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 .
Status of Application
The Examiner acknowledges receipt of the amendments filed 08/07/2026, wherein claims 5 and 10 have been amended, and claim 20 has been added.
Claims 1-20 are presented for examination on the merits. The following rejections are made.
Priority
Acknowledgement is made of applicant’s claim for foreign priority based on two applications filed in the United Kingdom of Great Britain on 04/01/2022 and 06/15/2022. Further, it is acknowledged that present application is a 371 of PCT/EP2023/058713 filed 04/03/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed 08/07/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Specification
Applicant’s amendments filed 08/07/2026 overcome the objection to the specification made by Examiner. This objection is withdrawn.
Modified Rejections of Record following Amendments
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.
Claim(s) 1-9, 11-12, 14-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (US 20220095671 A1) in view of Bredenberg (WO 2016142705 A1).
Regarding claim 1, 5, and 20, Kindvall teaches a solid, oral pouched nicotine product that contains a pH regulating agent (see claim 1). Kindvall describes that the source of nicotine in the pouch is a nicotine salt, specifically nicotine bitartrate dihydrate (para. [0143]). Kindvall further teaches that the pH regulating agent would be added after the manufacture of the product (para. [0060]), therefore the intraoral formulation is formed in the absence of the pH regulating agent.
While Kindvall teaches many elements of instant claim 1, as described above, it does not teach that the active agent (i.e. nicotine) is located within the pores of a ceramic system. Bredenberg discloses a transdermal drug administration composition that utilizes a chemically bonded ceramic system, which is made up of calcium phosphates, calcium sulfates, and calcium silicates (pg. 6, line 32). Bredenberg further describes that the active ingredient (i.e. nicotine) is located within the pores of the ceramic system (pg. 10, line 19). It is described in Bredenberg that ceramic systems have become increasingly useful due to their durability to the corrosive effects of bodily fluids (i.e. saliva, pg. 1, line 31) as well as their ability to be carriers for controlled-release pharmaceutical formulations (pg. 2, line 5).
Kindvall and Bredenberg are considered to be analogous to the claimed invention since they are all in the same field of delivering drugs via absorption through the tissue. It would have been obvious to combine the formulation taught in Kindvall with the ceramic system taught in Bredenberg. As described above, Bredenberg teaches that ceramic systems can function as carriers for the controlled-release of pharmaceutical formulations (pg. 2, line 5). The person of ordinary skill in the art would have reasonable expectation of success in combining the ceramic system taught in Bredenberg with the nicotine formulation taught in Kindvall for the benefit of controlled-release of nicotine, and enhanced durability of the solid. MPEP § 2143(I)(a).
Regarding claims 2-4, Bredenberg teaches that the ceramic system is a porous solid material selected from the group of calcium sulfate or calcium phosphate (see claim 5).
Regarding claims 6, 7, 9, and 17, Kindvall teaches an example of an intraoral pouched nicotine product containing nicotine bitartrate dihydrate and sodium carbonate (para. [0143]). As discussed above, Kindvall teaches that the pH regulating agent (i.e. sodium carbonate) would be added after the manufacture of the product (para. [0060]), and as such would be located outside of the pores of the ceramic system. Kindvall discloses that sodium carbonate can be utilized as a pH adjuster to achieve the desired pH of 7-10 (para. [0006]). The range of the pH claimed in instant claim 11 overlaps with that disclosed in Kindvall, and as such is obvious. MPEP § 2144.05(I).
Regarding claim 8 and 15, Bredenberg teaches that the active ingredient is within the pores of the ceramic system (see claim 6). Bredenberg further teaches that the active pharmaceutical ingredient (i.e. nicotine) can be incorporated into the device at any stage during manufacturing (pg. 26, line 31). As such, it would be obvious to incorporate the nicotine while forming the chemically bonded ceramic system.
Regarding claims 11 and 14, as discussed above, Kindvall teaches the intraoral pouch containing nicotine bitartrate (para. [0143]), with a pH regulating agent (i.e. sodium carbonate, para. [0143]). Kindvall further teaches that the pH regulating agent would be added after the manufacture of the product (para. [0060]), therefore the intraoral formulation is formed in the absence of the pH regulating agent. Bredenberg teaches the solid, porous, ceramic system is formed from calcium sulfate (see claim 5). As stated above, Bredenberg teaches the use of a ceramic system, in an application for drug administration. It would be obvious to incorporate this element into the intraoral pouch taught in Kindvall for the benefit of enhanced durability of the system, as taught in Bredenberg (pg. 1, line 31). MPEP § 2143(I)(a).
