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 .
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NIELSEN et al. (WO 2015/090337 A1).
With respect to claim 1, NIELSEN et al. discloses a nicotine powder composition (Abstract; Title) for oral mucosa delivery comprising nicotine (Page 2, lines 10-25; Page 9, lines 15-30) and a cryoprotectant, in an amount of 30 and 60 wt% of the powder (Page 15, lines 1-15) and the cryoprotectant is trehalose.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
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Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN et al. (WO 2015/090337 A1) in view of INOU et al. (EP 1210880 A1).
With respect to claims 2 and 3, NIELSEN et al. does not explicitly disclose the type of trehalose. INOU et al. discloses compositons that contain sucralose (Abstract; Title), such as an oral composion (Paragraph [0009]) including tobacco compositions (Paragraphs [0434]-[0501]). The sweetener for the composition includes α-α type trehalose, so that it does not cause Millard reaction, is stable to acids and alkalies, is resistant to heat decomposition and is non-cariogenic (Paragraphs [0030]-[0032]). Thus, it would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use α-α type trehalose as the trehalose of NIELSEN et al., as taught by INOU et al. so that it does not cause Millard reaction, is stable to acids and alkalies, is resistant to heat decomposition and is non-cariogenic.
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Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN et al. (WO 2015/090337 A1) in view of UCHIDA (WO 2004/060077 A1, machine translation).
With respect to claim 4, NIELSEN et al. does not explicitly disclose that the trehalose is anhydrous. UCHIDA disclose a method for reducing unpleasing tapes from compsoitions (Abstract). The composition includes α-α type trehalose (See highlight [0001]) and is used in tobacco compositions (See highlight [0002]). The trehalose includes anhydrous trehalose and provides a sweeter taste (See highlight [0003]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use anhydrous trehalose in NIELSEN et al., as taught by UCHIDA so as to increase sweetness.
With respect to claim 5, NIELSEN et al. does not explicitly disclose that the trehalose is present as a crystal powder. UCHIDA disclose a method for reducing unpleasing tapes from compsoitions (Abstract). The composition includes α-α type trehalose (See highlight [0001]) and is used in tobacco compositions (See highlight [0002]). The trehalose includes α-α type trehalose in crystal powder form (See highlight [0004]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use α-α type trehalose in crystal powder form in NIELSEN et al., as taught by UCHIDA so as to increase sweetness.
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Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN et al. (WO 2015/090337 A1) in view of UCHIDA (WO 2004/060077 A1, machine translation) as applied to claims 4 and 5 above, and further in view of GONDA (US 2008/0138398).
With respect to claim 6, modified NIELSEN et al. does not explicitly disclose the particle size of the trehalose. GONDA discloses dual release nicotine formuations (Abstract; Title). The carrier (e.g., trehalose of NIELSEN et al.) is sized so that it is not inhalable and have a mean diameter of between 50 and 200 microns (Paragraph [0114]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to use a particle size of the trehalose of NIELSEN et al. in the range of between 50 and 200 microns, as taught by GONDA so that the powder isn’t inhalable when use in an oralmucosal application.
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Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over NIELSEN et al. (WO 2015/090337 A1) in view of REINBOLD et al. (US 2020/0352214).
With respect to claim 7, NIELSEN et al. discloses an oral pouch product comprising the oral compositon of claim 1 (Page 34, lines 25-30), but does not discose the claimed packaging. REINBOLD et al. discloses a smokeless tobacco product for oral use (Abstract). The product is packaged and stored in a suitable packaging (Paragraph [0105]). It would have been obvious to one having ordinary skill in the art, prior to the effective filing date of the claimed invention, to provide a packaging for the pouches of NIELSEN et al., as taught by REINBOLD et al. so that the product can be stored for future use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX B EFTA whose telephone number is (313)446-6548. The examiner can normally be reached 8AM-5PM EST M-F.
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/ALEX B EFTA/Primary Examiner, Art Unit 1745
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