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 .
Response to Amendment
Applicant’s amendment filed August 14, 2025 amending claims 1, 11, 15, 17 and 22 have been amended. Claims 1-22 are currently pending and presented for examination.
Response to Arguments
Due to Applicant’s amendment to claim 22, the previous rejection of claim 22 under 35 U.S.C. 112(d) is hereby withdrawn.
Applicant's arguments filed August 14, 2025 with respect to the remaining rejections have been fully considered but they are not persuasive.
With respect to the rejection under 35 USC 112(a) Applicant argues that the Examiner has acknowledged that the specification provides written description support for claiming less than 4% by weight of beta-hydroxybutyrate salt and also less than 0.5% by weight of beta-hydroxybutyrate salt, and also that the specification provides written description support for claiming greater than 96% by weight of beta-hydroxybutyric acid and also greater than 99.5% by weight of beta-hydroxybutyric acid. Applicant argues that because the Application discloses less than 0.5% by weight of beta-hydroxybutyrate salt, Applicant is entitled to exclude these embodiments and combine this with the disclosure of less than 4% by weight of beta-hydroxybutyrate salt, to arrive at support for claiming the range of 0.5% to 4% by weight of beta-hydroxybutyrate salt which would provide support for the range of 96% to 99.5% by weight of beta-hydroxybutyric acid since beta-hydroxybutyric acid and beta-hydroxybutyrate salt together must necessarily equal 100% by weight by definition. Applicant argues that this same argument applies to all other ranges recited in the claims as previously presented and currently amended.
These arguments are found not persuasive since MPEP 2173.05(i) states that Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). There is no teaching in this section of the MPEP which states that positive limitations can be excluded and combined with other portions of the specification to arrive at support for ranges not originally included in the specification. In the instant case, claim 1 now recites greater than about 98% to about 99% of the acid and about 1% to less than about 2% of the salt.
In the instant specification, guidance with respect to the amount of the salt is found in paragraphs [0027], [0064] and [0076].
Paragraph [0027] states that it may be desirable to include incrementally higher, but still small, amounts of beta-hydroxybutyrate salts, such as less than 4%, 3%, or 2% of such salts by combined weight of beta-hydroxybutyric acid and beta-hydroxybutyrate salt(s), in order to further offset the acidity of beta-hydroxybutyric acid.
Paragraph [0064] states that Beta-hydroxybutyric acid compositions are free or substantially free of beta-hydroxybutyrate salts so as to contain less than 1%, or less than 0.9%, or less than 0.8%, or less than 0.7%, or less than 0.6%, or less than 0.5%, or less than 0.4%, or less than 0.3%, or less than 0.2%, or less than 0.1% of one or more beta-hydroxy butyrate salts by combined weight of beta-hydroxybutyric acid and beta-hydroxy butyrate salt(s). Beta-hydroxybutyric acid compositions can be essentially or totally free of beta- hydroxybutyrate salts, i.e., contain 0% by weight of beta-hydroxy butyrate salts.
Paragraph [0076] states that it may be desirable to include incrementally higher, but still small, amounts of beta-hydroxybutyrate salts, such as less than 4.0%, or less than 3.75%, or less than 3.5%, or less than 3.25%, or less than 3.0%, or less than 2.75%, or less than 2.5% or less than 2.25%, or less than 2%, or less than 1.75%, or less than 1.5%, or less than 1.25%, of such salts by combined weight of beta-hydroxybutyric acid and beta- hydroxybutyrate salt(s), in order to further offset the greater acidity of higher concentrations and/or amounts of beta-hydroxybutyric acid in compositions that are enriched with, or contain enantiomerically pure, S-beta-hydroxy butyric acid.
There is no disclosure in the instant specification of an amount of about 1% as claimed or a range of about 1% to less than about 2%. Furthermore, there is no disclosure in the instant specification of a range of 0.5% to less than about 4%, or about 0.5% to about 1%, or about 0.5% to less than about 3% as claimed in the current claims. The specification does not disclose any ranges for the amount of the salt or the acid. The specification only teaches that the amount of the salt can be less than a certain number which is at most 4% or less than a certain number which is at the minimum less than 0.1%. Therefore since the ranges recited in the current claims are not disclosed in the instant specification, the claims are properly rejected under 35 USC 112(a). Thus it is maintained that the instant specification does not support the ranges as claimed and thus are rejected as failing to comply with the written description requirement. For these reasons the previous rejection under 35 USC 112(a) is hereby maintained and reproduced below.