Regarding claim 12, Kindvall teaches that the nicotine formulation is within a permeable pouch (para. [0004]), and the pH regulating agent (i.e. sodium carbonate) would be added after the manufacture of the product (para. [0060]), and as such would be located outside the pores of the ceramic system. Kindvall further teaches that pH is known to contribute to regulating the uptake of nicotine through the mucous membranes in the oral cavity (para. [0006]). The person of ordinary skill in the art would be motivated to have the pH regulating agent to be associated with the permeable material of the pouch, since this is the outermost layer of the formulation and could more quickly adjust the pH of the environment for the benefit of improved uptake of nicotine. MPEP § 2143(I)(g).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (US 20220095671 A1) in view of Bredenberg (WO 2016142705 A1), in further view of Nielsen (US 20190174812 A1).
While Kindvall and Bredenberg teach the claimed invention as described above, they fail to teach the presence of a mucoadhesive promoting agent in the tablet.
Regarding claim 13, Nielson teaches a solid oral nicotine formulation that contains a pH regulating agent. The solid formulation disclosed in Nielson can be an orally disintegrating tablet (see claim 9), and further comprises absorption enhancers such as mucoadhesives (para. [0238]).
Kindvall, Bredenberg, and Nielsen are considered to be analogous to the claimed invention because they are all in the same field of formulations for the controlled-release of a drug. Nielsen describes that mucoadhesives function as absorption enhancers (para. [0238]), which are known in the art to allow for better absorption of active pharmaceutical ingredients. As such, it would have been obvious to one of ordinary skill in the art to incorporate the tablet form of the nicotine product with the mucoadhesive, as taught in Nielson, with the formulation taught in Kindvall for the benefit of improved absorption of the active ingredient. MPEP § 2143(I)(a).
Claim(s) 10, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (US 20220095671 A1) in view of Bredenberg (WO 2016142705 A1), as evidenced by Azhir (US 20190307740 A1)
Kindvall and Bredenberg teach the claimed invention as above, but they do not teach the benefits of administering a nicotine product, or that substantially all of the nicotine or salt is released upon contact with an aqueous liquid.
Regarding claims 16, 18, and 19, Azhir teaches a composition containing nicotine that functions to treat neurogenerative diseases. Azhir discloses the administration of a nicotine salt (para. [0382]) for the benefit of helping patients with cognitive disorders such as Alzheimer’s, Parkinson’s, and Huntington’s (para. [0060]). The formulation taught in Azhir can be formed into a tablet (para. [0142]).
Regarding claim 10, as discussed above, Azhir teaches the benefits of nicotine within a formulation. Azhir teaches that the drug release profile of a nicotine salt containing composition, and teaches that over 80% of the composition dissolves (i.e. over 80% of the active nicotine agent is released, see Figure 8). While Kindvall and Bredenberg do not teach the amount of the active agent that is released upon contact with an aqueous liquid, one of ordinary skill in the art would be motivated to modify the formulation to optimize the release of the active ingredient to maximize the benefits of nicotine that are taught in Azhir.
Kindvall, Bredenberg, and Azhir are considered to be analogous to the claimed invention because they are in the same field of formulations for the controlled-release of a drug. While Kindvall and Bredenberg fail to explain the benefits of an intraoral nicotine product to a patient, Azhir teaches an intraoral formulation comprising nicotine that benefits individuals with Alzheimer’s, Parkinson’s, and Huntington’s (para. [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to administer an intraoral nicotine product, such as the nicotine pouch taught in Kindvall, for the benefit of helping patients with cognitive disorders. Additionally, as taught in Azhir, this product can be administered as a tablet. MPEP § 2143(I)(g).
Response to Applicant’s Arguments
Applicant’s amendments filed 08/07/2026 overcome the rejection of claims 5 and 10 made by Examiner under 35 U.S.C. 112(b). This rejection is withdrawn.
Applicant asserts the following:
Applicant's claims do not require that the intraoral formulation of claim 1, or the permeable sealed bag of claim 11, is formed in the absence of the pH regulating agent. The combination of Kindvall and Bredenberg fail to teach or suggest Applicant's claims because they fail to teach a formulation incorporating both a solid, porous chemically bonded ceramic system and a pH regulating agent, where the solid ceramic system is formed in the absence of the pH regulating agent.
