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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,730,546. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose a surgical instrument that includes a first member extending between a proximal end and a distal end configured for fixation with tissue, a second member defining a longitudinal passageway and being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component, the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the first member, and a third member extending between a proximal end and a distal end, the third member being mountable with the first member along the orientation such that the distal end of the third member is engageable with the tissue.
Both the present application and granted patent disclose a surgical instrument that includes an anchor extending between a proximal end and a distal end configured for fixation with tissue, a dilator defining a longitudinal passageway and being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component, the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the anchor, and a drill guide being mountable with the anchor along the orientation such that a distal end of the drill guide is engageable with the tissue
Both the present application and granted patent disclose a surgical instrument that includes an anchor configured for fixation with tissue, a dilator defining a longitudinal passageway and being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component, the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the anchor, a drill guide being mountable with the anchor along the orientation such that a distal end of the drill guide is engageable with the tissue, and an anchor tool connectable with the anchor and configured to adjust a depth of the anchor relative to tissue and the navigation component.
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.
Claims 1-5, 7-9, and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by by U.S. Patent Pub. No. 2016/0166338 to Hartmann et al.
As to Claim 1, Hartmann discloses a surgical instrument [0007-0008]. The instrument includes a first member (110) extending between a proximal end (near ref. 100, Fig. 2B) and a distal end (150) configured for fixation with tissue (12, [0082]), a second member (108) defining a longitudinal passageway [0064] and being connected with a navigation component (58) such that the distal end is disposable with the passageway (seen in Fig. 3) at a selected distance from the navigation component [0070], the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the first member [0071-0073], and a third member (106) extending between a proximal end and a distal end (162), the third member being mountable with the first member along the orientation such that the distal end (162) of the third member is engageable with the tissue [0066-0067, 0071-0072].
As to Claim 2, Hartmann discloses a surgical instrument wherein the orientation includes an axial trajectory of the anchor (110) relative to tissue (trajectory described in [0082]).
As to Claim 3, Hartmann discloses a surgical instrument wherein the third member (106) is guided by the first member (110) along the axial trajectory for engagement with tissue [0067, 0071].
As to Claim 4, Hartmann discloses a surgical instrument wherein the second member (108) is removable from the first member such that the third member (106) is mountable with the first member [0066-0067, 0071-0072].
As to Claim 5, Hartmann discloses a surgical instrument wherein the distal end of the first member (110) includes a pointed tip (150) configured to penetrate tissue (12, [0082]).
As to Claim 7, Hartmann discloses a surgical instrument wherein the second member (108) includes a tapered tip (near 164, Fig. 2B).
As to Claim 8, Hartmann discloses a surgical instrument wherein the second member (108) includes a cannulated dilator [0064].
As to Claim 9, Hartmann discloses a surgical instrument further comprising a fourth member (104) connectable with the first member and configured to adjust a depth of the first member [0067].
As to Claim 12, Hartmann discloses a surgical instrument wherein the fourth member (104) includes a part (168) configured to adjust a depth (via 172) of the first member (110) relative to tissue and the navigation component [0088-0089].
As to Claim 13, Hartmann discloses a surgical instrument wherein the part is translatable to adjust the depth of the first member (movement of 168 relative to 166, [0089]).
As to Claim 14, Hartmann discloses a surgical instrument wherein in the part (168) includes a fixation element (176) configured to fix the part between a first position and a second position [0089].
As to Claim 15, Hartmann discloses a surgical instrument [0007-0008]. The instrument includes an anchor (110) extending between a proximal end (near ref. 100, Fig. 2B) and a distal end (150) configured for fixation with tissue (12, [0082]), a dilator (108) defining a longitudinal passageway [0064] and being connected with a navigation component (58) such that the distal end is disposable with the passageway (seen in Fig. 3) at a selected distance from the navigation component [0070], the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the anchor [0071-0073], and a drill guide (106) being mountable with the anchor along the orientation such that a distal end (162) of the drill guide is engageable with the tissue [0066-0067, 0071-0072].
As to Claim 16, Hartmann discloses a surgical instrument wherein the orientation includes an axial trajectory of the anchor (110) relative to tissue (trajectory described in [0082]).
As to Claim 17, Hartmann discloses a surgical instrument wherein the drill guide (106) is guided by the anchor (110) along the axial trajectory for engagement with tissue [0067, 0071].
As to Claim 18, Hartmann discloses a surgical instrument [0007-0008]. The instrument includes an anchor (110) configured for fixation with tissue (12, [0082]), a dilator (108) defining a longitudinal passageway [0064] and being connected with a navigation component (58) such that the distal end is disposable with the passageway (seen in Fig. 3) at a selected distance from the navigation component [0070], the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the anchor [0071-0073], and a drill guide (106) being mountable with the anchor along the orientation such that a distal end (162) of the drill guide is engageable with the tissue [0066-0067, 0071-0072], and an anchor tool (104) connectable with the anchor and configured to adjust a depth of the anchor relative to tissue and the navigation component [0067].
As to Claim 19, Hartmann discloses a surgical instrument wherein the orientation includes an axial trajectory of the anchor (110) relative to tissue (trajectory described in [0082]).
As to Claim 20, Hartmann discloses a surgical instrument wherein the drill guide (106) is guided by the anchor (110) along the axial trajectory for engagement with tissue [0067, 0071].
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.
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.
Claims 6, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2016/0166338 to Hartmann et al. in view of U.S. Patent Pub. No. 2017/0333057 to Kostrzewski et al.
As to Claims 6, 10, and 11, Hartmann discloses the claimed invention except for wherein the proximal end of the first member includes a groove, the fourth member includes a lock being releasably engageable with the first member and wherein the lock includes a spring button.
Kostrzewski discloses a surgical instrument (400, Fig. 4A) wherein the proximal end of the first member (422) includes a groove (near ref. 418, Fig. 4A), a fourth member (1032) includes a lock (1032) being releasably engageable with the first member [0019, 0094-0095] and wherein the lock includes a spring button (1032, [0095]) in order to lock the first member at a desired distance [0094-0095].
It would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the surgical instrument of Hartmann with the lock and groove modification of Kostrzewski in order to lock the first member at a desired distance.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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