DETAILED ACTION
This office action is responsive to the reply of June 19, 2025. By that reply, claims 24-31 were canceled. Claims 1-23 stand pending.
This is a second non-final office 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 .
Response to Arguments
Regarding the rejection of claim 3 under 35 USC 112(b), examiner does not necessarily agree, but will take the position that applicant has clarified his position on the record as to what is meant by the claim, especially in context with the rest of the claim. Examiner will withdraw the rejection, and treat the limitation as meaning “the first portion being a greater portion of the circumferential perimeter than the second portion”, as generally suggested by the remarks. If examiner’s understanding as to the meaning of the claim is incorrect, examiner requests clarifying amendment.
Applicant’s arguments, see the remarks, filed June 19, 2025, with respect to the rejection(s) of claim(s) 1-23 under 35 USC 102(a)(1) or 103 in view of von Oepen (US 7,771,459), alone, or in combination with Tomaszewski (US 11,028,870), Kull (US 2,969,250), or Johnston (US 2,267,925), have been fully considered and are persuasive. Upon review in light of applicant’s comments, Examiner is no longer clear that von Oepen teaches each of the limitations. While he believes the reference might still teach what the prior rejection stated, examiner will agree to withdraw the rejection since the particulars of the structure of von Oepen’s driver are not sufficiently clearly demonstrated. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made, below.
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, 10-13, 16, and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wunderlich et al. (US 2016/0305462 A1).
Regarding claim 1, Wunderlich teaches a tapered lobular surgical driver and implant system (there being no reason that Wunderlich’s screw could not be used in a surgery as a bone implant), the system comprising:
(a) a bone implant 100 having a length (top to bottom) extending from a proximal end 104 to a distal end (tip of 102), the proximal end 104 of the implant defining a socket 106 wherein:
(i) the socket 106 has a sidewall defining a plurality of grooves 112 and a plurality of alternating protrusions 130; and
(ii) the sidewall tapers from the proximal end toward the distal end at an implant angle of taper (the angle of walls 130); and
(b) a driver 600 comprising an engagement portion 652 configured to engage the socket 106 of the bone implant 100, wherein:
(i) the engagement portion 652 comprises a conical surface of 604 tapering at a driver taper angle on 606 (seen most clearly in fig. 6, bottom right fig.) corresponding to the implant angle of taper ([0070]: “The core of the wing section 604, in contrast, is conically tapering towards the cone section 602.” As can be seen in the figures and described throughout the specification, 106 corresponds to the shape of driver 600 for form-locking fit [0053], etc.); and
(ii) the engagement portion 652 comprises at least one lobe 608 configured to be inserted into one of the plurality of grooves 112 defined by the socket 106 of the bone implant 100, the at least one lobe 608 projecting radially outwardly relative to the conical surface of 604.
Regarding claim 3, the driver engagement portion 652 defines a circumferential perimeter as in fig. 6 (bottom left), the conical surface 604 comprises a first portion of the circumferential perimeter (between portions 608), and the at least one lobe 608 (picking at least one, thereof) comprises a second portion of the circumferential perimeter, the first portion being greater than the second portion.
Regarding claim 4, when picking only a single lobe 608, the conical portion is far greater than 50% of the circumference. Further, even if all of the lobes were taken into consideration, the further proximal one travels as in fig. 6 (bottom right), the ratio of cylindrical portion increases relative to the portion of lobes. At some points, it is clear that the cylindrical portion is greater than 50% of the perimeter.
Regarding claim 6, the engagement portion 652 includes at least two lobes 608 spaced equidistant about a perimeter of the engagement portion 652 (choosing at least two oppositely positioned lobes 608; or six lobes 608).
Regarding claim 7, each of the at least two lobes 608 are spaced from each other by a portion of the conical surface of 606.
Regarding claim 8, the at least one lobe 608 projects radially outwardly from the conical surface of 606. The conical surface defines a first circumferential perimeter having a first radius. The apex of each lobe 608 defines a second perimeter having a second radius, greater than the first radius.
Regarding claim 10, the socket 106 is hexalobular having six grooves 112 and six protrusions 130. See figs. 1 and 1A.
Regarding claim 11, three of the lobes 608 (choosing every other lobe 608) are substantially equidistant about a perimeter of the engagement portion 652.
Regarding claim 12, it is taught that use of a second driver such as a Torx TX bit is possible. [0060] Torx bits are known to have straight sidewalls and six lobes.
