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 .
Response to Amendment
This action is in response to the remarks filed on 10/14/2025.
The amendments filed on 10/14/2025 have been entered. Accordingly claims 1-3, 6-17 and 20-24 remain pending, claims 21-24 are newly added. Claims 4, 5, 18 and 19 are cancelled. Claims 8-17 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The objections to the claims have been withdrawn in light of the amendments and the applicant’s remarks.
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.
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.
Claims 1-3, 6 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sahni (US20110190787) in view of
Regarding claim 1, Sahni teaches a needle-guiding device for guiding and positioning a needle-shaped device on a patient (figures 1 and 2 and the associated pars.), comprising:
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a base element (1),
a needle-guiding element (6) on which the needle-shaped device (20) is guidable along its longitudinal extent (“a needle guide (6) that slides on the superior surface of the carrying arc for the needle (20)” [0023]), wherein an angular orientation of the needle-guiding element (6) relative to the base element is adjustable in two mutually independent degrees of freedom (e.g., see above re-produced fig. 1 and the angles on the arc 3 and a fixing screw (4) which fixes the carrying arc for the needle guide (3)),
an operating element (see figures 2 (5), 6 and 8) by which the angular orientation of the needle-guiding element (6) is fixable in the two degrees of angular freedom (as shown in figures 2 (5), 6 and 8), and by which the angular orientation of the needle-guiding element is releasable from a fixed position in two degrees of angular freedom (“arc that allows quick release of the needle” abst),
a retaining bracket to which the needle-guiding element is fastenable (e.g., carrying arc (3)), wherein the retaining bracket is movable relative to the base element in a first degree of angular freedom of the two degrees of angular freedom (see figs. 1-6 show arc 3 being movable with respect to the base element), wherein the needle guiding element is movable relative to the retaining bracket in a second degree of angular freedom of the two degrees of angular freedom (e.g., see base plate/top surface (7) movable with respect to the retaining bracket); and
a clamping bracket which is fastenable to the base element and is pivotable relative to the base element (“FIG. (10) Shows angled three-dimensional back view of needle guide (6), showing the back plate (35). The back plate of needle guide has a tapped hole (36) for a screw to fix needle guide to the arc blade (19)” [0032] under BRI, the screw would allow the back plate 35 to fasten to the arc which the arc is fastened to the base since the claim does not require a direct fastening of clamping bracket to the base element. Hence claim merely recites “fastenable”).
As can be clearly seen above, under the BRI, Sahni teaches all the claimed limitations. Yet, in different interpretations if argued otherwise and solely to provide compact prosecution, Chieng is brought in to show specifics the teachings as shown in detail below;
In the same field of endeavor, teaches Chieng teaches an apparatus (100) for guiding a surgical needle with improved accuracy as seen in figs 1-8, 15-16, 18-20, 22-23 and specifically in re-produced figs. 2 and 4 below. The apparatus (100) having a base (1) for positioning the apparatus (100) on a patient; a second arc member (6) attached to the base (1); a first arc member (4) moveably attached to the second arc member (6) (“fixable in the two degrees of angular freedom, and by which the angular orientation of the needle-guiding element is releasable from a fixed position in two degrees of angular freedom”); an arm (2) attached to a needle guide support (3) at one end and moveably attached to the first arc member (4) at a distal end (“an angular orientation of the needle-guiding element relative to the base element is adjustable in two mutually independent degrees of angular freedom”), and an angle marking device (7) attached to the arm (2) to indicate a vertical reference point for measuring the angle of tilt of the arm (2) from the vertical reference point relative to the base (1). Wherein the first arc member (4) is configured to move on the second arc member (6) to facilitate movement of the needle guide support (3) in a cranio-caudal plane and the arm (2) is configured to move on the first arc member (4) to facilitate movement of the needle guide support (3) in an axial plane.
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with needle-guiding device fixable in the two degrees of angular freedom which guiding element is releasable from a fixed position as taught by Chiang because there is a need for a cost effective and less intrusive diagnostic apparatus whereby the angle of entry of a needle can be configured on the apparatus after placement on the body of a patient. ([0007] of Chiang).
Regarding claim 2, Sahni teaches a clamping mechanism that is actuatable by the operating element wherein the angular orientation of the needle-guiding element relative to the base element in the two degrees of angular freedom is fixable by clamping through operation of the clamping mechanism by the operating element (e.g., see “needle guide (6), showing the back plate (35). The back plate of needle guide has a tapped hole (36) for a screw to fix needle guide to the arc blade (19)” [0032]).
Regarding claim 3, Sahni teaches the angular orientation of the needle-guiding element relative to the base element is steplessly adjustable in the two degrees of angular freedom (“The needle is made free by removing the locking pin (5)” [0038]).
