DETAILED ACTION
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 .
Election/Restrictions
Newly submitted claims 68-76 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 68-73 and claim 1 do not share the same or corresponding technical feature. In particular, claims 68-73 requires a product (e.g., food, beverage or nutraceutical) that comprises a CaSR agonist and/or positive allosteric modulator, which is not present in claim 1, and claim 1 requires a step of adding, or a medicament that comprises a therapeutical agent that causes bitter taste, neither of which is present in claims 68-73. Further, the shared technical feature between claims 74-76 and claim 1 does not make a contribution over Dubois, as shown in the 35 USC 103 rejection set forth below.
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 Accordingly, claims 68-76 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim status
Claims 1, 2, 6, 11, 16-17 and 68-76 are pending in the application. Claims 1, 11 and 16 are currently amended. Claims 2, 6 and 17 are previously presented. Claims 12-15, 29, 62 and 65 are currently cancelled. Claims 68-76 are newly presented but are considered withdrawn under the doctrine of election by original presentation (see “Election/Restrictions” above). Claims 1, 2, 6, 11 and 16-17 and are hereby examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 6, 11, 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the concentrations of the first, the second and third taste modulator components. It is unclear whether the concentrations as recited are relative to the taste modulator composition, or relative to the product. For the purpose of examination, the concentrations are considered to be relative to the product. Appropriate correction is required.
Claims 2, 6, 11 and 17 ultimately depend from claim 1 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claim 16 is rejected for being indefinite because it depends from claim 151, which does not exist in the instant application. For the purpose of examination, claim 16 is interpreted to depend from claim 1. Clarification is required.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 6, 11 and 16-17 are rejected under 35 U.S.C. 103 as obvious over Dubois WO 2019/202402 A1 (hereinafter referred to as Dubois).
Regarding claims 1, 2, 6 and 11, Dubois teaches a sweetener composition comprising a sweetening agent (for example, a non-caloric sweetener the example of which is a steviol glycoside such as Reb A, 0131), and a taste modulator composition; wherein the latter could mitigate bitter off-taste associated with the former and improve sweetness (0007; 0136); and wherein the taste modulator composition comprises a first salt having a first cation selected from Na+, K+, Ca2+ and Mg2+ and a first anion (e.g., citrate, phosphate, chloride, carbonate, sulfate, etc.); (optionally), a second salt having a second cation selected from Na+, K+, Ca2+ and Mg2+ and a second anion (e.g., citrate, phosphate, chloride, carbonate, sulfate, etc.); and (optionally), a third salt having a third cation selected from Na+, K+, Ca2+ and Mg2+ and a third anion (e.g., citrate, phosphate, chloride, carbonate, sulfate, etc.) (0049-0051); and specifically, Dubois includes an embodiment teaching the combination of K+, Ca2+ and Mg2+ as the first, second and third cations (0054).
Further, Dubois teaches a food product, a beverage (see para. 0256; 0424; 1201; 1222) or a medicament (e.g., pharmaceutical and nutraceutical) comprising the sweetening composition that comprises the sweetener and the taste modulator composition (0011-0012; 0424; 0255), wherein the concentration of Mg2+ is 1-5 mM (0440), the concentration of Ca2+ is 1-5 mM (0445), and the concentration of K+ (or Na+) is 1-10 mM (0431;0435); for example, a beverage comprises the sweetener agent and the taste modulator composition, wherein the concentration of Mg2+ is 0.1 -5 mM or narrowly 1-5 mM, the concentration of Ca2+ is 0.1 -5 mM or narrowly 1-5 mM, and the concentration of K+ is 0.1- 10 mM or narrowly 1-10 mM (0200; 0213; 0216; 1034; 1062; 1082). Dubois further teaches the step of adding the taste modulator composition to the product (1201; 1222). Further, Dubois teaches a method of increasing the taste and flavor intensity of a food product (e.g., comestible) comprising the step of combining the comestible product with the taste modulator composition (0236).
A medicament that comprises a non-caloric sweetener such as Reb A is known to be associated with a bitter taste (see Dubois para. 0003-0006) thus reading on the limitation that the medicament is associated with a bitter taste due to an excipient (e.g., Reb A).
Further, where Dubois teaches that the aforementioned taste modulator composition is able to mitigate a bitter off-taste associated with a noncaloric sweetener such as Reb A, and a medicament (e.g., pharmaceutical and nutraceutical) comprising the sweetening composition that comprises the sweetener such as Reb A and the taste modulator composition, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have added the taste modulator composition to any Reb A-containing medicament regardless of whether the therapeutic agent therein is bitter or not bitter, so as to mitigate bitter off-taste associated with the noncaloric sweetener present in the medicament and improve the sweetness. As such, the limitation that the medicament is associated with a bitter taste due to a therapeutic agent or a therapeutic agent and an excipient is obvious over prior art. Note that the pending claims are very silent regarding what kind of bitter therapeutic agent is present in the medicament.
Dubois as recited above teaches a taste modulator composition comprises a first taste modulator component which is a Mg2+ salt, (optionally) a second taste modulator component which is a Ca2+ salt and (optionally) a third taste modulator component is a K+ salt, thus reads on the claim limitation that the taste modulator composition “consists essentially of” 3 taste modulator components each of which consisting essentially of one salt.
