DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claims 2-7 and 11-16 are rejected under 35 USC 112(b). Claim 1 is rejected under 35 USC 102(a)(1). Claims 2-20 are rejected under 35 USC 103.
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 .
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 2-7 and 11-16 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.
Claim 2 recites “defining a plurality of openings” in line 3. It is not clear if the surface is defining the plurality of openings, or if the staple pockets define a plurality of openings. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 4 recites “one opening of the plurality of openings” in lines 2-3. It is not clear whether the plurality of light sources and photodetectors are aligned with a single opening, or if each of the light sources and each of the detectors are each aligned with a respective opening (e.g. a light source/detector pair has one opening, a different source/detect has different opening, etc.). Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 11 recites “defining a plurality of openings” in line 3. It is not clear if the surface is defining the plurality of openings, or if the staple pockets define a plurality of openings. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 13 recites “one opening of the plurality of openings” in lines 2-3. It is not clear whether the plurality of light sources and photodetectors are aligned with a signal opening, or if each of the light sources and each of the detectors are each aligned with a respective opening (e.g. a light source/detector pair has one opening, a different source/detect has different opening, etc.). Clarification is required. For the purposes of examination, the latter definition will be used.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zand et al. (U.S PGPub 2009/0054908 A1).
Regarding Claim 1, Zand teaches a surgical stapler (Abstract) [0053] comprising:
a stapler cartridge (Fig. 2A, 202) including a plurality of staples [0059] (as the stapling side has holes for the staples to go through, it must be a cartridge contains staples);
a spectroscopy assembly [0073] (the sensor can be a spectrometer) disposed within the stapler cartridge and including a plurality of light sources and a plurality of photodetectors (Fig. 2b, 234+236) [0060] ([0070]+[0073] states the sensing elements can be light sources and photodetectors) interspersed among the plurality of light sources [0066]-[0067] (the detecting fibers are interspersed with the emitting fibers for each element);
and a controller coupled to the spectroscopy assembly [0055], the controller configured to:
activate the plurality of light sources to irradiate tissue contacting the stapler cartridge with a light [0070]-[0071];
receive signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors [0073]; and
determine a degree of blood perfusion in the tissue based on the signals [0084]-[0085].
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zand et al. in view of Scampoli et al. (U.S PGPub 2021/0177422 A1).
Regarding Claim 2, Zand teaches the invention substantially as claimed. Zand further teaches wherein the stapler cartridge includes a tissue-contacting surface (Fig. 2A, the surface of 202 with 204+210) [0059].
While Zand shows the staple line and where the light is emitted from in the surface, Zand is silent regarding the surface a plurality of staple pockets containing the plurality of staples and defining a plurality of openings.
Scampoli teaches a surgical stapling system (Abstract). This system has a stapler cartridge that has a plurality of staple pockets containing the plurality of staples and defining a plurality of openings [0046].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the surface of Zand with a surface the stapler cartridge which has a plurality of staple pockets and defines a plurality of openings, as taught by Scampoli, as the substitution for one known stapler cartridge surface with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a stapler cartridge with staple pockets and a plurality of openings are reasonably predictable.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli as applied to claim 2 above, and further in view of Worrell et al. (U.S PGPub US 20170238991 A1).
Regarding Claim 3, the combination of references teaches the invention. Zand fails to explicitly teach wherein the spectroscopy assembly includes a flexible circuit with the plurality of light sources and the plurality of photodetectors disposed thereon.
Worrell teaches a surgical instrument (Abstract). This surgical instrument has an optical sensing system, with photodetectors and light source of the optical system disposed on a flexible circuit [0706].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of mounting the optical system of the combined system to have the photodetectors and light sources disposed on flexible circuit, as taught by Worrell, as the substitution for one known method of disposing the optical system with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the light sources and photodetectors disposed on a flexible circuit are reasonably predictable.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli and Worrell as applied to claim 3 above, and further in view of Hufnagel et al. (U.S PGPub 2015/0238088 A1).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach wherein each light source of the plurality of light sources and each photodetector of the plurality of photodetectors is aligned with one opening of the plurality of openings.
Hufnagel teaches a system for optical detection of tissue properties (Abstract). This system has each light source and each photodetector aligned with an opening of the plurality of openings (Fig. 8, 143) [0051].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the light source and detectors aligned with openings, as taught by Hufnagel, as the this allows the light source/detector to obtain reflections from the tissue, thereby allowing the system to calculate tissue properties and improving the effectiveness of the surgery, as recognized by Hufnagel [0006].
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach a tubular housing configured to removably couple to the stapler cartridge.
Scampoli further teaches a tubular housing (Fig. 1, 14) configured to removably couple to the stapler cartridge [0044]+[0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a tubular housing removable coupled to the staple cartridge, as taught by Scampoli, because this facilitates reuse of the stapling device, as recognized by Scampoli [0050].
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli, Worrell, and Hufnagel as applied to claim 5 above, and further in view of Shelton IV et al. (U.S PGPub 2021/0196265 A1).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach wherein the tubular housing includes: a connector configured to electrically or optically couple to the flexible circuit; and a wiring harness extending through the tubular housing and connecting the connector to the controller.
Worrell further teaches a connector (Fig. 154) configured to electrically or optically couple to the flexible circuit [0246]+[0649]-[0650].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a connector which electrically couples to the flexible circuit, as taught by Worrell, because this allows for the circuit to be disconnect, thereby allowing for the circuit to be used on different reuseable handles, thereby increasing the number of uses of the instrument, as recognized by Worrell [0649]-[0650].
While Zand teaches the spectroscopic system is conventionally connected to the controller [0053], Zand fails to explicitly teach a wiring harness extending through the tubular housing and connecting the connector to the controller.
Shelton IV further teaches and a wiring harness extending through the tubular housing and connecting the connector to the controller [0574].
It would have been obvious to one of ordinary skill in the art to substitute the conventional connection with a wiring harness, as taught by Shelton IV, as the substitution for one known method of electrically connecting components with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a wiring harness to electrically connect the connector and the controller are reasonably predictable.
Regarding Claim 7, the combination of reference teaches the invention substantially as claimed. While Zand teaches using conventional signal processors, Zand fails to explicitly teach wherein the connector includes at least one analog-to-digital converter configured to convert the signals from the plurality of photodetectors from analog to digital.
Worrell further teaches wherein the connector includes at least one analog-to-digital converter configured to convert the signals from the plurality of photodetectors from analog to digital [0710].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the signal processing circuitry include an analog to digital converter, as taught by Worrell, as the substitution for one known method of processing the optical signals with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the using an analog to digital converter are reasonably predictable
The combination is silent regarding the analog to digital converter being in the connector.
Hufnagel further teaches the processor (i.e. signal processing circuitry) can be located in the jaw or shaft (i.e. as a part of the connector, which is located in the jaw/shaft) [0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the converter in the connector, as taught by Hufnagel, as the substitution for one known location of the processing circuitry with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the converter being in the connector are reasonably predictable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Mozdzierz (U.S PGPub 2018/0235484 A1) and Zemlok (U.S PGPub 2015/0122870 A1).
Regarding Claim 8, Zand teaches the invention substantially as claimed. Zand fails to explicitly teach a display configured to show a graphical user interface, wherein the controller is further configured to output the degree of the blood perfusion on the graphical user interface
Mozdzierz teaches a method for characterizing the tissue (Abstract). This system can be a stapler [0006]. The instrument contains a display with a graphical user interface the shows the degree of blood perfusion [0049]+[0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Zand to show a display with an interface showing perfusion, as taught by Mozdzierz, because this allows the user to easily visualize the parameters, thereby aiding the surgeon and allowing successful surgical procedure, as recognized by Mozdzierz [0004].
While Mozdzierz teaches the display shows data, Mozdzierz fails to explicitly teach it shows a graphical user interface.
Zemlok teaches a surgical stapler system (Abstract). This instrument has a display with a graphical user interface on the stapler [0081].
It would have been obvious to one of ordinary skill in the art to modify the display of the combination to show a graphical user interface, as taught by Zemlok, because this obviates the need for switches, thereby making it easier to sterilize the instrument, as recognized by Zemlok [0081].
Claims 9-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zand et al. in view of Scampoli et al. and Zemlok
Regarding Claim 9, Zand teaches a surgical stapler (Abstract) [0061] comprising:
an annular reload including a stapler cartridge (Fig. 2c, side with 264) having a plurality of staples [0061];
an anvil assembly (Fig. 2c, 276) movable relative to the annular reload and configured to compress tissue therebetween [0061];
a knife assembly (Fig. 2c, 272) disposed within the annular reload configured to cut the tissue [0061];
a spectroscopy assembly [0073] (the sensor can be a spectrometer) disposed within the stapler cartridge and including a plurality of light sources and a plurality of photodetectors (Fig. 2c, 264) [0060] ([0070]+[0073] states the sensing elements can be light sources and photodetectors) interspersed among the plurality of light sources [0066]-[0067] (the detecting fibers are interspersed with the emitting fibers for each element);
a controller coupled to the spectroscopy assembly [0055], the controller configured to:
activate the plurality of light sources to irradiate tissue contacting the stapler cartridge with a light [0070]-[0071];
receive signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors [0073]; and
determine a degree of blood perfusion in the tissue based on the signals [0084]-[0085].
Zand fails to explicitly teach the annular stapler cartridge is an annular reload, or that the cutter is a knife, or that the system includes a handle assembly.
Scampoli teaches a surgical stapler system (Abstract). This system contains an annular reload with a stapler cartridge [0044], and anvil assembly movable relative to the annular reload and for compressing the tissue [0044], and a knife assembly for cutting the tissue [0046]. This system is controlled using a handle assembly [0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use an annular reload, knife assembly, and handle, as taught by Scampoli, because this provides an improved structure for cutting and stapling the tissue, as recognized by Scampoli [0005]. It further would have been obvious to substitute the method of holding the system of Zand to have a handle assembly, as taught by Scampoli, as the substitution for one known method of holding a medical instrument with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a handle to hold an instrument are reasonably predictable.
The combination fails to explicitly teach at least one motor configured to actuate the anvil assembly, the stapler cartridge, and the knife assembly; and a controller to control the at least one motor.
Zemlok teaches a surgical stapling system (Abstract). This system has at least one motor in the handle configured to actuate the anvil assembly, the stapler cartridge, and the knife assembly [0074]+[0101]-[0102]. This motor is controlled by a controller (Fig. 20, 500 controls 200) [0131]. The motor (200) and controller (500) are located in the handle assembly (Fig. 6) [0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to contain a motor, as taught by Zemlok, because this allows the system to automatically adjust the stapling of the system, thereby increasing the safety of using the device and making deploying the staples easier, as recognized by Zemlok [0005]-[0007].
Regarding Claim 10, Zand further teaches measuring blood perfusion [0084]-[0085].
Zand fails to explicitly teach wherein the controller is further configured to control the at least one motor based on the degree of blood perfusion.
Zemlok further teaches the controller controlling the motor based on the measured parameter [0213].
It would have been obvious to one of ordinary skill in the art to modify the combined system to control the motor based on the measured parameter, as taught by Zemlok, because this increases the safety of the procedure, as recognized by Zemlok [0213]. One of ordinary skill would recognize that, as Zand teaches measuring tissue perfusion, the combined system would control the motor based on tissue perfusion.
Regarding Claim 11, Zand teaches the invention substantially as claimed. Zand further teaches wherein the stapler cartridge has an annular shape and includes a tissue-contacting surface (Fig. 2C, the surface of 270 with 272+264) [0061].
While Zand shows the staple line and where the light is emitted from in the surface, Zand is silent regarding the surface a plurality of staple pockets containing the plurality of staples and defining a plurality of openings.
Scampoli teaches a surgical stapling system (Abstract). This system has a stapler cartridge that has a plurality of staple pockets containing the plurality of staples and defining a plurality of openings [0046].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the surface of Zand with a surface the stapler cartridge which has a plurality of staple pockets and defines a plurality of openings, as taught by Scampoli, as the substitution for one known stapler cartridge surface with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a stapler cartridge with staple pockets and a plurality of openings are reasonably predictable.
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach a display configured to show a graphical user interface.
Zemlok teaches a surgical stapler system (Abstract). This instrument has a display with a graphical user interface on the stapler [0081].
It would have been obvious to one of ordinary skill in the art to modify the display of the combination to show a graphical user interface, as taught by Zemlok, because this obviates the need for switches, thereby making it easier to sterilize the instrument, as recognized by Zemlok [0081].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli and Zemlok as applied to claim 11 above, and further in view of Worrell et al.
Regarding Claim 12, the combination of references teaches the invention. Zand further teaches the light sources and photodetectors are arranged in an annular shape (Fig. 2C, 264) [0061].
Zand fails to explicitly teach wherein the spectroscopy assembly includes a flexible circuit with the plurality of light sources and the plurality of photodetectors disposed thereon.
Worrell teaches a surgical instrument (Abstract). This surgical instrument has an optical sensing system, with photodetectors and light source of the optical system disposed on a flexible circuit [0706].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of mounting the optical system of the combined system to have the photodetectors and light sources disposed on flexible circuit, as taught by Worrell, as the substitution for one known method of disposing the optical system with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the light sources and photodetectors disposed on a flexible circuit are reasonably predictable. One of ordinary skill would recognize that, as the sources and detectors of Zand are arranged annularly, the flexible circuit holding them would similarly be arranged annularly).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli, Zemlok, and Worrell as applied to claim 12 above, and further in view of Hufnagel et al.
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach wherein each light source of the plurality of light sources and each photodetector of the plurality of photodetectors is aligned with one opening of the plurality of openings.
Hufnagel teaches a system for optical detection of tissue properties (Abstract). This system has each light source and each photodetector aligned with an opening of the plurality of openings (Fig. 8, 143) [0051].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the light source and detectors aligned with openings, as taught by Hufnagel, as the this allows the light source/detector to obtain reflections from the tissue, thereby allowing the system to calculate tissue properties and improving the effectiveness of the surgery, as recognized by Hufnagel [0006].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach a tubular housing coupled to the handle assembly, the tubular housing configured to removably couple to the stapler cartridge.
Scampoli further teaches a tubular housing (Fig. 1, 14) coupled to the handle assembly (Fig. 1, 12) configured to removably couple to the stapler cartridge [0044]+[0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a tubular housing removable coupled to the staple cartridge, as taught by Scampoli, because this facilitates reuse of the stapling device, as recognized by Scampoli [0050].
Claim) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli, Zemlok, Worrell, and Hufnagel as applied to claim 14 above, and further in view of Shelton IV et al.
Regarding Claim 15, the combination of references teaches the invention substantially as claimed. Zand fails to explicitly teach wherein the tubular housing includes: a connector configured to electrically or optically couple to the flexible circuit; and a wiring harness extending through the tubular housing and connecting the connector to the controller.
Worrell further teaches a connector (Fig. 154) configured to electrically or optically couple to the flexible circuit [0246]+[0649]-[0650].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a connector which electrically couples to the flexible circuit, as taught by Worrell, because this allows for the circuit to be disconnect, thereby allowing for the circuit to be used on different reuseable handles, thereby increasing the number of uses of the instrument, as recognized by Worrell [0649]-[0650].
While Zand teaches the spectroscopic system is conventionally connected to the controller [0053], Zand fails to explicitly teach a wiring harness extending through the tubular housing and connecting the connector to the controller.
Shelton IV further teaches and a wiring harness extending through the tubular housing and connecting the connector to the controller [0574].
It would have been obvious to one of ordinary skill in the art to substitute the conventional connection with a wiring harness, as taught by Shelton IV, as the substitution for one known method of electrically connecting components with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a wiring harness to electrically connect the connector and the controller are reasonably predictable.
Regarding Claim 16, the combination of reference teaches the invention substantially as claimed. While Zand teaches using conventional signal processors, Zand fails to explicitly teach wherein the connector includes at least one analog-to-digital converter configured to convert the signals from the plurality of photodetectors from analog to digital.
Worrell further teaches wherein the connector includes at least one analog-to-digital converter configured to convert the signals from the plurality of photodetectors from analog to digital [0710].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the signal processing circuitry include an analog to digital converter, as taught by Worrell, as the substitution for one known method of processing the optical signals with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the using an analog to digital converter are reasonably predictable
The combination is silent regarding the analog to digital converter being in the connector.
Hufnagel further teaches the processor (i.e. signal processing circuitry) can be located in the jaw or shaft (i.e. as a part of the connector, which is located in the jaw/shaft) [0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the converter in the connector, as taught by Hufnagel, as the substitution for one known location of the processing circuitry with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the converter being in the connector are reasonably predictable.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Scampoli and Zemlok as applied to claim 17 above, and further in view of Mozdzierz.
Regarding Claim 18, Zand teaches the invention substantially as claimed. Zand fails to explicitly teach the controller is further configured to output the degree of the blood perfusion or oximetry on the graphical user interface.
Mozdzierz teaches a method for characterizing the tissue (Abstract). This system can be a stapler [0006]. The instrument contains a display which shows the degree of blood perfusion [0049]+[0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Zand to show a display with an interface showing perfusion, as taught by Mozdzierz, because this allows the user to easily visualize the parameters, thereby aiding the surgeon and allowing successful surgical procedure, as recognized by Mozdzierz [0004].
