DETAILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 28, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Species D (best shown by Figs. 19A and including Fig. 24A) in the reply filed on August 4, 2025 is acknowledged.
Priority
This Application is a CIP and some of the claims are generic back to earlier embodiments fully disclosed in parent cases.
Claims 2, 9, and 15 require the tensioning member to be cannulated. This feature is not disclosed in the parent cases, so claims 2, 9, and 15-21 are given a priority date of 9/30/2023.
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, 15, 18-21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregersen et al. (US 11317956; “Gregersen”), in view of Muckter (US 2002/0198527).
Claim 2, Gregersen discloses a bone screw (Figs. 13A-13D) insertable into a bone (Figs. 13A-13D), the bone screw comprising: a distal member (1120) comprising bone-engaging threads (1106 points to the threads); a proximal member (1104) configured to slidably engage the distal member (cols. 20-22); and a tension member (1108) comprising: a proximal end (1140) coupled to the proximal member (Fig. 13A); and a distal end (1142) coupled to the distal member such that, in response to motion of the distal member away from the proximal member, the tension member elongates and urges the distal member to move toward the proximal member (Fig. 13A; cols. 20-22); wherein: one of the proximal member and the distal member comprises a torque transmission socket (Fig. 13B 1114); the other of the proximal member and the distal member comprises a shaft (Fig. 12; 1120) adjacent to a torque transmission protrusion (the splines just above the threaded portion) that is slidably receivable within the torque transmission socket to transmit torque between the proximal member and the distal member (Fig. 13A); and the torque transmission protrusion comprises a torque transmission feature with a first maximum diameter larger than a second maximum diameter of a portion of the shaft that is adjacent to the torque transmission feature (Figs. 12 and 13C); and the shaft comprises a circular cross-section (Figs. 12 and 13C).
However, Gregersen does not disclose the shaft comprising a cannula sized to receive a guidewire.
Muckter teaches a bone screw (Figs. 6A-6B) that has a proximal member (17), distal member (19) and a tension member (18), wherein the tension member is cannulated (paragraph [0045]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a cannula, as taught by Muckter, in the tension member shaft of Gregersen, in order to allow the entire device to be inserted over a guide wire which helps get the screw to the desired location (paragraph [0045]).
Claim 9, Gregersen discloses a bone screw (Figs. 13A-13D) insertable into a bone (Figs. 13A-13D), the bone screw comprising: a distal member (1120) comprising bone-engaging threads (1106 points to the threads); a proximal member (1104) configured to slidably engage the distal member (cols. 20-22); and a tension member (1108) comprising: a proximal end (1140) coupled to the proximal member (Fig. 13A); and a distal end (1142) coupled to the distal member such that, in response to motion of the distal member away from the proximal member, the tension member elongates and urges the distal member to move toward the proximal member (Fig. 13A; cols. 20-22); wherein: the tension member has a length from the proximal end to the distal end (Fig. 13D); the proximal member and the distal member cooperate to define a length limiting mechanism (Figs. 13A-13D; 1212 and 1218) configured to prevent the length from exceeding a maximum length (Fig. 13A; col. 22, lines 14-30); the length limiting mechanism comprises: a distal shoulder (Fig. 13B; 1216) and a proximal shoulder (opposite proximal shoulder), both of which are on one of the proximal member and the distal member (Fig. 13B); and a stop feature (Fig. 13C; 1212) on the other of the proximal member and the distal member (Fig. 13C); and the stop feature is positioned between the distal shoulder and the proximal shoulder to define a minimum length and the maximum length by abutting the stop feature against the distal shoulder and the proximal shoulder (Fig. 13A).
However, Gregersen does not disclose the shaft comprising a cannula sized to receive a guidewire.
Muckter teaches a bone screw (Figs. 6A-6B) that has a proximal member (17), distal member (19) and a tension member (18), wherein the tension member is cannulated (paragraph [0045]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a cannula, as taught by Muckter, in the tension member shaft of Gregersen, in order to allow the entire device to be inserted over a guide wire which helps get the screw to the desired location (paragraph [0045]).
