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 Objections
Applicant is advised that should claims 1-9 be found allowable, claims 10- 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Examiner notes the claims differ only in the preamble where claim 1 is directed to “A composition of an oral soluble film comprising” and claim 10 is directed to “An oral soluble film comprising a composition comprising”. In essence the preambles of both claims are directed to a composition that is an oral soluble film.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (CA 2711974).
With regards to claims 1, 10, and 20, Lee et al teaches pectin films for drug delivery were well known in the art (pg 3 last ¶). Active agents disclosed include nicotine (pg 14, last ¶). The film may include additional agents, such as plasticizing agents and sweeteners (pg 16, 2nd full ¶).
Lee et al does not disclose an embodiment with pectin, a plasticizer, and active agent, but it would have been obvious to one of ordinary skill in the art to select from the components taught to be suitable, especially where the background section teaches pectin was a well-known film forming agent.
With regards to claim 2 and 11, the films may include mixtures of pectin and gelatin (pg 25, second ¶).
With regards to claim 3 and 12, plasticizers may be used and include polyethylene glycol or glycerol (pg 26, second ¶).
With regards to claim 4 and 13, nicotine is discussed above as the active.
With regards to claim 5 and 14, the polysaccharide includes pectin, which is discussed above.
With regards to claims 6 and 7, flavoring agents include fruit flavors, such as cherry, berry, citrus, etc (pg 17, last ¶).
With regards to claims 8 and 9, the film forming agents is taught to be present preferably from about 60 to about 65 wt% (pg 25, second ¶). The plasticizers are taught to be present preferably from about 0 to about 20 wt% (pg 26, second ¶).
With regards to claim 15, the working embodiments teach including an active at 10 wt% (pg 44).
With regards to claims 16-19, the standard process of mixing components, heating, and shaping are taught to be well known (see Examples).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
Prosecution Insights