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 .
Response to Amendment
Acknowledgment is made to the amendment received 1/20/2026.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive. Regarding claims 1 and 14, applicant argues that Jürgens does not disclose the claim language because Jürgens does not disclose a system wherein an operation parameter is detected and a type of use of a surgical instrument is identified based on a pattern parameter. However, Jürgens uses an image evaluation unit to receive image data of the surgical field. The imagery of the surgical field, which depicts the location of the device, is an operation parameter that is detected. The structure and situation analysis described in paragraph [0036] of Jürgens describes a pattern parameter. Thus, Jürgens does disclose a system wherein an operation parameter is detected and a type of use of a surgical instrument is identified. Additionally, regarding the amended claim language, the claim states “wherein the type of use comprises: a total duration from a beginning of a surgical operation to a termination of the surgical operation, at least one activation duration during the total duration …, and at least one deactivation duration during the total duration …”. The “total duration” here is considered the entire time that the patient is in the operating room. Thus, while the device is being placed, as described in paragraph [0031] of Jürgens, the device has not been activated yet. This is therefore considered a deactivation duration that occurs during the total duration. Also, while the device is retracted from the target tissue, it is also not activated, thus, this is another deactivation duration during the total duration. Paragraph [0033] of Jürgens describes supplying energy to an electrode and this is considered an activation duration that occurs during the total duration. Thus, Jürgens does disclose the amended claim language. Also, while Jürgens uses image detection and evaluation to perform its method of operation, there is no claim language that prevents a system like the one disclosed in Jürgens from reading on the claim language, even if applicant’s specification does not describe image detection. Thus, Jürgens does read on the amended claim language and the previous rejection of claims 1 and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Jürgens stands.
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 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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jürgens et al., US 20220233229, herein referred to as “Jürgens”.
Regarding claim 1, Jürgens discloses a surgical system comprising: a surgical instrument adapted to influence tissue (Figure 1: handheld HF surgical instrument 20), a surgical apparatus configured to connect to the surgical instrument ([0033]: “The HF electrode 22 of the handheld HF surgical instrument 20 is connected via a supply cable 26 to a HF generator 30 that supplies the HF electrode 22 with HF energy. ”) and having a control unit (Figure 3: processor 204) configured to control at least one operation parameter of the surgical instrument ([0033-[0034]), an evaluation unit communicatively connected to the surgical apparatus (Figure 1: image evaluation unit 50), wherein the evaluation unit is configured to identify a currently carried out or a planned type of use of the surgical instrument ([0036]) based on at least one pattern parameter (Figure 2 and [0037]: “During the selection of the suitable HF mode 106.sup.1-4, a quality of the anatomical structure can be taken account of in addition to the size or intensity of a bleeding. It is therefore possible to select a suitable HF mode 106.sup.1-4, in the suggestion unit 54, from a set 106 of preset HF modes of the HF generator 30, which is either made available to the operating surgeon for selection or is automatically implemented.”) for comparison to the at least one operation parameter for determination and initiation of at least one measure to be carried out depending on the result of the comparison (Figures 2-3 and [0037]: “The surgeon can be made aware of the change in the HF mode 106.sup.1-4 or of another parameter acoustically or audiovisually, for example by a voice which announces the change and the adjusted HF mode 106.sup.1-4.” And [0038]-[0039]); wherein the type of use comprises: a total duration from a beginning of a surgical operation to a termination of the surgical operation (A total duration of a surgical operation is the entire time the patient is in the operating room), at least one activation duration during the total duration during which the surgical instrument is activated and influences the tissue ([0033]), and at least one deactivation duration during the total duration during which the surgical instrument is deactivated and not used for influencing the tissue (While the patient is in the operating room, the device is not activated until it is placed at the target tissue; [0031]: “the handheld HF surgical instrument 20 and the endoscope 40 are introduced through two trocars 12, 14 through the abdominal wall 2 of the patient into the abdomen”).
Regarding claim 2, Jürgens discloses the surgical system according to claim 1, wherein the type of use is characterized by a temporal sequence of settings of the at least one operation parameter ([0038]-[0039]).
