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 .
Amended claims 25, 27-40 and withdrawn claims 42-45 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Previously presented rejection of claims 25, 27-40 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention, is maintained for reasons of record::
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed.
Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521,222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Therefore the position taken is that Applicants, have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure to make and possibly use the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Further a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). The written description will provide the clearest explanation of the appellant’s invention, by exemplifying the invention, explaining how it relates to the prior art and explaining the relative significance of various features of the invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
It is not seen where in the specification an oral composition comprising an
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Applicants argument that
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is not persuasive. Applicants point to
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However as noted in the previous action at bottom of page 13.
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed.
Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed.
Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024]
Claim Rejections - 35 USC § 112
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.
Previously presented rejection of claims 25, 27-40 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is maintained for reasons of record:
Amendments to base claim 25 with regards to the term ‘botanical’
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is considered. Applicant did not address the previously raised issue of ‘selection within claim’ problem. For example consider the possibilities for active ingredient hemp and cannabis in base claim 25. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. ... The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Dependent claims 27-40 do not solve the problem of the base claim.
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:
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.
Previously presented rejection of claims 25, 27-40 rejected under 35 U.S.C. 103 as being unpatentable over Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Victor US 20180255801, Szel, The Journal of European Academy of Dermatology and Venereology, vol. 29, Issue 12, Dec. 2015, 2333-2341, Shin, Biomolecules 2019, 9, 281, 1-15; Shokri, INTECH, Cellulose – Medical, Pharmaceutical and Electronic Applications, 2013, 47-66 AND additional references Essen WO2007126361 and Essen WO2008133563 is maintained for reasons of record. Note that Essen(s) are in view of amendments to base claim 25.
Instant amendment to base claim 25:
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is considered
According to Applicant at page 2, second paragraph that
There is no suggestion or motivation
There is no reasonable expectation of success
All the claimed elements are not present in the cited references.
Amendments to claims and applicants arguments are not persuasive.
Argument at page 3 reminds Examiner that Bruun is drawn to nicotine patches, a
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here ignores that the proviso
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This limitation was addressed specifically in the previous action.
Applicant also argument at page 2, first paragraph implies (with repeated use of the word ‘alleged’) that CBD of Victor does not relate to the cannabis (of instantly amended active ingredient). Applicant also notes (at penultimate paragraph of page 3) that Victor
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(The word ‘once’ is interesting in the context of complete absence of working example in the disclosure; see section under 112-1 ). See below, for more on the filler cellulose.
Regardless, applicant is again reminded that the instant rejection is not under Claim Rejections - 35 USC § 102. Multiple references have been invoked here in the obviousness analysis.
Victor’s teachings was pointed out at page 3 office action 05/13/2025 at page 3:
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TSM:
Again the teachings of Bruun for nicotine pouch products, Victor pouch for cannabis CBD and Essen teaching for nicotine-free pouches are used here in this action. Szel for suggestion for use of xylitol for irritation reduction; Shin & Shokri for cellulose filler as limited, See below for more on Essen, Szel, Shin & Shokri.
As to suggestion and motivation alleged to be absent in the cited references, it is clear Applicant overlooks everything at page 4-6:
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As to Applicants ‘each and every claim element’ argument:
In this regard, Applicant is encouraged to revist office action filed 01/17/2025 for extensive discussion of ‘each and very element’.
With regards to the argument at page 4
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note that a compound and its property are inseparable. The excipients (inacive ingredients) are routinely used in the art. According to Applicant, filler cellulose limitation
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is not present in the cited art. Cellulose and its derivatives have been used as filler matrix in pharmaceutical composition and their amount depending on desired release (of the active ingredient). See for example, Shin, Biomolecules 2019, 9, 281, 1-15; Shokri, INTECH, Cellulose – Medical, Pharmaceutical and Electronic Applications, 2013, 47-66. On top of this Examiner cannot ignore the guidelines with respect to range limitations in compositon claims. According to Exanunatuin guidelines: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” (see MPEP 2144.05(II)). For the reasons above, it is believed that the dosages required by the present claims and those taught/suggested by Pistolesi et al., in the absence of evidence to the contrary, are not patentably distinct. There is nothing in the specification (see section under Claim Rejections - 35 USC § 112 (written description) for secondary consideration. It is known that Xylitol reduces irritation by inhibiting bacteria that cause inflammation in both the mouth and on the skin. It works by preventing the growth of harmful bacteria that produce acids and cause inflammation, while also reducing inflammatory markers like IL-1β and TNF-α in skin cells, for example as taught by
Essen WO2008133563 is invoked here in view of amendments to claims.
