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 included in the prosecution are claims 55-58, 60-63, 65-69 and 77-96.
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.
1. Claims 55-58, 60-63, 65-69, 77-82 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) (IDS reference) (hereinafter Labib).
Labib discloses a cleaning composition comprising a carrier fluid and minute fibrils suspended in the carrier fluid (abstract). The composition may be used for removing dental biofilm and dental plaque from teeth or oral cavity (¶ [0187]). Minute Fibrils is a term coined to encompass what the industry terms as microfibrillated cellulose and nanofibrillated cellulose (i.e. claimed water-insoluble hydratable polymer fibers) (¶ [0028]). The carrier fluid can be an aqueous carrier fluid comprising an organic solvent and optionally a co-solvent (¶ [0091]). A 3-D network structure results from entanglements of fibrils as well as due to hydrogen bonding when the fibrillated materials are properly mixed with water or solvents (¶ [0034]). Such mixing is referred to as activation (¶ [0171]). The organic solvent may be a propylene glycol (¶ [0091]). Suitable propylene glycols include propane-1,2-diol (i.e. claimed humectant) (¶ [0092]). Water and organic solvent may be from about 95% to about 99% by weight, with water comprising a major portion of the solvent component (Table 12). It is desirable that the storage modulus G’ of the composition is larger than the loss modulus G” (¶ [0142]). The storage modulus G’ describes the elastic properties (¶ [0141]). The minute fibrils may have a diameter of 0.3-20 µm (300-20,000 nm) and a length of 20-200 µm (20,000-200,000 nm) (Table 2). The minute fibril concentration may be from about 0.1% w/w to about 3% w/w (¶ [0218]). The composition may further comprise about 0.01% to about 0.5% surfactant (Table 10). The minute fibrils have thicker polymer bundle segments from which branch thinner polymer bundle segments (¶ [0010], Fig. 2). The composition may further include 0.1% to 5% solid particles (i.e. claimed non-fibrillated particles) (¶ [0076]). The solid particles may be within the network (¶ [0079]). Suitable solid particles include calcium carbonate (i.e., abrasive particle) (¶ [0077]). The composition may also comprise about 0.1 to 10% microcrystalline cellulose to provide rigidity, stiffness and hardness to the composition (¶ [0073]). The specific surface area of the nano- or microfibrillated cellulose can be more than about 10 m2/g as determined by the Brunauer-Emmett-Teller theory (¶ [0036] and [0037]). The storage modulus of the composition may be more than about 2000 Pa or more than 4000 Pa (¶ [0187]). The yield stress of the composition may be about 5 Pa to about 100 Pa (¶ [0225]). A polymeric thickener is not required in the composition (Table 12). The composition may additionally comprise about 0.1% to about 5% abrasive (Table 11). The composition can include a buffering additive to help maintain a desired pH of the composition (¶ [0097]). A composition of any desired pH can be formulated and used depending on the surface and on the contaminants to be cleaned. A pH range between 3 to 11.5 can be useful for the composition (¶ [0097]). The composition may be formulated as toothpaste (i.e., prophylaxis paste) (¶ [0187]). The composition may contain an antimicrobial substance or an antibiotic (¶ [0166]).
The prior art discloses a composition containing a carrier fluid (abstract), minute fibrils (i.e. claimed water-insoluble hydratable polymer fibers) (abstract), water (¶ [0091]), and propane-1,2-diol (i.e. claimed humectant) (¶ [0092]). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since 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. See MPEP 2143(I)(A).
In regards to instant claims 55 and 60 reciting a water activity of 0.78 or lower, the instant specification discloses in paragraph [00126] wherein in order to lower water activity down to 0.75 or lower, the humectant may be propane diol at a concentration of 30%, 40% or even 50% of the composition. As discussed above, Labib discloses wherein the composition comprises about 95% to about 99% water and organic solvent (e.g. propane-1,2-diol (i.e. claimed humectant)), wherein water comprises a major portion of the solvent component. Accordingly, Labib teaches a composition comprising an amount of humectant to lower water activity down to 0.75 or lower.
In regards to instant claim 55 reciting wherein the composition has a reduced presence of microstructural voids compared to an otherwise identical composition except without said one or more humectant, as discussed above, the composition of Labib comprises a humectant. Therefore, the composition of Labib has a reduced presence of microstructural voids like the claimed invention.
