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 .
This communication is in response to the amendment received on 12/10/2025. Claims 17-20 have been newly added. Therefore, claims 1-20 remain pending in this application.
The objection for claim 1 has been withdrawn in light of the amendment.
The 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejection of claims 1-16 has been withdrawn in light of the amendments.
The claims have been amended, however, the amendments have not been marked as required per MPEP 37 CFR 1.121, and a Miscellaneous Communications has been submitted to the Applicant. No response has been received, and Examiner marked the amendments based on comparison on the previous and current claims.
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 1-16 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 claims contain 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.
In particular, claim 1 recites “a server receiving data of the sensed anomalous variation in local conditions; the server executing software to identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions; the server providing first visual data visible to a human eye identifying the available procedures, with or without a hierarchal preference among the available procedures;…medical practitioner manually executing at least one of the identified medical procedures or directing a robotic element to perform at least a portion of the identified medical procedure; and while undergoing continued sensed observation, additional sensed output is transmitted to the server and effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions, identifying operational value in the execution of the execution of the available procedure; and the server providing a a second provided visual data”, however, the current specification does not describe the server. The current specification recites a central computer: “FIG. 2A shows screen shots of received information and stored information and underlying algorithms stored on a central computer and instructions that may be provided in response to specific sensed input.”, on page 10, lines 4-6, a host computer: “As shown in FIG. 4, sensors 461 may be connected to a host computer 461, wherein diagnostic algorithms 480 can be used to evaluate treatment plans for individual patients 462 and to actively modify existing treatment plans by physicians 442. A computer-based 491 tracking system 400 can be used in DVT and PE patient studies to investigate clot composition with respect to the age 450, composition 460 and size of a thrombus 470. During formation of a thrombus, characteristic alterations in fluorescence contrast imaging 410 and thrombus imaging 430 may be registered by the host computer 499. Observation of imaging changes 499 can be clinically useful in evaluating the potential utility of various alternative therapeutic interventions, such as, for example, drug thrombolytic therapy 440 and mechanical thrombectomy 441. Imaging 410, 430 may be used to guide the thrombectomy device through the vasculature 510 through under manual control of a host computer 460. Since branching of the main pulmonary arteries may be anatomically complex, it may be difficult to locate and catheterize an occluded vessel 499 when using single plane fluoroscopy 410.” on page 20, lines 6-20.
It's not clear whether the server is the central computer server or the host computer server that are recited in the claims.
Claims 2-16 inherit the deficiencies of claim 1 through dependency and are therefore also rejected.
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 1-16 are rejected under 35 U.S.C. 101 because claims fail to recite a living subject matter as part of the method/system, since claim 1 recites “a living medical practitioner manually executing at least one of the identified medical procedures or directing a robotic element to perform at least a portion of the identified medical procedure”.
Claims 2-16 inherit the deficiencies of claim 1 through dependency and are therefore also rejected.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-16 are drawn to a method (see the rejection above).
Step 2A, Prong 1:
Claims 1 and 17 recite “…identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions”, “…effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions”, and “identifying operational value in the execution of the execution of the available procedure”. These limitations correspond to an abstract idea of “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic thrombus retrieval device and generic server does not take the claim out of the methods of organizing human interactions grouping.
The server is recited in the current specification only on page 4, line 15 to page 5, line 5, which repeats the claim language. Examiner considers that the server is a generic computing device, since there is no mentioning of any non-generic or special purpose server.
The limitations of “…identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions”, “…effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions”, and “identifying operational value in the execution of the execution of the available procedure” also correspond to an abstract idea of “mental processes”. That is, other than reciting “a server executing,” nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “a server” and “the server executing” language, “identifying”, “comparing”, “evaluating”, “determining” in the context of this claim encompasses the user manually (or using pen and paper) determining and identifying available procedures based on the obtained data.
Claims 10-15 recite “providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device” which correspond to mathematical calculations, falls within the “mathematical concept” grouping of abstract ideas.
