DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
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 1-9, 11, 18, and 20 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 1 recites ‘electrodes’ after reciting ‘a plurality of electrodes’ making it unclear if each recitation is meant to refer to the same element or not. It appears ‘electrodes’ should read ‘the plurality of electrodes’.
Claim 9 recites ‘an application of electrical current’ and is dependent back to claim 1 which recites the same, making it unclear if the recitation in claim 9 is meant to refer to that in claim 1 or not.
Claim 11 recites ‘sixty electrodes’ and ‘eight electrodes’ and is dependent back to claim 10 which recites ‘a plurality of electrodes’ twice making it unclear if ‘sixty electrodes’ and ‘eight electrodes’ are part of the pluralities or not.
Claim 18 recites ‘an application of electrical current’ and is dependent back to claim 10 which recites the same, making it unclear if the recitation in claim 18 is meant to refer to that in claim 10 or not.
Claim 20 recites ‘an application of electrical current’ and is dependent back to claim 19 which recites the same, making it unclear if the recitation in claim 20 is meant to refer to that in claim 19 or not.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 only recites language already recited in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-3, 8, 10-12, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knapp et al. (US 2021/0153866) in view of Church et al. (US Patent No. 6501984).
Regarding claim 1, Knapp teaches a surgical system (Abstract) comprising:
a surgical stapler (10) including an end effector (Figure 1), the end effector including a first jaw (60) having an anvil (62/64; Paragraph 0024) and a second jaw (70) having a stapler cartridge (74; Paragraph 0025); and
an electrical impedance tomography system (Paragraph 0005) including:
an electrode array including a plurality of electrodes operably coupled to the first jaw (Paragraph 0009; “The jaw assembly further includes an impedance sensor including an array electrodes. The array of electrodes are supported by at least one of the cartridge assembly and the anvil assembly.”), and
control an application of electrical current across electrodes of the electrode array (Paragraph 0009; “The array electrodes includes a first set of electrodes configured to receive a current therebetween, and at least one second set of electrodes configured to measure a voltage therebetween.”; Paragraph 0034);
measure a voltage difference across electrodes of the electrode array (Paragraph 0009; “The array electrodes includes a first set of electrodes configured to receive a current therebetween, and at least one second set of electrodes configured to measure a voltage therebetween.”; Paragraph 0034);
calculate electrical impedance based on the measured voltage difference (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”); and
generate an electrical impedance tomography reconstruction based on the calculated electrical impedance (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”).
Knapp is silent on a processor though one is implied given the functionality of the system of Knapp.
Church teaches an EIT system (Abstract) with a processor (Column 4, Lines 51-67; “The computer 18 may be a personal computer equipped with a digital signal processor card used for the image reconstruction process and a suitable display 20 for displaying the images”).
It would have been obvious to one of ordinary skill in the art to have modified Knapp with Church because these are common structures conventionally used in the EIT field and thus the usage of these structures would yield predictable results.
Regarding claim 2, Knapp teaches wherein the electrode array includes a plurality of electrodes (Paragraph 0009; “The jaw assembly further includes an impedance sensor including an array electrodes. The array of electrodes are supported by at least one of the cartridge assembly and the anvil assembly.”).
Regarding claim 3, Knapp is silent on wherein each electrode of the electrode array is about 3 mm long and about 1 mm wide. Church teaches an EIT system with various electrode sizes and that such a size change is a design choice (Column 6, Lines 40-50). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Church because the Applicant’s specification provides no specifical reasoning or critical functionality for the use of 3 mm long and about 1 mm wide electrodes, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the 3 mm long and about 1 mm wide electrodes as desired by the user as a matter of routine engineering design choice.
Regarding claim 8, Knapp teaches wherein the processor is configured to detect tumor margins based on the electrical impedance tomography reconstruction (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”).