Applicant’s request to hold the double patenting rejections in abeyance is found not persuasive since a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated.
Accordingly, the previous double patenting rejections are hereby maintained and reproduced below.
In addition, Applicant argues that the double patenting rejection over U.S. Patent No. 11,806,324 is in error because the instant application is a division over ‘324 as a result of a restriction requirement between solid and aqueous compositions. This argument is found not persuasive since the claims of the instant application are not the same as the claims of Invention II of the restriction requirement dated 06/02/2021 in parent application no. 17/210,646. The group restriction in the parent application was required since the compositions of the different inventions contained different components (see explanation on page 3 of restriction requirement dated 06/02/2021 in parent application). The composition of the instant application does not contain the same components as the composition of Invention II since said composition contained a flavorant and a stabilizer which is not included in the composition of the instant claims. Thus if the composition as claimed in the instant claims were presented with Invention I of the parent application, no group restriction would have been required since the components of the compositions are the same.
The prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply if the claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
With respect to the rejections under 35 USC 103, Applicant argues that claim 1 was amended to be commensurate in scope with the evidence of unexpected results. Llosa and Clarke do not recognize or suggest how to form a solid composition. Llosa does not teach or suggest a composition that contains just two components in the claimed ranges. Applicant further argues that the Examiner cannot ignore the teaching in paragraph [0027] that states that when 1-25% by weight of beta-hydroxybutyrate salt is included, the composition necessarily also contains 1-10% by weight of 1,3-butanediol, and 1-49% by weight of Ketone Ester, both of which are liquids and would prevent formation of a stable solid. Applicant argues that Llosa therefore fails to teach or suggest how to select a combination of BHB acid and BHB salt in concentrations that satisfies the dual condition of containing a very high concentration of BHB acid and a very low concentration of BHB salt while forming a solid composition. Applicant argues that Clarke fails to cure this deficiency.
Applicant further argues that the previously submitted declaration, being commensurate in scope with amended claim 1, rebuts any prima facie case. Applicant argues that claims 11 and 15 as amended are virtually identical to the test data in the declaration such that the previously submitted declaration, being commensurate in scope with amended claim 1, rebuts any prima facie case. Applicant further argues that claim 19 as previously presented is commensurate in scope with the test data, which rebuts any prima facie case of obviousness.
These arguments are found not persuasive because Llosa specifically teaches a Ketone Blend which is defined as a blend of two or more compounds described in the patent that are either comprised of a free acid of β-hydroxybutyrate, salt of β-hydroxybutyrate, ketone ester of hydroxybutyrate, or 1,3-butanediol which when taken orally shall increase serum levels of (D)-β-hydroxybutyrate [0025]. Llosa teaches the Ketone Blend containing any two or more of the above listed compounds can be in any relative concentration ratios, wherein the preferred embodiments shall be as follows: 51-99% free acid, 1-25% Ketone Salt, 1-10% 1,3-butanediol, and 1-49% Ketone Ester [0027]. Thus up to 99% of the blend can be the free acid and 1% can be a ketone salt. Thus the teachings of Llosa et al. encompass a ketone blend which comprises 99% of beta-hydroxybutyric acid and 1% -hydroxybutyrate salt which is forms the same solid beta-hydroxybutyrate composition for oral delivery to increase blood ketone level in a subject as claimed which forms a crystalline solid and is free of 1,3-butanediol and ketone ester.
