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 .
Claims 1-14, as amended in the listing of 1/8/2024 are examined in the application.
Information Disclosure Statement
The information disclosure statement filed 1/12/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Item #157, The Kasai reference was not received.
The other references cited have been reviewed.
Claim Objections
Claims 3 and 13 are objected to because of the following informalities:
Claim 3 is objected to for the recitation of “compound” in last line, as last word, it should be “compounds”.
Claim 13 recites “blockes bitterness” (emphasis added), which appears to be a typographical error. For the purposes of this office action, the above recitation will be assumed to be equivalent of “blocks bitterness” .
Claim 13 is further objected to for the recitation of “enhance”, which should be “enhances” and “umami” should be “umami flavor”
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (second Paragraph)
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 2-3, 8, 9 and 11-13 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.
Regarding claim 2, the phrases "for example", and “such as” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). These phrases are used several times in the list of choices for the one or more additional sweetener. It is not clear if the materials listed after each instance of “for example” and “such as” further limits the choices listed in the claim.
Claim 2 contains the trademark/trade name Splenda. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe sucralose and, accordingly, the identification/description is indefinite.
Claim 3 recites "The formulation of claim 1, wherein the one or more flavor
modifying compound is" followed by a few structures. It is not clear if the structure is "one of" the structures shown or all of them, as the recitation in claim is "the one or more flavor modifying compound is" (see underlined part of limitation above). For the purposes of this office action, it will be assumed that the above structure or structures are representative of the compositions disclosed in para 7 of the PGPUB of the application.
Claim 8 recites ten sub-groups of materials/ingredients each group ending in "and/or", and the last line of the claim is "or any combination thereof". It is not clear if at least one material/ingredient of each sub-group is required, or if only one of the materials/ingredients of any of the 10 sub-groups reads on the claim. For the purposes of this office action, it will be assumed that the claim requires only one of the materials/ingredients of any of the 10 sub-groups reads on the claim (i.e. any one of all the materials/ingredients recited in claim 8).
Claim 9, line 2 recites “flavor modulator”. There is insufficient antecedent basis for this limitation in the claim. Although there is recitation of “flavor modifying compound”, if by “flavor modulator”, the applicant is referring to “flavor modifying compound” then the claim should be worded as such. Clarification and/or correction is required.
For the purposes of this office action “flavor modulator” as recited in claim 9 will be regarded the same as flavor modifying compound.
Claims 11 and 12 are rejected for the recitation of “wherein isomogroside IVE is present in an amount of 50 ppm or less” (claim 11) and “wherein isomogroside IVE is present in an amount of 25 ppm or less” (claim 12), as the above recitations render these claims unclear. Regarding the proportion of isomogroside IV E, 0 ppm isomogroside IV E is less than 50 and 25ppm, which makes inclusion of isomogroside IV E optional. If that is the case then claims 11 and 12 broader in scope than claim 1, from which they depend.
However, since claims depend from claim 1, which lists a composition comprising isomogroside IV E without any amount, which means that the lower limit for the isomogroside IV E cannot be 0ppm. Thus, absence a lower limit for isomogroside IV E range for claims 11 and 12 renders them indefinite. Clarification and/or correction is required.
For the purpose of this office action the above limitation will be regarded as “wherein isomogroside IVE is present in an amount of 50 ppm or less but more than 0 ppm” (claim 11) and ““wherein isomogroside IVE is present in an amount of 25 ppm or less but more than 0 ppm” (claim 12).
Claim 13 recites "the flavor modifying compound is a compound that reduces sourness, reduces licorice taste, blockes bitterness, enhance umami, enhance saltiness, enhance a cooling effect, or any combination of the foregoing". Given that the recitation ends in "any combination of the foregoing" means that any one of the properties such as "reduces sourness" only reads on the claim, and this is not clear. For the purposes of this office action, the above recitation will be considered equivalent of "the flavor modifying compound is one of a compound that reduces sourness, reduces licorice taste, blockes bitterness, enhance umami, enhance saltiness, and enhance a cooling effect, or any combination of the foregoing thereof"
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Patron (US 20170119032), hereinafter Patron.