The newly added claim 18 recites “the server applies a wavelet transform to the sensed observation data further includes computing a convolution coefficient for each of a plurality of daughter wavelets, wherein each wavelet of the plurality of daughter wavelets is a time-scaled variant of a common mother wavelet, and wherein the sensed observation data is indicative of a similarity between the wavelet and the sensed observation data signal”, where the limitation of “computing a convolution coefficient for each of a plurality of daughter wavelets” correspond to mathematical calculations, falls within the “mathematical concept” grouping of abstract ideas.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 2-16 and 18-20 are ultimately dependent from claims 1, 17 and include all the limitations of claims 1, 17. Therefore, claims 2-16 and 18-20 recite the same abstract idea. Claims 2-16 and 18-20 describe a further limitation regarding the basis for identifying available procedures. These are all just further describing the abstract idea recited in claims 1, 17, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements that are shown below in the in bolded format:
“deploying a thrombus retrieval device into a blood vessel in the living patient having a thrombus within the blood vessel while a region surrounding and including the thrombus is under sensed observation,
sensing an output signal or visualization responsive to at least motion of or within or on the outside of the thrombus, the motion being in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device,
sensing the existence of the anomalous variation in the local conditions,
a server receiving data of the sensed anomalous variation in local conditions;
the server executing software to identify available procedures to identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions;
the server providing first visual data visible to a human eye identifying the available procedures, with or without a hierarchal preference among the available procedures;
a living medical practitioner manually executing at least one of the identified medical procedures or directing a robotic element to perform at least a portion of the identified medical procedure; and
while undergoing continued sensed observation, additional sensed output is transmitted to the server and effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions, identifying operational value in the execution of the execution of the available procedure; and the server providing a second provided visual data”
These additional elements are directed to hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
The newly added claim 17 recites “…at least one sensed observation comprises vibrations caused by a movement of the thrombus retrieval device dragging or sliding against a vessel wall”, and this feature correspond to ultrasound technology. This feature is found to be a well-understood, routine and conventional activity, as evidenced by the applied prior art, Vale (US12268476B2). In particular, Vale discloses “In some embodiments, the classifying the clot comprises one or more of a clinical exam, a blood test, a computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, a carotid ultrasound, a cerebral angiogram, and an echocardiogram.” in col. 3, line 66 to col. 4, line 3 and “Step 510 can also include carotid ultrasound, cerebral angiogram, echocardiogram, intravascular ultrasound (IVUS), and/or optical coherence tomography (OCT).” in col. 32, lines 54-56.
Claims also recite other additional limitations beyond abstract idea, including functions such as receiving data from/to a database is an insignificant extra-solution activity (see MPEP 2106.05 (g)), which does not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a server to perform identifying, evaluating, comparing and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vale et al. (hereinafter Vale) (US 12,268,476 B2).
Claim 1 has been amended to recite a method of alerting a user to the existence of a sensed anomalous variation in local conditions within a blood vessel during deployment, manipulation and/or withdrawal of a thrombus retrieval device in a living patient, the method comprising:
deploying a thrombus retrieval device into a blood vessel in the living patient having a thrombus within the blood vessel while a region surrounding and including the thrombus is under sensed observation, sensing an output signal or visualization responsive to at least motion of or within or on the outside of the thrombus, the motion being in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device, sensing the existence of the anomalous variation in the local conditions, a server receiving data of the sensed anomalous variation in local conditions; the server executing software to identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions (Vale discloses “a method or use for managing one or more acute ischemic events is disclosed, that can include determining criteria of a clot; classifying the clot based on the criteria and generating a classification; determining an individualized treatment protocol for the clot based on the classification, the individualized treatment protocol comprising one or more techniques selected from using at least one of aspirating, restoring perfusion using a first reperfusion device, and restoring perfusion using a second reperfusion device; and treating the clot based on the individualized treatment protocol” in col. 3, lines 50-60, “…a microcatheter is disclosed for analyzing an ischemic clot in the vasculature. The microcatheter can include a lumen having a proximal end and a distal end. A spectroscopic sensing device can be connected to the distal end whereby the spectroscopic sensing device can be configured to measure properties of the clot through the distal end of the microcatheter.” in col. 7, lines 19-30);
the server providing first visual data visible to a human eye identifying the available procedures, with or without a hierarchal preference among the available procedures (Vale discloses “…one step of method or use 500 can include clot analysis 510. Clot analysis 510 can include a variety of some or all of a range of steps, without limitation: considering the patient's clinical history, stroke severity, such as the National Institute of Health Stroke Severity (NIHSS) clinical exam and/or neurological exam. Steps of clot analysis 510 can also include blood tests, non-contrast computerized tomography (CT) scan, including quantitative method or uses to analyze stroke severity, such as Alberta stroke program early CT score (e.g., ASPECTS), and automatic assessments of ASPECTS using software (e-ASPECTS)” in col. 31, lines 42-54);
a living medical practitioner manually executing at least one of the identified medical procedures or directing a robotic element to perform at least a portion of the identified medical procedure; and while undergoing continued sensed observation, additional sensed output is transmitted to the server and effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions (Vale; col. 40, lines 1-30),
identifying operational value in the execution of the execution of the available procedure; and the server providing a a second provided visual data (Vale discloses “Depending on the classification following step 510, a treatment protocol can be individualized for a patient that dictates whether step 520, 530, and/or 540 is carried out, which advantageously avoids needless use of time from the available timeframe in attempting procedures which are not effective in the circumstances, especially in the context of treatment of acute ischemic stroke.” In col. 34, lines 16-46).
