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 .
Status of the Claims
Claims 1-45 are pending in a Response of 07/02/2026 and claims 36-45 have been withdrawn by way of applicant’s election of 08/05/2024. Thus, claims 1-35 are being examined.
Information Disclosure Statement
The two (2) information disclosure statement (IDS) submitted on 06/30/2026 and 07/16/2026 were filed after the mailing date of the Action on 05/06/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn objection/ rejections:
Applicant's amendments and arguments filed 07/02/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the limitations of claims 7-10 are not found in the specification.
New Grounds of Rejection --- as necessitated by IDS
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Claims 1-3, 6-15, 17-21, 23-25, 28-31 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Winterson et al. (US9044049B2, IDS of 06/30/2026, citation is obtained from its corresponding US publication 2007/0261707A1) in view of Jonsson et al. (US2006/0147498A1, of record).
Applicant claims the below claims 1 and 31 filed on 07/02/2026:
PNG
media_image1.png
293
848
media_image1.png
Greyscale
PNG
media_image2.png
345
846
media_image2.png
Greyscale
For examination purpose, each system of instant claims 1 and 31 is directed to a product. Thus, the limitations of “the matrix is printed on the paper-based substrate” of claims 1 and 31, “the matrix is printed on the substrate via screen printing” of claim 23, and “the first liquid mixture and the second liquid mixtures are separately printed on the paper-based substrate” of instant claim 35 relate to how the printed matrix is made, and thus they are product-by-process limitations, which does not structurally limit the claimed system; and thus they are interpreted to recite “the matrix placed on the paper-based substrate” (claims 1, 23 and 31) and “the first liquid mixture and the second liquid mixture are separately placed on the paper-based substrate” (claim 35). Those limitations are not seen as structurally limiting the instant composition because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113 reads “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”.
And the limitations of “the paper-based substrate, having the matrix placed thereon, fits on a user’s gum” (claim 1), “a user can easily tear off a portion providing an individual dose of the active ingredient component” (claim 26), “it fits on a user’s gums without forming a protrusion that is visible on the user’s face” (claim 28), and “the multiple connected segments are connected to allow a user to easily separate a segment of the multiple connected segments of the paper-based substrate having matrix printed thereon” (claim 31) are intended uses and/or properties. Particularly, an intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, those intended use/properties limitations do not carry patentable weight, and it is seen that the claimed system would implicitly have those intended uses/properties.
Prior Art
Winterson discloses a pouched tobacco product which reads on the claimed nicotine because tobacco contains nicotine naturally, comprising: a lined pouch material comprising: a web; and a water-soluble liner adjacent said web; and a tobacco component at a moisture content of 10 to 15% contained within said lined pouch material (abstract and claim 1 of prior art); the web is constructed from cellulose fiber such as tea bag material that reads on the claimed paper-based substrate comprising fibers ([0022]) and additionally can contain cotton, etc. ([0019]), and Winterson does not expressly teach the amounts of cellulose and cotton in substrate of instant claims 7-10. However, paper is made of cellulose fibres, and this prior art teaches the fibres are made of cellulose and additionally cotton can be added and therefore, the ordinary artisan would optimize the relative amounts of cotton and cellulose pulp of paper-based sheet, depending on the intended purpose, type of nicotine-containing product, the amounts of nicotine and carrier, sheet dimensions, etc., in the absence of criticality of the ranges of instant claims 7-10 (instant claims 7-10); the prior art remains silent about viscose fibers; the liner may comprises antioxidant such as ascorbic acid, vitamin E, etc. [0068] that reads on the claimed active ingredient, and flavorants ([0061]) that reads on the claimed carrier, and sweetener ([0060]), and thus, the liner reads on the claimed matrix, or the combination of tobacco (elected species of active ingredient) and liner may read on the claimed matrix because the instant publication at [0018] refers “matrix” to a combination of substances including one or more active ingredient components, one or more fluid or solid carriers, one or more flavor components, a softening agent, viscosity regulators, and one or more sweeteners; the liner is coated on the web prior to assembly of the pouched tobacco product wherein the coating thickness can be only a few microns and up to 1 cm ([0027] and [0056]), the coating is performed by gravure printing ([0056]), and the thickness of the web can be varied to achieve desired levels of solubility ([0025]) (instant claims 1, and 31, in part, and instant claims 6, 11, 13-15, 17, 19, 23, 28 and 29); the liner can contain food-grade plasticizer such as glycerin and sorbitol ([0054], [0060] and [0065]) that reads on the claimed softening agent (instant claims 2, 3, 33 and 34), sweetener and flavorant ([0060])(instant claim 30); and humectant such as propylene glycol ([0049])(instant claims 18 and 21); the liner can be chosen to provide rapid flavor release (i.e., immediate or a few seconds) or provide a long lasting, time-release flavor (i.e., prolonged up to several minutes and having the property of retarded or gradual dissolution in water to produce a sustained effect) ([0031])(instant claim 20); the moisture content of the tobacco can be maintained between about 5 to about 6% ([0052]) that overlaps the instant range of greater than 20% or 35-75%(instant claims 24-25).
