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 .
Status of the Claims
Claims 1-18 are pending and under current examination.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites polymethyl methacrylate twice in the listing of alternatives.
Appropriate correction is required.
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 1-18 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.
Claim 1 recites the limitation "formed implant" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “high-strength polymer” in line 1. There is insufficient antecedent basis for this limitation in the claims.
The term “high-strength” in claims 1 and 7 is a relative term which renders the claim indefinite. The term “high-strength” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. With no definition provided in the specification, it is impossible to discern which polymer(s) may be considered “high-strength”
Regarding claims 2-6 and 8-18, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 1-3, 5-6, and 8-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez Santos (WO2014131375A2, publication year: 2014, citations refer to machine translation).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Gonzalez Santos teaches a developed biomaterial suitable to function as substitutes for bone grafting or for the manufacture of implantable devices in bone or for replacement of whole bones (pg. 3, twelfth paragraph) comprising an organic chase, an inorganic phase, and a mixture of photoinitiators and activators (pg. 4, fifth paragraph). The organic phase in liquid form, or in the form of a suspension, consists of mixtures of photopolymerizable polymers and monomers (pg. 4, sixth paragraph). An exemplary mixture includes polymethyl methacrylate and vinyl acetate (Table 1, examples 3, 6, and 8). The organic phase consists of calcium salts, such as phosphate and hydroxyapatite (pg. 4, ninth paragraph). The calcium salts are added to the solution polymer composition, followed by the photoinitiatior mixture. The blend is placed in a mold and irradiated for 20 minutes to yield a rigid solid which is easily removed from the mold (pg. 5, Example 1). The instant specification defines ceramic particles to include hydroxyapatite and trisodium phosphate [0006 of the instant specification], therefore the Examiner considers the hydroxyapatite of Gonzalez Santos to read on the “ceramic” limitation of the instant claim.
Regarding claim 2, Gonzalez Santos teaches a developed biomaterial suitable to function as substitutes for bone grafting or for the manufacture of implantable devices in bone or for replacement of whole bones (pg. 3, twelfth paragraph).
Regarding claims 3, 5-6, and 9, Gonzalez Santos teaches that an exemplary mixture includes polymethyl methacrylate and vinyl acetate (Table 1, examples 3, 6, and 8).
Regarding claim 8, Gonzalez Santos teaches that the organic phase consists of calcium salts, such as phosphate and hydroxyapatite (pg. 4, ninth paragraph).
Regarding claims 10-11, Gonzalez Santos teaches that the photopolymerization is carried out by influencing light from the visible region to the ultraviolet according to the characteristics of the photoinitiator employed (pg. 5, first paragraph).
Regarding claims 12 and 13, Gonzalez Santos teaches that the calcium salts are added to the solution polymer composition, followed by the photoinitiatior mixture (pg. 5, Example 1). The photopolymerization is carried out by influencing light from the visible region to the ultraviolet according to the characteristics of the photoinitiator employed (pg. 5, first paragraph).
Regarding claims 14-16, Gonzalez Santos teaches that the main object of the invention is to obtain or prepare composite biomaterials formed by mixtures of biocompatible and photopolymerizable polymers loaded with calcium salts in such a way that when hardening or polymerizing by the action of light a homogenous solid with bioactive and mechanical properties is obtained (pg. 3, eleventh paragraph). Gonzalez Santos does not disclose the mechanical properties of the surgical implant relative to the formed implant as recited in claims 14-16. However, the invention as claimed is not structurally distinguishable from the disclosure of Gonzalez Santos and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Regarding claim 17, Gonzalez Santos teaches that the calcium salts are added to the solution polymer composition, followed by the photoinitiatior mixture (pg. 5, Example 1).
Regarding claim 18, Gonzalez Santos teaches that the biomaterials can be used in 3D printers operated by the light polymerization method (pg. 3, eleventh paragraph). The instant specification defines additive manufacturing to include a 3D printer [0085 of the instant specification], therefore the Examiner considers the 3D printer of Gonzalez Santos to read on the additive manufacturing limitation of the instant claim 18.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Gonzalez Santos does teach a single embodiment or example meeting all limitation of the invention of claim 1.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the exemplary production process of Gonzalez Santos to produce the exemplary composition comprising vinyl acetate and polymethyl methacrylate. One would have understood that the inventive implant of Gonzalez Santos could be formed by the process taught by Gonzalez Santos. It would have therefore been obvious that the exemplary composition comprising vinyl acetate and polymethyl methacrylate may also be formed by such a process. This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. From MPEP 2143 A: “...all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSA, 550 U.S. at __, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).” One of ordinary skill in the art of filing would have been motivated to utilize the production process of Gonzalez Santos to form the exemplary composition because Gonzalez Santos teaches the process as suitable for forming the inventive implant. The artisan of ordinary skill in the art would have had reasonable expectation of success because Gonzalez Santos teaches that the process is suitable for the inventive implant.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez Santos (WO2014131375A2, publication year: 2014, citations refer to machine translation), as applied to claims 1-3, 5-6, and 8-18 above, and further in view of Nien et. al. (Journal of Applied Polymer Science, pg. 3727-3732, publication year: 2006).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Gonzalez Santos teaches that the organic phase consists of mixtures of photopolymerizable polymers and monomers (pg. 4, sixth paragraph).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Gonzalez Santos does not teach allyl methacrylate or diallyl crosslinking. However, this deficiency is cured by Nien.
Nien teaches that crosslinked poly(methylmethacrylate-acrylic acid-allylmethacrylate) may be applied to bone cement. The copolymer exhibits the ability to absorb body fluids and swell in a controlled manner to compensate shrinkage of the cement during polymerization. The modified bone cement is able to enhance the mechanical properties of bone cement (pg. 3727, Abstract).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize allyl methacrylate as the monomer to be polymerized with the polymethylmethacrylate of Gonzalez Santos. One would have understood in view of Nien that poly(methylmethacrylate) (PMMA) crosslinked with allyl methacrylate has enhanced mechanical properties and is able to compensate shrinkage of the cement during polymerization. It would have been obvious to utilize allyl methacrylate to crosslink the PMMA of Gonzalez Santos. One of ordinary skill in the art would have been motivated to utilize allyl methacrylate in order to impart improved mechanical properties to the bone graft or implant. The artisan of ordinary skill would have had reasonable expectation of success because Nien teaches that poly(methylmethacrylate) polymerized with allyl methacrylate may be utilized to form bone cement.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez Santos (WO2014131375A2, publication year: 2014, citations refer to machine translation), as applied to claims 1-3, 5-6, and 8-18 above, and further in view of Graham et. al. (The Journal of Arthroplasty, pg. 1028-1035, publication year: 2000).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Gonzalez Santos teaches the relevant limitations of claim 1 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Gonzalez Santos does not teach a molecular weight of the high-strength polymer. However, this deficiency is cured by Graham.
Graham teaches that when the molecular weight of a PMMA bone cement decreases, the ability to bridge defects that precede the nucleation a macroscopic cracks in plastics also decreases (pg. 1033, Discussion).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The molecular weight of the high-strength polymer is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal molecular weight in order to best achieve the desired results as such would provide advantageous mechanical strength. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Graham teaches that a decrease in the molecular weight of a PMMA-based bone cement directly leads to a decrease in the mechanical strength of the bone cement. The Examiner considers it prima facie obvious to optimize the molecular weight of the polymer bone graft of Gonzalez Santos, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the molecular weight would have a direct effect on the mechanical strength of the bone graft and therefore be an optimizable variable.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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