Claim 2 has been amended to recite the method of claim 1 wherein the sensed anomalous variation in local conditions is selected from the group consisting of changes in shape of the thrombus, particles separating from the thrombus, sensed vibrations from movement of the thrombectomy device, and visually sensed alterations in the surface of the blood vessel (Vale; col. 32, lines 54-56, col. 40, lines 1-30).
Claim 3 recites the method of claim 1 wherein an available procedure to be executed is selected from the group consisting of rotation of a portion of the thrombectomy device, at least partial retraction or extension of the thrombectomy device, alteration in the shape of deployment of a thrombus capture segment of the thrombectomy device, vibrating a distal element in the thrombus capture segment of the thrombectomy device, generating heat or reducing temperature around the thrombus capture segment of the thrombectomy device, introducing chemicals or pharmaceuticals around the thrombus capture segment of the thrombectomy device, and aspirating blood around the thrombus capture segment of the thrombectomy device to withdrawn particles (Vale; col. 3, lines 50-60, col. 40, lines 1-30).
Claim 4 recites the method of claim 2 wherein an available procedure to be executed is selected from the group consisting of rotation of a portion of the thrombectomy device, at least partial retraction or extension of the thrombectomy device, alteration in the shape of deployment of a thrombus capture segment of the thrombectomy device, vibrating a distal element in the thrombus capture segment of the thrombectomy device, generating heat or reducing temperature around the thrombus capture segment of the thrombectomy device, introducing chemicals or pharmaceuticals around the 61 thrombus capture segment of the thrombectomy device, providing liquid to the regions, and aspirating blood around the thrombus capture segment of the thrombectomy device to withdrawn particles (Vale; col. 3, lines 50-60, col. 40, lines 1-30).
Claim 5 recites the method of claim 1 wherein sensed observation is selected from the group consisting of optical fiber or semiconductor observation, MRI observation or sonogram observation of the region (Vale; col. 4, lines 4-11).
Claim 6 recites the method of claim 2 wherein sensed observation is selected from the group consisting of optical fiber or semiconductor observation, MRI observation or sonogram observation of the region (Vale; col. 4, lines 4-11).
Claim 7 recites the method of claim 3 wherein sensed observation is selected from the group consisting of optical fiber or semiconductor observation, MRI observation or sonogram observation of the region (Vale; col. 4, lines 4-11).
Claim 8 recites the method of claim 4 wherein sensed observation is selected from the group consisting of optical fiber or semiconductor observation, MRI observation or sonogram observation of the region (Vale; col. 4, lines 4-11).
Claim 9 recites the method of claim 1 wherein the server applies a wavelet transform to the sensed observation data further includes computing a convolution coefficient for each of a plurality of daughter wavelets, wherein each wavelet of the plurality of daughter wavelets is a time-scaled variant of a common mother wavelet, and wherein the sensed observation data is indicative of a similarity between the wavelet and the sensed observation data signal (Vale; col. 37, lines 34-52).
Claim 10 recites the method of claim 1 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale; col. 37, lines 34-52).
Claim 11 recites the method of claim 3 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale; col. 29, lines 22-51).
Claim 12 recites the method of claim 4 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale; col. 29, lines 22-51).
Claim 13 recites the method of claim 5 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale; col. 29, lines 22-51).
Claim 14 recites the method of claim 8 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale; col. 29, lines 22-51).
Claim 15 recites the method of claim 9 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale; col. 29, lines 22-51).
Claim 16 recites the method of claim 10, further comprising providing a control signal to a robotic surgical system if it is determined that the physical motion of the clot is an artificially induced response to movement of the thrombus retrieval device (Vale; col. 47, lines 57-67).