Original rejections under 35 U.S.C. 103 state that the pH regulating agent disclosed in Kindvall is added after the manufacture of the product, thus the intraoral formulation is formed in the absence of the pH regulating agent. Applicant asserts that Kindvall discloses that pH values may be achieved after manufacture, and does not concern any details of the manufacturing process itself.
Bredenberg fails to suggest incorporating a solid, porous chemically bonded ceramic system into an intraoral formulation or a permeable, sealed bag, nor forming such a ceramic system in the absence of the pH regulating agent. Bredenberg teaches loading drugs into the drug delivery systems, mentioning "pH modifiers" as one of several possible pharmaceutically acceptable excipients, which contrary to Applicant's claims, teaches that the excipients be included when forming the porous solid system.
Kindvall does not explain the circumstances in which pH modifiers are required, and Bredenberg does not mention nicotine or any salt forms thereof. Because the need to include a pH regulating agent arises from the fact that the intraoral formulations and sealed bags are engineered to deliver nicotine, this is an important deficiency.
While Kindvall teaches oral delivery of nicotine through placement of a pouched product in the mouth, Kindvall discusses transdermal delivery of drugs across the skin through microneedles that penetrate a patient's skin to enhance drug delivery. Kindvall utilizes a physical barrier, that is a layer of pouch fabric, that would prevent the microneedles of Bredenberg's drug delivery devices from penetrating any tissue. Therefore, nothing in the combination of Kindvall and Bredenberg would suggest to one of ordinary skill in the art that the devices of Bredenberg would be expected to function when incorporated into Kindvall's pouches.
Both Kindvall and Bredenberg suggest incorporating both the nicotine and pH adjuster together within the ceramic carrier, contrary to Applicant's claims. Kindvall teaches homogenously mixing the carrier, the nicotine source, the water, and the pH adjuster. Even if one of ordinary skill in the art had been motivated to use Bredenberg's ceramic system in Kindvall's pouches, one would be guided to incorporate both the nicotine and the pH adjuster together within the ceramic carrier, as Bredenberg suggests including the pH modifiers when forming the solid system.
Nothing in the combination of Kindvall and Bredenberg suggests any problem might be encountered when including a pH regulating agent during the formation of the solid ceramic system. The combination fails to suggest that omitting a pH regulating agent during the formation of the solid system would avoid loss of nicotine.
Further combination with Nielsen fails to cure the deficiencies of Kindvall and Bredenberg, specifically regarding the formation of the ceramic system in the absence of a pH regulating agent. Nielsen teaches that the nicotine and pH regulating agent are added simultaneously.
Azhir is cited as evidence of the benefits of administering nicotine to patients, and that the formulation of Azhir can be formed into a tablet. Azhir fails to cure the deficiencies of Kindvall and Bredenberg, as it does not teach incorporating an active agent within the pores of a ceramic system, and forming the carrier in the absence of the pH regulating agents.
In response to arguments A, B, C, D, F, G, H, and I, regarding the addition of the pH regulating agent following developing the formulation, the maintained prior art rejections under 35 U.S.C. 103 cover this. While Kindvall does teach that the ingredients, including the sodium carbonate pH adjusting agent, can be combined homogenously, Kindvall teaches that the desired pH can be achieved after the manufacture of the product (para. [0060]). The broadest reasonable interpretation of this statement is that the pH values are attained following the manufacture of the product, which could allude to the adjusting agent being added following the manufacture of the product. Bredenberg further teaches that the excipients (i.e. pH adjusting agents, pg. 11 lines 26-28) are used as carriers for active ingredients (i.e. nicotine). Bredenberg describes that the active ingredient is located predominantly on the outer surface of the porous solid (pg. 20 line 29), supporting that the carrier for the active ingredients would also be located outside the ceramic solid system. Therefore, Kindvall and Bredenberg do provide motivation to incorporate the pH adjusting agent following developing the product, and having it outside the ceramic system.