In regards to the properties recited in instant claims 63 and 87, the instant claims recite wherein the water-insoluble hydratable polymer fibers have a diameter of about 10 to about 20,000 nm and a length of at least 100 nm. The instant specification discloses in paragraphs [00213] and [00214] wherein the claimed invention comprises about 0.05 to about 8% water-insoluble hydratable polymeric fibers, about 10% to about 95% water, and from about 5% to about 80% humectant, as discussed above, Labib discloses a composition comprising about 0.1% w/w to about 3% w/w minute fibrils (i.e. claimed water-insoluble hydratable polymers) and about 95% to about 99% water and organic solvent (e.g. propane-1,2-diol (i.e. claimed humectant)), wherein the minute fibrils may have a diameter of 0.3-20 µm (300-20,000 nm) and a length of 20-200 µm (20,000-200,000 nm). Accordingly, since Labib et al. disclose substantially the components as claimed in substantially the same amounts, the composition of Labib would necessarily have the claimed property recited in instant claims 63 and 87.
In regards to instant claim 82 reciting about 0.2% to about 2.0% of a buffer, as discussed above, Labib discloses wherein the composition may comprise a buffer to help maintain a desired pH and wherein the pH may be between about 3 to 11.5. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the amount of buffer depending on the specific pH desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
2. Claims 83 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) (IDS reference) (hereinafter Labib) in view of Modak et al. (US 2013/0230609, Sep. 5, 2013) (IDS reference) (hereinafter Modak).
The teachings of Labib are discussed above. Labib does not disclose wherein the composition comprises 0.1% to 0.5% chlorhexidine gluconate.
However, Modak discloses wherein chlorhexidine gluconate is an antimicrobial agent (¶ [0100]). Such antimicrobial may be used in amounts ranging from about 0.1 to about 2.0% w/w (¶ [0102]). The antimicrobial may be used in oral products (¶ [0108]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Labib discloses wherein the composition may comprise an antimicrobial substance. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 0.1 to about 2.0% w/w chlorhexidine gluconate into the composition of Labib since it is a known and effective antimicrobial substance and amount thereof as taught by Modak.
In regards to instant claim 84 reciting wherein the dentifrice is subgingival, this is merely a recitation of intended use. The composition of Labib is a dentifrice (e.g., toothpaste) and comprises substantially the same components as the claimed invention and therefore, is usable as a subgingival dentifrice, whether the prior art discloses such use or not.
3. Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) (hereinafter Labib) in view of Cordon (US 4,075,316, Feb. 21, 1978) (IDS reference).
The teachings of Labib are discussed above. Labib does not disclose wherein the composition comprises 0.1% to 1% fluoride ions.
However, Cordon discloses a dentifrice composition (abstract). The composition may contain a fluorine-containing compound having a beneficial effect on care and hygiene of the oral cavity, e.g. diminution of enamel solubility in acid and protection of the teeth against decay. These materials, which dissociate or release fluorine-containing ions in water, suitably may be present in an effective but non-toxic amount, usually within the range of about 0.01 to 1% by weight of the water-soluble fluorine content thereof (co. 4, lines 51-64).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated about 0.01 to 1% fluoride ions into the composition of Labib motivated by the desire to provide a beneficial effect on care and hygiene of the oral cavity, e.g. diminution of enamel solubility in acid and protection of the teeth against decay as taught by Cordon.
Allowable Subject Matter
Claims 86 and 88-96 are free of prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 86 is free of prior art since the subject matter of claim 86 has been found allowable. Claim 86 is identical to claim 34 in U.S. Patent No. 12,064,495.
Claims 88-96 are free of prior art since the claims recite a carrier liquid comprising water and at least one of glycerol and sorbitol, wherein at least one of glycerol or sorbitol is present in excess of 20 wt. %. Applicant has shown in the 03/21/2024 declaration of U.S. Application No. 17/225,049 that having glycerin and sorbitol as the humectant and in high amounts provided significantly improved G’, which would not have been obvious from the teachings of Labib.
Double Patenting (Statutory)
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 86 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 34 of prior U.S. Patent No. 12,064,495. This is a statutory double patenting rejection.
Double Patenting (Non-Statutory)
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 55-58, 60-63, 65-69 and 77-96 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12,064,495. Although the claims at issue are not identical, they are not patentably distinct from each other because pending claim 1 would have been obvious from the combination of patented claims 1, 31 and 32, pending claim 86 would have been obvious from patented claim 34 since they are identical, and pending claim 88 would have been obvious from patented claim 1 since pending claim 88 is broader in scope.
Conclusion
Claims 55-58, 60-63, 65-69 and 77-96 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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, Ali Soroush can be reached at 571-272-9925. 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.
/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights