DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on October 15, 2025, is acknowledged. Applicant has argued that the method of Group II (process of making claims) invoke (depend from) the product of claim 1. Applicant’s arguments have been fully considered however they are not persuasive of error over the grounds of record, including that the composition may be made by a materially different process than the process of Group II (i.e. by a process not comprising a gelling step). The restriction requirement is still deemed proper and therefore made FINAL.
Claims 1-20 are pending of which claims 1820 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Pending claims 1-17 have been examined on the merits.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
I. Claim 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,155,772.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant ‘561 Application’s and the ‘772 patent’s claims are drawn to oral compositions (in ‘772 at claim 1: a “soft, chewable and orally dissolvable and/or disintegrable product”, and instantly the oral composition as claimed being further disclosed, based on the shared specification, as inclusive of so functioning), and each reciting “comprising” the specifically enumerated components (and embracing of the disclosed broad genus of materials thereunder). Also, whereby ‘772 recites the following (at claim 1):
“a carrageenan and fructose (carrageenan/fructose) based matrix comprising enzyme-treated tobacco powder distributed throughout the carrageenan/fructose based matrix, the carrageenan being present in an amount of about 1 wt % to about 35 wt % of product, the fructose being present in an amount of about 2 wt % to about 60 wt % of the product and the enzyme-treated tobacco powder being present in an amount of about 30 wt % to about 75 wt % of the product and flavor beads uniformly distributed throughout the carrageenan/fructose based matrix; wherein said product has a density of less than 2.0 g/cm.sup.3 and a water activity of about 0.70 aw to about 0.30 aw.”
‘772 is not distinguished patentably over ’561 as the latter recites each composition (at least optionally) comprising carrageenan (‘561, at claims 3, 13); fructose (Id., at claims 1,6 (sugar), 12 (fructose); tobacco powder (Id., at claim 5, and identification of enzyme treated tobacco powders within the genus of tobacco powder at paragraphs [0034-0043]); see ‘772 at col 6 lines 24-55 and examples for enzymes within the genus of enzymes claimed therein); amounts of 1-35% (w/w), 2-60% (w/w), and 30-75%(w/w) (‘561, at claims 1,4); flavor beads ((Id., at claims 14-17); density < 2.0 g/cm3 (Id., at claim 8); and 0.70-0.30 water activity (aw) or 0.6 (Id., at claims 10, 11; see ‘772 at claims 1,7). Although ‘772 does not expressly claim the process steps making the product, the product (composition) is not limited by the steps but by the materials and transformations imparted thereby, which appear to be at least obvious (and not patentably distinguished) based upon the shared material and features mutually claimed and by the shared disclosures disclosing the method steps of ‘772 (claim 1) as steps for forming a product including the instant ‘791 product claimed.
Regarding instant claims 7-8, the claims are not patentably distinguished over ‘772 which recites (at claims 3-5, respectively) the “powder has at least one linear dimension of less than 50 mesh”, “wherein the product is up to about 1 inch in height, up to about 1 inch in width, and up to about 1 inch in length and wherein the product has a density of less than 0.9 g/cm3”, and “wherein the product ranges in size from about 0.1 inch to about 0.5 inch in height, about 0.5 inch to about 1.0 inch in width and about 0.25 to about 0.5 inch in length”. Also, regarding instant claim 9, the claims are not distinguished over ‘772 which similarly recites (at claim 6) “(a) at least one vitamin, (b) at least one mineral, (c) at least one nutraceutical, (d) at least one amino acid, (e) at least one energizing agent, (f) at least one soothing agent, (g) at least one sweetener, (h) at least one coloring agent, (i) at least one chemesthesis agent, (j) at least one antioxidant, (k) at least one food-grade emulsifier, (l) at least one pH modifier and (m) mixtures thereof”. Additionally, the instant claims and conflicting patent mutually claim a hard, polymeric coating and a rough surface thereof (instant claims 14.15; ‘772 at claims 11-13); flavor beads are present in an amount of about 1 wt % to about 5 wt % based on the weight of the product (instant claims 17; ‘772 at claims 9,10). The additional limitations claimed, including among the dependent claims, depend from the rejected claims(s) and are disclosed in each as mere alternatives or conditions suitable to provide the oral composition/pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product within the genus claimed and are therefore also considered obvious variants and not patentably distinguished, remaining within the “comprising” claim language as claimed.
II. Claim 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,245,227.
The conflicting ‘227 patent is rejected as being not patentably distinguished over the instantly claimed invention as the claims in each are directed to the process of making or the product-by-process thereof of a “a pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product”, each (‘227 at claim 1; ‘561 at claims 1) reciting the steps of: “dissolving a biopolymer and a sugar in water to form a solution; adding an amount of a botanical powder to the solution; stirring the solution to form a suspension; gelling the suspension to form a gel; drying the gel to form a dried gel; and portioning the dried gel to form a pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product, wherein the amount of the [botanical powder/enzyme-treated tobacco powder] is distributed in a biopolymer-sugar based matrix.”; and further the dependent claims of the instant ‘561 application at claims 2, 3, 6-13, and 15-18 recite limitations which are patentably indistinguishing from and at least obvious over the shared limitations of ‘227 corresponding respectively to ‘227 at claims 5, 3, 6-13,and 15-18, such that practicing at least one of the instant or conflicting patent claimed invention would have at least been obvious to one in the art practicing the inventions at claimed.
The additional limitations claimed, including among the dependent claims depend from the rejected claims(s) and are disclosed in each as mere alternatives or conditions suitable to provide the pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product within the genus claimed and are therefore also considered obvious variants and not patentably distinguished, remaining within the “comprising” claim language as claimed.
III. Claim 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,712,415.
The conflicting ‘415 patent is rejected as being not patentably distinguished over the instantly claimed invention as the claims in each are directed to the process of making or the product-by-process thereof of an oral composition or a pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product, each (at claim 1), ‘415 reciting the steps of: “dissolving a biopolymer and a sugar in water to form a solution; adding an amount of a botanical powder to the solution; stirring the solution to form a suspension; gelling the suspension to form a gel; drying the gel to form a dried gel; and portioning the dried gel to form a pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product, wherein the amount of the [botanical powder/enzyme-treated tobacco powder] is distributed in a biopolymer-sugar based matrix.”; and further the dependent claims of the instant ‘561 application at claims 2, 3, 6-13, and 15-18 recite limitations which are patentably indistinguishing from and at least obvious over the shared limitations of ‘415 corresponding respectively to ‘415 at claims 5, 3, 6-13,and 15-18, such that practicing at least one of the instant or conflicting patent claimed invention would have at least been obvious to one in the art practicing the inventions at claimed.
The additional limitations claimed, including among the dependent claims depend from the rejected claims(s) and are disclosed in each as mere alternatives or conditions suitable to provide the pre-portioned, soft, chewable and orally-dissolvable and/or -disintegrable product within the genus claimed and are therefore also considered obvious variants and not patentably distinguished, remaining within the “comprising” claim language as claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655