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 .
Response to Amendment
This office action is in response to the amendment filed on 4/22/2025. Currently claims 1, 3-4, 7-8, 10-11, 13-14, 17-18, 22-26 are pending with claim 26 newly added.
Response to Arguments
Applicant's arguments filed 4/22/2025 with respect to the previous rejection of claims 1-4, 7-8, 10-14, 17-18, 23-24 and 26 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant’s arguments here rest on the crux that the claimed invention generates a real-time map of the heart, identifying clusters and arrhythmia types. As applicant argues:
“Similarly, the present claims address the inherent limitations faced by physicians during cardiac procedures by providing a specialized user interface that generates a real-time map of the heart, identifying clusters representing arrhythmia types. This practical application enhances a physician's ability to process critical information during procedures, thereby overcoming the shortcomings of the prior art. Accordingly, consistent with the reasoning in these precedents, the present claims are not directed to an abstract idea and should be deemed patent-eligible under 35 U.S.C. § 101, warranting withdrawal of the rejection.” [see pg. 25 of applicant’s arguments received on 4/22/2026].
Indeed, the arguments from pgs. 11-27 of applicant’s arguments received on 4/22/2026 seem to rest on this assertion that the claimed invention requires real-time mapping. However, this is more specific than what is claimed. The claims only require all the steps related to identifying PPI values and presenting this PPI values be done during the cardiac procedure. During the cardiac procedure can include in real-time or simultaneously with other steps of the procedure as applicant argues, but the scope also includes after the other steps. This is because performing the identifying and/or presenting as claimed are still part of the cardiac procedure under broadest reasonable interpretation. Therefore, under broadest reasonable interpretation, the claims are not limited to real-time. Thus, applicant’s arguments are not commensurate in scope with the claimed invention as the claims are broader than what applicant argues. Therefore, while the rejection is updated for the changes in claim language, for similar reasons as discussed on pgs. 2-3 of the previous non-final rejection mailed on 1/22/2025 the rejection remains.
If applicant has support in the disclosure for real-time mapping and/or dynamic mapping of the heart or their equivalent as argued by applicant, amending to include this feature could potentially make applicant’s arguments commensurate with the claims and could potentially overcome the 101 (and possibly the current 102/103 rejections outlined below) depending on the arguments presented and the exact language used in the claim as it appears from applicant’s arguments this real-time aspect of the mapping seems to be a key point (when combined with other features) based on applicant’s arguments for why this invention is an advancement over the current state of prior art. Regardless if applicant has support and amends in this direction, additional search and/or consideration would be required to determine if this overcomes the current rejections.
Applicant's arguments see pgs. 27-30, filed 4/22/2025 with respect to the previous rejections of:
claim(s) 1, 2, 4, 11-12, 14, 22 and 24-25 rejected under 35 USC 102(a)(1) and 102(a)(2) as being anticipated by Fishel
claim(s) 3, 7-8, 10, 13 and 17-18 rejected under 35 USC 103 as being unpatentable over Fishel in view of Boveja
have been fully considered but they are not persuasive.
Applicant argues that not all the limitations of the independent claims are anticipated by Fishel and uses claim 1 as the example for all the claim and applicant argues the following points:
First applicant argues that the limitation:
“detecting, during the cardiac procedure, whether the capturing was successful
by measuring morphology changes of the anatomical structure between the pre-pacing conditions and conditions when the stimulating pacing signal was delivered by the one or more catheters”
is not taught by Fishel. As applicant argues:
“Fishel does not disclose or suggest detecting whether cardiac capture was successful by comparing morphology changes between pre-pacing and post-pacing conditions. Instead, Fishel assumes that pacing captures the local tissue and proceeds to measure the post-pacing interval (PPI) without confirming capture through any analysis of morphology. The claimed invention improves upon this by storing prepacing morphology data and verifying capture based on detected changes, thereby enhancing the reliability of the subsequently determined PPI values.” [see pg. 28 of applicant’s arguments received on 4/22/2025]
In response this argument is not persuasive. While, not explicitly stated applicant appears to be arguing a more specific interpretation of anatomical structures like the tissue, but even applicant’s own disclosure describes anatomical structure quite broadly [see para 66 of applicant’s specification received on 12/17/2020 … “As described herein, the anatomical structure can be any anatomical structure, body part, organ, or portion thereof (e.g., such as the heart or a ventricle or atria of the heart) can be a target for pacing, mapping, and diagnosis.”]. While, the claim does further limit the anatomical structure to the ventricle or atria, it’s not specific to something more specific like the tissue, overall shape, etc. Therefore, analysis of morphology of an anatomical structure of an atria or ventricle encompasses entrainment of signals and/or cycles from these structures is included under broadest reasonable interpretation. If applicant can clarify in the claim(s) what specific morphology of the atria or ventricle is being analyzed, this could potentially overcome the 102/103 rejections below.