While Mozdzierz teaches the display shows data, Mozdzierz fails to explicitly teach it shows a graphical user interface.
Zemlok teaches a surgical stapler system (Abstract). This instrument has a display with a graphical user interface on the stapler [0081].
It would have been obvious to one of ordinary skill in the art to modify the display of the combination to show a graphical user interface, as taught by Zemlok, because this obviates the need for switches, thereby making it easier to sterilize the instrument, as recognized by Zemlok [0081].
Regarding Claim 19, the combination of reference teaches the invention substantially as claimed. Zand further teaches output the degree of the blood perfusion or oximetry each segment of the tissue corresponding to each photodetector of the plurality of photodetectors [0091] (by mapping the data from the sensors to the tissue, it is associating data from the sensor for each segment of the tissue that is measured by the photodetectors).
It would have been obvious to one of ordinary skill in the art to modify the stapling embodiment of Zand to include the mapping, as taught by Zand, because this proves a more complete output of tissue health, thereby improving the treatment of the patient, as recognized by Zand [0091].
Zand fails to explicitly teach the controller is further configured to output the degree of the blood perfusion or oximetry on the graphical user interface.
Mozdzierz teaches a method for characterizing the tissue (Abstract). This system can be a stapler [0006]. The instrument contains a display which shows the degree of blood perfusion [0049]+[0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Zand to show a display with an interface showing perfusion, as taught by Mozdzierz, because this allows the user to easily visualize the parameters, thereby aiding the surgeon and allowing successful surgical procedure, as recognized by Mozdzierz [0004].
While Mozdzierz teaches the display shows data, Mozdzierz fails to explicitly teach it shows a graphical user interface.
Zemlok teaches a surgical stapler system (Abstract). This instrument has a display with a graphical user interface on the stapler [0081].
It would have been obvious to one of ordinary skill in the art to modify the display of the combination to show a graphical user interface, as taught by Zemlok, because this obviates the need for switches, thereby making it easier to sterilize the instrument, as recognized by Zemlok [0081].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zand in view of Zemlok.
Regarding Claim 20, Zang teaches a surgical stapler (Abstract) [0020] comprising:
a first jaw including a stapler cartridge (Fig. 2A, 202) having a plurality of staples [0059];
a second jaw (Fig. 2a, 214) [0059];
a spectroscopy assembly [0073] (the sensor can be a spectrometer) disposed within at least one of the first jaw or the second jaw [0059], the spectroscopy assembly including a plurality of light sources and a plurality of photodetectors (Fig. 2A, 204+206) [0059] ([0070]+[0073] states the sensing elements can be light sources and photodetectors) interspersed among the plurality of light sources [0066]-[0067] (the detecting fibers are interspersed with the emitting fibers for each element);
a controller coupled to the spectroscopy assembly [0055], the controller configured to:
activate the plurality of light sources to irradiate tissue contacting the stapler cartridge with a light [0070]-[0071];
receive signals from the plurality of photodetectors based on reflected light detected by the plurality of photodetectors [0073]; and
determine a degree of blood perfusion in the tissue based on the signals [0084]-[0085].
The Zand fails to explicitly teach the second jaw movable relative to the first jaw and configured to compress tissue therebetween, a handle assembly at least one motor configured to move at least one of the first jaw or the second jaw and to eject the plurality of staples; and a controller to control the at least one motor.
Zemlok teaches a surgical stapling system (Abstract). This system has jaws which are moveable relative to one another to compress tissue [0014]. This system has handle assembly (Fig. 1, 110) [0068], and at least one motor in the handle configured to move at least one of the first jaw or the second jaw and to eject the plurality of staples [0074]+[0102]. This motor is controlled by a controller (Fig. 20, 500 controls 200) [0131]. The motor (200) and controller (500) are located in the handle assembly (Fig. 6) [0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to contain a motor, as taught by Zemlok, because this allows the system to automatically adjust the stapling of the system, thereby increasing the safety of using the device and making deploying the staples easier, as recognized by Zemlok [0005]-[0007].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zand et al. (U.S PGPub 2009/0234248 A1), which teaches a sensing stapler assembly.
Shelton IV et al. (U.S Patent 11,793,514 B2), which teaches a stapler assembly with a sensor located in the stapler cartridge.
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/SEAN D MATTSON/ Primary Examiner, Art Unit 3798