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 . This action is in response to the set of claims received on July 18, 2025. Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chiang (US Publication 2017/0348010).
Regarding claim 8, Chiang discloses a cranial access drill (Figure 1) comprising: a motor(11, Figure 1); a drill bit (10, Figure 1) mechanically coupled to the motor [paragraph 0034], the drill bit being capable of puncturing a cranial drilling surface by drilling the cranial drilling surface with the drill bit using the motor (i.e., the device is capable of being guided by a guide-hub placed against the drilling surface); and a controller (20, Figure 1) electrically coupled to the motor, the controller being configured to detect an electrical parametric change at the motor that corresponds to puncturing the cranial drilling surface(i.e. the controller compares the instantaneous electrical signal with reference electrical signal, and if the instantaneous electrical signal has a step drop with respect to the reference electrical signal, the controller 20 will send a stop command to the motor 11 to stoop the operation of the motor [paragraph 0035]), the electrical parametric change comprising a voltage change at the motor, and deactivate the motor in response to detecting the electrical parametric change(i.e. the controller continues monitoring and obtaining an instantaneous electrical signal, wherein the electrical signal is represented by one including, but not limited to, a voltage [0035]).
Regarding claim 10, the modified Chiang’s drill discloses wherein the drill bit has a conical tip (Figure 6 depicts a conically tapered/pointed tip and drills through layers 30 and 32).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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 1-4, 6, 7, 11-13,15,16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang (US Publication 2017/0348010) in view of Ghahremani et al. (US Patent 6,206,885), hereinafter “Ghahremani”.
Regarding claim 1, Chiang discloses a cranial access drill (Figure 1) comprising: a motor (11, Figure 1); a drill bit (10, Figure 1) mechanically coupled to the motor [paragraph 0034], the drill bit being capable of puncturing a cranial drilling surface by guiding the drill bit into a guide-hub placed against the cranial drilling surface,(i.e., the device is capable of being guided by a guide-hub placed against the drilling surface); and a controller (20, Figure 1) electrically coupled to the motor, the controller being capable of detecting an electrical parametric change at the drill bit that corresponds to puncturing the cranial drilling surface, and deactivate the motor in response to detecting the electrical parametric change (i.e. the controller compares the instantaneous electrical signal with reference electrical signal, and if the instantaneous electrical signal has a step drop with respect to the reference electrical signal, the controller 20 will send a stop command to the motor 11 to stoop the operation of the motor [paragraph 0035]).
Chiang fails to disclose a guide-hub placed against the cranial drilling surface and comprising an axial direction and drilling the cranial drilling surface in the axial direction with the drill bit using the motor.
However, Ghahremani teaches a drilling guide-hub (10, Figure 1) placed against the cranial drilling surface (Col. 5, lines 1-5) comprising an axial direction and drilling the cranial drilling surface in the axial direction with the drill bit using the motor (i.e. along drill 50, Figure 9).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the drill of Chiang with a guide-hub as taught by Ghahremani in order to allow a neurosurgeon to more accurately place the drill and maintain the guide-hub in an accurate position relative to the hole in the cranium for catheter placement.
Regarding claim 2, the modified Chiang’s drill discloses wherein detecting the electrical parametric change at the drill bit comprises detecting an electrical parametric change at the motor (i.e., when the tip of the drill bit 10 drills through the bone, the voltage changes which changes an output of the motor 11 [paragraph 0038 of Chiang]).
Regarding claim 3, the modified Chiang’s drill discloses wherein the electrical parametric change at the motor is a voltage change at the motor corresponding to puncturing the cranial drilling surface (i.e. the controller continues monitoring and obtaining an instantaneous electrical signal, wherein the electrical signal is represented by one including, but not limited to, a voltage [0035 of Chiang]).
Regarding claim 4, the modified Chiang’s drill discloses wherein the electrical parametric change is a change in electrical properties of an electrical circuit comprising the drill bit, the cranial drilling surface, and the motor [0038 of Chiang].
Regarding claim 6, the modified Chiang’s drill discloses wherein the drill bit has a conical tip (Figure 6 depicts a conically tapered/pointed tip of Chiang).
Regarding claim 7, the modified Chiang’s drill discloses wherein the conical tip is a cutting tip (i.e. it drills through layers 30 and 32 of Chiang).
Regarding claim 11, Chiang discloses a cranial access drill (Figure 1) comprising: a motor(11, Figure 1); a drill bit (10, Figure 1)mechanically coupled to the motor[paragraph 0034], the drill bit capable of puncturing a cranial drilling surface by drilling the cranial drilling surface with the drill bit using the motor(i.e., the device is capable of being placed against the drilling surface); and a controller electrically coupled to the motor, the controller capable of detecting an electrical parametric change at the motor that corresponds to puncturing the cranial drilling surface, the electrical parametric change being a voltage change at the motor, and deactivate the motor in response to detecting the electrical parametric change(i.e. the controller compares the instantaneous electrical signal with reference electrical signal, and if the instantaneous electrical signal has a step drop with respect to the reference electrical signal, the controller 20 will send a stop command to the motor 11 to stoop the operation of the motor [paragraph 0035]).
Chiang fails to disclose a drilling alignment component configured to align the drill bit with a target drilling trajectory relative to the cranial drilling surface.
However, Ghahremani teaches a drilling alignment component (10, Figure 1) placed against the cranial drilling surface (Col. 5, lines 1-5) comprising an axial direction and drilling the cranial drilling surface in the axial direction with the drill bit using the motor (i.e. along drill 50, Figure 9).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the drill of Chiang with a drilling alignment component as taught by Ghahremani in order to allow a neurosurgeon to more accurately place the drill and maintain the drilling alignment component in an accurate position relative to the hole in the cranium for catheter placement.
Regarding claim 12, the modified Chiang’s drill discloses wherein the controller is a microcontroller capable of detecting the electrical parametric change [paragraph 0035 of Chiang].
Regarding claim 13, the modified Chiang’s drill discloses further comprising: a drill housing mechanically coupled to the drill bit, the microcontroller being disposed in the drill housing (i.e. as shown in Figure 1, 20 is located within the drilling housing of Chiang).
Regarding claim 15, the modified Chiang’s drill discloses wherein the drilling alignment component is a guide-hub (10, Figure 1 of Ghahremani) capable of being placed against the cranial drilling surface(Col. 5, lines 1-5 of Ghahremani).
Regarding claim 16, the modified Chiang’s drill discloses further comprising: a catheter guide (32, Figure 2) capable of being inserted into the guide-hub, the guide-hub capable of guiding a catheter (100, Figure 2) along a catheter trajectory (Col. 5, lines 34-50).
Regarding claim 19, the modified Chiang’s drill discloses wherein the drilling trajectory is within 10° of perpendicular to the cranial drilling surface [i.e., substantially 90 degrees of a drilling surface paragraph 0032 of Ghahremani].
Regarding claim 20, the modified Chiang’s drill discloses wherein the drilling trajectory is substantially perpendicular to the cranial drilling surface[i.e., substantially 90 degrees of a drilling surface paragraph 0032 of Ghahremani].
Claims 5, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang (US Publication 2017/0348010) in view of Ghahremani et al. (US Patent 6,206,885), hereinafter “Ghahremani”; further in view of Yedlicka et al. (US Patent 8,465,491), hereinafter “Yedlicka”.
Regarding claim 5, the modified Chiang’s drill fails to disclose a drill housing mechanically coupled to the drill bit, the controller being a microcontroller disposed in the drill housing; and a battery disposed in the drill housing.
However, Yedlicka teaches a drill housing(416, Figure 20) mechanically coupled to the drill bit (458, Figure 20), the controller (496, Figure 25) being a microcontroller disposed in the drill housing; and a battery (494, Figure 25) disposed in the drill housing.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the drill assembly of the modified Chiang’s drill with the drill assembly and components within it as taught by Yedlicka in order allow the operator to place an access conduit into the target area in a single step without various devices.
Regarding claim 9, the modified Chiang’s drill fails to disclose further comprising: a drill housing mechanically coupled to the drill bit, the controller being a microcontroller being disposed in the drill housing; and a battery disposed in the drill housing.
However, Yedlicka teaches a drill housing (416, Figure 20) mechanically coupled to the drill bit (458, Figure 20), the controller (496, Figure 25) being a microcontroller disposed in the drill housing; and a battery (494, Figure 25) disposed in the drill housing.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the drill assembly of the modified Chiang’s drill with the drill assembly and components within it as taught by Yedlicka in order allow the operator to place an access conduit into the target area in a single step without various devices.
Regarding claim 14, the modified Chiang’s drill fails to disclose a battery disposed in the drill housing.
However, Yedlicka teaches a drill housing (416, Figure 20) and a battery (494, Figure 25) disposed in the drill housing.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the drill assembly of the modified Chiang’s drill with a battery disposed in the drill housing as taught by Yedlicka in order to avoid various devices.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang (US Publication 2017/0348010) in view of Ghahremani et al. (US Patent 6,206,885), hereinafter “Ghahremani”; and further in view of Coleman et al. (GB 254262A).
Regarding claim 17, the modified Chiang’s drill fails to disclose wherein the drilling alignment component comprises a position sensor system comprising one or more accelerometers, gyroscopes, or combinations thereof.
Coleman, however, teaches a surgical-drill orientation using accelerometers and gyroscopes. The device component comprises a position sensor system (20, Figure 6) comprising one or more accelerometers (21, Figure 6), gyroscopes (22, Figure 6), or combinations thereof.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the Chiang’s drill with a position sensor comprising one or more accelerometers, gyroscopes, or combinations thereof as taught by Coleman in order to process data from the various position sensors in order to determine the absolute or relative orientation of the device.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang (US Publication 2017/0348010) in view of Ghahremani et al. (US Patent 6,206,885), hereinafter “Ghahremani”; and further in view of Nikou et al. (US Patent 8,961,536), hereinafter “Nikou”.
Regarding claim 18, the modified Chiang fails to disclose wherein the drilling alignment component comprises a position sensor system comprising infrared position tracking.
Nikou, however, teaches a surgical tool and kit, comprising a position sensor system comprising infrared position tracking (i.e., infrared camera 10, tracker 12A, and IR reflective markers 35).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the Chiang’s drill comprising an infrared position tracking as taught by Coleman in order to perform surgical navigation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
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