Newly added claim 17 recites a method of alerting a user to the existence of a sensed anomalous variation in local conditions within a blood vessel during deployment, manipulation and/or withdrawal of a thrombus retrieval device in a living patient, the method comprising:
a) deploying a thrombus retrieval device into a blood vessel in the living patient having a thrombus within the blood vessel while a region surrounding and including the thrombus is under sensed observation, b) sensing an output signal or visualization responsive to at least motion of or within or on the outside of the thrombus, the motion being in response to the deployment, manipulation or withdrawal of the thrombus retrieval device, c) sensing the existence of the anomalous variation in the local conditions, d) a server receiving data of the sensed anomalous variation in local conditions; e) the server executing software to identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions (Vale discloses “a method or use for managing one or more acute ischemic events is disclosed, that can include determining criteria of a clot; classifying the clot based on the criteria and generating a classification; determining an individualized treatment protocol for the clot based on the classification, the individualized treatment protocol comprising one or more techniques selected from using at least one of aspirating, restoring perfusion using a first reperfusion device, and restoring perfusion using a second reperfusion device; and treating the clot based on the individualized treatment protocol” in col. 3, lines 50-60, “…a microcatheter is disclosed for analyzing an ischemic clot in the vasculature. The microcatheter can include a lumen having a proximal end and a distal end. A spectroscopic sensing device can be connected to the distal end whereby the spectroscopic sensing device can be configured to measure properties of the clot through the distal end of the microcatheter.” in col. 7, lines 19-30);
f) the server providing first visual data visible to a human eye identifying the available procedures, with or without a hierarchal preference among the available procedures (Vale discloses “…one step of method or use 500 can include clot analysis 510. Clot analysis 510 can include a variety of some or all of a range of steps, without limitation: considering the patient's clinical history, stroke severity, such as the National Institute of Health Stroke Severity (NIHSS) clinical exam and/or neurological exam. Steps of clot analysis 510 can also include blood tests, non-contrast computerized tomography (CT) scan, including quantitative method or uses to analyze stroke severity, such as Alberta stroke program early CT score (e.g., ASPECTS), and automatic assessments of ASPECTS using software (e-ASPECTS)” in col. 31, lines 42-54);
g) a medical practitioner manually executing at least one of the identified medical procedures or directing a robotic element to perform at least a portion of the identified medical procedure (Vale; col. 40, lines 1-30); and
while undergoing continued sensed observation, additional sensed output is transmitted to the server and effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions, identifying operational value in the execution of the execution of the available procedure; and the server providing a second provided visual data; wherein at least one sensed observation comprises sensed vibrations caused by a movement of the thrombus retrieval device dragging or sliding against a vessel wall (Vale discloses “Depending on the classification following step 510, a treatment protocol can be individualized for a patient that dictates whether step 520, 530, and/or 540 is carried out, which advantageously avoids needless use of time from the available timeframe in attempting procedures which are not effective in the circumstances, especially in the context of treatment of acute ischemic stroke.” In col. 34, lines 16-46, “In some embodiments, the classifying the clot comprises one or more of a clinical exam, a blood test, a computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, a carotid ultrasound, a cerebral angiogram, and an echocardiogram.” in col. 3, line 66 to col. 4, line 3 and “Step 510 can also include carotid ultrasound, cerebral angiogram, echocardiogram, intravascular ultrasound (IVUS), and/or optical coherence tomography (OCT).” in col. 32, lines 54-56).
Newly added claim 18 recites the method of claim 17 wherein the server applies a wavelet transform to the sensed observation data further includes computing a convolution coefficient for each of a plurality of daughter wavelets, wherein each wavelet of the plurality of daughter wavelets is a time-scaled variant of a common mother wavelet, and wherein the sensed observation data is indicative of a similarity between the wavelet and the sensed observation data signal (Vale discloses “In some embodiments, the classifying the clot comprises one or more of a clinical exam, a blood test, a computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, a carotid ultrasound, a cerebral angiogram, and an echocardiogram.” in col. 3, line 66 to col. 4, line 3 and “Step 510 can also include carotid ultrasound, cerebral angiogram, echocardiogram, intravascular ultrasound (IVUS), and/or optical coherence tomography (OCT).” in col. 32, lines 54-56).
Newly added claim 19 recites the method of claim 17 further comprising providing an indication of statistical confidence for the determination that the anomalous variation in local conditions includes a shape change in the thrombus indicative of internal stress in the thrombus that will break the thrombus into smaller particles in response to the insertion, deployment, manipulation or withdrawal of the thrombus retrieval device (Vale discloses “analysis stage” in col. 33, lines 37-50).
Newly added claim 20 recites the method of claim 17 wherein sensed observation is supplemented by additional procedures selected from the group consisting of optical fiber or semiconductor observation, MRI observation or sonogram observation of the region (Vale discloses “In some embodiments, the spectroscopic mechanism includes an optical fiber or bundle of fibers extended up to or adjacent the distal end of the catheter; and a mirror oriented at a predetermined angle adjacent or at the distal end…” in col. 6, lines 62-66).
