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 .
Status of Claims
Claims 1-10, 12-21, 23-32, and 34-36 are rejected. Claims 11, 22, and 33 are canceled.
Response to Arguments
Claim Objections
The previous claim objection of claims 1 and 12 has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
The previous 112(b) rejection has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 9/10/26 have been fully considered but they are not persuasive.
Applicant asserts that a human brain does not possess separately addressable processing cores that can independently receive datasets, execute processing chains in parallel, and remain synchronized with hardware input switching operations. However, the processing steps are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that a human cannot mentally perform the claimed coordination among multiple processor cores while optical ports are actively switched and new optical measurement data is acquired. However, the multiple processor cores amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application. The switching amounts to pre-solution activity of data gathering for the optical measurement data.
Applicant asserts that not only do the recited claims result in faster performance by using multiple processor cores, but they ensure that such processor cores do not sit idle or begin with incomplete data due to delayed data delivery. However, MPEP 2106.05(f) states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Applicant asserts that nothing in the Office Action or the cited art demonstrates that it was conventional to dynamically assign sequentially acquired optical measurement datasets to different available processing cores while prior processing remained incomplete and while coordinating such assignments with optical port switching and synchronized display intervals. However, MPEP 2106.05 states:
As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
Applicant asserts that the claims improve the operation of the computer itself through a specific, multi-core processing architecture in which optical measurement datasets are dynamically allocated across separate processing cores in synchronization with catheter-port switching events, which could not be performed through human mental performance or through generic sequential computer processing. However, the Examiner disagrees. MPEP 2106.05(a) states:
…the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology.
Claim Rejections - 35 USC § 102
Applicant’s arguments with respect to claims 1-10, 12-21, 23-32, and 34-36 have been considered but are moot in view of the new ground of rejection.
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. The limitation of “processing unit” in claims 1-5 and 10-18 has been interpreted under 35 U.S.C. 112(f).
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.
For “processing unit” recited in claims 1, 12, 23, and all dependent claims thereof , the specification hardware, firmware, software, or any combination” (¶44). Therefore, the Examiner is interpreting the processing unit to be hardware, firmware, software, any combination, or any equivalents thereof.
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 1-10, 12-21, 23-32, and 34-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-10, 12-21, 23-32, and 34-36 are directed to statutory subject matter as the claims recite a method, system, and non-transitory computer-readable medium for assessing ablation lesions.
Step 2A, Prong One
Regarding claims 1, 12, and 23, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 1, 12, and 23, the limitations of “assigning the first optical measurement data; implementing a processing chain on the first optical measurement data in order to identify an optical property at a first location of a lesion; generating a first graphical representation from the optical property at the first location; assigning the second optical measurement data; implementing the processing chain on the second optical measurement data in order to identify the optical property at a second location of the lesion; generating a second graphical representation from the optical property at the second location; and displaying the first graphical representation and the second graphical representation at a predefined interval” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional being assigned to analyze first and second optical measurement data sets on paper, making judgments on them to identify an optical property, and drawing on paper a first and second graphical representation of the optical property at the first and second locations.
Step 2A, Prong Two
For claims 1, 12, and 23, the judicial exception is not integrated into a practical application. In particular, claims 1, 12, and 23 recite a first catheter optical port of a multi-port optical component; at least one computing device; a processor; a first available processing core in a processing unit; a second catheter optical port; a second available processing core in the processing unit; switching an input of the at least one computing device from the first catheter optical port to a second catheter optical port, such that the second catheter optical port becomes the active port; and displaying the first graphical representation and the second graphical representation on a user interface. The first catheter optical port, second catheter optical port, and the switching step amount to nothing more than pre-solution activity of data gathering. The at least one computing device, a processor, first available processing core in a processing unit, a second available processing core in the processing unit, and a user interface are recited at a high-level of generality and amount to nothing more than parts of a generic computer. The step of displaying the first graphical representation and the second graphical representation on a user interface amounts to post-solution activity. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
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 elements of the first catheter optical port and second catheter optical port amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the first catheter optical port and second catheter optical port are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20090132019 (¶34-hub 124 includes a first catheter port 126 and a second catheter port 128 for accommodating insertion of one or more conventional balloon catheters), US 20190009043 (¶52-a conventional light source (not shown) through the first port 14, through a first lumen 20 of the valve 12, which connects the first and second ports 14, 16), and US 20070010847 (¶22-conventional design, having a first port 35 allowing the guidewire 32 to pass into and out of the guidewire lumen, and a second port 36 in fluid communication with the shaft's inflation/deflation lumens). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-10, 13-21, 24-32, and 34-36, the limitations of claims 1, 12, and 23 further define the limitations already indicated as being directed to the abstract idea.
