DETAILED ACTION
Background
The response dated October 22, 2025 (response) including a Rule 132 Declaration has been entered. Claims 16 and 19-23 as filed with the response have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 22, 2025 has been entered.
Claim Objections
Claim 23 is objected to because of the following informalities:
In claim 23, at line 2 before “dihydrochalcone” correct the spelling of --hespereee--.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 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.
Claims 16 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140235624 A1 to Adamski-Werner et al. (Adamski-Werner), of record.
Regarding instant claim 16, Adamski-Werner in Example 1 at [0116] discloses the claimed compound N-(1-((4-amino-2,2-dioxo-1H-benzo[c][1,2,6]thiadiazin-5- yl)oxy)-2-methyl-propan-2-yl) isonicotinamide as compound A1, below, which is the same as
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the recited compound (I) (“flavor-modifying compound of formula (I)”); and, Adamski-Werner at [0149] discloses the flavor-modifying compound of formula (I) mixed in an ingestible composition (at [0151]) comprising a sweetener of sucrose or high-fructose corn syrup, wherein the composition (at the Table accompanying [0155]) enhances the sweetness of the sweetener. At [0075] Adamski-Werner discloses sweetener compositions enhanced by the flavor-modifying compound of formula (I), wherein (at [0076]) the sweeteners comprise glucose and steviol glycosides, including steviosides, rebaudioside and other steviol glycosides, as well as combinations of sweeteners.
However, Adamski-Werner does not disclose an example of an ingestible composition comprising a sweetener which is any of glucose, a steviol glycoside, sucralose, allulose, erythritol, or any mixture thereof.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Adamski-Werner to form an ingestible composition comprising the flavor-modifying compound of formula (I) as well as a sweetener as glucose or a steviol glycoside because Adamski-Werner discloses at [0076] that glucose and steviol glycosides are suitable sweeteners for use in making sweetener compositions enhanced by the flavor-modifying compound of formula (I).
Regarding instant claims 20, 21 and 22, Adamski-Werner at [0106] discloses flavoring agents (“flavorings”) and, at [0079] discloses its composition added to food and beverage products including (at [0097]) a variety of packaged food products, such as bread and cakes.
Claims 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140235624 A1 to Adamski-Werner et al. (Adamski-Werner) as applied to claim 16 above, and further in view of US 9752174 B2 to Markosyan et al. (Markosyan).
As applied to claim 16, Adamski-Werner in Example 1 at [0116] discloses the claimed compound N-(1-((4-amino-2,2-dioxo-1H-benzo[c][1,2,6]thiadiazin-5- yl)oxy)-2-methyl-propan-2-yl) isonicotinamide as compound A1 (“flavor-modifying compound of formula (I)”); and, Adamski-Werner at [0149] discloses the flavor-modifying compound of formula (I) mixed in an ingestible composition (at [0075]) comprising a sweetener to enhance the sweetness of the sweetener, and (at [0076]) the sweetener comprises glucose, steviol glycosides, and mixtures thereof.
Regarding instant claims 19 and 23, Adamski-Werner does not disclose an umami taste enhancer, a bitter taste blocker, or any combination thereof as in claim 19; and, further, Adamski-Werner does not disclose an ingestible composition further comprising hesperetin dihydrochalcone, hesperetin dihydrochalcone-4'-O'glucoside, neohesperetin dihydrochalcone, brazzein, thaumatin, hesperidin, phyllodulcin, naringenin, naringin, phloretin, glucosylated steviol glycosides, (2R,3R)-3-acetoxy-5,7,4'-trihydroxyflavanone, (2R,3R)-3- acetoxy-5,7,3'-trihydroxy-4'-methoxyflavanone, rubusosides, or any salts or combinations thereof as in claim 23.
Markosyan at Abstract discloses ingestible compositions comprising steviol glycosides as a sweetener combined (at col. 24, lines 27-33) with neohesperetin dihydrochalcones (claim 23). Further, Markosyan at col. 26, lines 34-55 discloses compositions that are used in various foods and beverages. Still further, Markosyan at col. 23, lines 43-48 discloses combinations of the sweeteners with other food ingredients that comprise (at col. 24, lines 41-44) umami taste enhancers (claim 19) like glutamates, and (at col. 27, lines 63-67) sweeteners including glucose and erythritol.
As of the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Markosyan for Adamski-Werner to include with its flavor-modifying compound of formula (I) any or all of an umami taste enhancer as in claim 19, and neohesperetin dihydrochalcone as a high-intensity sweetener as in claim 23. Both references disclose sweet ingestible compositions comprising combinations of sweeteners, flavor enhancers and a variety of foods or beverages containing them. The ordinary skilled artisan reading Adamski-Werner would have desired to include the umami taste enhancers of Markosyan, and the added sweetness enhancers of Markosyan, including neohesperetin dihydrochalcone to improve the flavor and sweetness of sweetener compositions and foods and beverages that contain them while reducing use of caloric sweeteners without sacrificing their desirable sweet flavor.
