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 .
Detailed Action
Filing Receipt and Priority
The filing receipt mailed 12/04/2023 states that the instant application is a 371 of PCT/US2021/059140, filed 11/12/2021, which claims benefit of provisional application 63/147,453, filed 02/09/2021. The provisional application supports the instant claims. Therefore, the effective filing date is 02/09/2021.
Information Disclosure Statement
The information disclosure statement received 04/29/2026 has been considered.
Rejections
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1, 3-8, 10-13 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ridall (US 10,064,849, published 2018) in view of Docherty (WO201920396) and Pedersen (US2012/0039981).
Independent claim 1 states “A lyophilized rapidly infusing composition, comprising: a pharmaceutically acceptable binder and/or excipient system comprising gelatin and mannitol, and nicotine, wherein the nicotine is present in an amount of 0.2 to 25wt.% based on a total dry weight of the lyophilized rapidly infusing composition.”
Dependent claims 3-4 specify that the composition has the property of specific disintegration times which are 1 to 30 seconds (claim 3) or 1-5 seconds (claim 4) in deionized water maintained at 37o C ± 2oC.
Dependent claims 5 and 8 specify concentrations of the gelatin, mannitol, and nicotine within the composition.
Dependent claims 6-7 specify that the gelatin is bovine gelatin.
Dependent claims 10-13 specify forms of the nicotine which are a nicotine salt or a nicotine complex (claim 11), a nicotine exchange resin complex (claim 12), and nicotine polacrilex (claim 13). Note that claims 10-13 successively dependent on each other. Claim 10 is dependent on claim 1.
Dependent claim 16 includes additional ingredients including sweetener, flavorant, and colorant.
Dependent claim 17 specifies a flavorant which comprises a mixture of orange and peppermint flavoring.
Dependent claim 18 specifies a mixture of sweeteners which comprise sucralose and acesulfame-K.
Regarding claims 1 and 5-8, Ridall in col. 12, Table 1 teaches a composition comprising bovine gelatin, mannitol, and mint flavoring. Concentrations of these ingredients are found in col. 13, table 2, shown below. Ridall in col. 9 teaches lyophilization of a pre-formulation composition to form the composition above.
Ridall, Table 2
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202
344
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Regarding claims 3-4, Ridall in col. 17-18, tables 11-12 teaches disintegration times. The shortest disintegration time is 4 seconds.
Ridall in col. 12, l. 61 contemplates the addition of sweeteners and flavorants.
Ridall in col. 3, l. 10-19 states “Disclosed herein are pharmaceutical compositions and methods for treating animals, for example humans, equines, bovines, canines, felines, ovines, and porcines. Various embodiments comprise administering an active pharmaceutical ingredient, also known as a therapeutic agent, into the bloodstream of the animal by introducing it transdermally across the animals non-keratinous fibers, e.g. the oral cavity,…lingual mucosa, palatal mucosa, pharyngeal mucosa, sublingual mucosa, and/or non-gastric mucosa. In various embodiments, a majority of the formulation may be absorbed prior to reaching the gastric mucosa. In certain embodiments, the formulation may be adapted…to dissolve in a relatively short period of time, e.g. 90 seconds or less.”
Ridall does not explicitly discuss nicotine, sucralose with acesulfame potassium, flavoring agents including orange and peppermint, or coloring. This is addressed by the combination of Pedersen.
Regarding claims 1, 10-13, and 16-18, Pedersen contemplates compositions comprising nicotine polacrilex (p. 21, para. [0245]-[0246]), gelatin (para. [0072]) as a polymer used as a modifying agent, mannitol (para. [0100]) as a polyhydric alcohol additive, sucralose and acesulfame potassium (para. [0100]) as sweetening additives, orange and peppermint flavoring (para. [0100]) as flavoring additives, and coloring agents (para. [0138]) as an ingredient within an outer shell.
Regarding the concentration of nicotine in claim 1, Ridall teaches concentrations of omeprazole which could be modified to instead be nicotine polacrilex in similar concentrations. Additionally, Docherty on p. 34, table 2 teaches a composition comprising nicotine in an amount of 2264.9 mg (total weight of composition is approximately 989.4 g). This amount of nicotine amounts to be 0.2 wt%. The composition of Docherty is, similarly, a dehydrated (lyophilized) composition which Docherty, in para. [00124] states “generally achieved faster absorption, higher peak absorption and higher overall quantities of nicotine, on average, in the blood than the concentration-matched control formulations…”. This teaching indicates that a composition can comprise as little as 0.2% by wt% nicotine and still achieve successful administration. One of ordinary skill would find it obvious to modify the composition of Ridall to achieve a composition comprising nicotine in a 0.1 to 25 wt%.