Regarding claims 2, 13, and 24, the transmitting step amounts to post-solution activity. Additionally, the hardware abstraction layer, processing unit, processor, and computing device amount are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Regarding claims 3, 14, and 25, the transmitting step amounts to post-solution activity. Additionally, the hardware abstraction layer, processing unit, processor, and computing device amount are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Regarding claims 4, 15, and 26, the limitations of “remove a glitch in the first optical measurement data; remove a phase noise from the first optical measurement data; or linearize a phase of the first optical measurement data” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional making changes to the first optical measurement data on paper. The limitations of “conduct a Hilbert transform on the first optical measurement data; or conduct a Fourier transform on the first optical measurement data” are mathematical calculations of performing integration, exponentials, division, multiplication, addition, and subtraction in order to assess ablation lesions. The limitation of “compensate for a polarization mode of the first optical measurement data” amounts to pre-solution of activity data gathering.
Regarding claims 5, 16, and 27, the limitations of “remove a glitch in the second optical measurement data; remove a phase noise from the second optical measurement data; or linearize a phase of the second optical measurement data” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional making changes to the second optical measurement data on paper. The limitations of “conduct a Hilbert transform on the second optical measurement data; or conduct a Fourier transform on the second optical measurement data” are mathematical calculations of performing integration, exponentials, division, multiplication, addition, and subtraction in order to assess ablation lesions. The limitation of “compensate for a polarization mode of the second optical measurement data” amounts to pre-solution of activity data gathering.
Claims 6, 17, and 28 are further directed to the abstract idea itself.
Claims 7, 18, and 29 are further directed to the abstract idea itself.
Claims 8, 19, and 30 are further directed to the abstract idea itself.
Regarding claims 9, 20, and 31, the first catheter optical port and second catheter optical port amount to nothing more than pre-solution activity of data gathering. This is well-understood, routine, and conventional activity as evidenced by claims 1, 12, and 23 above.
Regarding claims 10, 21, and 32, the predetermined time is regarding the data gathering of receiving the second optical measurement data from the second catheter optical port. The second catheter optical port amounts to nothing more than pre-solution activity of data gathering.
Regarding claims 34-36, the processor and computing device are recited at a high-level of generality and amount to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-9, 12-20, 23-31, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Sancho (US 20210212569 published on 7/15/21 as cited in the IDS) in view of Pratten (US 20180168729 filed on 5/25/16).
