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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 19, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8, 9, 11, 19, 28-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The Examiner cannot find “a pre-trained …,” (note that a trained estimation model is supported but it is possible that the scope of a trained estimation model is different than a pre-trained estimation model. Applicant has not explained if they are the same or different), “…based on threshold probability output from the model” and “automatically stop” from the Originally filed Spec.
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 8, 9, 11, 19, 28-36 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.
In re claims 8 and 19, and dependent claims thereafter, the term “high” in these claims is a relative term which renders the claim indefinite. The term “high” 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. The Examiner will just interpret it as any frequency.
In re claims 9 and 30, it is unclear what the metes and bounds of limitation “a resistance of the body tissue as obtained by multiplying the phase difference to the impedance value” are. Is this just a mathematical algorithm? So does this mean R (resistance) = delta Phase * Z (impedance)? The Spec. has not explained how this limitation is being mathematically modeled any differently than the standard Z = R + jX, where Z is impedance, R is resistance, and j is 90 phase shift and X is the reactance.
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) 8, 9, 11, 19, 28-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Timm et al. (US 2013/0267975, hereinafter Timm ‘975) in view of Wolf et al. (US 2020/0237452, hereinafter Wolf ‘452).
In re claims 8 and 19, Timm ‘975 teaches a control device comprising a processor, the processor being configured to:
obtain output information comprising ultrasonic and high-frequency electrical characteristics including current, voltage, and impedance values from an energy treatment tool when an energy is being applied from the energy treatment tool to a body tissue to affect an incision (0352, 0401, 0461, 0488, 0490);
input the output information to a pre-trained estimation model generated by which is a machine learning, which can be either supervised or non-supervise, it would have been obvious to choose either as a design choice) using training data comprising electrical characteristics and incision-completion labels (0352, 0401, 0461, 0488, 0490); repeatedly evaluate the output information in real time using the estimation model incision completion based on threshold probability output from the model (0574-0575, 0611, 0624, 0625); and when evaluation of the output information determines the incision is complete, automatically stop the energy being applied from the energy treatment tool (0207, deactivate is “stop”, 0305, 0308, 0328, 0447, 0449-0451).
Wolf ‘452 also teaches input the output information to a pre-trained estimation model generated by supervised
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Timm ‘975 to include the features of Wolf ‘452 in order to identify particular surgical procedures, surgical phases, intraoperative events, and/or event characteristics appearing in the video footage.
In re claims 9 and 30, Timm ‘975 teaches:
wherein the current is an electric current value to be supplied to an ultrasound transducer or to a pair of electrodes which generates the energy in the energy treatment tool (0467, 0468, 0469),
wherein the voltage is a voltage value to be supplied to the ultrasound transducer or to the pair of electrodes (0467-068),
wherein impedance values is an impedance value of the body tissue as calculated from the electric current value and the voltage value or an ultrasound impedance value calculated from the electric current value and the voltage value (0179, 0180, 0198), and
wherein the electrical characteristics further include:
an electric power value to be supplied to the ultrasound transducer or to the pair of electrodes (0181, 0184-0188, 0197, 0218, 0228, 0235, 0237 etc.),
frequency of electric current or frequency of voltage to be supplied to the ultrasound transducer (0256, 0258, 0261, 0262, 0267, 0268, 0271, 273-0275, etc.),
a phase difference between electric current and voltage to be supplied to the pair of electrodes (0275),
elapsed time since start of application of the ultrasound energy to the body tissue (0341-0345, 0383, 0424).
But Timm ‘975 teaches the impedance value (0179, 0180, 0198) and phase difference (0275) as shown.
It is known mathematical formular that: Z (impedance) = R + j X, wherein Z is impedance, R is resistance, and X is the reactance, and j would be the phase shift.
Hence, it would have been obvious to obtain the resistance from “multiplying the phase difference to the impedance value” which is a standard math algorithm. It would have been a design choice to choose the resistance value in order to include additional data for machine learning to obtain more data learning experience for better decision making.
In re claim 11, Timm ‘975 teaches further comprising: a first power source configured to output a first driving signal to the ultrasound transducer in the energy treatment tool for causing generation of the ultrasound current or voltage (0445, 0457, 0493, 0495), and a second power source configured to output a second driving signal to the pair of electrodes in the energy treatment tool for causing generation of the HF current or voltage (0256, 0258, 0330, 0447-0450, 0453, etc.).
In re claims 28 and 31, Timm ‘975 teaches wherein the output information further includes a photography data (0479) and a label (0318, 0498), wherein the photography data is obtained from an imaging element and includes information on the energy treatment tool and the body tissue (0479), and wherein the label indicates whether the incision is complete (0182, 0305, 0381, 0447, 0449, 0451, 0488, 0500, 0501).
Wolf ‘452 also teaches wherein the output information further includes a photography data (0420, 0421, photograph can be in anyone of jpeg, png, tiff, from camera’s video/image data) and a label (0116, note that the video footage is merely multiple frames of photography data; 0268), wherein the photography data is obtained from an imaging element and includes information on the energy treatment tool and the body tissue (0268), and wherein the label indicates whether the incision is complete (0156, 0268, 0330-0333, 0357, 0363, 0381, 0687).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Timm ‘975 to include the features of Wolf ‘452 in order to identify particular surgical procedures, surgical phases, intraoperative events, and/or event characteristics appearing in the video footage.
In re claims 29 and 32, Timm ‘975 teaches wherein the impedance values include an ultrasound impedance value calculated from the electric current value and the voltage value (0439-0442), and wherein the electrical characteristics further include elapsed time since start of application of the ultrasound energy to the body tissue (0466, 0468).
In re claims 33 and 35, Timm ‘975 teaches wherein the estimation model is generated by
Furthermore, Wolf ‘452 teaches wherein the estimation model is generated by supervised machine learning using training data comprising electrical characteristics (0093), imaging data (0116, note that the video footage is merely multiple frames of photography data; 0268), and incision-completion labels (0156, 0268, 0330-0333, 0357, 0363, 0381, 0687).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Timm ‘975 to include the features of Wolf ‘452 in order to identify particular surgical procedures, surgical phases, intraoperative events, and/or event characteristics appearing in the video footage.
In re claims 34 and 36, Timm ‘975 teaches wherein the processor is configured to obtain imaging data of the body tissue during energy application and input the imaging data together with the electrical characteristics to the estimation model (0205, 0479, 0624, input variables).
Wolf ‘452 also teaches wherein the processor is configured to obtain imaging data of the body tissue during energy application and input the imaging data together with the electrical characteristics to the estimation model (0105-0107, 0114, 0115)
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Timm ‘975 to include the features of Wolf ‘452 in order to identify particular surgical procedures, surgical phases, intraoperative events, and/or event characteristics appearing in the video footage.
Response to Arguments
Applicant’s arguments with respect to claim(s) 8, 9, 11, 19, 28-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM 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, ANNE M KOZAK can be reached at (571) 270-0552. 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.
/BO JOSEPH PENG/ Primary Examiner, Art Unit 3797
Prosecution Insights