Both Ridall and Pedersen are drawn to compositions designed to orally administer a compound. In the case of Ridall, the compound is omeprazole where Pedersen can administer nicotine. Docherty teaches a composition comprising nicotine within the claimed concentration range. One of ordinary skill in the art would find it obvious to modify the composition of Ridall to include nicotine polacrilex in the range of 0.1 wt% to 25 wt%, sucralose and acesulfame potassium, orange and peppermint flavoring, and coloring as discussed in Pedersen. Critically, the composition of Ridall is designed to administer a compound rapidly.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have modified the composition of Ridall to include nicotine polacrilex in the amount of Docherty in place of omeprazole and also to include the additional ingredients of Pedersen to arrive at the claims with a reasonably assumption of success. One of ordinary skill in the art would find motivation to make the modifications as the composition of Ridall can be used to rapidly deliver nicotine polacrilex.
The addition of Docherty has been necessitated by amendments made to the claims.
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.
Patents
U.S. Patent 10,918,631
Claims 1-13 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,918,631 in view of Pedersen (US2012/0039981).
The reference claims are drawn to a method of making a pharmaceutical composition comprising bovine gelatin, mannitol, a surfactant, a flavorant and an active pharmaceutical ingredient in ranges of dry mass concentrations that read on the instant claims.
Via the teachings of Pedersen, one of ordinary skill in the art would be able to modify the reference method in order to create a composition comprising bovine gelatin, mannitol, flavorants, sweeteners, colorant, and nicotine polacrilex.
U.S. Patent 10,064,849
Claims 1-13 and 16-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,064,849 in view of Pedersen (US2012/0039981).
The reference claims are drawn to a composition comprising bovine gelatin, mannitol, a flavorant, and a proton pump inhibitor in concentrations of dry mass %.
For similar reasoning as discussed in the 103 rejection above, one of ordinary skill in the art would be able to modify the reference method in order to create a composition comprising bovine gelatin, mannitol, flavorants, sweeteners, colorant, and nicotine polacrilex.
U.S. Patent 12,005,053
Claims 1-13 and 16-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,005,053 in view of Pedersen (US2012/0039981).
Reference claims 1-9 are drawn to a veterinary composition comprising bovine gelatin, mannitol, surfactant, and a proton pump inhibitor in concentrations of dry mass % that read on the instant claims. Reference dependent claims 5 and 6 claim disintegration times of 7 seconds or less and 4 seconds or less.
Reference claims 10-19 are drawn to a method of manufacturing the composition of claims 1-9.
The arguments made in the 103 rejection above regarding the modification of the composition to include sweeteners, flavorants, colorants, and nicotine polacrilex. Similarly, the method claims can be modified to create a composition that would read on the instant claims, as discussed in the double patenting rejection under U.S. Patent 10,918,631.
U.S. Patent 12,496,295
Claims 1-13 and 16-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, and 12 of U.S. Patent No. 12,496,295 (formerly application 18/654,308) in view of Pedersen (US2012/0039981).
The reference claims are drawn to a pre-formulation comprising bovine gelatin in about 1 to 10% mass%, mannitol in about 1 to 10% mass%, a flavorant in about 0.0 to 0.2 mass% and a proton pump inhibitor in about 10 to 30 mass%.
Via the teachings of Pedersen and for similar reasoning used the 103 rejection above, one of ordinary skill in the art could modify the pre-formulation to arrive at the instant claims with a reasonable assumption of success.
Co-pending applications
18/307,228
Claims 1-13 and 16-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 and 31-32 of copending Application No. 18/307,228 in view of Pedersen (US2012/0039981).
The reference claims are drawn to a buccal composition comprising gelatin and a sugar alcohol. Reference claim 22 further claims a flavorant.
Considering the teachings of Pedersen, which teach nicotine polacrilex, sweeteners, and colorants as additional ingredients, one of ordinary skill in the art would find it obvious to modify the composition of the reference claims to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,681
Claims 1-13 and 16-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18,252,681 in view of Pedersen (US2012/0039981).
The reference claims 1-18 are drawn to a rapidly infused composition comprising a pharmaceutically acceptable binder and/or excipient system comprising gelatin and mannitol, and vitamins D, A, E, K, B, C, and/or caffeine.
