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 of Group I, claims 1-11, and Species A, FIGS. 1 and 3-5, in the reply filed on 10 August 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 August 2026.
Claims 9 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species D or E, there being no allowable generic or linking claim. See Rejections under 35 U.S.C. 112 for further discussion. Because the limitation “the locking mechanism” in claim 9 renders the claim indefinite because it lacks proper antecedent basis in the claims, claim 9 is interpreted as dependent upon claim 6, which recites a locking mechanism (claim 6 / line 2) and would resolve this rejection. However, in this interpretation that claim 9 is dependent upon claim 6, the fastener of claim 9 cannot be the rotation element (84) since a rotation element is recited in claim 6, and the fastener of claim 9 would thus correspond to a different feature. The fastener as recited in claim 9 is the threaded screw (292) that connects the attachment flange (270) to the main outrigger body via corresponding holes, in the non-elected species D shown in FIG. 21; or the key (392) that connects the attachment flange (370) to the main outrigger body via corresponding holes, in the non-elected species E shown in FIG. 23. Therefore claim 9 is withdrawn from further consideration as being drawn to nonelected Species D or E. Because the limitations “the first hole”, “the second hole”, and “the fastener” in claim 10 render the claim indefinite because they lack proper antecedent basis in the claims, claim 10 is interpreted as dependent upon claim 9, which recites these features. However, as discussed above, claim 9 is withdrawn as directed to a non-elected species, and therefore claim 10 is also withdrawn. The screw and threaded holes of claim 10 correspond to the screw (292) that connects the attachment flange (270) to the main outrigger body via corresponding threaded holes, in the non-elected species D shown in FIG. 21.
Priority
The priority date is 13 September 2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the wire slot configured to confine a translation of a surgical wire within a longitudinal axis therethrough (claim 5) must be shown or the feature(s) canceled from the claim(s). The connecting flange and its wire slot are curved and the drawings do not show where a longitudinal axis would be disposed through the curved wire slot.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The specification fails to provide proper antecedent basis for the outrigger releasably lockable in the unobstructed position (claim 2). The main outrigger body is releasably lockable in the aligned position (FIG. 4) but not in the unobstructed position (FIG. 5).
The specification fails to provide proper antecedent basis for the wire slot configured to confine a translation of a surgical wire within a longitudinal axis therethrough (claim 5). The connecting flange and its wire slot are curved and the specification does not provide proper antecedent basis for where a longitudinal axis would be disposed through the wire slot. Rather, the wire slot is configured to confine a translation of a surgical wire along the wire slot.
The specification fails to provide proper antecedent basis for an actuator connected to the locking mechanism (claim 6). Rather, the locking mechanism comprises an actuator (button 186) (par. [0048] in publication).
The specification fails to provide proper antecedent basis for a retention element coupled to the at least one spring (claim 8). The retention element is coupled to the button (FIG. 10) but not directly to the spring.
Claim Objections
Claims 1-8 and 11 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 1: “aiding [[the]] insertion”
Claim 1 / line 2: “a distal end of [[an]] the intramedullary nail;”
Claim 1 / line 8: “locking the main outrigger body”
Claim 2 / lines 1-2: “the main outrigger body”
Claim 2 / line 2: “the main outrigger body”
Claim 2 / line 3: “the unobstructed position [[and]] in which the first aligning aperture is non-concentrically”
Claim 4 / lines 3-4: “the main outrigger body”
Claim 5 / line 5: “the main outrigger body”
Claim 6 / line 7: “that
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 9 and 10, although withdrawn, are discussed here in support of such withdrawal.
As to claim 6, the limitation “the attachment flange” (line 2) renders the claim indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as, and amendment is suggested to, “an attachment flange”.
As to claim 8, the limitation “the locking mechanism” (line 1) renders the claim indefinite because it lacks proper antecedent basis in the claims. For examination purposes, claim 8 will be interpreted as dependent upon claim 6, which recites a locking mechanism (claim 6 / line 2) and would resolve this rejection. However, this interpretation results in a further rejection under 35 U.S.C. 112(b) since it is unclear if “a button” as recited in claim 8 / line 4 refers to “an actuator” as recited in claim 6 / line 6, or to a different button. For examination purposes, the limitation will be interpreted as the actuator comprises a button.
