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 Preliminary Amendment
The preliminary amendment filed 05/08/2025 has been entered. Claims 23-42 are pending in the application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 23-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9737301 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. For example, claim 1 of patent 9737301 recites “sensing module to measure a characteristic of the cutting surface” that comprises a “optical sensor”, whereas current claim 23 recites “an optical sensor configured to measure an intensity of light reflected by the knife edge”, which is deemed to be equivalent and refers to the same thing. Further, patented claim 10 recites having a processor and “cutting surface sharpness testing module” of the tissue, such as “evaluate sharpness”, whereas current claim 23 recites a processor/control circuit analyzing the intensity detection and current claim 2 recites “monitor a sharpness of the knife edge” based on the measured intensity. These determinations basically refer to the same thing; i.e. the sharpness of a knife and controlling the knife based on detected sharpness. The above comparison equally applies to patented dependent claims 15-16 as to its similarity to current claims 23-42, in regards to the phraseology used and equally applies to current claims 23-42, in regards to the phraseology used. Generally, claims 1-5 and 10-11 of the patent set forth the equivalent subject matter of the claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the term “user interface” in claims 25, 33 and 35 is not found in the specification. Fig. 1 shows a plurality of interfaces between the handle assembly and the power assembly but it is not clear which interface is the “user interface”.
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 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)(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.
(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.
Claim(s) 23-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Overmyer et al. (US 20160066916 A1).
Regarding claims 23-24, 33-34, and 42, Overmyer et al. discloses a surgical instrument (10) comprising: an end effector (300/ 3150) comprising a first jaw and a second jaw to clamp tissue (306/198 [0188-0195, 0372, figs. 1-3, 20 and 74-75);
a knife/ firing beam (E-beam 178) comprising a knife/cutting edge (182), wherein the knife is advanceable along a firing path within the effector to cut the clamped tissue ([0229], figs. 1, 20, and 74-76);
a light source (1110) configured to emit light towards the knife edge and a portion of the firing path ([0374-0389], figs. 74-75 and 77-78);
a user interface (trigger 32 and/or controller 1112/microprocessor 1114/processor 4313, use indicator 2106, feedback system 1120 [0381], see spec objection above for unclarity of user interface, figs. 1 and 19-22);
an optical sensor (1108) configured to measure an intensity of light reflected by the knife/cutting edge ([0374-0398], figs. 74-78 and 88-89);
a control circuit (controller 1112/microprocessor 1114/processor 4313 and/or usage cycle circuit 2102 [0268]) configured to prevent an advancement of the knife based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold ([0382, 0424], figs. 88-89), wherein the control circuit is configured to monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge ([0374-0398, 0424], figs. 75-78 and 89) and the control circuit is configured to cause the user interface (controller 1112/microprocessor 1114/processor 4313, feedback system 1120 [0381], see spec objection above for unclarity of user interface) to provide a notification (alert/warn [0381, 0388, 0413-0424], figs. 75-78 and 88-89) associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold ([0374-0398, 0413-042], figs. 74-78 and 88-89).
Regarding claims 25, Overmyer et al. discloses a user interface (trigger 32 and/or controller 1112/microprocessor 1114/processor 4313, use indicator 2106, feedback system 1120 [0381], see spec objection above for unclarity of user interface, figs. 1 and 19-22), wherein the control circuit is configured to cause the user interface to provide an alert (alert/warn, “may inform the user that the sharpness of the cutting edge 182 is within an acceptable range” [0381, 0388, 0413-0424], figs. 75-78 and 88-89) based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold ([0374-0398, 0413-042], figs. 75-78 and 88-89).
Regarding claims 26, Overmyer et al. discloses a motor (4402, 4330 [0408-0414, 0428]) actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor ([0198, 0268, 0382, 0388, 0408-0414, 0418, 0421-0424, 0442], figs. 88-89). Also, the phrase “prevent advancement of the knife based on disabling an actuation of the motor” is result achieved without indicating/reciting the particular structure of how the “disabling” is performed/achieved. Is the knife also manually prevented from moving if motor disabled? If so, how is the knife prevented from adavacement?