Reference claim 27 is drawn to a process for manufacturing the composition of claims 1-26.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-18 via the teachings of Pedersen to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 27 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,735
Claims 1-13 and 16-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/252,735 in view of Pedersen (US2012/0039981).
Reference claims 1-14 are drawn to a composition comprising gelatin, a sugar alcohol, and methotrexate. Reference claims 3-4 specify disintegration time. Reference claim 7 specifies bovine gelatin. Reference claim 9 specifies mannitol. Reference claim 15 is drawn to a process for manufacturing the composition of reference claims 1-14.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-15 via the teachings of Pedersen to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 15 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,676
Claims 1-13 and 16-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/252,676 in view of Pedersen (US2012/0039981).
Reference claims 1-25 are drawn to compositions comprising gelatin, mannitol, and a PDE.sub.5 inhibitor. Claim 26 is drawn to a process of manufacturing comprising lyophilizing a solution to achieve the composition of claims 1-25.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-25 via the teachings Pedersen to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 26 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
18/252,707
Claims 1-13 and 16-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/252,676 in view of Pedersen (US2012/0039981).
The reference claims are drawn to a composition comprising a gelatin, a sugar alcohol, and tetrahydrocannabinol (THC), and further comprising a flavorant. The reference claims also claim a process of manufacturing comprising lyophilizing a mixture of the above ingredients.
One of ordinary skill in the art would find it obvious to modify the composition of reference claims 1-20 via the teachings of Pedersen to arrive at the instant claims. One of ordinary skill would also find it obvious to modify the method of reference claim 21 to create a lyophilized composition (instant claim 2) of the instant claims.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Regarding the 103 rejection, applicant writes that “Ridall1 further emphasizes that its formulations are specifically designed to maximize the proportion of active pharmaceutical ingredient and minimize inactive materials. Another disadvantage of many oral and injectable formulations is that those formulations require administering a relatively high mass percentage (‘mass %’) of inactive material to the animal. For example, many oral and injectable formulations comprise significant amounts of carriers and/or excipients that provide no direct benefit to the animal. Many care providers generally agree that animals should not consume unnecessary pharmaceutical substances. Accordingly, it would be advantageous to minimize the amount of non-therapeutic materials administered…”.
Applicant then adds “Claim 1 recites ‘wherein the nicotine is present in an amount of 0.1 to 25 wt.% based on a total dry weight of the lyophilized rapidly infusing composition.’ Thus, the claimed subject matter employs a formulation architecture in which the active ingredient does not compose the majority of the composition, which is directly contrary to Ridall1’s express teaching that inactive materials should be minimized and that the active ingredient should constitute the majority of the formulation. A person of ordinary skill in the art therefore would not have been motivated to modify Ridall1’s compositions in the manner alleged by the Office Action without fundamentally departing from the principles taught by Ridall1.”
The citation to Ridall regarding the disadvantages of compositions comprising majority non-therapeutic ingredients does not sufficiently teach away from motivating one of ordinary skill in the art to modify a composition to comprise the claimed concentration range. Ridall’s teachings amount to a preferred embodiment which does not show that minimal concentrations lose efficacy. As shown by Docherty, a composition can still retain efficacy with relatively small concentrations of nicotine.
Regarding the non-statutory double patenting rejections, applicant argues that “the terminal disclaimer was filed in error because it includes reference patents that are not commonly owned with the present application and are not subject to an obligation of assignment.”
The MPEP 804 states:
Some commonality of inventorship or (deemed) ownership must exist between two or more patents or applications before consideration can be given to the issue of double patenting. For example, the patents or applications may have the same inventive entity. The patents or applications may also have at least one common (joint) inventor, which covers the situations where at least one patent or application names a sole inventor and the other patent(s) or application(s) names joint inventors and where all the patents or applications name joint inventors. For example, if one application names inventor A and the second application names joint inventors A and B, then the applications have one common (joint) inventor. As another example, if one application names joint inventors A and B and a second application names joint inventors A, B, and C, then the applications have two common joint inventors, and thus, have at least one common joint inventor. See 35 U.S.C. 100(f) for definition of “inventor” and 35 U.S.C. 100(g) for definition of “joint inventor”. Alternatively, the patents or applications may have a common applicant, and/or be commonly assigned/owned or non-commonly assigned/owned but subject to a joint research agreement as set forth in 35 U.S.C. 102(c) or in pre-AIA 35 U.S.C. 103(c)(2) and (3).
The reference applications and/or patents at least share an inventor with the instant application.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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