DETAILED ACTION
This office action is in response to the communication received on 08/29/2025 concerning application no. 19/314,133 filed on 08/29/2025.
Claims 1-9 are pending.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“acquire the tissue information from an intracorporeal device located in an area associated with the tissue” in claim 4: Paragraph 0023 discloses “As the intracorporeal device 10, for example, an existing implantable device such as a pacemaker may be used. The intracorporeal device 10 may be covered with, for example, a film attached to the surface of damaged tissue, a biomimetic surface with a surfactant polymer, or the like.” Paragraph 0026 discloses “The intracorporeal device 10 includes a first sensor 11 and a first transmitter 12. The first sensor 11 detects tissue information indicating a state of tissue related to a disease in the body of the subject. The first sensor 11 corresponds to, for example, a sensor that detects mechanical characteristics of lesional tissue or surrounding tissue. Specifically, the first sensor 11 is implemented as an acceleration sensor that detects the acceleration of the lesional tissue or the surrounding tissue, a temperature sensor that detects the temperature of the lesional tissue or the surrounding tissue, a pressure sensor that detects the pressure of the lesional tissue or the surrounding tissue, or the like. For the sake of specific description, the first sensor 11 is described as an acceleration sensor. In this case, the tissue information corresponds to the acceleration (intracorporeal acceleration) of the lesional tissue or the surrounding tissue.”
“acquire the body surface information from an extracorporeal device located outside the body of the subject” in claim 4: Paragraphs 0030-31 disclose “Further, the extracorporeal device 20 may be incorporated in, for example, a sensor (an electrocardiographic sensor or the like) that measures an electrocardiogram of the subject P. For the sake of specific description, the extracorporeal device 20 is described as a device that is attached to the subject P. The extracorporeal device 20 includes a second sensor 21 and a second transmitter 22. The second sensor 21 detects body surface information indicating a state of the body surface of the subject P. The second sensor 21 corresponds to, for example, a sensor that detects mechanical characteristics of the body surface of the subject P. Specifically, the second sensor 21 is implemented as an acceleration sensor that detects the acceleration (extracorporeal acceleration) of the body surface of the subject P, a temperature sensor that detects the temperature of the body surface of the subject P, a pressure sensor that detects the pressure of the body surface of the subject P, or the like. For the sake of specific description, the second sensor 21 is described as an acceleration sensor. In this case, the body surface information corresponds to the acceleration of the body surface of the subject P.”
“acquire body motion information indicating a body motion of the subject from a body motion detection device configured to detect a body motion of the subject” in claim 5: Paragraph 0094 discloses “Examples of the body motion detection device include an electrocardiogram monitor, a respirometer, and a pulse rate meter.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 4 is 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.
Claim 4 recites “acquire the body surface information by inputting the tissue information to a trained model”. While paragraph 0048 discloses that the tissue information can be from a trained model and that the model can be trained in advance1, the specification does not disclose the manner of training for the performance of the acquisition and inputting the tissue information. For example, type of machine learning {e.g. supervised machine learning, unsupervised machine learning, self-supervised machine learning, reinforcement learning, semi-supervised learning, etc.} and/or architecture {e.g. layers, weights, feedback, feedforward, kernel, etc.} of the machine learning in sufficient details to inform one of ordinary skill the intended function of the system.For example, type of neural network {e.g. convolution, recurrent, perceptron, Long Short-Term Memory, Generative Adversarial Network, etc.} and/or architecture {e.g. layers, weights, feedback, feedforward, kernel, etc.} of the neural network in sufficient details to inform one of ordinary skill the intended function of the system. However, the specification does not describe how the data is input or out, how it is analyzed or manipulated, what elements of the data are considered, what weighting considerations are given, or what parameters are being used in the algorithm. In conclusion, the specification provides no written support on what the algorithm is, how it is utilized, or how it functions with the information fed into it. Due to this, the claim contains subject matter that is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor or joint inventor had possession of the claim invention at the time of filing.
