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 Invention II (claims 9-21) in the reply filed on July 31, 2025 is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 31, 2025.
Claim Objections
Claim 9 is objected to because of the following informalities: there should be a semicolon after “pin channel” (line 2 on pg. 5). Appropriate correction is required.
Claim 10 is objected to because of the following informalities: there is both a comma and a semicolon between “throughbore” and “and” (line 6). Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0257288 A1) in view of Dall et al. (US 2014/0371801 A1).
Claim 9. Chang discloses a femoral array clamp, comprising:
a housing (housing 400; labeled as housing 240 in Fig. 1);
a pin channel (aperture 422, which is mislabeled as 322 in Fig. 4B) extends through the housing and has a pin channel axis (extends into the page in Fig. 4B);
a throughbore (bore 406) extends through the housing;
a passageway (see Fig. 4B inset) couples the pin channel and the throughbore, and the passageway has a passageway axis (see Fig. 4B inset);
a counterbore (bore 432) extends in the housing and has a counterbore axis (see Fig. 4B inset), wherein the counterbore intersects the pin channel (see para. 0055);
a fastener (actuation member 600 and wedge member 620) disposed in the counterbore (Figs. 1-6; paras. 0038-0058).
Claim 10. Chang discloses:
a bone pin (received in pin clamp 500; see bone pin 480 in Fig. 11) disposed in the pin channel, wherein
the bone pin defines a bone pin axis (extends into the page in Fig. 4B),
the femoral array clamp comprises a relaxed configuration (prior to actuating actuation member 600 such that wedge member 620 acts on pin clamp 500) in which the housing is capable of translating along the bone pin axis (see para. 0055), and
the femoral array clamp comprises a locked configuration (after actuating actuation member 600 such that wedge member 620 acts on pin clamp 500, thereby decreasing the diameter of bore 520) in which the fastener engages the bone pin against an array (rod 120) to prevent translation of the housing along the bone pin and prevent movement of the array in the throughbore (see paras. 0055-0056) (Figs. 1-6; paras. 0038-0058).
Claim 11. Chang discloses wherein the counterbore axis and the passageway axis are offset from each other where they intersect the pin channel (see Fig. 4B) (Figs. 1-6; paras. 0038-0058).
Claim 12. Chang discloses wherein the pin channel axis is perpendicular to the counterbore axis (see Fig. 4B) (Figs. 1-6; paras. 0038-0058).
Claim 13. Chang discloses wherein the pin channel axis is perpendicular to the passageway axis (see Fig. 4B) (Figs. 1-6; paras. 0038-0058).
Claim 14. Chang discloses wherein the pin channel axis is perpendicular to the counterbore axis (see Fig. 4B) (Figs. 1-6; paras. 0038-0058).
Claim 16. Chang discloses wherein the counterbore comprises internal threads (for engagement with threaded portion 604 of actuation member 600; see para. 0052), the fastener is a set screw (actuation member 600 has threaded portion 604) that engages the internal threads, and the counterbore axis is parallel to the passageway axis (see Fig. 4B) (Figs. 1-6; paras. 0038-0058).
Claim 19. Chang discloses system for surgical repair of a femur, the system comprising:
a femoral array clamp comprising
a housing (housing 400; labeled as housing 240 in Fig. 1);
a pin channel (aperture 422, which is mislabeled as 322 in Fig. 4B) extends through the housing and comprises a pin channel axis (extends into the page in Fig. 4B);
a throughbore (bore 406) extends through the housing;
a passageway (see Fig. 4B inset) extends between the pin channel and the throughbore, and the passageway has a passageway axis (see Fig. 4B inset);
a counterbore (bore 432) in the housing with a counterbore axis (see Fig. 4B inset), wherein the counterbore intersects the pin channel (see para. 0055) and the counterbore axis is parallel to the passageway axis (see Fig. 4B);
a fastener (actuation member 600 and wedge member 620) disposed in the counterbore;
a bone pin (received in pin clamp 500; see bone pin 480 in Fig. 11) configured to be located in the pin channel; and
an array (rod 120) is configured to traverse the throughbore (Figs. 1-6; paras. 0038-0058).
