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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites ‘“Natto”(soybeans fermented in their own bacteria)’. It is not clear if the terms in quotations and the parenthetical are limitations of the instant claim. Therefore, the claims are indefinite.
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.
Claim(s) 1, 2, 3, 5-13, 16, 18, 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN104840958A, disclosed by applicant).
Liu et al. disclose a mucosa composition comprising a bioadhesive material; wherein the bioadhesive material is selected from sodium carboxymethyl cellulose and hydroxyethyl cellulose at a concentration of 0.5-5%, a moisturizing agent at a concentration of 0.1-25%, 0.1-3% of repairing agent, 0.1-3.0% of bactericide, 0-1.0% of milk immune protein, 0-1.0% of lysozyme, a proper amount of pH value neutralizer, sweetening agent, flavoring agent and preservative and the balance of deionized water, wherein the total weight percent is 100%. The composition has good biocompatibility and bioadhesion, is proper in price, has small toxic and side effects, does not have foreign feel and has long moisturizing time and long-acting antibacterial ability and anti-inflammatory repairing ability (Abstract). Liu et al. disclose the moisturizing agent as hyaluronic acid; restorative agents including tea polyphenols; which would include catechins and camphor, ginseng extract and seaweed extract; bactericide as chlorhexidine; sweeteners consisting of xylitol ([0026]-[0030]). Liu et al. disclose a method of preparation wherein the components are mixed to provide the composition with a pH of 6.8 ([0142] and [0148]). Liu et al. disclose a method for improving the mucous membrane of the oral cavity; wherein the composition if applied to the mouth of a person and provided long-lasting oral moisturizing ability and ability to prevent plaque formation ([0179]). The compositions of Liu et al. may be free of the components of instant claims 11-13.
The prior discloses compositions containing components (a)–(d). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists.
It would have been obvious to have varied the hyaluronic acid molar mass and the viscosity of the composition to meet the known properties of the oral composition by routine experimentation.
Claim(s) 1, 17, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN104840958A) in view of Ebine et al. (US Patent 5178869A).
Liu et al. is discussed above and differs insofar as they do not disclose the component (d) of instant claim 17 or a mouth guard of aligner.
Ebine et al. disclose oral compositions comprising bactericides including chlorohexidine and bisabolol (column 5, lines 33-44). Ebine et al. disclose the composition is applied to a mouth piece and has a viscosity of 20-180 poise (Abstract).
It is obvious to replace one component for another equivalent component if it is recognized in the art that two components are equivalent and is not based on the Applicant disclosure. It is also prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See MPEP 2144.06. It would have been obvious to one of ordinary skill in the art to have used bisabolol in place of the bactericides in the compositions of the primary reference based on the prior art's recognition that such species are equivalent in function, as supported by cited precedent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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/NANNETTE HOLLOMAN/ Primary Examiner, Art Unit 1612