Regarding claim 3, Jürgens discloses the surgical system according to claim 1, wherein the at least one operation parameter comprises an electrical signal provided to the surgical instrument and/or a fluid parameter of a fluid provided to the surgical instrument and/or an optical signal provided to the surgical instrument (Figure 1: video endoscope 40 and [0034]).
Regarding claim 4, Jürgens discloses the surgical system according to claim 1, wherein the at least one operation parameter can comprise one or more of the following operation parameters ([0037] and Figure 2): an amplitude or a frequency of an electrical output signal provided to the surgical instrument ([0033]: “The HF generator 30 is configured to generate the HF energy in various HF modes with various waveforms, voltages, frequencies, etc. ”), a crest factor of the electrical output signal, a duty cycle of the electrical output signal if the electrical output signal is pulse width modulated, a wave form or a mode of the electrical output signal ([0013]: “Depending on the type of the HF electrode of the handheld HF surgical instrument, this may be the selection of a monopolar or bipolar mode, for example one of the coagulation modes available for selection, or an operating parameter such as the HF voltage, HF waveform or the admission or suppression of an acoustic or audiovisual “seal incomplete” signal.”), a fluid pressure and/or a volume flow rate of a fluid provided to the surgical instrument.
Regarding claim 5, Jürgens discloses the surgical system according to claim 1, wherein the evaluation unit is configured to modify the operation parameter or at least one of the operation parameters as the at least one measure (Figures 2-3 and [0037]: “It is therefore possible to select a suitable HF mode 106.sup.1-4, in the suggestion unit 54, from a set 106 of preset HF modes of the HF generator 30, which is either made available to the operating surgeon for selection or is automatically implemented. The surgeon can be made aware of the change in the HF mode 106.sup.1-4 or of another parameter acoustically or audiovisually, for example by a voice which announces the change and the adjusted HF mode 106.sup.1-4.”).
Regarding claim 6, Jürgens discloses the surgical system according to claim 1, wherein the evaluation unit is further configured to determine a deviation between the operation parameter or at least one of the operation parameters and the respectively assigned pattern parameter as result or as one of the results of the comparison ([0038]: “If the calculated probability that the blood vessel approached is to be sealed is low, then an acoustic or audiovisual warning signal which displays an incomplete sealing can be suppressed.”).
Regarding claim 7, Jürgens discloses the surgical system according to claim 6, wherein the evaluation unit is further configured to determine and initiate the measure or one of the measures, if the deviation fulfills a deviation criterion ([0038]: “If the calculated probability that the blood vessel approached is to be sealed is low, then an acoustic or audiovisual warning signal which displays an incomplete sealing can be suppressed. This probability can be calculated, taking account of the progression of the approach, in particular a decreasing approach speed or pausing at the blood vessel. Conditions of the blood vessel approached can also be taken account of, in particular whether it is skeletized, which would be indicative of a high probability that the blood vessel is to be closed.”).
Regarding claim 8, Jürgens discloses the surgical system according to claim 1, wherein the evaluation unit is configured to output information as measure or as at least one of the measures, wherein the information can comprise one or more of the following pieces of information: warning about a deviation of the at least one operation parameter from the at least one pattern parameter ([0037]: “The surgeon can be made aware of the change in the HF mode 106.sup.1-4 or of another parameter acoustically or audiovisually, for example by a voice which announces the change and the adjusted HF mode 106.sup.1-4.”), recommendation referring to a change of the operation parameter or at least one of the operation parameters, information referring to one or more steps to be carried out subsequently, information referring to one or more required resources for one or more steps to be subsequently carried out, or information referring to a time duration for one or more steps to be subsequently carried out.
Regarding claim 9, Jürgens discloses the surgical system according to claim 1, wherein the surgical apparatus is connected to a data management system by a communication network (Figure 3: computer-based clinical decision support system (CDSS) 200 and [0043]-[0044]).
