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 .
Specification
The disclosure is objected to because of the following informalities:
The following legal phraseology, “are means of”, is used—page 1, line 21
The following legal phraseology, “according to any preceding claim”, is used—page 2, lines 30-31
Topographical error, “8,5”, should read, “8.5”—page 5, line 6
Topographical error, “*Additives include sweetener, salt, humectant, binder”, should read, “*Additives include sweetener, salt, humectant, and/or binder”—page 28, line 4,
Appropriate correction is required.
Claim Objections
Claims 7 is objected to because of the following informalities:
Regarding claim 7; “…according to according to claim 6...”, should read, “.
Appropriate correction is required
Claim 13 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
Accordingly, the claim 13 has not been further treated on the merits.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 15 must be renumbered 14.
Appropriate correction is required.
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) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sievert ‘200 (Publication No. WO2022/224200A1).
Regarding claim 1, Sievert ‘200 teaches; a nicotine oral delivery composition comprising a source of nicotine and a proflavour compound (“Oral products…include a mixture of ingredients in the form of a composition…the compositions provided herein may include one or more active ingredients eg. ... nicotine…a filler, a binder component, a flavorant, etc….”—page 6, lines 9-14).
With regard to the limitation ‘the proflavour compound comprises a flavour component and a support component joined by an enzymatically cleavable bond, wherein the nicotine oral delivery composition is in solid form and wherein the enzymatically cleavable bond is not a glycosidic bond’, Sievert ‘200 teaches a nicotine oral delivery composition in a pastille-type product which, one of ordinary skill in the art would reasonably recognize as a solid form (“…products of the present disclosure may be provided in the form of a pastille-type product.”—page 6, lines 16-17). Sievert ‘200 also discloses that an ‘organic acid’ can be used as an additive in oral nicotine delivery compositions for a variety of reasons (“…it may be desirable to include organic acids in the composition…for purposes such as, but not limited to, providing desirable organoleptic properties, stability, as flavor components, and the like.”—page 18, lines 10-15). As shown by the applicant in Table 1, on pages 17-18 of the specification, carboxylic acids and alcohols can each take on the role of a flavour or support component as defined therein. In some embodiments, Sievert ‘200 teaches that the ‘organic acid’, when used as a flavorant, can be formed from a reaction of an alcohol and carboxylic acid (“…the alcohol forming the mono ester of the dicarboxylic acid is a lipophilic alcohol.”—Organic Acid, page 17, lines 7-12). In Sievert 200’s embodiment above, the alcohol and carboxylic acid take on the role of flavour and support components. The mono ester Sievert ‘200 teaches for use as an ‘organic acid’ flavorant, is an ester compound made from reactants of a basic esterification reaction. One of ordinary skill in the art would recognize that the resulting ester compound reasonably contains an ester bond, which is not a glycosidic bond. Additionally, one of ordinary skill in the art would reasonably recognize that the ester bond of Sievert ‘200’s mono ester ‘organic acid’, is an enzymatically cleavable bond. To one of ordinary skill in the art, the nicotine oral delivery composition, with the mono ester ‘organic acid’, as taught by Sievert ‘200 in the above embodiment, reasonably meets all of the limitations of claim 1.
Regarding claim 2, Sievert ‘200, as shown above, teaches all of the limitations of claim 1. It is noted that the limitation, ‘is cleaved by reaction with an enzyme present in saliva’, is merely intended use of the composition. The manner in which the composition is intended to be used is not germane to the issue of patentability of the composition itself. If the prior art structure is capable of being cleaved by an enzyme present in saliva it meets the claim. Sievert ‘200, does however, teach; the enzymatically cleavable bond is cleaved by reaction with an enzyme present in saliva, wherein the enzymatically cleavable bond is an ester bond, an amine bond or an anhydride bond. As shown above, the ‘organic acid’, as taught by Sievert ‘200, on page 17, lines 7-12, reasonably contains an ester bond that, upon contact and reaction with an enzyme in saliva, such as salivary carboxylesterase, will cleave. Additionally, since the invention of Sievert ‘200 is intended for oral usage, it will, with a reasonable expectation of success, come in contact with a user’s salivary enzymes. (“… saliva in the mouth of the user causes one or more of the components of the product e.g., flavoring agents and or nicotine, to pass into the mouth of the user.”—page 6, lines 25-33).
