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 .
A complete action on the merits of pending claims 1-15 appears herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 6-13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/810,222 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims comprise overlapping subject matter with minor grammatical differences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6-13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-15 of copending Application No. 18/810,407 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims comprise overlapping subject matter with minor grammatical differences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 are not being rejected under 35 U.S.C. 101 abstract idea because the selection of the activation mode is considered a practical application.
Claims 11-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims can be seen as “signals per se” as the processor can be interpreted as not just a hardware component.
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 3 is 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.
The term “rapid” in claim 3 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, any recitation of repeated jaw closures is interpreted as reading on the claimed “sequence of rapid jaw closures.”
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(s) 1, 5, and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (US 2017/0202591 A1).
Regarding claim 1, teaches a method for a surgical instrument configured to operate in a first activation mode associated with radio frequency (RF) energy (Par. [0404]: RF modality) and a second activation mode associated with ultrasonic energy, (Par. [0404]: Ultrasonic energy modality) the method comprising:
monitoring first data from a first data source and second data from a second data source; (Par. [0404]: Tissue thickness is measured using a combination of at least two measured tissue parameters)
detecting an actuation event of a button of the surgical instrument; (Par. [0403]: Multiple switches may be used, each with different functions such as activating the ultrasonic transducer and/or the RF energy)
selecting, based on the first data and the second data, an activation mode from the first activation mode and the second activation mode; and (Par. [0404]: A change in energy modality between an RF energy modality and an Ultrasonic energy modality is based on the tissue thickness based on the at least two measured tissue parameters)
delivering, in response to the actuation event, an energy of an energy output modality associated with the selected activation mode. (Par. [0403]: Multiple switches may be used, each with different functions such as activating the ultrasonic transducer and/or the RF energy)
Regarding claims 11, the claim is similarly rejected to claims 1 above over Shelton as the processor merely executes the method steps. The system of claim 11 further claims a processor which is taught by Shelton see Fig. 69, element 1952: microcontroller.
Regarding claim 5, Shelton further teaches the first data comprises mechanical data from the surgical instrument, (Par. [0404]: jaw gap sensing) and the second data comprises electrical data, (Par. [0404]: impedance) and the method further comprises:
determining, based on the mechanical data, a jaw of the surgical instrument is closed; (Par. [0428]) and
determining, based on the electrical data, whether an impedance of a tissue located in the jaw of the surgical instrument is above a threshold impedance, wherein, upon a determination that the impedance of the tissue is above the threshold impedance, selecting the activation mode comprises selecting the first activation mode. (Par. [0422])
Regarding claim 8, Shelton further teaches initiating, in response to the actuation event, a data retrieval mode, wherein the data retrieval mode comprises requesting third data (Par. [0393]: instructions) from a third data source, (Par. [0393]: memory) wherein selecting the activation mode is further based on the third data. (Par. [0393]: Processor (1954) of microcontroller (1952) retrieves instructions from memory (1956) to perform functions/calculations, which would include determination/selection of the operating mode.)
Regarding claim 9, Shelton further teaches detecting a second actuation event associated with the surgical instrument; (Par. [0403]: Multiple switches may be used, each with different functions such as opening/closing the jaws) and initiating, in response to the second actuation event, a tissue analysis mode, (Par. [0404]: The measurement/determination of tissue thickness/type) wherein the tissue analysis mode comprises requesting third data from a third data source, wherein the third data includes a tissue condition indication of a tissue in contact with the surgical instrument, (Par. [0393]: Processor (1954) of microcontroller (1952) retrieves instructions from memory (1956) to perform functions/calculations, which would include determination of the tissue thickness/type) wherein selecting the activation mode is further based on the tissue condition indication. (Par. [0405])
Regarding claim 10, Shelton further teaches detecting an interruption in monitoring the first data; (Par. [0404]: The sensing of the parameters used to determine tissue thickness would stop when said thickness is determined.) and initiating, in response to the detected interruption, a data retrieval mode, wherein the data retrieval mode comprises requesting third data from a third data source, wherein selecting the activation mode is further based on the third data. (Par. [0393]: Processor (1954) of microcontroller (1952) retrieves instructions from memory (1956) to perform functions/calculations, which would include determination/selection of the operating mode.)