Second applicant argues that the limitation:
“determining that the portion of the anatomical structure is synchronized with the stimulating pacing signal using a refractory period of the anatomical structure”
is not taught by Fishel. As applicant argues:
“Fishel does not disclose determining synchronization using the refractory period. Rather, Fishel merely compares the PPI to a tachycardia cycle length (TCL) and annotates cardiac sites based on the difference. The claimed approach is technically distinct and advantageous, using physiological properties of the heart (i.e.,
its refractory behavior) to establish synchronization and ensure the integrity of the PPI
measurement.” [see pg. 28-29 of applicant’s arguments received on 4/22/2025]
This argument is not persuasive. Applicant arguments do not appear commensurate with the claims. The claim requires using a “refractory period”, which is fairly broad. Based on applicant’s own specification [see para 70 or applicant’s specification received on 12/18/2020] as there are many different effects such as a different order, direction and morphology or even having electrical signals conduct differently that fall under the broad language. Given how broad “using refractory period” is and that this is a cellular biological response to stimulus the PPI is a measured response providing an indication of successful capture under broadest reasonable interpretation. If applicant can clarify how or what about the refractory period is being used to define success, this could potentially overcome the 102/103 rejections below.
Third applicant argues that the limitation:
“presenting, on a display, the PPI values as a map that is superimposed on the visualization during the cardiac procedure”
is not taught by Fishel. As applicant argues:
“Fishel shows electroanatomical timing maps with annotated sites but does not
describe superimposing dynamically determined PPI values on a real-time anatomical
visualization during the procedure. Fishel's annotations are generated based on a
calculated difference (PPI - TCL) and appear to be derived after-the-fact, not in real
time or during the delivery of the pacing signal. [see pg. 29 of applicant’s arguments received on 4/22/2025]
In response this argument is not persuasive because applicant’s arguments are not commensurate with the scope of the claims. Applicant equates “during the cardiac procedure” to mean real-time thereby dynamic mapping. However, during the cardiac procedure includes real-time, but also includes after other steps because the mapping is understood to be part of the cardiac procedure. Therefore, applicant is arguing a further limitation not currently claimed. If applicant has support can clarify in the claims this real-time and/or dynamic mapping, it could potentially overcome the 102/ 103 rejections below.
Finally, applicant’s argues that because this combination of limitations the claimed combination is not disclosed.
Accordingly, Fishel fails to disclose or suggest several key limitations of
independent claim 1, including morphology-based detection of successful capture
using stored pre-pacing conditions, synchronization determination based on the
refractory period of the heart, and real-time presentation of PPI values superimposed
on an anatomical visualization during the procedure. These features work together to
improve the accuracy, reliability, and clinical utility of PPI mapping during cardiac
procedures in a manner not contemplated by Fishel. As such, the claimed invention is
not rendered obvious by Fishel.” [see pg. 29 of applicant’s arguments received on 4/22/2025]
In response, this argument is not persuasive. As outlined above, the arguments presented that the key limitations applicant argues are not disclosed by the Fishel were found to not be persuasive for the reasons outlined above. Therefore, the argument that the combination of these key limitations not being taught is found to not be persuasive either. For this reason, while the rejection has been amended to account for the changes in claim language, much of the rejection is similar to the previous grounds of rejection.
.
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, 3-4, 7-8, 10 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 as amended recites the limitation “capturing, during the cardiac procedure, a from a portion of the anatomical structure in response to the stimulating pacing signal, wherein the portion comprises a ventricle or an atria”
There appears to be a word missing in the bolded part of the limitation. The missing word has been interpreted to be “signal” based on the disclosure and the language used in the other independent claim. Therefore, for this examination the limitation has been interpreted as if written “capturing, during the cardiac procedure, a signal from a portion of the anatomical structure in response to the stimulating pacing signal, wherein the portion comprises a ventricle or an atria”. Regardless, if this is applicant’s intention or not, applicant should clarify what is being claimed.
Claims 3-4, 7-8, 10 and 26 are rejected under 35 USC 112(b) as well based on dependency to 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, 3-4, 7-8, 10-11, 13-14, 17-18, 23-24 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim(s) recite(s) a method and system for signal processing providing post-pacing interval measurement in an anatomical structure with improved accuracy.
Step 2A, Prong One
Regarding claims 1 and 11, the limitation of “detecting whether the capturing was successful by measuring morphology changes of the anatomical structure between pre-pacing conditions and conditions when the stimulating pacing was generated by the one or more catheters,” “in response to the measuring indicating that the capturing was successful,“ “identifying the PPI values by determining, a time duration between the stimulating pacing signal and a subsequent response from the portion of an anatomical structure” are processes, as drafted, that cover performance of limitations that can be performed in the mind.
