DETAILED ACTION
This office action is responsive to the amendment filed December 17, 2025. By that response, claim 10 was amended; claims 1-9 and 14-20 were canceled; and claims 21-26 were newly presented. Claims 10-13 and 21-26 are pending.
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 .
Response to Arguments
The outstanding rejection under 35 USC 112(b) of claims 8, 9, 14, 15 and 20 was overcome by cancellation of the claims.
The outstanding rejection of claims 1, 8, 9, and 16 under 35 USC 102(a)(1) in view of Baumgartner et al. (US 2011/0160870 A1) was overcome by cancellation of the claims.
The outstanding rejection of claims 2-4 and 17-20 under 35 USC 103 in view of Baumgartner was overcome by cancellation of the claims.
The outstanding rejection of claims 5-7, 14, and 15 under 35 USC 103 in view of Baumgartner and Dewey (US 2007/0233071 A1) was overcome by cancellation of the claims.
The outstanding rejection of claims 10-13 under 35 USC 103 in view of Baumgartner and Dewey was overcome by the amendment to the claims of December 17, 2025. The arguments related thereto have been considered but are considered moot since the new rejection is made in view of a different combination of prior art references. The newly presented rejection was necessitated by the amendments to the claims of December 17, 2025.
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.
Claim(s) 10-13 and 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dewey et al. (US 2007/0233071 A1) in view of Drewry et al. (US 2003/0083657 A1).
Regarding claim 10, Dewey teaches an orthopedic screw as at fig. 12, comprising:
an inner core member 316 having a proximal end 314 and a distal end 322, a proximal radiopaque thread, a distal radiopaque thread, and an intermediate radiopaque thread disposed between and axially spaced from the proximal radiopaque thread and the distal radiopaque thread:
Dewey demonstrates various threadforms with two materials 316/318 with the materials located in various regions of the screw (e.g. figs. 8, 10, 12). Further, Dewey states that additional regions of bone interface portion 318 can exist with ‘two or three or more axial regions being defined’ in an alternating fashion. The alternating fashion described encompasses the arrangement claimed.
Material 316 is taught being a metal such as titanium [0034]. Examiner takes official notice of titanium being radiopaque.
Dewey further teaches a first outer body member 318 defining a first radiolucent outer body member external thread that is disposed between and continuous with the proximal radiopaque thread and the intermediate radiopaque thread and
a second outer body member 318 defining a second radiolucent outer body member external thread that is disposed between and continuous with the intermediate radiopaque thread and the distal radiopaque thread. (see discussion of arrangement, above, with alternating regions of 316/318; as at [0034] 318 can be formed of PEEK. Examiner takes official notice of PEEK being radiolucent.)
Dewey fails to teach the inner core 316 defining a proximal and distal opening with a lumen extending only between the proximal opening and the distal opening.
Drewry teaches a threaded fastener including such a lumen as best seen at fig. 3.
It would have been obvious to one with ordinary skill in the art at the time of the invention to add a central lumen 42 of Drewry to the Dewey device as a matter of simple modification of the Dewey structure in light of the Drewry teaching. One would have done so in order to permit use of a K-wire or other guide means passed through the lumen to guide the screw into place in a hard to access location in a surgical theater, such that the procedure may be carried out in a more minimally invasive manner.
Regarding claim 11, the inner core member 316 comprises a metal. [0034]
While the general teaching of use of biocompatible metals is considered to encompass anodized metals, there is no specific mention of the metal being anodized.
The instant application states at [0052] that anodization processes for preparing metal members for orthopedic purposes are known to be conventional.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the combination device portion 316 of anodized metal since the instant application has taught that such is conventional. Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice – in this case, for purposes of providing the screw with desired structural properties.
Regarding claim 12, each of the first outer body member and the second outer body member comprises a polymeric material – 318 are taught being polymeric [0034].
Regarding claim 13, the inner core member 316 comprises a titanium alloy [0034] and each of the first outer body member and the second outer body member 318 comprises PEEK composite. The particular composite is not disclosed.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the combination device with portions 318 being formed of CFR PEEK since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, in this case for the purpose of providing desired structural properties.
Regarding claim 21, the inner core member 316 defines a first circumferential recess defining a first circumferential recess floor and a second circumferential recess defining a second circumferential recess floor (at each location where portions 318 are present).
Regarding claim 22, the first outer body member 318 is disposed about the inner core member 316 in the first circumferential recess and the second outer body member is disposed about the inner core member in the second circumferential recess as seen at fig. 12.
Regarding claims 23-26, one of the first circumferential floor and the second circumferential floor defines a plurality of circumferential grooves; and wherein one of the first outer body member and the second outer body member extends into the plurality of circumferential grooves: various designs of an inner member floor portion of 316 are taught in Dewey, including a smooth floor and a floor with a helical trough 17a (spiral grooves alternating with spiral projections) (compare figs. 2 and 6). This formation is considered to read on the claimed grooves.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the structure of 316 to include grooves based on the disclosure of both grooved and non-grooved structures in a second embodiment of Dewey. One would have done so in order to improve interface between the inner and outer members 316/318, thereby increasing frictional retention between the components.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799