Regarding claims 1-2, Patron (US 20170119032) teaches a formulations suitable for sweeteners (para 22) comprising Mogroside or lsomogroside variations (para 42), such as Mogroside IVE, lso-mogroside V and 11-oxo-Mogroside IVE - see para 42, which is substantially similar to claim 1. Patron also teaches that the formulation may further include one of more additional sweeteners and in this context, at least Luo-Han-Guo (fruit, powder, or extracts), as is disclosed, which reads on claim 2. Regarding the limitation of "(ii) one or more flavoring modifying compound; or (iii) a flavoring agent" of claim 1, Patron also teaches that the formulation may further comprise one or more flavoring modifying compound (para 244; also see para 116) or a flavoring agent (para 244, also see para 117).
Patron does not specifically disclose the variation of isomogroside that is specifically "isomogroside IV E” as recited in claim 1. However, Patron teaches that individual isomers of disclosed compounds may exist and selective synthesis of selective isomers can be accomplished by known methods (para 151), and such isomers (para 151), or '"resonance forms or tautomers of compounds that may be fairly represented by other chemical structures" (para 152), and other variations (para 153-155) are also considered within the scope of Patron's disclosure. Further, Patron teaches that sweeteners are characterized by properties such as at least odor, flavor, mouthfeel and aftertaste (para 7), and recognizes the need to improve the above properties by variations in composition (para 10).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute one art recognized functional equivalent (i.e., replacing a one variant of mogroside with another) in a similar application; i.e. as a sweetener, depending on the taste profile (as determined by at least odor, flavor, mouthfeel and aftertaste, described above). The ordinary artisan would have been motivated to modify Patron at least for the purpose of using a variation of a known compound such as lsomogroside or Mogroside IVE or lso-mogroside V, to provide the same characteristic (i.e. sweetness) with a desired adjustment in one of more of odor, flavor, mouthfeel and aftertaste of the sweeter formulation.
Regarding claim 3, applicant requires the formulation of claim 1 wherein the flavor modifying compound is as shown in the formulas, or a salt or solvate thereof, or any combination thereof (also see 35 USC 112, 2nd paragraph rejection above).
Referring to applicant's specification (see para 7 of PGPUB), it further describes compounds that encompass the above shown structures. In this context, the specification describes that "the one or more flavor modifying compound" is "hesperetin dihydrochalcone, hesperetin dihydrochalcone-4'-O'glucoside, neohesperetin dihydrochalcone, brazzein, hesperidin, phyllodulcin, naringenin, naringin, phloretin, glucosylated steviol glycosides, {2R,3R)-3-acetoxy- 5,7,4'-trihyd roxyflavanone, (2R,3R)-3-acetoxy-5,7,3'-trihydroxy-4'- methoxyflavanone, rubusosides, thaumatin, monellin, miraculin, glycyrrhizin and comestibly acceptable salts thereof (such as the mono-ammonium salt), naringin dihydrochalcone, myricetin, nobiletin, polymethoxy flavones, mixed methoxy- and hydroxyflavones, quercetin, amino acids, or any combinations thereof".
Patron (para 188) teaches that at least Glycyrrhizin, Naringin Dihydrochalcone, Naringin and Thaumatin, and as such teaches claim 3.
Regarding claim 3, applicant is requested to clarify whether the compounds disclosed in para 7 of PGPUB are at least a partial list of compounds covered by the structures shown in claim 3. Absent such clarification, it will be assumed that the compounds disclosed in para 7 of PGPUB, some of which are also disclosed in para 188 of Patron (as explained above) read on the structure claimed in claim 3.
Regarding claim 4, Patron teaches the formulation of claim 1, which is an ingestible composition (para 2).
Regarding claims 5-6, Patron para 2 discloses the formulation may be food or beverage, and para 183 of Patron discloses that By "Food or beverage products", it is meant "any edible product intended for consumption by humans or animals, including solids, semi-solids, or liquids (e.g., beverages} and includes functional food products (e.g., any fresh or processed food claimed to have a health- promoting and/or disease-preventing properties beyond the basic nutritional function of supplying nutrients)". As such, Patron teaches (as recited in claim 5) the ingestible composition of claim 4, which is in the form of a food or beverage product (para 2) and wherein (as recited in claim 6) the food or beverage product is for human or animal consumption.
Regarding claim 7, Patron teaches the ingestible composition of claim 6, wherein the beverage is may be fruit juice (para 57 and 68).
[AltContent: ]Regarding claim 8, Patron teaches the ingestible composition of claim 6, wherein the beverage product comprises: citric acid (para 57 and 186), caffeine (para 186), purple carrot (para 186), sodium benzoate (para 186), ascorbic acid (para 186), resveratrol (para 186), tangeretin (as tangerine and other citrus extracts/oil are disclosed in para 186, and tangeretin is known to be found in tangerine and citrus fruits), ester gum or brominated vegetable oil (para 186), gum Arabic (para 186), cellulose gum (para 186).
Regarding claim 9, Patron teaches the formulation of claim 1, wherein the formulation enhances the sweetness of the additional sweetener and/or flavor modulator (para 190, especially in the first sentence; also see para 191 that describes inclusion of "sweetness enhancers" and "flavor enhancers" with "sweetening agents").
Regarding claims 10-12, Patron teaches the formulation of claim 1, but does not teach that isomogroside IVE (taught by Patron as modified for claim 1) is present in an amount of a). "from 1 ppm to 1000 ppm" (as recited in claim 10); b). "50 ppm or less" (as recited in claim 11); or "25 ppm or less" (as recited in claim 12). However, Patron describes concentration of other variations of similar mogroside compounds as being "less than 50 ppm" (para 36), which suggests one of ordinary skill to employ similar amounts of the claimed compound, and noting that this range overlaps with the claimed ranges. As noted for claim 1, the above is substituting one art recognized functional equivalent with another in a similar application; i.e. as a sweetener. Regarding the overlapping of ranges between the invention and prior art composition it is noted that in the case where the claimed ranges "overlap or lie inside the ranges disclosed by the prior art" a prima facie case of obviousness exists (In re Wertheim, 541 F2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990)).
Note that recitation of claim 11 of isomogroside in amount of “50 ppm or less” and a similar recitation of claim 12 for the amount of isomogroside IVE of “25 ppm or less” also read on isomogroside IVE being present in an amount of 0 ppm, which is less than 50ppm and also less than 25ppm.
Regarding claim 13, Patron teaches addition of "Peppermint Leaves" and "Peppermint Oil" (see para 188, especially on page 129, Col. 2, lines 16-17), which is known to enhance a cooling effect.
Regarding claim 13, Patron teaches the formulation of claim 1, wherein the flavor modifying compound is a compound that enhances sweetness (para 116).
Double Patenting
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of copending Application No. 18/271414 (published as US20240065302 to Manam). Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are directed a formulation comprising a sweetening compound; “and at least one or more of: (i) one or more additional sweetener; (ii) one or more flavoring modifying compound; or (iii) a flavoring agent.”
Current application 18/271412 (Published as 20240188613 A1) differs from the copending application 18/271414 in the primary sweetening compound which for current application 18/271412 is " isomogroside IV E”, which is recited in claim 2 of copending application. Further, the sweetener disclosed in claim 1 of copending application 18/271414 reads on “one or more additional sweetener”, as such all requirements of current claim 1 are taught by claims 1 and 2 of copending application 18/271414.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of copending Application No. 18/271406 (published as 20240090547 A1 to Manam). Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are directed a formulation comprising a sweetening compound; “and at least one or more of: (i) one or more additional sweetener; (ii) one or more flavoring modifying compound; or (iii) a flavoring agent.”
Current application 18/271412 (Published as 20240188613 A1)differs from the copending application 18/271406 in the primary sweetening compound which for current application 18/271412 is " isomogroside IV E”, which is recited in claim 2 of copending application. Further, the sweetener disclosed in claim 1 of copending application 18/271406 reads on “one or more additional sweetener”, as such all requirements of current claim 1 are taught by claims 1 and 2 of copending application 18/271406.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI CHAWLA whose telephone number is (571)272-8212. The examiner can normally be reached M-F 9:30- 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JYOTI CHAWLA/Primary Examiner, Art Unit 1791
Prosecution Insights