Essen teaches at claim 1 A moist non-tobacco snuff product comprising cocoa fibers in an amount of 5-100 % by weight of bulk material of the product, and optionally additional component(s) of food grade, provided in a form for oral placement and
at claim 4 4. The moist non-tobacco snuff product according to any one of claims 1-3, wherein the bulk material as an additional component comprises at least one type of plant fiber chosen from the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers, molasses fibers, rye fibers, sugar beet fibers, buck wheat fibers, potato fibers, cellulose fibers, apple fibers, bamboo fibers, citrus fibers;
and at claim 8. The moist non-tobacco snuff product according to any one of claims 1-7, wherein the product as additional component(s) comprises at least one ingredient chosen from the group consisting of ammonium chloride, liquorice, caffeine, red clover, Echinacea, Green tea extract, Maca, Mate, Matcha, Roiboos, Ginger, Rose hips, white clover, sweet clover, cocoa, ginseng, guarana, arctic root, rosemary, buckthorn, bilberry, cranberry, lingonberry, anise, clove, gum tragacanth, gum arabic, gum acacia, gum karaya, locust bean gum, and xanthan gum.
Essen thus explicitly teaches formulation for oral placemnt of non-tobacco formulation containing the active ingredients selected from citrus, maca, ginger, ginseng and clove.
Also Essen WO2007126361 invoked here in view of amendments to claims, Claims 1, claim 10, 121 and 24 for
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All the limitations of the claims: active ingredients, inactive ingredients filler celluloses, irritation reducing agents and how to make oral pouches with these are known in the art.
Each ingredient is known in the art; the claimed composition as a whole would have been obvious in view of the cited references for the reasons set forth above.
There is no data for secondary consideration. Therefore Applicants argument at bottom of page 4 with regards to ‘predicatable’ use of the instant composition is not persuasive.
Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024]
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Neidle, US 8685478.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Previously presented rejection of claims 25, 27-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11672862 further in view of further in view of Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Victor US 20180255801, Szel, The Journal of European Academy of Dermatology and Venereology, vol. 29, Issue 12, Dec. 2015, 2333-2341, Shin, Biomolecules 2019, 9, 281, 1-15; Shokri, INTECH, Cellulose – Medical, Pharmaceutical and Electronic Applications, 2013, 47-66, Essen WO2007126361 and Essen WO2008133563. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Applicants arguments are not persuasive.
Applicant argues
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Applicant points out the absence of nicotine or caffeine in the instantly claimed pouch.
It is acknowledged that nicotine is excluded here. Caffeine is not excluded here.
It is also acknowledged that the botanicals as defined instantly does not include Caffeine.
It is noted that the rejection is not under 101 type statutory double patenting. Caffeine is a botanical compound, a plant alkaloid, found in over 60 plants like coffee, tea, cacao, and guarana, acting as a defense mechanism for the plant, though it's also produced synthetically for drinks and meds.
Further the interchangeable use of botanical caffeine and instantly recited botanicals is taught in the claims of Essen(s) 2007126361 and 2008133563 respectively in claim 15 and claim 6.
The teachings of Victor, Essen(s) renders instantly recited botanicals and caffeine of claims of issued patent US 11672862 obvious variants of each other as active ingredients.
The teachings of victor, Essen(s) and other references invoked here (in view of amendments to claims) are discussed extensively in rejection under Claim Rejections - 35 USC § 103, though awkward to repeat here, is as follows:
Instant amendment to base claim 25:
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is considered
According to Applicant at page 2, second paragraph that
There is no suggestion or motivation
There is no reasonable expectation of success
All the claimed elements are not present in the cited references.
Amendments to claims and applicants arguments are not persuasive.
Argument at page 3 reminds Examiner that Bruun is drawn to nicotine patches, a
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here ignores that the proviso
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This limitation was addressed specifically in the previous action.
Applicant also argument at page 2, first paragraph implies (with repeated use of the word ‘alleged’) that CBD of Victor does not relate to the cannabis (of instantly amended active ingredient). Applicant also notes (at penultimate paragraph of page 3) that Victor
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(The word ‘once’ is interesting in the context of complete absence of working example in the disclosure; see section under 112-1 ). See below, for more on the filler cellulose.
Regardless, applicant is again reminded that the instant rejection is not under Claim Rejections - 35 USC § 102. Multiple references have been invoked here in the obviousness analysis.
Victor’s teachings was pointed out at page 3 office action 05/13/2025 at page 3:
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TSM:
Again the teachings of Bruun for nicotine pouch products, Victor pouch for cannabis CBD and Essen teaching for nicotine-free pouches are used here in this action. Szel for suggestion for use of xylitol for irritation reduction; Shin & Shokri for cellulose filler as limited, See below for more on Essen, Szel, Shin & Shokri.