Response to Amendment
The Declaration of Dr. Guy Servant under 37 CFR 1.132 filed October 22, 2025 (Servant Declaration) is insufficient to overcome the rejections of claims 16 and 20-22 based upon US 20140235624 A1 to Adamski-Werner et al. (Adamski-Werner) or the rejections of claims 19 and 23 based upon US 20140235624 A1 to Adamski-Werner et al. in view of US 9,752,174 B2 to Markosyan et al. (Markosyan), as set forth in the last Office action for the following reasons:
The sweetness enhancement data presented in Table 1 at page 3 of the Servant Declaration are not remotely commensurate in scope with the claimed invention. Even taking the data in the Servant Declaration as true and accurate, the scope of the sweeteners for which a such a result was shown includes fructose, which is not claimed, and rebaudioside M which is one of at least 50 known steviol glycosides. No evidence of the alleged unpredictability in enhancing the sweetness of glucose, allulose, sucralose, erythritol or any of the other known steviol glycosides is given in the Servant Declaration.
In addition, the data in the Servant Declaration are not indicative that the result in Table 1 at page 48 of the instant specification is actually unpredictable because the response appears to be concentration dependent; and, the data in the specification and the Servant Declaration are not in line with one another. Whereas the data in Table 1 of the instant specification reflect the effect of using a 200 ppm concentration of Rebaudioside M (MW ~1290), this concentration equates to about (0.2g/Kg divided by 1290 g/mole for Rebaudioside M or) 155 µM which is far higher than the 3 µM for which an unpredictable sweetness enhancement was indicated.
Further, the data in Exhibit A to the Servant Declaration (PNAS paper) are found not to be of probative value because they were not generated using the claimed compound (I). Instead, the data closest to data from compound (I) were generated using SE-3, which is only a 4-amino-2,2-dioxo-1H-benzo[1,2,6]thiadiazine group, are presented at Fig. 3 on page 4749 of Exhibit A. However, the claimed compound (I) is not SE-3; rather, it is one of over 100 known such compounds reported in US 8,877,922 B2 to Tachdjian et al., of record, containing a 4-amino-2,2-dioxo-1H-benzo[1,2,6]thiadiazine group to say nothing of other possible substituted compounds. And the effect of compound (I) cannot be determined from data made using only SE-3. Meanwhile, SE-1 and SE-2 in Exhibit A are each a 4-amino-2-thiocarbonyl-1H-furanylsulfide[1,2,6]thiadiazine group and are not related to the claimed compound (I). Even if the purported results are indeed unpredictable, the ordinary skilled artisan cannot ascribe the effect of using the claimed compound (I) which is a specific oxoisopropyl isonicotinamide substituted 4-amino-2,2-dioxo-1H-benzo[1,2,6]thiadiazine compound to data that was generated using only SE-3.
Response to Arguments
The positions taken in the remarks accompanying the response dated October 22, 2025 (Reply) have been fully considered but they are not found persuasive for the following reasons:
Regarding the position taken in the Reply at page 4 that the Servant Declaration shows that the results from a PNAS paper authored by the same Dr. Servant show the results in the instant specification as unexpected over the art, the position is not found persuasive. Respectfully, those data relate to use of SE-1 and SE-2, which are each a 4-amino-2-thiocarbonyl-1H-furanylsulfide [1,2,6]thiadiazine group that is not related to the claimed compound (I). Meanwhile, the sucralose data in Fig. 3 at 4749 of Exhibit A to the Servant Declaration were generated using SE-3, a 4-amino-2,2-dioxo-1H-benzo[1,2,6]thiadiazine group which has many thousands of substituted forms that may include the claimed compound (I). The effect of the claimed compound (I), especially if it were unpredictable, could not be inferred without testing compound (I) or from the testing of a fragment of that compound that has thousands of known variants only one of which is actually compound (I).
Regarding the position taken in the Reply at pages 4-5 alleging that data from Table 1 of the Servant Declaration demonstrate that the claimed invention could not have been predicted from the art of Adamski-Werner, respectfully this position is not found persuasive. The data in Table I of the Servant Declaration, even if taken as true and accurate only show that sweetness enhancement may or may not be unpredictable for rebaudioside M, which is just one of many of known steviol glycosides. The data do not demonstrate the unpredictability of sweetness enhancement for steviol glycosides in general and do not address any other of the claimed sweeteners glucose, allulose, sucralose, erythritol or any of the myriad other known steviol glycosides. In addition, the data reported are concentration dependent; and, the concentration reported in the Servant Declaration for Rebaudioside M (3 µM) is a fraction of the concentration reported in Table 1 of the instant specification (about 155 µM). Further, those data reproduce some of the data already set forth in Adamski-Werner, which at [0155] and [0157] already discloses the effect of compound (I), respectively, on sucrose and fructose.
Regarding the position taken in the Reply that Markosyan does not motivate one to enhance the sweetness of the sweeteners of claim 16, respectfully the rejection does not rely on Markosyan to show this. Rather, Adamski-Werner at [0155] and [0157] discloses specific examples of enhancing sweeteners and (at [0076]) discloses such sweeteners including glucose, erythritol, various steviol glycosides and sucralose.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki H Dees can be reached on (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.M./Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791