Regarding claims 27 and 37, Overmyer et al. discloses a shaft assembly (200); an end effector (300/ 3150) coupled to the shaft assembly, wherein the end effector comprises comprising a first jaw and a second jaw (306/198 [0188-0195, 0372, figs. 1-3, 20 and 74), and; a firing drive (E-beam 178) extending along the shaft assembly, wherein the firing drive is actuatable to cause the advancement of the knife (182), wherein the knife is advanceable from an unfired position to a fired position, wherein the unfired position is located proximal to the staple cartridge when the staple cartridge is received in the first jaw, and wherein the fired position is located at a distal end of the first jaw ([0372-0398, 0413-042], figs. 1-3, 20, 74-78 and 88-89).
Regarding claims 35, Overmyer et al. discloses the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator (usage cycle circuit 2102 display, audible, 1120 visual feedback systems such as display screens, backlights, and/or LEDs, combinations of visual, audio, and/or tactile feedback systems and provides graph 4340, actions to take [0223, 0235, 0269, 0381, 0388, 0418-0419]) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold ([0388, 0413, 0415-0419, 0424], figs. 88-89).
Regarding claims 36, Overmyer et al. discloses a motor (4402, 4330 [0408-0414, 0428]) actuatable to cause the advancement of the knife ([0198, 0268, 0382, 0388, 0408-0414, 0418, 0421-0424, 0442], figs. 88-89), wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold ([0198, 0268, 0382, 0388, 0408-0414, 0418, 0421-0424, 0442], figs. 88-89).
Regarding claims 28-30 and 38-40, Overmyer et al. discloses the optical sensor (1108) is configured to measure the intensity of the light reflected by the knife edge when the knife is in the unfired position, wherein the optical sensor (1108) is configured to measure the intensity of the light reflected by the knife edge when the knife is in the fired position, wherein the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is between the unfired position and the fired position [0382-0401].
Regarding claim 31 and 41, Overmyer et al. discloses the light source (1110) comprises a first light source (1110) configured to emit first light towards a first lateral side of the knife edge, wherein the optical sensor comprises a first optical sensor configured to measure a first intensity of the first light reflected by the first lateral side of the knife edge, the surgical instrument further comprising: a second light source (1110) configured to emit second light towards a second lateral side of the knife edge; anda second optical sensor configured to measure a second intensity of the second light reflected by the second lateral side of the knife edge (4/tip 2, [0386-0398], figs. 74-81).
Regarding claim 32, Overmyer et al. discloses the light source (1110) comprises a fiber optic cable [0398].
Claim(s) 23-26 and 33-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kolchin (US 8915766 B1).
Regarding claims 23-24 and 33-34, Kolchin discloses a surgical instrument (200) comprising: a knife (202) comprising a knife edge (col. 6, lines 23-67, fig. 2A), wherein the knife is advanceable to cut tissue (functionality – capable of cutting tissue); a light source configured to emit light towards the knife edge (col. 9, lines 1-40);
a user interface (display 109/110);
an optical sensor (edge/optic sensor 203, col. 9, lines 12-41) configured to measure an intensity of light reflected by the knife edge (col. 17, lines 65-67, col. 18, lines 1-67);
a control circuit (100/101) configured to prevent an advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67 and prevents advancement if - needs very little sharpening, edge should be stropped if sharp, determines no sharpening necessary, col. 17, lines 25-67, col. 18, lines 47-67) based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, wherein the control circuit is configured to monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2) and the control circuit is configured to cause the user interface (109/110 - audio input and output devices, display images, col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Kolchin also discloses determining if knife is sharp to prevent advancement/sharpening process and states: “a sensor is able to indicate to the computing device 207 that a knife is being inserted or removed, the computing device 207 may determine that the knife 202 has not been removed since the last sharpening, and thus that no sharpening is necessary at all… emitter-receiver sensor, for instance, whose beam will be interrupted while a knife is in the holder, and may thus enable the sensor to indicate the presence or absence of the knife, and thus enable to computing device 207 to determine whether the knife 202 has been removed since the last sharpening” (col. 19, lines 1-17)
Regarding claims 25, Kolchin discloses a user interface (display 109/110), wherein the control circuit is configured to cause the user interface to provide an alert (degree of wear in the captured image, indicate type of sharpening - coarse grinding, honing or light grinding procedure, stropped, col. 3, lines 1-25, user interface 109/110 - audio input and output devices, display images, col. 5, lines 1-37) based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Regarding claims 26, Kolchin discloses a motor (col. 7, lines 40-67, col. 13, lines 1-3) actuatable to cause the advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67), wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor (computing device 207 may cease sharpening deemed disabling actuation of the motor since no actuated motorized movement if no sharpening necessary). Also, the phrase “prevent advancement of the knife based on disabling an actuation of the motor” is result achieved without indicating/reciting the particular structure of how the “disabling” is performed/achieved. Is the knife also manually prevented from moving if motor disabled? If so, how is the knife prevented from adavacement?
