrate salts include sodium beta-hydroxybutyrate and arginine beta-hydroxybutyrate, or beta-hydroxy butyrate sodium salt and beta-hydroxy butyrate potassium salt. Other .beta.-hydroxybutyrate ketone sources include, without limiting the scope, 1,3-butanediol, ethyl acetoacetate, and ethyl beta-hydroxybutyrate. The compounds, are optionally administered between 2 grams and 50 grams, between 5 grams and 30 grams, or between 10 grams and 20 grams. For example, the ketone compounds are optionally administered at 2 grams, 4 grams, 5 grams, 6 grams, 7 grams, 8 grams, 9 grams, 10 grams, 11 grams, 12 grams, 13 grams, 14 grams, 15 grams, 17 grams, 19 grams, 20 grams, 22 grams, 24 grams, 26 grams, 28 grams, 30 grams, 32 grams, 34 grams, 36 grams, 38 grams, 40 grams, 42 grams, 44 grams, 46 grams, 48 grams, or 50 grams.
Claim 2. The composition of claim 1, wherein the at least one beta-hydroxybutyrate compound comprises one or more of: a beta-hydroxybutyrate salt comprising sodium beta-hydroxybutyrate, arginine beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, or citrulline beta-hydroxybutyrate; 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; or a combination of a beta-hydroxybutyrate salt and 1,3-butanediol, beta-hydroxybutyrate salt and ethyl acetoacetate, beta-hydroxybutyrate salt and ethyl beta-hydroxybutyrate, a salt mixture and 1,3-butanediol, a salt mixture and ethyl acetoacetate, or a salt mixture and ethyl beta-hydroxybutyrate.
Since, D'Agostino et al discloses a ready-to -drink liquid, D'Agostino et al inherently discloses water. In any case, one of ordinary skill in the art would have been motivated to include water in the hydroxybutyrate ketone composition in order to obtain a ready-to-drink liquid as disclosed by D'Agostino et al.
D'Agostino et al does not disclose that beta hydroxybutyrate is D-beta hydroxybutyrate, and that 1,3-butanedio is R-1,3-butanediol, and no, or substantially no, S-1,3-butanediol.
Clarke et al discloses that “[t]he combustion of d-β-hydroxybutyrate produces greater amounts of energy compared to that of the glycolytic substrate, pyruvate, increasing hydraulic efficiency in the working perfused rat heart by approximately 30% (Introduction).
Clarke et al also discloses that “most (R)-1,3-butanediol is metabolized to the ketones, (R)-3-hydroxybutyrate and acetoacetate, while only approximately one-third of (S)-1,3-butanediol is converted to ketone bodies (4. Discussion).
In regard to the recitation of R-1,3-butanediol and substantially no S-1,3-butanediol, it is noted that this limitation reads on the presence of both R-1,3-butanediol and S-1,3-butanediol.
In any case, one of ordinary skill in the art would have been motivated to modify D'Agostino et al in view of Clarke et al and to employ (R)-1,3-butanediol instead of (S)-1,3-butanediol because most (R)-1,3-butanediol is metabolized to the ketones while only approximately one-third of (S)-1,3-butanediol is converted to ketone bodies as disclosed by Clarke et al. One of ordinary skill in the art would have been motivated to modify D'Agostino et al in view of Clarke et al and to employ D-beta hydroxybutyrate as beta hydroxybutyrate because D-beta hydroxybutyrate produces great amount of energy as suggested by Clarke et al.
Further in regard to the amount/ concentration of 1,3-butanediol, it is noted that:
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. "[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) (MPEP 2144.05, II A).
Further, regarding the 1,3-butanediol ranges as examined above, it is noted that 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). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
In regard to claims 2-3 and 8-9, D'Agostino et al discloses flavoring agents ([0041]).
In regard to claims 6 and 12, it is noted that the recitation of the beverage being carbonated refers to the process of making the beverage.
[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See also Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ( "a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim" ).
Conclusion
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/VERA STULII/Primary Examiner, Art Unit 1791
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