Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the documents received on June 28, 2024 and October 7, 2024; as well as, the preliminary amendment received on September 16, 2024.
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 34-39 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 34 recites the limitation "the second impedance sensing assembly" in line 22 and “the first impedance sensing assembly” in lines 22-23. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 27, 28, 31 and 32 are rejected under 35 U.S.C. 102(a)(1) being anticipated by SWAYZE et al. (US 2016/0066913).
Regarding claims 27, figure 41 of SWAYZE et al. discloses a cartridge for a surgical instrument, the cartridge comprising: an elongate slot (see Diagram I below) extending through a deck of the cartridge, the elongate slot dividing the deck into a first lateral side and a second lateral side; a plurality of staple cavities (see Diagram I below) defined in the deck and having staples removably positioned therein; a first impedance sensing electrode assembly positioned in a first zone to apply a first energy to tissue positioned in the first zone to indicate a thickness of the tissue positioned in the first zone (paragraph [0308]), the first impedance measuring assembly including a first impedance measuring electrode 3272a and a second impedance measuring electrode 3272h; a second impedance sensing electrode assembly positioned in a second zone to apply a first energy to tissue positioned in the first zone to indicate a thickness of the tissue positioned in the first zone (paragraph [0308]), the second impedance sensing electrode assembly including a third impedance sensing electrode 3272d and a fourth impedance sensing electrode 3272e; wherein advancement of a knife (I-Beam drives the knife; paragraph [0343]) through the elongate slot is based on the determined impedance indicative of the tissue thickness in the first zone and the thickness of the tissue in the second zone (3760; figure 58).
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Diagram I
Regarding claim 28, Diagram I above illustrates the first impedance electrode 3272a and the third impedance electrode 3272d of SWAYZE et al. on the first lateral side of the elongate slot while the second impedance sensing electrode 3272h and the fourth impedance electrode 3272e are on the second lateral side of the elongate slot.
In reference claim 31, Diagram I above further illustrates a longitudinal gap (distal spacing) between the first impedance sensing electrode assembly 3272a, 3272h and the second impedance sensing electrode assembly 3272d, 3272e.
Regarding claim 32, paragraph [0308] of SWAYZE et al. discloses the staple cartridge comprising a first control circuit and second control circuit in communication with one another.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 103 that form the basis for the rejections under this section made in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 20, 22-25, 29, 34-36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over SWAYZE et al. (US 2016/0066913) in view of SHELTON, IV et al. (US 2014/0005653).
In reference to claims 20, figure 41 of SWAYZE et al. discloses a cartridge for a surgical instrument, the cartridge comprising: an elongate slot (see Diagram II below) extending through a deck of the cartridge; a plurality of staple cavities (see Diagram II below) defined in the deck and having staples removably positioned therein; a first impedance sensing electrode positioned in a first zone to apply a first energy to tissue positioned in the first zone to indicate a thickness of the tissue positioned in the first zone (paragraph [0308]); a second impedance sensing electrode 3272d, 3272e positioned in a second zone to apply a first energy to tissue positioned in the first zone to indicate a thickness of the tissue positioned in the first zone (paragraph [0308]); wherein advancement of a knife (I-Beam drives the knife; paragraph [0343]) through the elongate slot is based on the determined impedance indicative of the tissue thickness in the first zone and the thickness of the tissue in the second zone (3760; figure 58).
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Diagram II
SWAYZE et al. does not disclose whether the first impedance sensing electrodes operate independently of the second impedance sensing electrodes. SHELTON, IV et al. teaches an insert for a surgical instrument (paragraph [0206]), the insert comprising: a first impedance sensing electrodes positioned in a first zone of the deck (see Diagram III below); second impedance sensing electrodes positioned in a second zone of the deck (see Diagram III below); the first impedance sensing electrode and the second impedance sensing electrode independently addressable by control circuit (paragraph [0432]). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the surgical instrument of SWAYZE et al. to have independently operable electrodes in different zones of the surgical instrument deck surface since paragraph [0306] of SWAYZE et al. expresses a desire to detect various parameters of tissue engaged with distinct zones of the surgical instrument deck.
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Diagram III
Regarding claims 22-23, Diagram I above illustrates the first impedance electrode 3272a and the second impedance electrode 3272d of SWAYZE et al. on a first lateral side of the elongate slot while a third impedance sensing electrode 3272h in the first zone of the deck and a fourth impedance electrode 3272e are on a second lateral side of the elongate slot.
With respect to claim 24, Diagram II above further illustrates a longitudinal gap (distal spacing) between the first impedance sensing electrode 3272a and the second impedance sensing electrode 3272d.
In reference to claim 25, paragraph [0308] of SWAYZE et al. discloses the staple cartridge comprising a first control circuit and second control circuit in communication with one another.