Regarding claim 1, Sancho teaches a computer implemented method for assessing ablation lesions in real-time, comprising: activating, as an active port, a first catheter optical port of a multi-port optical component (¶109-a particular optical view port section being active at a given time; ¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip); receiving, by at least one computing device (¶10-computing device), a first optical measurement data from the first catheter optical port (¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip); assigning, by the at least one computing device upon completion of the receiving, the first optical measurement data to a first available processing core in a processing unit (¶121-computer system 1800 may include one or more processors (also called central processing units, or CPUs), such as a processor 1804); directing, by the at least one computing device, the first available processing core to implement a processing chain on the first optical measurement data in order to identify an optical property at a first location of a lesion (¶18-a full chain of integration of data acquisition of the optical signals; ¶119-a lesion progression of the lesion may be determined by using the plurality of optical ports in the distal section of the catheter to acquire the optical measurement data at a plurality of different angles with respect to the portion of tissue); generating, by the at least one computing device, a first graphical representation from the optical property at the first location (¶69-these signals may be combined and processed to measure optical properties of tissue, such as birefringence, tissue stability, dragging speed, and the like. The processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ); ¶105-determine a lesion progression in tissue from a plurality of different angles with respect to the positioning of the catheter tip in the tissue); switching an input of the at least one computing device from the first catheter optical port to a second catheter optical port, such that the second catheter optical port becomes the active port (¶43- proximal section 102 may include various buttons or switches that allow a user to control when laser energy is applied at distal section 104 , or when the beams of radiation are transmitted from distal section 104 , allowing for the acquisition of optical data; ¶66-optical switch 409 allows for selection of one or more beams through the multiple output fibers 410; ¶98-one or more beams from the optical view ports may be switched on or off (e.g., using optical switch 409 in optical system 401 ) for obtaining optical measurements from the tissue), after a predetermined time of receiving the first optical measurement data but prior to completion of the processing chain by the first available processing core (¶141-creating a model representing a correlation between lesion depths and ablation times using the time of denaturation, the one or more optical properties, and the predetermined period of time); receiving, by the at least one computing device (¶10-computing device), a second optical measurement data from the second catheter optical port (¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip; ¶141-the one or more optical properties, and the predetermined period of time); assigning, by the at least one computing device, the second optical measurement data to a second available processing core in the processing unit (¶121-computer system 1800 may include one or more processors (also called central processing units, or CPUs), such as a processor 1804); directing, by the at least one computing device, the second available processing core to implement the processing chain on the second optical measurement data in order to identify the optical property at a second location of the lesion (¶18-a full chain of integration of data acquisition of the optical signals; ¶119-a lesion progression of the lesion may be determined by using the plurality of optical ports in the distal section of the catheter to acquire the optical measurement data at a plurality of different angles with respect to the portion of tissue); generating, by the at least one computing device, a second graphical representation from the optical property at the second location (¶69-these signals may be combined and processed to measure optical properties of tissue, such as birefringence, tissue stability, dragging speed, and the like. The processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ); ¶105-determine a lesion progression in tissue from a plurality of different angles with respect to the positioning of the catheter tip in the tissue); and displaying, by the at least one computing device, the first graphical representation and the second graphical representation on a user interface at a predefined interval (¶69-the processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ). In some embodiments, the GUI may be refreshed such that multiple channels of the detector (e.g., 15 channels) may be represented at once; ¶69-the console 310 may buffer optical data from all or multiple channels, and the data may be refreshed and presented in the GUI once the data has been processed).
However, Sancho does not explicitly teach at a time that is synchronized with an amount of time taken to complete the switching and receiving the second optical measurement data; and corresponding to the amount of time taken to complete the switching and receiving the second optical measurement data.
Pratten relates to a catheter system and to a method of ablating a tissue in a subject and visualising the ablation process in real time via an image of the tissue (¶1). Pratten further teaches the invention using the following steps:
at a time that is synchronized with an amount of time taken to complete the switching and receiving the second optical measurement data (¶122-the optical switch is connected to and controlled by the electronic controller which can synchronise the switching of the optical switch with detection of the reflected imaging beam to generate images of the tissue portion); and corresponding to the amount of time taken to complete the switching and receiving the second optical measurement data (¶122-the optical switch is connected to and controlled by the electronic controller which can synchronise the switching of the optical switch with detection of the reflected imaging beam to generate images of the tissue portion).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sancho to include at a time that is synchronized with an amount of time taken to complete the switching and receiving the second optical measurement data; and corresponding to the amount of time taken to complete the switching and receiving the second optical measurement data of Pratten in order for ablating a tissue portion of a body and visualising the ablation in real time (Pratten, ¶13), more accurate and quicker ablation performance, and may reduce requirements for repeat ablations on the same patient (Pratten, ¶230).
