DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 2-21 are pending.
Claims 4, 5, 12 and 17 are withdrawn.
Election/Restrictions
Claims 4, 5, 12 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/12/2026.
Applicant's election with traverse of Species 1A and 2A in the reply filed on 3/12/2026 is acknowledged.
The traversal is on the ground(s) that the Office has failed to establish that the alleged species as claimed are either independent or distinct from each other, and the species do no not recite mutually exclusive characteristics of the species.
The Applicant argues Applicant respectfully submits that such a non-limiting example embodiment falls within each of the four alleged species of Species 1A, 1B, 1C, and 1D as asserted by the Office. Tricarboxylate includes ester linkages bonding each of the flavorant F' or F" to the polymeric backbone R. Therefore, tricarboxylate falls within alleged Species 1A. Tricarboxylate also includes three ester linkages. Therefore, tricarboxylate falls within Species 1B as including a tri-ester linkage. The chemical formula of tricarboxylate is CH(CO2-)3. Therefore, tricarboxylate falls within alleged Species 1 C. As stated above, tricarboxylate forms an ester linkage. Therefore, tricarboxylate falls within alleged Species 1D.
The Applicant further argues that at least paragraph [0030] of the specification as filed discloses that monomers containing two or more different types of flavorants with same or different concentrations can be utilized to prepare a copolymer containing multiple types of flavorants. Therefore, the specification as filed discloses embodiments including both a (meth)acrylate repeating unit of alleged Species 2A and an itaconate repeating unit of alleged Species 2B. Because the claims recite elements that are all encompassed by a single species, the alleged species overlap in scope. Thus, the Office has failed to establish that such alleged species are mutually exclusive. As a consequence, the Office has failed to establish that the alleged species are independent or distinct.
This is not found persuasive because tricarboxylate is not a claimed limitation. The Species 1 claims are directed to non-carbonate linking groups, not organic compounds. With regard to Species 2, paragraph [0030] of the specification fails to teach that the flavorant-containing repeating unit includes both a (meth)acrylate repeating unit AND an itaconate repeating unit in one embodiment.
The requirement is still deemed proper and is therefore made FINAL.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 2, 3, 8, 10, 11, 13-16, 18 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Eilerman (US 5147463) in view of Plochocka (US 20040253188).
Regarding claims 2, 3, 8, 10 and 13-16, Eilerman teaches delayed release flavorants, that release flavor upon heating or wetting, and may be used in tobacco compositions or tobacco substitutes, and chewing gums (abstract and col. 1, lines 25-30). Eilerman states that “tobacco” and “tobacco substitutes” includes non-smokable forms such as snuff and chewable compositions (col. 4, lines 41-45).
Although Eilerman discloses the use of these compounds to delay the release of flavorant, Eilerman does not disclose a copolymer including a flavorant-containing repeating unit and a salt-containing repeating unit, the flavorant-containing repeating unit including a flavorant linked with a non-carbonate linking group.
Plochocka et al. discloses flavorants comprising a copolymer for use in oral mediums that comprises menthyl itaconate and acrylic acid, ester, or amino [0046]. The copolymer is then further reacted with a base NaOH [0051]. Although Plochocka does not expressly disclose the salt of acrylic acid, the reaction between the acrylic acid and NaOH would inherently yield Na acrylate and the resulting copolymer would be a copolymer comprising a flavorant-containing repeating unit and a salt-containing repeating unit. The composition promotes flavorants specifically for oral administration. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the copolymer of Plochocka in place of the compound of Eilerman because it would have been obvious to substitute one known controlled release flavor compound with another known controlled release flavor compounds. Although the references are in different arts, they concern the same problem, namely controlled release of flavor. The combination would have been within the abilities of one of ordinary skill in the art at the time of invention and the results would have been predictable (i.e. controlled release of menthol).
Regarding claim 11, modified Eilerman teaches that the flavorant-containing repeating unit can include a (meth)acrylate repeating unit (Plochocka,[0034]).
Regarding claims 18 and 20, the first flavorant and the second flavorant are interpreted to be the same flavor, and since modified Eilerman teaches flavorant containing repeating units, modified Eilerman meets these limitations.
Claims 6, 7, 9 and 21 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Eilerman in view of Plochocka as applied to claim 2 above, and further in view of Yolles (US 4206301).
Regarding claim 6 and 21, modified Eilerman does not expressly teach that the copolymer is in the form of a powder.
Yolles teaches sustained flavor release compositions are disclosed which comprise polymer backbones (abstract). Yolles teaches that the composition is in powder form which is added to a chewing gum in an amount of 6-10% to provide the slow release of the flavorant (col. 8, lines 19-22). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the teachings of the copolymer of Yolles to the compound of modified Eilerman because both are directed to controlled release flavor compounds. Although the references are in different arts, they concern the same problem, namely controlled release of flavor. The combination would have been within the abilities of one of ordinary skill in the art at the time of invention and the results would have been predictable (i.e. controlled release of menthol).
Regarding claim 7, modified Eilerman teaches that the composition is incorporated into the product (Yolles, col. 8, lines 18-22). Since the composition is incorporated into the product, the composition will coat all of the components of the product, including the tobacco or tobacco substitute.
Regarding claim 9, modified Eilerman teaches that the polymer has a number average molecular weight (Mn) between about 2,000 and 20,000 (Yolles, col. 2, lines 47-53).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not teach or make obvious the claimed polymer structure, specifically where the flavorant-containing repeating unit of the polymer includes a flavorant linked to a backbone of the polymer with a non-carbonate linking group, the flavorant including a first flavorant and a second flavorant, wherein the first flavorant and the second flavorant are different, and wherein the first flavorant and the second flavorant are bound to the polymeric backbone through the non-carbonate linking group.
The closest prior art of record is Plochocka (US 20040253188). Plochocka discloses flavorants comprising a copolymer for use in oral mediums wherein the copolymer comprises a flavorant- containing repeating unit and a salt-containing repeating unit. Plochocka, however, does not teach that the flavorant-containing repeating unit of the polymer includes a flavorant linked to a backbone of the polymer with a non-carbonate linking group, the flavorant including a first flavorant and a second flavorant, wherein the first flavorant and the second flavorant are different, and wherein the first flavorant and the second flavorant are bound to the polymeric backbone through the non-carbonate linking group.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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