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 .
DETAILED ACTION
Allowability of claim 3 indicated in the last office action is withdrawn due to new ground of rejection.
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.
Claims 11 and 12 are 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.
The recited “the use” and “the compatibilizer” of claim 11 and “the compatibilizer” of claim 12” would lack antecedent basis in claim 5.
The recited “the preparation method” and “the use amount” of claim 11 would lack antecedent basis in claim 5.
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.
Claims 1, 2, 4, 6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Machine translated CN 107670108 A (Feb. 9, 2018).
CN teaches a porous polylactic acid material for scaffold for tissue engineering and preparation method thereof.
CN teaches that the porous polylactic acid material comprising a mixture of poly-L-lactic acid and poly-D-lactic acid is obtained by a solution casting of the mixture and a pore-foaming agent and removal of the pore-foaming agent in abstract.
The recited steps of claim 1 (i.e., melt blending) would have little probative value since an invention in a product-by-process is a product, not a process. See In re Brown, 459 F2d 531, 173 USPQ 685 (CCPA 1972) and In re Thorpe, 777 F2d 695, 697, 227 USPQ 964 (Fed. Cir. 1985). MPEP 2113.
The porous polylactic acid material taught by CN would be a piezoelectric
material having the recited stacking structure of claim 1 and piezoelectric constant of claim 2 inherently.
Since PTO does not have equipment to conduct the test, it is fair to require applicant to shoulder the burden of proving that his material differs from those of CN. See In re Best, 195 USPQ 430, 433 (CCPA 1977). Charles Pfizer & Co. v. FTC, 401 F.2d 574, 579 (6th Cir. 1968). Inherent anticipation does not require that a person of ordinary skill in the art would have recognized the inherent disclosure, Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed. Cir. 2002). See MPEP 2112.01.
Thus, the instant invention lacks novelty.
Regarding claim 4, the claimed piezoelectric material is devoid of a pore-forming agent and an invention in a product-by-process is a product, not a process. Thus, the recited pore-forming agent would have little probative value.
Regarding claim 6, the claimed invention is piezoelectric material and an invention in a product-by-process is a product, not a process.
Regarding claim 8, the recited “for use” is an intended use which would have little probative value. Also, CN teaches a scaffold for tissue engineering in abstract which would meet the recited implantable piezoelectric devices for induced regeneration of tissues. Further, claim does not recite any particular form/shape and thus the scaffold can be used for tooth whitening and dye/pigment degradation inherently.
Regarding claims 9 and 10, the claimed invention is a piezoelectric polylactic acid material per se, and thus the scaffold comprising the porous polylactic acid material comprising a mixture of poly-L-lactic acid and poly-D-lactic acid taught by CN would meet claims 9 and 10 absent further limitations.
Claims 1, 2, 4, 5, 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Machine translated CN 107670108 A (Feb. 9, 2018).
Regarding claim 5, CN teaches a mass ratio of the poly-D-lactic acid to the poly-D-lactic acid is 1:9 to 9:1 and the mass ratio of polylactic acid to the pore-forming agent is 1:6 to 1:2 in abstract.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to utilize the recited amounts of components in CN since amounts taught by CN encompass the recited amounts absent showing otherwise.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In re Woodruff, 919F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Machine translated CN 107670108 A (Feb. 9, 2018) as applied to claims 1, 2, 4, 6 and 8-10 above, and further in view of Machine translated JP 2020130495 A (Aug. 31, 2020).
Regarding claim 14, JP teaches porous biodegradable poly L lactic acid and poly D lactic acid having a molecular weight of 1x104 to 1x106 and their use as a scaffold material in middle of page 2. Although JP does not teach whether the molecular weight is a weight-average (Mw) or a number average (Mn). The polylactic acid known to be a linear polymer (i.e., low polydispersity (Mw/Mn)) and thus the Mw and Mw are expected to be very similar.
Although JP does not teach the recited optical purity of 90% or more, the biodegradable poly L lactic acid and poly D lactic acid taught by JP would be expected to have the recited optical purity since the molecular weights fall within scope of the instant molecular weights. JP teaches various applications of porous biodegradable poly L lactic acid and poly D lactic acid including orthopedic field, dental and oral surgery field in a first full paragraph of page 3.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to utilize the art well known biodegradable poly L lactic acid and poly D lactic acid having the molecular weight of 1x104 to 1x106 taught by JP in CN since both JP and CN teaches the porous biodegradable polylactic acid absent showing otherwise.
Selection of a known material based on its suitability for its intended use is prima facie obvious, see Sinclair & Carroll Co. v. Interchemical Corp., 325 US 327, 65 USPQ 297 (1945). MPEP 2144.07.
The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). MPEP 2141
CLAIM OBJECTION
Claims 13 and 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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/TAE H YOON/ Primary Examiner, Art Unit 1762