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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, 18 in the reply filed on 12/29/25 is acknowledged. Re. claim 18, however, see 112(b) below. It is believed claim 18 was intended to depend on claim 16 and should therefore also be withdrawn.
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.
Claim(s) 3, 9, 11, 12, 18 is/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 3 refers to “first segment” and “second segment.” However, it is unclear whether the segments are intended to be temporal or spatial. Claim 2 recites “curing a first segment of the first firing” which indicates a temporal segment, but then claim 3 recites “the second segment is distal to the first segment,” indicating a spatial segment. Further clarification is required.
Claim 9 recites “the different staple cartridge type.” There is insufficient antecedent basis for this limitation in the claim. It is assumed this was intended to depend on claim 8.
Claim 11 recites “a proximal[distal] portion of the first firing.” The firing is an event, and proximal and distal portions are spatial regions. It is unclear how an event can have proximal/distal portions.
Similarly, claim 12 refers to spatial characteristics of the firing event and is thus unclear.
Claim 18 recites “the second period,” “the first period,” “the dropped voltage potential,” and “the power source lower threshold.” There is insufficient antecedent basis for this limitation in the claim. It is assumed that this claim was intended to depend from claim 16, in which case it is drawn to a non-elected embodiment.
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.
Claim(s) 1-3, 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. [US 2019/0201020 A1, hereinafter “Shelton,” embodiment of Fig. 97] in view of Hazelton et al. [US 2020/0315735 A1, hereinafter “Hazelton”].
Re. claim 1 , Shelton discloses a method [Fig. 97] for firings of staple cartridges, the sequential firings including a first firing that deploys first staples into a first tissue portion from a first staple cartridge [150304, Fig. 25], and a second firing [Par. 0009 describes sequential stapling in different zones], wherein the method comprises:
monitoring a parameter [tissue impedance] indicative of a tissue response associated with the first firing [“Receiving sensor signals from the sensor circuits,” Step 25032, Fig. 97];
assessing the tissue response based on the parameter [“Determining tissue impedance…based on the received sensor signals,” Step 25034]; and
adjusting an operational parameter associated with the second firing based on the tissue response during the first firing “Proceed at standard closure rate,” step 25042, or “Proceed at a slower closure rate,” step 25044. Note that the adjustment is necessarily associated with a second firing, as it cannot adjust a firing previously implemented].
The method of Shelton differs from the claimed method in that Shelton fails to teach the second staple cartridge (used in a sequential firing to a second tissue portion).
However, Hazelton discloses a method for sequential firings of staple cartridges, the sequential firings including a first firing that deploys first staples into a first tissue portion from a first staple cartridge, and a second firing that deploys second staples into a second tissue portion from a second staple cartridge [Par. 0052. The “first staple cartridge” has staples which are deployed in a first area, and when those staples are depleted, that cartridge is replaced by a “second staple cartridge” which “can be used to further perform the surgical procedure.” Note that by necessity the staples are inherently placed in a different area], wherein the method comprises: monitoring a parameter associated with the first firing [“properties,” such as “state of compression of a material, a desiccation level of the material,” Par. 0088]; and adjusting an operational parameter associated with the second firing based on the tissue response during the first firing [Par. 0088]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton by using a second cartridge, performing sequential firing and using the method of Shelton to adjust the operation al parameter associated with the second firing, as taught by Hazelton, in order to allow the first cartridge to be replaced with a second one to provide “a new set of staples that can be used to further perform the surgical procedure,” [Hazleton Par. 0052].
Re. claim 2, Shelton discloses the tissue response is a first tissue response [Z.tissue of inner zone, Fig. 97] assessed during a first segment [stapling of Zone 3, Fig. 90] of the first firing, and wherein the method further comprises implementing a first adjustment to an output of the motor based on the first tissue response during the first segment of the first firing [Force to close, Par. 0622-0623].
