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 .
Acknowledgment of Papers Received: Response dated 1/13/26.
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, 23-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Svandal et al (US 2013/0251779 A1 hereafter Svandal) in view of Nilsson et al (WO 2012/134380 hereafter Nilsson).
Svandal discloses an oral pouch product comprising a powder [abstract, 0018-0021]. The powder comprises nicotine bound to an ion exchange resin such as a weak cation exchange resin like polacrilex [0038, Table 4]. The powder further comprises pH adjusting agents such as bicarbonates, borates and carbonates [0028, 0045]. The powder further comprises at least one filler [0049]. The powder can comprise microcrystalline cellulose [0049]. The powder maty further comprises one or more polyalcohols like a sweetener such as aspartame [0047]. The powder comprises about 1.5% nicotine, 12% pH adjusters, 64.9% filler [Table 6]. The pouch for the powder is soluble to saliva and can be made from non-woven material [0032, 0052].
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 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 Svandal 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 no 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.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 in to the similar formulation of Svandal 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 filed 1/13/26 have been fully considered but they are not persuasive. Applicant argues that the combination of Svandal and Nilsson do not render the claims obvious as they do not disclose the features of the instant claims.
Regarding this argument, it is the position of the Examiner that the combination continues to render the claims obvious. Applicant argues that the application of Svandal and Nilsson are in error as the pouch is not water soluble. However, while the pouch of Svandal is recited to be water insoluble, it is further recited to be permeable to saliva, with the powder dissolving through the pouch as the permeable to the saliva (page 8-9). Applicant further argues that the combination does not disclose or suggests the solubility or release fraction of the claims, however Nilsson discloses that within 30 minutes up to 100% of the nicotine powder is completely dissolved (Table 5)./ As the powder permeates through the pouch, that would assume that within the 30 minutes, that 1005 powder dissolution would have permeated through the bag and have been released based on the dissolution data of Table 5). This would meet the limitations of claims 32. The solubility of the formulation is a compositional feature of the powder. The powder of the combination of have the same components, nicotine in an ion exchange resin, .15-2% nicotine, 6-11% pH adjusters, about 40% filler and microcrystalline cellulose about 35%, present in the powder, inside of a pouch that is permeable to saliva. By meeting these compositional limitations, it would naturally fall that the composition would have the same chemical and compositional properties of the instant claims. Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). For these reasons, the prior art combination continues to render the claims obvious.
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 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 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.
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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