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 .
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statements filed on 03/07/2024, 06/27/2024, 07/02/2024, 09/25/2024, 10/08/2024, and 02/07/2025. The Examiner has considered the reference cited therein to the extent that each is a proper citation. Please see attached USPTO form.
Election/Restrictions
Applicant's election of Group 1 (claims 1-13) without traverse in the reply filed on 03/24/2026 is acknowledged.
Claims 14-20 are withdrawn from consideration from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims. Please note, although claims 14 and 16 have been amended to depend from claim 1, they are being withdrawn because claim 14 is drawn to a liquid formulation and claim 16 is drawn to a method making.
Claims 1-13 are under examination and the requirement for restriction is made final.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6-8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zeese et. al (US20220403303A1) hereinafter Zeese.
Zeese teaches a unit dose article comprising a non-woven web and a water-soluble film (see Abstract). With regards to claim 1, Zeese teaches “a nonwoven web in the form of a pouch defining a second interior pouch volume encompassing the water-soluble film” where “the nonwoven webs of the disclosure are generally sheet-like structures” (see [0005]; see also [0163]). Celluloses, methylcelluloses, carboxymethylcelluloses and salts thereof (which includes NaCMC), ethylcelluloses, hydroxyethyl celluloses, and hydroxypropyl methylcelluloses can be used in the fiber of the film (see [0041]). The active ingredient in the nonwoven film can be a surfactant (see [0008]). Polyvinyl alcohol (PVA) is listed as a suitable polymer for the fiber composition, but it is not required and need not be present.
Although Zeese does not disclose a cellulose fiber substrate, a cellulose derivative, and the surfactant active in a single embodiment to the point of anticipation, it would have been obvious to a person with ordinary skill in the art before the effective filing date to combine these elements into a nonwoven web water-soluble sheet taught by Zeese. The person of ordinary skill in the art would have done so for the benefit of improved stability in humid environments, increased functionality, and prolonged release of a liquid composition while maintaining mechanical integrity of the article for a duration of use (see [0021]).
With regards to claim 2, Zeese does not explicitly state the composite to comprise of nanocellulose. However, Zeese does teach the fibers in the nonwoven web to have a diameter in the range of 10-300 microns which overlaps with the ranges noted in the specification (see [0111]). The instant specification notes “a nanocellulose substrate may also include micron scale cellulose fibers” (see Applicant Specification [0057]).
With regards to claim 6, Zeese teaches the use of nonionic, catanionic, anionic, and other surfactants in the films (see [0061]).
With regards to claim 7, Zeese teaches the use of glycerin as a plasticizer (see [0060]).
With regards to claim 8, Zeese teaches the use of protease, amylase, lipase, and other enzymes in the nonwoven web (see [0065]-[0066]).
With regards to claim 10, Zeese teaches “the unit dose article and/or the nonwoven of the disclosure can advantageously prolong the release of a composition contained in the unit dose article and/or nonwoven after contact with water” (see [0224]).
With regards to claim 11, Zeese teaches a single nonwoven film to have a basis weight within the range of 0.1g/m2- 700 g/m2 and multilayer nonwoven webs to have a basis weight that is the sum of the individual basis weights (see [0116]). Although the exact weight of the film is not provided, the person or ordinary skill in the art would reasonably expect the weight of the sheet taught by Zeese to fall within 1-8 grams because of the large basis weight range taught. Zeese does not disclose exact dimensions of the sheet, hence a person of skill in the art could optimize the dimensions of the nonwoven sheet to various sizes.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zeese (US20220403303A1) as applied to claims 1-2, 6-8, 10-11, in view of Patel et. al (US20160317400A1) hereinafter Patel.
The general teachings of Zeese are recited above. With regards to claim 3, Zeese teaches the use of carboxymethylcelluloses and salts thereof in the fiber of the film (see [0041]). It is known in the art that NaCMC is a salt of carboxymethylcellulose. Zeese does not explicitly disclose 1-15 wt% of NaCMC to be present in the final composition.
Patel teaches a teaches a single layer film formed from hydroxyalkyl cellulose and polyvinyl acetate, which can further comprise water, corn starch, surfactants, and emulsifiers (see [0019]). The use of polyvinyl alcohol (PVA) is not required, hence the composition can be formulated free of PVA. Patel also teaches 1-5 wt%, and more preferably about 1-3 wt%, of NaCMC in the composition as a thickening material (see [0044]-[0045]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to add 1-5 wt% of NaCMC as taught by Patel to Zeese’s nonwoven sheet for the benefit of providing a desirable consistency and stabilizing the performance of the formulation (see [0044]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zeese (US20220403303A1) as applied to claims 1-2, 6-8, 10-11, in view of Xu et. al (US20240052276A9) hereinafter Xu, further in view of Patel (US20160317400A1).
The general teachings of Zeese are recited above. With regards to claim 9, Zeese teaches enzymes (which can include protease, amylase, lipase, and others) to be present in in the nonwoven film in at least 1 wt% and glycerin to be present in 10 wt% (see [0064]-[0065]; see also [0079]). Additionally, Zeese generally teaches the amount of surfactant in the composition can range from 10-40 wt% but fails to disclose the breakdown ranges of nonionic vs anionic surfactant (see [0061]). Zeese also does not explicitly state the presence of 25-55 wt% cellulose, 1-15 wt% cellulose derivative, 0.5-8 wt% starch, 0.01-0.5 wt% preservative, and 1-20 wt% water in the film.