Regarding claims 35, Kolchin discloses the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator (user interface (109/110) provides audio input and output devices, display images (col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Regarding claims 36, Kolchin discloses a motor actuatable to cause the advancement of the knife (col. 7, lines 40-67, col. 13, lines 1-3), wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” which inherently would not actuate the advancement of the knife (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
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) 25-26 and 35-36 is/are rejected under 35 U.S.C. 103 as obvious over Kolchin (US 8915766 B1) alone.
Regarding claims 25, Kolchin discloses a user interface (display 109/110), wherein the control circuit is configured to cause the user interface to provide an alert (degree of wear in the captured image, indicate type of sharpening - coarse grinding, honing or light grinding procedure, stropped, col. 3, lines 1-25, user interface 109/110 - audio input and output devices, display images, col. 5, lines 1-37) based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
In the alternative, if it can be argued that Kolchin fails to disclose having a user interface, wherein the control circuit is configured to cause the user interface to provide an alert based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold -
Given the teachings of Kolchin of having a display, provide images, indicate type of sharpness needed with audio input and output devices- it 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 to modify the display/display and/or audio input and output devices with having a user interface, wherein the control circuit is configured to cause the user interface to provide an alert based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold, have guidance indicators, displaying indicator information including sharpness, and/or for feedback purposes as taught Kolchin.
Regarding claims 26, Kolchin discloses a motor (col. 7, lines 40-67, col. 13, lines 1-3) actuatable to cause the advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67), wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor (computing device 207 may cease sharpening deemed disabling actuation of the motor since no actuated motorized movement if no sharpening necessary). Also, the phrase “prevent advancement of the knife based on disabling an actuation of the motor” is result achieved without indicating/reciting the particular structure of how the “disabling” is performed/achieved. Is the knife also manually prevented from moving if motor disabled? If so, how is the knife prevented from advancement?
In the alternative, if it can be argued that Kolchin fails to disclose the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor-
Given the teachings of Kolchin of having a motor and detecting no sharpening necessary if knife has been sharpened - it 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 to modify the motor control to have the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor for safety purposes (locking the knife if motor fails), provide automated motor stop when knife is sharpening is complete, and/or for saving/conserving power when not being used.
Regarding claims 35, Kolchin discloses the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator (user interface (109/110) provides audio input and output devices, display images (col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
In the alternative, if it can be argued that Kolchin fails to disclose the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold -
Given the teachings of Kolchin to determine sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold and having a user interface that provides audio input and output and other audio input/output devices and display images - it 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 to modify the motor control to have the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold for safety purposes (prevent damage of over sharpening, reducing too material and etc.), provide notification that sharpening is complete, and/or for feedback purposes.
Regarding claims 36, Kolchin discloses a motor actuatable to cause the advancement of the knife (col. 7, lines 40-67, col. 13, lines 1-3), wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” which inherently would not actuate the advancement of the knife (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
In the alternative, if it can be argued that Kolchin fails to disclose a motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold -
Given the teachings of Kolchin of having a motor and detecting no sharpening necessary if knife has been sharpened - it 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 to modify the motor control to have the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold for safety purposes (stopping when knife is sharp to prevent damage), provide automated motor stop when knife is sharpening is complete, and/or for saving/conserving power when sharpening not necessary.
Claim(s) 23-30 and 32-40 is/are rejected under 35 U.S.C. 103 as obvious over TAKASHINO (EP 2526883 A1) in view of Zemlok et al. (US 20090114701 A1) and further in view of Kolchin (US 8915766 B1).
