DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 02/27/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 01/20/2026 (Response After Final Action), is acknowledged.
Applicant has previously elected with traverse the invention of Group I, claims 1-13, drawn to compositions comprising a thermoplastic polymer, a plasticizer, a flavoring agent, and an active ingredient.
Claims 1-5, 7-9, 13-20 are pending in this action. Claims 6, 10-12 have been cancelled previously. Claims 1, 3, 13 have been amended. Claims 14-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1-5, 7-9, 13 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application is a continuation of PCT/IB2020/061616, filed December 8, 2020, and also is a continuation-in-part of U.S. Application No. 16/707,580, filed December 9, 2019.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 comprises the typographic error “amount of about 40% by weight to” that needs to be corrected to “amount of from about 40% by weight to”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-9, 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Newly amended claim 1 discloses a composition comprising “40-75 wt% of a particulate filler comprising non-tobacco plant material or derivatives thereof in an amount” and ”5-15 wt% of a plasticizer” that can be xylitol, mannitol. As stated previously, the instant specification teaches that “a particulate filler may include mannitol, xylitol” (Para. 0107). Therefore, it is unclear if a particulate filler may also include xylitol, mannitol, or said compounds should be excluded from the recited composition of a particulate filler (i.e., comprising). Therefore, the structure of recited constituents to be included into the claimed product/composition is not clearly delineated. Similar is applied to claim 7. Clarification is required.
As stated previously, claim 1 recites the limitation “at least one thermoplastic polymer comprising at least one cellulose ether” that is unclear. Does this limitation disclose a polymer/compound as a mixture of components/compounds (i.e., comprising), or as a block copolymer comprising at least one cellulose ether block? Similar is applied to claim 2 and to claim 9 regarding the limitation “active ingredient comprises”. Clarification is required.
Claim 1 recites the term "about” that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 4, 8, 13. Clarification is required.
Claim 8 (dependent on claim 1) recites the limitation “at least one plasticizer is capable of lowering the softening temperature of the al least one thermoplastic polymer by about 20 oC or more” that is not reasonably clear. As stated previously, it is unclear under what conditions said property should be observed/estimated. To this point, it is noted that it is well known in the field that properties of multicomponent systems (i.e., compositions) depends on compounds included as well as on concentrations of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, the function/property of a particular compound may change and/or depend on conditions. Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. Clarification is required.
Claims 3, 5, 7 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-5, 7-9, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rajewski et al., US 2013/0005831 (cited in IDS; hereinafter referred to as Rajewski), in view of Gao et al., US 2014/0332013 (cited in IDS; hereinafter referred to as Gao), and Marshall et al., US 2015/0101627 (cited in IDS; hereinafter referred to as Marshall)
Rajewski teaches orally dissolving core-shell capsules and films comprising pullulan/thermoplastic polymer (Abstract). Rajewski teaches that the capsule shells may include (based on total capsule shell solids):
50-99 wt % of pullulan (i.e., thermoplastic polymer; Claims 1, 2; Para.0005. 0028 as applied to claims 1, 2, 5, 13);
less than 20 wt% of maltodextrin, guar gum, gum arabic, cellulose derivatives identified in the present application as thermoplastic polymers (Claims 13, 20; Para. 0010, 0032 as applied to claims 1-3, 5);
0.1-20 wt% of a plasticizer such as glycerol/glycerin, propylene glycol, polyvinyl alcohol, sorbitol, maltitol, etc. (Claims 6, 7; 8; Para. 0007, 0030 as applied to claims 1, 7); and/or 0.1-35 wt% of sorbitol, mannitol, xylitol, maltitol, and/or isomalt (identified in the present application as plasticizers) as a dissolution enhancing agent (Claims 8-10, 19; Para. 0008, 0031 as applied to claims 1, 7);
up to 5 wt% of a flavoring agent, a sweetener (Claim 11; Para. 0009, 0014. 0037, 0038, as applied to claims 1, 13).
