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 .
There are two claim-sets in the instant application, both filed on 3/27/2024. The first claim set is directed to a preform and contains 10 claims. The second claim set is directed to a peroxide cross-linked and high temperature melted polymeric material and starts at claim 1 and ends at claim 25. The second claim set includes status identifiers such as “Currently Amended” and “original”. However, the second claim (1) contains a numbering issue as claim numbers are missing (claims 4, 6-10, 13) and (2) does not follow 37 CFR 1.121 which requires amendments to the claims to re-write the entire claim with all changes. As the second claim set appears to be a preliminary amendment, this claim set is to be examined in this Office Action. The claims are required to be renumbered and will be referred to as the renumbered claims in this Office Action. For example, claim 5 is renumbered as claim 4, claim 11 is renumbered as claim 5, and claim 25 is renumbered as claim 18, etc.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,970,600. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite a peroxide cross-linked and high temperature melted polymeric material fabricated from peroxide crosslinked ultra-high molecular weight polyethylene containing vitamin-E, wherein ultra-high molecular weight polyethylene is first blended with di-cumyl peroxide and vitamin E to form a blend, wherein said blend is compression molded to obtain a crosslinked and consolidated article and cooled to about room temperature, wherein the crosslinked and consolidated article is then subjected to a high temperature melting (HTM) cycle in a reduced oxygen environment to produce a peroxide cross-linked and high temperature melted polymeric material, wherein the peroxide cross-linked and high temperature melted polymeric material has an acetophenone (ACP) index less than 0.03 and an elongation at break (EAB) less than 400%, wherein the high temperature melting cycle comprises heating the crosslinked and consolidated article above 250° C. for at least 50 hours and less than 70 hours, wherein during the heating the crosslinked and consolidated article is heated at 295±5° C. for a duration that is not longer than 9 hours. The dependent claims appear to be identical.
US ‘600 does not recite the same acetophenone index as claimed (no greater than 0.06). However, the range in US ‘600 is less than 0.03, which meets the range of the instant claims. This is an anticipatory type double patenting rejection.
Claim Rejections - 35 USC § 103
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Muratoglu (US 2016/0215117).
Muratoglu teaches polymeric materials used in orthopedic applications (abstract) which is formed by blending a polymeric material with an antioxidant and a peroxide followed by consolidating to form a crosslinked polymeric material of ultrahigh molecular weight polyethylene (abstract, ¶ 17-18) where examples of the crosslinking agent are peroxides (abstract, ¶ 8-9) which include dicumyl peroxide (¶ 23) and examples of the antioxidant include vitamin E (¶ 24). Muratoglu teaches amounts of the antioxidant is 0.001-50wt% (¶ 25) and 0.01-50 wt% of the peroxide (¶ 26) which correspond to 10-500,000 ppm antioxidant and 100-500,000 ppm peroxide. Muratoglu teaches examples having an elongation of less than 400% (Figure 10, 18).
Specifically, Muratoglu teaches a product formed from blending 0.1 wt% vitamin E with UHMWPE and then blending peroxides (¶ 428) where the concentration of the peroxide was 1 wt% and includes dicumyl peroxide (DCP) (¶ 428). 0.1 wt% corresponds to 1,000 ppm and 1 wt% corresponds to 10,000 ppm. Muratoglu teaches the UHMWPE/vitamin E/DCP is then consolidated by compression molding and then cooled down to room temperature (¶429). Then the consolidated blends are optionally heated (¶ 430) followed by irradiation (¶ 431).
Muratoglu teaches the preferred embodiment include dicumyl peroxide with vitamin E which includes 0.2 wt% (¶ 268). Muratoglu teaches that the polymer includes UHMWPE (¶ 147). Muratoglu teaches post crosslinking treatments include further heat treating the article (¶ 376-381). Muratoglu teaches the elevated temperature, at for example 300˚C, for a duration between 1 minute to 24 hours (¶ 397).
Muratoglu polymeric materials used in orthopedic applications (abstract) where the materials are formed by a process where the polymer is blended with antioxidant and crosslinking agent, consolidated into a preform, then heated to a temperature such as 300˚C in an inert atmosphere followed by machining to give a final implant which is packaged and sterilized by irradiation (¶ 397). Muratoglu teaches the consolidation step includes compression molding (¶ 19) which includes cooling the article after compression molding (¶ 176) to room temperature (¶ 186). An inert atmosphere has a reduced oxygen environment.
Muratoglu teaches cleaning the implant (¶ 182) and that the implant is a tibial knee insert (¶ 197). Muratoglu teaches the consolidated products were formed into cubes having a 1 x 1 x 1 cm (¶ 429) which corresponds to a height of about 0.4 inches and meets claims 18-21.
Regarding the acetophenone index of less than 0.06, the instant specification states that acetophenone index is a function of the duration of the high temperature treatment. It is noted that the acetophenone index is a measure of the amount of acetophenone present quantified with FTIR. See instant specification, pg. 7, ¶ 26-27. Muratoglu teaches an elevated temperature treatment, at for example 300˚C, for a duration between 1 minute to 24 hours (¶ 397). As acetophenone has a boiling point of 202˚C (see instant specification, ¶ 8), heating above 202˚C accelerates the removal of acetophenone. Muratoglu teaches a heat treatment at 300˚C (¶ 397) which is above the boiling point of acetophenone and thus gives the claimed property of acetophenone index of less than 0.06. It is noted that the instant specification provides examples where the acetophenone index was measured at Figure 2 where hat treated samples all had an acetophenone index under about 0.045 and the only sample with an acetophenone index outside the claimed range was the sample that was not HTM treated. See Fig. 2 and ¶ 10. This supports the position that the heat treatment of Muratoglu results in the claimed property.
It is noted that the claims are recited in the product-by-process format by use of the language, “fabricated from…” and “comprises the steps…”Case law holds that:
Even 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
To the extent that the process limitations in a product-by-process claim do not carry weight absent a showing of criticality, the reference discloses the claimed product in the sense that the prior art product structure is seen to be no different from that indicated by the claims. In this case, Muratoglu teaches the structural features claimed, notably, a crosslinked polymeric material derived from UHMWPE crosslinked with a peroxide and containing vitamin E having a EAB less than 400% and an ACP no greater than 0.06. Process limitations are found in claims 1-10 and 15-17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT C BOYLE whose telephone number is (571)270-7347. The examiner can normally be reached Monday-Thursday, 10am-4pm.
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/ROBERT C BOYLE/Primary Examiner, Art Unit 1764