Regarding claim 3, Sievert ‘200, as shown above, teaches all of the limitations of claim 1. Sievert ‘200 further teaches; the proflavour compound is an ester compound, an amide compound, an anhydride compound or a combination thereof (as shown above, the mono ester ‘organic acid’, as taught by Sievert ‘200, on page 17, lines 7-12, is an ester compound).
Regarding claim 4, Sievert ‘200, as shown above, teaches all of the limitations of claim 3. Sievert ‘200 further teaches; the proflavour compound is an ester compound (as shown above, the mono ester ‘organic acid’, as taught by Sievert ‘200, on page 17, lines 7-12, is an ester compound).
Regarding claim 5, Sievert ‘200, as shown above, teaches all of the limitations of claim 4. Sievert ‘200 further teaches; the ester compound is one or more of a glycerol ester, a propylene glycol ester, a cholesterol ester, a choline ester, a glyceric acid ester (or glycerate), a carboxylic cholesterol ester, a lactic acid ester, a diglyceride and a triglyceride (“In some embodiments the alkyl carboxylic…include[s]… lactic acid…”—page 15, lines 14-15). One of ordinary skill in the art would reasonably recognize that using lactic acid as the carboxylic acid component for the formation of the mono ester ‘organic acid’, as taught by Sievert ‘200 on page 17, lines 7-12, and shown above, teaches a lactic acid ester.
Regarding claim 6, Sievert ‘200, as shown above, teaches all of the limitations of claim 4. Sievert ‘200 further teaches; the ester compound is formed by reaction of an alcohol and a carboxylic acid, wherein either the flavour component or the support component is derived from the alcohol and the other of the flavour component and the support component is derived from the carboxylic acid (as shown above, in the formation of the mono ester ‘organic acid’ as taught by Sievert ‘200, the alcohol and carboxylic acid take on the role of flavour and support components.)
Regarding claim 7, Sievert ‘200, as shown above, teaches all of the limitations of claim 6. Sievert ‘200 further teaches; wherein the flavour component is derived from the carboxylic acid and the support component is derived from the alcohol (as shown by the applicant in Table 1, on pages 17-18 of the specification, carboxylic acids and alcohols can each take on the role of a flavour or support component as defined therein.). In some embodiments, Sievert ‘200 teaches that the ‘organic acid’, when used as a flavorant, can be formed from a reaction of an alcohol and carboxylic acid (“…the alcohol forming the mono ester of the dicarboxylic acid is a lipophilic alcohol.”—Organic Acid, page 17, lines 7-12). One of ordinary skill in the art would reasonably recognize that in Sievert 200’s embodiment above, the alcohol and carboxylic acid take on the role of flavour and support components.
Regarding claim 8, Sievert ‘200, as shown above, teaches all of the limitations of claim 7. Sievert ‘200 further teaches; the carboxylic acid is selected from ascorbic acid, citric acid, malic acid, oxalic acid, lactic acid, butyric acid, caproic acid, caprylic acid and lauric acid, and/or wherein the alcohol is selected from glycerol, propylene glycol, cholesterol and/or choline (“In some embodiments the alkyl carboxylic…include[s]… lactic acid…”—page 15, lines 14-15).
Regarding claim 9, Sievert ‘200, as shown above, teaches all of the limitations of claim 6. Sievert ‘200 further teaches; the flavour component is derived from the alcohol and the support component is derived from the carboxylic acid(as shown by the applicant in Table 1, on pages 17-18 of the specification, carboxylic acids and alcohols can each take on the role of a flavour or support component as defined therein.). In some embodiments, Sievert ‘200 teaches that the ‘organic acid’, when used as a flavorant, can be formed from a reaction of an alcohol and carboxylic acid (“…the alcohol forming the mono ester of the dicarboxylic acid is a lipophilic alcohol.”—Organic Acid, page 17, lines 7-12). One of ordinary skill in the art would reasonably recognize that in Sievert 200’s embodiment above, the alcohol and carboxylic acid take on the role of flavour and support components.
Regarding claim 10, Sievert ‘200, as shown above, teaches all of the limitations of claim 9. Sievert ‘200 further teaches; the alcohol is selected from citronellol, geraniol, farnesol, phenylhexanol, borneol, polysantol, (Z)-3-hexenol, phenethylol, dimethyl benzyl carbinol and menthol, a-ionol, 0- ionol or 3-hydroxy-p-ionol and/or wherein the carboxylic acid is selected from glyceric acid, carboxylic cholesterol and lactic acid (“Examples of suitable lipophilic alcohols include, but are not limited to…menthol…”—page 17, lines 7-12).
