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 statements received 05/11/2023 and 11/18/2025 have been considered.
Restriction/Species Election
Applicant’s election of Group I with traverse in the remarks received 11/20/2025 are acknowledged. Applications election with traverse of the following species is also acknowledged.
The elected species are i) a nicotine complex, ii) a mixture of sucralose and acesulfame-K (acesulfame potassium, aces-K), iii) a mixture of orange flavor and peppermint flavor, iv) inclusion of a colorant.
In applicant’s traverse, applicant argues that “the claims as drafted are directed to a single general inventive concept of a rapidly infusing composition and are therefore properly examinable together.” The restriction requirement of 10/08/2025 on p. 7 states “Should applicant traverse on the ground that the inventions have unity of invention…applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case.”
Applicant has not provided evidence that would indicate that the inventions are obvious variants of each other and has not provided evidence that would indicate that the Chen (US2007/0298090) reference does not embrace the instant claims.
Regarding the species election, applicant argues that “a search for any one of the elected species in each of the species groups would yield references applicable to all of the species in each of the respective species groups.” This is not persuasive, at least for sweeteners, which have different structures and properties. For example, the structure of the elected species sucralose is considerably different from that of another commercially available sweetener aspartame.
Sucralose and aspartame
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Art applicable to sucralose would not be applicable to aspartame and vice versa. Therefore, the arguments are not persuasive. The restriction is made final.
Claim 14 states “wherein the nicotine has a purity between 95 and 100% by weight on a basis of nicotine free base.”
Claim 15 states “The rapidly infusing composition of claim 1, which is formulated with a solid form of nicotine.”
As applicant has elected “nicotine complex”, claims 14 and 15 are hereby withdrawn being drawn to a non-elected species.
Claims 14-15 and 19-34 are hereby withdrawn from consideration being drawn to a non-elected invention.
At examiner’s discretion, search and examination has been broadened to include “nicotine polacrilex”.
Specification
The use of the terms “RITe” , which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Objection
Claims 1-13, and 16-18 are objected to for the following informality:
Claim 1 recites “A rapidly infused composition”. Claims 2-18 state “the rapidly infusing composition”
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) 1-13 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 Pedersen (US2012/0039981).
Independent claim 1 states “A rapidly infused composition, comprising: a pharmaceutically acceptable binder and/or excipient system comprising gelatin and mannitol, and nicotine.”
Dependent claim 2 specifies that the composition is lyophilized.
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, 8, and 9 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, Table 2
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Regarding claim 2, Ridall in col. 9 teaches lyophilization of a pre-formulation composition to form the composition above.
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 claim 9, Ridall teaches concentrations of omeprazole. As omeprazole is the active ingredient in Ridall, one of ordinary skill in the art could modify the composition to include nicotine polacrilex in similar concentrations.
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. Where these two compositions differ, one of ordinary skill in the art would find it obvious to modify the composition of Ridall to include nicotine polacrilex, 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 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.
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.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624