Regarding claim 10, Knapp teaches a powered surgical instrument (Abstract) comprising:
an end effector (Figure 1) including a first jaw (60; Paragraph 0024) and a second jaw (70; Paragraph 0025);
an electrical impedance tomography system (Paragraph 0005) including:
a first electrode array including a plurality of electrodes operably coupled to the first jaw (Paragraph 0009; “The jaw assembly further includes an impedance sensor including an array electrodes. The array of electrodes are supported by at least one of the cartridge assembly and the anvil assembly.”; Paragraph 0032);
a second electrode array including a plurality of electrodes operably coupled to the second jaw (Paragraph 0033; “The electrodes 142a-h of the array of electrodes 140 are disposed along a tissue contacting surface 176 of the cartridge assembly 170.”); and
control an application of an electrical current across the first electrode array and the second electrode array (Paragraph 0009; “The array electrodes includes a first set of electrodes configured to receive a current therebetween, and at least one second set of electrodes configured to measure a voltage therebetween.”; Paragraph 0034);
measure a voltage difference across the first electrode array and the second electrode array (Paragraph 0009; “The array electrodes includes a first set of electrodes configured to receive a current therebetween, and at least one second set of electrodes configured to measure a voltage therebetween.”; Paragraph 0034);
calculate electrical impedance based on the measured voltage difference (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”); and
generate an electrical impedance tomography reconstruction based on the calculated electrical impedance (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”).
Knapp is silent on a processor though one is implied given the functionality of the system of Knapp.
Church teaches an EIT system (Abstract) with a processor (Column 4, Lines 51-67; “The computer 18 may be a personal computer equipped with a digital signal processor card used for the image reconstruction process and a suitable display 20 for displaying the images”).
It would have been obvious to one of ordinary skill in the art to have modified Knapp with Church because these are common structures conventionally used in the EIT field and thus the usage of these structures would yield predictable results.
Regarding claim 11, Knapp is silent on wherein the first electrode array includes sixty electrodes and the second electrode array includes eight electrodes. The Applicant’s specification provides no specifical reasoning or critical functionality for the use of having sixty electrodes and eight electrodes, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the sixty electrodes and eight electrodes as desired by the user as a matter of routine engineering design choice.
Regarding claim 12, Knapp is silent on wherein each electrode of the first electrode array is about 3 mm long and about 1 mm wide and each electrode of the second electrode array is about 3 mm long and about 3 mm wide. Church teaches an EIT system with various electrode sizes and that such a size change is a design choice (Column 6, Lines 40-50). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Church because the Applicant’s specification provides no specifical reasoning or critical functionality for the use of about 3 mm long and about 1 mm wide about 3 mm long and about 3 mm wide electrodes, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the about 3 mm long and about 1 mm wide about 3 mm long and about 3 mm wide electrodes as desired by the user as a matter of routine engineering design choice.
Regarding claim 17, Knapp teaches wherein the processor is configured to detect tumor margins based on the electrical impedance tomography reconstruction (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”).
Regarding claim 19, Knapp teaches a surgical system (Abstract) comprising:
a powered surgical instrument (10) including a first jaw (60; Paragraph 0024; Figure 1) and a second jaw (70; Paragraph 0025; Figure 1);
an electrical impedance tomography system (Paragraph 0005) including:
a first electrode array including a plurality of electrodes operably coupled to the first jaw (Paragraph 0009; “The jaw assembly further includes an impedance sensor including an array electrodes. The array of electrodes are supported by at least one of the cartridge assembly and the anvil assembly.”; Paragraph 0032);
a second electrode array including a plurality of electrodes operably coupled to the second jaw (Paragraph 0033; “The electrodes 142a-h of the array of electrodes 140 are disposed along a tissue contacting surface 176 of the cartridge assembly 170.”); and
control an application of an electrical current across the first electrode array and the second electrode array (Paragraph 0009; “The array electrodes includes a first set of electrodes configured to receive a current therebetween, and at least one second set of electrodes configured to measure a voltage therebetween.”; Paragraph 0034);
measure a voltage difference across the first electrode array and the second electrode array (Paragraph 0009; “The array electrodes includes a first set of electrodes configured to receive a current therebetween, and at least one second set of electrodes configured to measure a voltage therebetween.”; Paragraph 0034);
calculate electrical impedance based on the measured voltage difference (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”); and
generate an electrical impedance tomography reconstruction based on the calculated electrical impedance (Paragraph 0034; “A grid may be created to solve for the current and voltage at each element, thereby producing an impedance image. The impedance image may be used to identify the type of tissue positioned within the tool assembly 50 between the anvil assembly 60 and the cartridge assembly 170. From this, a cancer margin of the tissue may be identified or detected.”); and
Knapp is silent on a processor and a display.