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 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(s) 2, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), as applied to claims 1 and 11 above, and further in view of Washington (US 2004/0267252 A1).
Regarding claims 2, 12, and 13 , Shelton, as applied to claims 1 and 11 above, teaches, and the second data comprises electrical data from the surgical instrument, (Par. [0404]: A tissue thickness is determined at least partially based on current from the motor) and the method further comprises: determining a tissue characteristic; (Par. [0404]: determining tissue thickness) and, selecting the activation mode is further based on the determined tissue characteristic. (Par. [0404]: A change in energy modality between an RF energy modality and an Ultrasonic energy modality is based on the tissue thickness)
Washington, in a similar field of endeavor, teaches using an imaging modality to determine a thickness of a target tissue. (Par. [0033])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton, as applied to claim 1 above, to incorporate the teachings of Washington, and use an imaging modality to view the target treatment zone and determine the thickness of the target tissue; and to compare the tissue thickness measured via the imaging modality of Washington with the tissue thickness measured via the at least two parameters of Shelton. Including the imaging modality of Washington would allow for the treatment zone to be visualized by the user, thereby allowing for easier navigation/placement of the forceps of Shelton. Taking two thickness measurements and comparing them would ensure the accuracy of said thickness measurements, minimizing the risk of setting energy parameters based on incorrect data.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), as applied to claim 1 above, and in view of Washington (US 2004/0267252 A1) further in view of Hibner (US 2016/0089175 A1).
Regarding claims 3, Shelton, as applied to claim 1 above, teaches the first data comprises mechanical data from the surgical instrument, (Par. [0404]: jaw gap sensing) and the method further comprises:
determining a tissue thickness of a tissue within a jaw of the surgical instrument, (Par. [0404]) wherein, upon a determination that the tissue thickness is above a thickness threshold, selecting the activation mode comprises selecting the second activation mode. (Claim 14: The system differentiates between a thick tissue and a thin tissue; There would be a thickness threshold separating a “thin” tissue from a “thick” tissue.)
Shelton further teaches determining a tissue thickness based at least partially on behavior of a force applied to the tissue by at least one jaw member. (Claims 10 and 13)
Shelton, as applied to claim 1 above, is silent regarding the second data comprising visual data from an imaging system, and the method further comprising determining the mechanical data indicates a sequence of rapid jaw closures; and the determination of the tissue thickness being based on the visual data from the imaging system.
Washington, in a similar field of endeavor, teaches using an imaging modality to determine a tissue thickness. (Par. [0033])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton, as applied to claim 3 above, to incorporate the teachings of Washington, and determine the tissue thickness via an imaging modality. Doing so would be a simple substitution of one thickness determination mechanism for another for the predictable result of measuring a thickness of a target tissue.
The combination of Shelton/Washington, as applied to claim 3 above, is silent regarding method further comprising determining the mechanical data indicates a sequence of rapid jaw closures.
Hibner, in a similar field of endeavor, teaches measuring a compression force applied to a target tissue via jaw members by opening and closing said jaw members at least two times such that a cyclical compression force is applied to said tissue. (Par. [0012])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Shelton/Washington, as applied to claim 3 above, to incorporate the teachings of Hibner, and determine the clamping force by opening and closing said jaw members at least two times such that a cyclical compression force is applied to the claimed tissue. Doing so would be a simple substitution of one force measurement procedure for another for the predictable result of measuring a clamping force applied to a target tissue.
Claim(s) 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), as applied to claims 1 and 11 above, in view of Madan (US 2017/0172608 A1) and further in view of Friedrich (US 2018/0132839 A1).
