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 B (Figs. 11-17) in the reply filed on October 16, 2025 is acknowledged.
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) 11-13, 24, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sweeney et al. (US 2006/0264954; “Sweeney”).
Claim 11, Sweeney discloses a bone screw (Fig. 2) insertable into a bone (abstract), the bone screw comprising: a proximal member (130); a distal member (160) comprising bone-engaging threads (170), wherein the distal member is configured to slidably engage the proximal member such that a variable-length cavity is defined within the proximal member and the distal member (Figs. 7A-7D); and a tension member (Fig. 2; 200) residing at least partially within the variable-length cavity (paragraph [0039]), the tension member comprising: a proximal end (Fig. 2; 210) coupled to the proximal member (paragraph [0039]); and a distal end (220) 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 (paragraphs [0039] and [0056]-[0060]; Figs. 7A-7D); wherein at least one of the proximal member and the distal member comprises a torque transmission feature (Fig. 2; paragraphs [0035]-[0038]; 150) that transmits torque from the proximal member to the distal member while permitting slidable engagement of the distal member relative to the proximal member (Figs. 2 and 3C; paragraphs [0056]-[0060]), wherein the torque transmission feature has torque transmitting surfaces that are oriented closer to a radial direction than to a circumferential direction, as to a cross section perpendicular to a longitudinal axis of the bone screw (Fig. 3C; the internal angle of each corner of a hexagon is 30 degrees, so similar to the angles shown in Applicant’s Fig. 4 the edge of the tooth will meet this claim limitation).
Claim 12, Sweeney discloses the bone screw of claim 11, wherein the distal member comprises a proximal end (Fig. 2; 150) extending proximally into a proximal portion (Figs. 1 and 7A), formed in the proximal member (Figs. 1 and 7A), of the variable-length cavity (Figs. 1 and 7A; 150 extends over half the length of the proximal member).
Claim 13, Sweeney discloses the bone screw of claim 12, wherein the proximal portion of the distal member comprises an extension (upper 1/3 of part 150) extending proximally of the torque transmission feature (interpreted as the lower 2/3 of part 150), within the proximal portion of the variable-length cavity (Figs. 1 and 7A).
Claim 24, Sweeney discloses a bone screw (Fig. 2) insertable into a bone (abstract), the bone screw comprising: a proximal member (130); a distal member (160) comprising bone-engaging threads (170), wherein the distal member is configured to slidably engage the proximal member such that a variable-length cavity is defined within the proximal member and the distal member (Figs. 7A-7D); and a tension member (Fig. 2; 200) residing at least partially within the variable-length cavity (paragraph [0039]), the tension member comprising: a proximal end (Fig. 2; end that 210 generally points to) coupled to the proximal member (paragraph [0039]); and a distal end (end that 220 generally points to) 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 (paragraphs [0039] and [0056]-[0060]; Figs. 7A-7D); wherein the distal end comprises a distal member coupling interface (Fig. 4A; 220, 410, 420 and the end of the wire 205 that attaches to the hub; paragraphs [0043], ) that can be inserted through an opening (Fig. 5B; 180) in a proximal end (near where 180 points) of the distal member and then coupled to the distal member from within the variable-length cavity (Figs. 1 and 2; paragraphs [0039], [0043], [0054], and [0056]); and the opening is larger than the distal member coupling interface (when the hub 220 is taken off the end of the wire 205, the wire portion can slide through the opening, so at least a part of the distal member coupling interface can meet the limitation, furthermore, it seems that based on the paragraphs [0043], [0054], and [0056] that the hub 220 may even be able to slide into the opening 180, note how inside the tube there can be projections that maintain wire, so while the hub could slide in the proximal opening, it could rest on top of the projections and still meet this claims limitation).
Claim 27, Sweeney discloses the bone screw of claim 24, wherein: the proximal member comprises: a proximal shank (Fig. 2; 140); a head (130) that is wider than the proximal shank (Fig. 2); a proximal interior surface (Fig. 3B; 185; paragraph [0036]) that defines a proximal portion of the variable-length cavity (paragraph [0036]); and a proximal aperture (Fig. 3B; aperture that 185 points to) that provides access to the proximal portion of the variable- length cavity through the head (Fig. 3B); the distal member comprises: a distal interior surface (Fig. 5B; 180; paragraph [0037]) that defines a distal portion of the variable-length cavity (paragraph [0037]); and a distal aperture that provides access to the distal portion of the variable-length cavity (Figs. 5A; paragraph [0037]; 180); and the proximal aperture (Fig. 5B; 180) and the distal aperture are sized to permit passage of a K-wire therethrough (Figs. 5A-5B; paragraph [0037]).
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 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney et al. (US 2006/0264954; “Sweeney”), in view of Yu (2011/0077693; “Yu”).
Claim 14, Sweeney discloses the bone screw of claim 11, comprising a hex connection between the proximal and distal member.
Sweeney does not disclose the Polydrive structure that is shown in Applicant’s Fig. 14 and described by claim 14.
Yu teaches a torque transmission feature that comprises a spline defined by the proximal member and the distal member; and the torque transmission feature comprises: a plurality of proximal member teeth that extend toward the distal member, the proximal member teeth comprising the torque transmitting surfaces; and a plurality of distal member teeth that extend toward the proximal member such that the distal member teeth interdigitate with the proximal member teeth, the distal member teeth comprising torque receiving surfaces that receive torque from the torque transmitting surfaces (Figs. 1 and 4; paragraph [0023]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the hex drive of Sweeney for a Polydrive as taught by Yu, since these are both well-known torque transmitting features (paragraph [0023]).
