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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 - 12) in the reply filed on 2/2/2026 is acknowledged.
Claims 13 - 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/2/2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to because “a” should be removed from “a one or more networks of remote servers” (line 5).
Claims 1, 4, 5, 6, and 7 are objected to because “doppler shifted” should be amended to recite “Doppler-shifted”.
Appropriate correction is required.
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 1 - 12 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 1 is indefinite because there is unclear antecedent basis for “at least one blood flow sample” in the last line. It is unclear if this is the blood flow sample that is recited in the previous paragraph.
Claim 2 is indefinite because it is unclear what is meant by “sample frequency rate”. It is unclear if the term is intended to refer to a sample rate or a sample frequency. For the purposes of examination, the term will be interpreted as intending either.
Claim 2 is indefinite because there is unclear antecedent basis for “the sample frequency”. It is unclear if this is the “sample frequency rate”.
Claim 2 is indefinite because it is unclear how “the sample frequency is predetermined or manually adjusted by a clinician or any other operator” relate to “defining a sample frequency rate”. It is unclear if the claim attempts to require that the method includes a step of ‘predetermining the sample frequency’ in addition to the step of “defining a sample frequency rate”, or if these are the same step. Similarly, it is unclear if the claim attempts to require that the method includes a step of ‘adjusting the sample frequency’ in addition to the step of “defining a sample frequency rate”, or if these are the same step.
Claim 3 is indefinite by virtue of dependency.
Claim 4 is indefinite because it is unclear what method step or material modification thereof is intended by the narrative recitation that the “doppler shifted signal is returned to a transmitter/receiver.” It is unclear if the claim attempts to recite a method step or to modify the previously recited receiving step.
Claim 5 is indefinite because it is unclear what is meant by a “doppler shifted probe’. It is unclear how a probe, rather than a signal, may undergo a Doppler shift.
Claim 5 is indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “any form of a vascular probe”, and the claim also recites “a doppler shifted probe” and “a cook probe”, which is/are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 is indefinite because there is unclear antecedent basis for “a integrated storage device”. It is unclear if this is the integrated storage device that is recited in claim 1.
Claim 6 is indefinite because it is unclear what is intended by “applying a waveform pattern recognition filter”. The term “pattern recognition filter” does not correspond to a known term in the art of Doppler signal processing. It is unclear if the claim intends to require (1) ‘filtering the waveform’ (i.e., applying a filter to the waveform) to produce a filtered waveform having components thereof altered and/or removed; or (2) application of a pattern recognition technique to the waveform to produce a determination of a recognized pattern therein, which is not understood int eh art as a “filter” per se. For the purposes of examination, the limitation will be interpreted as intending either. It is noted that the specification provides no specific examples of any “filter” in the context of pattern recognition, but explains that “pattern recognition algorithms determine a waveform pattern is abnormal” ([0038], as published).
Claim 7 is indefinite because the claim narrates functions of the signal processor. It is unclear if the claim attempts to set forth that the method comprises steps of performing the narrated activities, or if the claim merely attempts to describe characteristics of the signal processor without setting forth any additional method steps.
Claim 8 is indefinite because there is unclear antecedent basis for “blood flow status is”. It is unclear if this is the “qualitative blood flow status”, the “quantitative blood flow status”, or some other blood flow status.
Claim 8 is indefinite because there is unclear antecedent basis for “the blood flow sample”. It is unclear if this is the sample in the third paragraph f claim 1, or the “at least one blood flow sample”.
Claim 10 is indefinite because there is unclear antecedent basis for “the blood flow status is”. It is unclear if this is the “qualitative blood flow status”, the “quantitative blood flow status”, or some other blood flow status.
Claim 10 is indefinite because it is unclear what is meant by “determining … systemic blood flow further comprises utilizing the blood flow conversion factor”. The claim has not set forth a step of “determining … systemic blood flow”. It is unclear how the step may be further limited, since the step is not recited as being part of the claimed method.
Claims 11 - 12 are indefinite by virtue of dependency.
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 - 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a mental-process type abstract idea) without significantly more.
Independent claim 1:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., an ultrasound system.
With regard to Step 2A: Prong 1, the claim recites a limitation directed towards ‘determining a qualitative blood flow status or a quantitative blood flow status of the free tissue flap with at least one blood flow sample’.