Regarding argument E, Bredenberg teaches that the drug delivery element of the drug administration device may take several forms, provided that it defines a contact surface for location against a patient’s skin (pg. 13, line 30), but further teaches that it is not essential that the drug delivery element is placed in direct contact with the skin (pg. 13, line 25). The microneedles of Bredenberg are not necessary for release of the drug, as it states that the product may contain them, implying it is optional. One of ordinary skill in the art would be motivated to use the ceramic system of Bredenberg, as Bredenberg teaches the ceramic system’s durability to the corrosive effective of bodily fluids (i.e. saliva, pg. 1 line 31). Both an intraoral pouched nicotine product, as taught in Kindvall, and a transdermal drug administration device would benefit from durability to bodily fluids. Further, the system disclosed in both Kindvall and Bredenberg allow for release of an active when making contact with the skin (see abstract). The ceramic system of Bredenberg is for a drug delivery element that has a contact surface against the skin, where the contact surface does not require the microneedles (pg. 4 line 35). As above, one of ordinary skill in the art would be motivated to use the ceramic system of Bredenberg, as Bredenberg teaches a system that allows for improved durability and controlled release of active agents.
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(s) 1-8, 11, and 14-19 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 3, 6, 12, 17, 20, 35, and 36 of co-pending U.S. Application No. 18/852,888 (hereafter App’888) in view of Kindvall (US 20220095671 A1).
Regarding claims 1-4, 6, and 8 of instant invention, App’888 teaches a porous chemically bonded ceramic system based on a calcium sulfate, that contains nicotine or a salt within the pores of the system (see claim 1). Further, App’888 teaches the presence of a pH regulating agent, specifically a carbonate (see claim 36). Kindvall teaches that the pH regulating agent would be added after the manufacture of the product (para. [0060]), so the intraoral formulation is formed in the absence of the pH regulating agent.
While App’888 does not teach that the ceramic system is formed in the absence of the pH regulating agent, this is taught in Kindvall (para. [0060]) for the benefit of preventing an increase in the pH of the product when it is stored (para. [0075]). As such, it would be obvious to one of ordinary skill in the art to add the pH regulating agent after the formation of the ceramic system for the benefit of improved pH of stored product.
Regarding claim 5, 7, and 17 of instant invention, App’888 teaches that the nicotine bitartrate salt is nicotine bitartrate dihydrate (see claim 35), and the formulation gives a pH of at least 8 upon contact with saliva (see claim 6).
Regarding claim 11, 14, and 15 of instant invention, App'888 teaches a porous chemically bonded ceramic system containing nicotine (see claim 1), with a pH regulating agent (see claim 12). The chemically bonded ceramic system is formed in the presence of the nicotine or salt (see claim 3). As described above, Kindvall teaches that the intraoral composition can be formed in the absence of the pH regulating agent (para. [0060]). App'888 further teaches that the formulation is contained in a permeable sealed bag.
Regarding claims 16, 18, and 19, App'888 teaches a method of treatment of administering an intraoral formulation containing nicotine for the benefit of treating nicotine dependence, and to help individuals with dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, and depression (see claim 20).
While App’888 teaches all elements of instant claims 1-8, 11, and 14-19, it does not teach that the ceramic system is formed in the absence of the pH regulating agent. However, this element is taught in Kindvall. It would have been obvious to one of ordinary skill in the art to incorporate the teachings of Kindvall into the formulation of App’888 to arrive at the current invention. As described above, Kindvall teaches that the pH regulating agent can be after the manufacture of the product (para. [0060]), for the benefit of improved pH of the stored product. MPEP § 2143(I)(g).
The conflicting claims of instant invention and App’888 differ only marginally in scope from claims 1-8, 11, and 14-19 of present invention. Kindvall teaches a composition that compensates for the deficiency in the claims regarding the later addition of the pH regulating agent.
This is provisional nonstatutory double patenting rejection because the conflicting claims have not yet been patented.
Claim(s) 1-7, 10-11, and 13-19 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4, 5, 9, 13, 15, 19, and 22 of co-pending U.S. Application No. 18/852,986 (hereafter App’986) in view of Kindvall (US 20220095671 A1).
Regarding claims 1-5 and 17 of instant invention, App’986 teaches an intraoral composition comprising nicotine bitartrate dihydrate (see claim 5) and a chemically bonded ceramic system formed from the group consisting of calcium aluminates, calcium silicates, calcium phosphates, and mixtures (see claim 1). App’986 further teaches that the ceramic system can be formed from alpha-tricalcium phosphate or tetracalcium phosphate (see claim 9).
