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 .
Specification
The abstract of the disclosure is objected to because it contains language that can be inferred: “are disclosed herein that can” (at line 1).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be inferred, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 22 and 31-33 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 22, line 2, “the toroid body” lacks consistent antecedent basis.
Claim 31, line 3, “configured to have a distal bone-engaging portion of the screw shank extends” does not make sense. As best understood, and for purposes of examination, “extends” will be treated as reciting “extending”.
Claim 32, lines 4-5, “the toroid body” lacks consistent antecedent basis.
Claim 33 depends from and includes the limitations of parent claim 32 and has therefore also been rejected.
Appropriate correction is required.
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 15-19, 21-26, 28 and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hynes et al. (2016/0106477; cited by Applicant).
Regarding claim 15, Hynes et al. disclose a connector (Figs. 1-5), comprising:
a base 12, 60 having a substantially toroid body portion (e.g., Fig. 2A, right side; annotated Fig. 5, below) with a radially protruding wing extending therefrom (e.g., Fig. 2A, left side; annotated Fig. 5, below), the base defining a first opening 64 having a first lumen therein with a first central longitudinal axis X1 (Fig. 2B) extending between a proximal-facing surface (top) and a distal-facing surface (bottom) of the toroid body portion, the first lumen being configured to receive a screw shank 46 therein, and the wing defining a second opening 36 having a second lumen with a second central longitudinal axis X3 (Fig. 2B) extending between the proximal-facing surface and the distal-facing surface of the toroid body portion, the second lumen being configured to receive an auxiliary anchor 38 therein; and
a receiver member 40 coupled to the toroid body portion by assembly therewith, the receiver member 40 having a proximal end (top), a distal end (bottom), and a lumen 44 extending along a central axis X1 (Fig. 1) therebetween, the proximal end having a pair of spaced apart arms 42 defining a U-shaped rod-receiving recess (Fig. 1) therebetween for receiving a spinal fixation element (para. 0065);
wherein at least a portion of the radially protruding wing is offset (e.g., laterally and/or at an angle) from the receiver member when the receiver member 40 is coupled to the toroid body portion.
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Regarding claim 16, the receiver member 40 further comprises a groove (annotated Fig. 5, below) formed on an internal surface thereof (id.).
Regarding claim 17, an extension (annotated Fig. 5, above) extends proximally from the proximally-facing surface, the extension being configured to be received in the lumen 44 of the receiver member 40.
Regarding claim 18, the extension further comprises a lip (i.e., the c-clip of the extension) that is configured to engage the groove of the receiver member 40 to couple the receiver member 40 to the toroid body portion (annotated Fig. 5, above).
Regarding claim 19, the lip (c-clip of the extension) is configured to compress radially inward when the lip is received within the lumen 44 of the receiver member 40, and is configured to expand radially outward when the lip aligns with the groove to retain the base 12, 60 with the receiver member 40 (e.g., when implanted in bone).
Regarding claim 21, the extension and the lip thereof includes deformable fingers (i.e., the ends of the c-clip that allow the c-clip to contract to enter the receiver member 40 and to expand to seat in the groove) with a gap therebetween that is configured to compress radially inward when received within the lumen 44 of the receiver member 40 and expand outward when the lip aligns with the groove of the receiver member 40 (annotated Fig. 5, above).
Regarding claim 22, a portion of the extension extends distally from the receiver member 40 to separate the proximal-facing surface (top) of the toroid body portion from the receiver member 40 (annotated Fig. 5, above).
Regarding claim 23, a lip (e.g., the circular upper edge of the first opening 64) is formed on the toroid body portion (annotated Fig. 5, above; it is noted that this lip is separate structure from the lip of the extension as set forth in the separate claim grouping of claims 18-21).
Regarding claim 24, the base 12, 60 is configured to rotate relative to the receiver member 40 about the central axis X1 of the receiver member 40 without translating along the first central longitudinal axis (e.g., about the head of the extension or as between the screw shank 46 relative to the first opening 64).
Regarding claim 25, the lumen 44 of the receiver member 40 is co-axial with the first lumen of the first opening 64 along the first central longitudinal axis (e.g., when the receiver 40 is oriented along the first central longitudinal axis; Fig. 1).
Regarding claim 26, the second central longitudinal axis X3 extends at an angled trajectory relative to the first central longitudinal axis X1 (Fig. 1).
Regarding claim 28, relative axial movement between the base 12, 60 and the receiver member 40 is restricted along the first central longitudinal axis X1 (e.g., at least downward movement as by interference between the lower surface of the receiver member 40 and the proximal-facing surface of the base 12, 60).
Regarding claim 31, the lumen 44 of the receiver member 40 is configured to receive a proximal head of a screw shank 46 and the first lumen of the first opening 64 of the base 12, 60 is configured to have a distal bone-engaging portion of the screw shank 46 extending distally therefrom (Fig. 4 and annotated Fig. 5, above). It is noted that while not necessary for separately dependent claim 31, the proximal head of the screw shank 46 is also a portion of the extension as set forth with respect to separately dependent claims above.
Regarding claim 32, Hynes et al. discloses a bone anchor assembly, comprising:
the connector of claim 15; and
a screw shank 46 having a proximal head (Fig. 5) and a distal threaded portion (id.), the screw shank being disposed in the base 12, 60 such that the distal threaded portion extends distally from the toroid body portion while the proximal head is received within the lumen 44 of the receiver member 40 (annotated Fig. 5, above).
Regarding claim 33, a set screw (para. 0065) is configured to be received in the receiver member 40 to capture a spinal fixation element between the pair of spaced apart arms 42 and fix the spinal fixation element with respect to the receiver member 40 (id.).
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.
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 27 is rejected under 35 U.S.C. 103 as being unpatentable over Hynes et al. (2016/0106477; cited by Applicant).
Hynes et al. disclose a wing (annotated Fig. 5, above) defining a second opening 36 having a second lumen configured to receive an auxiliary anchor 38 therein. The inclusion of an additional opening and anchor provides stability to a treated region (see, e.g., paras. 0003-0004).
Hynes et al. do not explicitly recite providing a third opening with a third lumen having a third central longitudinal axis extending between the proximal-facing surface and the distal-facing surface of the toroid body portion, the third lumen being configured to receive a second auxiliary anchor therein.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the connector with a third opening having a third lumen and a third central longitudinal axis extending between the proximal-facing surface and the distal-facing surface of the toroid body portion, the third lumen being configured to receive a second auxiliary anchor therein, in view of the teaching of Hynes et al., to provide further stability to a treated region where necessary or desired.
Allowable Subject Matter
Claims 20, 29 and 30 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773