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 . 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 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.
Newly submitted claim 34 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Noting the distinct differences between claim 7, and claim 34, in that the specifics surrounding the display, torques and first/second axis relating to medio-lateral torque component and the anterior- posterior torque components and the new limitations further provide specifics relating to motor speeds and processor configurations of torque thresholds.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 34-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7,10,13,15,16,26-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7, 31, the phrase “medio-lateral torque component and the anterior- posterior torque component” are unclear. It is unclear how the specifics of the components differ from a “torque component” and it is unclear what can and cannot be considered “medio-lateral and anterior- posterior”. For the purposes of examination, all such limitations will be treated as only a torque component.
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.
Claims 7, 13, 15-16 and 26, 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Shenberger (U.S. Patent No. 7,691,106) in view of Kostrzewski (U.S. Patent Pub. No. 2015/0100066) in view of Iceman (U.S. Patent Pub.No. 2018/0296299) in view of Wixey (U.S. Patent No. 2019/0038371).
Regarding claim 7, Shenberger teaches a surgical cutting system comprising a surgical saw (5) including a sawblade (10) (Figure 9 and Abstract); a cut guide (100) including an elongated slot adapted to receive the sawblade wherein the sawblade performs a surgical cut (Figure 10 and Col. 13, Lines 45-49) using the cut guide; and a sensor (12) positioned on the sawblade (Figures 2 and 4) the sensor to detect force on the sawblade by the cut guide during the surgical cut (Figure 9 and Col. 13, Lines 19-25); a processor (13) to control operation
Regarding claim 7, Shenberger does not provide wherein the sensor positioned on the cut guide.
Kostrzewski teaches it is old and well known in the art of surgical systems to incorporate a force sensor (602a, 602b, 602c) in a variety of positions, on a robot arm (604a-604c), between the robot arm and a tool guide (606a-606c) or on the tool guide to provide direct measurements of forces and torques on the tool (Paragraphs 0114-0115 and Figure 16).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the device of Shenberger to incorporate the teachings of Kostrzewski to provide an additional sensor in order to guide the device to the correct positioning to accurately measure force. In doing so, it allows for a variety of force measurements directly applied to the guide tool (Paragraph 0114).
Therefore, Shenberger in view of Kostrzewski provides a surgical cutting system comprising a surgical saw (5) including a sawblade (10) (Shenberger Figure 9 and Abstract); a cut guide (100) including an elongated slot adapted to receive the sawblade wherein the sawblade performs a surgical cut (Figure 10 and Col. 13, Lines 45-49) using the cut guide; and a sensor (602a-602c) positioned on the cut guide (Kostrzewski Paragraphs 0114-0115 and Figure 16) the sensor to detect torque on the sawblade by the cut guide during the surgical cut (Shenberger Figure 9 and Col. 13, Lines 19-25 and Kostrzewski Paragraphs 0114-0115 and Figure 16); a processor (13) to control operation of the surgical saw in response to signals from the sensor indicative of torque on the sawblade (Figures 9 and 10; Col. 13, Lines 12-23).
Regarding claim 7, Shenberger does not provide wherein the processor is further to determine whether the detected torque transgressed a threshold, and wherein to control operation of the surgical saw, the processor is to control operation of the surgical saw in response to determining that the detected torque transgressed the threshold.
Iceman provides wherein the processor is further to determine whether the detected force transgressed a threshold (Paragraphs 0052-0054), and wherein to control operation of the surgical instrument, the processor is to control operation of the surgical instrument in response to determining that the detected force transgressed the threshold (Figures 1 and 2A; Paragraphs 0052-0055).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have further modified the device of Shenberger to incorporate the teachings of Iceman to provide a control threshold. Doing so provides proper guidance and alerts a user to reduce unnecessary damage during use.
Therefore, the modified device of Shenberger in view of Iceman provides wherein the processor is further to determine whether the detected torque transgressed a threshold (Iceman Paragraphs 0052-0055), and wherein to control operation of the surgical saw (Shenberger Figure 9), the processor is to control operation of the surgical saw in response to determining that the detected torque transgressed the threshold.
Regarding claim 7, Shenberger does not provide wherein the processor is further configured to: determining whether the detected torque transgressed a first threshold or a second threshold, wherein the first threshold is within the second threshold; control operation of the surgical saw based on which threshold was transgressed, wherein: transgressing the first threshold causes the processor to slow the sawblade; and transgressing the second threshold causes the processor to cease operation of the sawblade; and generate for display on a display screen a two-dimensional torque map showing a representation of the detected torque the two-dimensional torque map including: a first axis corresponding to a medio-lateral torque component; and a second axis corresponding to an anterior-posterior torque component.
