DETAILED ACTION
This office action is responsive to the amendment filed May 18, 2026, and the Request for Continued Examination filed June 17, 2026. Claim 10 was amended. 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026, has been entered.
Response to Arguments
Applicant's arguments filed May 18, 2026, have been fully considered but they are not persuasive.
As discussed in the Advisory Action of May 26, 2026, the amendments and arguments were considered at that time, and not agreed to overcome the rejection of record.
It is argued that the rejection of claims 10-13 and 21-26 in view of Dewey (US 2007/0233071 A1) and Drewry (US 2003/0083657 A1) is improper since the combination allegedly does not teach or suggest each and every claimed element of claim 10. In particular, it is argued that the base reference Dewey fails to teach the claimed lumen. Such was admitted in the prior office action, and examiner continues to agree. The argument notes that Examiner cured this deficiency of Dewey by stating it was obvious in view of Drewry to include the claimed lumen through the screw.
Applicant then argues that the proposed combination would teach someone with ordinary skill in the art to only produce a cannulation 42 of Drewry through only a portion 316 of Dewey, and not through 318 – especially at the tip portion. The argument states that this is because Dewey’s inner core does not extend all the way to the distal end of the device.
Examiner disagrees with this analysis of the combination of references. Drewry teaches a cannulation 42 extending all the way from a distal tip to a proximal end. It is examiner’s opinion that one with ordinary skill in the art would understand to modify Dewey to include the cannula through both 316 and 318 based on the Drewry teaching that the cannula passes entirely from the proximal end through the distal tip. In particular, examiner proposed to make the modification to Dewey in order to permit passage of a guide wire through the cannulation – if the tip were closed as suggested by applicant, this modification would not have succeeded in achieving that goal.
Therefore, the rejection of record is maintained. The rejection of record is duplicated, below, as modified only to correlate to the amended claim language.
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 having a screw proximal end and screw distal end (up, and down, in fig. 12, respectively), 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 from the proximal end to the distal end of the screw.
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 (from top to bottom, through 316 and 318) 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
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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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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