Regarding claims 23-24, 27, 33-34, and 37, TAKASHINO discloses: a surgical instrument (10/12) comprising: a knife (180) comprising a knife edge (180a), wherein the knife is advanceable to cut tissue ([0101-0111], figs. 12-16); a light source (sensor using light) configured to emit light towards the knife ([0111], figs. 12-16);
an optical sensor (185) configured to measure movement of the knife/regulation pin 42a ([0111], figs. 12-16);
a user interface (14/108/speaker 110);
a control circuit (14/102/132);
a shaft assembly (24); an end effector (26) coupled to the shaft assembly, wherein the end effector comprises comprising a first jaw and a second jaw (52/54, figs. 1-3 and 15), and; a firing drive (182) extending along the shaft assembly, wherein the firing drive is actuatable to cause the advancement of the knife (180), wherein the knife is advanceable from an unfired position to a fired position, wherein the unfired position is located proximal to the staple cartridge when the staple cartridge is received in the first jaw, and wherein the fired position is located at a distal end of the first jaw ([0101-0137], claim 1, figs. 12-16 and see figs. 17-24) and TAKASHINO discloses notifying when the knife has returned to home/original position ([0614], fig. 23).
TAKASHINO fails to explicitly disclose a light source configured to emit light towards the knife edge and the optical sensor configured to measure an intensity of light reflected by the knife edge, wherein the first jaw is configured to receive a staple cartridge and the control circuit is configured to prevent an advancement of the knife based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, wherein the control circuit is configured to cause the user interface to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge, wherein the control circuit is configured to monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge.
Zemlok et al. teaches surgical stapler (60) having an end effector (72/74) coupled to a shaft assembly (66/68), wherein the end effector comprises comprising a first jaw and a second jaw (72/74), a knife (54/102) comprising a knife edge (figs. 6-7), wherein the knife is advanceable to cut tissue (tissue section T [0033-0038]); a light source (insert 70/106, light rays are emitted from a face surface 104, and other light sources [0035-0044]) configured to emit light towards the knife edge ([0042-0043]), wherein the first jaw (72) is configured to receive a staple cartridge (62 [0035]) and teaches having user interface (64) with having switching mechanisms and electrical supplying means [0041].
Zemlok et al. states: “intensity of the light rays "R" emitted through windows 104 may be also utilized to give a general indication of the positioning of staple drivers 96 and 98 as well as the position of knife blade 102 within body portion 80 of cartridge insert 70 and/or the anvil member 74” [0042]
Kolchin teaches a surgical instrument (200) comprising: a knife (202) comprising a knife edge (col. 6, lines 23-67, fig. 2A), wherein the knife is advanceable to cut tissue; a light source configured to emit light towards the knife edge (col. 9, lines 1-40); an optical sensor (edge/optic sensor 203, col. 9, lines 12-41) configured to measure an intensity of light reflected by the knife edge (col. 17, lines 65-67, col. 18, lines 1-67);
a control circuit (100/101) configured to prevent an advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67 and prevents advancement if - needs very little sharpening, edge should be stropped if sharp, col. 17, lines 25-67, col. 18, lines 47-67) based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, wherein the control circuit is configured to monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2) and the control circuit is configured to cause the user interface (109/110 - audio input and output devices, display images, col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of TAKASHINO of having optical sensor with a light source configured to measure movement of a knife, it 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 to modify the light source to emit light towards the knife edge and the optical sensor configured to measure an intensity of light reflected by the knife edge, wherein the first jaw is configured to receive a staple cartridge and the control circuit is configured to prevent an advancement of the knife based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, wherein the control circuit is configured to cause the user interface to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge, wherein the control circuit is configured to monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge for safety purposes (ensure knife is properly sharpened), provide automated motor stop if the knife is not sharp enough, and/or for maintenance purposes (detecting knife needs replaced or sharpened).
Regarding claims 28-30 and 38-40, TAKASHINO teaches the light source (sensor using light) configured to emit light towards the knife and determine correct position of the knife ([0111], figs. 12-16).
TAKASHINO fails to disclose the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is in the unfired position, wherein the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is in the fired position, wherein the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is between the unfired position and the fired position.
Zemlok et al. teaches tracking the knife progress based on light reflected by the knife edge when the knife is in the unfired/fired and in between positions via windows 104 [0033-0043].
Kolchin teaches detecting the position of the knife in the holder, obtaining the edge length to sharpen and orienting the knife and grinders in correct location/orientation (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of TAKASHINO of having using the optical sensor to determine correct position of the knife, it 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 to modify the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is in the unfired position, wherein the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is in the fired position, wherein the optical sensor is configured to measure the intensity of the light reflected by the knife edge when the knife is between the unfired position and the fired position for continuous checking of knife sharpness prior/before, during, and after use, provide progress of the knife with sharpness, and/or for monitoring/feedback purposes as taught by Zemlok et al. and Kolchin.
Regarding claim 32, TAKASHINO teaches using fiber output and laser light (286, [0185]) but fails to disclose the light source comprises a fiber optic cable.
Kolchin teaches using a fiber optic cable for the communications interface 108 (col. 4, lines 11-30) and teaches using optic sensors and laser profile sensors and states: “edge sensor 203 may include a fiber-optic position sensor. The edge sensor may include an optical position sensor” (col. 9, lines 11-41).
Zemlok et al. teaches the light source comprises a fiber optic cable [0040].
Given the teachings of TAKASHINO of having using fiber output and laser light, it 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 to modify the light source to comprises a fiber optic cable for providing higher quality/brighter light, more efficient power to save on power consumption, provide immunity to electromagnetic interference, centralized light source and/or for lighter cable needs as taught by Kolchin and Zemlok et al.
Regarding claims 25, TAKASHINO fails to disclose having a user interface, wherein the control circuit is configured to cause the user interface to provide an alert based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold
Kolchin teaches a user interface (display 109/110), wherein the control circuit is configured to cause the user interface to provide an alert (degree of wear in the captured image, indicate type of sharpening - coarse grinding, honing or light grinding procedure, stropped, col. 3, lines 1-25, user interface 109/110 - audio input and output devices, display images, col. 5, lines 1-37) based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of Kolchin of having a display, provide images, indicate type of sharpness needed with audio input and output devices, it 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 to modify TAKASHINO’s display/display and/or audio input and output devices with having a user interface, wherein the control circuit is configured to cause the user interface to provide an alert based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold, have guidance indicators, displaying indicator information including sharpness, and/or for feedback purposes as taught Kolchin.
Regarding claims 26, TAKASHINO fails to disclose the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor.
Kolchin teaches a motor (col. 7, lines 40-67, col. 13, lines 1-3) actuatable to cause the advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67), wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor (computing device 207 may cease sharpening deemed disabling actuation of the motor since no actuated motorized movement if no sharpening necessary). Also, the phrase “prevent advancement of the knife based on disabling an actuation of the motor” is result achieved without indicating/reciting the particular structure of how the “disabling” is performed/achieved. Is the knife also manually prevented from moving if motor disabled? If so, how is the knife prevented from advancement?
Given the teachings of Kolchin of having a motor and detecting no sharpening necessary if knife has been sharpened, it 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 to modify TAKASHINO’s motor control to have the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor for safety purposes (locking the knife if motor fails), provide automated motor stop when knife is sharpening is complete, and/or for saving/conserving power when not being used.
Regarding claims 35, TAKASHINO fails to disclose the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold.
Kolchin teaches the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator (user interface (109/110) provides audio input and output devices, display images (col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of Kolchin to determine sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold and having a user interface that provides audio input and output and other audio input/output devices and display images, it 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 to modify TAKASHINO’s motor control to have the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold for safety purposes (prevent damage of over sharpening, reducing too material and etc.), provide notification that sharpening is complete, and/or for feedback purposes.
Regarding claims 36, TAKASHINO fails to disclose a motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold.
Kolchin teaches a motor actuatable to cause the advancement of the knife (col. 7, lines 40-67, col. 13, lines 1-3), wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” which inherently would not actuate the advancement of the knife (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of Kolchin of having a motor and detecting no sharpening necessary if knife has been sharpened - it 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 to modify TAKASHINO’s motor control to have the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold for safety purposes (stopping when knife is sharp to prevent damage), provide automated motor stop when knife is sharpening is complete, and/or for saving/conserving power when sharpening not necessary.
Claim(s) 23-26, 31-36, and 41-42 is/are rejected under 35 U.S.C. 103 as obvious over TAKASHINO (EP 2526883 A1) in view of HELLSTROM et al. (US 20140107496 A1) and further in view of Kolchin (US 8915766 B1).