As to suggestion and motivation alleged to be absent in the cited references, it is clear Applicant overlooks everything at page 4-6:
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As to Applicants ‘each and every claim element’ argument:
In this regard, Applicant is encouraged to revist office action filed 01/17/2025 for extensive discussion of ‘each and very element’.
With regards to the argument at page 4
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note that a compound and its property are inseparable. The excipients (inacive ingredients) are routinely used in the art. According to Applicant, filler cellulose limitation
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is not present in the cited art. Cellulose and its derivatives have been used as filler matrix in pharmaceutical composition and their amount depending on desired release (of the active ingredient). See for example, Shin, Biomolecules 2019, 9, 281, 1-15; Shokri, INTECH, Cellulose – Medical, Pharmaceutical and Electronic Applications, 2013, 47-66. On top of this Examiner cannot ignore the guidelines with respect to range limitations in compositon claims. According to Exanunatuin guidelines: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” (see MPEP 2144.05(II)). For the reasons above, it is believed that the dosages required by the present claims and those taught/suggested by Pistolesi et al., in the absence of evidence to the contrary, are not patentably distinct. There is nothing in the specification (see section under Claim Rejections - 35 USC § 112 (written description) for secondary consideration. It is known that Xylitol reduces irritation by inhibiting bacteria that cause inflammation in both the mouth and on the skin. It works by preventing the growth of harmful bacteria that produce acids and cause inflammation, while also reducing inflammatory markers like IL-1β and TNF-α in skin cells, for example as taught by Szel reference titled ‘Anti-irritant and anti-inflammatory effects of glycerol and xylitol in sodium lauryl sulphate-induced acute irritation’
Essen WO2008133563 is invoked here in view of amendments to claims.
Essen teaches at claim 1 A moist non-tobacco snuff product comprising cocoa fibers in an amount of 5-100 % by weight of bulk material of the product, and optionally additional component(s) of food grade, provided in a form for oral placement and
at claim 4 4. The moist non-tobacco snuff product according to any one of claims 1-3, wherein the bulk material as an additional component comprises at least one type of plant fiber chosen from the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers, molasses fibers, rye fibers, sugar beet fibers, buck wheat fibers, potato fibers, cellulose fibers, apple fibers, bamboo fibers, citrus fibers;
and at claim 8. The moist non-tobacco snuff product according to any one of claims 1-7, wherein the product as additional component(s) comprises at least one ingredient chosen from the group consisting of ammonium chloride, liquorice, caffeine, red clover, Echinacea, Green tea extract, Maca, Mate, Matcha, Roiboos, Ginger, Rose hips, white clover, sweet clover, cocoa, ginseng, guarana, arctic root, rosemary, buckthorn, bilberry, cranberry, lingonberry, anise, clove, gum tragacanth, gum arabic, gum acacia, gum karaya, locust bean gum, and xanthan gum.
Essen thus explicitly teaches formulation for oral placemnt of non-tobacco formulation containing the active ingredients selected from citrus, maca, ginger, ginseng and clove.
Also Essen WO2007126361 invoked here in view of amendments to claims, Claims 1, claim 10, 121 and 24 for
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Restatement of response to 103 rejection as applied to odp over claims of 11672862 here:
Amendment
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is considered
According to Applicant at page 2, second paragraph that
There is no suggestion or motivation
There is no reasonable expectation of success
All the claimed elements are not present.
Amendments to claims and applicants arguments are not persuasive.
Argument at page 3 that Bruun is drawn to nicotine patches, a
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here ignores that the proviso
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was addressed specifically in the previous action.
Applicant is again reminded that the instant rejection is not under Claim Rejections - 35 USC § 102.
As to suggestion and motivation alleged to be absent in the cited references, it is clear Applicant overlooks everything at page 4-6:
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As to Applicants ‘each and every claim element’ argument:
In this regard, Applicant is encouraged to revist office action filed 01/17/2025 for extensive discussion of ‘each and very element’.
With regards to the argument at page 4
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note that a compound and its property are inseparable. The excipients (inacive ingredients) are routinely used in the art. According to Applicant, limitation for example,
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is not present in the cited art. According to Exanunatuin guidelines: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” (see MPEP 2144.05(II)). For the reasons above, it is believed that the dosages required by the present claims and those taught/suggested by Pistolesi et al., in the absence of evidence to the contrary, are not patentably distinct. There is nothing in the specification (see section under Claim Rejections - 35 USC § 112 (written description) for secondary consideration.
