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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/30/2026 has been entered.
Status of the Claims
Claims 1 and 5-8 are currently pending and amendments to the claims filed on 06/30/2026 are acknowledged.
Allowable Subject Matter
Claim 7 is allowed because the art of record does not teach or suggest, alone or in combination, with sufficient specificity each of the components in the composition claim and the transitional phrase of “consisting of” limits the composition to only those components recited.
Withdrawn rejections:
Applicant's amendments and arguments filed 06/30/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
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 of this title, 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.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical/food research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from food medicine, pharmacy, physiology and chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lowery et al. (US2017/0296501A1) in view of Kataoka et al. (US2018/0249729A1, IDS of 11/28/2022).
Applicant claims the below claim 1 filed on 06/30/2026:
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Determination of the scope and content of the prior art; Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143).
Lowery teaches an oral composition comprising (R)-3-beta-hydroxybutyric acid or its potassium salt for maintaining ketosis in an individual (e.g., [0005], [0038], [0067], [0100] and claim 1 of prior art) and R-beta-hydroxybutyrate may have a greater impact on a health of an individual (e.g., due to decreased side effects; increase ketone levels, weight loss, mental acuity, fat loss, etc.); the composition further comprises at least one fat and/or oil including long chain triglycerides with more than 12 carbons, etc. (abstract and claims 3 and 12 of prior art) which reads on the claimed fat and/or oil; the composition is delivered in the form of e.g., food products ([0068]) (instant claim 1, in part), and the composition containing R-hydroxybutyrate salt is in the form of powders ([0069], [0070], [0093]); the R-hydroxybutyrate in the composition is present in an amount of approximately 0.5 to approximately 10g ([0008] and [0011]); and the composition containing 10g of MCT and 8g hydroxybutyrate is administered. Lowery further teaches R-beta-hydroxybutyrate and one or more additional compounds such as triglyceride tributyrin (claims 10-13 of prior art) (instant claim 8). This art further teaches butyrate and/or butyric acid may not be palatable to individuals (e.g., since the odor and taste are often compared to vomit) ([0047]).
Lowery teach fat and/oil such as long chain triglyceride with e.g., more than 12 carbons, and however, Lowery does not expressly or specifically teach beta-form fat and/or oil containing Cx triglyceride, its aspect ratio and beta-form fat and/or oil, and its amount of instant claim1. The deficiencies are cured by Kataoka.
Kataoka discloses powdery fat or oil composition as a coating agent comprising a fat and/or oil ingredient containing a XXX triglyceride having fatty acid residue X, each with x carbon atoms, at positions 1 to 3 of glycerin wherein x number of carbon atoms is an integer selected from 10 to 22, and the fat and/or oil ingredient comprises a β-form fat and/or oil; and particles of the powdered fat and/or oil composition have a plate-like shape (claim 1 of prior art) wherein the beta-form fat and/or oil is a fat and/or oil constituted only of a beta-form ([0045]) and all the fat and/or oil ingredient is preferably the beta-form fat and/or oil ([0049]), and the plate-like powdered fat and/or oil particles have an average particle diameter of e.g., 5-200 microns wherein the plate-like shape has an aspect ratio of 1.1 or more, preferably of 1.2 to 3.0 ([0061]) which overlaps or inside the claimed ranges and the aspect ratio can be determined as the average of the measured particles ([0061])(instant claim 1 – fat and/oil particles containing TG having C10-22 and aspect ratio); the powdered fat and/or oil compositions have been widely used in the fields of foods such as cake mixes, coffee creams, and shortenings, adhesive, coatings ([0002], [0009] and [0062]); and the compositions containing the said fat and/oil particles can be used to coat the food surface to prevent deterioration or moisture absorption due to contact with the outside air or water, improve the flowability, and impart the sustained releasability, masking activity, elution prevention, acid resistance, and so forth ([0137], [0140] and [0217]). Further the fat and/oil powder can be incorporated in various foods in an amount of 0.1-99%, 1 to 90%, or 5 to 85% relative to 100% by mass of the finally obtained food as a whole ([0103]) which overlaps the instant range of 5 to 100 parts (instant claim 1, amount of fat/oil powder).
It would have been obvious to modify the teachings of Lowery with addition of food coating agent containing specific beta-form of fat and/or oil particles having certain aspect ratio of Kataoka in order to enhance the properties of e.g., food composition containing 3-hydroxybutyric acid and/or its salt of Lowery because the beta-form TG coating agent of Kataoka having overlapping aspect ratio improves quality of the food by preventing deterioration and/or protecting from easy moisture absorption due to contact with the outside air or water, improves the flowability, sustained releasability, masking, elution prevention, acid resistance, etc. as taught by Kataoka ([0137]).
Since Kataoka teaches overlapping range of fat/oil powder, relative food composition, and therefore, from the skill and knowledge of the ordinary artisan, it would have been obvious to optimize or adjust the amount fat/oil powder relative to food composition containing butyric acid and fat/oil powder, depending on the intended purpose and used ingredients.
In light of the foregoing, instant claims 1 and 8 are obvious over Lowery in view of Kataoka.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lowery et al. (US2017/0296501A1) in view of Hu et al. (CN110372487A, IDS of 11/28/2022) and further in view of Kataoka et al. (US2018/0249729A1, IDS of 11/28/2022).
Applicant claims the below claim 5 filed on 06/30/2026:
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Determination of the scope and content of the prior art; Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143).
Lowery was discussed as noted above with respect to instant claim 1.