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 2 and 5-7 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 2 is indefinite for the following reasons:
Recites “fluid or air around the tissue”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art in what manner air is distinct from a fluid. Air is a fluid2. It would be unclear to one with ordinary skill in the art if the claim is referring to a fluid or air specifically.
Applicant is encouraged to provide consistent and clear language.
Claim 5 is indefinite for the following reasons:
Recites “a body motion”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “body motion” is the same as the “body motion” established in the preceding claim element or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 6 is indefinite for the following reasons:
Recites “a disorder”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “disorder” is the same as the “disease” established in claim 1 or is a separate and distinct feature. If it is the later, it would be unclear to one with ordinary skill in the art in what manner a disorder is distinct from a disease as the disease is an abnormality of the body.
Applicant is encouraged to provide consistent and clear language.
Claim 7 is indefinite for the following reasons:
The term “body motion becomes small based on the body motion information” is a relative term which renders the claim indefinite. The term “small” 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. It would be unclear to one with ordinary skill in the art what constitutes as sufficient to be considered small such that it prompts the acquisition step.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biological tissue information processing apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “compare the tissue information with the body surface information and calculate a result of a comparison between the tissue information and the body surface information; estimate a change in characteristics of the tissue based on a temporal change of the result of the comparison”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the comparison of tissue information with body surface information and determining a result that is the basis of estimation of a change in tissue characteristic. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “processing circuitry configured to: acquire tissue information indicating a state of tissue related to a disease in a body of a subject, and body surface information indicating a state of a body surface of the subject; control a terminal to display an estimation result of the change in the characteristics of the tissue”. The acquisition of tissue information and body surface information is a data gathering step that is a form of a pre-solution insignificant activity. Display of the estimation result is a display step that merely amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biological tissue information processing apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the characteristics include hardness of the tissue and accumulation of fluid or air around the tissue”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of a characteristic that is the hardness and accumulation of fluid. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biological tissue information processing apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “perform matching on the acquisition date and time of the tissue information with the acquisition date and time of the body surface information; and calculate, as the result of the comparison, a difference between the tissue information and the body surface information for each of the acquisition dates and times using the matched tissue information and the body surface information”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to performance of matching according to acquisition and time of tissue information and the calculation for the difference in information. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the tissue information and the body surface information include an acquisition date and time of the tissue information and an acquisition date and time of the body surface information, respectively, and wherein the processing circuitry is further configured to”. The information acquisition of the time and date is a data gathering step that is a form of a pre-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 3 is ineligible.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 4 recites the following elements: “wherein the processing circuitry is further configured to: acquire the tissue information from an intracorporeal device located in an area associated with the tissue; and acquire the body surface information from an extracorporeal device located outside the body of the subject, or acquire the body surface information by inputting the tissue information to a trained model”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 4 is ineligible.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biological tissue information processing apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “correct the tissue information using the body motion information; and compare the corrected tissue information with the body surface information and calculate the result of the comparison”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to correction of tissue information and the comparison of the corrected information. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processing circuitry is further configured to: acquire body motion information indicating a body motion of the subject from a body motion detection device configured to detect a body motion of the subject”. The acquisition of body motion information is a data gathering step that is a form of a pre-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biological tissue information processing apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “estimate a state corresponding to a disorder in the tissue based on the estimation result”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to an estimation of a state relating to a disorder. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the processing circuitry is further configured to: control the terminal to display the state of the disorder”. Control of a terminal for a display is a display step that merely amounts to a post-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 6 is ineligible.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 7 recites the following elements: “wherein the processing circuitry is further configured to: acquire body motion information indicating a body motion of the subject from a body motion detection device configured to detect a body motion of the subject; and acquire the tissue information and the body surface information at a predetermined timing when the body motion becomes small based on the body motion information”. This claim element is a mere data gathering step which amounts to a pre-solution insignificant activity. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a biological tissue information processing method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “comparing the tissue information with the body surface information and calculating a result of a comparison between the tissue information and the body surface information; estimating a change in characteristics of the tissue based on a temporal change of the result of the comparison”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the comparison of tissue information with body surface information and determining a result that is the basis of estimation of a change in tissue characteristic. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “acquiring tissue information indicating a state of tissue related to a disease in a body of a subject, and body surface information indicating a state of a body surface of the subject; and controlling a terminal to display an estimation result of the change in the characteristics of the tissue”. The acquisition of tissue information and body surface information is a data gathering step that is a form of a pre-solution insignificant activity. Display of the estimation result is a display step that merely amounts to a post-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a non-transitory computer-readable storage medium storing a biological tissue information processing program and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “compare the tissue information with the body surface information and calculate a result of a comparison between the tissue information and the body surface information; estimate a change in characteristics of the tissue based on a temporal change of the result of the comparison”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the comparison of tissue information with body surface information and determining a result that is the basis of estimation of a change in tissue characteristic. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “acquire tissue information indicating a state of tissue related to a disease in a body of a subject, and body surface information indicating a state of a body surface of the subject; and control a terminal to display an estimation result of the change in the characteristics of the tissue”. The acquisition of tissue information and body surface information is a data gathering step that is a form of a pre-solution insignificant activity. Display of the estimation result is a display step that merely amounts to a post-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
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, 4-5, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strommer et al. (PGPUB No. US 2001/0031919).