Regarding claims 23-24, 31, 33-34, and 41-42, TAKASHINO discloses: a surgical instrument (10/12) comprising: a knife (180) comprising a knife edge (180a), wherein the knife is advanceable to cut tissue ([0101-0111], figs. 12-16); a light source (sensor using light) configured to emit light towards the knife ([0111], figs. 12-16);
an optical sensor (185- light sensor) configured to measure movement of the knife/regulation pin 42a ([0111], figs. 12-16);
a user interface (14/108/speaker 110);
a control circuit (14/102/132);
a shaft assembly (24); an end effector (26) coupled to the shaft assembly, wherein the end effector comprises comprising a first jaw and a second jaw (52/54, figs. 1-3 and 15), and; a firing drive (182) extending along the shaft assembly, wherein the firing drive is actuatable to cause the advancement of the knife (180), wherein the knife is advanceable from an unfired position to a fired position, wherein the unfired position is located proximal to the staple cartridge when the staple cartridge is received in the first jaw, and wherein the fired position is located at a distal end of the first jaw ([0101-0137], claim 1, figs. 12-16 and see figs. 17-24) and TAKASHINO discloses notifying when the knife has returned to home/original position ([0614], fig. 23).
TAKASHINO fails to explicitly disclose a light source configured to emit light towards the knife edge and the optical sensor configured to measure an intensity of light reflected by the knife edge, the control circuit configured to prevent an advancement of the knife based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, wherein the control circuit is configured to cause the user interface to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge, and wherein the light source comprises a first light source configured to emit first light towards a first lateral side of the knife edge, wherein the optical sensor comprises a first optical sensor configured to measure a first intensity of the first light reflected by the first lateral side of the knife edge, the surgical instrument further comprising: a second light source configured to emit second light towards a second lateral side of the knife edge; and a second optical sensor configured to measure a second intensity of the second light reflected by the second lateral side of the knife edge.
HELLSTROM et al. teaches a catheter (1) with a light source (5a, 5b) configured to emit light towards a camera and tip end (4/tip 2- light and radiant energy around the camera to provide light treatment rays 6a/6b into a patient and a visual image for “observation of the internal tissue” [0053-0079]), wherein the light source comprises a first light source (5a) configured to emit first light towards a first lateral side of the camera, wherein an optical sensor comprises a first optical sensor (lens of fiber optic and/or camera [0068, 0078-0082]) configured to measure a first intensity (reflected energy spectral analyzer [0010], energy control, radiant energy [0021, 0078-0079], spectral analysis, a color analysis, a texture analysis, or a fluorescence analysis [0082]) of the first light reflected by the first lateral side of the camera and tip end edge (4/tip 2), the surgical instrument further comprising: a second light source (5b) configured to emit second light towards a second lateral side of the camera and tip end (4/tip 2- light and radiant energy around the camera to provide light treatment rays 6a/6b into a patient and a visual image for “observation of the internal tissue” [0053-0079]); and a second optical sensor (lens of fiber optic and/or camera [0068, 0078-0082]) configured to measure a second intensity (reflected energy spectral analyzer [0010], energy control, radiant energy [0021, 0078-0079], spectral analysis, a color analysis, a texture analysis, or a fluorescence analysis [0082]) of the second light reflected by the second lateral side of the knife edge (4/tip 2, [0053-0082], claims 1-2).
Kolchin teaches a surgical instrument (200) comprising: a knife (202) comprising a knife edge (col. 6, lines 23-67, fig. 2A), wherein the knife is advanceable to cut tissue; a light source configured to emit light towards the knife edge (col. 9, lines 1-40); an optical sensor (edge/optic sensor 203, col. 9, lines 12-41) configured to measure an intensity of light reflected by the knife edge (col. 17, lines 65-67, col. 18, lines 1-67);
a control circuit (100/101) configured to prevent an advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67 and prevents advancement if - needs very little sharpening, edge should be stropped if sharp, col. 17, lines 25-67, col. 18, lines 47-67) based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold, wherein the control circuit is configured to monitor a sharpness of the knife edge based on the measured intensity of the light reflected by the knife edge (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2) and the control circuit is configured to cause the user interface (109/110 - audio input and output devices, display images, col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Regarding claim 32, TAKASHINO teaches using fiber output and laser light (286, [0185]) but fails to disclose the light source comprises a fiber optic cable.
Kolchin teaches using a fiber optic cable for the communications interface 108 (col. 4, lines 11-30) and teaches using optic sensors and laser profile sensors and states: “edge sensor 203 may include a fiber-optic position sensor. The edge sensor may include an optical position sensor” (col. 9, lines 11-41).
HELLSTROM et al. teaches the light source comprises a fiber optic cable (20/21, [0011-0015, 0081, 0087-0092], claims 4-5, figs. 6-9 and 16-18).
