20190100489DETAILED 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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 6, 10, 12, 14, 19, 27, 33 in the reply filed on 06/03/2026 is acknowledged.
Claims 36-37, 40-42, 45-48, 50-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 10, 12, 14, 19 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prusty et al., (US 2020/0261324, cited in IDS).
Prusty et al. teaches “fib-reinforced dental composites (FRCs)” wherein the composites comprise “a polymerizable resin and from about 0.5% to about 25% w/w of fibers” (Abstract).
Prusty et al. teaches a specific embodiment of a composite below:
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335
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(see p. 6).
Here, the UDMA (clm. 19) suffices as the monomer suitable for photopolymerization; CQ suffices as the photoinitiator; strontium glass suffices as the inorganic filler.
Concerning claim 10, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In this case the wherein clause provides a product by process limitation i.e. “formed via 3D printing”, where the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention.
Concerning claims 12 and 14, Prusty et al. further teaches adding “glass fibres” to this composite (Id. para. [0094]).
Since the composite is taught to be applied in the mouth, i.e. “bridge across gaps and fill cavities in teeth as well as advantageously allowing the formation of naturally shaped contours” (p. 5, para. [0075]), it suffices as an implant, as per claim 33.
The prior art is anticipatory insofar as it teaches a biocomposite formed from a combination of at least one monomer for photopolymerization (UDMA), a photoinitiator (CQ), and an inorganic filler (strontium glass).
2) Claim(s) 1, 10, 12, 14, 19, 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holt et al., (EP 3572874).
Holt et al. teaches, “a method for making a three-dimensional (3D) image by additive manufacturing or 3D printing” (Abstract).
The mixture for forming 3-dimensional objects comprises “a liquid photopolymer formulation; and a plurality of particles; wherein the photopolymer formulation comprises: at least one monomeric or oligomeric chemical species . . . at least one organometallic or metallocene photoinitiator . . .” (p. 2, para. [0006]).
The at least one monomeric species may comprise “Bisphenol A-glycidyl methacrylate (BisGMA)” (p. 4, para. [0025]); as well as a combination of “Urethane dimethcylate (UDMA)” and “Triethylene glycol dimethacrylate (TEGMA) . . . present in a weight:weight ratio in the range from 70:30 to 90:10 UDMA:TEGMA” (p. 4, para. [0026]).
Suitable particles include “sand or a mixture of sand and a bunder selected from glass and organic binder” (Id. para. [0027]), or ceramics such as “silica or silicate ceramic” (p. 5, para. [0031]). “Silica and silicate ceramics can be used as filler materials for 3D printing, e.g. sand, corderite, mullite, steatite, and zeolites” (Id.).
Particles may also include bioceramics such as “hydroxyapatites, substituted apatites, and tricalcium phosphate” (clm. 12, 14), wherein “[t]he combination of bioceramics with 3D printing techniques enables the fabrication of customized bone replacement implants with a unique fit to the respective patient” (p. 5, para. [0032]).
The prior art teaches a specific formulation for 3D printing comprising “Urethane dimethacrylate (UDMA) 135 g, Triethylene glycol dimethacrylate (TEGMA) 55g, Pentaerythritoltetra(3-mercaptopropionate) 6g, bis(ր5-2,4-cyclopentadien-1-yl)-bis(2,6-difluoro-3-(1H-pyrrol-1-yl)-phenyl) titanium” followed by the addition of “alumina particles” (p. 15, para. [0120]; Example 8)).
Concerning claim 10, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In this case the wherein clause provides a product by process limitation i.e. “formed via 3D printing”, where the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention.
The prior art is anticipatory insofar as it teaches a composition comprising at least one monomer suitable for photopolymerization (UDMA), a photoinitiator (titanium compound), and an inorganic filler (alumina particles).
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.
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.
Claim(s) 2, 6, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holt et al., (EP 3572874) as applied to claims 1, 10, 12, 14, 19, 33 above, and further in view of Schmid et al., (US 2005/0100578).
Holt et al., which is taught above, differs from claims 2, 6, 27 insofar as it does not teach surface modification of the composition (e.g. with plasma), nor the inclusion of a pharmaceutically active compound.
Schmid et al. teaches, “a bone in-growth material that improves orthopedic implant performance at a reasonable cost” (p. 3, para. [0026]).
Concerning surface modifications, claims 2 and 6, Schmid et al. teaches, “A ceramic layer may be microtextured by laser ablation, chemical etching, photochemical etching, or ultrasonic machining” (p. 5-6, para. [0085]). Further, “Methods of the present invention may be used to produce layers of scaffold material that are subsequently coated with another material by chemical vapor deposition, physical vapor deposition, sputtering, plasma or metal spray, using sol-gel techniques, electroplating, mechanical plating or any other plating technique” (p. 6, para. [0099]).
Since the prior art teaches plasma etching (see also p. 5, para. [0070]), the property of increasing the concentration of hydroxyl groups, for example, as per claim 6, would have been inherent.
Concerning claim 27, Schmid et al. teaches adding a barrier layer to the implants, i.e. “When there is a transition between tissues, such as soft tissue/bone attachment, a barrier layer of the present invention may define the in-growth limits of the two tissues” (p. 8, para. [0119]). The barrier layer may be formulated to allow “controlled release of bone morphogenetic proteins (BMPs) or growth factors, such as the TGF-beta superfamily . . .drugs such as bisphosphonates . . .” (p. 8, para. [0121]).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art to add plasma etching and a pharmaceutically active to the implants of Holt et al. based on the art recognized suitability for its intended use in bone implants, as taught by Schmid et al. The artisan would have been motivated to add the etching in an effort to create a textured surface that promotes biological integration with the surrounding bone. With the addition of the pharmaceutically active, the artisan would have been motivated to treat the patient receiving the bone implant.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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