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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 05/08/2026; and IDS filed on 11/18/2025 and 06/04/2023.
Claims 1-16 are pending in the instant application.
Claims 1-9 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 10-16) and specie elections of “flavor agent” in the reply filed on 05/08/2026 is acknowledged.
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 10-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/875,144 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because co-application recites a first component including a pH sensitive rheology modifying polymer, a calcium ion source, and an acidifying agent, and wherein the first component has a pH in the range of about 2.0 to about 6.5; a second component including a phosphate ion source, a positively charged basic amino acid and/or a cationic peptide, and an alkalizing agent, and wherein the second component has a pH in the range of about 9.5 to about 14.0; and wherein the first component and the second component are combined into a mixture, wherein a cationic amorphous calcium phosphate gel composition is created instantly when the pH of the mixture reaches a pH range of about 7.0 to about 9.5 (see claim 1), wherein the first component and the second component are combined into a mixture via a mixing tip or a mixing chamber (see claim 2), wherein viscosity of the instantly formed cationic amorphous calcium phosphate gel is larger than about 5,000 cP (see claim 10).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112, 1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The term “variations thereof” does not meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus of “variations thereof” encompassed by the claim, since there is no description of the structural relationship of these “variations thereof” provided in the specification and Applicant has not provided a description as to how the base molecule may be changed while remaining a “variation thereof”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10, 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ANDINA et al (US 2018/0185493).
Regarding claim 10, ANDINA teaches a two-component system kit (see abstract) comprised of: first component, such as a pH sensitive gelling agent (see [0035]), such as Carbopol polymer (see [0026], which is the same polymer disclosed by Applicant; in water solvent (see [0027] and [0057]) at a pH value of less than 7 (see claim 1), which reads on acidic pH.
Carbopol is the tradename of a high molecular weight polymer of a crosslinked polyacrylic acid which is available from Lubrizol Corporation and is a preferred pH-sensitive gelling agent. At acidic pH the polymer is uncharged whereas at neutral pH the acid groups are deprotonated and result in a negatively charged polymer. The anionic form of the polymer has the ability to absorb and retain water and swell to many times of their original volume thereby forming a hydrogel (see [0026]).
ANDINA further teaches the second component is sodium hypochlorite (NaOCl) solution in the range of 10 to 13 (see claim 1), which reads on alkaline pH, wherein after mixing the two components, the pH has a range of 6.5 to 7.5 optimal to provide good viscosity (see [0018]) and antimicrobial activity (see [0031]). Additional disclosures include: the system of the two-component system is a dual cartridge or a dual syringe (see [0031]), which reads on mixing tip or chamber, wherein mixing arrangements in which the components which are contained in two syringes are discharged together through a mixer and mixed in the process. Furthermore, it is known to connect two syringes to one another at their ends so that the components which are contained in the syringes can be thoroughly mixed by backward and forward transfer (see [0031]); treating periodontal disease, such as gingivitis (see [0036]).
Regarding claim 15, ANDINA teaches humectant such as glycerin and other polyols can be avoided. Therefore, it is possible to obtain a glycerin-free hydrogel Since there is a significant number of patients who do not want to be treated with a product containing glycerin derived from animal (see [0035]). Thus, glycerin is not excluded for people that does not mind animal product and would read on a co-solvent.
Regrading claim 16, ANDINA does not teach a preservative is required.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HARIHARAN (US 2017/0151260).
HARIHARAN teaches “a kit for oromucosally administering a metastable supersaturated solution of a pharmaceutical active agent to a human patient includes a first compartment comprising a first composition comprising a pharmaceutical active agent in solution at or below equilibrium solubility, and a second composition comprising an acidic buffer. The first and second compartments maintain separation of the first and second compositions during storage, and allow for mixing of the first and second compositions to form a supersaturated solution above equilibrium solubility of the pharmaceutical active agent for immediate oromucosal administration to a human patient. In one embodiment, the second composition comprises an acidic buffer and the supersaturated solution has an acidic pH. Alternatively, the second composition comprises a basic buffer and the supersaturated solution has a basic pH” (see abstract), such as a first compartment at a pH≦6 (see [0082]), which reads on acidic pH, and a second liquid at pH≧6 containing a buffer or alkaline components (see [0082]), which reads on alkaline pH, such as NaOH (see [0167] at Table 4 and 6), wherein the pH of the resultant composition is 7.5 (see [0082]).
Additional disclosures include: polymers for imparting viscosity to the liquid and/or forming a gel (see [0130]), such as Carbopols (see [0130]); co-solvents, such as propylene glycol (see [0132]) and flavors (see [0122]), which reads on flavoring agents, such as menthol (see [0121]). In FIG. 5, the syringe is a double barrel syringe wherein the two barrels are conjoined and each contains the two liquids of the invention separated from one another during storage (see [0038] and Fig. 5).
Note, HARIHARAN teaches the composition may contain methylparaben and propylparaben as preservatives. Thus, the composition may NOT contain preservatives.
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.
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.
Claim(s) 10-11, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over ANDINA et al (US 2018/0185493) in view of HARIHARAN (US 2017/0151260).
As discussed above, ANDINA teaches Applicant’s invention.
ANDINA does not teach flavoring agents, such as menthol.
HARIHARAN (US 2017/0151260) teaches the prior art had known of using flavors (see [0122]), which reads on flavoring agents, such as menthol (see [0121]) in two component kits for r gingival areas of the oral cavity (see [0084]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate flavoring agents, such as menthol. The person of ordinary skill in the art would have been motivated to make those modifications, because the flavoring agent would improve flavor while in the mouth area, and reasonably would have expected success because both references dealt in the same area of endeavor.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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