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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
The status of the claims stands as follows:
Pending claims: 1-13 and 15-21
Canceled claims: 14
Currently rejected claims: 1-13 and 15-21
Allowed claims: None
Claim Objections
Claim 13 is objected to because of the following informalities: the first word recites “he” instead of “The”. Appropriate correction is required.
Applicant is advised that should claim 15 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 17-19 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 17 recites the limitation “said sweetener” in line 5. There is insufficient antecedent basis for this limitation in the claim, since it is not clear whether the term refers to the sweetener formulation or the sweetener of claim 1(a).
Claims 18 and 19 recite the limitation “said sweetener” in line 2. There is insufficient antecedent basis for this limitation in the claim, due to the issue described in relation to claim 17.
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.
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 1-13, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Baniel et al. (U.S. 2019/0021381 A1) in view of Catani et al. (U.S. 2008/0069939 A1) and Purandare et al. (U.S. 2016/0090385 A1).
Regarding claim 1, Baniel et al. discloses a sweetener formulation comprising sweetener particles containing a sweetener carbohydrate or a sweetener polyol and a carrier disposed within the sweetener particles, where a weight-to-weight ratio of the carrier to the sweetener within the particles is within a range of 0.02-1.5% ([0004]), and where a total weight content of the carbohydrate/polyol within the sweetener formulation is at least 10% ([0036]).
Baniel et al. does not disclose the carrier as being a carboxymethyl cellulose (CMC) or the sweetener formulation as having a mucosal adhesion that is greater than that of a control formulation devoid of CMC by 1-200%.
However, Catani et al. discloses a solid, unit dose, sweetening composition ([0009]) that may comprise a “food-grade gum” ([0035]) that may be CMC ([0039]).
It would have been obvious to one having ordinary skill in the art to incorporate carboxymethylcellulose as the carrier in the composition of Baniel et al. First, Baniel et al. indicates that the carrier compound may be any of several types of compounds, including a natural gum, chitosan, microcrystalline cellulose, pectin, or carrageenan ([0031]). Catani et al. discloses “food-grade gums” as including carrageenan, pectin, microcrystalline cellulose, chitosan, and various gums, as well as CMC ([0039]). MPEP 2144.06 II indicates that substituting equivalents known for the same purpose is prima facie obvious, so long as the equivalency is recognized in the prior art and not based merely on the fact that the components are functional equivalents. Since Baniel et al. discloses broadly that the carrier may be a natural gum and Catani et al. discloses CMC as being a gum within the same group of compounds that are used in solid sweetener compositions, the substitution of CMC as the carrier of the sweetener composition of Baniel et al. would be obvious to a skilled practitioner.
As for the mucosal adhesion, Purandare et al. discloses a composition for oral administration that may comprise a sweetener as well as sodium carboxymethyl cellulose as “an excipient to aid mucosal adhesion” ([0072]).
It would have been obvious to one having ordinary skill in the art to produce a sweetener formulation having an increase in mucosal adhesion due to the presence of CMC. Since Catani et al. provides limited description regarding the purpose of the addition of the food-grade gums, a skilled practitioner would be motivated to consult Purandare et al. for clarification regarding the nature of the ingredient. Since Purandare et al. discloses that CMC was known to “aid mucosal adhesion”, an increase in mucosal adhesion for a composition comprising CMC compared to a control composition lacking the ingredient would be obvious to a skilled practitioner.
As for the degree of increase in mucosal adhesion, the effect of the CMC would simply be dependent on the concentration of the component. The concentration of the CMC is a result-effective variable, and the increase in mucosal adhesion is the result that is modified dependent on the concentration. The concentration of the CMC would be obvious based on routine optimization of the desired degree of mucosal adhesion, and the degree of mucosal adhesion would consequently be obvious as well. MPEP 2144.05 II A; MPEP 2144.05 III C (“[I]f the prior art does recognize that the variable affects the relevant property or result, then the variable is result-effective.”).
As for claims 2-5, the previous analysis pertaining to claim 1 applies, such that the degree of mucosal adhesion would be obvious due to being modified as desired in relation to the concentration of the CMC. The claimed degrees of increase in mucosal adhesion of at least 2% (claim 2), 3-80% (claim 3), 3-60% (claim 4), and 4-30% (claim 5) would thus be obvious to a skilled practitioner.
As for claims 6 and 7, the method for calculating mucosal adhesion does not materially alter the claimed composition and thus does not patentably distinguish the claimed composition from the prior art, wherein the mucosal adhesion was determined to be obvious as being the result dependent on the concentration of CMC. The claimed characterizations by which mucosal adhesion is calculated are thus considered obvious to a skilled practitioner.