Regarding claim 6, Sahni teaches a first angle scale of the plurality of angle scales is arranged on the retaining bracket and/or the clamping bracket (e.g., scale of carrying arc for the needle guide (3)), and/or a second angle scale of the plurality of angle scales is arranged in a region of a fastening arrangement of the retaining bracket on the base element (e.g., base plate/top surface (7) arranged in a region of a fastening arrangement of the retaining bracket on the base element in figs 1-6 and the associated pars.).
Regarding claim 20, Sahni teaches wherein the clamping bracket is pivotable relative to the base element about a same pivot axis as the retaining bracket (e.g., scale of carrying arc for the needle guide (3) in figs. 1-6 and the associated pars.).
Regarding claim 21, Sahni teaches a plurality of angle scales comprising a respective an angle scale for each of the two adjustable degrees of angular freedom (“(1); angle at which the needle guide (6) has to be placed on the Arc blade (19) and the depth of the target from the skin at the centre of base plate to the target. These angles and the depth of the target can be alternatively obtained with the help of a specifically designed 3D frame, in which the coordinates are manually adjusted.” [0036]; “arc for needle guide (3) and the needle guide (6) is adjusted these can be secured by placing fixing screw (4) in the hole in foot of carrying arc (24) and a screw in tapped hole in back plate of needle guide (36).” [0037]; also see figs. 1-6 and the associated par.), and
an angle indicator assigned to each respective angle scale such that a currently set angular orientation of the needle- guiding element in the two degrees of angular freedom can be read off by a user on a basis of a position of the respective angle indicator in relation to the assigned angle scale (see figs. 1-6 and the associated par.),
Also, Chiang teaches these limitations especially the angle indicators see in above re-produced figs.
Regarding claim 22, Sahni teaches wherein a first angle scale of the plurality of angle scales is arranged on the retaining bracket or the clamping bracket (see e.g., (3) in fig. 2), and a second angle scale of the plurality of angle scales is arranged in a region of a fastening arrangement of the retaining bracket on the base element (see e.g., (7) in fig. 3).
Further, Chiang also teaches these limitations especially the angle indicators see in above re-produced figs. above; also see “needle guide support (3) at one end and moveably attached to the first arc member (4) at a distal end, and an angle marking device (7) attached to the arm (2) to indicate a vertical reference point for measuring the angle of tilt of the arm (2) from the vertical reference point relative to the base (1)” abst)
Regarding claim 23, Sahni teaches all the limitations of the claims except for the specifics of wherein the retaining bracket is pivotably mounted to a first retaining bracket pivot bearing and a second retaining bracket pivot bearing positioned on the base element, and the clamping bracket is pivotably mounted to a first clamping bracket pivot bearing and a second clamping bracket pivot bearing positioned on the base element.
However, in the same field of endeavor, Chiang teaches an apparatus (100) for guiding a surgical needle with improved accuracy. The apparatus (100) having a base (1) for positioning the apparatus (100) on a patient; a second arc member (6) attached to the base (1); a first arc member (4) moveably attached to the second arc member (6); an arm (2) attached to a needle guide support (3) at one end and moveably attached to the first arc member (4) at a distal end, and an angle marking device (7) attached to the arm (2) to indicate a vertical reference point for measuring the angle of tilt of the arm (2) from the vertical reference point relative to the base (1). Wherein the first arc member (4) is configured to move on the second arc member (6) to facilitate movement of the needle guide support (3) in a cranio-caudal plane and the arm (2) is configured to move on the first arc member (4) to facilitate movement of the needle guide support (3) in an axial plane (abst as also can be seen in re-produced figs below).
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with retaining bracket is pivotably mounted to a first retaining bracket pivot bearing and a second retaining bracket pivot bearing positioned on the base element, and the clamping bracket is pivotably mounted to a first clamping bracket pivot bearing and a second clamping bracket pivot bearing positioned on the base element as taught by Chiang because there is a need for a cost effective and less intrusive diagnostic apparatus whereby the angle of entry of a needle can be configured on the apparatus after placement on the body of a patient. ([0007] of Chiang).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sahni in view of Chiang and further in view of Daum (US 20030055436 A1).
Regarding claim 7, The above noted combination teaches all the claimed limitations except for an annular operating element with an inner cavity, wherein at least part of the needle-guiding element extends through the inner cavity.
However, in the same field of endeavor, Daum teaches as shown in FIG. 4 an angle measurement between instrument insertion channel and device [0009]. Instrument insertion channel 10 and the adjustment of the device 3 (i.e., annular operating element with an inner cavity, wherein at least part of the needle-guiding element extends through the inner cavity).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with an annular operating element with an inner cavity, wherein at least part of the needle-guiding element extends through the inner cavity as taught by Daum because it ensures a minimally-invasive approach to the brain through a hole in the top of the patient (abst of Daum).
Allowable Subject Matter
Claim 24 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.
Response to Arguments
Applicant’s arguments 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.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797