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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-9 in the reply filed on 4/14/2026 is acknowledged. Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/14/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim term “UHMWPE” should first state that it is “ultra-high molecular weight polyethylene” before using the abbreviated form (UHMWPE) in later instances. Examiner finds this abbreviation to be clear/concise once it is defined in the claim and informal as drafted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the use of scientific notation of “5*106 g/mol to 107 g/mol” is not clear as to the second value. Is this supposed to be 5*107 or 1*107? As such, the metes and bounds of this limitation are not clear, as drafted.
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).
Conclusion
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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