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 .
Response to Arguments
Applicant’s arguments filed 04/01/2026 have been fully considered but are not persuasive.
Applicant has amended independent claim 1 to include the limitation of previous dependent claim 2, namely that the lipid has “a melting point of about 36°C to about 45°C.” Applicant argues that Robinson in view of Cantrell fails to render obvious the claimed composition because Robinson is directed to a chewing gum composition, while Cantrell is directed to a meltable smokeless tobacco composition. Applicant further argues that modifying Robinson to include Cantrell’s lipid amount and lipid melting point would render Robinson unsatisfactory for its intended purpose as a chewing gum.
This argument is not persuasive because it is based on an overly narrow reading of Robinson and on a bodily-incorporation theory that is not required by the rejection. Robinson is not relied upon solely for the wax/fat disclosure in the gum base. Robinson also teaches oral compositions having a solid candy region or center-fill region including active ingredients, flavorants, and fat/lipid components. Robinson further teaches that fat may be used in the solid candy region for taste-masking. Thus, Robinson itself contemplates fat-containing solid candy compositions in oral products, not merely waxes in a gum base.
Applicant’s argument is also not commensurate with the scope of the pending claims. The pending independent claims are not limited to a chewing gum, gum base, elastomer-containing composition, or composition having any required chewability or elasticity. Rather, the claims broadly recite a composition comprising a filler, a lipid, water, and a flavoring agent and/or active ingredient, wherein the lipid has a melting point of about 36°C to about 45°C and is present in an amount of about 20% to about 50% by weight based on the total dry weight of the composition. Therefore, even assuming arguendo that the proposed modification would affect the chewability of one embodiment of Robinson, such argument does not overcome the rejection because the claims do not require the composition to remain a chewing gum.
Cantrell is relied upon for its teaching that lipid melting point and lipid amount are selectable variables for controlling melting characteristics, texture, and mouthfeel in an oral composition. Cantrell teaches that the melting characteristics of the composition may generally be attributed to a lipid component, and that the melting point of the lipid component may be selected so that the resulting product has desired melting characteristics when placed in the oral cavity. Cantrell further teaches a lipid having a melting point of about 36°C to about 45°C and lipid amounts including about 10 to about 60 dry weight percent, more typically about 20 to about 40 dry weight percent, which overlaps the claimed range of about 20% to about 50%.
Accordingly, the rejection does not require bodily incorporating Cantrell’s tobacco material into Robinson or converting Robinson’s entire product into Cantrell’s meltable smokeless tobacco product. Rather, Cantrell is relied upon for the known lipid melting point and lipid amount suitable for providing desired oral melting, texture, mouthfeel, and taste characteristics. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Robinson’s fat/lipid-containing oral composition to include a lipid having the melting point and amount taught by Cantrell in order to provide desired oral melting, mouthfeel, texture, and taste-masking characteristics.
Applicant further argues that Cantrell’s lipid melting point is outside the range taught by Robinson. This argument is not persuasive. Robinson teaches low-melting waxes having a melting point below 60°C, including about 45°C to about 55°C, and the claimed range of about 36°C to about 45°C overlaps at about 45°C. In any event, Cantrell expressly teaches the claimed lipid melting point range for achieving desired oral melting characteristics. Thus, Cantrell provides sufficient reason to select the claimed lipid melting point.
Applicant’s argument regarding claim 11 is likewise not persuasive because it depends on the same arguments made with respect to independent claim 1. As discussed above, the combination of Robinson and Cantrell properly renders the subject matter of independent claim 1 obvious. Duggins is relied upon for the additional limitation of claim 11 and need not cure a deficiency that is not present in the Robinson/Cantrell combination.
Applicant’s arguments regarding the provisional nonstatutory double patenting rejection have also been fully considered but are not persuasive. Applicant has not substantively traversed the merits of the provisional double patenting rejection, but instead requests that the rejection be held in abeyance and states that a terminal disclaimer may be filed if the claims are otherwise allowable. Such remarks do not overcome the provisional rejection. Accordingly, the provisional nonstatutory double patenting rejection of claims 1-7 and 9-11 over claim 1 of copending application no. 17/836,794 is maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-10, 12-13, 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2009/0142443) and further in view of Cantrell et al. (US 2012/0037175).
