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 .
Receipt is acknowledged for request for continued examination under 37 CFR 1.114, amendment and remarks filed 07/30/2026.
Claims 22, 32, 34-36 and 38 are amended.
Claim 31 is canceled.
Claims 22-30, 32-38 and 40 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/30/3036 has been entered.
Priority
This application is a 371 of PCT/EP2022/067658 filed 06/28/2022 and which claims benefit of EPO application 21183308.2 filed 07/01/2021.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant argues that Gerardi does not teach that the pouch is imprinted; that Reddick and Begin do not cure the shortcomings of Gerardi; that Reddick and Begin do not disclose, teach or suggest "wherein the saliva permeability of the pouch sleeve and the saliva removability of the imprint are constituted such that the food-safe ink of the imprint progressively fades during oral use and becomes no longer visually perceptible upon substantial or complete extraction of the active ingredient composition from the pouch, and wherein the imprint acts as a visual indicator of a consumption status of the active ingredient composition" now recited in amended claim 22; that rather, Reddick and Begin are directed to labeling or identification and not to an imprint that is a visual indicator of consumption status of the active ingredient contained in the pouch. Applicant further argues that a “marking for identification on a pouch serves different purpose from a marking intentionally configured to visually indicate consumption status of the contents of the pouch.” That the office has treated saliva permeability, saliva solubility, controlled wash-off or fading as the same while these properties are different; and that a material may be saliva-permeable without an exterior imprint necessarily fading or in the claimed manner or at the claimed stage of use and that none of the cited references teaches coordinating the fading of imprint on the pouch and the releasing of the active ingredient from the pouch.
Response: 1st, the examiner agrees that Gerardi does not teach that the pouch is imprinted and that was the reason for making the rejection under 35 USC 103 relying on Reddick and Begin to remedy the deficiency of Gerartdi. The examiner also agrees that REDDICK teaches that nicotine containing pouches are imprinted with product information for identification. Begin was relied upon for teaching using food-safe inks to print on pouches. There is no teaching in Begin that the food-safe ink on a pouch placed in the mouth/oral cavity or between the lower lip and upper lip would not dissolve when it comes in contact with saliva in the oral cavity. Further, claim 22 is a product claim and similar product of the prior that is placed in the oral cavity or between the lower lip and upper lip would be expected to predictably undergo the same faith.
The examiner also agrees with applicant that saliva permeability, saliva solubility, controlled wash-off or fading are properties of the pouch containing caffeine/taurine, vitamin, and sweetener. The examiner’s position is that prior art pouch comprising caffeine and taurine and vitamin having imprinted food-safe ink, be it for identification would release the active agent when saliva in the oral cavity contacts it. A food-safe ink would also fade as time progresses. Applicant has not factually shown that a prior art pouch containing caffeine, taurine and vitamin placed in the oral cavity and contacted by the saliva of the mouth/oral cavity would not be permeable to saliva, would not be soluble in the saliva and the food-sake ink printed on the pouch would not fade with time. These properties, saliva permeability, saliva solubility, controlled wash-off or fading do not have to be the same, but the product, in this case, pouch constructed from cellulose, non-woven fiber/material, and comprising caffeine, taurine and vitamin inherently has all these properties absent a showing that it would not. And because the printed ink is on the pouch, it is reasonable to expect that as saliva permeates the pouch which results in dissolution and release of the actives, the food-safe ink print would also fade away with time. The claims are not directed to monitoring how long the food-safe ink fades or correlation of the extent of ink-fade with how much active is released within the time period. The claims are not directed to controlled wash-off or fading of food-safe ink imprinted on a pouch or controlled release of active; and the claims have not recited the excipients responsible for controlling the release of the actives or wash-off or fading.
While marking for identification may not be the same as marking that tracks active agent release, it would be expected that a pouch imprinted with food-safe ink for any purpose when placed in contact with saliva in the oral cavity/mouth would inherently dissolve and as it dissolves, the intensity of the food-safe ink would fade.
Based on applicant’s desire to preserve the “Doctrine of Equivalents,” applicant states that amendment to the claims is not related to patentability.
Response: The examiner notes.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 22-30, 32-38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over HUTCHENS et al., (WO 2021116895 A2, publication date 06/17/2021) in view of BEGIN et al. (WO 2020014665 A1).
Claim 22 is currently amended to say that the nonwoven is saliva-permeable. Claim 22 is also amended to state "wherein the saliva permeability of the pouch sleeve and the saliva removability of the imprint are constituted such that the food-safe ink of the imprint progressively fades during oral use and becomes no longer visually perceptible upon substantial or complete extraction of the active ingredient composition from the pouch, and wherein the imprint acts as a visual indicator of a consumption status of the active ingredient composition."
Using the as filed disclosure as a dictionary shows that the material for the pouch is made cellulose non-woven material (see at least paragraph [0039], and the abstract of EP 3 192 380 B1 cited by in the as filed disclosure and incorporated therein in paragraph [0035]). Thus, a pouch/pouch sleeve made of cellulose would inherently be permeable to saliva.
An oral product comprising an active ingredient is inherently characterized to be placed in the oral cavity or oral vestibule.
