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
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mulliez et al. (US 2019/0218355), hereinafter Mulliez.
Regarding claims 1 and 5-6, Mulliez discloses a method of producing an implant based on UHMWPE comprising the steps of: (a) mixing UHMWPE powder with 0.1% by weight of an antioxidant (α-tocopherol) (par. 0038);
(b) compacting (“compression molding”) (par. 0038) the mixture of UHMWPE and antioxidant into a molded body (see also ref. claim 4);
(c) manufacturing one or more elements from the molded body by material-removing machining (“machining” – par. 0034; “cut” – par. 0039, where cutting is considered a form of material-removing machining); and
(d) irradiating the machined body by gamma radiation (par. 0011) or x-ray radiation (par. 0018, 0031-0033, 0041) in order to crosslink the UHMWPE (ref. claim 1), wherein the method comprises no thermal post-treatment of the irradiated element (par. 0036).
Mulliez does not explicitly disclose that the radiation dose is between 25-45 kGy, instead suggesting a range of 60-110 kGy (par. 0031). However, the reference also notes that the radiation dose is result-effective upon amount of cross-linking that occurs among the molecular chains (par. 0027), while also noting that the temperature of the mixture also causes a greater degree of crosslinking. It has been held that the optimization of a result-effective variable is within routine skill in the art and supports a case of prima facie obviousness. Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to have modified the above from Mulliez to have specified that the radiation dose is as required in the claims.
Regarding claim 2, Mulliez discloses the subject matter of claim 1, and further discloses that the UHMWPE is in the range of 5*10^6 to 10^7 g/mol and a density of 0.92-0.94 g/cm^3 (par. 0024).
Regarding claims 3-4, Mulliez discloses the subject matter of claim 1, and further discloses that the antioxidant is a tocopherol as claimed (par. 0020-0021).
Regarding claim 7, Mulliez discloses the subject matter of claim 1, and further discloses that the irradiation of the element is performed with gamma (par. 0011) or x-ray radiation (par. 0018. 0031-0033, 0041) for 4 to 5 hours (par. 0033).
Regarding claim 8, Mulliez discloses the subject matter of claim 1, and further discloses packaging the implant element (par. 0041)
Regarding claim 9, Mulliez discloses the subject matter of claim 1, and further discloses that the irradiation is performed in a receiving space (par. 0041 – x ray irradiation apparatus).
Response to Arguments
Applicant's arguments filed 9/4/2026 have been fully considered but they are not persuasive. In the remarks, Applicant argues that the order of steps is incorrect in the Mulliez reference as well as other points which will be addressed below.
First, Examiner points out that the claim uses the transitional phrase “comprising” which means that claim may include additional, unrecited elements. Additionally, Mulliez, par. 0038 first produces the molded bodies by producing plates by mixing and compacting the material, and par. 0039 cuts the molded bodies in the form of bars.
Mulliez, par. 0040-0042 applies an irradiating step to the molded bodies (and specifically, the cut bars – which have been once “machined” by cutting). As such, the specific sequence of steps appears to be met here, with a cutting step being the “material removing machining.” Examiner agrees that it appears in the reference there is a second machining step conducted (see at least Mulliez, par. 0043; ref. claim 15; and as argued in the remarks), but instant claim 1 can include additional, unrecited elements (due to the use of the term “comprising”), and thus, does not preclude a second machining step. The only thing that the claim explicitly precludes is “no thermal post-treatment of the irradiated sliding surface element” (Mulliez, par. 0036 teaches this claim element in almost the same language), which does not preclude a second machining. The claim also does not preclude any thermal pre-treatment of the pre-irradiated material (see Mulliez, par. 0036, 0040). As such, the cutting would read upon the claimed machining step, and this occurs prior to the irradiation of the material.
Furthermore, there is no specific structure required here for the sliding surface element product being produced by the claimed process. Under BRI, the term “sliding surface element” is broad and not limited in the claims to have any particular structure. Thus, the “bars” could be viewed as sliding surface elements, under BRI. Limitations from the specification are not imported into the claims. Additionally, it is noted that Mulliez is also producing elements for an implant for a joint (see Mulliez, par. 0017), which is similar to what is described in Applicant’s specification. Applicant also concludes that the proposed modification would not have been obvious because of this different order of steps, but this is not the case under the discussion above since the steps do not map to the claim elements as is argued in the remarks.
Accordingly, the prior art rejections are maintained as outlined above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW D GRAHAM whose telephone number is (469)295-9232. The examiner can normally be reached Monday - Friday 7:30AM-4:00PM (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at (571) 272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW D GRAHAM/Primary Examiner, Art Unit 1742
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