Detailed Action
This is the first office action on the merits for US application number 19/137,361.
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 .
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 “one or more openings comprise concentric circles” of claims 8 and 18 must be shown or the feature(s) canceled from the claim(s). 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.
Claim Objections
Claim(s) 11 is/are objected to because of the following informalities:
Claim 11 line 2 should read “inserting a portion of a medical device into a knee joint space”.
Appropriate correction is required.
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(s) 2, 3, 7, 8, 12, 13, 17, and 18 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 2 is/are unclear with regards to “the distal end, such that the hook is forked” in lines 3-4 and which structure “such that” is intended to reference. Examiner is interpreting this as referring to, and suggests amending as, “to the distal end[[,]] such that the hook is forked.”.
Claim(s) 7 is/are unclear with regards to “the offset drill guide is one or more of a single piece with the shaft and connected to the shaft via a fusion, welding, crimping, or soldering process” in lines 1-3 and how it can be reasonably possible for the guide to be more than one of a single piece and connected via fusion, welding, etc.. Examiner is interpreting this as referring to, and suggests amending as, “the offset drill guide is one
Claim(s) 8 is/are unclear with regards to “the one or more openings comprise concentric circles” in lines 1-2 and how the shown openings 162, 164, and 166 can be reasonably interpreted as being concentric, i.e. “having a common center” (https://www.merriam-webster.com/dictionary/concentric). Examiner notes that it does not appear that Applicant has originally disclosed an alternate definition of “concentric”. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 12 is/are unclear with regards to “the distal end, such that the hook is forked” in lines 3-4 and which structure “such that” is intended to reference. Examiner is interpreting this as referring to, and suggests amending as, “to the distal end[[,]] such that the hook is forked.”.
Claim(s) 17 is/are unclear with regards to “the offset drill guide is one or more of a single piece with the shaft and connected to the shaft via a fusion, welding, crimping, or soldering process” in lines 1-3 and how it can be reasonably possible for the guide to be more than one of a single piece and connected via fusion, welding, etc.. Examiner is interpreting this as referring to, and suggests amending as, “the offset drill guide is one
Claim(s) 18 is/are unclear with regards to “the one or more openings comprise concentric circles” in lines 1-2 and how the shown openings 162, 164, and 166 can be reasonably interpreted as being concentric, i.e. “having a common center” (https://www.merriam-webster.com/dictionary/concentric). Examiner notes that it does not appear that Applicant has originally disclosed an alternate definition of “concentric”. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
Claim(s) 1, 2, 5-7, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Durlacher et al. (US 5,562,664, hereinafter “Durlacher”).
As to claim 1, Durlacher discloses a medical instrument (Figs. 1-7) comprising: a handle (33) at a proximal end (left end as shown in Fig. 1, i.e. right end as shown in Figs. 2 and 5, Figs. 1, 2, and 5); a shaft (see illustration of Fig. 2, Figs. 1, 2, and 5) connected to the handle (Figs. 1, 2, and 5); and an offset drill guide (portion to the left of the shaft as shown on the illustration of Fig. 2, Figs.1, 2, and 5) connected to the handle (via the shaft, Figs. 1, 2, and 5) and located at a distal end (Figs. 4 and 7 5), the offset drill guide comprising one or more openings (portion of 36 as shown on the illustration of Fig. 2, Figs. 4 and 7) and a hook (see illustration of Fig. 2, Figs.1, 2, and 5) having a first portion (see illustration of Fig. 2, Figs.1, 2, and 5) that curves above a longitudinal axis of the shaft (see illustration of Fig. 2, Figs.1, 2, and 5) and a second portion (see illustration of Fig. 2, Figs.1, 2, and 5) that extends below the longitudinal axis of the shaft (Figs. 1, 2, and 5).
As to claim 2, Durlacher discloses that the offset drill guide further comprises: a channel (portion of 36 as shown on the illustration of Fig. 2, Figs. 4 and 7) that extends from the one or more openings to the distal end (as defined) such that the hook is forked (Figs. 4 and 7).
As to claim 5, Durlacher discloses that the shaft is substantially circular in cross-section (Figs. 1, 2, and 5).
As to claim 6, Durlacher discloses that the offset drill guide is substantially flat (at least to the left of 37 as shown in Figs. 3 and 4, Figs. 1-7).
As to claim 7, Durlacher discloses that the offset drill guide is one of a single piece with the shaft and connected to the shaft via a fusion, welding, crimping, or soldering process (Figs. 1-7).
As to claim 10, Durlacher discloses one or more measurement lines (37) on the offset drill guide between the one or more openings and the shaft (Figs. 1-7).
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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 of this title, 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) 3, 4, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durlacher.
As to claim 3, Durlacher discloses the invention of claim 2 as well as the channel has a width (Figs. 4 and 7).
Durlacher is silent to the width being about 1mm.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specify that the width of the channel of Durlacher is about 1mm, since such a modification would have involved a mere change/specification in the size of a component to allow a surgeon to view the guide pin as it passes through the knee structures on completion of the guide pin drilling operation (col. 4 lines 12-14), allow the guide pin to pass beyond the marking hook without impinging on the marking hook (col. 4 lines 14-16), and allow the marking hook to be removed from around the guide pin after the guide pin is inserted in place in the knee (col. 4 lines 20-22). A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 4, Durlacher discloses the invention of claim 1 as well as the offset drill guide has a length and a width (Figs. 1-7).
Durlacher is silent to the length being about 0.75in and the width being about 0.25in.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specify the length and the width of the offset drill guide of Durlacher as the length being about 0.75in and the width being about 0.25in, since such a modification would have involved a mere change/specification in the size of a component to accurately and consistently positions a sighting device, so that a guide pin can be delivered to an appropriate location (col. 2 lines 29-35). A change in size is generally recognized as being within the level of ordinary skill in the art.
As to claim 8, Durlacher discloses the invention of claim 1 as well as the one or more openings comprise concentric circles having a diameter (Figs. 1-7).
Durlacher is silent to the diameter being about 1.6 mm to about 5.6 mm.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specify the diameter of the one or more openings of Durlacher to be about 1.6 mm to about 5.6 mm, since such a modification would have involved a mere change/specification in the size of a component to allow a surgeon to view the guide pin as it passes through the knee structures on completion of the guide pin drilling operation (col. 4 lines 12-14), allow the guide pin to pass beyond the marking hook without impinging on the marking hook (col. 4 lines 14-16), and allow the marking hook to be removed from around the guide pin after the guide pin is inserted in place in the knee (col. 4 lines 20-22). A change in size is generally recognized as being within the level of ordinary skill in the art. Further, Applicant places no criticality on the diameters claimed, indicating simply that the openings “can have” a diameter within the claimed sizes (paragraph 31).
As to claim 9, Durlacher discloses the invention of claim 1 as well as the one or more openings are located a distance from the distal end (Figs. 1-7).
Durlacher is silent to the distance being about 4mm, about 6mm, or about 8mm from the distal end.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specify the distance of the of the one or more openings from the distal end of Durlacher to be about 4mm, about 6mm, or about 8mm, since such a modification would have involved a mere change/specification in the size of a component to accurately and consistently positions a sighting device, so that a guide pin can be delivered to an appropriate location (col. 2 lines 29-35). A change in size is generally recognized as being within the level of ordinary skill in the art.
Allowable Subject Matter
Claims 11, 14-16, 19, and 20 are allowed.
Claim 13 is 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (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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/AMY R SIPP/Primary Examiner, Art Unit 3775
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