As to claim 9, the limitation “the locking mechanism” (line 1) renders the claim indefinite because it lacks proper antecedent basis in the claims. . For examination purposes, claim 9 will be interpreted as dependent upon claim 6, which recites a locking mechanism (claim 6 / line 2) and would resolve this rejection. However, this interpretation reinforces the above discussion that the fastener as recited in claim 9 is the threaded screw (292) that connects the attachment flange (270) to the main outrigger body in the non-elected species D shown in FIG. 21, or the key (392) that connects the attachment flange (370) to the main outrigger body in the non-elected species E shown in FIG. 23. The interpretation that claim 9 is dependent upon claim 6 means that the fastener of claim 9 is not the rotation element (84) since a rotation element is recited in claim 6, and the fastener of claim 9 would thus correspond to a different feature, i.e. the threaded screw or key of the non-elected species.
As to claim 10, the limitations “the first hole”, “the second hole”, and “the fastener” render the claim indefinite because they lack proper antecedent basis in the claims. For examination purposes, claim 10 will be interpreted as dependent upon claim 9, which recites these features. However, as discussed above, claim 9 is withdrawn as directed to a non-elected species, and therefore claim 10 is also withdrawn.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-8, and 11 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U. S. Patent No. US 8,303,600 to Metzinger et al. (hereinafter, “Metzinger”).
As to claim 1, Metzinger discloses an outrigger for use in aiding the insertion of an intramedullary nail (10), FIGS. 7-9C, comprising: a nail connecting portion (104) releasably connectable to a distal end of an intramedullary nail (col. 7 / lines 59-62), FIGS. 7-8; a main outrigger body (125) connected to the nail connecting portion (via 102), FIG. 7; the main outrigger body comprising: a first portion (130) with a first aligning aperture (131) (col. 8 / lines 7-13), FIG. 8; a second portion (135) with a second aligning aperture (136), FIG. 8; a connecting flange (center portion between 130 and 135) that connects the first portion and the second portion; and a mechanism (155, 142, 150, 151) for releasably locking the outrigger in an aligned position with the intramedullary nail (col. 8 / lines 20-67), FIG. 9C, wherein the aligned position comprises the first aligning aperture (131) in concentric alignment with a first nail aperture of the intramedullary nail (along A) to allow an alignment of a fastener with the first nail aperture through the first aligning aperture, FIG. 9C.
As to claim 2, Metzinger discloses the outrigger of claim 1, wherein the mechanism is configured to allow movement of the outrigger to an unobstructed position with the intramedullary nail, FIG. 9A, the outrigger releasably lockable in the unobstructed position and the first aperture non-concentrically aligned with the first nail aperture of the intramedullary nail (since the second aligning aperture 136 is aligned in this position) (col. 8 / lines 58-67).
As to claim 3, Metzinger discloses the outrigger of claim 1, wherein: the first portion (130) has a first face (top face of 130); the second portion (135) has a second face (side face of 135); the first face approximately perpendicular to the second face, FIG. 8.
As to claim 4, Metzinger discloses the outrigger of claim 1, wherein: the connecting flange further comprises a wire aperture (127); the wire aperture configured to hold an insertion of a surgical wire (119; where a pin is a short wire and is surgical because it is a component of a surgical device) therethrough when the outrigger is in the aligned position (col. 8 / lines 7-9), FIG. 8.
As to claim 6, Metzinger discloses the outrigger of claim 1, wherein the mechanism comprises: a locking mechanism (142, 150, 151) that retains a position between the attachment flange (112) and the main outrigger body (col. 8 / lines 20-67); a rotation element (119) coupled to the main outrigger body, the rotation element rotatably coupling the main outrigger body around an axis of the rotation element (col. 8 / lines 2-9), FIGS. 9A-9C; and an actuator (155) connected to the locking mechanism (functionally connected to the locking mechanism and frictionally connected to 142), the actuator capable of disengaging the locking mechanism such that that the main outrigger body can rotate around the axis of the rotation element (col. 8 / lines 39-47).
