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 Group I (claims 1-20) in the reply filed on June 3, 2026 is acknowledged. Claims 1-20 have been examined on the merits in this office action and claims 21-54 have been withdrawn from further consideration because they are directed to a non-elected invention.
Drawings
The drawings are objected to because of heavy shading or lack of contrast making details difficult to understand. 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.
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
The preamble of claims 1-20 recites “device” but the body of the claims recites several elements or components working together. It appears that the claims are directed to a system.
In claim 7, the recitation “the one or more arms” lacks antecedent basis. It appears that claim 7 should depend on claim 6 and is interpreted as such for examination.
In claim 12, “the connection” lacks antecedent basis.
In claim 19, the recitation “detachable from the device” renders the claims vague and indefinite because claim 18 recites the handles to be connectable to each of the plurality of retaining elements. See rejection under 35 USC 112, fourth paragraph.
In claim 20, the recitation “one or more retaining elements” renders the claim vague and indefinite because it is unclear whether these are the previously recited retaining elements or different retaining elements.
Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 is broader than claim 18. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Appropriate correction is required.
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)(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.
Claim(s) 1-5, 8-10, 12-16, 18 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Campbell et al. (US 11076900).
Regarding claims 1 and 5, Campbell et al. disclose a device for positioning two or more segments 3 and 3’ (Fig. 1), the device including: one or more base elements (locking posts 20, Figs. 50A-C and 52); a plurality of retaining elements (locking caps 30, Figs. 50A-50C and 52), each retaining element having a first end operatively coupled to one of the one or more base elements 20 (Figs. 50A-50C) and a second end constructed and arranged to hold at least one of the segments or structures (end disposed on top of bone segment 102, Fig. 50B); and one or both of a rail component (guiding structure in the form of longitudinal member 4, Figs. 48 and 52) or hinge component for providing positioning to the two or more segments (col. 9, lines 9-67, cols. 10-12 and col. 13, lines 1-56).
Regarding claim 2, the rail component 4 (Figs. 48 and 52) is rectilinear.
Regarding claims 3 and 4, the rail component 4 is curved or includes offsets (for e.g. cleats) (Figs. 5-6, 45-46, 50A-50C, col. 9, lines 25-67 and col. 10, lines 1-3).
Regarding claim 8, each retaining element 30 has a plurality of opposing sharp points or edges (defined by cut-outs 32 constructed and arranged to penetrate soft tissue and engage bone (col. 5, lines 44-48).
Regarding claim 9, each retaining element includes a surface 3(top and bottom, Figs. 50B-50C) constructed and arranged to support the two or more segments or structures (bone 102, tether 130 and external drive tool 70, Figs. 50A-50C).
Regarding claim 10, the surface includes a convex surface (Fig. 50A).
Regarding claim 12, the connection between each of the plurality of the base elements and the plurality of retaining elements is constructed and arranged to be
locked to a position.
Regarding claim 13, each of the plurality of base elements further
includes a head or protrusion 26 adapted or configured to connect to an external support.
Regarding claim 14, the rail component further comprises one or
more stops (defined by slots 14, Fig. 4-8, col. 9, lines 9-35) along its length constructed and arranged to limit translation of the plurality of base elements.
Regarding claim 15, each of the plurality of retaining elements includes one or more contact points (defined by cut-outs 32, Fig. 13, col. 10, lines 21-35) for contacting or grasping the two or more segments or structures.
Regarding claim 16, cut-outs 32 have edges defining tines (Fig. 13).
Regarding claims 18 and 19, Campbell et al. disclose an external drive tool 70 and a removal driver 80, each interpreted to be a handle wherein each handle is detachable from the device (Fig. 50A, 53, and col. 13, lines 15-31).
Claim(s) 1, 6-7, 11 and 15-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated Williams et al. (US 9550277).
Williams et al. disclose a device for positioning two or more segments (Figs. 4 and 12), the device including: one or more base elements (92, Fig. 7); a plurality of retaining elements (jaws 120, Fig. 7), each retaining element having a first end (threaded post 100, Fig. 5) operatively coupled to one of the one or more base elements 92 and a second end constructed and arranged to hold at least one of the segments or structures (jaws 120 grasp bone segments, Fig. 12); and a hinge component 24 for providing positioning to the two or more segments or structures constructed and arranged to hold at least one of the segments or structures (col. 2, lines 7-67, col. 3 and col. 4, lines 1-36).