As drafted, this limitation amounts to nothing more than a step that can practically be performed in the human mind and/or with the aid of pen/paper. For example, a human can ‘determine the qualitative or quantitative blood flow status’ by thinking about the blood flow sample, or information derived by processing the blood flow sample in some way (e.g., a graph, chart, etc., depicting features of the blood flow sample), and arriving at a conclusion about the blood flow status, and/or can perform the determination with the aid of pen and paper. Therefore, the limitation recites a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements directed towards ‘receiving a doppler shifted signal’, which is mere extra-solution activity (i.e., data-gathering). The claim also recites that the signal is “from a probe installed at least partially in a free tissue flap”, which merely limits the judicial exception to a particular technological environment or field of use. The claim further recites “storing the doppler shifted signal in an integrated storage device or uploading the doppler shifted signal in a one or more networks of remote servers”, which is further extra-solution activity. The claim also recites “processing at least part of the doppler shifted signal on the integrated storage device or on the one or more networks of remote servers with a signal processor to form a blood flow sample of the free tissue flap”, which is a generic processing step that would be required in any implementation of the method to render the Doppler-shifted signal usable by a computer for analysis, and is therefore considered to amount to no more than an instruction to implement the judicial exception on a computer and/or extra-solution activity. Consequently, the additional elements, when considered separately and in combination, do not integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations comprise extra-solution activity, limitations of the judicial exception to a particular technological environment or field of use, and instructions to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Dependent claims:
claim 2 recites additional limitations directed towards ‘defining a sample frequency rate’, which reads on a mental step that can practically be performed in the human mind and/or with the aid of pen/paper. The claim further recites “wherein the sample frequency is predetermined or manually adjusted by a clinician or any other operator”, which merely limits the judicial exception to a particular technological environment or field of use.
claim 3 recites additional limitations directed towards “applying power to a blood flow monitor”, which is extra-solution activity.
claim 4 recites additional limitations directed towards “the doppler shifted signal is returned to a transmitter/receiver”, which merely limits the judicial exception to a particular technological environment or field of use.
claim 5 recites additional limitations directed towards the probe being “any form of a doppler shifted probe, any form of a vascular probe, and/or a cook probe”, which merely limits the judicial exception to a particular technological environment or field of use.
claim 6 recites additional limitations directed towards “applying a waveform pattern recognition filter to a generated waveform produced from the doppler shifted signal”. The limitations are interpreted as reading on a mental step of recognizing a pattern (i.e., the outcome of the step of “applying a waveform pattern recognition filter …”), which can practically be performed in the human mind and/or with the aid of pen/paper. The specific feature of the use of the ‘filter’ is a description if implementing the step on a computer, and is therefore is interpreted as an instruction to implement the judicial exception on a computer. The claim further recites “saving the waveform in a file on a integrated storage device or the one or more networks of remote servers”, which is extra-solution activity. It is noted that the claimed step is disembodied from the claimed method, as the waveform is not used in any way int eh claimed method.
claim 7 recites additional limitations directed towards receiving and amplifying the doppler shifted signal with a doppler receiver amplifier, which is extra-solution activity. The claim further recites limitations directed towards ‘multiplying a reference signal received from a reference signal generator with the doppler shifted signal to form a blood flow signal’, which is a mathematical function. The claim further recites limitations directed towards ‘sampling the blood flow signal to obtain a blood flow sample’, which reads on a mental step that can practically be performed in the human mind and/or with the aid of pen/paper.
samples the blood flow signal to obtain a blood flow sample
claim 8 recites additional limitations directed towards blood flow status being “determined by computing an energy sample value from the blood flow sample and comparing the energy sample value to a dip value and setting the energy sample value to the dip value if the energy sample value is less than the dip value”, which reads on a mental step that can practically be performed in the human mind and/or with the aid of pen/paper.
claim 9 recites additional limitations directed towards “a blood flow conversion factor is determined based on tissue of the free tissue flap”, which reads on a mental step that can practically be performed in the human mind and/or with the aid of pen/paper.
claim 10 recites additional limitations directed towards “determining the blood flow status of the free tissue flap and/or systemic blood flow further comprises utilizing the blood flow conversion factor”, which merely modifies the judicial exception, and does not preclude the step from being practically performed in the human mind and/or with the aid of pen/paper.
claim 11 recites additional limitations directed towards “the quantitative blood flow status is systematic blood flow”, which merely modifies the judicial exception, and does not preclude the step from being practically performed in the human mind and/or with the aid of pen/paper.
claim 12 recites additional limitations directed towards “the qualitative blood flow status is whether there is blood flow within a blood vessel of free tissue flap”, which merely modifies the judicial exception, and does not preclude the step from being practically performed in the human mind and/or with the aid of pen/paper.