Wixey teaches it is known in the art of surgical systems (Abstract) to incorporate a computer assisted program for surgical (and non-surgical) equipment (130) (Paragraph 0025) to incorporate a device (110) coupled to a control unit (140) controlled by a processor (150) and utilizing memory (160) for storing programs.applications including positions, motion, force, torque amd other sensor information (Paragraphs 0028-0031; Examiner notes the tool may be a cutting surgical cutting instruments);
wherein the processor is further configured to: determining whether the detected torque transgressed a first threshold or a second threshold (paragraph 0061-0063), wherein the first threshold is within the second threshold; control operation of the surgical device based on which threshold was transgressed, wherein: transgressing the first threshold causes the processor to slow the surgical tool; and transgressing the second threshold causes the processor to cease operation of the surgical tool (Paragraphs 0067-0075); and generate for display (Paragraph 0049) on a display screen a two-dimensional torque map showing a representation of the detected torque the two-dimensional torque map (Paragraph 0077)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the device of Shenberger to incorporate the teachings of Wixey to provide a detailed computer aid for further control during operation. In doing so, it allows for smoother operation during use (Paragraph 0044).
The modified device Shenberger in view of Wixey does not specifically provide the torque map displaying a first axis corresponding to a medio-lateral torque component; and a second axis corresponding to an anterior-posterior torque component.
The modified device Shenberger in view of Wixey discloses the invention essentially as claimed as discussed above and Shenberger, Iceman and Wixey disclose displays, and torque maps as noted above.
However, Shenberger does not expressly disclose the torque map displaying a first axis corresponding to a medio-lateral torque component; and a second axis corresponding to an anterior-posterior torque component.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shenberger to have a variety of data points laid out in a visual representation in an effort to improve overall performance and operation of the device. In the instant case, the modified device of Shenberger would not operate differently with the claimed data representation since the surgical instruments include displays capable of overlaying the data and include sensors capable of sensing the torque components required and the device would function appropriately having the claimed data. Further, applicant places no criticality on the data points claimed, indicating simply that the claimed torque values are displayed.
Regarding claim 26, Shenberger teaches surgical cutting system comprising:
a surgical saw (5) including a sawblade (10) (Figure 9 and Abstract);
a cut guide (100) including an elongated slot adapted to receive the sawblade, wherein the sawblade performs a surgical cut using the cut guide (Figure 10 and Col. 13, Lines 45-49);
a sensor (12) positioned on the saw blade, the sensor to detect torque on the sawblade by the cut guide during the surgical cut; a display screen; and a processor (13)configured to control operations (Figures 9 and 10; Col. 13, Lines 12-23).
Shenberger does not provide wherein the sensor positioned on the cut guide.
Kostrzewski teaches it is old and well known in the art of surgical systems to incorporate a force sensor (602a, 602b, 602c) in a variety of positions, on a robot arm (604a-604c), between the robot arm and a tool guide (606a-606c) or on the tool guide to provide direct measurements of forces and torques on the tool (Paragraphs 0114-0115 and Figure 16).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the device of Shenberger to incorporate the teachings of Kostrzewski to provide an additional sensor in order to guide the device to the correct positioning to accurately measure force. In doing so, it allows for a variety of force measurements directly applied to the guide tool (Paragraph 0114).
Shenberger does not provide wherein the processor is further to determine whether the detected torque transgressed a threshold, and wherein to control operation of the surgical saw, the processor is to control operation of the surgical saw in response to determining that the detected torque transgressed the threshold.
Iceman provides wherein the processor is further to determine whether the detected force transgressed a threshold (Paragraphs 0052-0054), and wherein to control operation of the surgical instrument, the processor is to control operation of the surgical instrument in response to determining that the detected force transgressed the threshold (Figures 1 and 2A; Paragraphs 0052-0055).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have further modified the device of Shenberger to incorporate the teachings of Iceman to provide a control threshold. Doing so provides proper guidance and alerts a user to reduce unnecessary damage during use.
Therefore, the modified device of Shenberger in view of Iceman provides wherein the processor is further to determine whether the detected torque transgressed a threshold (Iceman Paragraphs 0052-0055), and wherein to control operation of the surgical saw (Shenberger Figure 9), the processor is to control operation of the surgical saw in response to determining that the detected torque transgressed the threshold.
Shenberger does not provide whether the detected torque transgressed a first threshold or a second threshold, wherein the second threshold represents a higher torque level than the first threshold; control operation of the surgical saw in response to determining that the detected torque transgressed at least one of the first threshold or the second threshold, wherein: transgressing the first threshold triggers the processor to reduce a speed of the sawblade; and transgressing the second threshold triggers the processor to cease operation of the sawblade; and generate for display on the display screen a directional indication showing a direction to move the surgical saw to decrease the detected torque.
Wixey teaches it is known in the art of surgical systems (Abstract) to incorporate a computer assisted program for surgical (and non-surgical) equipment (130) (Paragraph 0025) to incorporate a device (110) coupled to a control unit (140) controlled by a processor (150) and utilizing memory (160) for storing programs, applications including positions, motion, force, torque and other sensor information (Paragraphs 0028-0031; Examiner notes the tool may be a cutting surgical cutting instruments);
the detected torque transgressed a first threshold or a second threshold, wherein the second threshold represents a higher torque level than the first threshold; control operation of the surgical saw in response to determining that the detected torque transgressed at least one of the first threshold or the second threshold, wherein: transgressing the first threshold triggers the processor to reduce a speed of the sawblade; and transgressing the second threshold triggers the processor to cease operation of the sawblade; and generate for display on the display screen a directional indication showing a direction to move the surgical saw to decrease the detected torque (Paragraphs 0061,0063, 0067, 0075, 0049 and 0077).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the device of Shenberger to incorporate the teachings of Wixey to provide a detailed computer aid for further control during operation. In doing so, it allows for smoother operation during use (Paragraph 0044).
Regarding claim 28, the modified device of Shenberger teaches the surgical cutting system of claim wherein the sensor is one of an accelerometers, a force sensor, a pressure sensor, or a strain gauge (Col. 13, Lines 12-25; Noting the sensor is a force sensor).
Regarding claim 29, the modified device of Shenberger teaches he surgical cutting system of claim 26, wherein the surgical saw further comprises a feedback component to provide feedback indicative of the detected torque (Col. 13, Lines 12-25).
Regarding claim 30, the modified device of Shenberger teaches the surgical cutting system of claim29, wherein the feedback includes at least one of a visual indication, an auditory indication, or haptic feedback (Col. 13, Lines 12-25).
Regarding claim 31, the modified device of Shenberger teaches the surgical cutting system of claim 26, wherein the processor is further configured to: generate for display on the display screen a two-dimensional torque map showing a representation of the detected torque the two-dimensional torque map including (Wixey Paragraphs 0044, 0067-0077)
The modified device Shenberger in view of Wixey does not specifically provide the torque map displaying a first axis corresponding to a medio-lateral torque component; and a second axis corresponding to an anterior-posterior torque component.
The modified device Shenberger in view of Wixey discloses the invention essentially as claimed as discussed above and Shenberger, Iceman and Wixey disclose displays, and torque maps as noted above.
However, Shenberger does not expressly disclose the torque map displaying a first axis corresponding to a medio-lateral torque component; and a second axis corresponding to an anterior-posterior torque component.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shenberger to have a variety of data points laid out in a visual representation in an effort to improve overall performance and operation of the device. In the instant case, the modified device of Shenberger would not operate differently with the claimed data representation since the surgical instruments include displays capable of overlaying the data and include sensors capable of sensing the torque components required and the device would function appropriately having the claimed data. Further, applicant places no criticality on the data points claimed, indicating simply that the claimed torque values are displayed.
Regarding claim 32, the modified device of Shenberger teaches the surgical cutting system of claim 31, wherein displaying the two-dimensional torque map includes displaying graduated coloration based on torque level (Wixey Paragraph 0078).
Regarding claim 33, the modified device of Shenberger teaches the surgical cutting system of claim 32, wherein the graduated coloration varies from green to red (Wixey Paragraph 0078).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shenberger (U.S. Patent No. 7,691,106) in view of Kostrzewski (U.S. Patent Pub. No. 2015/0100066) in view of Iceman (U.S. Patent Pub.No. 2018/0296299) in view of Wixey (U.S. Patent No. 2019/0038371) as applied to claim 7 above, and further in view of Haider (U.S. Patent No. 8,560,047).
Regarding claim 10 the modified device of Shenberger does not provide wherein to cause the sawblade to cease operation in response to determining that the detected torque transgressed the threshold and wherein to cause the sawblade to cease operation, the processor is to cause a motor to stop the saw blade.
Haider teaches it is known in the art of surgical systems to provide wherein to control operation of the surgical saw includes to cause the sawblade to cease operation in response to determining that the detected torque transgressed the threshold (Col. 4, Lines 16-25) and wherein to cause the sawblade to cease operation, the processor is to cause a motor to stop the saw blade (Col. 1 Lines 65-67 and Col. 2, Lines 1-5; Col. 4, Lines 16-25; Examiner notes the device/motor is turned off).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have further modified the device of Shenberger to incorporate the teachings of Haider to provide a motor shutoff operation. Doing so prevents unnecessary damage during use (Col. 4, Lines 24-25).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Shenberger (U.S. Patent No. 7,691,106) in view of Kostrzewski (U.S. Patent Pub. No. 2015/0100066) in view of Iceman (U.S. Patent Pub.No. 2018/0296299) in view of Wixey (U.S. Patent No. 2019/0038371) as applied to claim 7 above, and further in view of Haider (U.S. Patent No. 8,560,047).
Regarding claim 27 the modified device of Shenberger does not provide, wherein to cease operation of the sawblade, the processor is to cause a guard to block the sawblade or cause a motor to stop the sawblade.
Haider teaches it is known in the art of surgical systems to provide wherein to control operation of the surgical saw includes to cause the sawblade to cease operation in response to determining that the detected torque transgressed the threshold (Col. 4, Lines 16-25) and wherein to cause the sawblade to cease operation, the processor is to cause a motor to stop the saw blade (Col. 1 Lines 65-67 and Col. 2, Lines 1-5; Col. 4, Lines 16-25; Examiner notes the device/motor is turned off).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have further modified the device of Shenberger to incorporate the teachings of Haider to provide a motor shutoff operation. Doing so prevents unnecessary damage during use (Col. 4, Lines 24-25).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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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/RICHARD D CROSBY JR/ 02/02/2023Examiner, Art Unit 3724 /BOYER D ASHLEY/ Supervisory Patent Examiner, Art Unit 3724