DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/25/2026 and 8/26/2026 has been entered.
Double Patenting
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.
The rejection is adequately set forth in the office action mailed on 2/13/2026 and is incorporated here by reference. Applicant’s Remarks are address below.
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.
Regarding the limitation where the ACP index is measured by FTIR analysis, there is no evidence that the method of measuring the ACP index provides any structural distinctions and therefore the prior art meets this limitation.
Response to Arguments
Applicant’s response filed 8/26/2026 has been fully considered but is not persuasive.
Applicant argues that the claims are patentably distinct from U.S. Patent No. 11,970,600 because they require heating above 250˚C for at least 50 hours and less than 70 hours, have an exposure at 295˚C no longer than 9 hours and an ACP index of no greater than 0.06.
However, as noted in the rejection, the range in US ‘600 is less than 0.03, which meets the range of the instant claims. US ‘600 teaches a high temperature melting (HTM) cycle in a reduced oxygen environment. The claims are directed to a product, not a process. Thus, the process limitations are interpreted as product-by-process limitations and there is no evidence on the record that establishes the instant claimed process limitations result in a structurally distinct product than the claims of US ‘600. Therefore, the double patenting rejection is maintained.
Applicant argues Muratoglu does not teach a dicumyl peroxided crosslinked material.
This is not persuasive because Muratoglu teaches dicumyl peroxide (DCP) (¶ 23, 428).
Applicant stresses the high temperature treatment provides a mechanism to decrease toxic by-products and balance wear resistance and EAB%. This is not persuasive because Muratoglu teaches EAB of less than 400% and treatment at elevated temperatures, at for example 300˚C, for a duration between 1 minute to 24 hours (¶ 397). Thus, Muradoglu provides guidance on this balance.
Applicant argues that the use of dicumyl peroxide is important because other peroxides give different EAB%. This is not persuasive. The prior art teaches (1) the correct peroxide, (2) overlapping EAB%, and (3) a high temperature melting (HTM) cycle. The rejection explains how the ACP index is tied to the HTM process, and no evidence has been provided that establishes the claimed ACP property is not present in the prior art.
Applicant appears to argue that the use of dicumyl peroxide results in the claimed ACP index. However, no data for the ACP has been provided using a different peroxide.
Applicant states that the process of Muratoglu is different than the process steps in the instant claims. However, as noted previously, there is no evidence that the different heating process results in a different ACP index. Absent such evidence, the position of inherency is maintained. Applicant has not provided any evidence that the ACP index of Muratoglu is outside the claimed range.
Applicant directs attention to the allowance of 17/703,288 (no US 11,970,600). However, in that application, data is present which established the claimed range (less than 0.03) was not necessarily present in the prior art. On review of this data and the scope of the instant claims, the data does not come to the same conclusion because there is no data establishing a HTM results in a ACP of not greater than 0.06. Attention is directed to Figure 2, where every example that uses a HTM gives a value within the range of not greater than 0.06. Therefore, the position of inherency is maintained.
Applicant states that the 82 hour cycle results in EAB values above 400%. Again, this is not persuasive because the prior art teaches how to arrive at an EAB in the claimed range. No inherency position is presented for the EAB.
The rejection of record is maintained as no data establishing the criticality of the claimed range, the criticality of the process steps, or that the prior art does not necessarily have the claimed property (ACP index) has been provided.
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