Regarding claim 1, Strommer teaches a biological tissue information processing apparatus comprising processing circuitry configured to:
acquire tissue information indicating a state of tissue related to a disease in a body of a subject, and body surface information indicating a state of a body surface of the subject (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal);
compare the tissue information with the body surface information and calculate a result of a comparison between the tissue information and the body surface information; estimate a change in characteristics of the tissue based on a temporal change of the result of the comparison; and control a terminal to display an estimation result of the change in the characteristics of the tissue (Paragraphs 0109-11 teaches the detection of the 2D image with the location and orientation with respect to the organ timing signal. This uses the ECG and associates it with each detected image with the location and orientation information. The images are modified to provide a reconstruction of the information without the artifacts and a complete 3D organ. Paragraph 0117 teaches the display of the selected 3D time in real time and in accordance with the organ timing signal cycle).
Regarding claim 4, Strommer teaches the biological tissue information processing apparatus in claim 1, as discussed above.
Strommer further teaches a biological tissue information processing apparatus, wherein the processing circuitry is further configured to:
acquire the tissue information from an intracorporeal device located in an area associated with the tissue; and acquire the body surface information from an extracorporeal device located outside the body of the subject, or acquire the body surface information by inputting the tissue information to a trained model (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal).
Regarding claim 5, Strommer teaches the biological tissue information processing apparatus in claim 1, as discussed above.
Strommer further teaches a biological tissue information processing apparatus, wherein the processing circuitry is further configured to:
acquire body motion information indicating a body motion of the subject from a body motion detection device configured to detect a body motion of the subject (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal);
correct the tissue information using the body motion information; and compare the corrected tissue information with the body surface information and calculate the result of the comparison (Paragraph 0013 teaches that the ECG system detects the timing of the heart and synchs or triggers the recording of the imaging for select time points. This provides the imaging of a specific slice of the heart at a specific activity level and the location and orientation of the images can be determined).
Regarding claim 8, Strommer teaches a biological tissue information processing method comprising:
acquiring tissue information indicating a state of tissue related to a disease in a body of a subject, and body surface information indicating a state of a body surface of the subject (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal);
comparing the tissue information with the body surface information and calculating a result of a comparison between the tissue information and the body surface information; estimating a change in characteristics of the tissue based on a temporal change of the result of the comparison; and controlling a terminal to display an estimation result of the change in the characteristics of the tissue (Paragraphs 0109-11 teaches the detection of the 2D image with the location and orientation with respect to the organ timing signal. This uses the ECG and associates it with each detected image with the location and orientation information. The images are modified to provide a reconstruction of the information without the artifacts and a complete 3D organ. Paragraph 0117 teaches the display of the selected 3D time in real time and in accordance with the organ timing signal cycle).