Regarding claim 1, Robinson teaches a composition (e.g., chewy nougat solid candy composition; Table 2) comprising
a filler, such as gelatin (Table 2),
a lipid, including vegetable oils and fats such as soybean oil and cottonseed oil ([0039]), water (Table 2),
a flavoring agent and/or an active ingredient, including stimulants such as caffeine ([0075], Table 2).
Robinson further teaches that the fats employed in the solid candy compositions are selected based on melting characteristics suitable for solid oral compositions, including fats having melting points above about 29°C, and further discloses fats having melting points in the range of about 36°C to about 45°C ([0033]). Thus, Robinson teaches a lipid having a melting point of about 29°C or above.
Robinson discloses compositions that do not require the presence of isomalt and does not include tobacco material. The absence of these optional ingredients meets the limitation that the composition is substantially free of isomalt and substantially free of tobacco material, as the exclusion of an optional component does not impart patentable distinction.
Robinson does not explicitly teach that the lipid is present in an amount of about 20% to about 50% by weight, based on the total dry weight of the composition, as recited in claim 1.
However, Cantrell teaches solid oral compositions comprising a lipid substance having a melting point of about 36°C to about 45°C, and expressly teaches that the lipid may be present in an amount of at least about 20 percent, or at least about 30 percent, on a dry weight basis, and less than about 50 percent or 60 percent, with exemplary lipid ranges including about 20–40% by dry weight ([0016]).
Robinson expressly teaches that the amount of fat is adjustable and that any amount of fat may be contemplated to provide sufficient taste masking and desired sensory properties, with multiple fat ranges disclosed depending on formulation needs ([0104]). This teaching demonstrates that lipid amount is a result-effective variable in Robinson’s compositions.
Accordingly, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify Robinson’s composition to include lipid in the amount taught by Cantrell, because both references are directed to solid oral compositions, and both teach that lipid amount and melting point are selected to control taste, texture, mouthfeel, and melting behavior in the oral cavity. Selecting a lipid amount within the range taught by Cantrell would have been a routine optimization of Robinson’s composition.
Regarding Claim 3:
Claim 3 depends from claim 1 and recites that the lipid is selected from palm oil, palm kernel oil, soybean oil, cottonseed oil, and combinations thereof.
Robinson teaches soybean oil and cottonseed oil as suitable lipids ([0039]), and Cantrell teaches palm oil and palm kernel oil as suitable lipids for solid oral compositions ([0015]). The selection of a lipid from among these known vegetable oils represents an obvious choice from a finite number of identified, predictable options.
Regarding Claims 4–6:
Claim 4 recites the inclusion of lecithin, sweeteners, salts, or mixtures thereof. Robinson expressly teaches sweeteners, salts, and emulsifiers, including lecithin-type components, as optional ingredients ([0075], [0077]).
Claim 5 recites one or more alkali metal salts, including sodium chloride, sodium carbonate, and sodium bicarbonate. Robinson teaches the use of salts and buffering agents, including sodium-based salts, in the disclosed compositions ([0077]).
Claim 6 recites that the active ingredient is selected from nicotine components, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, or combinations thereof. Robinson expressly teaches stimulants such as caffeine and other nutraceutical-type active agents for use in the disclosed compositions ([0075]).
Regarding claim 7, Robinson teaches that active ingredients for use in chewing gum and solid candy compositions include nicotine ([0086], [0087], [0090]). Robinson further discloses in Table A that nicotine may be present in an amount of about 0.0001 to about 10 percent by weight.
Claim 7 recites that the composition comprises from about 0.001 to about 10 percent by weight of a nicotine component, calculated as free base and based on the total weight of the composition. Robinson’s disclosed nicotine range overlaps and encompasses the claimed range.
It has been held that overlapping ranges are prima facie evidence of obviousness (MPEP § 2144.05). Where, as here, the prior art discloses a range that overlaps or encompasses the claimed range, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a value within the disclosed range.
Further, Robinson teaches incorporating nicotine into solid oral compositions, including solid candy and chewing gum compositions, for delivery to a user ([0086]–[0090]). The claimed calculation of nicotine as free base does not impart patentable distinction, as it merely defines the manner in which the nicotine amount is expressed.
Regarding claims 8–10:
Robinson teaches a chewing gum composition comprising a filler and a lipid, water, and a flavoring agent or active ingredient (see, e.g., Table 3, ingredient 220; [0033], [0041], [0075]). Robinson further teaches that flavor agents may be absorbed onto water-soluble materials such as cellulose ([0062]), thereby disclosing the use of cellulose materials as fillers in chewing gum compositions.