Further, Rajewski teaches that said capsule includes a fill formulation (i.e., core) that may include a large variety of drugs/pharmaceuticals or salts thereof (Para. 0051, 0054-0092, 0103, 0104), nicotine (Para. 0062), vitamins (Para. 0093), and provides examples of compositions, wherein no tobacco is present (Examples 1-6 as applied to claims 1, 9, 13). Rajewski further teaches that said fill formulations may also include (by the weight of capsule fill):
hydroxypropyl cellulose, hydroxypropyl methylcellulose, gum acacia, polyvinyl alcohol, polyvinylpyrrolidone identified in the instant application as thermoplastic polymers (Para. 0096, 0099 as applied to claims 1-5);
mannitol, sorbitol, xylitol (Para. 0098), polyethylene glycols identified in the instant application as plasticizers (Para. 0100 as applied to claims 1, 7);
0.1-70 wt% of sweetener, 0.1-5 wt% of flavoring agent (Para. 0103, 0104 as applied to claims 1, 13); and also may include
corn starch, potato starch as a disintegrant (Para. 0105, 0106 as applied to claims 1, 13), i.e., non-tobacco plant material identified in the instant specification as a particulate filler (see instant specification, Para. 0107).
Rajewski does not specifically teach the use of 20-40 wt% of a thermoplastic binder system comprising a thermoplastic polymer(s) and a plasticizer(s) (claims 1, 13), and/or 40-75 wt% of a particulate filler (claims 1, 13).
Gao teaches oral products that can be free of tobacco (Claim 9; Para. 0009, 0025), can have a variety of different shapes, e.g., disk, shield, rectangle, square, triangle, oval; and may include: (i) a mouth-soluble binder that may include hydroxypropyl cellulose, hydroxypropyl methylcellulose, pullulan, xanthan gum, polyvinylpyrrolidone, polyethylene oxide, maltodextrin, or a combination thereof (i.e., thermoplastic polymers), and can be present in an amount of 0.05-1 wt% (Claim 5; Para. 0008, 0032, 0051, 0052); (ii) 0.5-10 wt% of a plasticizer, e.g., propylene glycol, glycerine, or combination thereof (Para. 0011, 0074); (iii) sweeteners, e.g., sorbitol, xylitol, mannitol, maltitol, isomalt, erythritol (Para. 0011); (iv) 0.1-6 mg of nicotine or its salt (Claim 18; Para. 0008, 0025, 0055); (v) flavorants, sweeteners, fillers (Para. 0063); and (vi) at least 10 wt% of non-tobacco cellulose fibers, e.g., sugar beet fiber, bran fiber (Claims 15, 16; Para. 0012, 0046, 0048), and also may include corn starch (Para. 0017). Gao teaches that said binders provide the oral product with a modified texture and flavor release profile, and also teaches that said oral product provides a tobacco-like flavor experience and favorable tactile experience (Para. 0008).
Marshall teaches oral compositions that can be provided in any predetermined shape or form, e.g., as a pill, pellet, tablet, coin, bead, etc. (Para. 0077) and may include: (i) 25-40 wt% of a binder material that may include xanthan gum, gum arabic, or combination thereof (i.e., thermoplastic polymer; Para. 0047); (ii) such sugar alcohol as isomalt, erythritol, polyglycitol, maltitol, xylitol, maltitiol, sorbitol in an amount of 45 wt% that can be used for controlling sweetness, texture and mouthfeel (i.e., plasticizer; Para. 0048, 0058); (iii) glycerine (i.e., plasticizer), salt, flavorant; (iv) comprise no tobacco, but only tobacco derived nicotine, e.g., in an amount of 0.1-5 wt% (Para. 0057; Examples 5, 11-17); and (v) at least 5 wt% of non-tobacco botanical particles (Para. 0012, 0042), corn starch, finely divided cellulose, and the like (Para. 0056).
Therefore, it is the examiner’s positions that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been collectively taught by the combined teachings of the references cited. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified compositions as taught by Rajewski for providing oral tobacco-free products as taught by Gao and Marshall. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach would provide oral tobacco-free products that can be prepared in different shapes, having controllable/desired texture and flavor release profile. Further, it is noted that it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a composition to be used for the very same purpose. (MPEP 2144.06). In the present case, cited prior teaches oral compositions that can be tobacco-free and provide controllable/desired dissolution and/or active agents release profile and can be prepared in different shapes.
Regarding the concentrations as instantly claimed (claims 1, 13), it is noted that one of ordinary skill in the art at would have recognized the concentration of each ingredient as result-effective variables that determine the composition’s efficacy and physical properties. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. MPEP § 2144.05 (II).