Regarding claim 10, Jürgens discloses the surgical system according to claim 9, wherein the evaluation unit is configured to receive a piece of information from the data management system prior to the start of using the surgical instrument ([0037]: “This would, for example, identify blood vessels as well as the bleeding in image 102.sup.1 and, in addition to the bleeding, the surface of the liver as well as, if applicable, further tissue types in image 102.sup.2. The bleeding can then be attributed, on the basis of its position in the respective image 102.sup.1,2, to the blood vessel or the liver. ”), which identifies the planned type of use ([0037]: “During the selection of the suitable HF mode 106.sup.1-4, a quality of the anatomical structure can be taken account of in addition to the size or intensity of a bleeding. It is therefore possible to select a suitable HF mode 106.sup.1-4, in the suggestion unit 54, from a set 106 of preset HF modes of the HF generator 30, which is either made available to the operating surgeon for selection or is automatically implemented.”).
Regarding claim 11, Jürgens discloses the surgical system according to claim 9, wherein the surgical apparatus is configured to store the at least one of the operation parameters during use of the surgical instrument or to transmit the at least one of the operation parameters to the data management system ([0041] and [0044]: “For example, the input interface 202 may transmit captured images directly to the CDSS during a therapeutic and/or diagnostic medical procedure. ”).
Regarding claim 12, Jürgens discloses the surgical system according to claim 1, wherein the evaluation unit is further configured to determine the at least one operation parameter during use of the surgical instrument and to compare it with the at least one pattern parameter of multiple usage patterns and to identify the currently carried out type of use in case of determination of a sufficient similarity between the at least one operation parameter and the at least one pattern parameter ([0009] and [0017] and [0038]).
Regarding claim 13, Jürgens discloses the surgical system according to claim 12, wherein the evaluation unit is configured to determine an assessment of the use of the surgical instrument, which is carried out as result of the comparison ([0035]-[0036]).
Regarding claim 14, Jürgens discloses a method of operating a surgical system (Figure 1 and Abstract), wherein the surgical system comprises a surgical apparatus and a surgical instrument connected thereto ([0033]: “The HF electrode 22 of the handheld HF surgical instrument 20 is connected via a supply cable 26 to a HF generator 30 that supplies the HF electrode 22 with HF energy. ”), wherein the surgical apparatus comprises a control unit (Figure 3: processor 204) configured to control at least one operation parameter of the surgical instrument ([0033-[0034]), wherein the method comprises: identifying a currently carried out or planned type of use of the surgical instrument ([0036]), wherein the type of use comprises: a total duration from a beginning of a surgical operation to a termination of the surgical operation (A total duration of a surgical operation is the entire time the patient is in the operating room), at least one activation duration during the total duration during which the surgical instrument is activated and influences the tissue ([0033]), and at least one deactivation duration during the total duration during which the surgical instrument is deactivated and not used for influencing the tissue (While the patient is in the operating room, the device is not activated until it is placed at the target tissue; [0031]: “the handheld HF surgical instrument 20 and the endoscope 40 are introduced through two trocars 12, 14 through the abdominal wall 2 of the patient into the abdomen”), assigning at least one pattern parameter to the type of use ([0038]-[0039]), comparing the at least one operation parameter of the type of use with the at least one pattern parameter and determining and initiating at least one measured to be carried out depending on a result of the comparison (Figure 2 and [0037]: “During the selection of the suitable HF mode 106.sup.1-4, a quality of the anatomical structure can be taken account of in addition to the size or intensity of a bleeding. It is therefore possible to select a suitable HF mode 106.sup.1-4, in the suggestion unit 54, from a set 106 of preset HF modes of the HF generator 30, which is either made available to the operating surgeon for selection or is automatically implemented. “The surgeon can be made aware of the change in the HF mode 106.sup.1-4 or of another parameter acoustically or audiovisually, for example by a voice which announces the change and the adjusted HF mode 106.sup.1-4.”).
Regarding claim 15, Jürgens discloses the surgical system according to claim 1, wherein the control unit is further configured to set one or more of the at least one operation parameter during each of the at least one activation duration ([0037]: “It is therefore possible to select a suitable HF mode 106.sup.1-4, in the suggestion unit 54, from a set 106 of preset HF modes of the HF generator 30, which is either made available to the operating surgeon for selection or is automatically implemented. The surgeon can be made aware of the change in the HF mode 106.sup.1-4 or of another parameter acoustically or audiovisually, for example by a voice which announces the change and the adjusted HF mode 106.sup.1-4.” And [0038]-[0039]; wherein the claim language only required one activation duration).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794