Regarding claims 4 and 14, Shelton, as applied to claims 1 and 11 above, teaches the first data comprises mechanical data from the surgical instrument, (Claim 10) and the method further comprises:
determining the mechanical data indicates a jaw force of a jaw of the surgical instrument; (Claim 10) and
Shelton, as applied to claim 1 above, is silent regarding the second data comprising visual data from an imaging system; and determining, based on the visual data from the imaging system, whether blade deflection of a blade of the surgical instrument has occurred, wherein, upon a determination that blade deflection has occurred, selecting the activation mode comprises selecting the second activation mode.
Madan, in a similar field of endeavor, teaches detecting levels of deflection of an ultrasonic blade and using said detected levels to determine a pressure experienced by said blade; (Par. [0050])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton, as applied to claim 4 above, to incorporate the teachings of Madan, and determine the clamping force using a sensed deflection of the ultrasonic blade. Doing so would be a simple substitution of one clamping force/presser measurement mechanism for another for the predictable result of determining the clamping force applied by the jaw member/ultrasonic blade of Shelton.
In this combination, because the measured tissue characteristic is determined based on the detected force/pressure, the selection of either the RF energy modality or the ultrasonic energy modality would be considered to be based on the detected blade deflection and associated force/pressure.
The combination of Shelton/Madan, as applied to claim 4 above, is silent regarding the second data comprises visual data from an imaging system; and the blade deflection being detected based on said visual data.
Friedrich, in a similar field of endeavor, teaches using a camera system to detect a deflection of clamping arm portions, and to convert said detected deflection into a force reading. (Par. [0160])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Shelton/Madan, as applied to claim 4 above, to incorporate the teachings of Friedrich, and use an imaging system to determine the blade deflection of the ultrasonic blade of Shelton. Doing so would be a simple substitution of one deflection detection method for another for the predictable result of determining the deflection in the ultrasonic blade of Shelton.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), as applied to claim 1 above, and further in view of Price (US 2015/0141981 A1).
Regarding claim 6, Shelton, as applied to claim 1 above, is silent regarding selecting the activation mode further comprises: determining a predicted activation mode based on the first data; and determining whether the predicted activation mode is consistent with the second data, wherein, upon a determination that the predicted activation mode is consistent with the second data, the predicted activation mode is selected.
Price, in a similar field of endeavor, teaches determining a predicted activation mode based on first and second data data; (Page 6, Table 1 and Par. [0049]: The perceived surgical intent for is determined based at least partially on clamp arm position and tissue presence) and determining whether the predicted activation mode is consistent with the first and second data, wherein upon determination that the predicted activation mode is consistent with the first and second data, the predicted activation mode is selected. (Par. [0050] – [0052]: Controller (118) selects/determines the appropriate predicted surgical intent based on the clamp arm position (first data) and the tissue presence (second data) and selects operating parameters according to said intent.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton, as applied to claim 1 above, to incorporate the teachings of Price, and configure the microcontroller of Shelton to select the appropriate predicted surgical intent using the data of Table 1 of Price, including the clamp arm position and tissue presence. Doing so would minimize the number of inputs required by a user to configure the system of Shelton to perform the surgical procedures listed in Table 1 of Price, thereby saving time.
Claim(s) 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2017/0202591 A1), as applied to claim 1 and 11 above, and further in view of Nau (US 2014/0121507 A1).
Regarding claims 7 and 15, Shelton, as applied to claims 1 and 11 above, teaches indicating the selected activation mode via at least one of an audible indication, a visual indication, or haptic feedback. (Par. [0233]: A display provides a visual display of surgical procedure parameters)
Shelton, as applied to claim 7 above, is silent regarding receiving a user feedback indication; and determining the user feedback indication is a confirmation of the selected activation mode, wherein, delivering the energy of the energy modality associated with the selected activation mode is based on the confirmation.
Walke, in a similar field of endeavor, teaches receiving a user feedback indication confirming a selected operating mode prior to energy delivery in said mode. (Par. [0144])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Shelton, as applied to claim 7 above, to incorporate the teachings of Walke, and configure the user interface of Shelton to receive a user input confirming selection of the activation mode prior to delivery of energy in said mode. Doing so would allow a user to double check the operating parameters prior to energy delivery and would minimize the risk of accidentally delivering energy to a target tissue in the wrong activation mode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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