Regarding claim 9, Strommer teaches a non-transitory computer-readable storage medium storing a biological tissue information processing program for causing a computer to:
acquire tissue information indicating a state of tissue related to a disease in a body of a subject, and body surface information indicating a state of a body surface of the subject (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal);
compare the tissue information with the body surface information and calculate a result of a comparison between the tissue information and the body surface information; estimate a change in characteristics of the tissue based on a temporal change of the result of the comparison; and control a terminal to display an estimation result of the change in the characteristics of the tissue (Paragraphs 0109-11 teaches the detection of the 2D image with the location and orientation with respect to the organ timing signal. This uses the ECG and associates it with each detected image with the location and orientation information. The images are modified to provide a reconstruction of the information without the artifacts and a complete 3D organ. Paragraph 0117 teaches the display of the selected 3D time in real time and in accordance with the organ timing signal cycle).
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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (PGPUB No. US 2001/0031919) in view of Kano et al. (PGPUB No. US 2015/0327780).
Regarding claim 2, Strommer teaches the biological tissue information processing apparatus in claim 1, as discussed above.
However, Strommer is silent regarding a biological tissue information processing apparatus, wherein the characteristics include hardness of the tissue and accumulation of fluid or air around the tissue.
In an analogous imaging field of endeavor, regarding diagnostic imaging, Kano teaches a biological tissue information processing apparatus, wherein the characteristics include hardness of the tissue and accumulation of fluid or air around the tissue (Paragraph 0068 teaches the index can reflect the vasculature hardness. Paragraph 0066 teaches that the functional index can reflect the FFR. Paragraph 0045 teaches application in multiple modalities).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Strommer with Kano’s teaching of characteristics including hardness and fluid accumulation. This modified apparatus would allow the user to have improve precision in image analysis (Paragraph 0313 of Kano). Furthermore, the modification provides the stress strain relationship of the vasculature and further understanding to the tissue dynamics (Paragraphs 0066-71 of Kano).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (PGPUB No. US 2001/0031919) in view of Tran et al. (US Patent No. 10,998,101).
Regarding claim 3, Strommer teaches the biological tissue information processing apparatus in claim 1, as discussed above.
Strommer further teaches a biological tissue information processing apparatus, wherein the tissue information and the body surface information include a time of the tissue information and a time of the body surface information, respectively, and wherein the processing circuitry is further configured to: perform matching on the acquisition date and time of the tissue information with the time of the body surface information; and calculate, as the result of the comparison, a difference between the tissue information and the body surface information for each of the times using the matched tissue information and the body surface information (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal. Paragraphs 0109-11 teaches the detection of the 2D image with the location and orientation with respect to the organ timing signal. This uses the ECG and associates it with each detected image with the location and orientation information. The images are modified to provide a reconstruction of the information without the artifacts and a complete 3D organ. Paragraph 0117 teaches the display of the selected 3D time in real time and in accordance with the organ timing signal cycle).
However, Strommer is silent regarding a biological tissue information processing apparatus, the utilization of acquisition dates.
In an analogous imaging field of endeavor, regarding diagnostic imaging, Tran teaches a biological tissue information processing apparatus, the utilization of acquisition dates;
calculate, as the result of the comparison, a difference between the tissue information and the body surface information for each of the acquisition dates and times using the matched tissue information and the body surface information (Col. 50, lines 9-40, teaches the determination of a trend and comparison of data points with a first and last value and the comparison based on time and date and the assessment of a past or current date and the time delta).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Strommer with Tran’s teaching of use of acquisition dates. This modified apparatus would allow the user to improve the health and consideration of the blood characteristics (Col. 1, lines 16-53 of Tran). Furthermore, the modification provides assessment of the trends over a period of time and consideration of past data (Col. 50, lines 9-40 of Tran).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (PGPUB No. US 2001/0031919) in view of Huennekens et al. (PGPUB No. US 2006/0241465).
Regarding claim 6, Strommer teaches the biological tissue information processing apparatus in claim 1, as discussed above.
However, Strommer is silent regarding a biological tissue information processing apparatus, wherein the processing circuitry is further configured to: estimate a state corresponding to a disorder in the tissue based on the estimation result; and control the terminal to display the state of the disorder.