Therefore, when considered separately and in combination, the limitations of the dependent claims do not integrate the judicial exception into a practical application, or result in the claims amounting to significantly more than the judicial exception.
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 1 - 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dillon et al. (US 2023/0127280).
Regarding claim 1, Dillon shows a method comprising:
receiving a Doppler-shifted signal (sound data from Doppler probe 46, [0034] - note that the signal is ‘Doppler-shifted’ due to the flow of blood, as is understood in the art) from a probe (Doppler probe 46, [0027]; Cook-Swartz Doppler probes, [0028] and fig. 2) installed at least partially in a free tissue flap (“sensor 40 contacting a first blood vessel 42 of a tissue flap 44”, [0027] and fig. 2);
storing the Doppler-shifted signal in an integrated storage device or uploading the doppler shifted signal in a network of a remote server (“data received from the first sensor … recorded … network …remote storage device”, [0037]. Also note the received signal is necessarily stored in memory prior to and during its analysis);
processing at least part of the Doppler-shifted signal on the integrated storage device or on the network with a signal processor to form a blood flow sample of the free tissue flap (“translating data from a sensor such that it can be displayed using a visual display field on a blood flow monitor… digital to analog processor”, [0037] - the analyzed data are the “blood flow sample”); and
determining a qualitative blood flow status or a quantitative blood flow status of the free tissue flap with the blood flow sample (blood flow over time, [0035] - [0036]; “data relating to blood flow of a blood vessel included in a tissue flap, tissue health, …”, [0039]).
Regarding claim 2, Dillon discloses the claimed invention substantially as noted above. Dillon further shows defining a sample frequency rate, wherein the sample frequency is predetermined or manually adjusted by a clinician or any other operator, as the data are necessarily sampled with a defined sampling frequency, such that the step of ‘defining’ the frequency is implicit; and the sampling frequency is necessarily predetermined and/or adjusted by the user.
Regarding claim 3, Dillon discloses the claimed invention substantially as noted above. Dillon further shows applying power to a blood flow monitor (“moving the blood flow monitor from an off state to an on state to observe the blood flow”, [0034]).
Regarding claim 4, Dillon discloses the claimed invention substantially as noted above. Dillon further shows the Doppler-shifted signal is returned to a transmitter/receiver, as the probe is a Doppler probe (Doppler probe 46, [0027]; Cook-Swartz Doppler probes, [0028] and fig. 2) that transmits sound waves to the blood vessel and receives the Doppler-shifted signal from the blood therein. The probe therefore comprises a transmitter/receiver for the transmission and reception.
Regarding claim 5, Dillon discloses the claimed invention substantially as noted above. Dillon further shows the probe is any form of a doppler shifted probe, any form of a vascular probe, and/or a cook probe (Doppler probe 46, [0027]; Cook-Swartz Doppler probes, [0028] and fig. 2).
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dillon in view of Kanayama et al. (US 2012/0136248).
Regarding claim 6, Dillon discloses the claimed invention substantially as noted above.
Dillon fails to show applying a waveform pattern recognition filter to a generated waveform produced from the Doppler-shifted signal and saving the waveform in a file on an integrated storage device or the one or more networks of remote servers.
Kanayama discloses ultrasound diagnosis. Kanayama teaches applying a waveform pattern recognition filter (wall filter, [0164]) to a generated waveform produced from a Doppler-shifted signal and saving the waveform in a file on an integrated storage device ([0060]; [0138]).
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 invention of Dillon to include applying a waveform pattern recognition filter to a generated waveform produced from the Doppler-shifted signal and saving the waveform in a file on an integrated storage device, as taught by Kanayama, in order to process the signal appropriately for analysis and keep a copy of the signal, as is understood in the art.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dillon in view of Nishihara (US 2022/0405885).
Regarding claim 7, Dillon discloses the claimed invention substantially as noted above. Dillon further shows that the signal processor samples a blood flow signal to obtain a blood flow sample ([0037]).
Dillon fails to show the signal processor receives and amplifies the Doppler-shifted signal with a Doppler receiver amplifier; and multiplies a reference signal received from a reference signal generator with the Doppler-shifted signal to form the blood flow signal.
Nishihara discloses ultrasound diagnosis. Nishihara teaches a signal processor that receives and amplifies a Doppler-shifted signal with a Doppler receiver amplifier ([0032]); and multiplies a reference signal received from a reference signal generator with the Doppler-shifted signal to form a blood flow signal (“…multiply the reception signal by a reference signal … blood flow”, [0034]).