Llosa et al. specifically teaches compositions and methods for producing near instant and/or therapeutic levels of nutritional ketosis, and in particular but not limited to compositions and methods related to the right hand enantiomer in particular in either in its pure enantiomer form or enantiomerically enriched form of a Ketone Blend, including any two or more of the following: (D)--hydroxybutyrate salts, (D)--hydroxybutyrate free acid, (D)-1,3-butanediol, and Ketone Ester, for mitochondrial health, treating other conditions, and physical performance [0002]. Llosa teaches that an aspect can include a foodstuff having free acid (D)--hydroxybutyrate, and/or a (D)--hydroxybutyrate salt, (D)-1,3-butanediol and/or Ketone Ester [0005]. Llosa further details, in some embodiments, the free acid (D)--hydroxybutyrate, and the (D)--hydroxybutyrate salt, and (D)-1,3-butanediol, and Ketone Ester can be in a molar ratio of 10±5:5±5:2±2:5±5 [0005]. Thus, based on said molar ratio 1,3-butanediol and the ketone ester may be left out to form a composition containing the free acid (D)--hydroxybutyrate, and the (D)--hydroxybutyrate salt.
With respect to Applicant’s declaration under 37 CFR 1.132 which states that there are at least two ways to limit or prevent self-polymerization of beta-hydroxybutyric acid, the first way is to form an aqueous composition in which the concentration of beta- hydroxybutyric acid does not exceed about 55% w/v of the aqueous composition, and the second way is to form a dry solid beta-hydroxybutyrate composition that comprises beta-hydroxybutyric acid and a relatively minor amount of a beta-hydroxybutyrate salt component (i.e., no greater than about 4%) and not expose it to water (see paragraphs 4-6 of declaration), the Examiner maintains that the data does not demonstrate criticality for the amounts of the salt as claimed. The declarant states “It was unexpectedly found that introducing a relatively minor amount of a beta-hydroxybutyrate salt component (i.e., no greater than about 4%) with the dry solid beta-hydroxybutyric acid, and maintaining it in a relatively dry state, limits the tendency of solid beta-hydroxybutyric acid to undergo condensation and self-polymerization.” (see paragraph 9 of declaration) The declaration further confirms the stability of the solid beta-hydroxybutyrate composition which initially contained 98.9% beta-hydroxybutyric acid and 1.1% sodium beta-hydroxybutyrate and after an initial minor amount of self-polymerization in the first two weeks, self-polymerization essentially stopped after 2 weeks as shown in Table 1 (see paragraphs 13-14 of the declaration).
However, Applicant does not demonstrate criticality for the claimed range of beta-hydroxybutyric acid. Applicant provides data for one concentration of beta-hydroxybutyrate salt (1.1%) and no other concentrations inside and outside of the claimed range. Thus there is no other data to compare Applicant’s data with to determine if Applicant’s invention actually demonstrates surprising and unexpected results. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Moreover, based on Applicant’s rationale that the salt prevents polymerization of the acid by functioning as an internal desiccant, there would be no reason why the amount of the salt would be limited to 4% since it would be expected that the more salt added would allow for more protection against more water content.
"[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
Thus Applicant’s declaration is found not persuasive.
Applicant further argues that claim 17 claims a composition that is not taught or suggested by Llosa and Clarke and the instant specification explains that there are clear physiological effects between S-BHB and R-BHB, which rebuts the argument in the Office Action that they are essentially equivalent. Applicant argues that R-BHB is endogenously produced by the human body, while S-BHB is not and S-BHB can be administered to provide different physiological effects than R-BHB. Applicant argues that S-beta-hydroxybutyric acid (S-beta-hydroxybutyrate at biological pH), which is not endogenously produced by mammals and is believed by some to be unnatural and potentially harmful, can provide other beneficial effects. These include one or more of: increased endogenous production of R-beta-hydroxybutyrate and acetoacetate; endogenous conversion into one or both of R-beta-hydroxybutyrate and acetoacetate; endogenous conversion into fatty acids and sterols; prolonged ketosis; metabolism of S-beta-hydroxybutyrate independent of its conversion to R-beta-hydroxybutyrate and/or acetoacetate; improved fetal development; increased growth years; reduced endogenous production of acetone during ketosis; signaling to modulate metabolism of R-beta-hydroxybutyrate and glucose; antioxidant activity; and production of acetyl-CoA. Beta-hydroxybutyric acid compositions that are enriched with, or contain enantiomerically pure, S-beta-hydroxybutyric acid may be administered in higher doses than compositions enriched with, or that contain enantiomerically pure, R-beta- hydroxybutyric acid to obtain the same rapid supply of R-beta-hydroxybutyrate in the body. In such cases, it may be desirable to include incrementally higher, but still small, amounts of beta-hydroxybutyrate salts, such as less than 4%, 3%, or 2% of such salts by combined weight of beta-hydroxybutyric acid and beta-hydroxybutyrate salt(s), in order to further offset the acidity of beta-hydroxybutyric acid. Thus, Applicant argues that R-BHB and S-BHB are not obvious variations of each other, thus rebutting any prima facie case based on the disclosure of R-BHB or racemic BHB in Llosa and Clarke.
