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 .
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 § 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, 6, 8, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al. (US 2006/0264954; “Sweeney”).
Claim 1, Sweeney discloses a bone screw (Fig. 2) insertable into a bone (Fig. 2), the bone screw comprising: a distal member (160) comprising bone-engaging threads (170); a proximal member (140) configured to slidably engage the distal member (Fig. 2; paragraphs [0035]-[0054]); and a tension member (Fig. 2; 200) comprising: a proximal end (210) coupled to the proximal member (Fig. 1; paragraphs [0035]-[0054]); and a distal end (220) coupled to the distal member (Fig. 1) 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 (paragraphs [0035]-[0054]); wherein: one of the proximal member and the distal member comprises a torque transmission socket (Fig. 2; paragraphs [0035]-[0054]; inside channel of 140); the other of the proximal member and the distal member comprises a shaft (Fig. 5A; could be lower half of 150) adjacent to a torque transmission protrusion (upper half of 150) that is slidably receivable within the torque transmission socket to transmit torque between the proximal member and the distal member (Fig. 2; paragraphs [0035]-[0054]); and the torque transmission protrusion comprises a torque transmission feature (Fig. 5A; 500) 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 (Fig. 5A).
Claim 6, Sweeney discloses the bone screw of claim 1, wherein: the bone screw has a length (Fig. 1) from a proximal-most end (130) of the proximal member to a distal-most end (180) of the distal member; and 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 (Figs. 1-7B; paragraphs [0035]-[0054]).
Claim 8, Sweeney discloses a bone screw (Fig. 2) insertable into a bone (Fig. 2), the bone screw comprising: a distal member (160) comprising bone-engaging threads (170); a proximal member (140) configured to slidably engage the distal member (Figs. 1-7B; paragraphs [0035]-[0054]); and a tension member (200) comprising: a proximal end (210) coupled to the proximal member (Fig. 1); and a distal end (Fig. 2; 220) coupled to the distal member (Fig. 1) 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 (Figs. 1-7B; paragraphs [0035]-[0054]); wherein: the tension member has a length (Fig. 1) from the proximal end to the distal end; and the proximal member and the distal member cooperate to define a length limiting mechanism (Figs. 1-7B; paragraphs [0035]-[0074]; the tension the surgeon feels could be the mechanism) configured to: prevent the length from exceeding a maximum length (Figs. 1-7B; paragraphs [0035]-[0074]).
Claim 22, Sweeney discloses the bone screw of claim 1, wherein the portion of the shaft that is adjacent to the torque transmission feature is cylindrical (see Fig. A below; note that adjacent can be defined as “near” so the cylindrical portion of the shaft is near the torque transmission feature).
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Fig. A: Annotated Fig. 5A of Sweeney to help show claim limitations.
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 Sweeney et al. (US 2006/0264954; “Sweeney”), in view of Muckter (US 2002/0198527).
Claim 2, Sweeney discloses the bone screw of claim 1, wherein the tension member further comprises a shaft (Fig. 2; 205) extending from the proximal end to the distal end (Fig. 2).
However, Sweeney 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 Sweeney, 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, Sweeney discloses the bone screw of claim 8, wherein the tension member further comprises a shaft (Fig. 2; 205) extending from the proximal end to the distal end (Fig. 2).
However, Sweeney 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 Sweeney, 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(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney et al. (US 2006/0264954; “Sweeney”), in view of Challis (US 9638491).
Claim 5, Sweeney discloses the bone screw of claim 1, wherein the torque mechanism is flat hexagonal surfaces, but other shapes can be used (paragraph [0050]).
However, Sweeney does not disclose splines.
Challis teaches using splines as a torque engaging mechanism (col. 2, lines 58-67).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the splines, as taught by Challis for the torque transmission features in Sweeney, since this is a well-known torque transmission feature for driving fasteners (col. 2, lines 58-67).
Claim(s) 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 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).
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 7, 12-14, 23, and 25 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.
Claim 7 requires distal and proximal engagement surfaces, best shown in Figs. 21B and 21C as 2226 and 2222. These surfaces are distinct from the torque transmission features. Sweeney does not have a portion above the torque transmission protrusion that performs the functions required by the engagement surfaces.
Claim 12 requires a specific length limiting mechanism requires shoulders and a stop feature shown in Figs. 21A-21C. Note how there are balls or some type of protrusions on the proximal member that fit in the gap 2210 that is between the shoulders 2216 and 2217. Sweeney teaches a length limiting and stop feature (Fig. 5A; 500) but there does not seem to be a way to make this read on the claim. Claims 13 and 23 depend on claim 12, so they are allowable for that reason.
Claim 14 is allowable for the same reason as claim 7, as noted just above.
Claim 25 is allowable because it requires a nut that can be received in the distal member and the distal end of the tension member has a flange that can abut a distal surface of the nut (see Applicant’s Fig. 21; where 2004 points to see this claimed feature). The prior art fails to teach a nut that interacts with the tension member flange as required by the claim.
Response to Arguments
In response to Applicant’s argument that Sweeney does not disclose the stop members 500 transmitting torque, the Examiner respectively disagrees. The claim only requires the members to be capable of transmitting torque. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the stop members 500 can be used to transmit torque since either the proximal member or a user could engage the stops to transmit torque.
In response to Applicant’s argument that the stop members would not function as intended if they did transmit torque, the Examiner respectfully disagrees. Along the lines as noted above, as long as the stop members are capable of transmitting torque, it does not matter if they do or not, the claims are still taught.
In response to Applicant’s argument that Sweeney does not teach a length limiting mechanism as required by claim 8, the Examiner respectfully disagrees. As noted in the rejection above the user feeling the tension in the tension member can act as a length limiting mechanism.
In response to Applicant’s argument that Gregersen in view of Muckter fails to teach a cannulated tension member, the Examiner respectfully disagrees. Mucker teaches having a cannulated tension member, as noted above. It is obvious to include this feature as noted above, and a person skilled in the art could be just as motivated as they were discouraged to make a cannulated tension member. The two references are combinable and teach toward each other. Both are medical devices that are doing nearly the exact same thing and the motivation to combine comes directly from the prior art and the primary reference has nothing as to why they would not want this feature.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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