Claim 15, Gregersen discloses a bone screw (Figs. 13A-13D) insertable into a bone (Figs. 13A-13D), the bone screw comprising: a distal member (1120) comprising bone-engaging threads (1106 points to the threads); a proximal member (1104) configured to slidably engage the distal member (cols. 20-22); and a tension member (1108) comprising: a proximal end (1140) coupled to the proximal member (Fig. 13A); a distal end (1142) coupled to the distal member such that, in response to motion of the distal member away from the proximal member, the tension member elongates and urges the distal member to move toward the proximal member (Fig. 13A; cols. 20-22); and a shaft (1144) extending from the proximal end to the distal end (Fig. 13D), wherein: the proximal member and the distal member define a longitudinal axis (Fig. 13A); the distal member comprises a distal engagement surface (Fig. 13C; 1212) facing away from the longitudinal axis (Fig. 13C); the proximal member comprises a proximal engagement surface (Fig. 13B; 1218) facing toward the longitudinal axis (Fig. 13B); and the distal engagement surface is positioned to abut the proximal engagement surface to transmit bending loads from the distal member to the proximal member without transmitting torque between the proximal member and the distal member (Figs. 13A-13D; cols. 20-22); the tension member is threadably attached at one of the proximal end and the distal end (Fig. 13A; distal end near where 1108 points); and the tension member abuts an internal feature (Figs. 13A-13B; 1116) at the other of the proximal end and the distal end (Fig. 13A).
However, Gregersen does not disclose the shaft comprising a cannula sized to receive a guidewire.
Muckter teaches a bone screw (Figs. 6A-6B) that has a proximal member (17), distal member (19) and a tension member (18), wherein the tension member is cannulated (paragraph [0045]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a cannula, as taught by Muckter, in the tension member shaft of Gregersen, in order to allow the entire device to be inserted over a guide wire which helps get the screw to the desired location (paragraph [0045]).
Claim 18, Gregersen in view of Muckter discloses the bone screw of claim 15, Gregersen discloses wherein: the proximal member comprises a proximal torque transmission feature (Fig. 13B; splines near where 1114 points) distinct from the proximal engagement surface (Fig. 13B); and the distal member comprises a distal torque transmission feature (Fig. 12; splines on 1106), distinct from the distal engagement surface (Fig. 12), configured to receive torque from the proximal torque transmission feature (Figs. 12-13D; cols. 20-22).
Claim 19, Gregersen in view of Muckter discloses the bone screw of claim 18, Gregersen discloses wherein: the proximal torque transmission feature is in a torque transmission socket (Fig. 12; where 1114 points); the distal torque transmission feature is on torque transmission protrusion (1120) that is slidably receivable within the torque transmission socket to transmit torque between the proximal member and the distal member (Fig. 13A); the proximal torque transmission feature comprises a female spline (Fig. 12; note sure if it’s the female spline, but doesn’t matter since it has been held that changing the male/female connections only requires routine skill in the art); and the distal torque transmission feature comprises a male spline configured to mate with the female spline (Figs. 12-13A).
Claim 20, Gregersen in view of Muckter discloses the bone screw of claim 15, Gregersen discloses wherein: the bone screw has a length from a proximal-most end of the proximal member to a distal-most end of the distal member; the proximal member and the distal member cooperate to define a length limiting mechanism configured to: prevent the length from exceeding a maximum length; and prevent the length from decreasing below a minimum length; the length limiting mechanism comprises: a distal shoulder and a proximal shoulder, both of which are on one of the proximal member and the distal member; and a stop feature on the other of the proximal member and the distal member; and the stop feature is positioned between the distal shoulder and the proximal shoulder to define the minimum length and the maximum length by abutting the stop feature against the distal shoulder and the proximal shoulder (Fig. 13A; where 1210 points teaches all the features).
Claim 21, Gregersen in view of Muckter discloses the bone screw of claim 20, Gregersen discloses wherein: the distal shoulder and the proximal shoulder are on the distal member; the stop feature is on the proximal member; the stop feature abuts the distal shoulder to define the minimum length; and the stop feature abuts the proximal shoulder to define the maximum length (Fig. 13A; where 1210 points teaches all the features).
Claim 24, Gregersen discloses the bone screw of claim 15 (everything is the same, but Fig. 3A-3D are being used, so there are only slight changed in the design for the threaded part 146), wherein, the proximal member (Fig. 3B) defines a threaded socket (147); and the proximal end comprises proximal threads (Fig. 3D; 146) configured to be coupled to the threaded socket (Fig. 3A).
Allowable Subject Matter
Claims 1, 5-8, 13-14, and 22-23 are allowed.
Claim 25 is 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.
Response to Arguments
Applicant’s arguments have been fully considered and they are addressed by the office action above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/Zade Coley/Primary Examiner, Art Unit 3775