Regarding claim 11, Sievert ‘200, as shown above, teaches all of the limitations of claim 1. Sievert ‘200 further teaches; the source of nicotine is selected from the group consisting of nicotine salt, free-base nicotine, stabilised nicotine or a combination thereof (“…the nicotine component is selected from the group consisting of nicotine free base, nicotine as an ion pair, and a nicotine salt.”—page 20, lines 35-37).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Svandal ‘779 (U.S. Patent Application Publication, No. 20130251779) in view of Sievert ‘200 (Publication No. WO2022/224200A1).
Regarding claim 12, Svandal ‘779 teaches; a nicotine oral delivery product comprising a pouch and a nicotine oral delivery composition, wherein the pouch is water-insoluble and is permeable for saliva and wherein the nicotine oral delivery composition is contained within the pouch (“The powder is filled into pouches and is maintained in the pouch by a sealing. An ideal pouch shall have the following characteristics; it shall be…insoluble in water…, provide a semi-permeable membrane layer which prevent the powder from leaving the bag but permit saliva…to freely pass through said pouch.”—paragraph [0052]).
Svandal ‘779, does not teach that the nicotine oral delivery composition is the composition according to claim 1.
Sievert ‘200 however, does teach the nicotine oral delivery composition of claim 1; comprising a source of nicotine and a proflavour compound (“Oral products…include a mixture of ingredients in the form of a composition…the compositions provided herein may include one or more active ingredients eg. ... nicotine…a filler, a binder component, a flavorant, etc….”—page 6, lines 9-14).
With regard to the limitation ‘the proflavour compound comprises a flavour component and a support component joined by an enzymatically cleavable bond, wherein the nicotine oral delivery composition is in solid form and wherein the enzymatically cleavable bond is not a glycosidic bond’, Sievert ‘200 teaches a nicotine oral delivery composition in a pastille-type product which, one of ordinary skill in the art would reasonably recognize as a solid form (“…products of the present disclosure may be provided in the form of a pastille-type product.”—page 6, lines 16-17). Sievert ‘200 also discloses that an ‘organic acid’ can be used as an additive in oral nicotine delivery compositions for a variety of reasons (“…it may be desirable to include organic acids in the composition…for purposes such as, but not limited to, providing desirable organoleptic properties, stability, as flavor components, and the like.”—page 18, lines 10-15). As shown by the applicant in Table 1, on pages 17-18 of the specification, carboxylic acids and alcohols can each take on the role of a flavour or support component as defined therein. In some embodiments, Sievert ‘200 teaches that the ‘organic acid’, when used as a flavorant, can be formed from a reaction of an alcohol and carboxylic acid (“…the alcohol forming the mono ester of the dicarboxylic acid is a lipophilic alcohol.”—Organic Acid, page 17, lines 7-12). In Sievert 200’s embodiment above, the alcohol and carboxylic acid take on the role of flavour and support components. The mono ester Sievert ‘200 teaches for use as an ‘organic acid’ flavorant, is an ester compound made from reactants of a basic esterification reaction. One of ordinary skill in the art would recognize that the resulting ester compound reasonably contains an ester bond, which is not a glycosidic bond. Additionally, one of ordinary skill in the art would reasonably recognize that the ester bond of Sievert ‘200’s mono ester ‘organic acid’, is an enzymatically cleavable bond. To one of ordinary skill in the art, the nicotine oral delivery composition, with the mono ester ‘organic acid’, as taught by Sievert ‘200 in the above embodiment, reasonably meets all of the limitations of claim 1.
Svandal ‘779 and Sievert ‘200 are considered to be analogous to the claimed invention because they are in the same field of oral nicotine delivery. It would therefore be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the powder of the nicotine oral delivery product, as taught by Svandal ‘779, with the nicotine oral delivery composition according to claim 1, as taught by Sievert ‘200, for the explicit motivation Svandal ‘779 teaches; to prevent the oral nicotine product from fully dissolving in water.
Regarding claim 14, Svandal ‘779 and Sievert ‘200, as shown above, teach all of the limitations of claim 12.
Svandal ‘779 further teaches; a method for oral delivery of nicotine, the method comprising placing the nicotine oral delivery product into a user's mouth (“The pouch is placed in the oral cavity of the user.”—paragraph [0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A CEFARATTI whose telephone number is (571)270-0482. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/JOSEPH ARTHUR CEFARATTI/Examiner, Art Unit 1749
/KATELYN W SMITH/Supervisory Patent Examiner, Art Unit 1749
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