These arguments are found not persuasive since claim 17 claims the use of pure S-forms or enriched with the S-forms, so as to contain at least 60% by enantiomeric equivalents of S-forms and no greater than 40% by enantiomeric equivalents of R-forms and although the prior art does not teach the pure S-forms or enriched with the S-forms, so as to contain at least 60% by enantiomeric equivalents of S-forms and no greater than 40% by enantiomeric equivalents of R-forms, the prior art teaches a racemic mixture which contains 50% R and 50% S forms. Thus the prior art does teach the use of the S-form in combination with the R form. 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) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d 329, 332 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); Gentiluomo v. Brunswick Bowling and Billiards Corp., 36 Fed. App'x 433 (Fed. Cir. 2002)(non-precedential)(disagreeing with argument that overlapping ranges were required to find a claim prima facie obvious); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Applicant has not provided any evidence of any surprising or unexpected results for the use of S enriched forms, so as to contain at least 60% by enantiomeric equivalents of S-forms and no greater than 40% by enantiomeric equivalents of R-forms, as compared to the use of a racemic form as taught in the prior art. Thus in the absence of secondary considerations such as unexpected results, the use of S-enriched forms as claimed are rendered obvious in view of the cited prior art teaching of a racemic mixture.
Thus, for these reasons, the previous rejections under 35 USC 103 are hereby maintained and reproduced below. This action is final.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-22 have been amended to claim a solid beta-hydroxybutyrate composition for oral delivery to increase blood ketone level in a subject, comprising beta-hydroxybutyric acid; and a beta-hydroxybutyrate salt component wherein the composition contains 96% to 99.5% of the beta-hydroxybutyric acid and 0.5% to 4% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, and wherein the composition is free of 1,3-butanediol and ketone ester. Claim 11 of the instant application has been amended to recite the composition contains about 98% to about 99% of the beta-hydroxybutyric acid and about 1% to about 2% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component. Claims 15 and 19 of the instant application has been amended to recite the composition contains about 99% to about 99.5% of the beta-hydroxybutyric acid and about 0.5% to about 1% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component. Claim 22 of the instant application has been amended to recite the composition contains about 97% to about 99.8% of the beta-hydroxybutyric acid and about 0.2% to about 3% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component.
There is no disclosure in the instant specification for a beta-hydroxybutyrate salt component in the range of 0.5% to 4%; about 1% to about 2%; about 0.5% to about 1% ; or about 0.2% to about 3%; and a beta-hydroxybutyric acid component in the range of 96% to 99.5%; about 98% to about 99%; about 99% to about 99.5%; or about 97% to about 99.8% as currently claimed. Paragraph [0027] as pointed out by Applicant for support recites “Beta-hydroxybutyric acid compositions that are enriched with, or contain enantiomerically pure, S-beta-hydroxybutyric acid may be administered in higher doses than compositions enriched with, or that contain enantiomerically pure, R-beta- hydroxybutyric acid to obtain the same rapid supply of R-beta-hydroxybutyrate in the body. In such cases, it may be desirable to include incrementally higher, but still small, amounts of beta-hydroxybutyrate salts, such as less than 4%, 3%, or 2% of such salts by combined weight of beta-hydroxybutyric acid and beta-hydroxybutyrate salt(s), in order to further offset the acidity of beta-hydroxybutyric acid. Paragraph [0064] as pointed out by Applicant for support recites “ Beta-hydroxybutyric acid compositions are free or substantially free of beta-hydroxybutyrate salts so as to contain less than 1%, or less than 0.9%, or less than 0.8%, or less than 0.7%, or less than 0.6%, or less than 0.5%, or less than 0.4%, or less than 0.3%, or less than 0.2%, or less than 0.1% of one or more beta-hydroxybutyrate salts by combined weight of beta-hydroxybutyric acid and beta-hydroxybutyrate salt(s). Beta-hydroxybutyric acid compositions can be essentially or totally free of beta-hydroxybutyrate salts, i.e., contain 0% by weight of beta-hydroxybutyrate salts.”