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Argument about 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejection:
Applicant argues that claims have been amended to overcome this rejection. In response, Examiner submits that as indicated in the rejection above, it’s not clear whether the claims 1 and 17 recite a method or a system claim. Both claims are directed to method claims, however, the limitations correspond to parts of a system (a server receiving data of the sensed anomalous variation in local conditions; the server executing software to identify available procedures to be used after identification of one or more anomalous variations in local conditions related to the sensed anomalous variation in local conditions; the server providing first visual data visible to a human eye identifying the available procedures).
Claims 1 and 17 also recite “a living medical practitioner manually executing at least one of the identified medical procedures or directing a robotic element to perform at least a portion of the identified medical procedure” and it’s unclear whether the living medical practitioner (a human being) is part of the method/system.
Argument about 35 USC 101 rejection:
Applicant argues that claims are directed to an improvement in the functioning of a computer, or an improvement to other technology or technical field, since the claims are directed to using specific classes of thrombectomy device components that clearly improve the performance of the method by enabling improved surgical performance, by providing both real time sensed information and offering options between surgical plans.
In response, Examiner submits that providing real time sensed information and offering options for surgical plans correspond to mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment. These features may improve an outcome for surgical plan options, but they do not provide an improvement to the technology of how the sensed data obtained or provided to the medical practitioner. The feature of providing choices of listed optimal order for use in selecting a pathway by the medical procedure odes not correspond to any technological improvements.
Applicant argues that the newly added claim 17 recite a new set of parameters (vibration caused by movement of the thrombectomy device against vessel wall) which is an addition of something more and clearly novel and unobvious as something more.
In response, Examiner submits that claim recites “at least one sensed observation comprises vibrations caused by a movement of the thrombus retrieval device dragging or sliding against a vessel wall”, and this feature correspond to ultrasound technology. This feature is found to be a well-understood, routine and conventional activity, as evidenced by the applied prior art, Vale (US12268476B2). In particular, Vale discloses “In some embodiments, the classifying the clot comprises one or more of a clinical exam, a blood test, a computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, a carotid ultrasound, a cerebral angiogram, and an echocardiogram.” in col. 3, line 66 to col. 4, line 3 and “Step 510 can also include carotid ultrasound, cerebral angiogram, echocardiogram, intravascular ultrasound (IVUS), and/or optical coherence tomography (OCT).” in col. 32, lines 54-56.
Applicant argues that claim 1 recites “additional sensed output is transmitted to the server and effects of the execution of the available procedure are compared from the continued sensed observation to evaluate resultant effects on the anomalous variation in local procedures to determine what alteration has occurred in the anomalous variation in local conditions identifying operational value in the execution of the execution of the available procedure; and the server providing a second provided visual data” coverts an asserted abstract concept into a practicable non-abstract process. Applicant also argues that this feature is similar to claims reciting “multiple AI layers with RPA (robotic process automatic) processes as recited in Ex parte Singh decision.
In response, Examiner submits that although the Appeal Brief decisions for other applications are informative, they are not binding on examination process. Additionally, Examiner submits that the current claims are directed to a server comparing the continued sensed observations to evaluate resultant effects, which correspond to mere instructions apply an exception. There is no Artificial Intelligence recited in the current claims. The specification recites “Additional techniques such as response gating, stimulus frequency modulation, artificial intelligence/structured machine learning, and/or ensemble approaches may also be used to make this detection more robust and/or provide a greater degree of confidence in the detection.” on page 39, line 27 to page 40, line 3, however, there is no indication in the claims nor in the current specification about how the AI being used (the server performing functions without any details about how the outcomes are accomplished).
Therefore, the arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Argument about 35 USC 102 rejection:
Applicant argues that Vale does not teach “real-time clot evaluation”, “continued sensed observation”, but recites pre-surgical analysis of clot properties.
In response, Examiner submits that Vale discloses “In some embodiments, the step of determining criteria of the clot includes interpreting information, by a computing device in operative communication with the clot, about the clot to determine in real-time levels (e.g., instantly or within minutes of undertaking the analysis) of at least one of red blood cell content, white blood cell content, levels of fibrin, levels of platelets, levels of hydration, a clot size, a clot shape, and/or a clot location in the vasculature. In some embodiments, the method or use can also include receiving, through a graphical user interface of the computing device, the individualized treatment protocol, monitoring, by the computing device, perfusion of the vessel with the clot, and, alerting, by the computing device, in response to perfusion being restored in the vessel.” in col. 18, lines 45-56.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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/DILEK B COBANOGLU/ Primary Examiner, Art Unit 3687