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 2 (Fig. 8B) in the reply filed on May 21, 2026 is acknowledged.
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.
Claim 35 is 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. Claim 35 recites the limitation "the rod slot" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting “the rod slot” as “a rod slot.”
Claims 37-41 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. Claim 37 recites “a second portion of the reducer shaft.” The recitation of a second portion implies the existence of a first portion. However, none of claims 33, 34, and 37 recite that the reducer shaft includes a first portion. Because claim 36 recites that the reducer shaft includes a first portion, the Examiner is interpreting claim 37 as depending from claim 36. Claims 38-41 are rejected because they depend from claim 37.
Claim Rejections - 35 USC § 102
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 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.
Claims 33-36 and 42-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hennard et al. (US 2014/0148865 A1).
Claim 33. Hennard discloses a surgical method, comprising:
positioning an instrument body (extender 32 and reducer 244) relative to a bone anchor assembly (bone fastener 82), the instrument body having:
a housing (extender 32 and housing 254) that terminates in a pair of fixed arms (arms 42 and 44), a central opening (opening between arms 42 and 44 and extending from the proximal end to the distal end), a proximal end (end adjacent cap 152), a distal end (end adjacent mounting surface 113), and a central longitudinal axis extending between the proximal and distal ends;
first and second pivoting arms (portions 64 and 118) movably coupled to the housing, each pivoting arm having a proximal end (adjacent ends 70, 86, 124, and 136) and a distal end (adjacent ends 72, 88, 126, and 138);
a reducer shaft (shaft 251) threadably mounted in the central opening of the housing (via threaded portion 253), the reducer shaft having a working channel (see Figs. 10 and 11, which show that shaft 251 is hollow) defined therethrough;
moving the surgical instrument relative to the bone anchor assembly such that the pair of pivoting arms splay outwards when passing over a first portion of the bone anchor assembly and move towards one another to engage a second portion of the bone anchor assembly (see paras. 0067-0068 and Figs. 14-17); and
rotating the reducer shaft relative to the instrument body (see para. 0078) (Figs. 1-20; paras. 0027-0080).
Claim 34. Hennard discloses positioning a spinal rod (rod 246) between the pivoting arms and proximal to a rod seat of the bone anchor assembly (see Fig. 19) (Figs. 1-20; paras. 0027-0080).
Claim 35. Hennard discloses positioning the bone anchor assembly between the pair of fixed arms of the instrument body such that the rod slot of the instrument body is aligned with the rod seat of the bone anchor assembly (see Fig. 19) (Figs. 1-20; paras. 0027-0080).
Claim 36. Hennard discloses wherein rotating the reducer shaft relative to the instrument body urges a first portion of the reducer shaft that includes an exterior thread (threaded portion 253) distally to rotate the reducer shaft relative to the housing (see para. 0078) (Figs. 1-20; paras. 0027-0080).
Claim 42. Hennard discloses wherein moving the distal ends of the pivoting arms towards one another occurs after positioning the bone anchor assembly between the pair of fixed arms of the instrument body (see paras. 0067-0068) (Figs. 1-20; paras. 0027-0080).
Claim 43. Hennard discloses pivoting the pivoting arms radially-outward with respect to the housing to release from the bone anchor assembly (see paras. 0070 and 0079) (Figs. 1-20; paras. 0027-0080).
Claim 44. Hennard discloses wherein pivoting the pivoting arms comprises pressing the proximal end of each of the pivoting arms radially-inward towards the axis to move the bodies distal ends radially-outward with respect to the axis (compare Figs. 14-15 to Figs. 16-17) (Figs. 1-20; paras. 0027-0080).
Claim 45. Hennard discloses wherein the first portion of the bone anchor assembly exerts a force onto the distal ends of the pair of pivoting arms to overcome a biasing force of the pair of pivoting arms towards the central opening (see para. 0067) (Figs. 1-20; paras. 0027-0080).
Claim 46. Hennard discloses implanting the bone anchor assembly in a bone (vertebra V1) of a patient (Figs. 1-20; paras. 0027-0080).
