DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 08/04/2026, 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, 4, 8, 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 Claims 14-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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Any rejection or objection not reiterated in this action is withdrawn.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 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.
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. Clarification is required.
In response to the applicant’s argument that said limitation will be understood by one of ordinary skills in the art based on the content of the instant specification, it is noted that “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). In the present case, said limitation does not clearly define “a polymer” to be used in the thermoplastic binding system. Therefore, metes and bounds the metes and bounds of the claim are not reasonably clear. Said limitation was interpreted as best understood as “comprising at least one thermoplastic polymer that is a cellulose ether”. Clarification is required.
Claim 1 recites the limitation “an active ingredient comprising from 0.1% to 10% by weight of a nicotine component” that not reasonably clear. In the present case it is unclear what is understood as “an active agent”. Is it a mixture of compounds that may include unrecited compounds even in a large amount? Similar is applied to claim 9. Clarification is required.
In response to the applicant’s argument that said limitation will be understood by one of ordinary skills in the art based on the content of the instant specification, as stated above “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). In the present case, said limitation does not clearly define metes and bounds of the claimed invention. Similar is applied to claim 9 regarding the limitation “the active ingredient comprises botanicals, …, terpenes, and combination thereof”. Clarification is required.
Claim 7 (dependent on claim 1) recites the limitation “the at least one plasticizer is in the form of a plasticizer blend comprising” that is unclear. To this point, it is noted that claim 1 discloses compounds that can be used in the claimed composition as a plasticizer. Therefore, it is unclear what compounds can be included even in large amounts (i.e., blend comprising) to be included into the plasticizer blend. Clarification is required.
Claims 3-5, 8, 13 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Claim Rejections - 35 USC § 103-MAINTAINED
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, the examiner maintains the position 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 modify 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 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 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 claims 1-5, 7, 9-10, 13 of copending Application 16/707,580.
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 08/04/2026, 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 amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to the applicant’s argument that Gao does not disclose the claimed thermoplastic binder system, it is noted that the instant specification clarifies/characterizes the thermoplastic binder system by compounds that can be included/used. Gao teaches oral products that can be free of tobacco and include compounds as instantly claimed. Further, it is noted that one cannot show nonobviousness by attacking references individually, where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggests the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it considers only knowledge, which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, all cited references are reasonably drawn to the same field of endeavor that is oral products that can be free of tobacco, and include compounds as instantly claimed. Therefore, the examiner maintains the position 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. Further, it is noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ.
the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.
it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed.
it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton).
it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Therefore, the examiner maintains the position that it would have been obvious to one of ordinary skill in the art to modify compositions as taught by Rajewski for providing oral tobacco-free products as taught by Gao and Marshall, because said 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. Applicant is advised to clarify the scope of the claims, 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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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