Given the teachings of TAKASHINO of having using fiber output and laser light, it 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 to modify the light source to comprises a fiber optic cable for providing higher quality/brighter light, more efficient power to save on power consumption, provide immunity to electromagnetic interference, centralized light source and/or for lighter cable needs as taught by Kolchin and HELLSTROM et al.
Regarding claims 25, TAKASHINO fails to disclose having a user interface, wherein the control circuit is configured to cause the user interface to provide an alert based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold
Kolchin teaches a user interface (display 109/110), wherein the control circuit is configured to cause the user interface to provide an alert (degree of wear in the captured image, indicate type of sharpening - coarse grinding, honing or light grinding procedure, stropped, col. 3, lines 1-25, user interface 109/110 - audio input and output devices, display images, col. 5, lines 1-37) based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of Kolchin of having a display, provide images, indicate type of sharpness needed with audio input and output devices, it 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 to modify TAKASHINO’s display/display and/or audio input and output devices with having a user interface, wherein the control circuit is configured to cause the user interface to provide an alert based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold, have guidance indicators, displaying indicator information including sharpness, and/or for feedback purposes as taught Kolchin.
Regarding claims 26, TAKASHINO fails to disclose the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor.
Kolchin teaches a motor (col. 7, lines 40-67, col. 13, lines 1-3) actuatable to cause the advancement of the knife (motive mechanism 206 moves both the knife and the grinder - “motive mechanism to move the first abrader and knife toward one another along a path between the knife and the first abrader” col. 2, lines 7-15, col. 14, lines 28-67), wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor (computing device 207 may cease sharpening deemed disabling actuation of the motor since no actuated motorized movement if no sharpening necessary). Also, the phrase “prevent advancement of the knife based on disabling an actuation of the motor” is result achieved without indicating/reciting the particular structure of how the “disabling” is performed/achieved. Is the knife also manually prevented from moving if motor disabled? If so, how is the knife prevented from advancement?
Given the teachings of Kolchin of having a motor and detecting no sharpening necessary if knife has been sharpened, it 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 to modify TAKASHINO’s motor control to have the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent advancement of the knife based on disabling an actuation of the motor for safety purposes (locking the knife if motor fails), provide automated motor stop when knife is sharpening is complete, and/or for saving/conserving power when not being used.
Regarding claims 35, TAKASHINO discloses notifying when the knife has returned to home/original position ([0614], fig. 23).
TAKASHINO fails to disclose the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator.
Kolchin teaches the notification associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator (user interface (109/110) provides audio input and output devices, display images (col. 5, lines 1-37) to provide a notification associated with a sharpness of the knife edge based on comparing the measured intensity of the light reflected by the knife edge to a light intensity threshold (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
HELLSTROM et al. teaches a catheter (1) has a camera (4) to provide visual indication ([0053-0079]).
Given the teachings of TAKASHINO of notifying when the knife has returned to home/original position, it 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 to modify TAKASHINO’s motor control to have the notification to also be associated with the sharpness of the knife edge provided by user interface comprises one or more of a visual indicator, an audio indicator, and a tactical feedback indicator for safety purposes (prevent damage of over sharpening, reducing too material and etc.), provide notification that sharpening is complete, and/or for feedback purposes as taught by Kolchin and HELLSTROM et al.
Regarding claims 36, TAKASHINO fails to disclose a motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold.
Kolchin teaches a motor actuatable to cause the advancement of the knife (col. 7, lines 40-67, col. 13, lines 1-3), wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold (determines sharpness via light intensity and determines “no sharpening necessary” which inherently would not actuate the advancement of the knife (col. 17, lines 25-67, col. 18, lines 47-67, col. 19, lines 1-17, figs. 1-2).
Given the teachings of Kolchin of having a motor and detecting no sharpening necessary if knife has been sharpened - it 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 to modify TAKASHINO’s motor control to have the motor actuatable to cause the advancement of the knife, wherein the control circuit is configured to prevent an actuation of the motor based on the comparison of the measured intensity of the light reflected by the knife edge to the light intensity threshold for safety purposes (stopping when knife is sharp to prevent damage), provide automated motor stop when knife is sharpening is complete, and/or for saving/conserving power when sharpening not necessary.
Conclusion
Additional prior art considered pertinent: see form 892.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731