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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 5/12/2026 in which claims 1 and 2 are amended. No claims are newly added or canceled.
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 3/4/2026, 3/17/2026 and 3/26/2026 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.
Withdrawn Rejections
Applicant’s amendment, filed on 5/12/2026, with respect to the rejection of claims 1 and 2 under 35 U.S.C. 101, has been fully considered and is persuasive. Applicant amended the claims to have the composition integrated into a practical application, which renders the claims patent eligible. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 5/12/2026, with respect to the rejection of:
Claims 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by Sasaki et al. (JPH 1112168A, 1999);
Claims 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by MacLeod (J. Inst. Brewing, 1951);
Claims 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by Wyse et al. (J. Am. Soc. Sugar Beet Technol., 1971);
Claims 1 and 2 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); and
Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (US 2018/0303781A1), has been fully considered and is persuasive. None of the cited prior art anticipates each limitation of the claims. The rejections are hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 5/12/2026, wherein instant independent claims 1 is amended to alter the breadth and scope of the claim, wherein the remaining pending claims depend from said independent claims. Therefore, new grounds of rejection have been made or rejections from the previous Office Action have been modified.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishida et al. (JP 2014133728A, 2014, reference of record).
Ishida et al. discloses an oral tablet comprising glutamic acid and/or aspartic acid and lactose. (Examples 1-3)
It is noted that the prior art does not teach that the composition can be used in the manner instantly claimed, for promoting proliferation of S. oralis. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are anticipated by the prior art.
Response to Arguments
Applicants’ arguments with respect to the anticipatory rejection over Ishida, have been fully considered but they are not persuasive.
Applicant argues that Ishida does not disclose a composition promoting proliferation of S. oralis. Applicants’ argument is not persuasive because as detailed in the modified rejection the promoting proliferation of S. oralis is an intended use and does not modify the structure of the composition of Ishida. Thus, the composition of Ishida anticipates claim 1 with the promoting proliferation of S. oralis being inherent.
The rejection is still deemed proper and is maintained.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (US 2018/0303781A1, IDS).
Han exemplifies a composition for promoting desired oral microbiota, in an oral cavity, comprising arginine, lactose and raffinose. (Example 1; Abstract) Han further discloses that, in general, the composition is formulated as an oral microbiota promoting composition to include at least one sugar containing substance and at least one amino acid containing substance, where the at least one sugar containing substance may include at least one monosaccharide, disaccharide, oligosaccharide, and polysaccharide. (¶0040) Han then specifically teaches that:
The at least one amino acid is selected from among L-cysteine, DL-aspartic acid, L-glutamic acid, L-serine, and L-tyrosine. (Claim 5);
The at least one sugar may be an oligosaccharide of galactose (a.k.a. galactooligosaccharides or GOS). (¶0043); and
The oral microbiota promoting composition may be formulated as an additive to an oral hygiene product acting as a carrier, such as toothpaste or mouthwash. (¶0028)
Han does not exemplify or claim that the composition comprises GOS and aspartate or GOS and glutamate.
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 and add a galactooligosaccharide, thereby arriving at the instant invention. Han suggests that the composition my further comprise additional amino acids beyond arginine and additional sugars beyond raffinose/lactose. One could easily select aspartic acid or glutamic acid, and/or GOS, 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).
It is noted that the prior art does not teach that the composition can be used in the manner instantly claimed, for promoting proliferation of S. oralis. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the obviousness rejection over Han, has been fully considered but is not persuasive.
Applicant argues that because Han does not anticipate the claimed composition, it is moot whether one would find it obvious to modify Han. Applicants’ argument is not persuasive because the question in a section 103 case is not only what the references expressly teach, but what they would collectively suggest to one of ordinary skill in the art. In re Antle, 58 CCPA 1382, 1387, 444 F.2d 1168, 1171, 170 USPQ 285, 287-88 (1971) The teaching and suggestions of Han make the modification of the exemplified embodiment, by: A) either substituting or adding to the exemplified sugar; or B) either substituting or adding to the exemplified amino acid, a prima facie obvious step for one of ordinary skill. Modifying the composition of Han as detailed in the above rejection yields an composition, formulated as a toothpaste or mouthwash, comprising GOS and aspartate or GOS and glutamate, which meets the limitations prescribed by elements (i) and/or (ii) of claims 1 and 2.
The rejection is still deemed proper and is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 extension fee 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.
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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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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