DETAILED ACTION
This office action is responsive to the response filed February 23, 2026. Claims 1-23 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
Applicant’s arguments, see the remarks, filed February 23, 2026, with respect to the rejection(s) of claim(s) 1, 3, 4, 6-8, 10-13, 16, and 19-22 under 35 USC 102(a)(1) in view of Wunderlich et al. (US 2016/0305462 A1); claims 2 and 9 under 35 USC 103 in view of Wunderlich and Falkenstein et al. (US 10,428,859 B2); claim 5 under 35 USC 103 in view of Wunderlich and Stiebitz et al. (US 2013/0068075 A1); claims 14 and 15 under 35 USC 103 in view of Wunderlich and Lukes (US 2013/0213193 A1); claim 18 under 35 USC 103 in view of Wunderlich and Ryder et al. (US 5,237,893); and claim 23 under 35 USC 103 in view of Wunderlich and Johnston (US 2,267,925); have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Campbell, II (US 9,422,965 B2), alone, or in combination with other references. See below.
Upon receipt of the arguments with applicant’s emphasis to the claim language, examiner now understands the claims differently than he did when reading the claims in the prior office action.
While the portion of the argument related to claimed structures of the device was found persuasive, examiner wishes to state that arguments related to intended use of claimed device as a ‘bone implant,’ as opposed to the prior art being, for example, a wood screw, are not found persuasive in relation to the Wunderlich reference or any other reference applied in rejecting the claims. It is examiner’s position that while a surgeon may not use a wood screw in bone, there is no reason that a wood screw could not be driven into bone material. Examiner therefore is not persuaded that it was improper to refer to a prior art wood screw as capable of use as a bone implant, since the prior art screw was capable of performing the claimed intended use.
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, 3, 4, 6-8, 10, 11, 13-17, and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell, II (US 9,422,965 B2).
Regarding claims 1 and 15, Campbell teaches a tapered lobular surgical driver and implant system as seen best at figs. 2, 3, 7 and 9, the system comprising:
(a) a bone implant 104 (there being no reason the Campbell device cannot be inserted into a properly prepared bone) having a length extending from a proximal end to a distal end (top and bottom in fig. 2), the proximal end of the implant defining a socket 110 wherein:
(i) the socket 110 has a sidewall defining a plurality of grooves 208 and a plurality of alternating protrusions 218; and
(ii) the sidewall tapers from the proximal end toward the distal end at an implant angle of taper (col. 3, lines 12-34); and
(b) a driver 102 at fig. 7 comprising an engagement portion 702 configured to engage the socket 110 of the bone implant, wherein:
(i) the engagement portion 702 comprises a conical surface 708 tapering at a driver taper angle corresponding to the implant angle of taper (col. 6, lines 25-43; col. 7, lines 37-47); and
(ii) the engagement portion 702 comprises at least one lobe as can be seen in fig. 7 configured to be inserted into one of the plurality of grooves 208 defined by the socket of the bone implant, the at least one lobe projecting radially outwardly relative to the conical surface 708.
Regarding claim 3, the driver engagement portion 702 defines a circumferential perimeter, the conical surface comprises a first portion of the circumferential perimeter, and the at least one lobe comprises a second portion of the circumferential perimeter, the first portion being greater than the second portion (this arrangement can be discerned from the fig. 3 view of the socket in the implant).
Regarding claim 4, the first portion of the circumferential perimeter of 702 comprising the conical surface is at least 50% of the circumferential perimeter, as can be discerned from the fig. 3 view of the socket in the implant.
Regarding claim 6, the engagement portion 702 of the driver 102 comprises at least two lobes spaced equidistant about a perimeter of the engagement portion.
Regarding claim 7, each of the at least two lobes are spaced from each other lobe by a portion of the conical surface as can be seen in fig. 7.
Regarding claim 8, the at least one lobe projects radially outwardly relative to the conical surface by: the conical surface defining a first circumferential perimeter having a first radius; an apex of each of the at least one lobe defining a second circumferential perimeter having a second radius; and the second radius is greater than the first radius, as is apparent from fig. 7.
Regarding claim 10, the socket 110 is a hexalobular socket having six grooves and six protrusions as best seen at fig. 3.
Regarding claim 11, the engagement portion of the driver has three lobes spaced substantially equidistant about a perimeter of the engagement portion (choosing three of the lobes thereon).
Regarding claim 13, each of the plurality of grooves 208 of the bone implant has a radius of curvature as can be seen in fig. 3, and each lobe of the engagement portion of the driver 102 has a radius of curvature less than or equal to the radius of curvature of the plurality of grooves.
Regarding claim 14, the plurality of grooves and the plurality of alternating protrusions each taper at the implant angle of taper (col 7, lines 20-47).
Regarding claim 16, the driver angle taper and the implant angle of taper are a same angle. (col. 6, lines 25-43; col. 7, lines 37-47)
Regarding claim 17, the driver angle taper and the implant angle of taper are each in a range from 0.5 degrees to 30 degrees (col. 3, lines 26-34).