Regarding claim 29, although paragraph [0308] of SWAYZE et al. states that the plurality of electrodes can be coupled to one or more circuits, SWAYZE et al. does not definitively disclose whether the first impedance sensing electrodes operate independently of the second impedance sensing electrodes. SHELTON, IV et al. teaches an insert for a surgical instrument (paragraph [0206]), the insert comprising: a first impedance sensing electrodes positioned in a first zone of the deck (see Diagram III below); second impedance sensing electrodes positioned in a second zone of the deck (see Diagram III below); the first impedance sensing electrode and the second impedance sensing electrode independently addressable by control circuit (paragraph [0432]). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the surgical instrument of SWAYZE et al. to have independently operable electrodes in different zones of the surgical instrument deck surface since paragraph [0306] of SWAYZE et al. expresses a desire to detect various parameters of tissue engaged with distinct zones of the surgical instrument deck.
With respect to claim 34, figure 41 of SWAYZE et al. discloses a cartridge for a surgical instrument, the cartridge comprising: an elongate slot (see Diagram I below) extending through a first zone of a deck of the cartridge and second zone of the deck, the elongate slot dividing the deck into a first lateral side and a second lateral side; a plurality of staple cavities (see Diagram I below) defined in the deck and having staples removably positioned therein; a first impedance sensing electrode assembly positioned in a first zone to apply a first energy to tissue positioned in the first zone to indicate a thickness of the tissue positioned in the first zone (paragraph [0308]), the first impedance sensing electrode assembly including a first impedance sensing electrode 3272a and a second impedance sensing electrode 3272h; a second impedance sensing electrode assembly positioned in a second zone to apply a first energy to tissue positioned in the first zone to indicate a thickness of the tissue positioned in the first zone (paragraph [0308]), the second impedance sensing electrode assembly including a third impedance sensing electrode 3272d and a fourth impedance sensing electrode 3272e; wherein advancement of a knife (I-Beam drives the knife; paragraph [0343]) through the elongate slot is based on the determined impedance indicative of the tissue thickness in the first zone and the thickness of the tissue in the second zone (3760; figure 58).
In reference to claims 35-36, Diagram II above illustrates the first impedance electrode 3272a and the second impedance electrode 3272d of SWAYZE et al. on a first lateral side of the elongate slot while a third impedance sensing electrode 3272h in the first zone of the deck and a fourth impedance electrode 3272e are on a second lateral side of the elongate slot in the second zone.
Regarding claim 38, paragraph [0308] of SWAYZE et al. discloses the staple cartridge comprising a first control circuit and second control circuit in communication with one another.
Claims 21 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over SWAYZE et al. (US 2016/0066913, hereinafter SWAYZE et al. ‘913) in view of SHELTON, IV et al. (US 2014/0005653) as applied to claims 20 and 34, and further in view of SWAYZE et al. (US 7,644,848, hereinafter SWAYZE et al. ‘848).
With respect to claims 21 and 37, the modified surgical instrument of SWAYZE et al. ‘913 in view of SHELTON, IV et al. discloses a cartridge/insert received within an elongate channel (3254 in figure 40 of SWAYZE et al ‘913; see Diagram II above) of a surgical instrument, wherein a deck (surface) of the cartridge/insert has a plurality of electrodes across a first zone and a second zone, and sidewalls extend from the deck. Neither SWAYZE et al. ‘913 nor SHELTON, IV et al. disclose electrical contacts positioned in the elongate channel as claimed.
SWAYZE et al. ‘848 teaches a surgical instrument comprising: a staple cartridge 34 including an elongate slot (figure 3) in a deck of the staple cartridge 34 and sidewalls that extend from the deck; an electrical conductor 290 coupled to the staple cartridge 34; an elongate channel 22 configured to receive the staple cartridge 34 with electrical conductor 290, the elongate channel 22 having a channel base (figure 43B) and channel sidewalls (figure 43A) extending therefrom; and electrical contacts 288a, 288b on sidewalls of the elongate channel that are operably coupled to a control circuit, the electrical conductor 290 configured to contact the electrical contacts 288a, 288b of the elongate channel when the staple cartridge is positioned in the elongate channel. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the cartridge of SWAYZE et al. ‘913 to have an electrical conductor and the elongate channel of SWAYZE et al. ‘913 to have electrical contacts operable coupled to a control circuit of the surgical instrument since column 12 lines 17-30 of SWAYZE et al. ‘848 states such a modification establishes a conductive path between the cartridge and the elongate channel when the cartridge is properly positioned within the elongate channel for the purpose of creating a connective state between the sensing elements of the cartridge and the control circuit of the surgical instrument.