However, Winterson does not expressly teach thickness of substrate of instant claims 1, 12 and 31. The deficiency is cured by Jonsson.
Jonsson discloses composition material for transmucosal delivery (title); in particular, this prior art refers to the composition material is for a highly efficient transmucosal delivery in the mouth of biologically active substance(s), a pouch containing the composition material as well as an envelope for the composition material or the pouch ([0001]); the biologically active substance includes nicotine ([0036]); the composition material can be in the form of a sheet (e.g., [0070]) wherein the sheet can be made from cellulose ([0074]), and the sheet conforms to a shape in mouth, and the length can be 15-30mm and thickness can be less than 5 mm, such as between 0.5 and 3 mm ([0072]) which overlaps the claimed range of at least 1 mm to at most 3 mm (instant claims 1, 12 and 31 - substrate height dimension). MPEP 2144.05. MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It would have been obvious to modify the teachings of Winterson with small size of film substrate of Jonsson in order that the film substrate can be readily placed in the user’s oral cavity and Jansson discloses overlapping thickness of sheet.
Claims 4, 5, 16, 22, 26, 27, 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Winterson et al. (US9044049B2, IDS of 07/02/2026, citation is obtained from its corresponding US publication 2007/0261707A1) in view of by Kaiserman et al. (WO2021/045753A1, IDS of 06/30/2026).
However, Winterson/Jonsson do not expressly teach the amounts of carrier e.g., glycerin, flavorant and active ingredient of instant claims 4, 5, 16 and 22; perforations of instant claims 27 and 32; and multiple layers of instant claims 26 and 35. The deficiencies are cured by Kaiserman.
Kaiserman discloses printed delivery device includes a support substrate, a first printed composition including a first supplement is coated onto the support substrate, and a second printed composition disposed on the first printed composition (abstract); the support substrate may be non-dissolvable release liner, and made of paper ([0050]) which is biodegradable; the support substrate can be multiple layers ([0048] and Fig. 2D); the printed delivery device may include one or more layers comprised of printed compositions and each layer may include active or inactive ingredients such as one or more supplements or pharmaceuticals ([0027]-[0028]) (instant claims 26 and 35); the printed delivery device can be made using any number of printing techniques, for example, screening printing, rotary screening printing, etc. ([0062]); dimensions and shapes of the device depend on the application ([0060]); this prior art discloses one dispensing configuration may be continuous tape with perforations for tearing ([0055]) (instant clams 27 and 32); the active ingredient includes THC, CBD, hemp oil or other foils in an amount of 10%, or more or less of the overall composition that may overlap the claimed range of about 0.02 to about 30%, and inactive ingredients include flavorings, sweeteners, viscosity modifiers, or other fillers such as flow aids including food grade glycols, polyglycols, xylitol and glycerol ([0038] and [0075]) in an amount of 27%, or more or less ([0075]) that may overlaps the instant range of 2-60% or 15-45% of glycerin, about 0.2 to about 15% of flavoring agent. MPEP 2144.05. MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (instant claims 4, 5, 16 and 22).
It would have been obvious to modify the teachings of Winterson with multiple substrate layers as a matter of design or choice, and overlapping amounts of active ingredient and carriers of Kaiserman would be optimized to obtain the claimed ranges.
It would have been obvious to modify the teachings of Winterson with paper sheet having perforations of Kaiserman in order to provide easy use with safety without the need of cutting tools or dispersers while keeping the sheet sterile and contained before use.
Conclusion
All the examined claims are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 07/02/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. 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.
/KYUNG S CHANG/Primary Examiner, Art Unit 1613
Prosecution Insights