Regarding claim 19, the driver comprises a shaft defining a longitudinal axis extending from a distal end comprising the engagement portion 702 to a proximal end (top of fig. 7), and the proximal end comprises a handle configured to be manually gripped by a user to apply rotational motion to the shaft (there being no reason the top portion of 102 cannot be handled to apply rotational motion).
Regarding claim 20, the driver comprises a shaft defining a longitudinal axis extending from a distal end comprising the engagement portion 702 to a proximal end at the top of fig. 7, and the proximal end comprises a connector configured to operatively connect the shaft to a powered driver (the hexagonally formed portion).
Regarding claim 21, the distal end of the implant 104 comprises threading in portion 106. See fig. 2.
Regarding claim 22, the bone implant 104 comprises a screw capable of use in bone having a head 108 and a shaft 106, the head 108 having a larger cross-sectional area than the shaft 106, wherein the head 108 comprises the proximal end of the implant defining the socket 110 and the shaft 106 comprises the distal end of the implant comprising threading.
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) 2, 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Falkenstein et al. (US 10,428,859 B2).
Regarding claims 2 and 9, Campbell teaches the limitations of claim 1, but fails to teach the engagement portion has a number of lobes less than a number of the plurality of grooves.
Falkenstein teaches a fastener arranged as at fig. 4 for use with various types of drivers as at figs. 2A-3D. When any other than the hexalobular driver is used, the driver has fewer lobes than the engagement portion has grooves.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Campbell device with additional grooves as arranged in fig. 5 of Falkenstein. This design includes at least 14 grooves at different levels and circumferences. One would have done so in order to permit use of different drive recess portions in the event that a first portion became stripped or damaged. In such a modified arrangement, when the engagement portion is inserted, there are at least twice the number of grooves as lobes.
Regarding claim 12, Campbell teaches the limitations of claim 10, as above, but does not teach including a second hexalobular driver with straight sidewalls in the system.
Falkenstein teaches use of a single fastener with a socket for use with various types of drivers, including a straight sidewall hexalobular driver.
It would have been obvious to one with ordinary skill in the art at the time of the invention to have modified the Campbell drive recess to include additional grooves, and provide the system with additional drivers, such as the standard hexalobular driver. One would have done so in order to permit use of different drive recess portions in the event that a first portion became stripped or damaged. In such a modified arrangement, if the first set of grooves were damaged, the second hexalobular tool would be capable of engaging the modified driving recess.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Stiebitz et al. (US 2013/0068075 A1).
Regarding claim 5, Campbell teaches the limitations of claim 1, as above. However, Campbell fails to teach the driver 102 including a flute on each side of each lobe on the engagement portion, the flute being recessed relative to the conical surface.
Steibitz teaches a driver with an engagement portion as at fig. 1. The engagement portion includes lobes 3, a conical surface 8, and flutes 4 recessed relative thereto on both sides of the lobes 3. See fig. 3.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form Campbell’s conical surface to include flutes therein as in Stiebitz. One would have done so in order to cause increased surface area of contact between the driver and the drive recess.
Examiner fails to find disclosure of any particular advantage of the claimed flute design. If such is present, Examiner requests identification of such teaching for his understanding for preparation of any subsequent office action. Absent such teaching, Examiner will take the position that the presence of absence of the claimed flutes is simply a matter of design choice.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Ryder et al. (US 5,237,893).
Regarding claim 18, Campbell teaches the limitations of claim 1, as above. Further, the distal end of the engagement portion is seen in the figures being planar.
It is unclear from the figures if the socket comprises a planar bottom wall.
It is noted that the instant application appears to fail to teach any particular advantage to a planar distal interface - and in fact, appears to teach that a sloped or angled wall would work equally well (instant [0040]). If such exists, examiner requests that applicant identify it for examiner's review prior to the next office action. It appears that this is a simple matter of design choice.
Ryder teaches a tool having lobes and grooves and a fastener having a socket with corresponding shapes. The tool and socket both have planar bottom surfaces as seen in fig. 1.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Campbell socket to have planar bottom surfaces, as suggested by Ryder, and as a matter of functioning equally well, as suggested by the instant application. Doing so would have been selection between functionally equivalent, known art solutions, and a matter of design choice.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Johnston (US 2,267,925).
Regarding claim 23, Campbell teaches the limitations of claim 22, as above, but fails to teach the shaft of the bone implant 104 being threaded along less than half of a length of the shaft.
It is noted that the instant application does not provide any advantage for the screw having the threading along less than half the length. In fact, the instant application provides for various lengths of threads of the shaft being threaded (instant [0071]) and appears to teach that these are functionally equivalent designs. If a teaching of a reason for such threading is present, examiner requests that applicant identify it for examiner's review prior to the next office action. It appears that this is a simple matter of design choice.
It is well known to have threads of different lengths on screws. One example is at Johnston, e.g. fig. 4.
Johnston teaches a screw being threaded along less than half of a length of the shaft.
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide Campbell’s screw with threads along only a portion (less than a half) of the length of the shaft. One would have done so in order to make the screw simpler to manufacture. Such is considered a functionally equivalent design, and a matter of design choice.
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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