DETAILED ACTION
This is the first office action on the merits in this application. The claims of February 14, 2025, are under consideration. Claims 1-24 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 .
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, 9, 11-20 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Culbert (US 10,349,982 B2).
Regarding claim 1, Culbert teaches a system at fig. 10 capable of use in performing a distraction histogenesis surgical procedure, the system comprising:
an anchor screw 344 comprising a hollow interior defined by a sidewall (hollow region, wherein the anchor screw 344 comprises internal actuation threading 345 attached to an interior surface of the sidewall and further comprises external anchor threading attached 350 to an exterior surface of the sidewall of 344;
an actuation screw 342 comprising a screw shaft that comprises external actuation threading 343; and
a magnet 346 coupled to the actuation screw 342;
wherein the external actuation threading 343 of the screw shaft of 342 corresponds with the internal actuation threading 345 of the anchor screw 344; and
wherein rotation of the magnet 346 causes synchronous rotation of the actuation screw 342 (col. 9, lines 15-20).
Regarding claim 2, the rotation of the magnet 346 causes the synchronous rotation of the actuation screw 342 and thereby causes the actuation screw 342 to screw into or out of the hollow interior defined by the sidewall of the anchor screw 344 (movement along arrow B in fig. 10).
Regarding claim 3, Culbert further teaches attachment of structures to the screws 342/344, as at fig. 7, in one example. Portions 311 and 312 are considered to be plates attached to a functionally equivalent distraction mechanism. Therefore, Culbert further teaches the system including a distraction plate 311 coupled to the actuation screw 342, wherein the distraction plate 311 is axially coupled to the actuation screw 342 (through use of internal threadings 316 (which will interact with external threads 348, or other threads) such that: the distraction plate 311 lifts away from the anchor screw 344 in response to the synchronous rotation of the actuation screw causing the actuation screw 342 to screw out of the hollow interior of the anchor screw 344; the distraction plate 311 lowers toward the anchor screw 344 in response to the synchronous rotation of the actuation screw 342 causing the actuation screw 342 to screw into the hollow interior of the anchor screw 344.
Regarding claim 4, the system includes a coupler at the threading 316 that couples the distraction plate 311 to the actuation screw 342, wherein the coupler permits the actuation screw to rotate independently of the distraction plate (e.g. threadedly) such that the distraction plate remains rotationally stationary in response to the synchronous rotation of the actuation screw causing the actuation screw to screw into or out of the hollow interior of the anchor screw 344.
Regarding claim 9, the magnet comprises a circular cross-sectional geometry; a first pole comprising a first polarity; and a second pole comprising a second polarity; wherein the first polarity is opposite to the second polarity; and wherein the circular cross-sectional geometry comprises each of the first pole and the second pole such that each of the first pole and the second pole comprises a half-circle cross- sectional geometry (best demonstrated in fig. 1B, the magnet 27; since all other shown magnets are given no additional detail, they are all understood to be radially poled magnets in the same manner as 27; various magnets used throughout the embodiments of Culbert are also described as a radially poled magnet).
Regarding claims 11 and 12, in the magnet of fig. 1B of Culbert, the magnet can be seen to be in the form of a plate magnet having top and bottom surfaces, which has a length making the device ‘elongate’. The bottom surface. In the fig. 10 embodiment, this magnet would have one surface coupled to the actuation screw, and each of a first polarity and a second polarity of the magnet would be present on a top surface of the magnet.
Regarding claim 13, as seen at fig. 10, the magnet is a component of the actuation screw 342, and wherein the magnet comprises an elongated magnetic core forming a component of the actuation screw 342.
Regarding claims 14-16 and 20, the system includes an external magnetic controller 180 at fig. 13 comprising an external magnet 178 configured to magnetically engage with the magnet 346, wherein rotation of the external magnet 178 comprises synchronous rotation of the magnet, and thereby further causes the synchronous rotation of the actuation screw 342. (col. 9, line 62 – col. 10, line 55).
Regarding claim 17, the anchor screw 344 is configured to be screwed into a tissue of a patient at threads 350 and remain stationary within the tissue of the patient; and the screw shaft of the actuation screw 342 is configured to rotate within the hollow interior of the anchor screw 344 to cause the actuation screw 342 to move up or down along a longitudinal axis B of the anchor screw 344 and relative to a position of the anchor screw 344.
Regarding claim 18, the anchor screw 344 is configured to be screwed into a bone tissue of a patient and remain stationary within the bone tissue of the patient. There is no reason that magnet 346 cannot be disposed underneath a periosteum of the patient. Rotation of the magnet 346 causes the synchronous rotation of the actuation screw 342 such that rotation of the magnet 346 in a first direction causes the actuation screw 342 to distract out of the anchor screw in direction B and thereby cause distraction of the periosteum of the patient, when inserted in this manner. The rotation of the magnet 346 causes the synchronous rotation of the actuation screw 342 such that rotation of the magnet 346 in a second direction causes the actuation screw to retract into the anchor screw, opposite to arrow B, and thereby cause retraction of the periosteum of the patient, when inserted in the manner described.
Regarding claim 19, the anchor screw 344 is configured to be screwed into a tissue substrate of a patient. A position of the actuation screw 342 relative to a longitudinal axis of the anchor screw 344 is adjusted and maintained by rotating the screw shaft of 342 within the hollow interior of the anchor screw 344.
Regarding claim 24, Culbert teaches a system for performing a distraction histogenesis surgical procedure, the system comprising an external magnetic controller 180 comprising an external magnet; and a device configured to be implanted within a patient, as described above in rejecting claim 1.
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 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Culbert.
Regarding claim 10, Culbert teaches the limitations of claim 1, above, but does not teach the magnet having multiple regions of different poles. Culbert, though, teaches “radially poled magnetic elements”, in general , which is a teaching understood to include magnets with multiple pole regions.
Magnets having multiple regions of different poles in the same structure are old and well known in the art. Examiner is of the position that applicant did not (and does not claim to have) invented a magnet with multiple poles. Selection of different prior art magnets to apply to the Culbert device would have been obvious at the time of the invention, including selection of a magnet with multiple poles. One would have done so in order to provide for a magnet which has a desired strength profile in order to achieve the distraction ability in a particular use case.
Regarding claim 21, Culbert teaches the limitations of claim 1, above. The system includes an external magnetic controller 180 configured to form a magnetic coupling with the magnet via one or more electromagnets, one or more power drivers; and a processor (controller). The processor controls synchronized actuation of the one or more electromagnets to form the magnetic coupling with the magnet and cause synchronized rotation of the magnet via the one or more power drivers.
There is no disclosure of a sensor. However, use of Hall effect sensors to monitor magnetic phenomena, and especially rotational movement of components, is old and well known in the art. Examiner takes the position that the controller being briefly described by Culbert, either does, or would have obviously included some sort of sensor to provide the controller with feedback as to its function. A Hall effect sensor would be an old and simple means to provide the controller with the information necessary to perform its functions. If such a sensor was not present in the Culbert device, one would have added one in order to monitor and control the actuation of the device in a location where its function cannot be visually assessed.
Allowable Subject Matter
Claims 5-8, 22 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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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/DAVID W BATES/Primary Examiner, Art Unit 3799
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