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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21, and 40 have been amended to recite the limitations “wherein the first member is advanced into the tissue to create a dilated pathway prior to connecting the second member to the first member”; and regarding claim 39, “wherein the dilator is advanced into the tissue to create a dilated pathway prior to connecting the drill guide to the dilator”; which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
While the specification discloses in paragraph [0064] “A cannula 150 is inserted into end effector 200 and is inserted into the surgical pathway. Surgical instrument 12 is assembled. Anchor 14 is disposed with passageway 38 of dilator 30”; and in paragraph [0067] “Surgical instrument 12 is inserted into cannula 150. Dilator 30 expands skin S1 along the surgical pathway”. The specification fails to explicitly disclose,
regarding claims 21 and 40, “wherein the first member is advanced into the tissue to create a dilated pathway prior to connecting the second member to the first member”; since the specification fails to explicitly state the order of the steps in the method being performed e.g. the cannula 150 being inserted prior to connecting the dilator 30; and Figure 14 fails to show the order the device was assembled / inserted into the tissue, just that the dilator 30 has been connected to the cannula 150 and that both have been inserted. In addition, since the specification describes the dilator 30, not the first member e.g. cannula 150 as expanding the skin S1 along the surgical pathway; and from Figure 14, that only a very tiny bottom portion of first member e.g. cannula 150 extends below the incision S1 in the skin, this would reasonably convey to one skilled in the relevant art that the first member was advanced into the tissue to create a dilated pathway prior to connecting the second member to the first member.
While the specification discloses in paragraph [0082] “Drill guide 100 is mounted with anchor 14, as shown in FIG. 19, such that anchor 14 is disposed with passageway 108. Anchor 14 directs and/or guides drill guide 100 along axial trajectory AT through cannula 150. End 104 of drill guide 100 extends from a distal end of cannula 150. Drill guide 100 is tamped along anchor 14 and axial trajectory AT causing end 104 to engage bone B1. As such, drill guide 100 is docked with bone B1 along navigated axial trajectory AT thereby maintaining the alignment and/or trajectory of drill guide 100 during docking”. The specification fails to explicitly disclose, regarding claim 39 “wherein the dilator is advanced into the tissue to create a dilated pathway prior to connecting the drill guide to the dilator”, since the specification fails to explicitly state the order of the steps in the method being performed e.g. the cannula 150 being inserted prior to connecting the drill guide 100; and Figure 19 fails to show the order the device was assembled / inserted into the tissue, just that the drill guide has been connected to the cannula 150 and that both have been inserted. In addition, since the specification describes the dilator 30, not the first member e.g. cannula 150 as expanding the skin S1 along the surgical pathway and being removed prior to connecting the drill guide 100 to the cannula 150 (see paras. [0080]-[0081]); and from Figure 19, that only a very tiny bottom portion of first member e.g. cannula 150 extends below the incision S1 in the skin, this would reasonably convey to one skilled in the relevant art that the dilator that is connected to the drill guide was advanced into the tissue to create a dilated pathway prior to connecting the drill guide to the dilator.
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 first member being advanced into the tissue to create a dilated pathway prior to connecting the second member to the first member, as required by amended claims 21 and 40; and the dilator being advanced into the tissue to create a dilated pathway prior to connecting the drill guide to the dilator, as required by amended claim 39, 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 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.
Claim(s) 21-24, 27-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lehman, JR. et al. (U.S. Pub. No. 2019/0350600 A1, hereinafter “Lehman”) in view of Markworth (U.S. Pub. No. 2003/0233098 A1, hereinafter “Markworth”).
Lehman discloses, regarding claim 21, a method for treating a spine (see ABSTRACT), the method comprising the steps of: connecting an end effector (120) to a first member (“sleeve, cannula and/or dilator”, see para. [0051]); connecting a second member to the first member (200a, see paras. [0051]-[0052]); and positioning a third member (12), wherein the first member is advanced into the tissue to create a dilated pathway (see para. [0051]) prior to connecting the member to the first member (see paras. [0051]-[0052]).
Regarding claim 22, further comprising connecting the end effector with a robot arm (126, see paras. [0044] and [0051]).
Regarding claim 23, wherein the robot arm includes position sensors which measure and identify positional data points of the end effector in three-dimensional space for a guide-wireless insertion of the members with tissue (see para. [0043] “Robotic arm 126 includes position sensors (not shown)… identify positional data points of the end effector 120 in three dimensional space for a guide-wireless insertion”).
Regarding claim 24, wherein connecting the end effector to the first member comprises inserting the first member through a channel (124) of the end effector (see paras. [0048] and [0051]).
Regarding claim 27, wherein the end effector comprises opposite proximal and distal end surfaces (e.g. top and bottom of 120, see Fig. 2), the distal end of the second member extending through the distal end surface (see Fig. 2), the second member comprising an opposite proximal end that directly engages the proximal end surface (see Fig. 2, see para. [0052]).
Regarding claim 28, further comprising connecting a navigation component with the third member such that the navigation component is positioned relative to a sensor to communicate a signal representative of an orientation of the third member (see para. [0042]).
Regarding claim 32, wherein the distal end of the second member extends through a distal end surface of the first member (see paras. [0051]-[0052]).
