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 5/4/2026 in which claims 2 and 9 are cancelled and claims 1, 3-7 and 12-16 are amended. No claims are newly added.
Claims 1, 3-8 and 10-16 are pending in the instant application.
Withdrawn Claims
Claim 1 and 3-6 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The invention as originally claimed was drawn to a composition. The amendment submitted by Applicant changed the category of invention for claims 1 and 3-6 such that the instant claims are drawn to a method of treatment.
The general policy of the Office is not to permit the applicant to shift to claiming another invention after an election is once made and action given on the elected subject matter. Note that the applicant cannot, as a matter of right, file a request for continued examination (RCE) to obtain continued examination on the basis of claims that are independent and distinct from the claims previously claimed and examined (i.e., applicant cannot switch inventions by way of an RCE as a matter of right). (see MPEP § 819)
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1 and 3-6 are withdrawn from consideration as being directed to a non-elected invention. (see 37 CFR 1.142(b) and MPEP § 821.03).
Claims 7, 8 and 10-16 are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/JP2022/015872, filed on 3/30/2022. The instant application claims foreign priority to JP 2021065419 filed on 4/7/2021. 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 10/4/2023.
Withdrawn Rejections
All rejection(s) of record for claim(s) 2 and 9 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 5/4/2026, with respect to the rejection of claims 7, 8 and 10-16 under 35 U.S.C. 101, has been fully considered and is persuasive. The claims have been amended to be directed to patent eligible subject matter. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 5/4/2026, with respect to the rejection of:
Claims 7, 8 and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Uchida et al. (US 5,494,667; 1996,), as evidenced by Sakamoto et al. (JP 2016108272 A);
Claims 7 and 10 under 35 U.S.C. 102(a)(1) as being anticipated by Puig et al. (Plants Medica, 1995);
Claim 7 under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (CN 101829243 A, 2010); and
Claim 7 under 35 U.S.C. 102(a)(1) as being anticipated by El-Hawary et al. (J. Food. Sci., 2011), has been fully considered and is persuasive. The claims have been amended such that none of the cited art anticipates the claims. The rejections are hereby withdrawn.
Applicant’s amendment, filed on 5/4/2026, with respect to the rejection of:
Claims 7, 8, 10-13 and 16 under 35 U.S.C. 103 as being unpatentable over Brewster et al. (US 2020/0306282), in view of Huang et al. (WO 2012/168474A1);
Claims 7, 10 and 15 under 35 U.S.C. 103 as being unpatentable over Hashizume et al. (US 2022/0401761A1), as evidenced by Sakamoto et al. (JP 2016108272 A); and
Claim 14 under 35 U.S.C. 103 as being unpatentable over Brewster et al. (US 2020/0306282), in view of Huang et al. (WO 2012/168474A1), further in view of Tsuchiya et al. (US 2015/0125589), has been fully considered and is persuasive. The rejections are hereby withdrawn.
Maintained Rejections
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 7, 8, 10-13, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kawashima et al. (JP 2021155376A, 2021, reference of record), in view of Chauhan et al. (Alcohol, 2015, reference of record).
Kawashima et al. discloses a cosmetic, food or drink composition for promoting collagen production, suppressing MMP-9 expression, promoting TIMP-2 expression, and promoting collagen gel contraction, where the composition comprises a compound of formula II (at 0.0001 to 10 wt%), which is identical to the instant compound 3”-alpha-monoglucosyl naringin: (p. 3, ¶4; p. 5; p. 7; p.13)
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Kawashima does not teach that the composition comprises any of the compounds of instant “compound B”.
Chauhan et al. discloses that thymol is known to suppress MMP-9 secretion. (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kawashima and add thymol to the composition, thereby arriving at the instant invention. One would be motivated to add thymol to the composition of Kawashima because Chauhan teaches that thymol suppresses MMP-9 secretion, which is an envisioned function of the composition of Kawashima. 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).
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations 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.
With respect to the ratios of compound A and compound B, as recited in claims 4 and 8, it would have been prima facie obvious for one of ordinary skill in the art to optimize the weight ratios of formula II and thymol, as taught by the combined prior art, to account for parameters such as age, gender, weight, and condition, thereby arriving at the instant invention. Moreover, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially in view of the large range instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of one of ordinary skill in the art. See also MPEP § 2144.05.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Kawashima/Chauhan, has been fully considered but is not persuasive.
Applicant argues that Kawashima is directed to formulation for treating skin condition, whereas Chauhan is directed towards formulations for treating GI conditions, such that there is no motivation to use the teaching of Chauhan regarding the use of thymol as an MMP-9 inhibitor, in order to modify the formulation of Kawashima. Applicants’ argument is not persuasive because Chauhan provides a teaching of a fundamental chemical property of thymol as an MMP-9 inhibitor, this fundamental chemical property transcends the specific use taught by Chauhan and would be recognized by one of ordinary skill in the art as applicable to any formulation with the express intent to inhibit MMP-9. Since Kawashima teaches the intent of the formulation to inhibit MMP-9, one could look to all known MMP-9 inhibitors to reasonably modify Kawashima. Moreover, it is known in the art, as per Costa et al. (J. Pharm. Pharm., 2019, PTO-892), that thymol is used as an MMP-9 inhibitor to treat skin conditions.
Applicant further argues that the specification presents evidence of unexpected results, in the form of synergistic promotion of GLP-1 secretion, which overcomes a prima facie case of obviousness. Applicants’ argument is not persuasive because the claims are not commensurate in scope with the evidence of unexpected results. The scope of the instant claims includes the combination of 3”-alpha-monoglucosyl naringin and the component B compounds in any ratio, preferably 10,000:1 to 1:10. In contrast, the evidence of unexpected results (Experiments 5 and 6) demonstrates synergy only for A:B ratios in the range 3000:1 to 1:10. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)(MPEP § 716.02(d)) Applicants’ arguments of unexpected results are not commensurate in scope with that of the claimed invention.
The rejection is still deemed proper and is maintained.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kawashima et al. (JP 20211155376A, 2021, reference of record), in view of Chauhan et al. (Alcohol, 2015, reference of record), further in view of Tsuchiya et al. (US 2015/0125589, reference of record).
The disclosure of Kawashima/Chauhan is referenced as discussed above. The combined prior art does not teach the composition as a flavoring agent.
Tsuchiya et al. discloses that selective improvement or decrease of unpleasant flavor, and not greatly changing savoriness of the food or drink, flavanoid glycosides are particularly preferred, where naringin is among the preferred flavanoid glycosides. (¶0086)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Kawashima/Chauhan could be used as a flavoring agent, thereby arriving at the instant invention. The compound of formula II of Kawashima is a naringin derivative and one would expect naringin and formula II to have similar properties. Hence the teaching of Tsuchiya that naringin is among preferred flavanoid glycosides to improve or decrease unpleasant flavor, would also apply to formula II, making it obvious to employ the composition of Kawashima/Chauhan as a flavoring agent.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
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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