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 1 and 16 have been amended, and claim 15 has been cancelled.
Claims 1-14 and 16-20 are presented for examination on the merits. The following rejections are made.
Priority
Receipt of priority document GB2204804.05 filed 04/01/2022 is acknowledged. Acknowledgment is made of applicant's claim for foreign priority based on two applications filed in the United Kingdom of Great Britain on April 1st, 2022 and June 15th, 2022. it is acknowledged that the instant application is a continuation of 18/852,956 filed 09/30/2024, which is a 371 of PCT/EP2023/058713 filed 04/03/2023
Information Disclosure Statement
The information disclosure statement 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 overcomes the objection to the specification made by Examiner. This objection is withdrawn.
Maintained Rejections Following Amendments
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) 1-11, 13-14, and 16-20 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, Kindvall teaches a solid, oral pouched nicotine product that contains a pH regulating agent. Kindvall teaches that the source of nicotine in the pouch is a nicotine salt (para. [0095]). The pH regulating agent disclosed in Kindvall is added after the manufacture of the product (para. [0060]), thus the intraoral formulation is formed in the absence of the pH regulating agent. Kindvall discloses that the intraoral nicotine product is contained within a permeable pouch (see claim 1).
While Kindvall teaches most 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 however, teaches 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 (e.g. nicotine) is located within the pores of the ceramic system (pg. 10, line 19). It is taught in Bredenberg that ceramic systems are being 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 because they are in the same field of delivering drugs via absorption through the tissue. The person of ordinary skill in the art would have had reasonable expectation of success in combining the oral nicotine formulation taught in Kindvall with the calcium ceramic system taught in Bredenberg. Bredenberg teaches that ceramic systems can function as carriers for the controlled-release of pharmaceutical formulations (pg. 2, line 5). As such, it would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the instant invention to utilize 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 5-8, Kindvall teaches an example of an intraoral pouched nicotine product containing nicotine bitartrate dihydrate and sodium carbonate (para. [0143]).
Regarding claims 9-11, as discussed above, Kindvall teaches that the pH regulating agent 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 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 14, Kindvall teaches an example where the product further contains propylene glycol (para. [0148]).
Regarding claims 13 and 16-17, Kindvall discloses that the intraoral nicotine product is contained within a permeable pouch (see claim 1), where the amount of nicotine is 0.1-20 mg of nicotine (para. [0100]), which fully encompasses the range of instant claims 13 and 17. MPEP § 2144.05(I).
Regarding claims 18-19, as stated above, all elements of instant claim 19 are taught in Kindvall and Bredenberg. Kindvall teaches the intraoral pouch containing nicotine bitartrate (para. [0143]), with a pH regulating agent (i.e. sodium carbonate, para. [0143]). The pouch described in Kindvall has an amount of nicotine is 0.1-20 mg of nicotine (para. [0100]), and can further contain propylene glycol (para. [0148]). Additionally, Bredenberg teaches the ceramic system 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 because of enhanced durability of the system, as taught in Bredenberg (pg. 1, line 31). MPEP § 2143(I)(a).
Regarding claim 20, Kindvall describes that the total weight of the oral pouched nicotine product is from the range of 0.3-1.5 g (para. [0043]). The range of the total weight of the total weight in instant claim 20 overlaps with that of Kindvall, and as such is obvious. MPEP § 2144.05(I).
Claim(s) 12 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 Chan (US 20050123502 A1).
While Kindvall and Bredenberg teach the claimed invention as described above, they do not teach the percent composition of the chemically bonded ceramic system.
Regarding claim 12, Chan teaches an oral composition comprising a nicotine active, that contains calcium sulfate (para. [0025]) and a pH regulating agent (claim 64). Chan teaches that the binder of the formulation should be in an amount of at least 40% of the total weight of the composition (para. [0021]). As taught in the instant specification, the calcium aluminate or calcium silicate phases (i.e. ceramic system) act as the binder phase (pg. 5, line 16). The range of percent composition of the binder (i.e. ceramic system) disclosed in instant claim 12 is fully encompassed by that described in Chan, and as such is obvious. MPEP § 2144.05(I). Chan teaches the importance of excipients, such as binders, for improved stability of the active ingredient (para. [0020]).
