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 .
Restriction
Applicant’s election of species dated 11/25/2025 has been acknowledged and is made final. Claims 13 and 10 are withdrawn from consideration. Further, claims 16-18, 20 are withdrawn from consideration for being generic to the non-elected species of claim 19.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-6, 9-12, 37, is/are rejected under 35 U.S.C. 102 as being anticipated by Siddiqui (US 20190366080).
Regarding claim 1, Siddiqui discloses powered surgical tool (FIG. 1) for a user to manipulate a desired tissue in surgical site within a patient, the powered surgical tool comprising:
a body including a main portion (FIG. 4, annotated) and a tissue manipulation portion (Tunneling member 30 provides tissue manipulation portion -tunneling shaft 31), the tissue manipulation portion being powerable (tunneling shaft 31 can be vibrated; subcutaneous tunneling tool 10 comprises a vibration mechanism; Para [0038]) and having a manipulation member (tunneling shaft 31) for manipulating the desired tissue, the body and the tissue manipulation portion being configured together so as to define an operative direction of the manipulation member relative to the surgical site (Tunneling member 30 define operative direction; FIG. 4), wherein the tissue manipulation member is powered and aligned in the operative direction to manipulate the desired tissue disposed along the operative direction (Tunneling shaft 31 can be vibrated to manipulate the tissue; Para [0038]); and
a projecting device (FIG.2, annotated) with an exit port (Converging lens 22; FIG. 4), the projecting device being powerable to emit an optical targeting marker (beam emitter 20; laser line 25; FIG.1-2; Para [0026]) from the exit port in a targeting direction (Direction along the laser; FIG. 4) onto the surgical site, the exit port being located on the body so that the targeting direction is operationally related to the operative direction (The operative direction is the direction of the laser. FIG. 2), wherein the optical targeting marker is visible to the user for providing information about at least one of a location and an orientation of the manipulation member (Direction of the laser provides the direction and orientation of the manipulation member 31; FIGS. 2,4) within the surgical site and for providing information about at least one of a location and an orientation of the operative direction within the surgical site (Laser 25 provides information about at least one of a location and an orientation of the operative direction of the member 31; second incision 102; FIGS. 2, 4, reproduced below).
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Regarding claim 2, Siddiqui discloses wherein the operative direction and the targeting direction are parallel (direction of incision and laser direction are parallel; Fig. 4).
Regarding claim 3, Siddiqui discloses wherein the body includes a central portion (Central portion of handle 11 ) and a distal end (distal end of handle 11) extending in a distal direction (direction towards the distal end from the handle 11) from the central portion, and wherein the operative direction and the targeting direction extend in the distal direction (Operative direction and targeting direction being along the laser direction, they extend in the distal direction. FIG. 4).
Regarding claim 4, Siddiqui discloses wherein the body includes a central portion and a distal end extending in a distal direction (direction of the handle towards the distal end.) from the central portion, and wherein the operative direction and the targeting direction extend in a lateral direction angled from the distal direction (laser beam emitter may adjustable to project a laser line that is aligned with the shape of the tunneling member 30 (which can be curved); Para [0030]; FIG. 1 Operative direction and the targeting direction extend in a lateral direction, i.e., they laterally extend in lateral direction. For example, when tunneling member 30 makes a curve, or vibrates, it extends in lateral direction).
Regarding claim 5, Siddiqui discloses wherein the lateral direction is perpendicular to the distal direction (Lateral direction is perpendicular to the distal direction.).
Regarding claim 6, Siddiqui discloses wherein the projecting device includes an electrically-powered light source (beam generator is configured to project a laser line toward the elongated shaft; para [0006]) and the exit port includes a lens (Converging lens 22; FIG. 4) for directing light from the electrically-powered light source in a beam in a targeting direction to form the optical targeting marker (FIG. 4).
Regarding claim 9, Siddiqui discloses wherein the exit port emits a light beam having parallel rays (The laser 25 has parallel rays; FIG. 2) so that a size of the optical targeting marker is substantially unchanged regardless of a distance between the exit port and the optical targeting marker within the surgical site (The target marker is pointed. FIG. 2).
Regarding claim 10, Siddiqui discloses wherein the optical targeting marker includes at least one point (Laser 25 provides at least one point.).
Regarding claim 11, Siddiqui discloses wherein the optical targeting marker includes at least one line (Laser 25 provides at least one line. FIG. 2).
Regarding claim 12, Siddiqui discloses wherein the optical targeting marker (laser 25) is sized relative to the manipulation member (tunneling shaft 31) so as to indicate the area within the surgical site that would be contacted by the manipulation member if moved in the operative direction to contact the desired tissue (As shown in FIG. 4, the laser 25 is sized to indicate the surgical site. Para [0035]).
Regarding claim 37, Siddiqui discloses wherein the manipulation member is one of a laser element, an ultrasonic element, an oscillating element (tunneling shaft 31 can be vibrated; subcutaneous tunneling tool 10 comprises a vibration mechanism; Para [0038), a rotary element, a thermal element, a radiofrequency element, an electrical element, an electromagnetic element, a magnetic element, a radiological element, a chemical element.
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) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Demers (US 20140336456).
Regarding claim 7, Siddiqui does not expressly disclose an optical unit remote from the tool, the electrically-powered light source being located in the optical unit.
Demers is directed to providing one or more improvements in a micro endoscope (abstract) and teaches an optical unit (An optical assembly 305; para [0075]) remote from the tool, the electrically-powered light source being located in the optical unit (Endoscope 300 also includes an optical assembly 305 which can provide illumination light to an illumination fiber 307 and can receive images from an image fiber 309 for imaging at the distal end of the probe. Para [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siddiqui to include optical unit in accordance with the teaching of Demers so that imaging could be done using fiber and displayed to a user.
Regarding claim 7, Siddiqui as modified teaches wherein the optical unit further includes a camera for receiving an image obtained of the surgical site (Demers: image fiber 309 for imaging at the distal end of the probe; para [0075]).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Hansen (US 20190053691).
Regarding claim 14, Siddiqui discloses wherein the exit port emits (laser emitter 21; FIG. 4; Para [0028]) a light beam.
Siddiqui does not expressly disclose wherein the tool includes a detector for electrooptical distancing to determine a distance between the exit port and the optical targeting marker within the surgical site.
Hansen is directed to laparoscopic tool system for minimally invasive surgery (abstract) and teaches wherein the tool includes a detector for electrooptical distancing to determine a distance between the exit port and the optical targeting marker within the surgical site (Time-of-flight camera set 124; The time-of-flight camera set emits light towards a surface area 125 and light is reflected back to the time-of-flight camera set for distance detection; FIG. 21 reproduced below; Para [0258]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siddiqui to include a distance detector in accordance with the teaching of Hansen so that a distance between the tool and surgical site could be identified and used during surgery.
Regarding claim 15, Siddiqui, as modified, teaches wherein the detector includes a camera (Hansen: camera set 124 is utilized for 3D images and shown on the monitor 109; FIGS. 19, 21; Para [0255]) within or connected to an optical receiver.
Claim(s) 21-28, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Hansen (US 20190053691).
Regarding claim 21, Siddiqui, as modified, teaches at least one imaging device (Hansen: Camera set 124 is utilized for 3D images and shown on the monitor 109; FIGS. 19, 21, reproduced below; Para [0255]) for obtaining an image of the surgical site.
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Regarding claim 22, Siddiqui, as modified, teaches wherein the at least one imaging device uses an optical receiver (Hansen: Camera set 124 uses light to image an area. It includes lens array 63 for collecting light. Para [0251]; The time-of-flight camera comprises an array of pixels for receiving the reflected light and based on the received pattern of light and on real time spatial position data obtained from said position tracking means 56, a real time 3D image may be determined. Para [0242]) attached to the body for obtaining the image of the surgical site.
Regarding claim 23, Siddiqui, as modified, teaches wherein the imaging device includes a camera (Camera set 124 uses light to image an area. It includes lens array 63 for collecting light. Para [0251]) for receiving the image from the optical receiver.
Regarding claim 24, Siddiqui, as modified, teaches wherein the camera is located in an optical unit remote from the tool (Hansen: Camera set 124 uses light to image an area. It includes lens array 63 for collecting light. Para [0251]; The unit is remote from the instrument 127; FIG. 21; Para [0258]).
Regarding claim 25, Siddiqui, as modified, teaches wherein the projecting device includes an electrically-powered light source (Laser 25; FIG. 4) and the exit port includes a lens (22) for directing light from the electrically-powered light source in a beam in a targeting direction to form the optical targeting marker, the electrically powered light source being located in the optical unit (FIG. 4).
Regarding claim 26, Siddiqui, as modified, teaches including a plurality of the exit ports (Siddiqui: Converging lens 22; FIG. 4) and a plurality of the optical receivers (Harsen: lens array 63 for collecting light. FIG. 15b; Para [0251]) distributed about the tool.
Regarding claim 27, Siddiqui, as modified, teaches wherein the at least one imaging device uses a plurality of the optical receivers (Hansen: Lens array 63 for collecting light. Para [0251]), the images obtained by the optical receiver devices being complimentary to each other (Hansen: Lens array light signal would be complementary to each other because of their positions. FIG. 21).
Regarding claim 28, Siddiqui, as modified, teaches wherein the optical receivers are spaced from each other on the body (Hansen: Lens array 63 are spaced for receiving 3D images. FIG. 21).
Regarding claim 30, Siddiqui, as modified, teaches wherein the at least one imaging device includes an optical receiver (Hansen: Lens array 63 are spaced for receiving 3D images. FIG. 21), and wherein the optical receiver is also the exit port of the projecting device (Hansen: FIG. 21).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Hansen (US 20170238962, “Hansen 962” herein after).
Regarding claim 29, Siddiqui does not expressly disclose wherein one of the imaging devices obtains an image including the optical targeting marker along the operative direction, and another of the imaging devices obtains an image directed differently from the operative direction.
Hansen 962 is directed to cannula assembly kit (abstract) and teaches wherein one of the imaging devices obtains an image including the optical targeting marker along the operative direction, and another of the imaging devices obtains an image directed differently from the operative direction (The minimally invasive surgery system comprises two or more cameras, such as at least one camera mounted to or integrated with the cannula and at least one camera mounted to or integrated with a scope. FIG. 5l; Para [0153]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siddiqui to include multiple cameras with the tool so that different area and direction could be imaged.
Claim(s) 32-36, is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Komp (US 20200188032).
Regarding claim 32, Siddiqui does not expressly disclose a display device for displaying an image providing the information about the at least one of the orientations of and the location of the manipulation member within the surgical site and for providing the information about the at least one of the locations and the orientation of the operative direction within the surgical site.
Komp is directed to system and method for enhanced surgical navigation (abstract) and teaches a display device (Graphical user interface 600a; FIGS. 6A-6B) for displaying an image providing the information about the at least one of the orientation of and the location of the manipulation member (surgical tool “ST”; surgical site “S”; Para [0059]) within the surgical site and for providing the information about the at least one of the location and the orientation of the operative direction within the surgical site (Graphical user interface 600a; FIG. 6A-6B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siddiqui to have displaying of the image in accordance with the teaching of Komp so that the location of the device could be seen by a user in the screen.
Regarding claim 33, Siddiqui, as modified, teaches wherein the image is a visual image of the surgical site (FIG. 6A-6B).
Regarding claim 34, Siddiqui, as modified, teaches wherein the image includes the optical targeting marker (FIG. 8B).
Regarding claim 35, Siddiqui, as modified, teaches wherein the image includes a representation of the location and the orientation of the manipulation member relative to the desired tissue (FIG. 8B).
Regarding claim 36, Siddiqui, as modified, teaches wherein the image is an augmented reality image (FIG. 8b; para [0004], [0063]).