Claim 15, Sweeney in view of Yu disclose the bone screw of claim 14, Yu also teaches wherein the torque receiving surfaces are also oriented closer to the radial direction than to the circumferential direction (Figs. 1 and 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the hex drive of Sweeney for a Polydrive as taught by Yu, since these are both well-known torque transmitting features (paragraph [0023]).
Claims 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sweeney et al. (US 2006/0264954; “Sweeney”).
Claim 25, Sweeney discloses the bone screw of claim 24.
However, Sweeny does not disclose the distal member coupling interface of the tension member to have a threaded connection with the distal member.
It would have been obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to use any type of the limited but well-known fixation/connection features such as male-female threads, magnetic, glue, the flange tip that is shown by Sweeney, a snap-fit connector, etc. since applicant has not disclosed that such solve any stated problem or is anything more than one of the numerous well-known connection features a person of ordinary skill in the art would find obvious for connecting two part. Sweeney mentions it would be obvious to use any type of retention means for connecting the wire to the distal and proximal portions.
Claim 26, Sweeney discloses the bone screw of claim 25, wherein: the proximal end of the tension member comprises an enlargement (Fig. 2; 210); the proximal member comprises: a proximal shank (140); a head (130) that is wider than the proximal shank (Fig. 2); a proximal interior surface (Fig. 3B-3C; 185) that defines a proximal portion of the variable-length cavity (Fig. 3B; paragraph [0036]); and a proximal aperture that provides access to the proximal portion of the variable- length cavity through the head (Fig. 3B; where 185 points); the proximal aperture is sized to permit passage of the distal end of the tension member therethrough (Figs. 2, 3B-3C); and the proximal aperture defines a shoulder (paragraph [0042]) on which the enlargement rests upon coupling of the distal member coupling interface to the distal member (paragraph [0042]).
Claims 53-54 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 53, Sweeney discloses the bone screw of claim 11.
However, Sweeney discloses a different type of torque transmission surface than shown by Applicant’s Fig. 4.
Challis teaches the polydrive style (Fig. 5C) wherein: the circumferential direction is a straight line that is tangent to a circle that circumscribes the torque transmission feature; the radial direction is a line segment that extends from a center point of the cross section to one of the torque transmitting surfaces; the radial direction intersects the circumferential direction; and the circumferential direction and the radial direction are perpendicular. (Fig. 5C; compare the design of Fig. 5C with Applicant’s Fig. 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape of the torque transmission feature of Sweeney, to be structured like Challis, since these are both well-known torque transmitting feature (col. 7, lines 40-56).
Claim 54, Sweeney in view of Challis discloses the bone screw of claim 53, Challis teaches wherein: the one of the torque transmitting surfaces defines an angle relative to the radial direction; and the angle is less than 45 degrees (Fig. 5C).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11317956. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims have more limitations than the current claims, but all the features in the current claims are present in the patent claims.
Allowable Subject Matter
Claims 1-10 are allowable over the prior art, but require the double patenting issue to be addressed. These claims are similar to claims in parent case 17412689 and in a similar fashion and as argued in the parent claims Sweeney fails to disclose the bending transmission feature as required by claim 1. This feature is the way the wall that 1218 references in Fig. 13B interacts with the distal member 1106 and its protrusion 1212. The key structural difference between the prior art cited and the current reference is that in the prior art the torque transmission features extend the entire proximal length of the distal member whereas in the current invention the torque transmission feature only extends a portion and then the bending transmission feature is located at the proximal end of the distal member, so that the device can bend without breaking.
Response to Arguments
In response to Applicant’s arguments that Sweeney fails to disclose torque transmitting surfaces that are oriented closer to a radial direction than to a circumferential direction, the Examiner respectfully disagrees. The terms “a radial direction” and “a circumferential direction” do not specifically point out the radial direction of what. So they can be any random direction based on anything within the vicinity of the device or of any part of the device itself. While Fig. 4 of Applicant’s disclosure shows an example of what the circumferential and radial directions could be the claim is not limited to what is shown in the figure. Furthermore, upon searching non-patent literature for what a circumferential direction is. There were some that showed it being the same as what Applicant shows in Fig. 4 as dotted line C. However, some showed the circumferential direction being a curved direction going around the cylinder or surface being measured. The literature also showed the dotted line C being called a tangential direction. Therefore, the language does not have an exact definition. Based on the previous rejection and what is shown, Fig. A shown below further clarifies how the surfaces of Sweeney read on the claim limitation. Fig B also shows another clarification of how Sweeney teaches which does not go against what was described in the rejection, note how a circumferential direction is outward where the circumference would be and radial is inward direction.
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Fig. A: Showing what the outer surface 150 looks like and how the surfaces of Sweeney read on claim limitations.
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Fig. B: Annotated figure of Sweeney showing how claim limitations are met.
In response to Applicant’s argument towards claim 24, upon further search and consideration it still seems Sweeney can be interpreted to read on the claim. In regards to this claim direction, the Examiner believes that if claim 25 were included in claim 24 and the proximal end of the wire comprises “a recess for rotating the wire to allow the exterior threads of the distal member coupling interface to engage with the interior threads of the distal member” (see Fig. 13D 1152; paragraph [0168]), this would appear to not be obvious or something that Sweeney considered with their device.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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