Kindvall, Bredenberg, and Chan are considered to be analogous to the claimed invention because they are all in the same field of formulations that can be used for the extended release of pharmaceuticals such as nicotine. While Kindvall and Bredenberg do not teach the percent composition of the ceramic system, Chan teaches that the binder formulation is present in an amount of at least 40 wt.%. One of ordinary skill in the art could routinely optimize the percent composition of the calcium sulfate in the formulation to be within the range taught in Chan. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the product taught in Kindvall and Bredenberg, which are ready for improvement, to adjust the percent composition of the ceramic system for the benefit of improved stability of the active ingredient.
Response to Applicant’s Arguments
Applicant asserts the following:
The combination of Kindvall and Bredenberg fails to teach or suggest 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 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 discusses the loading of drugs into the drug delivery systems, and states that pharmaceutically acceptable excipients (i.e. pH modifiers) may be included when forming the porous systems. However, Bredenberg does not disclose how the excipients may be incorporated into the products. Further Bredenberg does not mention nicotine, which is an important deficiency since the need for the pH regulating agent arises from the fact that the pouches are engineered to deliver nicotine.
Bredenberg is drawn to transdermal delivery of drugs across exterior skin, where Kindvall is drawn to oral delivery of nicotine through placing a pouched product in the mouth. While Bredenberg discusses using delivery devices with micro-needles to penetrate the skin of a patient, Kindvall produces a physical barrier (i.e. layer of pouch fabric), that prevent the delivery device from having to penetrate the tissue. Nothing in the combination of Kindvall and Bredenberg would suggest one of ordinary skill in the art that the devices of Bredenberg would be expected to function when incorporated into Kindvall's pouches.
One of ordinary skill in the art would be motivated to combine the carrier, nicotine and pH adjuster together first before adding the composition to Bredenberg's ceramic system, as Kindvall teaches homogenous mixture of these components. Thus, neither prior art source teaches a system where the pH regulating agent is located outside of the pores of the chemically bonded ceramic system. Applicant's claimed formulation exhibited an unexpected reduced nicotine losses during manufacture by forming the chemically bonded ceramic system without any pH regulating agent being present. One of ordinary skill in the art would incorporate both the nicotine and the pH adjuster together within the ceramic carrier. Neither Kindvall or Bredenberg would suggest problems with including the pH regulating agent during the formation of the solid ceramic system. The combination of Kindvall and Bredenberg fails to suggest omitting a pH regulating agent during formation of the solid, porous chemically bonded system.
Further, Chan does not cure the deficiencies of teaching the formation of the ceramic system in the absence of a pH regulating agent.
Chan does not disclose that any loss of nicotine might occur when including a pH regulating agent during the formation of a solid, chemically bonded ceramic system.
In response to arguments A, B, C, E, F and G, regarding the addition of the pH regulating agent following developing the formulation, the maintained prior art rejections under 35 U.S.C. 103 teach this element. 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. 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 predominately located 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 D, Applicant is correct that Bredenberg teaches a delivery system that incorporates micro-needles to administer the active agent. However, one of ordinary skill in the art would be motivated to use the ceramic system, as Bredenberg teaches the ceramic system's durability to the corrosive effects 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 body fluids. Further, the systems disclosed in both Kindvall and Bredenberg allow for release of an active when making contact with skin (see abstract). The ceramic system of Bredenberg is for a drug delivery element that has a contact surface against the skin, which can broadly be interpreted as any surface to make contact with the skin and release an active agent (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.
Examiner thanks Applicant for the amendments and following arguments, but the rejections of claims 1-14 and 16-20 under 35 U.S.C. 103 are maintained.
Maintained Double Patenting
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) 1-7, 11-12, and 14-16, and 18 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 5, 6, 11, 12, 17, 18, and 36 of co-pending U.S. Application No. 18/852,888 (hereafter App’888) in view of Pilgaonkar (US 20210228488 A1).