Regarding claim 36, wherein the first member includes a cannulated dilator (“cannula and/or dilator”, see para. [0051]).
Lehman discloses, regarding claim 39, a method for treating a spine (see ABSTRACT), the method comprising the steps of: connecting an end effector (120) to a dilator (“dilator”, see para. [0051]); connecting a second member to the dilator (200a, see paras. [0051]-[0052]); positioning a third member (12); wherein the dilator is advanced into the tissue to create a dilated pathway prior to connecting the member to the dilator (see paras. [0051]-[0052]).
Lehman discloses, regarding claim 40, a method for treating a spine (see ABSTRACT), the method comprising the steps of: connecting an end effector (120) to a first member (“sleeve, cannula and/or dilator”, see para. [0051]); connecting a second member to the first member (200a, see paras. [0051]-[0052]); positioning a third member (12); connecting a navigation component with the third member such that the navigation component is positioned relative to a sensor to communicate a signal representative of an orientation of the third member (see para. [0042]); and connecting the end effector with a robot arm (126, see paras. [0044] and [0051]), wherein the first member is advanced into the tissue to create a dilated pathway prior to connecting the second member to the first member (see paras. [0051]-[0052]), wherein the robot arm includes position sensors which measure and identify positional data points of the end effector in three-dimensional space for a guide-wireless insertion of the members with tissue (see para. [0043] “Robotic arm 126 includes position sensors (not shown)… identify positional data points of the end effector 120 in three dimensional space for a guide-wireless insertion”).
Lehman discloses inserting a drill, driver, and surgical instrument through the first member to create a pilot hole in the vertebrae / to create threads in the vertebra (see paras. [0051]-[0052]). Lehman fails to explicitly disclose, regarding claim 21, connecting a second member to the first member; and positioning a third member through the first member and the second member to adjust a depth of the third member relative to tissue and the end effector; regarding claim 29, wherein the distal end of the second member comprises a plurality of teeth extending radially about the distal end of the second member; regarding claim 30, wherein the third member extends through the end effector when the third member is positioned through the first member and the second member; regarding claim 31, wherein the third member extends through opposite proximal and distal end surfaces of the end effector when the third member is positioned through the first member and the second member; regarding claim 33, wherein the distal end of the third member extends through the distal end of the second member; regarding claim 34, wherein the distal end of the third member includes a pointed tip configured to penetrate tissue; regarding claim 35, further comprising removing the third member from the first member and the second member; regarding claim 37, wherein the second member includes a part configured to adjust the depth of the third member relative to tissue and the end effector; regarding claim 38, wherein the part is translatable to adjust the depth of the third member; and regarding claim 39, connecting a drill guide to the dilator; and positioning an anchor through the dilator and the drill guide to adjust a depth of the anchor relative to tissue and the end effector; and regarding claim 40, connecting a second member to the first member; and positioning a third member through the first member and the second member to adjust a depth of the third member relative to tissue and the end effector.
Markworth discloses a variable depth drill guide (see Fig. 5) comprising a second member / drill guide (14), and a third member / anchor (12) extending through the second member (see Fig. 5), with a part (16) translatable to adjust the depth of a third member (12); wherein the distal end of the second member comprises a plurality of teeth (24) extending radially about the distal end of the second member (see Fig. 2); wherein the distal end of the third member extends through the distal end of the second member (see Fig. 5); wherein the distal end of the third member includes a pointed tip configured to penetrate tissue (see Fig. 6); further comprising removing the third member from the first member and the second member (see para. [0057]); wherein the part is translatable to adjust the depth of the third member (see paras. [0048]-[0049]) in order to enable the surgeon performing an orthopedic procedure to drill and / or tap a hole in the bone to a specific depth (see para. [0055]), in order to prevent the drill guide from slipping on the bone (see para. [0057]), and in order to control the desired depth of the insertion of the third member and prevent over insertion or under insertion of the third member (see paras. [0047] and [0059]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify method in Lehman to including connecting a second member / drill guide to the first member / dilator and include a part translatable and positioning a third member / anchor through the first member and the second member to include a part translatable to adjust the depth of the third member relative to the tissue in view of Markworth in order to enable the surgeon performing an orthopedic procedure to drill and / or tap a hole in the bone to a specific depth, in order to prevent the drill guide from slipping on the bone, and in order to control the desired depth of the insertion of the third member and prevent over insertion or under insertion of the third member. It is noted that since the third member in Markworth extends past the proximal and distal ends of the second member, that when the third member is positioned through the first member and the second member, the third member will extend through the end effector through opposite proximal and distal end surfaces of the end effector.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lehman in view of Markworth, as applied to claim 21 above, and in further view of Kostrzewski et al. (U.S. Pub. No. 2015/0196365 A1, hereinafter “Kostrzewski”).
Lehman in view of Markworth discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 25, wherein connecting the end effector to the first member comprises releasably engaging a lock of the end effector with the first member; and regarding claim 26, wherein the lock includes a spring button.
Kostrzewski discloses a surgical instrument guide (1030) with a lock (1032) that includes a spring button (see para. [0094]) in order to lock the position of the instrument within the guide (see para. [0094]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the cannula of the end effector in Lehman in view of Markworth to include a lock that includes a spring button in further view of Kostrzewski in order to enable locking of the first member within the cannula of the end effector.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
