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 .
Status of the Claims
Claims 1, 2 and 5-8 are currently pending and amendments to the claims filed on 03/02/2026 are acknowledged.
Withdrawn rejections:
Applicant's amendments and arguments filed 03/02/2026 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 Any rejection and/or objection not specifically addressed below are herein withdrawn.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 Objection
Claim 1 is objected to a minor informality.
Claim 1 recites “all 3-hydroxybutyric acid” in line 6, but which would be better to write “the 3-hydroxybutyric acid”. Appropriate correction is requested.
New Grounds of Rejection --- as necessitated by amendment
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, 2 and 7-8 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 claims 1 and 7 filed on 03/02/2026:
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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 instant claim 3), 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 that reads on the amount of instant claim 2 (instant claim 2). Lowery further teaches R-beta-hydroxybutyrate and one or more additional compounds such as triglyceride tributyrin (claims 10-13 of prior art) (instant claim 7, in part, and instant claim 8).
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 of instant claims1 and 7. 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, and impart the sustained releasability and masking activity ([0137], [0140] and [0217]).
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 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]).
Although the applied art does not expressly teach “consisting of” language recited by instant claim 7, it would be obvious because Lowery teaches R-hydroxybutyrate and one additional ingredient of triglyceride tributyrin or palm oil (see, [0045], claims 10-13 of Lowery) which increases ketone levels ([0045] of Lowery), and Kataoka discloses fat/oil as claimed (see entire document including [0010] and the Examples of Kataoka). Thus, it would be obvious to modify the teachings with replacing the fat/oil components of Lowery with fat/oil particles only having the instant claimed properties as taught by Kataoka because such replacement would have yielded no more than the predictable results. Further, MPEP 706 states: “The mere fact that a claim recites in detail all of the features of an invention (i.e., is a “picture” claim) is never, in itself, justification for the allowance of such a claim.” The principle of law further states from MPEP 2141 I: “When considering obviousness of a combination of known elements, the operative question is thus “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at ___, 82 USPQ2d at 1396.” 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).” Here, the applied art would achieve the claimed invention as noted above. Further, the claimed composition using “consisting of” language (instant claim 7) does not provide any unexpected results in view of the present specification. Simply instant claim 7 would be obtained from the combination of Lowery /Kataoka as noted above.
In light of the foregoing, instant claims 1, 2 and 7-8 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 03/02/2026:
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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.
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 03/02/2026:
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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. 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 provides unexpected results based on Examples 1-21, Comparative Examples 1-6 and Tables 1-2.
The Examiner responds that since Lowery alone or Lowery/Kataoka discloses the claimed invention, alleged instant results would be expected. Specifically, Lowry (R) 3-hydroxybutyric acid or its potassium salt and at least one fat and/oil including long chain triglyceride (TG) with more than 12 carbons, and Kataoka teaches the claimed fat and/oil containing TG in beta form and overlapping aspect ratio, and both references using fat/oil 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 (e.g., flowability, sustained releasability, masking, elution prevention, acid resistance, storage stability and prevention of absorption and caking). 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 remain 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 examined claims are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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