Thus the instant specification provides support for less than 4%, 3%, 2%, or 1% of beta-hydroxybutyrate salts by combined weight of beta-hydroxybutyric acid and beta-hydroxybutyrate salt, or less than 0.9%, 0.8%, etc. beta-hydroxybutyrate salts by combined weight of beta-hydroxybutyric acid and beta-hydroxybutyrate salt. For example the specification provides support for less than 0.5% or less than 4% but not between 0.5% and 4% as currently claimed.
Thus these newly added limitations of particular ranges represent new matter.
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.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,806,324 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application the cited claims of ‘324 are substantially overlapping in scope and mutually obvious.
Claims 1-22 of the instant application claim a solid beta-hydroxybutyrate composition for oral delivery to increase blood ketone level in a subject, comprising: beta-hydroxybutyric acid; and a beta-hydroxybutyrate salt component; wherein the composition contains 96% to 99.5% of the beta-hydroxybutyric acid and from 0.5% to 4% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, wherein the composition is free of 1,3-butanediol and ketone ester.
Claims 1-27 of ‘324 claim an aqueous beta-hydroxybutyric acid composition formulated as a nutritional supplement, or for addition to water, beverage, or food product, for ingestion by oral delivery to provide exogenous ketone bodies that exogenously increase blood ketone level in a mammal, the composition comprising: water; and 0.4% w/v to 55% w/v of exogenous beta-hydroxybutyric acid in monomeric form at least partially dissolved in the water, wherein the composition is free or substantially free of beta-hydroxybutyrate salts so as to contain less than 0.8% of total beta-hydroxybutyrate salts and greater than 99.2% of the exogenous beta-hydroxybutyric acid by combined weight of the exogenous beta-hydroxybutyric acid and any beta-hydroxybutyrate salts, wherein the composition is free of 1,3-butanediol and ketone esters, wherein the composition is a nutritional supplement that provides a unit dose of about 0.5 gram to about 25 grams of the exogenous beta-hydroxybutyric acid to exogenously increase blood ketone level in a mammal.
The difference between the cited claims of the instant application and the cited claims of ‘324 are the instant claims claim a solid composition, whereas, ‘324 claims an aqueous composition.
However, the claims of ‘324 encompass the same solid beta-hydroxybutyrate composition as claimed comprising: beta-hydroxybutyric acid; and a beta-hydroxybutyrate salt component; wherein the composition contains greater than 99.1% and up to 99.9% of the beta-hydroxybutyric acid and less than 0.9% of the beta- hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, wherein the composition is free of 1,3-butanediol and ketone ester, since in order to form the aqueous composition of ‘324, the solid composition as claimed would have been combined with water to form the composition of the ‘324 claims.
Thus the cited claims of the instant application would be anticipated over the cited claims of ‘324.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,925,843 B2 (Provided on IDS 05/01/2023) in view of Llosa et al. U.S. Publication No. 2018/0057846 A1 (Provided on IDS dated 05/01/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application the cited claims of ‘843 are substantially overlapping in scope and mutually obvious.
Claims 1-22 of the instant application claim a solid beta-hydroxybutyrate composition for oral delivery to increase blood ketone level in a subject, comprising: beta-hydroxybutyric acid; and a beta-hydroxybutyrate salt component; wherein the composition contains 96% to 99.5% of the beta-hydroxybutyric acid and from 0.5% to 4% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, wherein the composition is free of 1,3-butanediol and ketone ester.
Claims 1-20 of ‘843 claim a composition for increasing ketone body level in a subject, the composition comprising: a dietetically or pharmaceutically acceptable carrier; one or more beta-hydroxybutyrate salts; one or more acetoacetate salts; beta-hydroxybutyrate free acid; and optionally acetoacetate free acid, wherein the form may be a powder, tablet or capsule (claims 9 and 16).