Claim 47. Hennard discloses derotating the surgical instrument relative to the bone of the patient (see para. 0028) (Figs. 1-20; paras. 0027-0080).
Claim 48. Hennard discloses a surgical method, comprising:
advancing an instrument body (extender 32 and reducer 244) having a distal rod slot (slot that receives rod 246 as shown in Fig. 19) formed therein towards a bone anchor (bone fastener 82) having a rod seat (seat that receives rod 246 as shown in Fig. 19) defined therein, the instrument body having a working channel (channel between arms 42 and 44 and extending from the proximal end to the distal end) extending through the instrument body and opposed pivoting arms (portions 64 and 118) movably coupled to the instrument body, wherein the pivoting arms are free to pivot relative to the instrument body when the instrument body is in an unlocked configuration (see para. 0067);
positioning the bone anchor in the working channel of the instrument body such that the rod slot of the instrument body is aligned with the rod seat of the bone anchor (see Fig. 19);
coupling the instrument body to the bone anchor such that distal ends of the pivoting arms move towards one another to engage a mating feature of the bone anchor (see para. 0068), the distal ends of the pivoting arms being biased towards the working channel to reduce a diameter of the working channel when the instrument body is in the unlocked configuration (see para. 0067); and
advancing a reducer shaft (shaft 251) disposed in the working channel towards the bone anchor, the reducer shaft having a proximal portion (adjacent end 248), a distal portion (adjacent end 250), and a lumen (see Figs. 10 and 11, which show that shaft 251 is hollow) extending therebetween (Figs. 1-20; paras. 0027-0080).
Claim 49. Hennard discloses wherein coupling the instrument body to the bone anchor further comprises receiving the bone anchor proximally through the instrument body (see Figs. 14 and 18), with the bone anchor exerting a force onto the distal ends of the pivoting arms to splay the pivoting arms apart from one another (see para. 0067) (Figs. 1-20; paras. 0027-0080).
Claim 50. Hennard discloses wherein advancing the reducer shaft further comprises rotating the proximal portion to translate the distal portion distally toward the bone anchor (see para. 0078) (Figs. 1-20; paras. 0027-0080).
Claim 51. Hennard discloses wherein rotating the proximal portion further comprises engaging a threaded exterior surface (threaded portion 253) of the proximal portion with a threaded interior surface of the instrument body to advance the reducer shaft (see para. 0078) (Figs. 1-20; paras. 0027-0080).
Claim 52. Hennard discloses locking the instrument body to prevent the pivoting arms from moving relative to the instrument body such that the pivoting arms cannot disengage from the mating feature of the bone anchor (see para. 0068) (Figs. 1-20; paras. 0027-0080).
Claim 53. Hennard discloses implanting the bone anchor in a bone (vertebra V1) of a patient (Figs. 1-20; paras. 0027-0080).
Claim 54. Hennard discloses placing a rod (rod 246) within the working channel and reducing the rod into the bone anchor (see Fig. 18) (Figs. 1-20; paras. 0027-0080).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Hennard et al. (US 2014/0148865 A1) in view of Stihl et al. (US 2011/0166606 A1).
Hennard fails to disclose inserting a set screw through the working channel to secure the set screw to the bone anchor (claim 55).
Stihl teaches a surgical method comprising: positioning a bone anchor (bone fixation element 10) in a working channel (lumen 118) of an instrument body (outer tube 110) (see Fig. 5); coupling the instrument body to the bone anchor (see para. 0039); advancing a reducer shaft (inner tube 150) disposed in the working channel towards the bone anchor (see Figs. 11-12); and inserting a set screw (locking cap 40) through the working channel to secure the set screw to the bone anchor and secure a rod (rod 45) to the bone anchor (see para. 0050) (Figs. 1-15; paras. 0028-0050).
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 method of Hennard by inserting a set screw through the working channel to secure the set screw to the bone anchor (claim 55), as suggested by Stihl, in order to secure the rod to the bone anchor.
Allowable Subject Matter
Claims 37-41 are objected to as being dependent upon a rejected base claim, but would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Note that, as stated above with respect to the 35 U.S.C. 112 rejection, the Examiner is interpreting claim 37 as depending from claim 36.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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