While App’986 does not teach the presence of a pH regulating agent, Kindvall teaches a pH regulating agent (i.e. sodium carbonate) that is added after the manufacture of the product (para. [0060]), and as such would be located outside of the pores of the ceramic system. As discussed above, Kindvall teaches the benefit of a pH regulating agent for the benefit of improved pH of the stored product. As such, a skilled artisan would have reasonable expectation of success in incorporating the pH regulating agent taught in Kindvall into the formulation disclosed in App’986 for improved pH of the stored product. MPEP § 2143(I)(g).
Regarding claim 6 and 7 of instant invention, as discussed above Kindvall teaches an intraoral composition with pH adjusters such as sodium carbonate (para. [0006]). Kindvall further teaches that the desired pH of oral pouched nicotine products is neutral or slightly alkaline, specifically from a range of 7-10 (para. [0006]). The range of instant claim 7 is fully encompassed by the range taught in Kindvall, and as such it is obvious.
Regarding claim 10 of instant invention, App’986 discloses that the formulation is capable of releasing substantially all of the active pharmaceutical agent (i.e. nicotine) upon contact with an aqueous liquid (see claim 13).
Regarding claim 11, 14, and 15 of instant invention, as discussed above, App'986 teaches an intraoral formulation with a chemically bonded ceramic system (see claim 1) that contains nicotine (see claim 4). The composition is in the form of a permeable, sealed bag (claim 15). While App'986 does not teach the pH regulating agent, Kindvall teaches an intraoral nicotine product that is contained in a permeable sealed pouch (see claim 1). Further, Kindvall teaches a pH regulating agent that is added after the manufacture of the product (para. [0060]).
Regarding claim 13 of instant invention, App’986 teaches that the composition is a sublingual tablet, buccal tablet, wafer, or lozenge that can comprise a bioadhesion or mucoadhesion promoting agent (see claim 17).
Regarding claims 16, 18, and 19 of instant invention, App’986 teaches a method of treating nicotine dependence, and alleviating symptoms associated with dementia, Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, and depression by administering an intraoral formulation (see claim 22).
This is provisional nonstatutory double patenting rejection because the conflicting claims have not yet been patented.
Response to Applicant’s Arguments – Double Patenting
Applicant asserts the following:
The non-statutory double patenting rejection in view of U.S. Applications No. 18/852,986 and 18/852,888 in view of Kindvall is flawed because Kindvall teaches the values provided by the product are achieved after manufacture of the product. It does not concern any details of the Kindvall's manufacturing process, and as such cannot teach that the intraoral formulation is formed in the absence of the pH regulating agent. Kindvall discloses a potential benefit associated with a pH adjuster generally and makes no mention of the timing of addition of the pH adjuster during the manufacturing process.
There is no reason provided for why a person of ordinary skill in the art would expect Kindvall's teachings, which do not include a ceramic system, to somehow particularly suggest omitting a pH adjuster when forming the ceramic system. This assertion ignores the teachings of Bredenberg in the rejections under 35 U.S.C. 103 made above.
Applicant's claims are non-obvious over cited claims of U.S. Applications No. 18/852,986 and 18/852,888 in view of Kindvall.
Applicant notes that the U.S. Application No. 18/832,626 is directed to an unrelated application, with different inventors, and believes the Examiner intended to refer to U.S. Application No. 18/831,626. Further, since the present application was filed earlier, the non-statutory double patenting rejection remains provisional, as stated in the prior rejection.
In response to arguments A, B, and C, as above, while Kindvall does teach that the ingredients, including the sodium carbonate pH adjusting agent, can be combined homogenously, Kindvall teaches that the desired pH can be achieved after the manufacture of the product (para. [0060]). The broadest reasonable interpretation of this statement is that the pH values are attained following manufacture of the product, which could allude to the adjusting agent being added following the manufacture of the product. Further, the assertions rely on Kindvall alone because the deficiencies in 18/852,986 and 18/852,888, regarding the addition of the pH regulating agent, are taught in Kindvall.
In response to argument D, applicant is correct in that the rejection was intended to be made under 18/831,626. Applicant is further correct that the rejection remains provisional as neither application has been made allowable. However, as 18/831,626 is a continuation of instant application, the double patenting rejection with respect to 18/831,626 has been withdrawn.
Conclusion
The rejections of claims 1-20 are maintained.
THIS ACTION IS MADE FINAL. 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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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