The claims of ‘843 do not claim the composition contains between 96% and 99.5% of the beta-hydroxybutyric acid and from 0.5% to 4% of the beta- hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, wherein the composition is free of 1,3-butanediol and ketone salts.
However, the claims of ‘843 do not claim the addition of 1,3-butanediol or ketone ester and thus the composition of ‘843 is free of 1,3-butandiol and ketone ester as claimed in the instant claims.
Llosa et al. teaches compositions and methods for producing near instant and/or therapeutic levels of nutritional ketosis, and in particular but not limited to compositions and methods related to the right hand enantiomer in particular in either in its pure enantiomer form or enantiomerically enriched form of a Ketone Blend, including any two or more of the following: (D)--hydroxybutyrate salts, (D)--hydroxybutyrate free acid, (D)-1,3-butanediol, and Ketone Ester, for mitochondrial health, treating other conditions, and physical performance [0002]. An aspect can include a foodstuff having free acid (D)--hydroxybutyrate, and/or a (D)--hydroxybutyrate salt, (D)-1,3-butanediol and/or Ketone Ester [0005]. In some embodiments, the free acid (D)--hydroxybutyrate, and the (D)--hydroxybutyrate salt, and (D)-1,3-butanediol, and Ketone Ester can be in a molar ratio of 10±5:5±5:2±2:5±5 [0005].
Llosa et al. teaches that a Ketone Blend is defined as a blend of two or more compounds selected from a free acid of -hydroxybutyrate, salt of -hydroxybutyrate, ketone ester of hydroxybutyrate, or 1,3-butanediol which when taken orally shall increase serum levels of (D)--hydroxybutyrate [0025]. The Ketone Blend containing any two or more of the above listed compounds can be in any relative concentration ratios and the preferred embodiments shall be as follows: 51-99% free acid, 1-25% Ketone Salt, 1-10% 1,3-butanediol, and 1-49% Ketone Ester [0027]. Thus the teachings of Llosa et al. encompass a ketone blend, without 1,3-butanediol and containing 99-96% of the free acid and 1-4% of the salt or 98-96% of the free acid and 1-3% of the salt and 1% of a ketone ester.
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the claims of ‘843 which claim a composition for increasing ketone body level in a subject, the composition comprising: a dietetically or pharmaceutically acceptable carrier; one or more beta-hydroxybutyrate salts; one or more acetoacetate salts; beta-hydroxybutyrate free acid; and optionally acetoacetate free acid, with the teachings of Llosa et al. which teaches compositions and methods for producing near instant and/or therapeutic levels of nutritional ketosis comprising a ketone blend containing any two or more of a free acid of -hydroxybutyrate, salt of -hydroxybutyrate, ketone ester of hydroxybutyrate, or 1,3-butanediol in the preferred embodiments of 51-99% free acid, 1-25% Ketone Salt, 1-10% 1,3-butanediol, and 1-49% Ketone Ester. Thus a person of ordinary skill in the art would have been motivated to formulate the composition of ‘843 containing up to 99% of the beta-hydroxybutyrate free acid and 1% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, and thus the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component would form a crystalline solid as claimed in the instant claims.
Thus a composition comprising 99% beta-hydroxybutyric acid and 1% salt is rendered obvious in view of the cited teachings and thus the cited claims of the instant application are rejected since 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) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d 329, 332 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); Gentiluomo v. Brunswick Bowling and Billiards Corp., 36 Fed. App'x 433 (Fed. Cir. 2002)(non-precedential)(disagreeing with argument that overlapping ranges were required to find a claim prima facie obvious); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
Thus the cited claims of the instant application are rendered obvious over the claims of ‘843.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,793,778 B2 in view of Llosa et al. U.S. Publication No. 2018/0057846 A1 (Provided on IDS dated 05/01/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application the cited claims of ‘778 are substantially overlapping in scope and mutually obvious.