Hu discloses 3-hydroxybutyrate sodium can provide energy source as main ketobodies in body most tissues, food area, etc.,([0005] of EPO English translation) and but this compound is easy to the moisture absorption and agglomeration (see entire document including [0009] of EP English translation). That is, it is well known from the teachings of Hu that 3-hydroxybutyrate sodium has deliquescence problem.
Kataoka was discussed as noted above. In particular, Kataoka discloses the powdered fat and/or oil compositions containing at least one type of Cx triglyceride have been widely used in the fields of foods such as cake mixes, coffee creams, and shortenings, adhesive, coatings ([0002], and [0062]); and the powdered fat and/or oil compositions can be used to coat the food surface to prevent deterioration or moisture absorption due to contact with the outside air or water, and impart the sustained releasability ([0137], [0140] and [0217] of Kataoka).
Lowery teaches (R) 3-hydroxybutyrate compound or its sodium salt for use in food area; Hu discloses 3-hydroxybutyrate is easy to absorb moisture and agglomerate, and Kataoka teaches fat and/oil containing Cx triglyceride is acted as a coating to prevent moisture absorption. All references are related to food field. Accordingly, it would have been obvious to modify the teachings of Lowery/Hu with addition of the said fat/oil composition in order to prevent moisture absorption and agglomeration, resulting in improving the deliquescence of 3-hydroxybutyrate, as taught/suggested by Hu/Kataoka.
In light of the foregoing, instant claim 5 is obvious over Lowery in view of Hu and further in view of Kataoka.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lowery et al. (US2017/0296501A1) in view of Jun (JP2017-201906A,l IDS of 11/28/2022) and further in view of Kataoka et al. (US2018/0249729A1, IDS of 11/28/2022).
Applicant claims the below claim 6 filed on 06/30/2026:
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Determination of the scope and content of the prior art; Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Lowery was discussed as noted above with respect to claim 1.
Lowery further discusses butyric acid may not be palatable to individuals (e.g., since the odor and taste are often compared to vomit) and thus hydroxybutyrate may be processed to reduce organoleptic reactions ([0047]).
Jun discloses nutrient composition and food supplement containing 3-hydroxybutyric acid and/or its salt (abstract), and but such compound has a sour taste (Table 2 of prior art). That is, it is well known from the teachings of Jun that 3-hydroxybutyric acid and/or its salt has a sour taste.
Kataoka was discussed as noted above. In particular, Kataoka discloses the powdered fat and/or oil compositions containing at least one type of XXX triglyceride have been widely used in the fields of foods such as cake mixes, coffee creams, and shortenings, adhesive, coatings ([0002], and [0062]); and the powdered fat and/or oil compositions can be used to coat the food surface to prevent deterioration or moisture absorption due to contact with the outside air or water, and impart the sustained releasability and masking ([0137], [0140] & [0217]).
Lowery teaches use of 3-hydroxybutyric acid compound is not palatable; Jun discloses the same compound has a sour taste; and Kataoka teaches the fat and/oil containing Cx triglyceride is used as a coating to impart masking activity. All references are related to food field. Accordingly, it would have been obvious to modify the teachings of Lowery/Jun with addition of the said fat/oil composition of Kataoka in order to mask and/or reduce acidic sour taste, as taught/suggested by Kataoka.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that the claimed invention requiring fat/oil powders having C16-18 and its amount provides unexpected results based on Examples 1-21, Comparative Examples 1-6 requiring a combination of 3HB or its salt with C1-3 glycerin- containing glycerin as the fat/oil component (See Tables 1-2); and Comparative compositions 1-6 did not form crystalline powder composition, and solidified fat and/or oil component exhibited a diffraction peak at 4.1 or 4.2A, and further 3-HB and alpha-form fat/oil exhibited agglomeration or deliquescence (Table 2).
The Examiner responds that since Lowery/Kataoka discloses the claimed invention, alleged instant results would be expected. Specifically, Lowry (R) 3-HB acid or its potassium salt and at least one fat and/oil including long chain triglyceride (TG) with more than 12 carbons, and in particular, Kataoka teaches the claimed fat and/oil containing TG with preferably C16-18 in beta form and overlapping aspect ratio and amount, and the fat/oil powder of Kataoka is used for prevent moisture absorption (deliquescence) and masking (for reduction of bad taste and odor, etc.), and both references using fat/oil powder in food product are in analogous art, and therefore, it would have been obvious to combine two references in order to enhance the properties of the composition containing 3-HB (e.g., prevention of absorption, flowability, sustained releasability, masking sour taste, elution prevention, acid resistance, storage stability and caking, etc.). Therefore, the alleged unexpected results would be expected. Further, the claimed invention does not require crystalline form and different peak. Even if those are recited in the instant claimed invention, it would also be expected since the applied art in combination teach the claimed composition and methods.
In this respect, please see case law stating that it is well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “…all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
In light of the foregoing, applicant’s arguments are not persuasive.
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 claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2 and 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-6 of copending application No. 17/794792.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require 3- hydroxybutyric acid and fat/oil plate-like particles comprising at least one type of XXX triglyceride in beta-form in overlapping amounts. The difference between them is that copending claims further require protein product. However, the claimed invention uses “comprising”, which does not exclude the introduction of such protein product.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Response to Arguments
Applicant argues that the copending application has a later effective filing date that that of the instant filing date, and when the double patenting rejection is only remaining rejection, it should be withdrawn.
The Examiner responds that the double patenting rejection is not the only remaining rejection in this application, and thus, the rejection is maintained until the prior art rejection is resolved.
Conclusion
All claims examined are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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