Regarding claim 6, base elements 92 terminate in a hinge (angular adjustment assembly 150) terminating in one or more arms 22 (col. 2, lines 7-67, col. 3 and col. 4, lines 1-36).
Regarding claim 7, the one or more jaws 120 are slidably coupled along a length of arms 22 via angular adjustment assembly 150 (Fig. 4).
Regarding claim 11, the device includes a hinge (40, Fig. 1) or a ball and socket joint (Fig. 6).
Regarding claims 15-17, jaws 120 have contact points plurality of teeth or tines (Fig. 6) wherein the contact points are disposed orthogonal to arms 22 based on the locked position of a jaw with respect to arm 22 (Figs. 4 and 3).
Claim(s) 1-2, 5, 6, 8-9, 11-16, and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bailey et al. (US 5743898).
Regarding claim 1, Bailey et al. disclose a device for positioning two or more segments 12, 14, Fig. 1), the device including: one or more base elements (bone screw support clamps 28, 34, Fig. 2); a plurality of retaining elements (bone screws 36), each retaining element having a first end operatively coupled to one of the one or more base elements (Fig. 1) and a second end constructed and arranged to hold at least one of the segments or structures (end engaging bone segments 12 and 14, respectively); and one or both of a rail component (guiding structure in the form of longitudinal members 18 and 20, Fig. 1) or hinge component (pins 64 received in apertures 60, Fig. 4) for providing positioning to the two or more segments (col. 3, lines 31-67, cols. 4-7 and col. 8, lines 1-54).
Regarding claim 2, the rail component (18, 20, Fig. 1) is rectilinear.
Regarding claim 5, the plurality of retaining elements are attached to the rail element via the one or more base elements (Fig. 1).
Regarding claim 6, the one or more base elements include a hinge defined by screws 94 when loosely and not fully engaged and terminate in a cover or arm (Fig. 8) for holding or grasping the bone segments or structures to be fixated (Fig. 8).
Regarding claim 8, each retaining element has a plurality of turns (defined by the screw thread) that define edges constructed and arranged to penetrate soft tissue and engage bone.
Regarding claim 9, each retaining element includes a surface (outer surface defined by a proximal end and a distal end) constructed and arranged to support the two or more segments or structures (bone and clamping member respectively, Fig. 1).
Regarding claim 11, the device further includes a second hinge defined by a second clamping member or base element and a ball and socket joint (defined by a spherical portion 32 and a spherical aperture 70 (Fig. 2).
Regarding claim 12, the connection between each of the plurality of the base elements and the plurality of retaining elements is constructed and arranged to be
locked to a position (when the base elements and the retaining members are locked).
Regarding claim 13, each of the plurality of base elements further
includes a protrusion adapted or configured to connect to an external support (handle 92, Fig. 8).
Regarding claim 14, the rail component further comprises one or
more stops (defined by slot in which the bone screw clamps 28 and 34 are received) along its length constructed and arranged to limit translation of the plurality of base elements.
Regarding claim 15, each of the plurality of retaining elements includes one or more contact points (defined by turns of the thread of bone screw 36) for contacting or grasping the two or more segments or structures.
Regarding claim 16, the crest of each turn of a respective bone screw or retaining element defines a tine.
Regarding claims 18 and 19, Bailey et al. disclose handles 92 that are arranged to be connectable to each of the plurality of the retaining elements via the base elements wherein the handles 92 are detachable (Fig. 8).
Regarding claim 20, the Bailey et al. device includes a first linkage arm (first cantilever arm 56, Fig. 4) which has a hinge (aperture and locking pin 64, Fig. 4) and retaining elements in the form of pins 64 and a second linkage arm (cantilever member 56 including a ball joint defined by spherical cavity 72 that receives a spherical portion 32, Fig. 8) and a retaining element in the form of locking pin 64 (Figs. 2 and 5), wherein the first and second linkage arms can be independently positioned to hold at least one of the arms to be fixated (col. 3, lines 31-67, cols. 4-7 and col. 8, lines 1-54).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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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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August 14, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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