As to claim 7, Metzinger discloses the outrigger of claim 3, wherein: the first face has a first longitudinal axis; the second face has a second longitudinal axis; the intramedullary nail has a third longitudinal axis; the first longitudinal axis is parallel to the third longitudinal axis; and the second longitudinal axis is parallel to the third longitudinal axis (the first and second longitudinal axes are parallel to a third longitudinal axis of the nail taken through at least part of the nail), FIGS. 9A-9C.
As to claim 8, Metzinger discloses wherein the locking mechanism further comprises: a cavity (146) within the main outrigger body; at least one spring (150) coupled to an end of the cavity (via 142); a button (155) coupled to an end of the at least one spring (via 142); and a retention element (151) coupled to the at least one spring and the button (via 142) to keep the at least one spring and the button at least partially within the cavity. (See the above rejections under 35 U.S.C. 112 for the interpretation that claim 8 is dependent upon claim 6.)
As to claim 11, Metzinger discloses the outrigger of claim 1, wherein the intramedullary nail is a fibular nail (interpreted as language of intended use; the intramedullary nail is fully capable of use in any long bone including a fibula, in which case it would be a fibular nail).
Claims 1, 3-5, and 11 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U. S. Patent No. US 10,918,426 to Peterson et al. (hereinafter, “Peterson”).
As to claim 1, Peterson discloses an outrigger, FIG. 112, for use in aiding the insertion of an intramedullary nail, comprising: a nail connecting portion (11207) releasably connectable to a distal end of an intramedullary nail (interpreted as language of intended use without positive recitation of an intramedullary nail; the nail connecting portion is fully capable of releasably connecting to a distal end of an intramedullary nail, e.g. 11203); a main outrigger body (11209) connected to the nail connecting portion (via 11205), FIG. 112; the main outrigger body comprising: a first portion (left arm) with a first aligning aperture (11221) (col. 146 / lines 4-12); a second portion (right arm) with a second aligning aperture (11221 in the right arm); a connecting flange (central portion between left and right arms) that connects the first portion and the second portion; and a mechanism (11205) for releasably locking the outrigger (col. 145 / line 67 – col. 146 / line 3) in an aligned position with the intramedullary nail, FIG. 112, wherein the aligned position comprises the first aligning aperture in concentric alignment with a first nail aperture of the intramedullary nail to allow an alignment of a fastener with the first nail aperture through the first aligning aperture (interpreted as language of intended use without positive recitation of an intramedullary nail; the first aligning aperture is fully capable of being in concentric alignment with a first nail aperture of the intramedullary nail if used with a correspondingly sized and shaped nail with an aligned nail aperture).
As to claim 3, Peterson discloses the outrigger of claim 1, wherein: the first portion has a first face (top surface of the left arm); the second portion has a second face (side surface of the right arm); the first face approximately perpendicular to the second face, FIG. 112.
As to claim 4, Peterson discloses the outrigger of claim 1, wherein: the connecting flange further comprises a wire aperture (11239); the wire aperture configured to hold an insertion of a surgical wire therethrough when the outrigger is in the aligned position, FIG. 112.
As to claim 5, Peterson discloses the outrigger of claim 1, wherein: the connecting flange further comprises a wire slot (11213); the wire slot extending between the first portion and the second portion (since the wire slot is in the connecting flange which extends between the first portion and the second portion); and the wire slot configured to confine a translation of a surgical wire within a longitudinal axis therethrough when the outrigger is in the aligned position (col. 146 / lines 13-20).
As to claim 11, Peterson discloses the outrigger of claim 1, wherein the intramedullary nail is a fibular nail (interpreted as language of intended use; the intramedullary nail is fully capable of use in any long bone including a fibula, in which case it would be a fibular nail).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights