1. This action aligns with the PCT Written Opinion cited in the IDS, with updates.
2. Claim 28 is objected to because of the following informalities: “The method of claim 25” should be ---The surgical drilling device of claim 25--- to correct a minor typographical error.
Appropriate correction is required.
3. 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, 3-4, 6-8, 10-12, 15-18, 20-21, 23-25, 27-28, 30-35, 37-39, and 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brett et al. (US 2011/0020084; “Brett” herein).
Regarding claim 1, Brett discloses a surgical drilling device (e.g. 1) comprising: a drill bit (e.g. 10) having a cutting surface, wherein at least a portion of the cutting surface is configured to remain in contact with a tissue of a patient when in operation; a drill motor (e.g. 64) operably coupled to the drill bit, wherein the drill motor is configured to generate a parameter when in operation (e.g. para. [0091]), and wherein the parameter is associated with the cutting surface; and a sensing element (e.g. para. [0096], line 11) configured to detect the parameter, wherein, when the parameter detected by the sensing element meets or exceeds a triggering threshold, the drill motor is configured to slow, stop, and/or reverse and thereby slow, stop, and/or reverse rotation of the drill bit (e.g. para. [162]).
Regarding claim 3, the cutting surface is configured to cause an increase in the parameter when the drill bit penetrates through the tissue (e.g. last two sentences of para. [0106]).
Regarding claim 4, Brett discloses the cutting surface is configured to cause the parameter to meet or exceed the triggering threshold when the drill bit penetrates through the tissue (e.g. para. [0154]).
Regarding claim 6, Brett discloses the cutting surface includes a sidewall of the drill bit (e.g. Fig. 14).
Regarding claim 7, Brett discloses at least a portion of the sidewall (e.g. a portion slightly above distalmost tip near 10 in Fig. 14) is configured to maintain contact with the tissue after the drill bit has penetrated through the tissue.
Regarding claim 8, Brett discloses the sidewall is tapered (e.g. slightly above where 10 points in Fig. 14) relative to a longitudinal axis of the drill bit.
Regarding claim 10, Brett discloses the drill bit further includes a cutting tip (e.g. sharp cutting tip at the bottom of 10 in Fig 14) at a distal end of the drill bit, wherein the sidewall extends proximally from the cutting tip.
Regarding claim 11, Brett discloses the sidewall is angled radially outward and in a proximal direction from the cutting tip (e.g. the sidewall angles radially outward and upward/proximally from sharp tip in Fig. 14).
Regarding claim 12, Brett discloses the triggering threshold includes a value of the parameter associated with penetration of the cutting tip through the tissue (e.g. para. [0166]).
Regarding claim 15, Brett discloses the sensing element includes an analog-to-digital converter (e.g. high-level controller 33 receives torque information from the drill motor driver via A/D converter 53; para [0099]).
Regarding claim 16, Brett discloses the parameter includes a drill motor current (e.g. motor current feedback from drill drive motor 64; para [0091]).
Regarding claim 17, Brett discloses the parameter is a first parameter and the triggering threshold is a first triggering threshold, and wherein the drill motor is configured to (i) generate a second parameter when in operation and (ii) slow, stop, and/or reverse to thereby inhibit slow, stop, and/or reverse the rotation of the drill bit when the second parameter meets or exceeds a second triggering threshold (e.g. at least two parameters and respective thresholds are monitored to determine of onset of breakout, and said onset ceases drill rotation; e.g. [0154], [0162]).
Regarding claim 32, Brett discloses control electronics operably coupled to the sensing element and configured to filter data detected via the sensing element and associated with the parameter (e.g. controller 33 receives force information from a force sensor in drill unit 1 via a low pass filter 50; para. [0099]).
Regarding claim 33, Brett discloses the control electronics comprise a low-pass filter (e.g. controller 33 receives force information from a force sensor in drill unit 1 via a low pass filter 50; para. [0099]).
Regarding claim 34, Brett discloses a processor (e.g. 33) operably coupled to the drill motor and the sensing element, wherein the processor is configured to: receive data from the sensing element associated with the parameter, filter the received data, and when the filtered data indicates that the parameter meets or exceeds the triggering threshold, cause the drill motor to slow, stop, and/or reverse (e.g. filtering and onset of breakout detection in para. [0099]).
Regarding claim 35, Brett discloses the tissue includes bone tissue of the patient and wherein at least a portion of the cutting surface is configured to remain in contact with the bone tissue when in operation (e.g. para. [0070]).
Regarding claim 18, Brett discloses one or more non-transitory computer readable media having instructions stored thereon (e.g. Fig. 2) that, when executed by one or more processors of a drilling system, cause the drilling system to perform operations comprising: providing power to a drill motor (e.g. 64) to cause rotation of a drill bit (e.g. 10) of the drilling system, wherein the drill bit includes a cutting surface, and wherein at least a portion of the cutting surface is configured to contact a tissue of a patient when in operation; determining, via a sensing element (e.g. para. [0096]) of the drilling system, a parameter of the drill motor including a drill motor torque, wherein the parameter corresponds to a shape of the cutting surface (e.g. torque detected corresponds to shape); and when the parameter meets or exceeds a triggering threshold, causing the drill motor to slow, stop, and/or reverse the rotation of the drill bit (e.g. para. [162]).
Regarding claim 20, Brett discloses causing, based at least in part on contact between the cutting surface and the tissue at or near penetration of the drill bit through the tissue, an increase in the parameter when the drill bit penetrates through the tissue (e.g. rising torque at the onset of breakout; para. [0156]).
Regarding claim 21, Brett discloses causing, based at least in part on contact between the cutting surface and the tissue, the parameter to meet or exceed the triggering threshold when the drill bit penetrates through the tissue (e.g. last line of para. [0154]).
Regarding claim 23, Brett discloses the triggering threshold includes a value of the parameter associated with penetration of the drill bit through the tissue, and wherein causing the drill motor to slow, stop, and/or reverse the rotation of the drill bit includes causing the drill motor to stop the rotation of the drill bit when the parameter meets or exceeds the value (e.g. when onset of breakout is detected, rotation of the drill ceases; para. [0162]).
Regarding claim 24, Brett discloses the parameter is a first parameter and the triggering threshold is a first triggering threshold, and wherein the instructions are further configured to cause the drill motor to slow,stop, and/or reverse the rotation of the drill bit when a second parameter of the drill motor meets or exceeds a second triggering threshold (e.g. at least two parameters and respective thresholds are monitored to determine of onset of breakout and detection of onset of breakout ceases drill rotation; e.g. [0154], [0162]).
Regarding claim 37, Brett discloses determining the parameter comprises: obtaining, via the sensing element, data associated with the parameter, and filtering the data (e.g. torque information received via low pass filter 50; para. [0099]); and the operations further comprise comparing the filtered data to the triggering threshold (e.g. comparisons according to para. [0155]).
Regarding claim 38, Brett discloses filtering the data includes low-pass filtering the data (e.g. para. [0099]).
Regarding claim 39, Brett discloses the tissue includes bone tissue of the patient and wherein at least a portion of the cutting surface is configured to remain in contact with the bone tissue when in operation (e.g. para. [0070]).
Regarding claim 25, Brett discloses a method of operating a surgical drilling device, comprising: providing power to a drill motor (e.g. 64) to cause rotation of a drill bit (e.g. 10) of the surgical drilling device, wherein the drill bit includes a cutting surface, and wherein at least a portion of the cutting surface is configured to contact a tissue of a patient when in operation; determining, via a sensing element (e.g. para. [0096]) of the surgical drilling device, a parameter of the drill motor, wherein the parameter corresponds to a shape of the cutting surface; and when the parameter meets or exceeds a triggering threshold, causing the drill motor to slow, stop, and/or reverse the rotation of the drill bit (e.g. para. [0162]).
Regarding claim 27, Brett discloses causing the drill motor to slow, stop, and/or reverse includes causing the drill motor to slow, stop, and/or reverse based at least in part on an increase in the parameter when the drill bit penetrates through the tissue (e.g. rising torque at the onset of breakout; para. [0156]).
Regarding claim 28, Brett discloses causing, based at least in part on contact between the cutting surface and the tissue, the parameter to meet or exceed the triggering threshold when the drill bit penetrates through the tissue (e.g. para. [0154]).
Regarding claim 30, Brett discloses the triggering threshold includes a value of the parameter associated with penetration of the drill bit through the tissue, and wherein causing the drill motor to slow, stop, and/or reverse the rotation of the drill bit includes causing the drill motor to slow, stop, and/or reverse the rotation of the drill bit when the parameter meets or exceeds the value (e.g. when onset of breakout is detected, rotation of the drill ceases; para. [0162]).
Regarding claim 31, Brett discloses the parameter is a first parameter and the triggering threshold is a first triggering threshold, and wherein the method further comprises causing the drill motor to slow, stop, and/or reverse the rotation of the drill bit when a second parameter of the drill motor meets or exceeds a second triggering threshold (e.g. at least two parameters and respective thresholds are monitored to determine of onset of breakout and detection of onset of breakout ceases drill rotation; e.g. [0154], [0162]).
Regarding claim 41, Brett discloses determining the parameter comprises: obtaining, via the sensing element, data associated with the parameter, and filtering the data (e.g. torque information received via low pass filter 50; para. [0099]); and the method further comprises comparing the filtered data to the triggering threshold (e.g. comparing according to para. [0155]).
Regarding claim 42, Brett discloses filtering the data includes low-pass filtering the data (para. [0099]).
Regarding claim 43, Brett discloses the tissue includes bone tissue of the patient and wherein at least a portion of the cutting surface is configured to remain in contact with the bone tissue when in operation (e.g. para. [0070]).
4. 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.
Claims 2, 5, 19, 22, 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Brett, as above, in view of Pfotenhauer et al. (US 2020/0054410; “Pfotenhauer” herein).
Regarding claim 2, Brett discloses a sensor may detect current drawn by the drill motor when in operation (para. [0069]) but it may be unclear whether Brett discloses the parameter includes a second derivative of current drawn by the drill motor when in operation. Pfotenhauer discloses a calculation of second derivative in the context of a bone drill (e.g. [0064]). It is considered obvious to have combined calculating a second derivative of Pfotenhauer to current detection per Brett to further optimize control of the drill through data analysis.
Regarding claim 5, Brett discloses the cutting surface includes a tapered sidewall (e.g. slightly above 10 in Fig. 14), wherein the drill bit further includes a cutting tip (e.g. bottom-most portion of 10), a sensor may detect current drawn by the drill motor when in operation (para. [0069]), and control of the drill using a parameter and a triggering threshold (e.g. [0162]). Brett may not clearly disclose an acceleration of current drawn by the drill motor when in operation, and wherein the tapered sidewall is configured to cause the acceleration of current to meet or exceed the triggering threshold at or after penetration of the cutting tip through the tissue. Pfotenhauer discloses a powered device may be capable of determining torque by reading current ([0008]) and calculation of second derivative of current (e.g. [0064]). It is considered obvious to have combined the teaching of reading current and calculation of second derivative of current to the parameter and triggering threshold of Pfotenhauer, in order to optimize operation of the drill through data analysis.
Regarding claim 19, Brett discloses a sensor may detect current drawn by the drill motor when in operation (para. [0069]) it is unclear if Brett discloses determining the parameter includes determining a second derivative of the drill motor current. Pfotenhauer discloses a calculation of second derivative in the context of a bone drill (e.g. [0064]). It is considered obvious to have combined calculating a second derivative of Pfotenhauer to current detection per Brett as such would have facilitated further optimizing control of the drill through data analysis.
Regarding claim 22, Brett discloses the cutting surface includes a tapered sidewall (e.g. slightly above 10 in Fig. 14), wherein the drill bit further includes a cutting tip (e.g. bottom-most portion of 10), a sensor may detect current drawn by the drill motor when in operation (para. [0069]), and control of the drill using a parameter and a triggering threshold (e.g. [0162]). Brett may not clearly disclose an acceleration of current drawn by the drill motor when in operation, and wherein the tapered sidewall is configured to cause the acceleration of current to meet or exceed the triggering threshold at or after penetration of the cutting tip through the tissue. Pfotenhauer discloses a powered device may be capable of determining torque by reading current ([0008]) and calculation of second derivative of current (e.g. [0064]). It is considered obvious to have combined the teaching of reading current and calculation of second derivative of current to the parameter and triggering threshold of Pfotenhauer, in order to provide additional data for optimizing operation of the drill through data analysis.
Regarding claim 26, Brett discloses a sensor determines current drawn by the drill motor when in operation (para. [0069]) but it may be unclear whether Brett discloses the parameter includes a second derivative of current drawn by the drill motor when in operation. Pfotenhauer discloses a calculation of second derivative in the context of a bone drill (e.g. [0064]). It is considered obvious to have combined calculating a second derivative of Pfotenhauer to current determination per Brett as such would have facilitated further optimizing control of the drill through data analysis.
Regarding claim 29, Brett discloses the cutting surface includes a tapered sidewall (e.g. slightly above 10 in Fig. 14), wherein the drill bit further includes a cutting tip (e.g. bottom-most portion of 10), a sensor detect current drawn by the drill motor when in operation (para. [0069]), and control of the drill using a parameter and a triggering threshold (e.g. [0162]). Brett may not clearly disclose causing an acceleration of current drawn by the drill motor when in operation, and wherein the tapered sidewall is configured to cause the acceleration of current to meet or exceed the triggering threshold at or after penetration of the cutting tip through the tissue. Pfotenhauer discloses a powered device may be capable of determining torque by reading current ([0008]) and calculation of second derivative of current (e.g. [0064]). It is considered obvious to have combined the teaching of reading current and calculation of second derivative of current to the parameter and triggering threshold of Pfotenhauer, in order to provide additional data for optimizing operation of the drill through data analysis.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Brett, as above, in view of Meyer (US 4936721; “Meyer” herein).
Meyer does not clearly disclose the sidewall is at an angle of between about 1 degree and about 15 degrees relative to a longitudinal axis of the drill bit. Meyer discloses a drill/reamer with a sidewall 52 having an angle relative to longitudinal axis of between 5 degrees and 15 degrees (e.g. col. 3, lines 45-48). It is considered obvious to have combined the teaching of a sidewall having an angle relative to longitudinal axis of between 5 degrees and 15 degrees per Meyer to the angle of the sidewall of Brett in order to provide an angle suitable for forming a hole in a substrate. Discovery of optimal or suitable ranges is not inventive.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Brett, as above, in view of Bjorn et al. (US 2017/0202560; “Bjorn” herein).
Regarding claims 13-14, Bjorn does not disclose the drill bit further includes a flute extending in a direction parallel to a longitudinal axis of the drill bit; and the flute has a linear shape. Bjorn discloses flutes (e.g. 321, 322) that extend in a direction parallel to a longitudinal axis of a drill bit (e.g. Fig. 4A) with a straight shape for improved transport of shavings (e.g. para. [0021]). It is considered obvious to have combined the teaching of flutes (e.g. 321, 322) parallel to a longitudinal axis of a drill bit per Bjorn to the drill bit of Brett in order to improve transport of shavings.
5. Claim 36 and 40 are 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.
6. The following is an examiner’s statement of reasons for the indication of allowable subject matter: The claims distinguish over closest prior art cited in the 892. In an exemplary prior art reference, Brett discloses a method/apparatus involving a controller (e.g. 33), a drill bit (e.g. 10), and a torque sensor (e.g. para. [0096]), but fails to disclose at least determining a second derivative by obtaining multiple drill motor current values during a drilling procedure; determining a first derivative of the multiple drill motor current values by obtaining a difference between individual ones of the multiple drill motor current values; and determining the second derivative of the drill motor current by obtaining a difference between individual ones of the first derivative of the multiple drill motor current values as claimed. There would have been no obvious reason(s) to modify the Brett reference to satisfy at least this/these and/or each of applicant’s claimed limitations without the use of impermissible hindsight reasoning. 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.”
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN A. SEVILLA whose telephone number is (571)270-5621. The examiner can normally be reached on Monday through Thursday, 8:00 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIAN A SEVILLA/ Primary Examiner, Art Unit 3775