Regarding claim 1-4 and 12 of instant invention, App’888 describes a composition comprising a chemically bonded ceramic system where nicotine is within the pores (see claim 1). Additionally, the ceramic system is present at about 40-98 wt.%, and is made up of calcium sulfate (see claim 1). App’888 describes that the composition further contains a pH regulating agent (see claim 12)
While App’888 does not teach a composition where the chemically bonded ceramic system is formed in the absence of the pH regulating agent, this is taught in Pilgaonkar (para. [0025]) as discussed above, for the benefit of controlling the release rate of the active agent (i.e. nicotine). As such, it would be obvious to one of ordinary skill in the art to add the pH regulating agent after preparing the ceramic system which contains the nicotine within the pores.
Regarding claim 5 and 6 of instant invention, App’888 describes that the formulation contains a salt of nicotine, where the salt is a nicotine bitartrate salt (see claim 5).
Regarding claim 7 of instant invention, App’888 teaches that the pH regulating agent is a carbonate (see claim 36).
Regarding claim 11 and 14 of instant invention, App’888 teaches that the composition gives a pH of at least 8 upon contact with saliva (see claim 6), and further comprises propylene glycol (see claim 11).
Regarding claim 15 and 16 of instant invention, App’888 discloses that the formulation is suitable for use in a pouch for releasing nicotine (see claim 17), where the pouch is a permeable, sealed bag (see claim 18).
Regarding claim 18 of instant invention, App’888 teaches that the pouch contains the ceramic system that is made up of calcium sulfate (see claim 1 and 18).
While App’888 teaches all elements of instant claims 1-7, 11-12, 14-16, and 18, besides the ceramic system being formed in the absence of the pH regulating agent, this is taught in Pilgaonkar. It would have been obvious to one of ordinary skill in the art to incorporate the teachings of Pilgaonkar into the formulation of App’888 to arrive at the current invention. As discussed in detail above, Pilgaonkar teaches that to achieve extended-release, active agents can be coated in release controlling agents. The instant specification discloses that a pH regulating agent can serve to regulate the delivery of the nicotine (pg. 3, line 15). The skilled artisan would have been motivated to use the pH regulating agent taught in Chan as the release controlling agent as taught in Pilgaonkar, to regulate the delivery of nicotine. MPEP § 2143(I)(g).
The conflicting claims of instant invention and App’888 differ only marginally in scope from claims 1-7, 11-12, and 14-16 of the present invention. Pilgaonkar teaches a composition that compensates for the deficiency in the claims regarding the later addition of the pH regulating agent.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not yet been patented.
Response to Applicant’s Arguments
Applicant asserts the following:
Pilgaonkar makes no reference to forming a chemically bonded ceramic system in the absence of a pH regulating agent, and Pilgaonkar's disclosure relates to coating agents. Pilgaonkar fails to teach or suggest forming the ceramic system in the presence of nicotine and in the absence of the pH regulating agent.
There is no reason why a person of ordinary skill in the art would reasonably expect Pilgaonkar's teachings for a product that does not contain a ceramic system to suggest omitting a pH adjuster when forming a ceramic system.
Combining Pilgaonkar with Chan does not cure the deficiencies of U.S. Application No. 18/852,888. Chan does not disclose how to incorporate the buffer into the formulation, and as such does not teach forming a solid, porous ceramic system in the absence of the pH regulating agent. Chan further does not disclose that omitting the pH regulating agent would avoid loss of nicotine.
The combined assertions of Pilgaonkar and Chan do not cure the deficiencies of U.S. Application No. 18/852,888.
Regarding arguments A, B, C, and D, Applicant is correct in that Pilgaonkar has a disclosure relating to coating agents. However, instant specification defines that the pH adjusting agents can enhance the delivery or release of nicotine (pg. 3 line 15), therefore the pH adjusting agents act as release control agents. Pilgaonkar describes that the nicotine containing product can have a release controlling agent (i.e. pH adjusting agent as defined in instant specification) that coats the nicotine product. While Pilgaonkar does not specifically disclose a ceramic system that has the pH regulating agent on the outside, Pilgaonkar describes the benefits of coating or surrounding a nicotine containing product with a release control agent, such as a pH regulating agent. From Pilgaonkar, one of ordinary skill in the art would be motivated to incorporate the pH adjusting agent outside the ceramic system of App. 18/852,888, for the benefit of controlled release of the active agent.
Conclusion
The rejections of claims 1-14 and 16-20 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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/M.R.M./Examiner, Art Unit 1611
/KYLE A PURDY/Primary Examiner, Art Unit 1611
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