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 amendment and remarks filed 04/09/2026.
Claims 22, 23 and 36 are amended.
Claim 39 is canceled.
New claim 40 is added.
Claims 22-38 and 40 are pending.
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 § 112
The rejection of claims 23 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendment to claim 23 and the cancelation of claim 39.
Claim Rejections - 35 USC § 101
The rejection of claim 39 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn because claim 39 is canceled.
Claim Rejections - 35 USC § 103
For the rejection under 35 U.S.C. 103, applicant argues that Gerardi does not teach and Reddick and Begin do not remedy Gerardi’s failure to teach the claimed pouch comprising saliva-driven, kinetically coordinated dual-release system that functionally and kinetically coordinates the release of the active ingredient composition and the disappearance of the imprint, such that the imprint is configured to act as a real-time visual indicator; that the disappearance of the imprint on the pouch corresponds to the release of active ingredient “such that when the imprint on the pouch is no longer visually perceptible, the active ingredient composition is nearly completely.” Applicant further argues that Reddick and Begin are silent with regard to the dissolution behavior of the imprint; Reddick and Begin do not disclose, teach or suggest any coordination between imprint disappearance and active ingredient release; that the combination of the prior art does not contemplate using the imprint as a real time visual indicator of the amount of active ingredient that has been consumed from the composition.
Response: Claim 22 is amended to state that the active ingredient, which is part of the pouch, is configured to be released into saliva according to defined kinetics over a given exposure. However, a pouch having a certain shape containing active agent reads on a composition comprising active agent that is configured to release the active agent contained in the pouch. Claim 22 is directed to a product/composition and release of the active agent defined by dissolution kinetics over given exposure time in the oral cavity does not define the structure of the composition but relates to the inherent characteristic behavior of the active agent loaded pouch. Claim 22 is also amendment to say that the imprint comprises saliva soluble material having a dissolution rate. A pouch/pouch sleeve made of cellulose and an imprinted would inherently be soluble in saliva and inherently have a dissolution rate and the fact that the material is soluble in saliva implies that the imprinted material has a dissolution rate. Further, the imprinted material dissolving in the saliva implies that the imprint is disappearing and as it disappears in the process of dissolution, the imprint would not be visible compared to the imprint before dissolution. Reddick and Begin were not relied upon for teaching dissolution behavior of the imprint but were relied upon for teaching that pouches are printed with food-safe inks (Begin, page 4, lines 17 and 20), and 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).
Therefore, the rejection under 35 U.S.C. 103 is maintained below.
Maintained Rejection
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) 22-38 remain rejected and new claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over GERARDI et al., (WO 2021116825 A1, publication date 06/17/2021) in view of REDDICK et al. (WO 2014164509 A1) and BEGIN et al. (WO 2020014665 A1) for reasons of record with minor modification to address the amendment.
Claim 22 is amended to state that the active ingredient, which is part of the pouch, is configured to be released into saliva according to defined kinetics over a given exposure. However, a pouch having a certain shape containing active agent reads on a composition comprising active agent that is configured to release the active agent contained in the pouch. Claim 22 is directed to a product/composition and release of the active agent defined by dissolution kinetics over given exposure time in the oral cavity does not define the structure of the composition but relates to the inherent characteristic behavior of the active agent loaded pouch. Claim 22 is also amendment to say that the imprint comprises saliva soluble material having a dissolution rate. A pouch/pouch sleeve made of cellulose and an imprinted would inherently be soluble in saliva and inherently have a dissolution rate and the fact that the material is soluble in saliva implies that the imprinted material has a dissolution rate. Further, the imprinted material dissolving in the saliva implies that the imprint is disappearing and as it disappears in the process of dissolution, the imprint would not be visible compared to the imprint before dissolution. The amendment to claims 23 and 36 do not change the scope of these claims.
Claim 22 is a pouch/pouch sleeve comprising caffeine and taurine as active agent. The material of the pouch sleeve is permeable to saliva. The outside /exterior surface of the pouch/pouch sleeve is labeled with food-safe ink. An oral product comprising an active ingredient is inherently characterized to be placed in the oral cavity or oral vestibule.
Using the as filed disclosure as a dictionary shows that the material for the pouch is made of non-woven material is a cellulose (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.
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.
For claims 22 and 23 and 31 and new claim 40 as vitamin B6 and B12 in GERARDI meets the limitation of the claim, GERARDI does not teach that the pouch is imprinted. However, it is known that medicinal tablets/capsules and/or pouches are imprinted as identification. For example, 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). Furthermore, 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 REDDICK and BEGIN would have been motivated to print label the pouch of GERARDI with food-safe inking with the expectation of predictably identifying the product. Thus, a pouch/pouch sleeve made of cellulose would inherently be permeable to saliva providing extraction of the active agent.
For claim 24, GERARDI 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 16, lines 7-9) and the hydrochloride salt is formed from hydrochloric acid which is gastric acid.
For claim 25 and 26, the pouch of GERARDI containing active agents taurine, caffeine, vitamin B12, vitamin B6 and vitamin C, and flavoring agent or sweetener or humectant (page 3, lines 27-30) is configured for oral use 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 particles of the particulate material are substantially spherical or granular (page 45, lines 15-16).
For claim 28, the product/granular product comprises cellulose fiber pulp (claims 3, 4, page 2, lines 30, 33).
For claims 32, 33, 34 and 35, the non-woven material comprising cellulose fibers, viscose fibers (page 27, lines 17, 20, 23) and pouch is sealable (page 27, line 21, page 49, line 1) meet 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. Claim 31 has been described above as being rendered prima facie obvious over GERARDI in view of REDDICK and BEGIN. “[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.
For claim 38, the saliva permeable pouch/pouch sleeve of GERARDI that 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 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. It is the placing of the pouch in the oral cavity/vestibule that results in the absorption of the active ingredients.
For claim 39, the placing of the pouch/pouch sleeve in the oral cavity/vestibule leads to the extraction of the active ingredients.
Therefore, GERARDI in combination with REDDICK and BEGIN renders claims 22-38 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.
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.
The rejection of new claim 40 is necessitated by the amendment
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).
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
Prosecution Insights