Regarding claim 2, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, further comprising: transmitting, by the at least one computing device, the first optical measurement data to a hardware abstraction layer that interfaces between the first catheter optical port and the processing unit (Sancho, ¶70-data transfer and data processing may be optimized in different software abstraction layers; ¶44-the optical view ports may transmit and collect light (e.g., optical signals) at various angles from the distal section 104).
Regarding claim 3, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, further comprising: transmitting, by the at least one computing device, the second optical measurement data to a hardware abstraction layer that interfaces between the second catheter optical port and the processing unit (Sancho, ¶70-data transfer and data processing may be optimized in different software abstraction layers; ¶44-the optical view ports may transmit and collect light (e.g., optical signals) at various angles from the distal section 104).
Regarding claim 4, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the processing chain comprises at least one of: removing a phase noise from the first optical measurement data (Sancho, ¶71-optimization algorithms may be applied to compensate for non-linearities and phase noise of the optical source while switching using an external reference interferometer at different optical path delays); or compensating for a polarization mode of the first optical measurement data (Sancho, ¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 5, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the processing chain comprises at least one of: removing a phase noise from the second optical measurement data (Sancho, ¶71-optimization algorithms may be applied to compensate for non-linearities and phase noise of the optical source while switching using an external reference interferometer at different optical path delays); or compensating for a polarization mode of the second optical measurement data (¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 6, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the optical property is birefringence (Sancho, ¶8-optical properties, such as birefringence).
Regarding claim 7, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the first graphical representation is an estimated lesion depth (Sancho, ¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 8, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the second graphical representation is an estimated lesion depth (Sancho, ¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 9, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the switching begins at the time of assigning the first optical measurement data to the first available processing core (Sancho, ¶98-one or more beams from the optical view ports may be switched on or off (e.g., using optical switch 409 in optical system 401 ) for obtaining optical measurements from the tissue; ¶109-individual tiles 1608 may be switched on or off (or may appear or disappear) based on a particular optical view port section being active at a given time; ¶43).
Regarding claim 12, Sancho teaches a system for assessing ablation lesions in real-time, comprising: a catheter comprising a first catheter optical port and a second catheter optical port (¶52-one or more optical view ports of catheter 302); a computing device coupled to the catheter (¶10-a computing device coupled to the plurality of optical fibers through a connector; ¶11-the processor of the computing device is configured to receive, from a catheter); and a user interface coupled to the computing device (¶69-a graphical user interface (GUI); ¶107-the GUI 1600…coupled to console 31; ¶11), the computing device comprising: a processor (¶10-processor), wherein the processor further comprises a processing unit (¶121-one or more processors (also called central processing units, or CPUs)); and a memory (¶124-a main or primary memory 1808), wherein the memory contains instructions stored thereon that when executed by the processor (¶124; ¶127) cause the computing device to: activate, as an active port, the first catheter optical port (¶109-a particular optical view port section being active at a given time; ¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip); receive a first optical measurement data from the first catheter optical port (¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip); upon completion of receiving the first optical measurement data, assign the first optical measurement data to a first available processing core in the processing unit (¶121-computer system 1800 may include one or more processors (also called central processing units, or CPUs), such as a processor 1804); direct the first available processing core to implement a processing chain on the first optical measurement data in order to identify an optical property at a first location of a lesion (¶18-a full chain of integration of data acquisition of the optical signals; ¶119-a lesion progression of the lesion may be determined by using the plurality of optical ports in the distal section of the catheter to acquire the optical measurement data at a plurality of different angles with respect to the portion of tissue); generate a first graphical representation from the optical property at the first location (¶69-these signals may be combined and processed to measure optical properties of tissue, such as birefringence, tissue stability, dragging speed, and the like. The processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ); ¶105-determine a lesion progression in tissue from a plurality of different angles with respect to the positioning of the catheter tip in the tissue); switch an input of the processing unit from