Claim 8 further requires that the filler is in particulate form and comprises a cellulose material. While Robinson teaches cellulose materials as fillers, Robinson does not explicitly specify that the cellulose filler is in particulate form.
Cantrell teaches that fillers and additives for oral and smokeless tobacco compositions are conventionally provided in powdered or granulated (particulate) form, including finely divided cellulose and microcrystalline cellulose, and that such particulate cellulose materials are used as fillers, binders, and disintegration or compressibility aids in oral compositions ([0029]–[0030]). Cantrell further teaches that such additives may have defined particle sizes and are admixed with other components to form the final composition.
Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to employ Cantrell’s known particulate cellulose fillers in the chewing gum composition of Robinson in order to provide a predictable and conventional filler form suitable for oral compositions.
Claim 9 depends from claim 8 and further recites that the cellulose material comprises microcrystalline cellulose. As noted above, Cantrell explicitly teaches the use of microcrystalline cellulose as a particulate additive in oral compositions. Selection of microcrystalline cellulose as the cellulose filler would have been a routine and predictable choice from among known cellulose materials disclosed by Cantrell, yielding no unexpected results.
Claim 10 depends from claim 9 and further recites that the filler comprises a cellulose derivative. Cantrell teaches the use of modified and derivative cellulose materials as binders and fillers in oral compositions, including chemically modified celluloses (paragraphs [0029]–[0030]). The selection of a cellulose derivative as a filler material would have been an obvious variation of the cellulose fillers disclosed by Robinson and Cantrell, representing a routine substitution of known equivalents.
Regarding claims 12-13 and 15-16, Robinson teaches a chewing gum composition (Table 3, ingredient 220) comprising a filler, a lipid having a melting point of about 29°C or above, and water ([0033]; Table 3). Robinson further teaches that fats employed in the composition may have melting points below about 60°C, and in some embodiments between about 45°C and about 55°C ([0033]).
Robinson also teaches that the chewing gum composition includes water in an amount of about 10–25% by weight (Table 3, example 220), which overlaps with the claimed requirement of at least about 15% by weight and at least about 20% by weight, based on total weight of the composition. Overlapping ranges are prima facie evidence of obviousness (MPEP § 2144.05).
Robinson further teaches the inclusion of a flavoring agent in the chewing gum composition in an amount of about 0.3–2.5% by weight (Table 3, example 220), and/or an active ingredient ([0075]).
Robinson does not explicitly disclose that the lipid is present in an amount of about 20% to about 50% by weight, as recited in amended claim 12.
However, Cantrell teaches solid oral compositions comprising a lipid having a melting point of about 36°C to about 45°C, wherein the lipid is present in an amount of at least about 20%, at least about 30%, and less than about 50–60% by dry weight of the composition ([0016]). Cantrell further teaches that lipid amount is selected to control melting behavior, mouthfeel, and oral performance of the composition.
Robinson expressly teaches that lipid amount is adjustable and that any amount of fat may be contemplated to achieve desired sensory and taste-masking properties ([0104]), demonstrating that lipid amount is a result-effective variable.
Accordingly, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify Robinson’s chewing gum composition to include lipid in the amount taught by Cantrell in order to optimize melting behavior and mouthfeel while maintaining a solid oral product.
Regarding claim 17, Robinson teaches a component selected from lecithin, sweeteners, salts, and mixtures thereof, including high fructose syrup in an amount of about 7.0% by weight (Table 3).
Regarding claim 18, Robinson teaches that the active ingredient may be selected from nicotine components, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, and combinations thereof ([0075]). Accordingly, claim 18 is unpatentable over Robinson.
Regarding claim 19, Claim 19 recites a composition comprising from about 0.001% to about 10% by weight of a nicotine component, calculated as free base and based on the total weight of the composition.
Robinson teaches that active ingredients for use in chewing gum and solid candy compositions include nicotine ([0086], [0087], [0090]). Robinson further discloses in Table A that nicotine may be present in an amount of about 0.0001 to about 10 percent by weight.
Robinson’s disclosed nicotine range overlaps and encompasses the claimed range.
It has been held that overlapping ranges are prima facie evidence of obviousness (MPEP § 2144.05). Where, as here, the prior art discloses a range that overlaps or encompasses the claimed range, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a value within the disclosed range.