Claims 1-22 of the instant application claim a solid beta-hydroxybutyrate composition for oral delivery to increase blood ketone level in a subject, comprising: beta-hydroxybutyric acid; and a beta-hydroxybutyrate salt component; wherein the composition contains 96% to 99.5% of the beta-hydroxybutyric acid and from 0.5% to 4% of the beta-hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, wherein the composition is free of 1,3-butanediol and ketone ester.
Claims 1-20 of ‘778 claim a composition for administering ketone bodies to a subject, comprising: one or more beta-hydroxybutyrate salts; one or more acetoacetate salts; beta-hydroxybutyrate free acid; and optionally acetoacetate free acid, wherein the form may be a powder, tablet or capsule (claim 10).
The claims of ‘778 do not claim the composition contains between 96% and 99.5% of the beta-hydroxybutyric acid and from 0.5% to 4% of the beta- hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, wherein the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component form a crystalline solid, wherein the composition is free of 1,3-butanediol and ketone salts.
However, the claims of ‘778 do not claim the addition of 1,3-butanediol or ketone ester and thus the composition of ‘778 is free of 1,3-butandiol and ketone ester as claimed in the instant claims.
Llosa et al. teaches compositions and methods for producing near instant and/or therapeutic levels of nutritional ketosis, and in particular but not limited to compositions and methods related to the right hand enantiomer in particular in either in its pure enantiomer form or enantiomerically enriched form of a Ketone Blend, including any two or more of the following: (D)--hydroxybutyrate salts, (D)--hydroxybutyrate free acid, (D)-1,3-butanediol, and Ketone Ester, for mitochondrial health, treating other conditions, and physical performance [0002]. An aspect can include a foodstuff having free acid (D)--hydroxybutyrate, and/or a (D)--hydroxybutyrate salt, (D)-1,3-butanediol and/or Ketone Ester [0005]. In some embodiments, the free acid (D)--hydroxybutyrate, and the (D)--hydroxybutyrate salt, and (D)-1,3-butanediol, and Ketone Ester can be in a molar ratio of 10±5:5±5:2±2:5±5 [0005].
Llosa et al. teaches that a Ketone Blend is defined as a blend of two or more compounds selected from a free acid of -hydroxybutyrate, salt of -hydroxybutyrate, ketone ester of hydroxybutyrate, or 1,3-butanediol which when taken orally shall increase serum levels of (D)--hydroxybutyrate [0025]. The Ketone Blend containing any two or more of the above listed compounds can be in any relative concentration ratios and the preferred embodiments shall be as follows: 51-99% free acid, 1-25% Ketone Salt, 1-10% 1,3-butanediol, and 1-49% Ketone Ester [0027]. Thus the teachings of Llosa et al. encompass a ketone blend, without 1,3-butanediol and containing 99-96% of the free acid and 1-4% of the salt or 98-96% of the free acid and 1-3% of the salt and 1% of a ketone ester.
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the claims of ‘778 which claim a composition for administering ketone bodies to a subject, comprising: one or more beta-hydroxybutyrate salts; one or more acetoacetate salts; beta-hydroxybutyrate free acid; and optionally acetoacetate free acid, with the teachings of Llosa et al. which teaches compositions and methods for producing near instant and/or therapeutic levels of nutritional ketosis comprising a ketone blend containing any two or more of a free acid of -hydroxybutyrate, salt of -hydroxybutyrate, ketone ester of hydroxybutyrate, or 1,3-butanediol in the preferred embodiments of 51-99% free acid, 1-25% Ketone Salt, 1-10% 1,3-butanediol, and 1-49% Ketone Ester. Thus a person of ordinary skill in the art would have been motivated to formulate the composition of ‘778 containing up to 99% of the beta-hydroxybutyrate free acid and at least 1% of the beta- hydroxybutyrate salt component by combined weight of the beta-hydroxybutyric acid and the beta-hydroxybutyrate salt component, and thus the beta-hydroxybutyric acid and beta-hydroxybutyrate salt component would form a crystalline solid as claimed in the instant claims.
Thus a composition comprising 99% beta-hydroxybutyric acid and 1% salt is rendered obvious in view of the cited teachings and thus the cited claims of the instant application are rejected since 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) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d 329, 332 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an a