Regarding claim 13, the grooves 112 in the implant 100 have a radius of curvature as seen in fig. 1. It is inherent that the radius of curvature of the lobes 608 of the engagement portion 652 is less than or equal to the radius of curvature of the grooves since form-fit coupling is taught [0053].
Regarding claim 16, since the implant 100 and driver 600 are taught having form-fit coupling, it is clear that the implant angle of taper and driver angle taper are the same angle.
Regarding claim 19, the driver includes a shaft 650 defining a longitudinal axis (up/down in fig. 6) extending from a distal end comprising the engagement portion 652 to a proximal end (down in fig. 6), and the proximal end comprises a handle configured to be manually gripped by a user to apply rotational motion to the shaft. There is no reason that portion 650 cannot be used as a handle for gripping and applying rotational motion. It is further noted that 600 can be formed as a wrench such as an L-shaped wrench, which the other portion of the L is a handle for use in the claimed manner. [0030]
Regarding claim 20, the driver includes a shaft 650 defining a longitudinal axis up/down in fig. 6 extending from a distal end comprising the engagement portion 652 to a proximal end opposite thereto, and the proximal end comprises a connector configured to operatively connect the shaft to a powered driver (hex connector as seen in fig. 6). [0029]
Regarding claim 21, the distal end of 100 includes threading on 102 (102 is described as a screw shaft with a thread [0052]).
Regarding claim 22, wherein the bone implant 100 comprises a bone screw having a head 104 and a shaft 102, the head 104 having a larger cross-sectional area than the shaft 102 as in fig. 1, wherein the head 104 comprises the proximal end of the implant 100 defining the socket 106 and the shaft 102 comprises the distal end of the implant comprising threading [0052]. There is no reason that the Wunderlich screw cannot be installed into a bone.
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 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wunderlich in view of Falkenstein et al. (US 10,428,859 B2).
Regarding claims 2 and 9, Wunderlich teaches the limitations of claims 1 and 10, as above. However, Wunderlich has not taught the engagement portion 652 having a number of lobes 608 less than the number of the plurality of grooves 112. It is noted that Wunderlich has identified that his lobes can function as slits across the body [0013], and that different numbers of wings may be used [0026].
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 Wunderlich 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 event that a first portion became stripped or damaged. In such a modified Wunderlich arrangement, when the tool 600 is inserted, there are at least twice the number of grooves as the number of lobes. The conical surface 604 of the tool 600 bounds the other non-utilized grooves.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wunderlich in view of Stiebitz et al. (US 2013/0068075 A1).
Regarding claim 5, Wunderlich teaches the limitations of claim 1 as above. However, Wunderlich does not teach inclusion of flutes on each side of the lobes 608 which are recessed relative to the conical surface.
Stiebitz teaches a screw including 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 (between lobes 3 and conical surface 8). See fig. 3.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form Wunderlich’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) 14, 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wunderlich in view of Lukes (US 2013/0213193 A1).
Regarding claims 14, 15 and 17, Wunderlich teaches the plurality protrusions 130 each taper at the implant angle of taper, but the grooves 112 do not include this same taper. Further, Wunderlich does not specify the angle of the taper.
Lukes teaches a design of fastener driver recess and driver tool as at figs. 1A-D fig. 3, and fig. 9, in which the grooves and protrusions of a driver recess all taper at an implant angle which is the same angle as an angle within the recess of a fastener (implant angle). Lukes specifies that the taper is between 15 and 45 degrees (abstract).
It would have been obvious to one with ordinary skill in the art at the time of the invention to provide the Wunderlich device with tapered grooves 112 (and correspondingly cause the lobes 608 to taper in the same angle) based on the teaching of Lukes. It would have been obvious to cause the taper angle to be in the range One would have done so in order to configure the Wunderlich device to be capable of use with various sized heads of implants (similar to Lukes figs. 1A-C demonstrating the same tool used on different sized implant heads).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wunderlich in view of Ryder et al. (US 5,237,893).
Regarding claim 18, Wunderlich teaches the limitations of claim 1, above, but fails to teach the socket including a planar bottom wall and a distal end of the engagement portion 652 including a planar wall. Wunderlich teaches a 70 degree inclination of an endwall at 122 [0056] (and discusses 616 being a cone-shape) but fails to provide any reason for such configuration.
It is noted that the instant application also 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 Wunderlich socket and tool 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 Wunderlich in view of Johnston (US 2,267,925).
Regarding claim 23, Wunderlich teaches the limitations of claim 22, as above, but fails to teach the shaft of the screw 100 being threaded along less than half a length of the shaft 102.
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 Wunderlich’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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/DAVID W BATES/Primary Examiner, Art Unit 3799