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 § 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.
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.
Claims 1, 4-9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vandevelde et al. (US 2015/0190232) in light of Van Der Zel (US 2012/0139142), Takada et al. (US 2017/0254378), Chentemirov et al. (US 4,241,138) and Kyomoto et al. (US 2015/0141545).
Claims 1, 5-6 and 16: Vandevelde teaches a process for producing a prosthesis (Abst.) comprising the steps of: fabricating a prosthesis from a core material comprising ultra-high molecular weight polyethylene (¶ 0028); positioning the core in a vessel for hot compression (i.e. claimed pressure vessel) (¶¶ 0040-0042); filling the vessel with titanium powder having an average grain size (i.e. claimed particle size) of 20-500µm (¶¶ 0021, 0040-0042); and performing hot compression to form a titanium coating on at least a portion of the polyethylene prosthesis core (¶¶ 0040-0042). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05(I). Thus, it would have been obvious to one of ordinary skill at the time of filing to have selected a D50 particle size of 200-250 µm or 225 µm.
Vandevelde is silent concerning how high the titanium is filled. Van Der Zel teaches a process of coating a prosthesis with titanium via compression molding (Abst.) and explains that the titanium particles are filled in a manner wherein they fully cover the core (¶ 0101). 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. MPEP § 2144.05(II)(A). Thus, it would have been obvious to one of ordinary skill at the time of filing to have selected a fill amount corresponding to 110% of the height of the core in order to have ensure complete coverage with the predictable expectation of success.
Vandevelde is silent regarding how pressure is applied. Takada teaches a process of hot compression and explains that the pressure is applied to the materials by providing a sealing pressure plate in contact with the materials (¶ 0087, e.g.). Combining prior art elements according to known methods to yield predictable results is prima facie obvious. MPEP § 2143. Thus, it would have been obvious to one of ordinary skill at the time of filing to have selected a pressure plate as the means for compression in Vandevelde with the predictable expectation of success.
Vandevelde teaches a pressure of 20-100 bars and a temperature up to 200˚C, but fails to teach a pressure of 10-50 MPa or a specific duration of compression. Chentemirov teaches a process of hot compression and explains that the spacing between particles can be controlled by controlling the pressure, temperature and duration of the process (3:30-37). 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. MPEP § 2144.05(II)(A). Thus, it would have been obvious to one of ordinary skill at the time of filing to have selected a pressure of 10-50 MPa and a duration of 10-600 minutes depending on the desired spacing on the final product.
Vandevelde implicitly teaches a cooling step, but fails to provide any details. Kyomoto teaches a method of coating a prosthesis via hot molding (Abst.) and explains that the part should be gradually cooled to a set temperature at a controlled rate to 25˚C after molding before releasing the pressure (i.e. claimed further uncontrolled cooling to ambient) (¶¶ 0082-0083). Combining prior art elements according to known methods to yield predictable results is prima facie obvious. MPEP § 2143. Thus, because Vandevelde is silent regarding how cooling is achieved and because Kyomoto teaches a controlled cooling to 25˚C followed by an uncontrolled cooling to ambient is a suitable means for cooling, it would have been obvious to one of ordinary skill at the time of filing to have employed the cooling of Kyomoto with the predictable expectation of success.
Claim 4: Vandevelde does not discuss whether the titanium serves as a working fluid. However, the modified process of Vandevelde teaches the same process steps using the same materials as those which applicant discloses to cause titanium to act as a working fluid. Thus, this feature is considered inherent in the cited art.
Claims 7-9: Vandevelde teaches that the prosthesis is an acetabular cup which is sized to fit a patient’s femoral head (Abst.; ¶ 0002).
Claim 12: Vandevelde teaches that the polyethylene is vitamin E enriched (¶ 0030).
Claim 13: Vandevelde teaches that the core is sized to fit a patient’s femoral head (¶ 0002). 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. MPEP § 2144.05(II)(A). Thus, it would have been obvious to one of ordinary skill at the time of filing to have selected a core size of 5-9 mm depending on the patient.
Claim 14: Vandevelde teaches a coating thickness of 50-800 µm (¶ 0044). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05(I). Thus, it would have been obvious to one of ordinary skill at the time of filing to have selected a thickness of 300-500µm.
Claim 15: Vandevelde teaches titanium coverage of 70-90% (i.e. not a unitary whole) (¶ 0046).
Claims 2 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Vandevelde, Van Der Zel, Takada, Chentemirov and Kyomoto in light of Kim et al. (US 2018/0363147).
Claims 2 and 3: Vandevelde is silent concerning whether the vessel is hermetically sealed or not. Kim teaches a process of hot compression (Abst.) and explains that the vessel may or may not be hermetically sealed (¶ 0054). Combining prior art elements according to known methods to yield predictable results is prima facie obvious. MPEP § 2143. Thus, it would have been obvious to one of ordinary skill at the time of filing to have either hermetically sealed or not hermetically sealed the vessel in Vandevelde with the predictable expectation of success.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vandevelde, Van Der Zel, Takada, Chentemirov and Kyomoto in light of Oral et al. (US 2012/0041094).
Claims 10 an 11: Vandevelde does not specify whether an oven is used. Oral teaches a method of making medical implants (Abst.) via compression molding (¶ 0616) and explains that the process occurs in a preheated oven (¶ 0616). Combining prior art elements according to known methods to yield predictable results is prima facie obvious. MPEP § 2143. Thus, it would have been obvious to one of ordinary skill at the time of filing to have used a preheated oven for the process of Vandevelde with the predictable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,320,007. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘007 Patent claims the same subject matter as the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert A Vetere whose telephone number is (571)270-1864. The examiner can normally be reached M-F 7:30-4:00 EST.
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/ROBERT A VETERE/ Primary Examiner, Art Unit 1712
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