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 .
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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a femoral head resurfacing implant, classified in A61F2/3603.
II. Claim 14-20, drawn to a method of implanting a resurfacing implant, classified in A61F2/4603.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process as claimed can be practiced with another materially different product such as a femoral head without a rim.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Daniela Caro-Esposito on 8/21/26 a provisional election was made without traverse to prosecute the invention of claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Timoteo (20090306788).
With regards to claim 1, Timoteo discloses a femoral head resurfacing implant (1) comprising: a head (3) having a rim (11) separating an outer surface of the head (7) from an inner surface (13) of the head (FIG 9), wherein a first plane extends through three separate locations along a length of the rim (X’); and a stem extending from the inner surface of the head (9) and being configured to be received within an opening of a femoral head of a femur (FIG 12), the stem being entirely on the first side of the first plane (FIG 6).
With regards to claim 2, Timoteo discloses the implant of claim 1, wherein the inner surface (13) is configured to contain a spherical interface region (FIG 7), a cylindrical region ([0033]), and an elevated, circular ridge surrounding the stem of the implant (11).
With regards to claim 3, Timoteo discloses the implant of claim 1, wherein the stem is oriented at an angle relative to a first axis (FIG 6), the first axis passing through a pole of the head and a center of an opening defined by the rim (FIG 6).
With regards to claim 4, Timoteo discloses the implant of claim 3, wherein a base of the stem is offset from the first axis (FIG 6).
With regards to claim 7, Timoteo discloses the implant of claim 1, wherein the length of the stem is not greater than 60% of an outer diameter of the implant ([0028]).
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.
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) 5-6, 8, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timoteo (20090306788).
With regards to claim 5, Timoteo discloses the implant of claim 3, wherein the stem is oriented at an angle relative to the first axis (alpha, [0025]). There is no evidence of record that establishes that an angle ranging from 15 to 45 degrees would result in a difference in the function of Timoteo’s femoral head resurfacing implant. A person having ordinary skill in the art, being faced with modifying Timoteo’s femoral head resurfacing implant, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the cohesiveness “may” be within the claimed range, and offering other acceptable ranges (5-20 degrees, specification at [0007]) and therefore there appears to be no criticality places on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stem of Timoteo to have an angle between 15 to 45 degrees as an obvious matter of design choice within the skill of the art.
With regards to claim 6, Timoteo discloses the implant of claim 3, wherein the stem is oriented at an angle relative to the first axis (alpha, [0025]). There is no evidence of record that establishes that an angle ranging from 25 to 35 degrees would result in a difference in the function of Timoteo’s femoral head resurfacing implant. A person having ordinary skill in the art, being faced with modifying Timoteo’s femoral head resurfacing implant, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the cohesiveness “may” be within the claimed range, and offering other acceptable ranges (5-20 degrees, specification at [0007]) and therefore there appears to be no criticality places on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stem of Timoteo to have an angle between 25 to 35 degrees as an obvious matter of design choice within the skill of the art.
With regards to claim 8, Timoteo discloses a femoral head resurfacing prosthesis (1) comprising: a head (3) having a rim (11) separating an outer surface of the head (7) from an inner surface of the head (13); and a stem extending from the inner surface toward an opening of the head defined by the rim (9, FIG 6), wherein a central axis of the head passes through a center of the opening and a pole of the head (X’) and the stem has an elongate dimension oriented at an angle relative to the central axis of the head (alpha, [0025]), and wherein the elongate dimension of the stem is less than 65% of an outer diameter of the head ([0028]). There is no evidence of record that establishes that an angle ranging from 5 to 20 degrees would result in a difference in the function of Timoteo’s femoral head resurfacing implant. A person having ordinary skill in the art, being faced with modifying Timoteo’s femoral head resurfacing implant, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the cohesiveness “may” be within the claimed range, and offering other acceptable ranges (15-45 degrees, specification at [0006]) and therefore there appears to be no criticality places on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stem of Timoteo to have an angle between 5 to 20 degrees as an obvious matter of design choice within the skill of the art.
With regards to claim 11, Timoteo discloses the femoral head resurfacing prothesis of claim 8 wherein the inner surface of the head (13) contains an elevated, circular ridge surrounding the stem (8).
With regards to claim 12, Timoteo discloses the femoral head resurfacing prothesis of claim 8 wherein the elongate dimension of the stem is oriented at an angle relative to the central axis of the head (alpha, [0025]). There is no evidence of record that establishes that an angle ranging from 10 to 15 degrees would result in a difference in the function of Timoteo’s femoral head resurfacing implant. A person having ordinary skill in the art, being faced with modifying Timoteo’s femoral head resurfacing implant, would have a reasonable expectation of success in making such a modification and it appears that the device would function as intended. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the cohesiveness “may” be within the claimed range, and offering other acceptable ranges (15-45 degrees, specification at [0006]) and therefore there appears to be no criticality places on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stem of Timoteo to have an angle between 10 to 15 degrees as an obvious matter of design choice within the skill of the art.
With regards to claim 13, Timoteo discloses the femoral head resurfacing prothesis of claim 8, wherein the elongate dimension of the stem is in a range from 50% to 60% of the outer diameter of the head ([0028], if the stem is not extending beyond the radius, the elongate dimension is 50% of the outer diameter).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timoteo (20090306788) in view of Collins (20080200991).
With regards to claim 9, Timoteo discloses the femoral head resurfacing prosthesis of claim 8, but fails to disclose wherein the head further comprises a base component and an articulating surface component attachable to the base component, the inner surface being on the base component and the outer surface being on the articulating surface component.
Collins also discloses a femoral head resurfacing prosthesis (210) comprising: a head (238, 225) having a rim (222) separating an outer surface of the head from an inner surface of the head (FIG 7a); and a stem extending from the inner surface toward an opening of the head defined by the rim (214, FIG 7a). Collins teaches wherein the head further comprises a base component (238) and an articulating surface (225) component attachable to the base component (FIG 7a), the inner surface being on the base component and the outer surface being on the articulating surface component (FIG 7a). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Timoteo’s femoral head resurfacing prosthesis to include wherein the head further comprises a base component and an articulating surface component attachable to the base component, the inner surface being on the base component and the outer surface being on the articulating surface component, as taught by Collins, because a two part design allows for ease of manufacturing ([0043]) and gives the surgeon more flexibility ([0044]).
With regards to claim 10, Timoteo as modified by Collins discloses a kit comprising: the femoral head resurfacing prosthesis of claim 9; and a second articulating surface component different from the first articulating surface component ([0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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