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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/31/26 has been entered.
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, 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.
Claim(s) 17-19 and 23-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Bruun (US 2019/0255035 A1 hereafter Bruun) in view of Nilsson et al (US WO 2012/134380 hereafter Nilsson).
Bruun discloses an oral pouch formulation comprising a powder composition comprising a nicotine source bound to an ion exchange resin, at least one pH adjusting agent and at least one filler where the nicotine in the resin is present at least 0.5% wt % [Example 4]. The pouch can be anon-woven cellulose material that is soluble to salvia [0100-0101]. The exchange resin is polacrilex [Example 1]. The powder can further comprise microcrystalline cellulose [0095]. The pH buffer can be sodium bicarbonate [0055]. The adjusters measure about 6.5 wt% [Table 7]. The polyalcohol include sweeteners like mannitol present 60-95% [0042-0049]. The formulation comprises flavors [0115-0117].
While the formulation discloses an oral pouch as defined by the instant claims, the reference does not exemplify a pouch powder comprising the range of microcrystalline cellulose, although microcrystalline cellulose is present in the powder. The use of microcrystalline cellulose in these ranges is known in the art as seen in the Nilsson patent.
Nilsson discloses an oral nicotine pouch comprising a nicotine compound in a free salt form (abstract, pg, 3, 7). The nicotine is in powder form in a saliva permeable pouch, where the nicotine dissolves and transports out through the pouch into the oral cavity (pg. 8-10). The powder comprises fillers like maltitol and microcrystalline cellulose (pg. 9). Microcrystalline cellulose (Avicel) is present about 49.8% in the powder (Example 5). The powder further comprises pH adjusters such as carbonates and bicarbonates present about 6-11% (pg. 8, 26, Example 5). The powder further comprises sweeteners such as polysaccharides and maltitol and other fillers with about 47% (Table 1). The nicotine can also be present in an ion exchange resin such as polacrilex (Table 4). The nicotine powder was released more than 50% in the mouth within 30 minutes (Figures 1, 2). It would have been obvious to include these components and formulations with that of the powder of Bruun as they solve the same problem in similar dosage forms.
Regarding the solubility of the powder formulation, it is the position of the Examiner that such limitations do not distinguish over the prior art. The solubility is a feature that relates to the dissolution of the powder and powders of Svandal and Nilsson combination are disclosed to dissolve faster than the insta claims, meaning the solubility differs from the instant claims. The powders comprise the same components, fillers, and pH adjusters present in the same concentrations as the instant claims. The Office does not have the facilities for examining and comparing applicant's product with the product of the prior art in order to establish that the product of the prior art does not possess the same material structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2 2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
With these aspects in mind, it would have been obvious to combine the prior art with an expected result of a stable oral nicotine formulation useful for quick release of nicotine. It would have been obvious to include the microcrystalline cellulose concentrations of Nilsson into the similar formulation of Bruun as they solve the same problem and are present in the same form of oral pouches filled with powdered formulations. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable, fast dissolving oral pouch.
Response to Arguments
Applicant’s arguments, see Remarks, filed 8/31/26, with respect to the rejection(s) of claim(s) 17-19 and 23-36 under 25 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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