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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/20/26 has been entered.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 1/6/26. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Response to Argument
The response filed on 2/20/26 has been entered.
Applicant’s arguments filed 2/20/26 have been fully considered but they are not deemed to be persuasive.
Claims 1-5, 7-10, 12-16 and 18-24 are pending in this office action.
The response filed on 2/20/26 presents remarks and arguments to the office action mailed on 11/21/25. Applicant’s request for reconsideration of the rejection of claims in the last office action has been considered.
Applicant’s arguments have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Modified Claim Rejections - 35 USC § 103 necessitated by Amendment
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.
The factual inquiries 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.
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 1-5, 7-10, 12-16 and 18-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Victor et al. (US 2016/0324777) in view of Yucel et al. (WO 2019036243) and Hang (US 20070184093) and further in view of Gao et al. (US 20150098996) and Repaka et al. (US 2017/0172995) and further in view of Anderson (US 2009/0196834) and Mua et al. (US 2009/0025738) and as evidenced by Sebastian et al. (US 2012/0103353).
Victor teaches an oral formulation (see abstract) comprising and active ginseng, caffeine (see 0015; 0020, as required by instant claims 1a, 2-3), sweetener (as required by instant claim 5, see 0025) and is nicotine free (see 0015; 0077as required by instant claims 1a and 7) in a pouch (see 0086) with a water content of 10% with water activity of 0.6-0.9 (see 0167, as required by instant claim 1, 8, 19) wherein the composition comprises a cellulose material from plant that is not a tobacco material (see 0010- 0013). Thus the cellulose material is a filler as further recited limited by instant claim 14-15) and will absorb a portion of the filler component (as required by instant claim 14 The reference also teaches with regards to instant claim 4, Victor also teaches that the active agent can or may comprise nicotine (see 0107) and the water present can be less than 5% (as required by instant claim 10, see 0036) with a moisture of less than 6% (see 0027, as required by instant claim 18). Victor also teaches the composition can have humectant such as propylene glycol (as required by instant claim 23, see 0016). Victors teaching fails to teach inclusion of sugar, thus no sugar is included but sweetners as stated above thus sugar free (as required by instant claim 16, see 0025)
However, Victor fails to teach a filler in their composition and fails to teach a buffering agent in an amount less than 5% as required by instant claim 1 and also fails to teach that the filler present is at least 40% by weight of the total weight of the composition and also fails to teach that the pouch is formed of a fleece..
Yucel with regards to instant claim 1, teaches an oral composition (see abstract), a filler (i.e., starch, as required by instant claims 1, 12-13 and 15, see pg. 60, lines 13+) and water less than 10% and less than 5% (see pg. claim 48, therefore the composition has a water activity of about 0.85 or less (as required by instant claims 1, 8 and 10) and will also have a water activity than 0.60 and 0.80, as required by instant claim 9) because claim 1 requires a water content less than 10% and therefore if the water content is less than 10% the water activity will be less than 0.80, 0.60. the recitation of claim 8, since there are several embodiments taught by Yucel, it is anticipated that the formulation comprising caffeine or ginseng do not have nicotine as nicotine was not exemplified. With regards to instant claim 2, Yucel further teaches the active agent can be a caffeine (see pg. 2, lines 33+) and in another embodiment the active agent can be a nicotine (see pg. 14, lines 14, as required by instant claim 4) or the active can also be a ginseng (as required by instant claim 3, see pg. 14, lines 5+) with one or more sweeteners (see pg. 49, lines 5+) and the composition comprises a filler component i.e. starch. Although Yucel per se did not teach that the at least a portion of the active agent is absorbed by at least a portion of the filler, it would have been obvious to one of ordinary skill in the art that the combination of an active agent such as nicotine, a filler such as starch and water less than 10% will have the active absorb some of the filler when mixed absent factual evidence to the contrary (as required by instant claims7 and 14).
Hang teaches an oral formulation in a pouch (see para 0043, as required by instant 11) wherein the active agent is a nutraceutical (see 0015, claim 15).
Gao teaches an oral composition (see abstract) comprising a tobacco free-nicotine (see 0004) comprising sugar free composition (see claim 18, as required by instant claim 16) packaged in a pouch (see 0003).
Repaka teaches with regards to instant claim 1, an oral composition (see claim 5) comprising an active i.e., nicotine (see claim 5), a filler i.e., starch (see 0075) wherein the filler/binder can be in the range of 1-15% (see 0075), thus one of ordinary skill in the art would be “obvious to try”, as the claimed invention would have been obvious to try in view of the fact that the courts have held that “an invention is obvious to try” where the prior art gives either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful, Merck & Co V. Biocraft Laboratories Inc., 10 USPQ2D 1813(Fed. Cir. 1919); In re O’Farrel, 7USPQ2D 1673, 1681 (Fed. Cir. 1988). Repaka further teaches adding water (see Example 3, wherein the q.s of water is 93.99%, thus less than 10% as required by instant claim 1 wherein the amount of buffering agent i.e., potassium carbonate and sodium carbonate together is less than 5% (see same) in one of the embodiments. Repaka also teaches that the filler (starch) is from 1-20% which meets the claim requirement for instant claim 17 (see 0079).
Anderson teaches an oral composition (see 0013) comprising an active agent i.e., caffeine or ginseng (see 0189; 0197), nicotine (see 0144) wherein the filler is from 0-50% (see 0098) thus it would have been obvious to one of ordinary skill in the art would recognize a variable that achieves a recognized result and determine the optimum workable dosage would have been well within the practice of routine experimentation by the skilled artisan.