the first catheter optical port to the second catheter optical port, such that the second catheter optical port becomes the active port (¶43-proximal section 102 may include various buttons or switches that allow a user to control when laser energy is applied at distal section 104 , or when the beams of radiation are transmitted from distal section 104 , allowing for the acquisition of optical data; ¶66-optical switch 409 allows for selection of one or more beams through the multiple output fibers 410; ¶98-one or more beams from the optical view ports may be switched on or off (e.g., using optical switch 409 in optical system 401 ) for obtaining optical measurements from the tissue) after a predetermined time of receiving the first optical measurement data but prior to completion of the processing chain on the first optical measurement data (¶141-creating a model representing a correlation between lesion depths and ablation times using the time of denaturation, the one or more optical properties, and the predetermined period of time); receive a second optical measurement data from the second catheter optical port (¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip; ¶141-the one or more optical properties, and the predetermined period of time); assign the second optical measurement data to a second available processing core in the processing unit (¶121-computer system 1800 may include one or more processors (also called central processing units, or CPUs), such as a processor 1804); direct the second available processing core to implement the processing chain on the second optical measurement data in order to identify the optical property at a second location of the lesion (¶18-a full chain of integration of data acquisition of the optical signals; ¶119-a lesion progression of the lesion may be determined by using the plurality of optical ports in the distal section of the catheter to acquire the optical measurement data at a plurality of different angles with respect to the portion of tissue); generate a second graphical representation from the optical property at the second location (¶69-these signals may be combined and processed to measure optical properties of tissue, such as birefringence, tissue stability, dragging speed, and the like. The processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ); ¶105-determine a lesion progression in tissue from a plurality of different angles with respect to the positioning of the catheter tip in the tissue); and display the first graphical representation and the second graphical representation on the user interface at a predefined interval (¶69-the processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ). In some embodiments, the GUI may be refreshed such that multiple channels of the detector (e.g., 15 channels) may be represented at once; ¶69-the console 310 may buffer optical data from all or multiple channels, and the data may be refreshed and presented in the GUI once the data has been processed).
However, Sancho does not explicitly teach at a time that is synchronized with an amount of time taken to switch the input and receive the second optical measurement data; and corresponding to the amount of time taken to complete the switching an receiving the second optical measurement data.
Pratten teaches at a time that is synchronized with an amount of time taken to switch the input and receive the second optical measurement data (¶122-the optical switch is connected to and controlled by the electronic controller which can synchronise the switching of the optical switch with detection of the reflected imaging beam to generate images of the tissue portion); and corresponding to the amount of time taken to complete the switching an receiving the second optical measurement data (¶122-the optical switch is connected to and controlled by the electronic controller which can synchronise the switching of the optical switch with detection of the reflected imaging beam to generate images of the tissue portion).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sancho to include at a time that is synchronized with an amount of time taken to switch the input and receive the second optical measurement data; and corresponding to the amount of time taken to complete the switching an receiving the second optical measurement data of Pratten in order for ablating a tissue portion of a body and visualising the ablation in real time (Pratten, ¶13), more accurate and quicker ablation performance, and may reduce requirements for repeat ablations on the same patient (Pratten, ¶230).
Regarding claim 13, the combination of Sancho and Pratten teaches the system of claim 12, wherein the memory contains further instructions stored thereon that when executed by the processor cause the computing device to: transmit the first optical measurement data to a hardware abstraction layer that interfaces between the first catheter optical port and the processing unit (Sancho, ¶70-data transfer and data processing may be optimized in different software abstraction layers; ¶44-the optical view ports may transmit and collect light (e.g., optical signals) at various angles from the distal section 104).
Regarding claim 14, the combination of Sancho and Pratten teaches the system of claim 12, wherein the memory contains further instructions stored thereon that when executed by the processor cause the computing device to: transmit the second optical measurement data to a hardware abstraction layer that interfaces between the second catheter optical port and the processing unit (Sancho, ¶70-data transfer and data processing may be optimized in different software abstraction layers; ¶44-the optical view ports may transmit and collect light (e.g., optical signals) at various angles from the distal section 104).
