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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/5/23 is being considered by the examiner.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities: “realtime” should recite –real-time--. Appropriate correction is required.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, it is unclear how the limitations “processing unit” and “processor” are related and/or different from one another. The specification provides the following description for the two limitations:
[0006] In another aspect, an example system is described. The system comprises a catheter comprising a first catheter optical port and a second catheter optical port, a computing device coupled to the catheter and comprising a processor and a memory, and a user interface coupled to the computing device. The processor further comprises a processing unit and the memory contains instructions that when executed by the processor cause the computing device to receive a first optical measurement data from the first catheter optical port, assign the first optical measurement data to a first available processing core in the processing unit, 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, and to generate a first graphical representation from the optical property at the first location. After a predetermined time, the computing device repeats the outlined steps for a second optical measurement data using the second catheter optical port and a second available processing core in order to generate a second graphical representation. The processor then causes the computing device to display the first and second graphical representations on the user interface at a predefined interval.
[0097] Computer system 800 includes one or more processors (also called central processing units, or CPUs), such as a processor 804.
As such, the scope of processor can be just processing unit alone and having the processing unit as a subcomponent. For the purpose of examination, the processor has been interpreted as processing unit and a memory consistent with [0006] of the specification and claim 12. Dependent claims 2-11 are indefinite for the same reason indicated for independent claim 1.
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 1-33 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 1-33 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; a first available processing core in a processing unit; a second catheter optical port; a second available processing core in the processing unit; and displaying the first graphical representation and the second graphical representation on a user interface.” The first catheter optical port and second catheter optical port amount to nothing more than pre-solution activity of data gathering. The 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 2-11, 13-22, and 24-33, 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 and processing unit 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 and processing unit 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.
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 11, 22, and 33, 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.
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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-9, 12-20, and 23-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sancho (US 20210212569 published on 7/15/21 as cited in the IDS).
Regarding claim 1, Sancho teaches a computer implemented method for assessing ablation lesions in realtime, comprising: receiving, by at least one processor (¶10-processor), a first optical measurement data from a 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 processor, 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 processor, 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 processor, 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); receiving, by the at least one processor (¶10-processor), a second optical measurement data from a second catheter optical port after a predetermined time of receiving the first optical measurement data (¶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 processor, 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 processor, 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 processor, 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 processor, 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).
Regarding claim 2, Sancho teaches the computer implemented method of claim 1, further comprising: transmitting, by the at least one processor, the first optical measurement data to a hardware abstraction layer that interfaces between the first catheter optical port and the processing unit (¶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, Sancho teaches the computer implemented method of claim 1, further comprising: transmitting, by the at least one processor, the second optical measurement data to a hardware abstraction layer that interfaces between the second catheter optical port and the processing unit (¶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, Sancho 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 (¶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 (¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 5, Sancho 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 (¶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, Sancho teaches the computer implemented method of claim 1, wherein the optical property is birefringence (¶8-optical properties, such as birefringence).
Regarding claim 7, Sancho teaches the computer implemented method of claim 1, wherein the first graphical representation is an estimated lesion depth (¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 8, Sancho teaches the computer implemented method of claim 1, wherein the second graphical representation is an estimated lesion depth (¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 9, Sancho teaches the computer implemented method of claim 1, further comprising: switching, by the at least one processor, an input of the at least one processor from the first catheter optical port to the second catheter optical port after the predetermined time (¶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 realtime, 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), 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: 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); 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); receive a second optical measurement data from the second catheter optical port after a predetermined time of receiving the first optical measurement data (¶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 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); and the user interface coupled to the computing device (¶107-the GUI 1600…coupled to console 31).
Regarding claim 13, Sancho 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 (¶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, Sancho 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 (¶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, Sancho 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 (¶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 (¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 16, Sancho 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 (¶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 (¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 17, Sancho teaches the system of claim 12, wherein the optical property is birefringence (¶8-optical properties, such as birefringence).
Regarding claim 18, Sancho teaches the system of claim 12, wherein the first graphical representation is an estimated lesion depth (¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 19, Sancho teaches the system of claim 12, wherein the second graphical representation is an estimated lesion depth (¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 20, Sancho 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: switch an input of the processor from the first catheter optical port to the second catheter optical port after the predetermined time (¶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: receiving a first optical measurement data from a 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 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); receiving a second optical measurement data from a second catheter optical port after a predetermined time of receiving the first optical measurement data (¶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).
Regarding claim 24, Sancho 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 (¶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, Sancho 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 (¶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, Sancho 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 (¶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 (¶64-different polarization modes of the light may be located in reference arm 408).
Regarding claim 27, Sancho 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 (¶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 28, Sancho teaches the non-transitory computer-readable medium of claim 23, wherein the optical property is birefringence (¶8-optical properties, such as birefringence).
Regarding clam 29, Sancho teaches the non-transitory computer-readable medium of claim 23, wherein the first graphical representation is an estimated lesion depth (¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 30, Sancho teaches the non-transitory computer-readable medium of claim 23, wherein the second graphical representation is an estimated lesion depth (¶29-graphical user interface (GUI) showing predicted lesion depths).
Regarding claim 31, Sancho teaches the non-transitory computer-readable medium of claim 23, wherein the operations further comprise: switching an input of the processing unit from the first catheter optical port to the second catheter optical port after the predetermined time (¶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).
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.
Claims 10-11, 21-22, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Sancho in view of Koblish (US 20190038349 filed on 10/9/18).
Regarding clam 10, Sancho teaches the computer implemented method of claim 1. However, Sancho does not teach wherein the predetermined time is 2 milliseconds.
Koblish teaches wherein the predetermined time is 2 milliseconds (¶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 2 milliseconds of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Regarding claim 11, Sancho teaches the computer implemented method of claim 1. However, Sancho does not teach wherein the predetermined time is 1 millisecond.
Koblish teaches wherein the predetermined time is 1 millisecond (¶538-measurements can be obtained and recorded at any desired frequency (e.g., every 1 ms)).
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 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, Sancho teaches the system of claim 12. However, Sancho does not teach wherein the predetermined time is 2 milliseconds.
Koblish teaches wherein the predetermined time is 2 milliseconds (¶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 2 milliseconds of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Regarding claim 22, Sancho teaches the system of claim 12. However, Sancho does not teach wherein the predetermined time is 1 millisecond.
Koblish teaches wherein the predetermined time is 1 millisecond (¶538-measurements can be obtained and recorded at any desired frequency (e.g., every 1 ms)).
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 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, Sancho teaches the non-transitory computer-readable medium of claim 23. However, Sancho does not teach wherein the predetermined time is 2 milliseconds.
Koblish teaches wherein the predetermined time is 2 milliseconds (¶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 2 milliseconds of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Regarding claim 33, Sancho teaches the non-transitory computer-readable medium of claim 23. However, Sancho does not teach wherein the predetermined time is 1 millisecond.
Koblish teaches wherein the predetermined time is 1 millisecond (¶538-measurements can be obtained and recorded at any desired frequency (e.g., every 1 ms)).
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 1 millisecond of Koblish in order to provide real-time information to a clinician to facilitate real-time contact assessment (Koblish, ¶264).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792