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 invention of Dillon to have the signal processor receive and amplify the Doppler-shifted signal with a Doppler receiver amplifier; and multiply a reference signal received from a reference signal generator with the Doppler-shifted signal to form the blood flow signal, as taught by Nishihara, in order to process the signal appropriately for analysis, as is understood in the art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dillon and Nishihara as applied to claim 7 above, and further in view of Srinivasan et al. (US 2008/0097212).
Regarding claim 8, the combined invention of Dillon and Nishihara discloses the claimed invention substantially as noted above.
Dillon fails to show blood flow status is determined by computing an energy sample value from the blood flow sample and comparing the energy sample value to a dip value and setting the energy sample value to the dip value if the energy sample value is less than the dip value.
Srinivasan discloses ultrasound diagnosis. Srinivasan teaches blood flow status is determined by computing an energy sample value from the blood flow sample and comparing the energy sample value to a dip value and setting the energy sample value to the dip value if the energy sample value is less than the dip value (“… ultrasound data representing flow that are below a display threshold are increased to values above the display threshold for the flow region. Velocity (V) and energy (E) estimates that are non-zero and less than the display threshold (displays are weighted or replaced…”, [0022]).
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 combined invention of Dillon and Nishihara to have blood flow status be determined by computing an energy sample value from the blood flow sample and comparing the energy sample value to a dip value and setting the energy sample value to the dip value if the energy sample value is less than the dip value, as taught by Srinivasan, in order to fill in holes in flow information, as suggested by Srinivasan ([0022]).
In the interest of compact prosecution, it is noted that while the prior art is interpreted as meeting the claim as discussed above, the prior art need not teach “setting the energy sample value to the dip value if the energy sample value is less than the dip value” in order to meet the claim, as the ‘setting’ is a contingent limitation. See MPEP 2111.04.II and Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016).
Claims 9 - 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dillon, Nishihara, and Srinivasan as applied to claim 8 above, and further in view of Dwarakaprasad et al. (US 2023/0132333).
Regarding claims 9 - 10, the combined invention of Dillon, Nishihara, and Srinivasan discloses the claimed invention substantially as noted above.
Dillon fails to determining the blood flow status of the free tissue flap comprises utilizing a blood flow conversion factor determined based on tissue of the free tissue flap.
Dwarakaprasad discloses calibrating a blood flow monitoring device. Dwarakaprasad teaches determining a blood flow status of a free tissue flap ([0037]) comprises utilizing a blood flow conversion factor (frequency response curve, [0033]) determined based on tissue of the free tissue flap.
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 combined invention of Dillon, Nishihara, and Srinivasan to have determining the blood flow status of the free tissue flap comprise utilizing a blood flow conversion factor determined based on tissue of the free tissue flap, as taught by Dwarakaprasad, in order to calibrate the blood flow monitor, as suggested by Dwarakaprasad ([0005]).
Claims 11 - 12 are rejected under 35 U.S.C. 103 as being unpatentable over Dillon in view of McCanna et al. (US 2023/0190124).
Regarding claim 11, Dillon discloses the claimed invention substantially as noted above.
Dillon fails to show the quantitative blood flow status is systematic blood flow.
McCanna discloses measuring blood flow. McCanna teaches a quantitative blood flow status is systematic blood flow (heart rate, [0040]).
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 invention of Dillon to have the quantitative blood flow status be systematic blood flow, as taught by McCanna, in order to indicate if the flap is well-perfused and the patient is effectively recovering post-surgery, as suggested by McCanna ([0040]).
Examiner notes that the prior art need not teach the “qualitative blood flow status” in order to meet claim 12, as the “qualitative blood flow status” is recited only in the alternative. Nevertheless, in the interest of compact prosecution, an art rejection is being provided.
Regarding claim 12, Dillon discloses the claimed invention substantially as noted above.
Dillon is not specific to the qualitative blood flow status being whether there is blood flow within a blood vessel of free tissue flap.
McCanna discloses measuring blood flow. McCanna teaches a qualitative blood flow status is whether there is blood flow within a blood vessel of free tissue flap (‘… “poor” perfusion values are characterized by a signal that completely lacks a pulsatile component (see, for example, the signal before about 30 seconds in FIG. 9), or features a sporadic, non-periodic pulsatile component or quasi-periodic pulsatile component that does not match the patient’s true heart rate’, [0040]).
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 invention of Dillon to have the qualitative blood flow status be whether there is blood flow within a blood vessel of free tissue flap, as taught by McCanna, in order to indicate if the flap is well-perfused and the patient is effectively recovering post-surgery, as suggested by McCanna ([0040]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
Prosecution Insights