Xu teaches a dissolvable, porous sheet containing cationic surfactant which further comprises cellulose derivatives such as hydroxypropylmethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, methylcellulose, and carboxymethylcellulose polymers (see Abstract; see also [0052]). The use of polyvinyl alcohol (PVA) is not required, hence the composition can be formulated free of PVA. Xu explicitly discloses the use of anionic surfactants from 1-10 wt% and nonionic surfactants from 10-20 wt% and 1-5 wt% starch in the sheet article (see [0095]; see also [0099]; see also [0057]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Zeese’s non-woven water-soluble film with 1-10 wt% anionic surfactant and 10-20 wt% nonionic surfactant as taught by Xu for the benefit of an improved dissolution profile of the sheet film (see [0099]). The person of ordinary skill in the art would further modify Zeese’s invention with 1-5 wt% starch as taught by Xu for the benefit of reducing the overall level of water-soluble polymers required in the film (see [0057]). Xu however, fails to disclose the presence of 25-55 wt% cellulose, 1-15 wt% cellulose derivative, 0.01-0.5 wt% preservative, and 1-20 wt% water in the sheet.
The general teachings of Patel are recited above. Patel teaches the hydroxyalkyl cellulose to be incorporated in the film matrix in 10-60 wt% and 20-32 wt% water in the film (see [0028]; see also [0006]). NaCMC can range from about 1-5 wt%, and more preferably about 1-3 wt% in the composition (see [0044]-[0045]). Patel also teaches the presence of an antibacterial agent (a preservative) in about 0.05-2 wt% of the composition (see [0055]).
It would have been obvious to one with ordinary skill in the art before the effective filing date to further modify Zeese’s invention in view of Xu with the 10-60 wt% hydroxyalkyl cellulose film matrix, 20-32 wt% water, and 1-5 wt% NaCMC as taught by Patel. The person of ordinary skill in the art would be motivated to make this modification for the benefit of increasing sheet stability (see [0029]; see also [0036]; see also [0044]). The person of ordinary skill in the art would also further modify Zeese’s invention in view of Xu with 0.05-2 wt% of an antibacterial preservative to add a therapeutic function to the nonwoven film composition (see [0014]). A prima facie case of obviousness exists because the claimed ranges "overlap or lie inside ranges disclosed by the prior art", see In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976; In re Woodruff; 919 F.2d 1575,16USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I).
Claims 1-2, 5, 7, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia et. al (US20180014568A1) hereinafter Garcia, as evidenced by Heinrich (US2048624A).
With regards to claim 1, Garcia teaches an ingestible nonwoven fabric composite comprising of tobacco material, the active ingredient herein being nicotine (see Abstract). The tobacco containing fabric can be made by carding methods to generate a nonwoven web of fibers with the desired porosity, thickness, fiber composition (see [0008]). The composite can be in the form of a pouch or sachet which dissolves in the user’s mouth upon contact with saliva and releases the water-soluble components (see [0004]). The fibers can comprise of polymers of cellulose esters, cellulose acetate with imbedded starch particles, cellulose coated with acetyl groups, thermoplastic cellulose, starch and starch derivatives, polysaccharides, among others (see [0025]; see also [0041]). Polyvinyl alcohol (PVA) is listed as a suitable polymer for the composition of fibers, but it is not required in the fiber of the nonwoven composite and need not be present. Garcia also teaches the additional inclusion of sodium carboxymethylcellulose (NaCMC) and other modified cellulosic types of binders in the tobacco composite (see [0051]).
Although Garcia does not teach the above limitations in a single embodiment to a point of anticipation, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate a NaCMC binder to the cellulose fiber nonwoven tobacco composite. The person of ordinary skill in the art would reasonably expect this modification to impart strength to the resulting fabric (see [0040]-[0041]).
With regards to claim 3, Garcia teaches the use of NaCMC as a biodegradable binder in the composition (see [0051]).
With regards to claim 5, Garcia teaches the additional use of corn starch as an organic filler, starch-based binders, and sodium starch glycolate, and pregelatinized corn starch as disintegration aids (see [0051]). Garcia also teaches the incorporation of a flavorant, binder, sweetener, colorant, filler, salt, pH buffering agent, preservative, polymeric material, liquid food binder (e.g., pectin), or combinations thereof (see [0080]).
With regards to claim 6, Garcia teaches the use of glycerin as a humectant in the composite (see [0051]).
With regards to claim 10, Garcia teaches a tobacco composite in the form of a pouch or sachet which dissolves in the user’s mouth upon contact with saliva and releases the water-soluble components (see [0004]). As evidenced by Heinrich, nicotine is soluble in water (see Column 1, lines 48-50). It is also known in the art that glycerin is soluble in water. A person of ordinary skill in the art before the effective filing date would reasonably expect the active ingredient to be released from the composite upon contact when exposed to water (which is present in saliva).
With regards to claim 12, Garcia teaches the thickness of the tobacco containing fabric to range from 5μm-5mm to provide rigidity, strength, and support to the composition (see [0050]).
With regards to claim 13, Garcia teaches the natural fibers from wood pulp and cellulose structural fibers can be used in the production of wet-laid nonwovens (see [0068]). Wood pulp is naturally derived from either hardwood or soft wood.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA PAUL whose telephone number is (571)272-1551. The examiner can normally be reached M-F: 7:30am-5:00pm.
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/SP/ Patent Examiner, Art Unit 1761
/ANGELA C BROWN-PETTIGREW/ Supervisory Patent Examiner, Art Unit 1761
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