Given that Dubois teaches a medicament that contains the same amounts of K+, Ca2+ and Mg2+ as that recited in the claim, it logically follows that the product that comprises the taste modulator composition has a bitterness that is at least 10% or 50% or about 100% diminished compared to a baseline product that is devoid of the taste modulator composition, when measured by a sensory panel. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP 2112.01 II).See MPEP 2112.01 I, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 16-17, Dubois teaches a medicament (a pharmaceutical formulation) formulated as a pill (e.g., tablet), or a suspension for enteral application (0258). Enteral application encompasses an oral administration. Further, incorporation of a sweetener such as steviol glycoside in a pharmaceutical formulation suggests that the formulation in for oral administration. See also para. [0225), which teaches that the taste modulator composition is for orally administered medicinal or nutraceutical products.
Double Patenting
Claims 2 and 6 of this application are patentably indistinct from claims 1 and 6 respectively of Application No. 18/640,711. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 11 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 13, 15-19, 21, 23, 25 and 28 of copending Application No. 18/640,711 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because aforementioned claims of ‘711 teaches a method of inhibiting bitterness in a product comprising adding the same taste modulator composition as recited in the instant claim at the same amounts to the product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6 and 11are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 93-112 of copending Application No. 18/676,083 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims of ‘083 teaches a method of inhibiting bitterness in a beverage comprising adding the same taste modulator composition as recited in the instant claim at the same amounts to the beverage.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Applicant asserts on page 6 bottom para. that newly presented claims 68-76 should be examined on the merits, for the reason that the basis for the restriction requirement no longer applies (e.g., claims 68-76 recite CASR agonist/ positive allosteric modulator, or a bitter therapeutic agent which distinguishes Dubois).
The assertion is considered. However, the examiner submits that claims 68-76 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 68-76 and claim 1 do not share the same or corresponding technical feature. In particular, claims 68-76 require a product (e.g., food, beverage or nutraceutical) that comprises a CaSR agonist and/or positive allosteric modulator, which is not present in claim 1, and claim 1 requires a step of adding, or a medicament that comprises a therapeutical agent that causes bitter taste, neither of which is present in claims 68-76. . Further, the shared technical feature between claims 74-76 and claim 1 does not make a contribution over Dubois, as shown in the 35 USC 103 rejection set forth in the instant office action.
Regarding the 35 USC 112(b) rejection of claim 1, applicant argues on page 7 of the Remarks that since mM is not a weight-based measurement, a skilled person will understand that the mM refers to the molar concentration of the taste modulator component in the product.
The argument is considered but found unpersuasive. The rejection means that it is unclear whether the concentrations as recited are relative to the taste modulator composition, or relative to the product.
Regarding the 35 USC 102/103 rejection over Dubois, applicant argues on page 8 of the Remarks that the office action has not established the Dubois teaches a taste modulator composition that consists essentially of the three recites taste modulator components each consists essentially of a single salt.
The argument is considered but found unpersuasive. Dubois teaches a taste modulator composition comprises a first taste modulator component which is a Mg2+ salt, (optionally) a second taste modulator component which is a Ca2+ salt and (optionally) a third taste modulator component is a K+ salt and nothing more, thus reads on the claim limitation that the taste modulator composition “consists essentially of” 3 taste modulator components each of which consisting essentially of one salt. See para. 17 of the office action issued 02/24/2026. Further, applicant is remined that Dubois reference is the work of the instant inventor, and Dubois reference is teaching a taste modulator composition that is 100% the same as the composition as recited in the instant claims.
For the reason set forth above, applicant’s argument on page 9 of the Remarks regarding the inherency reasoning is not persuasive, either. It is noted that applicant also argues that Dubois has not shown any data showing the bitterness reduction for a medicament. However, applicant is reminded that the office action is adopting the inherency reasoning in the absence of data. In other words, the office action submits that where prior art teaches treating the same substrate (e.g., a medicament) with the same taste modulator composition, the reduction of bitterness is necessarily present in the prior art.
Applicant argues on page 8 of the Remarks that Dubious fails to teach a medicament associated with a bitter taste due to a therapeutic agent or therapeutic agent and an excipient.
The argument is considered but found unpersuasive. A medicament that comprises a non-caloric sweetener such as Reb A is known to be associated with a bitter taste (see Dubois para. 0003-0006) thus reading on the limitation that the medicament is associated with a bitter taste due to an excipient (e.g., Reb A). Further, where Dubois teaches that the aforementioned taste modulator composition is able to mitigate a bitter off-taste associated with a noncaloric sweetener such as Reb A, and a medicament (e.g., pharmaceutical and nutraceutical) comprising the sweetening composition that comprises the sweetener such as Reb A and the taste modulator composition, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have added the taste modulator composition to any Reb A-containing medicament regardless of whether the therapeutic agent therein is bitter or not bitter, so as to mitigate bitter off-taste associated with the noncaloric sweetener present in the medicament and improve the sweetness. As such, the limitation that the medicament is associated with a bitter taste due to a therapeutic agent or a therapeutic agent and an excipient is obvious over prior art. Note that the pending claims are very silent regarding what kind of bitter therapeutic agent is present in the medicament.
For the reason set forth above, applicant ‘s argument on the para. that bridges pages 8 and 9 of the Remarks that a skilled artisan would not have motivation to apply the taste modulator to a medicament that has a bitter therapeutic agent is not persuasive.
Conclusion
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 CHANGQING LI whose telephone number is (571)272-2334. The examiner can normally be reached 9:00-5:00.
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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