Church teaches an EIT system (Abstract) with a processor and a display operably couped to the electrical impedance tomography system and configured to display the electrical impedance tomography reconstruction (Column 4, Lines 51-67; “The computer 18 may be a personal computer equipped with a digital signal processor card used for the image reconstruction process and a suitable display 20 for displaying the images”).
It would have been obvious to one of ordinary skill in the art to have modified Knapp with Church because these are common structures conventionally used in the EIT field and thus the usage of these structures would yield predictable results.
Claim(s) 4-5 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knapp et al. (US 2021/0153866) in view of Church et al. (US Patent No. 6501984) and in further view of Cheney et al. (US Patent No. 5351697).
Regarding claim 4, Knapp is silent on wherein the electrodes of the electrode array are arranged in four columns and fifteen rows. Cheney teaches an EIT system with electrodes arranged in variable column and row numbers (Column 2, Lines 54-65). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Cheney because the Applicant’s specification provides no specifical reasoning or critical functionality for the use of electrodes arranged in four columns and fifteen rows, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the electrodes arranged in four columns and fifteen rows as desired by the user as a matter of routine engineering design choice.
Regarding claim 5, Knapp is silent on wherein the electrodes of the electrode array are grouped into four distinct sets of ten electrodes. Cheney teaches an EIT system with electrodes arranged in variable amounts and groups (Columns 3-4). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Cheney because the Applicant’s specification provides no specifical reasoning or critical functionality for the use of electrodes grouped into four distinct sets of ten electrodes, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the electrodes grouped into four distinct sets of ten electrodes as desired by the user as a matter of routine engineering design choice.
Regarding claim 13, Knapp is silent on wherein the electrodes of the first electrode array are arranged in four columns and fifteen rows and the electrodes of the second electrode array are arranged in two columns and four rows. Cheney teaches an EIT system with electrodes arranged in variable column and row numbers (Column 2, Lines 54-65). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Cheney because the applicant's specification provides no specifical reasoning or critical functionality for the use of electrodes arranged in four columns and fifteen rows and in two columns and four rows, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the electrodes arranged in four columns and fifteen rows and in two columns and four rows as desired by the user as a matter of routine engineering design choice.
Regarding claim 14, Knapp is silent on wherein at least a portion of the plurality of electrodes of the first electrode array are grouped into four distinct sets of ten electrodes, each set of ten electrodes being paired with eight electrodes of the second electrode array. Cheney teaches an EIT system with electrodes arranged in variable amounts and groups (Columns 3-4). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Cheney because the Applicant’s specification provides no specifical reasoning or critical functionality for the use of electrodes grouped into four distinct sets of ten electrodes, each set of ten electrodes being paired with eight electrodes of the second electrode array, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the electrodes grouped into four distinct sets of ten electrodes, each set of ten electrodes being paired with eight electrodes of the second electrode array as desired by the user as a matter of routine engineering design choice.
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knapp et al. (US 2021/0153866) in view of Church et al. (US Patent No. 6501984) and in further view of Iope (US 2023/0039829).
