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 .
Restriction/Election
Applicant’s election without traverse of claims 1-17 in the reply filed on 06/12/2026 is acknowledged.
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) 1-8, and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klein et al. US 20090069899 A1, herein referred to as Klein.
Regarding claim 1, Klein discloses a modifiable ([0005], moldable component recited) antibiotic ([0004 teaches antibiotic element]) spacer apparatus (Fig 1, 10) comprising: a shaft (Fig 5, 34); and plurality of planar members (Fig 5, 42, 43, 40) coupled to the shaft (Fig 4), wherein: each planar member of the plurality of planar members is approximately perpendicular to the shaft (Fig 5); and each planar member comprises an outer perimeter (Fig 5); and the plurality of planar members are configured such that the outer perimeter of each planar member can be intra-operatively modified ([0002]; cement is introduced and later removed from planar members).
Regarding claim 2, Klein discloses further comprising antibiotic cement ([0006]) between a first planar member of the plurality of planar members and a second planar member of the plurality of planar members ([0006]).
Regarding claim 3, Klein discloses wherein the plurality of planar members are configured such that the outer perimeter of each planar member can be intra-operatively modified to correspond to a prepared bone cavity created after removal of infected bony material ([0006]; modified following removal of infection).
Regarding claim 4, Klein discloses wherein the plurality of planar members are configured such that the outer perimeter of each planar member can be intra-operatively modified to correspond to the prepared bone cavity, and wherein the prepared bone cavity is in a femur [0018].
Regarding claim 5, Klein discloses wherein at least one planar member of the plurality of planar members comprises an aperture extending through the at least one planar member (Fig 5, port 38 [0021]).
Regarding claim 6, Klein discloses further comprising antibiotic cement proximal to the at least one planar member of the plurality of planar members comprising the plurality of apertures extending through the at least one planar member ([0006]).
Regarding claim 7, Klein discloses wherein the aperture is configured to allow the antibiotic cement to flow through the aperture ([0021]).
Regarding claim 8, Klein discloses wherein at least one planar member of the plurality of planar members comprises one or more slots proximal to the shaft (Fig 5, 43).
Regarding claim 10, Klein discloses wherein each planar member of the plurality of planar members comprises an implantable polymeric material ([0020] polyethylene).
Regarding claim 11, Klein discloses wherein each planar member of the plurality of planar members comprises polyethylene ([0020] polyethylene).
Regarding claim 12, Klein discloses further comprising a base plate configured to engage an articular surface (Fig 1, 28; [0018] acetabular cavity is for articulating the joint).
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein in view of Michielli et al. US 5766178 A, herein referred to as Michielli.
Regarding claim 9, Klein discloses the invention substantially as claimed and as discussed above with respect to claim 8, but does not explicitly disclose wherein the one or more slots proximal to the shaft allow the at least one planar member to move laterally with respect to the shaft.
However, in the same field of endeavor, Michielli teaches a spacer (Fig 1, 10) apparatus comprising: a shaft (12); and a plurality of planar members coupled to the shaft (Fig 1), wherein: each planar member of the plurality of planar members (14, 16, 18) is approximately perpendicular to the shaft (Fig 1); wherein the one or more slots (space between flanges) proximal to the shaft allow the at least one planar member to move laterally with respect to the shaft (Col 3, lines 35-42).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Klein to incorporate wherein the one or more slots proximal to the shaft allow the at least one planar member to move laterally with respect to the shaft, as taught and suggested by Michielli in order to provide a grip (Michielli Col 3, lines 35-42).
Claim(s) 13-14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein in view of Meridew et al. US 20070129809 A1, herein referred to as Meridew.
Regarding claim 13, Klein discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose.
However, in the same field of endeavor, Meridew teaches a spacer (Fig 13, 12i/150/10i) apparatus comprising: a shaft (Fig 13, 12i); further comprising an augment (Fig 13-14, 10i) configured to receive the [shaft section including] plurality of planar members (Fig 14 receives 12i; [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Klein to incorporate further comprising an augment configured to receive the [shaft section including] plurality of planar members, as taught and suggested by Meridew in order to provide biological fixation (Meridew [0052]).
Regarding claim 14, Klein as modified by Meridew discloses the invention substantially as claimed and as discussed above with respect to claim 13, and additionally teaches wherein the augment comprises a plurality of apertures (Meridew Fig 14, 142).
Regarding claim 16, Klein as modified by Meridew discloses the invention substantially as claimed and as discussed above with respect to claim 13, and additionally teaches wherein the augment is formed from antibiotic laced polymer material, a silver coated material, tantalum or titanium (Meridew [0003] and [0066]).
Regarding claim 17, Klein as modified by Meridew discloses the invention substantially as claimed and as discussed above with respect to claim 13, and additionally teaches further comprising an insert and a receptacle (Klein Fig 3, 38; [0021]; teaches port is injected with a needle or tube to allow the movement of cement throughout spacing components), wherein the insert is configured to direct bone cement through the plurality of apertures of the augment (Cement of Klein would fill the apertures as described by Meridew).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klein in view of Meridew and further in view of Meridew et al. US 20130018482 A1, herein referred to as Meridew 482’.
Regarding claim 15, Klein as modified by Meridew discloses the invention substantially as claimed and as discussed above with respect to claim 14, and but does not disclose wherein the plurality of apertures have a diameter of at least 5 mm.
However, in the same field of endeavor, Meridew 482’ teaches a spacer (Fig 14, 110) comprising a shaft (122) and an augment (Fig 410), wherein the plurality of apertures (Fig 15, 42a’) have a diameter of at least 5 mm [0034].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Klein as modified by Meridew to incorporate wherein the plurality of apertures have a diameter of at least 5 mm, as taught and suggested by Meridew 482’ in order to allow the sleeve to compress as needed in fitting (Meridew 482’ [0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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