Claim(s) 38, 39, 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Hansen (US 20170238962, “Hansen 962” herein after).
Regarding claim 38, Siddiqui discloses body includes a handle (FIG. 1).
Siddiqui does not expressly disclose wherein the body includes a handle and a shield, the shield being located adjacent the manipulation member of the tissue manipulation portion and configured to at least partially surround a first part of the manipulation member so that the first part is precluded from contact with the surgical site, the shield configured so that a second part of the manipulation member is exposed for use in manipulating the desired tissue within the surgical site.
Hansen 962 is directed to cannula assembly kit (abstract) and teaches wherein the body includes a shield, the shield (Cannula shaft portion 43; FIG. 5) being located adjacent the manipulation member (tip portion 48) of the tissue manipulation portion (tip portion 48; FIG. 5) and configured to at least partially surround a first part of the manipulation member so that the first part is precluded from contact with the surgical site, the shield configured so that a second part of the manipulation member is exposed (The part outside is exposed and the part inside is covered; FIG. 5; Para [0212]) for use in manipulating the desired tissue within the surgical site.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Siddiqui to include shield in accordance with the teaching of Hansen 962 so that manipulation portion could be covered to avoid unnecessary contamination and damage to the surgical area.
Regarding claim 39, Siddiqui, as modified, teaches wherein the exit port is located on the shield (Hansen 962: Projector 42 arranged for projecting a light pattern; para [0212]).
Regarding claim 41, Siddiqui, as modified, teaches wherein the projecting device is configured with two of the exit ports, one of the exit ports being located on the shield (projector 42; FIG. 5; para [0212]) and another of the exit ports being located on the body spaced from the shield (Siddiqui: Beam emitter 20; laser line 25; FIG.1-2; Para [0026]).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Hansen (US 20190053691) and further in view of Hansen (US 20170238962, “Hansen 962” herein after).
Regarding claim 42, Siddiqui does not expressly disclose an imaging device with at least two optical receivers attached to the body for obtaining the image of the surgical site, at least one of the optical receivers being located on the shield and at least another of the optical receivers being located on the body spaced from the shield.
Hansen teaches an imaging device with at least another of the optical receivers being located on the body spaced from the shield (Hansen: Time-of-flight camera set 124; The time-of-flight camera set emits light towards a surface area 125 and light is reflected back to the time-of-flight camera set for distance detection; FIG. 21; Para [0258]).
Hansen 962 teaches at least one of the optical receivers being located on the shield (Hansen 962: The camera may optionally be mounted at the distal end of the cannula arranged for monitoring reflected light. Para [0042], [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siddiqui to include optical receivers at different locations in accordance with the teaching of Hansen and Hansen 962 so that close and distance image of the site could be recorded for use.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui (US 20190366080) in view of Baker (US 20160324562).
Regarding claim 31, Siddiqui does not disclose positioning markings distributed on the body for identifying an orientation of the body by detecting positions of the positioning markings.
Baker is directed to an orthopedic driver instrument (abstract) and teaches positioning markings distributed on the body for identifying an orientation of the body by detecting positions of the positioning markings (indentations/depressions 34 dispersed along the length of the gripping portion 20 and about the circumferential periphery of the gripping portion 20; FIG. 4; Para [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siddiqui to include markers in accordance with the teaching of Siddiqui so that position or orientation of the handle or the body portion could be identified during surgery.
Allowable Subject Matter
Claim 40 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.
Claim 40
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination, a powered surgical tool for a user to manipulate a desired tissue in surgical site within a patient, wherein the at least a distal portion of the shield is located on the body distally relative to the manipulation member and the handle, and the exit port is located on the distal portion of the shield, along with the remaining features of claims 40, 39, 38 and 1.
The closest art Hansen (US 20170238962, “Hansen 962” herein after) could not be modified to have the shield located on the body distally relative to the manipulation member and the exit port located on the distal portion of the shield. Accordingly, claim 40 is allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO – 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached on 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 12/23/2025