[AltContent: textbox (Passageway Axis)][AltContent: textbox (Passageway)][AltContent: textbox (Counterbore Axis)]
Chang fails to disclose a swage assembly disposed in the throughbore, a portion of the swage assembly protrudes through the passageway into the pin channel (claim 9), wherein in the relaxed configuration, the swage assembly is capable of rotating within the throughbore, wherein in the locked configuration, the fastener engages the bone pin against the swage assembly to prevent rotation of the swage assembly in the throughbore (claim 10), wherein the throughbore comprises an inner surface having a semi-spherical shape (claim 15), wherein the swage assembly comprises a first swage member having a semi-spherical outer surface and an inner surface, and a second swage member having a semi-spherical outer surface and an inner surface (claim 17), a swage assembly in the throughbore, wherein a portion of the swage assembly protrudes through the passageway into the pin channel (claim 19), and wherein the swage assembly comprises a first swage member with a semi-spherical outer surface and an inner surface, and a second swage member with a semi-spherical outer surface and an inner surface (claim 20).
Dall teaches a clamp comprising: a housing (brackets 6 and 8); a pin channel (channel that receives bone screw 2) extending through the housing; a throughbore (bore that receives fixation rod 4) extending through the housing; a ball assembly (ball parts 12 and 14) disposed in the pin channel; and a swage assembly (ball parts 16 and 18) disposed in the throughbore, wherein in a relaxed configuration (prior to actuating locking screw 10), the swage assembly is capable of rotating within the throughbore (see para. 0020), wherein in a locked configuration (after actuating locking screw 10), a fastener (locking screw 10) prevents rotation of the swage assembly in the throughbore (see para. 0020), wherein the throughbore comprises an inner surface having a semi-spherical shape (see para. 0021), and wherein the swage assembly comprises a first swage member (ball part 16) having a semi-spherical outer surface (see para. 0021) and an inner surface, and a second swage member (ball part 18) having a semi-spherical outer surface (see para. 0021) and an inner surface, wherein the use of the ball assembly with a bone pin (bone screw 2) and the swage assembly with an array (fixation rod 4) allows for positioning of the bone pin and array in a desired orientation with respect to each other (see para. 0020), thereby allowing for connection to additional clamps, bone pins, and arrays (see Fig. 3) (Figs. 1-3; paras. 0018-0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamp of Chang such that it includes a swage assembly disposed in the throughbore (claim 9), wherein in the relaxed configuration, the swage assembly is capable of rotating within the throughbore (claim 10), wherein the throughbore comprises an inner surface having a semi-spherical shape (claim 15), wherein the swage assembly comprises a first swage member having a semi-spherical outer surface and an inner surface, and a second swage member having a semi-spherical outer surface and an inner surface (claim 17), a swage assembly in the throughbore (claim 19), and wherein the swage assembly comprises a first swage member with a semi-spherical outer surface and an inner surface, and a second swage member with a semi-spherical outer surface and an inner surface (claim 20), as suggested by Dall, as the use of a swage assembly with the array in addition to the ball assembly (see pin clamp 500 of Chang) with the bone pin would allow for greater adjustability in the positioning of the bone pin and array with respect to each other, thereby allowing for connection to additional clamps, bone pins, and arrays as needed. In view of such modifications, a portion of the swage assembly would protrude through the passageway into the pin channel (claim 9), in the locked configuration, the fastener would engage the bone pin against the swage assembly to prevent rotation of the swage assembly in the throughbore (claim 10), and a portion of the swage assembly would protrude through the passageway into the pin channel (claim 19).
Allowable Subject Matter
Claims 18 and 21 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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