Regarding claim 6, Knapp is silent on wherein the processor is configured to filter the calculated electrical impedance by removing noisy patterns prior to generating the electrical impedance tomography reconstruction. Iope teaches wherein the processor is configured to filter the calculated electrical impedance by removing noisy patterns prior to generating the electrical impedance tomography reconstruction (Paragraph 0050). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Iope because mitigating noise is a common practice in signal processing and through routine experimentation would yield predictable results.
Regarding claim 15, Knapp is silent on wherein the processor is configured to filter the calculated electrical impedance by removing noisy patterns prior to generating the electrical impedance tomography reconstruction. Iope teaches wherein the processor is configured to filter the calculated electrical impedance by removing noisy patterns prior to generating the electrical impedance tomography reconstruction (Paragraph 0050). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Iope because mitigating noise is a common practice in signal processing and through routine experimentation would yield predictable results.
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knapp et al. (US 2021/0153866) in view of Church et al. (US Patent No. 6501984) and in further view of Elia et al. (US 2022/0000385).
Regarding claim 7, Knapp is silent on wherein the generated electrical impedance tomography reconstruction includes conductive inclusions and resistive inclusions, wherein the conductive inclusions are optically distinguishable from the resistive inclusions. Elia teaches wherein the generated electrical impedance tomography reconstruction includes conductive inclusions and resistive inclusions, wherein the conductive inclusions are optically distinguishable from the resistive inclusions (Paragraph 0234). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Elia because it enables a map to denote specific regions of interest in relation to other surrounding elements (Paragraph 0234 of Elia).
Regarding claim 16, Knapp is silent on wherein the generated electrical impedance tomography reconstruction includes conductive inclusions and resistive inclusions, wherein the conductive inclusions are optically distinguishable from the resistive inclusions. Elia teaches wherein the generated electrical impedance tomography reconstruction includes conductive inclusions and resistive inclusions, wherein the conductive inclusions are optically distinguishable from the resistive inclusions (Paragraph 0234). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Elia because it enables a map to denote specific regions of interest in relation to other surrounding elements (Paragraph 0234 of Elia).
Claim(s) 9, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knapp et al. (US 2021/0153866) in view of Church et al. (US Patent No. 6501984) and in further view of Teschner et al. (US 2007/0246046).
Regarding claim 9, Knapp is silent on wherein the processor is configured to control an application of the electrical current at a frequency from about 10 kHz to about 80 kHz. Teschner teaches wherein the processor is configured to control an application of the electrical current at a frequency from about 10 kHz to about 80 kHz (Paragraph 0003). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Teschner because the applicant's specification provides no specifical reasoning or critical functionality for the use application of the electrical current at a frequency from about 10 kHz to about 80 kHz, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the application of the electrical current at a frequency from about 10 kHz to about 80 kHz as desired by the user as a matter of routine engineering design choice.
Regarding claim 18, Knapp is silent on wherein the processor is configured to control an application of the electrical current at a frequency from about 10 kHz to about 80 kHz. Teschner teaches wherein the processor is configured to control an application of the electrical current across the first electrode array and the second electrode array at a frequency from about 10 kHz to about 80 kHz (Paragraph 0003). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Teschner because the applicant's specification provides no specifical reasoning or critical functionality for the use application of the electrical current at a frequency from about 10 kHz to about 80 kHz, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the application of the electrical current at a frequency from about 10 kHz to about 80 kHz as desired by the user as a matter of routine engineering design choice.
Regarding claim 20, Knapp is silent on wherein the processor is configured to control an application of the electrical current at a frequency from about 10 kHz to about 80 kHz. De Limon Teschner teaches wherein the processor is configured to control an application of the electrical current across the first electrode array and the second electrode array at a frequency from about 10 kHz to about 80 kHz (Paragraph 0003). It would have been obvious to one of ordinary skill in the art to have modified Knapp with Teschner because the applicant's specification provides no specifical reasoning or critical functionality for the use application of the electrical current at a frequency from about 10 kHz to about 80 kHz, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the application of the electrical current at a frequency from about 10 kHz to about 80 kHz as desired by the user as a matter of routine engineering design choice.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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