In an analogous imaging field of endeavor, regarding diagnostic imaging, Huennekens teaches a biological tissue information processing apparatus, wherein the processing circuitry is further configured to: estimate a state corresponding to a disorder in the tissue based on the estimation result; and control the terminal to display the state of the disorder (Paragraph 0051 teaches the display of the image with the disease state of the vessel segment and the location with respect to the patient).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Strommer with Huennekens’s teaching of display of a disease state. This modified apparatus would allow the user to have instant awareness of both disease state and the location (Paragraph 0051 of Huennekens). Furthermore, the modification ensures proper treatment of diseased vessels and verify the efficacy of treatment (Paragraph 0003 of Huennekens).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Strommer et al. (PGPUB No. US 2001/0031919) in view of Hamilton (PGPUB No. US 2010/0081937).
Regarding claim 7, Strommer teaches the biological tissue information processing apparatus in claim 1, as discussed above.
Strommer further teaches a biological tissue information processing apparatus, wherein the processing circuitry is further configured to: acquire body motion information indicating a body motion of the subject from a body motion detection device configured to detect a body motion of the subject (Paragraphs 0146-49 teaches the use of IVUS for imaging the organ over a period of time. Paragraph 0148 teaches that IVUS is imaging the coronary arterial interior for diagnosis. Paragraphs 0063-68 teach the ultrasound of the image transducer to image the organ and define the spatial and orientation. Paragraphs 0069-70 teach the ultrasound of ECG to assess the cardiac motion of the heart. Paragraph 0115 teaches the detection of the organ timing signal).
However, Strommer is silent regarding a biological tissue information processing apparatus, acquire the tissue information and the body surface information at a predetermined timing when the body motion becomes small based on the body motion information.
In an analogous imaging field of endeavor, regarding diagnostic imaging, Hamilton teaches a biological tissue information processing apparatus, acquire the tissue information and the body surface information at a predetermined timing when the body motion becomes small based on the body motion information (Paragraph 0012 teaches that a trigger can be thresholded according to the signal for the determination of the cardiac cycle and defining the time window for integration. The assessment can based on amplitude thresholding or timing conditions).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Strommer with Hamilton’s teaching of acquiring based on body motion. This modified apparatus would allow the user to have real time feedback for the data acquisition and the measure of signal and tissue state (Paragraph 0005 of Hamilton). Furthermore, the modification allows for dynamic determination and identification (Paragraph 0012 of Hamilton).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kovacs et al. (PGPUB No. US 2007/0208262): Teaches assessment of the body movement and the tissue information for diagnosis.
Nakayama et al. (PGPUB No. US 2015/0374265): Teaches assessment of the body movement and the tissue information for diagnosis.
Silver et al. (PGPUB No. US 2019/0224434): Teaches assessment of the body movement and the tissue information for diagnosis.
Yui (PGPUB No. US 2011/0038520): Teaches assessment of the body movement and the tissue information for diagnosis.
Lee et al. (PGPUB No. US 2005/0074741): Teaches assessment of the body movement and the tissue information for diagnosis.
Jafari et al. (PGPUB No. US 2014/0230818): Teaches assessment of the body movement and the tissue information for diagnosis.
Barash et al. (PGPUB No. US 2020/0305759): Teaches assessment of the body movement and the tissue information for diagnosis.
Tupin et al. (PGPUB No. US 2011/0060215): Teaches assessment of the body movement and the tissue information for diagnosis.
Strommer et al. (PGPUB No. US 2006/0058647l): Teaches assessment of the body movement and the tissue information for diagnosis.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 “As a modified example of the present exemplary embodiment, the acquisition function 34a may input tissue information to a trained model and acquire body surface information from the trained model. In this case, the trained model is trained in advance and is stored in the memory 33. The acquisition function 34a may acquire the body surface information from the tissue information using statistical analysis processing in place of a trained model.”
2 1. “having particles that easily move and change their relative position without a separation of the mass and that easily yield to pressure: capable of flowing” 2. “a substance (such as a liquid or gas) tending to flow or conform to the outline of its container (Link: https://www.merriam-webster.com/dictionary/fluid)
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