Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1 and 2 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/JP2021/047772, filed on 12/23/2021. The instant application claims foreign priority to JP 2020-218922 filed on 12/28/2020. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 6/26/2023.
Information Disclosure Statement
The information disclosure statements (IDS) dated 9/26/2023, 11/14/2024 and 12/19/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) that does not integrate the judicial exception into a practical application, without significantly more. The claims are directed to compositions comprising sugars and amino acids, which are known naturally occurring compounds that occur together in naturally occurring compositions. For instance: 1) MacLeod (J. Institute Brewing, 1951, PTO-892) discloses that barley grain comprises raffinose, glutamic acid and aspartic acid; 2) Wyse et al. (J. Am. Soc. Sugar Beet Technol., 1971, PTO-892) discloses that sugar beets comprise raffinose and amino acids, specifically glutamic acid. (pp. 370; Ref. 23); and 3) Zhang et al. (Nutrients, 2013, PTO-892) discloses that breast milk comprises glutamic acid and aspartic acid (Table 5) and Castanys-Muñoz et al. (Nutr. Rev., 2013, PTO-892) discloses that breast milk comprises lactose and 2’-fucosyllactose. (Abstract) The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional intended use limitation (i.e. “for an oral cavity”) does not distinguish the invention from that which would naturally occur. Barley grain, sugar beets and breast milk are all natural food sources consumed through the oral cavity of various animals.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sasaki et al. (JPH 1112168A, 1999, IDS).
Sasaki et al. discloses an oral tablet or capsule comprising glutamic acid and lactose. (Examples 1 and 3)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishida et al. (JP 2014133728A, 2014, PTO-892).
Ishida et al. discloses an oral tablet comprising glutamic acid and/or aspartic acid and lactose. (Examples 1-3)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacLeod (J. Inst. Brewing, 1951, PTO-892).
MacLeod discloses that barley grain comprises raffinose glutamic acid and aspartic acid. (Abstract) With respect to the limitation “for an oral cavity”, this limitation is inherently met by MacLeod because barley grain is a natural food source consumed through the oral cavity of various animals.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyse et al. (J. Am. Soc. Sugar Beet Technol., 1971, PTO-892).
Wyse et al. discloses that sugar beet comprises raffinose and glutamic acid. (p. 370; Ref 23) With respect to the limitation “for an oral cavity”, this limitation is inherently met by Wyse because sugar beet is a natural food source consumed through the oral cavity of various animals.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Nutrients, 2013, PTO-892) with Castanys-Muñoz et al. (Nutr. Rev., 2013, PTO-892).
Zhang et al. discloses that breast milk comprises glutamic acid and aspartic acid. (Table 5) Castanys-Muñoz et al. discloses that breast milk comprises lactose and 2’-fucosyllactose. (Abstract) Thus, breast milk meets each and every limitation of the claimed invention. With respect to the limitation “for an oral cavity”, this limitation is inherently met by the prior art because breast milk is consumed through the oral cavity of human infants.
Accordingly, the instant claims are anticipated by the prior art.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (US 2018/0303781A1, IDS).
Han discloses a composition for promoting desired oral microbiota, in an oral cavity, comprising arginine, lactose and raffinose. (Example 1; Abstract)
Accordingly, the instant claims are anticipated by the prior art.
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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (US 2018/0303781A1, IDS).
Han discloses a composition for promoting desired oral microbiota, in an oral cavity, comprising arginine, lactose and raffinose. (Example 1; Abstract) Han further discloses that the composition may further comprise an amino acid selected from among L-cysteine, DL-aspartic acid, L-glutamic acid, L-serine, and L-tyrosine. (Claim 5)
Han does not disclose that the composition specifically comprises an acidic amino acid.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exemplified composition of Han and add one or more of DL-aspartic acid and L-glutamic acid, thereby arriving at the instant invention. Han suggests that the composition my further comprise additional amino acids beyond arginine and one could easily select aspartic acid or glutamic acid from among the limited options taught by Han, to yield an obvious modification of the primary composition of Han. The rationale to support a conclusion that the claim would have been obvious is that 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).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693