Essen WO2008133563 is invoked here here in view of amendments to claims.Essen teaches at claim 1 A moist non-tobacco snuff product comprising cocoa fibers in an amount of 5-100 % by weight of bulk material of the product, and optionally additional component(s) of food grade, provided in a form for oral placement and
at claim 4 4. The moist non-tobacco snuff product according to any one of claims 1-3, wherein the bulk material as an additional component comprises at least one type of plant fiber chosen from the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers, molasses fibers, rye fibers, sugar beet fibers, buck wheat fibers, potato fibers, cellulose fibers, apple fibers, bamboo fibers, citrus fibers;
and at claim 8. The moist non-tobacco snuff product according to any one of claims 1-7, wherein the product as additional component(s) comprises at least one ingredient chosen from the group consisting of ammonium chloride, liquorice, caffeine, red clover, Echinacea, Green tea extract, Maca, Mate, Matcha, Roiboos, Ginger, Rose hips, white clover, sweet clover, cocoa, ginseng, guarana, arctic root, rosemary, buckthorn, bilberry, cranberry, lingonberry, anise, clove, gum tragacanth, gum arabic, gum acacia, gum karaya, locust bean gum, and xanthan gum.
Essen thus explicitly teaches formulation for oral placemnt of non-tobacco formulation containing the active ingredients selected from citrus, maca, ginger, ginseng and clove.
Also see Essen WO2007126361 is invoked here in view of amendments to claims,
Claims 1, claim 10, 121 and 24 for
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Therefore Applicants argument at bottom of page 4 with regards to ‘predicatable’ use of the instant composition is not persuasive.
Restatement of previously filed 103 rejection 08/19/2025 as applied to odp over claims of 11672862 here:
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Likewise means for same rationale as above:
Claims 25 and 27-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 13 and 15 of U.S. Patent No. 12439949 further in view of Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Victor US 20180255801, Szel, The Journal of European Academy of Dermatology and Venereology, vol. 29, Issue 12, Dec. 2015, 2333-2341, Shin, Biomolecules 2019, 9, 281, 1-15; Shokri, INTECH, Cellulose – Medical, Pharmaceutical and Electronic Applications, 2013, 47-66, Essen WO2007126361 and Essen WO2008133563. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter as explained below:
The limitations of instant claims with respect to active and inactive ingredients are highlighted below in the claims of 12439949:
1. An oral composition comprising: at least one active agent; a filler component; and water in an amount of less than 10% by weight, based on the total weight of the composition; wherein the oral composition has a water activity of about 0.5 to about 0.6.
3. The oral composition of claim 1, wherein the at least one active agent comprises ginseng.
9. The oral composition of claim 1, wherein the oral composition is provided within a pouch.
13. The oral composition of claim 1, where the filler component is selected from a group consisting of cellulose, starch, calcium carbonate, calcium phosphate, lactose, dextrose, mannitol, xylitol, sorbitol, and combinations thereof.
15. The oral composition of claim 1, wherein the active agent is selected from the group consisting of botanical materials, stimulants, nicotine components, amino acids, vitamins, antioxidants, cannabinoids, cannabimimetics, terpenes, pharmaceutical agents, nutraceuticals, and combinations thereof.
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Likewise means for same rationale as above:
claims 25 and 27-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11793230 further in view of Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Victor US 20180255801, Szel, The Journal of European Academy of Dermatology and Venereology, vol. 29, Issue 12, Dec. 2015, 2333-2341, Shin, Biomolecules 2019, 9, 281, 1-15; Shokri, INTECH, Cellulose – Medical, Pharmaceutical and Electronic Applications, 2013, 47-66, Essen WO2007126361 and Essen WO2008133563. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter as explained below:
The limitations of instant claims with respect to active and inactive ingredients are in the claims of 11793230.
1. An oral product comprising: an active ingredient comprising a positively charged group; and a filler which is carboxylated microcrystalline cellulose; wherein the active ingredient is retained by the filler through bonding of the positively charged group and the carboxylated microcrystalline cellulose, wherein the active ingredient is configured for release when the product is present in an oral cavity.
2. The product of claim 1, wherein the active ingredient is selected from the group consisting of a nicotine component, botanicals, stimulants, amino acids, vitamins, cannabinoids, nutraceuticals, and combinations thereof.
10. The product of claim 1, wherein at least the active ingredient and the filler are combined as a mixture that is enclosed in a pouch to form a pouched product, the mixture optionally being in a free-flowing particulate form.
13. A method for improving binding of an active ingredient in an oral product, the method comprising: mixing an active ingredient comprising a positively charged group with a filler which is carboxylated microcrystalline cellulose such that the active ingredient is retained by the filler though bonding between the positively charged group and carboxyl groups, and such that the active ingredient that is so-retained is configured for release therefrom when the product is present in an oral cavity.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625