Further, Robinson teaches incorporating nicotine into solid oral compositions, including solid candy and chewing gum compositions, for delivery to a user ([0086]–[0090]). The claimed calculation of nicotine as free base does not impart patentable distinction, as it merely defines the manner in which the nicotine amount is expressed.
Regarding claim 20, Claim 20 recites a composition comprising, by dry weight:
about 10–70% filler,
about 15–60% water,
about 0.1–5% alkali metal salts, and
about 0.001–10% active ingredient selected from nicotine components, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, or combinations thereof.
Robinson teaches a composition comprising:
a filler present in an amount from about 15% to about 40%, and more specifically from about 20% to about 30% by weight of the gum base ([0041]);
water present in an amount of about 10–25% (Table 3, example 220);
alkali metal salts, including sodium chloride in an amount of about 0.01–1% (Table A); and
an active ingredient, including stimulants such as caffeine or nicotine, in an amount of about 0.0001–10% (Table A).
Each of Robinson’s disclosed component ranges overlaps or falls within the claimed ranges. It has been held that overlapping ranges are prima facie evidence of obviousness (see MPEP § 2144.05). Robinson’s disclosure therefore renders the selection of the claimed ranges an obvious matter of routine optimization.
Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to arrive at the composition of claim 20 based on Robinson’s teachings.
Regarding claim 21:
Claim 21 recites that the filler is present in an amount of at least about 20% by weight, based on the total dry weight of the composition.
Although Robinson does not explicitly state the filler amount as a percentage of total dry weight of the composition, Robinson teaches that bulking agents serving as fillers may be present in an amount from about 15% to about 40%, and more specifically from about 20% to about 30% by weight of the gum base ([0041]).
Given that the gum base constitutes a substantial portion of the overall composition, Robinson’s disclosure necessarily encompasses filler levels of at least about 20% by weight when considered on a dry-weight basis.
Furthermore, it would have been obvious to one of ordinary skill in the art to select a filler amount of at least about 20% in order to control size, expansion, texture, and structural integrity of the composition, as taught by Robinson ([0041]).
Claim 11 is rejected under 35 U.S.C. § 103 as being unpatentable over Robinson (US 2009/0142443 A1) in view of Cantrell (US 2012/0037175 A1) and further in view of Duggins et al. (US 2013/0209540 A1).
Regarding claim 11, Robinson teaches a composition comprising a filler that includes a cellulose material, wherein flavor agents and/or active ingredients may be absorbed onto water-soluble materials such as cellulose for incorporation into oral compositions ([0062]).
Cantrell further teaches that fillers and additives used in oral compositions are preferably provided in powdered or particulate form, and that such fillers include finely divided cellulose and microcrystalline cellulose used as disintegration aids and carriers for active ingredients ([0029]–[0031]).
However, Robinson and Cantrell do not explicitly teach that the cellulose derivative is hydroxypropylcellulose.
Duggins remedies this deficiency by expressly teaching hydroxypropylcellulose as a suitable cellulose derivative, binder, and excipient for oral and pharmaceutical compositions ([0044]), thereby rendering obvious the selection of hydroxypropylcellulose as the cellulose derivative in the composition of Robinson, as modified by Cantrell.
It would have been obvious to one of ordinary skill in the art at the time of the invention to select hydroxypropylcellulose as the cellulose derivative in the composition of Robinson, as modified by Cantrell, in view of Duggins’ express teaching that hydroxypropylcellulose is a known and suitable cellulose derivative for the same intended purpose. Such a substitution represents a predictable use of a known equivalent material to obtain expected results (See MPEP § 2143I (B)).
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 2 of copending Application No. 17836794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application explicitly teaches a composition comprising microcrystalline cellulose as a filler, a lipid component, water, and one or more active ingredients, which corresponds to the same compositional framework recited in claim 1 of the instant application.
Further, the lipid amounts recited in the copending application overlap with the lipid amount range recited in claim 1 of the instant application, such that the differences between the claims amount to an obvious variation in concentration within overlapping ranges of the same components. Accordingly, the claims define patentably indistinct subject matter.
Claim 3 of the instant application is the same as claim 3.
Claim 4-7 and 9 of the instant application is render obvious by claim 1.
Claim 10-11 of the instant application is the same as claim 10-11.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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 JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached on Monday - Thursday 7:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached on (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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