Mua teaches a smokeless tobacco composition in a pouch, wherein the pouch is fleece that provides a liquid-permeable container of a type that may be considered to be similar in character to the mesh-like type of material that is used for the construction (see 0135; 0146)..Therefore it would have been obvious to one of ordinary skill in the art to be motivated to substitute the pouch taught by Victor above with a reasonable expectation of success because the art recognizes the use of a fleece material that is nonwoven (as evidenced by Sebastian et al. (see 0038)
It would have been obvious to one of ordinary skill in the art to have expanded the teachings of Victor having an oral formulation comprising an active agent such as ginseng for example or caffeine with water activity from 0.6-0.9 (as required by instant claim 19) incorporating the teachings of Yucel, Hang, Gao, Repaka, Anderson and Mua and formulate an oral composition in a pouch formed of a fleece comprising nonvowen material with various actives, such as nicotine, caffeine and ginseng to include fillers a water activity of 0.6 and the moisture content of less than 10% as required by instant claim 1 with a reasonable expectation of success because the combination of the references makes it obvious to do so as the references are all drawn to an oral formulation for various uses such as providing tobacco without the use of nicotine (as taught by Gao). Additionally as explained above, Anderson does teach an oral composition comprising a filler from 0-50%. Thus the inclusion of a filler in the oral composition having at least 40% is well within the purview of the skilled artisan.
Applicant’s argument have been fully considered but found unpersuasive because Victor teaches their composition is nicotine free (see 0015; 0077as required) and comprises a plant material or cellulose material from plant that is not a tobacco material (see 0010, 0013). The argument that there is no motivation is found unpersuasive. Clearly as indicated supra Victor teaches a nicotine free composition. One of ordinary skill in art would have been motivated to modify the teachings of the cited art to result in the instant claimed invention.
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, nanoparticle polymer chemistry— without being told to do so.
Maintained Double Patenting and modified
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7-10, 12-16 and 18-24 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 21 of U.S. Patent Application No. 11617744 in view Victor et al. (US 2016/0324777), Rapeka, Anderson and Mua as set forth above (US 2009/0025738) above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the patent and the instant claims are directed to an oral composition comprising at least one active agent, at least one filler and water, specifically wherein the active can be nicotine. Additionally, the patent teaches the use of non-tobacco plant, therefore one of ordinary skill in the art would have used the patented claims to practice the instant claimed invention (col. 5, lines 16+)
Rapeka teaches their composition comprises a binder/filler with a reasonable expectation of success Because their oral composition comprises these components at a concentration of 20% (see rejection above).
Victor, and Anderson are applied here as above because . Additionally when the patented specification is used as a dictionary or guidance it teaches at least about 40 percent, based on the total weight of the composition.(see col. 6, lines 37-53). Mua is applied here as above.
It would have been obvious to one of ordinary skill in the art to have employed the patented claims in practicing the instant claims with a reasonable expectation of success that substituting one for the other would yield success.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-5, 7-10, 12-16 and 18-24 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 24 of U.S. Patent Application No. 11672862 in view of Victor et al. (US 2016/0324777) Rapeka ,Anderson and Mua above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows
Although the claims of the copending differ slightly from the instant claims, because both oral composition claims are open ended employing the term “comprising” it would have been obvious to one of ordinary skill in the art to have added xylitol as part of the sweetener as taught by Gao (see 0039), Filler/binder component taught by Rapeka with a reasonable expectation of success Because Repaka teaches their oral composition comprises these components at a concentration of 20% (see rejection above.). Mua is applied her as above.
Victor, Anderson and Mua are applied here as above. Additionally when the patented specification is used as a dictionary or guidance it teaches at least about 40 percent, based on the total weight of the composition.(see col. 7, lines 11-26).
Additionally, the patent teaches the use of non-tobacco plant, therefore one of ordinary skill in the art would have used the patented claims to practice the instant claimed invention (col. 5, lines 56+)
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-5, 7-10, 12-16 and 18-24 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1- 16 of U.S. Patent Application No. 16707069 in view of Victor et al. (US 2016/0324777) ,Yucel and Repaka, Anderson and Mua above is withdrawn based on the abandonment of the copending application.
Claims 1-5, 7-10, 12-16 and 18-24 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1- 20 of U.S. Patent Application No. 11872231 Victor et al. (US 2016/0324777), Yucel and Repaka above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
Both sets of claims recites an oral composition comprising: at least one active agent; a filler component; a sweetener in a pouch and free of nicotine. The cited references are applied here from above.
It would have been obvious to one of ordinary skill in the art to have employed the instant claims in formulating the oral composition. Based on that the determination of a dosage having the optimum therapeutic index is well within the level of the ordinary skill in the art, and the artisan would be motivated to determine the optimum amounts to get the maximum effect of the drug, hence the reference makes obvious the instant invention. Specifically because the patented claims fails to teach nicotine. Thus the assumption is that the composition is free of nicotine.
The cited references are applied here as above. Additionally when the patented specification is used as a dictionary or guidance it teaches at least about 40 percent, based on the total weight of the composition.(see col. 8, lines 14-25).
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
Claims 1-5, 7-10, 12-16 and 18-24 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-19 of U.S. Patent Application No. 16707057. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the copending are to an oral composition configured for oral use, the composition comprising a filler, an active ingredient, flavoring agent’s particulate filler, whilst the instant claims are to the same
It would have been obvious to one of ordinary skill in the art to have been motivated to use the copending claims in practicing the instant claims with a reasonable expectation of success. Even though the copending claims does not recite free of nicotine, nonetheless claim 4 of the instant claims recites the composition having or comprises niocotine. Therefore one of ordinary skill in the art would have used the instant claims to practice the copending claims.
The cited references are applied here as above. Additionally when the copending specification is used as a dictionary or guidance it teaches at least about 40 percent, based on the total weight of the composition.(see 0054).
In view of the foregoing, the copending application claims and the current application claims are obvious variations.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached on M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 6/17/26
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