Claims 26 and 39 and are rejected under 35 U.S.C. 103 as being unpatentable over SWAYZE et al. (US 2016/0066913) in view of SHELTON, IV et al. (US 2014/0005653) as applied to claim 25 and 38 above, and further in view of YATES et al. (US 8,459,525).
In reference to claims 26 and 39, paragraph [0308] of SWAYZE et al. discloses the staple cartridge comprising a first control circuit and second control circuit in communication with one another, but does not disclose a multiplexer as claimed. YATES et al. teaches a staple cartridge for a surgical instrument, the cartridge comprising: an elongate slot (see Diagram I below) extending through a deck of the cartridge; a plurality of staple cavities (see Diagram IV below) defined in the deck and having staples (see Diagram IV below) removably positioned therein; a first impedance sensing electrode 5004 positioned in a first zone (figure 25) to apply a first energy to tissue positioned in the first zone; a second impedance sensing electrode 5001 positioned in a second zone (figure 25); and a control circuit including a multiplexer configured to individually address the first impedance sensing electrode and the second impedance sensing electrode (column 16 line 63- column 17 line 18). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the circuit of SWAYZE et al. to include a multiplexer since column 17 lines 5-17 of YATES et al. suggests such a modification facilitates effective control of various electrodes independently and simultaneously.
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Diagram IV
Claims 30 are rejected under 35 U.S.C. 103 as being unpatentable over SWAYZE et al. (US 2016/0066913) in view of SWAYZE et al. (US 7,644,848, hereinafter SWAYZE et al. ‘848).
Regarding claim 30, SWAYZE et al. ‘913 discloses a cartridge within an elongate channel (3254 in figure 40 of SWAYZE et al ‘913) of a surgical instrument, wherein a deck (surface) of the cartridge/insert has a plurality of electrodes across a first zone and a second zone, and sidewalls extend from the deck. SWAYZE et al. ‘913 does not disclose electrical contacts positioned in the elongate channel as claimed.
SWAYZE et al. ‘848 teaches a surgical instrument comprising: a staple cartridge 34 including an elongate slot (figure 3) in a deck of the staple cartridge 34 and sidewalls that extend from the deck; an electrical conductor 290 coupled to the staple cartridge 34; an elongate channel 22 configured to receive the staple cartridge 34 with electrical conductor 290, the elongate channel 22 having a channel base (figure 43B) and channel sidewalls (figure 43A) extending therefrom; and electrical contacts 288a, 288b on sidewalls of the elongate channel that are operably coupled to a control circuit, the electrical conductor 290 configured to contact the electrical contacts 288a, 288b of the elongate channel when the staple cartridge is positioned in the elongate channel. It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the cartridge of SWAYZE et al. ‘913 to have an electrical conductor and the elongate channel of SWAYZE et al. ‘913 to have electrical contacts operable coupled to a control circuit of the surgical instrument since column 12 lines 17-30 of SWAYZE et al. ‘848 states such a modification establishes a conductive path between the cartridge and the elongate channel when the cartridge is properly positioned within the elongate channel for the purpose of creating a connective state between the sensing elements of the cartridge and the control circuit of the surgical instrument.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over SWAYZE et al. (US 2016/0066913) in view of YATES et al. (US 8,459,525).
With respect to claim 33, paragraph [0308] of SWAYZE et al. discloses the staple cartridge comprising a first control circuit and second control circuit in communication with one another, but does not disclose a multiplexer as claimed. YATES et al. teaches a staple cartridge for a surgical instrument, the cartridge comprising: an elongate slot (see Diagram I below) extending through a deck of the cartridge; a plurality of staple cavities (see Diagram IV below) defined in the deck and having staples (see Diagram IV below) removably positioned therein; a first impedance measuring assembly 5004 positioned in a first zone (figure 25) to apply a first energy to tissue positioned in the first zone; a second impedance measuring assembly 5001 positioned in a second zone (figure 25); and a control circuit including a multiplexer configured to individually address the first impedance measuring assembly and the second impedance assembly (column 16 line 63- column 17 line 18). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the circuit of SWAYZE et al. to include a multiplexer since column 17 lines 5-17 of YATES et al. suggests such a modification facilitates effective control of various measuring assemblies (e.g. electrodes) independently and simultaneously.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to the attached PTO-892 for a notice of references cited and recommended for consideration based on their disclosure of limitations related to the claimed invention. In particular, the cited references are found related due to their respective disclosures of surgical instruments comprising a measuring system coupled to the surfaces of an end effector configured to contacts tissue and determine parameters of the tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GLORIA R WEEKS whose telephone number is (571)272-4473. The examiner can normally be reached M-F 8am-2pm & 5pm-7pm EST.
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/GLORIA R WEEKS/Primary Examiner, Art Unit 3731
April 7, 2026
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