Re. claim 3, as best understood, Shelton discloses implementing a second adjustment to the output of the motor during a second segment [firing in Zone 2/intermediate zone] of the first firing, wherein the second segment is distal to the first segment [Fig. 90], and wherein the second adjustment is based on an effectiveness of the first adjustment [Pars. 0630].
Re. claim 11, as best understood, Shelton discloses monitoring the parameter comprises:
determining a first value of the parameter at a proximal portion of the first firing [z.sub.tissue of inner zone, Fig. 97]; and determining a second value of the parameter at a distal portion of the first firing [z.sub.tissue of outer zone, Fig. 97].
Re. claim 12, as best understood, Shelton discloses the first firing comprises a proximal firing region [zone 3, Fig. 90] and a distal firing region [Zone 1, Fig. 90], wherein assessing the tissue response comprises determining a change in the tissue response between the proximal firing region and the distal firing region [Fig. 97, step 25038].
Re. claim 13, Shelton discloses adjusting the operational parameter associated with the second firing is based on the change in the tissue response between the proximal firing region and the distal firing region [Fig. 97, steps 25038 to 25044[.
Claim(s) 1, 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton [embodiment of Fig. 64] in view of Hazelton.
[Alternate application] Re. claim 1, Shelton discloses a method for firings of staple cartridges, the sequential firings including a first firing that deploys first staples into a first tissue portion from a first staple cartridge [150304, Fig. 25], and a second firing [Par. 0009 describes sequential stapling in different zones], wherein the method comprises:
monitoring a parameter indicative of a tissue response associated with the first firing [“Time based monitoring of the plurality of sensors,” Par. 0515, which include strain gauges, Par. 0515];
assessing the tissue response based on the parameter [Par. 0515 describes how the sensor information, including the force measurement, determines tissue thickness, placement, and/or material properties]; and
adjusting an operational parameter associated with the second firing based on the tissue response during the first firing [“dynamically adjust the end effector…and/or tissue clamped between the anvil…and the staple cartridge,” Par. 0515. Note that the adjustment is necessarily associated with a second firing, as it cannot adjust a firing previously implemented].
The method of Shelton differs from the claimed method in that Shelton fails to teach the second staple cartridge (used in a sequential firing to a second tissue portion).
However, Hazelton discloses a method for sequential firings of staple cartridges, the sequential firings including a first firing that deploys first staples into a first tissue portion from a first staple cartridge, and a second firing that deploys second staples into a second tissue portion from a second staple cartridge [Par. 0052. The “first staple cartridge” has staples which are deployed in a first area, and when those staples are depleted, that cartridge is replaced by a “second staple cartridge” which “can be used to further perform the surgical procedure.” Note that by necessity the staples are inherently placed in a different area], wherein the method comprises: monitoring a parameter associated with the first firing [“properties,” such as “state of compression of a material, a desiccation level of the material,” Par. 0088]; and adjusting an operational parameter associated with the second firing based on the tissue response during the first firing [Par. 0088]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton by using a second cartridge, performing sequential firing and using the method of Shelton to adjust the operation al parameter associated with the second firing, as taught by Hazelton, in order to allow the first cartridge to be replaced with a second one to provide “a new set of staples that can be used to further perform the surgical procedure,” [Hazleton Par. 0052].
Re. claim 4, Shelton discloses assessing the tissue response based on the parameter comprises comparing a reading of a sensor to a predetermined threshold [Par. 0487].
Re. claim 5, Shelton discloses the parameter is a force exerted against the drive shaft [Par. 0355].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton [either of the above embodiments] in view of Hazelton, as applied to claim 1 above, and further in view of Fitzsimmons et al. [US 20150305729 A1, hereinafter “Fitzsimmons”].
Re. claim 6, Shelton discloses the method set forth above but is silent re. adjusting the operational parameter comprises adjusting a predetermined threshold. However, Fitzsimmons teaches, in a method for filing staple cartridges, adjusting an operational parameter comprises adjusting a predetermined threshold [See Fig. 5, Par. 0012]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Shelton by, in the step of adjusting the operational parameter, further adjust a predetermined threshold as taught by Fitzsimmons in order to determine the end of life of the device, adjusting the threshold based on continually aggregated data [Fitzsimmons Pars. 0011-0012].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton [either of the above embodiments] in view of Hazelton, as applied to claim 1 above, and further in view of Shelton IV et al. [US 20170296173 A1, hereinafter “Shelton ‘173”]
Re. claim 7, Shelton discloses the method set forth above but is silent re. adjusting the operational parameter being conditioned upon receiving an adjustment approval through a user interface. However, Shelton ‘173 teaches adjusting parameters being conditioned upon receiving an adjustment approval through a user interface [Par. 0427]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton by requiring approval of adjustment of operational parameters through a user interface in order to improve the safety of the operation.
Claim(s) 8-9, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton [either of the above embodiments] in view of Hazelton, as applied to claim 1 above, and further in view of Zemlok [US 20150209035 A1].
Re. claim 8, Shelton discloses the method set forth above but is silent re. detecting an identifier of the second cartridge. Zemlok teaches, in a method of surgical stapling, 8. The method of Claim 1, wherein adjusting the operational parameter associated with the second firing comprises: detecting an identifier of a staple cartridge [Par. 0156]; determining a staple cartridge type of the staple cartridge based on the identifier [Par. 0154].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton so that adjusting the operational parameter associated with the second firing comprises: detecting an identifier of the second staple cartridge; determining a staple cartridge type of the second staple cartridge based on the identifier as taught by Zemlok in order to allow the system to automatically provide appropriate force and other parameters for the detected staple type.
Re. recommending a different staple cartridge type for the second firing based on the tissue response in the first firing, Shelton discloses the system making “suggestions to the surgeon during the course of the surgical procedure.” [Par. 0579] Given the above teachings, it would have been obvious to modify the system to recommend a different staple cartridge type [of the detected size, length, etc., Zemlok Par. 0154] based on the response from the first firing if the system determines the results from the first firing would benefit from a different type of staple cartridge.
Re. claim 9, as best understood, the modified Shelton discloses the different staple cartridge type comprises a different staple-size than the second staple cartridge [Shelton as modified by Zemlok above. Given that the size is detected, selecting the appropriate size would have been obvious as set forth above in order to ensure that a proper size of staple is used.
Re. claim 14, Shelton discloses the method set forth above but is silent re. adjusting the operational parameter associated with the second firing is further based on a temperature of a motor measured during the first firing. However, Zemlok teaches detecting a temperature of a motor measured during a first firing [Par. 0121]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton such that adjusting the operational parameter associated with the second firing is further based on a temperature of a motor measured during the first firing in order to “ensure safe operation of the instrument” [Zemlok Par. 0121].
Re. claim 15, Shelton discloses the method set forth above but is silent re. adjusting the operational parameter associated with the second firing is further based on a voltage condition of a battery during the first firing. However, Zemlok teaches detecting a voltage condition of a battery during a first firing [Par. 0194]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton such that adjusting the operational parameter associated with the second firing is further based on a voltage condition of a battery during the first firing because this allows the system to “indicate when a damaging limitation is reached or approached” [Zemlok Par. 0194].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton [either of the above embodiments] in view of Hazelton, as applied to claim 1 above, and further in view of Harris et al. [US 20190200981 A1, hereinafter “Harris”].
Re. claim 10, Shelton discloses the method set forth above but is silent re. adjusting the operational parameter further comprises modifying the operational parameter in response to an override input through a user interface. However, Harris teaches, in a method of operating a surgical stapler, adjusting an operational parameter further comprises modifying an operational parameter in response to an override input through a user interface [Par. 0731]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shelton by configuring adjusting the operational parameter further comprises modifying the operational parameter in response to an override input through a user interface, as taught by Harris, in order to allow a user to better control the function of the stapler.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771