As for claim 8, Baniel et al. discloses the average particle size as being within a range of 100-1500 µm ([0063]).
As for claim 9, Baniel et al. discloses the total weight content of the polyol/carbohydrate within the sweetener formulation as being at least 60% ([0036]).
As for claim 10, Baniel et al. discloses the weight-weight ratio as being within a range of 0.1-0.8% ([0004]).
As for claim 11, Baniel et al. discloses the carbohydrate as including sucrose ([0030]).
As for claim 12, Baniel et al. discloses the sweetener formulation as being a free-flowing powder ([0056]).
As for claim 13, Purandare et al. discloses CMC as “an excipient to aid mucosal adhesion” ([0072]), which renders the formation of a composition comprising CMC as a “bioadhesive formulation” obvious.
As for claims 15 and 16, the previous analysis pertaining to claim 1 applies, such that the degree of mucosal adhesion—including a minimal threshold of mucosal adhesion—would be obvious due to being modified as desired in relation to the concentration of the CMC. The claimed bioadhesive concentration (claim 15) and bioadhesive content (claim 16) would thus be obvious to a skilled practitioner.
Claims 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Baniel et al. (U.S. 2019/0021381 A1) in view of Catani et al. (U.S. 2008/0069939 A1) and Purandare et al. (U.S. 2016/0090385 A1) as applied to claim 1, and further in view of Smiddy et al. (Smiddy, M. A., Kelly, A. L., and Huppertz, T., “4 Cream and Related Products”, Dairy Fats and Related Products, Tamine, A. Y., ed., Blackwell Publishing Ltd., (2009)).
As for claim 17, Baniel et al. discloses an edible formulation comprising the sweetener formulation and dairy cream ([0083], [0053]).
Baniel et al. does not specifically disclose the formulation as comprising at least 30% w/w of the sweetener formulation and fat.
However, Smiddy et al. discloses cream as comprising 30-40% w/w fat (p. 61, ¶1).
It would have been obvious to one having ordinary skill in the art to produce an edible formulation comprising at least 30% w/w of the sweetener formulation and fat. Since Baniel et al. does not provide any instruction regarding the nature of the cream component, a skilled practitioner would be motivated to consult Smiddy et al. for clarification regarding the cream composition. Since Smiddy et al. discloses that cream comprises 30-40% w/w fat (p. 61, ¶1) and Baniel et al. discloses producing a composition comprising cream and the sweetener formulation, the production of an edible formulation comprising at least 30% w/w of a combination of fat and the sweetener composition would be obvious to a skilled practitioner.
As for claim 18, Baniel et al. discloses the sweetener composition is “used as a sweetener” ([0083]), which suggests that the concentration is a result-effective variable that may be modified as desired to achieve a particularly-desired sweetness. MPEP 2144.05 II A; MPEP 2144.05 III C. As such, any sweetener formulation concentration would be obvious to a skilled practitioner, including the claimed concentration at least 8% w/w.
As for claim 19, Smiddy et al. discloses the fat content as being at least 5% of the edible formulation (p. 61, ¶1). Any sweetener formulation concentration would be obvious as detailed previously in relation to claim 18, including the claimed concentration of at least 5% w/w.
As for claim 20, any sweetener formulation concentration would be obvious as detailed previously in relation to claim 18, including the claimed concentration of at least 5% w/w. Baniel et al. further discloses that the sweetener composition may comprise starch in an amounts ranging from 0-99% w/w of the sweetener formulation ([0072]). Since the sweetener composition may comprise up to 99% w/w starch and any amount of sweetener was determined to be obvious, corresponding amounts starch in the sweetening composition would likewise be obvious, which at least renders the claimed range of at least 5% starch in the edible formulation obvious.
As for claim 21, any sweetener formulation concentration would be obvious as detailed previously in relation to claim 18, including the claimed concentration of 10%-80% w/w.
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.
Claims 1, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, and 16 of U.S. Patent No. U.S. 11,896,714 in view of Catani et al. (U.S. 2008/0069939 A1).
The claimed compositions would be obvious in view of the noted claims of the ‘714 patent in view of Catani et al., since the claimed compositions comprise essentially the same components as those of a composition produced according to the methods of the ‘714 patent. The present claims are narrower due to requiring the carrier to be CMC. The use of CMC as the carrier would be obvious in view of Catani et al., since Catani et al. discloses that CMC is a gum ([0039]) that falls within the scope of “natural gums” disclosed in the ‘714 patent as being suited for use as carriers (C5, L63 – C6, L26).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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, Emily Le can be reached at 571-272-0903. 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.
/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793