Regarding claim 15, the combination of Sancho and Pratten teaches the system of claim 12, wherein the processing chain comprises at least one of: remove a phase noise from the first optical measurement data (Sancho, ¶71-optimization algorithms may be applied to compensate for non-linearities and phase noise of the optical source while switching using an external reference interferometer at different optical path delays); or compensate for a polarization mode of the first optical measurement data (Sancho, ¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 16, the combination Sancho and Pratten teaches the system of claim 12, wherein the processing chain comprises at least one of remove a phase noise from the second optical measurement data (Sancho, ¶71-optimization algorithms may be applied to compensate for non-linearities and phase noise of the optical source while switching using an external reference interferometer at different optical path delays); or compensate for a polarization mode of the second optical measurement data (Sancho, ¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 17, the combination of Sancho and Pratten teaches the system of claim 12, wherein the optical property is birefringence (Sancho, ¶8-optical properties, such as birefringence).
Regarding claim 18, the combination of Sancho and Pratten teaches the system of claim 12, wherein the first graphical representation is an estimated lesion depth (Sancho, ¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 19, the combination of Sancho and Pratten teaches the system of claim 12, wherein the second graphical representation is an estimated lesion depth (Sancho, ¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 20, the combination of Sancho and Pratten teaches the system of claim 12, wherein the memory contains further instructions stored thereon that, when executed by the processor, cause the computing device to: begin switching an input of the processing unit from the first catheter optical port to the second catheter optical port at the time of assigning the first optical measurement data to the first available processing core (Sancho, ¶98-one or more beams from the optical view ports may be switched on or off (e.g., using optical switch 409 in optical system 401 ) for obtaining optical measurements from the tissue; ¶109-individual tiles 1608 may be switched on or off (or may appear or disappear) based on a particular optical view port section being active at a given time; ¶43).
Regarding claim 23, Sancho teaches a non-transitory computer-readable medium having instructions stored thereon that, when executed by at least one computing device (¶10-a computing device coupled to the plurality of optical fibers through a connector; ¶11-the processor of the computing device is configured to receive, from a catheter), cause the at least one computing device to perform operations comprising: activating, as an active port, a first catheter optical port of a multi-port optical component (¶109-a particular optical view port section being active at a given time; ¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip) receiving a first optical measurement data from the first catheter optical port (¶10-a computing device coupled to the plurality of optical fibers through a connector; ¶11-the processor of the computing device is configured to receive, from a catheter); upon completion of the receiving, assigning the first optical measurement data to a first available processing core in a processing unit (¶121-computer system 1800 may include one or more processors (also called central processing units, or CPUs), such as a processor 1804); directing the first available processing core to implement a processing chain on the first optical measurement data in order to identify an optical property at a first location of a lesion (¶18-a full chain of integration of data acquisition of the optical signals; ¶119-a lesion progression of the lesion may be determined by using the plurality of optical ports in the distal section of the catheter to acquire the optical measurement data at a plurality of different angles with respect to the portion of tissue); generating a first graphical representation from the optical property at the first location (¶69-these signals may be combined and processed to measure optical properties of tissue, such as birefringence, tissue stability, dragging speed, and the like. The processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ); ¶105-determine a lesion progression in tissue from a plurality of different angles with respect to the positioning of the catheter tip in the tissue); after a predetermined time of receiving the first optical measurement data but prior to completion of the processing chain by the first available processing core (¶141-creating a model representing a correlation between lesion depths and ablation times using the time of denaturation, the one or more optical properties, and the predetermined period of time), switching an input of the at least one computing device from the first catheter optical port to a second catheter optical port, such that the second catheter optical port becomes the active port (¶43-proximal section 102 may include various buttons or switches that allow a user to control when laser energy is applied at distal section 104 , or when the beams of radiation are transmitted from distal section 104 , allowing for the acquisition of optical data; ¶66-optical switch 409 allows for selection of one or more beams through the multiple output fibers 410; ¶98-one or more beams from the optical view ports may be switched on or off (e.g., using optical switch 409 in optical system 401 ) for obtaining optical measurements from the tissue); receiving a second optical measurement data from the second catheter optical port (¶44-a plurality of optical view ports, the plurality of optical view ports may be referred to herein as orifices in the catheter tip; ¶141-the one or more optical properties, and the predetermined period of time); assigning the second optical measurement data to a second available processing core in the processing unit (¶121-computer system 1800 may include one or more processors (also called central processing units, or CPUs), such as a processor 1804), directing the second available processing core to implement the processing chain on the second optical measurement data in order to identify the optical property at a second location of the lesion (¶18-a full chain of integration of data acquisition of the optical signals; ¶119-a lesion progression of the lesion may be determined by using the plurality of optical ports in the distal section of the catheter to acquire the optical measurement data at a plurality of different angles with respect to the portion of tissue); generating a second graphical representation from the optical property at the second location (¶69-these signals may be combined and processed to measure optical properties of tissue, such as birefringence, tissue stability, dragging speed, and the like. The processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ); ¶105-determine a lesion progression in tissue from a plurality of different angles with respect to the positioning of the catheter tip in the tissue); and displaying the first graphical representation and the second graphical representation on a user interface at a predefined interval (¶69-the processed signals may be shown on a graphical user interface (GUI) presented on a display (e.g., display 325 ). In some embodiments, the GUI may be refreshed such that multiple channels of the detector (e.g., 15 channels) may be represented at once; ¶69-the console 310 may buffer optical data from all or multiple channels, and the data may be refreshed and presented in the GUI once the data has been processed).
However, Sancho does not explicitly teach at a time that is synchronized with an amount of time taken to complete the switching and receiving the second optical measurement data; and corresponding to the amount of time taken to complete the switching and receiving the second optical measurement data.
Pratten teaches at a time that is synchronized with an amount of time taken to complete the switching and receiving the second optical measurement data (¶122-the optical switch is connected to and controlled by the electronic controller which can synchronise the switching of the optical switch with detection of the reflected imaging beam to generate images of the tissue portion); and corresponding to the amount of time taken to complete the switching and receiving the second optical measurement data (¶122-the optical switch is connected to and controlled by the electronic controller which can synchronise the switching of the optical switch with detection of the reflected imaging beam to generate images of the tissue portion).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sancho to include at a time that is synchronized with an amount of time taken to complete the switching and receiving the second optical measurement data; and corresponding to the amount of time taken to complete the switching and receiving the second optical measurement data of Pratten in order for ablating a tissue portion of a body and visualising the ablation in real time (Pratten, ¶13), more accurate and quicker ablation performance, and may reduce requirements for repeat ablations on the same patient (Pratten, ¶230).
Regarding claim 24, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the operations further comprise: transmitting the first optical measurement data to a hardware abstraction layer that interfaces between the first catheter optical port and the processing unit (Sancho, ¶70-data transfer and data processing may be optimized in different software abstraction layers; ¶44-the optical view ports may transmit and collect light (e.g., optical signals) at various angles from the distal section 104).
Regarding claim 25, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the operations further comprise: transmitting the second optical measurement data to a hardware abstraction layer that interfaces between the second catheter optical port and the processing unit (Sancho, ¶70-data transfer and data processing may be optimized in different software abstraction layers; ¶44-the optical view ports may transmit and collect light (e.g., optical signals) at various angles from the distal section 104).
Regarding claim 26, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the processing chain comprises at least one of: removing a phase noise from the first optical measurement data (Sancho, ¶71-optimization algorithms may be applied to compensate for non-linearities and phase noise of the optical source while switching using an external reference interferometer at different optical path delays); or compensating for a polarization mode of the first optical measurement data (Sancho, ¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 27, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the processing chain comprises at least one of: removing a phase noise from the second optical measurement data (Sancho, ¶71-optimization algorithms may be applied to compensate for non-linearities and phase noise of the optical source while switching using an external reference interferometer at different optical path delays); or compensating for a polarization mode of the second optical measurement data (Sancho, ¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 28, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the optical property is birefringence (Sancho, ¶8-optical properties, such as birefringence).
