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.
In claim 13, line 2 is unclear. Specifically it is unclear as to how a tissue defect can have a “coating” of a dental preparation containing a shaped body.
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.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wahlig et al 4291013 in view of Liu et al 20140039056.
With regard to claims 12-14, Wahlig et al discloses a method for producing a dental preparation, comprising drying a raw material aqueous solution (see column 2, lines 35-46, which discloses that injection molding may be utilized to form the shaped body, such injection molding inherently utilizing an aqueous solution, since collagen contains water). Wahlig et al also disclose that the solution may contain an active material and calcium phosphate (see column 2, lines 10-17), which is a water soluble divalent metal salt. Wahlig also discloses that the active material may be used to treat inflammation. See column 5, lines 45-57.
Wahlig et al do not disclose the active material to be a free form and/or alkali metal salt of bromfenac.
Liu et al discloses bromfenac metal salts which may be used to treat inflammation, or as an analgesic. See paragraph 1.
It would have been obvious to one skilled in the art to include a free form or alkali metal salt of bromfenac as the active material in the dental preparation of Wahlig et al, in view of the teaching of Liu et al that such forms of bromfenac may be used to treat inflammation.
With regard to claims 13 and 14, Wahlig et al/Liu et al do not specifically disclose filling or coating a tissue defect in a dental region with the dental preparation.
However, Wahlig et al specifically discloses that the dental preparation (shaped body) may be used to fill a tissue defect in the human body, such as to reduce inflammation. See paragraphs 47,48 and 51.
It would have been obvious to one skilled in the art to utilize the shaped body of Wahlig et al/Liu et al to fill a tissue defect in a dental region of the body, in view of the teaching of Wahlig et al that such a resorbable shaped body may be used to treat a tissue defect in the body.
With further regard to claim 14, it is noted that Wahlig et al discloses the use of calcium phosphate, which is a divalent metal salt. Thus, when the alkali metal salt of bromfenac (of Liu et al) is combined with the calcium phosphate of Wahlig et al, a divalent metal salt (calcium salt) of bromfenac is produced.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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/NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772