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 .
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.
Claim(s) 1-4, 6, 7, 11, 12, 13, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wogoman et al. (U.S. Patent No. 8986390).
Wogoman et al. discloses a system for aligning a keel punch in a planned position and orientation, the system comprising: a keel punch alignment guide (14) configured to guide the keel punch to form one or more keel receiving features in a material (Figure 34, 35); and a keel post tool (16) configured to be temporarily inserted into a prepared post hole formed in the material to assist with aligning the keel punch alignment guide (the disclosure is silent regarding the prepared post hole, however, the limitation is functional, and the spikes 130 are capable of being inserted into prepared holes).
Regarding claim 2, the keel punch alignment guide (14) has a planar shape (Figure 2).
Regarding claim 3, the keel punch alignment guide (14) further comprises one or more guiding apertures (38, 42).
Regarding claim 4, the one or more guiding apertures have a shape and size that matches, or slightly exceeds, the outline or perimeter of the keel punch (Figure 15, 35, 36, (Column 18, Lines 21-32)).
Regarding claim 6, the one or more guiding apertures include a post guiding aperture (38) and a set of groove guiding apertures (42) that correspond to a keel post punch component and a set of keel groove punch components, respectively, of the keel punch (Figure 15).
Regarding claim 7, the keel punch alignment guide (14) further comprises an end-effector interaction member (54) configured to interact with an end-effector of a surgical robot to permit the end-effector to assist in aligning the keel punch alignment guide and the material is a bone of a subject (since the notch 54 is used with a handle 26, it is considered capable of being used with an end-effector).
Regarding claim 11, claim the end-effector interaction member (54) is at least one of an enclosed channel, a receptacle, a notch (Figure 2), a divot, a hole, a groove, or a marking that aligns with a longitudinal axis of the end-effector.
Regarding claim 12, the system further comprises at least one securement (Column 11, Lines 7-17 “The fastener holes 72 are configured to receive fasteners such as fixation pins”) configured to be inserted through apertures in the keel punch alignment guide and into an underlying bone of a subject.
Regarding claim 13, the keel post tool (16) comprises a handle (28), a shaft (Figure 25 portion of handle connecting to element 16), a collar (82), and an insertable post (130).
Regarding claim 15, the collar is configured to abut against a top surface of the keel punch alignment guide or the collar has a collar diameter that exceeds the diameter or width of the insertable post (130), (Figure 2).
Claim(s) 1, 13, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Todorov et al. (U.S. Publication No. 2016/0278754).
Todorov et al. discloses a system for aligning a keel punch in a planned position and orientation, the system comprising: a keel punch alignment guide (12) configured to guide the keel punch to form one or more keel receiving features in a material (Figure 11C); and a keel post tool (367) configured to be temporarily inserted into a prepared post hole formed in the material to assist with aligning the keel punch alignment guide.
Regarding claim 13, the keel post tool comprises a handle/collar combo, a shaft, and an insertable post (see attached)
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Regarding claim 17, the insertable post has a post length and further comprises notches or grooves formed along the post length (see above)
Claim Rejections - 35 USC § 103
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.
Claim(s) 5, 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wogoman et al. (U.S. Patent No. 8986390).
Regarding claim 5, Wogoman et al. discloses the claimed invention except for the shape and size of the one or more guiding apertures exceeds the outline perimeter of the keel punch by 1% to 5% of the maximum outline or perimeter of the keel punch. It can be construed from figures 15, 35, 36 that the keel punch (22) fits within aperture (38) with a small tolerance. It would have been obvious to one having ordinary skill in the art to construct the shape and size of the one or more guiding apertures exceeds the outline perimeter of the keel punch by 1% to 5% of the maximum outline or perimeter of the keel punch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, Wogomon discloses the claimed invention except for the end-effector interaction member further comprises a semi-circular channel that assembles with an interacting portion of the end-effector, it would have been an obvious matter of design choice to one skilled to construct the end-effector interaction member further comprises a semi-circular channel that assembles with an interacting portion of the end-effector, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a member for interacting with an end effector. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding claim 9, the end-effector member is considered only functionally claimed, since it is only functionally recited prior to claim 9. Thus, it is considered that the device of Wogomon would be capable of interacting with the claimed end-effector member.
Regarding claim 10, It would have been obvious to one having ordinary skill in the art to construct the semi-circular channel has a radius that is from 1% to 5% larger than a second radius of the interaction portion of the end-effector, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wogoman et al. (U.S. Patent No. 8986390) in view of Wherry (U.S. Publication No. 2005/0006111).
Wogoman et al. discloses the claimed invention except for the handle (28) of the keel post tool is sphere shaped. Wherry teaches a tool (10) with a handle portion (11) that is a sphere. The spherical shape allows the user to grip the tool ergonomically in the palm of the hand. It would have been obvious to one skilled in the art to construct the handle of Wogoman et al. with a spherical handle in view of Wherry since such would allow for a more ergonomic grip portion.
Allowable Subject Matter
Claims 18-21 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose a method for aligning a keel punch alignment guide by positioning an end effector to an alignment position based on at least one of a keel punch guide geometry, an implant geometry, and a planned position and orientation of the implant. Aligning an end-effector interaction member on the keel punch alignment guide, placing the keel punch alignment guide on a prepared bone surface and removing the end effector. Although the use of robotics and end-effectors is becoming more common throughout surgical procedures. There is no anticipation or obviousness to the steps involving the keel punch alignment guide and the end effector. The prior art indicates the placement or movement of drills/saws and respective guides however such remain attached to the end effector and not secured to bone and the end-effector removed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775