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 .
Status of the Application
This Office Action is in response to applicant’s arguments filed on 5/14/26. Claims 1-24, 26, 36-38, 41-43, 47-49 have been cancelled. Claims 25, 27-35, 39-40, 44-46 are pending. Claims 44-46 have been withdrawn. Claim 25 has been amended. Claims 25, 27-35, 39-40 are examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejection of the last Office Action is maintained for reasons of record and repeated below for Applicant’s convenience.
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 25, 27-35, 39-40 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-16 of copending Application No. 17/922,623 in view of Redmond et al. (US Patent Application 2010/0158988 A1, of record). The fact pattern is the same as the 103 obviousness rejection below. The limitation “pouch” is given little patentable weight since it is considered preamble or intended use of a composition.This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 25, 27-35, 39-40 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-23 of copending Application No. 18/265,921 in view of Redmond et al. (US Patent Application 2010/0158988 A1, of record). The fact pattern is the same as the 103 obviousness rejection below. The limitation “pouch” is given little patentable weight since it is considered preamble or intended use of a composition. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant argues that the claimed composition is in the form of a pouch, which is “cohesive, homogenous” to provide “a controllable and desirable release profile of the active agent when in contact with the oral or nasal cavity,” whereas the referenced claims are in the form of a film/coating.
This is not persuasive because nothing the claims recite any substance or material that would distinguish it from being a pouch or not.
The arguments directed to β-glucan will be addressed below in the 103 rejection.
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 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.
Claims 25, 27-35, 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hubinette et al. (WO 2010/104464, of record) in view of Redmond et al. (US Patent Application 2010/0158988 A1, of record).
The instant claims are directed to a pouch comprising a composition comprising water, a biologically active agent (nicotine), β-glucan, and a filling agent.
Hubinette et al. teach a semi-permeable pouch designed for delivery of an active agent in the oral cavity of a subject comprising multiple particles, such as sodium alginate, and the active agents, nicotine (abstract) and antioxidants (page 14, lines 15-18). Fillers, such as microcrystalline cellulose (or plant fiber), can be added to the pouch (page 15, lines 7-9). Flavoring agents, taste maskers, plasticizers, gums, and sweeteners (or polyols), such as sorbitol, xylitol, and mannitol are taught (page 16, lines 1-20). Examples 6-8 show a composition comprising 5.5 g of nicotine, 3 g of sorbitol, and 80 or 150 g of aqueous potassium phosphate buffer with pH 8.5.
However, Hubinette et al. fail to disclose β glucans and the specific amounts of water.
Redmond et al. teaches compositions comprising cereal β (1-3) β (1-4) glucans together with pharmaceutical, medicinal, and therapeutic agents (paragraph 0002), for example nicotine (paragraph 0125) for oral use (paragraph 0114). Cereal β (1-3) β (1-4) glucans are distinctive polymers of glucose that forms a matrix to sequester pharmaceutical, medical, and therapeutic agents for delivery in the mouth (abstract). In a preferred embodiment, the glucan and compound of interest are mixed and left undisturbed for a period of time sufficient to form a homogenous composition or a homogenous emulsion. In an another embodiment, an aqueous solution is formed (paragraphs 0030-0032). The compositions can also be in the form of a tablet, capsule, floss (paragraph 0048), films (paragraph 0090), and powders (paragraph 0074). The amount of glucan can range from 5 to 50 wt% (paragraph 0082) and the amount of pharmaceutical, medicinal, and therapeutic agent can range from 0.0001 to 50 wt% (paragraph 0083). Other gums, such as those listed in Table 2, are taught (paragraph 0012). By “gum” Redmond et al. means a plant or microbial polysaccharide or their derivatives that are dispersible in either cold or hot water to produce viscous mixtures or solutions, and may be classified by origin: exudate gums, seaweed gums, seed gums, starch and cellulose derivative, and microbial gums (paragraph 0061). Sorbitol esters (filling agent) and other surfactants, such as Atmos 300 and Polysorbate 80 (paragraph 0111), flavouring agents (paragraph 0090), sweeteners (paragraphs 0094-0098), and methyl cellulose (tables 1-2) are taught. The amount of surfactants can be from 0.1 to 15% by weight (paragraph 0111).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used cereal β (1-3) β (1-4) glucan in an aqueous solution, as taught by Redmond et al., to sequester nicotine in a pouch, as taught by Hubinette et al.
A person of ordinary skill in the art would have been motivated to use cereal β (1-3) β (1-4) glucan in an aqueous solution to sequester nicotine in a pouch because both Redmond and Hubinette et al. teach pharmaceutical compositions comprising nicotine for oral delivery. Furthermore, Redmond et al. teach that cereal β (1-3) β (1-4) glucans are known to sequester pharmaceutically active agents, such as nicotine, in a matrix with water to form various homogenous compositions that are effective to orally deliver the pharmaceutical. Therefore, the skilled artisan would have had a reasonable expectation of success in forming a pouch comprising nicotine, cereal β (1-3) β (1-4) glucan, sorbitol, microcrystalline cellulose, and water for delivery to the oral cavity.
Furthermore, it would have been obvious to optimize the amount of water to 30-60 wt% because both Redmond and Hubinette et al. teach pharmaceutical compositions comprising water. Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382; lt has been held that it is within the skills in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. In re Boesch, 205 USPQ 215 (CCPA 1980) MPEP 2114.04
Response to Arguments
Applicant argues that neither Hubinette nor Redmond teaches the water content as claimed since they are drawn to dried structures, rather than a wet pouch comprising 30-60 wt% of water.
This is not persuasive because both references teach aqueous compositions. For example, Hubinette teaches in Example 6-8 a composition comprising 5.5 g of nicotine, 3 g of sorbitol, and 80 or 150 g of aqueous potassium phosphate buffer. Redmond also teaches that in another embodiment, an aqueous solution is formed (paragraphs 0030-0032).
Applicant argues that neither Hubinette nor Redmond teaches less than 5 wt% of β-glucan content as claimed.
This is not persuasive because Redmond clearly teaches that the amount of glucan can range from 5 to 50 wt% (paragraph 0082). Therefore, the skilled artisan would view a change from 5 wt% to 4.9 or just under 5 wt% to be obvious through routine optimization.
Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382; lt has been held that it is within the skills in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. In re Boesch, 205 USPQ 215 (CCPA 1980) MPEP 2114.04
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 extension fee 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 Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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