Permeability of the pouch sleeve to saliva and the progressive fading of the food-safe ink during oral use is characteristic property of the pouch and as the saliva permeates the pouch during oral use, the pouch inherently releases the active and the food-safe ink on the pouch progressively fades in response to the action of the saliva on the material of the pouch. Because, the pouch imprinted with food-safe ink and containing the actives and in contact with saliva releases the actives and the food-safe ink progressively fades/diminishes in color intensity, the fading of the ink-print when visually examined is inherently indicative of the movement of actives out from the pouch into the surrounding --- characteristic property.
For claims 22 and 23 and 38 and claim 40 as vitamin B6 and B12, HUTCHENS teaches pouch comprising chromogenic material or electronic component and where the chromogenic material and electronic component are responsive to stimuli (page 2, lines 5-7) and the pouch is configured for oral use (see at least page 2, lines 16, 32, 33-35); the pouch comprises taurine and caffeine in one embodiment (page 13, lines 26-31) and combination of vitamins B6, B12, C and E (page 14, lines 13-26). HUTCHENS teaches that saliva in the mouth of the user during use causes one or more of the active ingredient and/or flavoring agent to pass into mouth of the user and the pouch comprising the composition is dissolvable (page 27, lines 24-35) and that in one aspect, the dissolvable product is capable of lasting in user’s mouth for a given period for given period of time until it completely dissolves and the dissolvable product is capable of lasting in the mouth for a period of time until it completely dissolves with the dissolution rate varying over a wide range from 1 to 60 minutes (page 28, lines 1-22). The pouch is based on cellulose based material (page 18, line 23; page 19, lines 18-20). The pouch/pouch sleeve is permeable to saliva such that the saliva and the active ingredients in the pouch make contact. It is the placing of the pouch in the oral cavity/vestibule that results in the absorption of the active ingredients.
HUTCHENS teaches printing chromogenic material onto the porous pouch (page 2, lines 8-13; page 3, lines 13-22, 30-31; page 7, lines 20-25; page 8, lines 19-20; claim 4). The chromogenic material is a leuco dyes (page 6, lines 3-23) and the leuco dyes are generally used in combination with pigments (page 7, lines 7-27).
HITCHENS differs from the claims because HUTCHENS does not use food-safe ink for printing.
However, Begin teaches that pouches are printed with food-safe inks (page 4, lines 17 and 20).
Therefore, before the effective date of the invention, the ordinary skilled artisan guided by the teachings of HUTCHENS and BEGIN would have been motivated to print the pouch of HUTCHENS with food-safe ink with the expectation of that the ink is orally/food safe and would not be toxic and suitable for oral use. Thus, a pouch/pouch sleeve made of cellulose would inherently be permeable to saliva providing extraction of the active agent.
For claim 24, HUTCHENS teaches that in some embodiment, the active agent is nicotine and can be present as salt and specifically as hydrochloride salt or dihydrochloride salt (page 4, lines 29-31; page 10, lines 8-15; page 16, lines 5-13) and the hydrochloride salt is formed from hydrochloric acid which is gastric acid.
For claim 25 and 26, the pouch of HUTCHENs containing active agents taurine, caffeine, vitamin B12, vitamin B6 and vitamin C, and flavoring agent or sweetener or humectant (page 13, lines 26-31; page 14, lines 13-26) and the pouch is configured for oral use (page 1, line 3; page 2, line 6; page 3, lines 25-26) meeting the requirement of claim 25. The active agent being released until an end of the given exposure and the giving exposure time of up to one hour is the characteristic of the product.
For claims 27 and 29 and 30, in some embodiments, the granules include fillers, caffeine, taurine, sweeteners (page 18, lines 8-29; page 23, line31; page 24, lines 9 and 14)
For claim 28, the product/granular product comprises cellulose fiber pulp (page 23, lines 30-31; page 29, lines 24-31).
For claims 32, 33, 34 and 35, the non-woven material comprising cellulose fibers, viscose fibers (page 3, lines 3-10; page 4, lines 18-16 and claims 19-21) meeting the requirement of the claims.
For claim 36, claim 36 (i) to (iv) teach the method of making the pouch according to claim 36 and thus claim 36 is a product by process claim. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
For claim 37, when the material is porous and cellulose based (page 5, line 28), the requirement of claim 37 is met.
Therefore, HUTCHENS in combination with BEGIN renders claims 22-30, 32-38 and 40 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Prior art of Interest:
GERARDI et al., (WO 2021226825 A1, publication date 06/17/2021): GERARDI discloses saliva permeable pouch/pouch sleeve made of moisture permeable non-woven fabric namely cellulose fibers (see the whole documents with emphasis page 1, lines 1-4; page 2, lines 12-14;) which is configured for oral use (page 25, lines 9-21); the permeable pouch/pouch sleeve comprises caffeine and taurine, vitamins B6 and B12 and C as active agents (page 10, lines 9-16; page 13, lines 26-27; paragraph bridging pages 13 and 14). The pouch/pouch sleeve is permeable to saliva such that the saliva and the active ingredients in the pouch make contact.
REDDICK et al. (WO 2014164509 A1): REDDICK teaches that nicotine containing pouches are imprinted with product information for identification (see the whole document with emphasis on the abstract, page 4, lines 8, 20-26, 29 and 34; page 5, lines 1-3; page 5, 23-27; page 14, lines 11-13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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