Regarding clam 29, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the first graphical representation is an estimated lesion depth (Sancho, ¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 30, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the second graphical representation is an estimated lesion depth (Sancho, ¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 31, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the switching operations further comprise: switching at the time of assigning the first optical measurement data to the first available processing core (Sancho, ¶98-one or more beams from the optical view ports may be switched on or off (e.g., using optical switch 409 in optical system 401 ) for obtaining optical measurements from the tissue; ¶109-individual tiles 1608 may be switched on or off (or may appear or disappear) based on a particular optical view port section being active at a given time; ¶43).
Regarding claim 34, the combination of Sancho and Pratten teaches the computer implemented method of claim 1, wherein the at least one processor receives optical measurement data from one catheter optical port at a time (Sancho, ¶9-acquiring optical measurement data from the portion of tissue using at least one optical port in the catheter; ¶109-optical measurements obtained from a respective optical view port section in the catheter).
Regarding claim 35, the combination of Sancho and Pratten teaches the system of claim 12, wherein the processor is configured to receive optical measurement data from one catheter optical port at a time (Sancho, ¶9-acquiring optical measurement data from the portion of tissue using at least one optical port in the catheter; ¶109-optical measurements obtained from a respective optical view port section in the catheter).
Regarding claim 36, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23, wherein the at least one computing device receives optical measurement data from one catheter optical port at a time (Sancho, ¶9-acquiring optical measurement data from the portion of tissue using at least one optical port in the catheter; ¶109-optical measurements obtained from a respective optical view port section in the catheter).
Claims 10, 21, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Sancho in view of Pratten as applied to claims 1-9, 12-20, 23-31, and 34-36 above, and further in view of Koblish (US 20190038349 filed on 10/9/18).
Regarding clam 10, the combination of Sancho and Pratten teaches the computer implemented method of claim 1. However, the combination of Sancho and Pratten does not teach wherein the predetermined time is either 2 milliseconds or 1 millisecond.
Koblish teaches wherein the predetermined time is either 2 milliseconds or 1 millisecond (¶538-measurements can be obtained and recorded at any desired frequency (e.g., every 1 ms, every 5 ms, every 10 ms, every 50 ms, or every 100 ms); while the reference does not explicitly recite 2 milliseconds, since the measurements can be obtained and recorded at any desired frequency, that frequency could be 2 milliseconds).
Koblish relates to facilitating assessment of a nature of contact between an electrode assembly of an ablation catheter and viable body tissue (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sancho to include wherein the predetermined time is either 2 milliseconds or 1 millisecond of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Regarding claim 21, the combination of Sancho and Pratten teaches the system of claim 12. However, the combination of Sancho and Pratten does not teach wherein the predetermined time is either 2 milliseconds or 1 millisecond.
Koblish teaches wherein the predetermined time is either 2 milliseconds or 1 millisecond (¶538-measurements can be obtained and recorded at any desired frequency (e.g., every 1 ms, every 5 ms, every 10 ms, every 50 ms, or every 100 ms); while the reference does not explicitly recite 2 milliseconds, since the measurements can be obtained and recorded at any desired frequency, that frequency could be 2 milliseconds).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sancho to include wherein the predetermined time is either 2 milliseconds or 1 millisecond of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Regarding claim 32, the combination of Sancho and Pratten teaches the non-transitory computer-readable medium of claim 23. However, the combination of Sancho and Pratten does not teach wherein the predetermined time is either 2 milliseconds or 1 millisecond.
Koblish teaches wherein the predetermined time is either 2 milliseconds or 1 millisecond (¶538-measurements can be obtained and recorded at any desired frequency (e.g., every 1 ms, every 5 ms, every 10 ms, every 50 ms, or every 100 ms); while the reference does not explicitly recite 2 milliseconds, since the measurements can be obtained and recorded at any desired frequency, that frequency could be 2 milliseconds).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sancho to include wherein the predetermined time is either 2 milliseconds or 1 millisecond of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20210212755: relates to catheters, systems, and methods utilizing optical and photonic technology to determine or predict structural changes in tissue associated with ablation-based lesions (¶2).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