Regarding the claims 4 and 8, it is noted that the cited prior art teaches formulations comprising the same components. Thus, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) see MPEP § 2112.02.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rudolph et al., US 2011/0129517 (cited in IDS) – teaches tablettable chewing gums comprising nicotine or its salt; povidone/polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, arabic gum, xanthan gum (i.e., thermoplastic polymers) in combination with glycerine/glycerol, polyethylene glycol, propylene glycol, maltitol, sorbitol, mannitol, xylitol, erythritol (i.e., plasticizers), flavors, filler.
Bruun, US 2019/0255035 (cited in IDS) - teaches nicotine pouches comprising nicotine (i.e., active ingredient); polyvinylpyrrolidone, xantham gum, polyvinylpyrolidone, polyvinyl alcohol (i.e., thermoplastic polymers); sorbitol, erythritol, xylitol, maltitol, mannitol, isomalt, polyethylene glycols, propylene glycol (i.e., plasticizers); sweeteners, flavors; and that is free of tobacco.
Cantrell et al., US 2013/263870 (cited in IDS) - teaches tobacco compositions comprising gum arabic, xanthan gum, maltodextrin, hydroxypropyl cellulose, hydroxypropyl methylcellulose (i.e., thermoplastic polymers) in combination with isomalt, erythritol, maltitiol, mannitol, xylitol, glycerine, propylene glycol (i.e., plasticizers), salt, flavorant, fillers.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7-9, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-4, 8-10 of U.S. Patent No. 11,889,856; (2) claims 1-6, 11, 13-14, 18, 22 of U.S. Patent No. 11,883,527; (3) claims 1, 7-9, 12 of U.S. Patent No. 12,310,959.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A composition comprising (1) hydroxypropyl cellulose, hydroxypropyl methylcellulose, maltodextrin, xanthan gum, gum arabic (i.e., thermoplastic polymer); (2) isomalt, sorbitol, erythritol, maltitol, mannitol, xylitol, glycerin, propylene glycol (i.e., plasticizers); (3) flavoring and active agents; (4) sweeteners, salts, fillers; and (5) can be free of tobacco material. Further, it is noted that the specifications of said prior patents also teach that said compositions may include fillers, e.g., a particulate filler(s) as non-tobacco plant material, and/or can be formed into a sheet. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents.
Claims 1-5, 7-9, 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-5, 7, 9-10, 13 of copending Application 16/707,580; (2) claims 1, 3-8, 11-13, 19 copending Application No. 17/205,800.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on that copending application since the referenced copending applications and the instant application are claiming common subject matter, as follows: A composition comprising (1) hydroxypropyl cellulose, hydroxypropyl methylcellulose, maltodextrin, xanthan gum, gum arabic (i.e., thermoplastic polymer); (2) isomalt, sorbitol, erythritol, maltitol, mannitol, xylitol, glycerin, propylene glycol (i.e., plasticizers); (3) flavoring and active agents; (4) sweeteners, salts, fillers; and (5) can be free of tobacco material. Further, it is noted that the specifications of said copending applications teach that said compositions may include fillers, e.g., a particulate filler(s), and/or can be formed into a sheet. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending applications. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 01/20/2026 (Response After Final Action), have been fully considered, but they were not found to be persuasive for the reasons set forth above. New rejections and arguments have been added to the record to address newly introduced applicant’s amendments and to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant’s argument that the limitation “polymer comprising at least one cellulose ether” will be understood by one of ordinary skills in the art in the context on the present invention, it is noted that the open language of said limitation (i.e., comprising) allows the presence of additional, unrecited compounds/constituents even in a large amount. Therefore, the structure of the claimed polymer is not clearly delineated. Further, it is noted “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
In response to applicant’s argument that the limitation recited in claim 8 (dependent on claim 1), i.e., “plasticizer is capable of lowering the softening temperature of the al least one thermoplastic polymer by about 20 oC or more” is clear, because the chemical structure of plasticizer is defined in claim 1, it is noted that it is well known in the field that properties of multicomponent systems (i.e., compositions) depends on compounds included as well as on concentrations of said compounds (see above). Therefore, the function/property of a particular compound may change and/or depend on conditions. Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Clarification is required.
Applicant is advised to clarify the claim language/scope, the structure of the constituents to be included into the claimed composition/product, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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