With regard to claim 11, these limitations are processes, as drafted, that cover performance of limitations that can be performed in the mind but for the recitation of generic computer components (“a memory and “a processor”). For instance, “detecting whether the capturing was successful” involves nothing more than a medical technician viewing an anatomical morphology on a display and noting changes in the anatomical morphology on a display, before and after pacing, “in response to the measuring indicating that the capturing was successful” involves nothing more than a medical technician responding after noting changes in the anatomical morphology on a display, before and after pacing, and “identifying the PPI values by determining, a time duration between a stimulating pacing signal and a subsequent response from an anatomical structure” encompasses nothing more than a medical technician determining the time from the end of a pacing pulse and the start of an intrinsic wave on an EKG printout. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in human mind, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two
Regarding claim 1, this judicial exception is not integrated into a practical application. In particular, the claim recites additional elements of “capture, during the cardiac procedure, a from a portion of an anatomical structure” (interpreted as capturing a signal as outlined under the 112 section above) “rendering a visualization of the anatomical structure and “presenting, on a display, the PPI values as a map that is superimposed on the visualization during the cardiac procedure”. The steps of “capturing a stimulating pacing signal” and “controlling during the cardiac procedure, one or more catheters to generate a stimulation pacing signal and deliver the pacing signal to the anatomical structure” are nothing more than pre-solution activity of data gathering and “rendering a visualization” and “presenting, on a display” amounts to nothing more than post-solution activity of displaying. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Regarding claim 11, this judicial exception is not integrated into a practical application. In particular, the claim recites additional elements of “capture, during the cardiac procedure, a signal from a portion of an anatomical structure” “rendering a visualization of the anatomical structure and “presenting, on a display, the PPI values as a map that is superimposed on the visualization with the time duration”. The step of “capturing a stimulating pacing signal” and “control, during the cardiac procedure, one or more catheters to generate a stimulation pacing signal and deliver the pacing signal to the anatomical structure” are nothing more than pre-solution activity of data gathering and “rendering a visualization” and “presenting, on a display” amounts to nothing more than post-solution activity of displaying. The processor (i.e. “processor” or “computer processor”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining set parameters) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
Regarding claim 1, the claim does 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. Therefore, the claims considered in combination/as a whole is are not patent eligible.
Regarding claim 11, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform capturing and exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore, the claims considered in combination/as a whole are not patent eligible.
Regarding claims 3 and 13, the limitation of “the stimulating pacing signal is provided by a coronary sinus catheter stationed within the anatomical structure” further limits the use of a catheter to provide the stimulating pacing signal. However, this limitation amounts to no more than pre-solution activity of data gathering.
Regarding claims 4 and 14, the limitation of “the time duration comprises an impediment value” further limits the composition of the time duration value further defines determination step already indicated as being directed to abstract idea.
Regarding 7 and 17, the limitation of “pacing comprises a train of sequential signals with the stimulating pacing signal being at an end of the train“ further limits the details of the stimulating pacing signal with well-known stimulation methods using sequential pulse train pacing signals. However, this limitation amounts to no more than pre-solution activity of data gathering.
Claims 8 and 18 recite the limitation of “the subsequent response from the portion of the anatomical structure comprises a next natural event of activity” which includes a natural event of an activity. The claim does not fall within at least one of the four categories of patent eligible subject matter because it is directed to non-statutory subject matter of a natural phenomenon.
Regarding claim 10, the limitation of “determining the accuracy of the time duration based on previously collected data” further limits the input data used by the determination engine further defines determination step already indicated as being directed to abstract idea.
Claim 23 recites the limitation of “the refractory period of the anatomical structure is determined by detecting a difference between an order, a direction, or a morphology of waves of the anatomical structure and an order, a direction, or a morphology of the stimulating pacing signal that clears, during the pacing, the anatomical structure” which further limits the details of determining the refractory period.
Claim 24 recites the limitation of “the time duration comprises a post pacing interval automatically determined after the pacing” which further limits the details of the time duration to identify the PPI. However, this limitation amounts to no more than post-solution activity of displaying the time duration output.
Claim 25 further recites “non-transitory computer readable storage medium storing instructions” (i.e. memory) and the use of a processor to run the instructions of memory. However, a memory and a processor are generic and well-known and convention. This can be seen in the references of Naryan et al (US 20040059237) hereafter known as Naryan [see paras 250-255] and Fishel et al (US 20190076040) hereafter known as Fishel [see paras 40-41]. Thus, because these elements are well known and conventional these structures don’t amount to significantly more than the judicial exception. Therefore, as an abstract idea in the form of a mental process (i.e. the judicial exception), this judicial exception is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 2, 4, 11-12, 14, 22 and 24-26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fishel (US 2019/0076040 A1, cited by Applicant).
Regarding claims 1 and 11, Fishel discloses a method and a system respectively for in identifying Post Pacing Interval (PPI) values in an anatomical structure with improved accuracy during cardiac procedure, the method and the system comprising:
a memory that stores pre-pacing conditions for the anatomical prior to the cardiac procedure (par. [0040]: In procedure 184, the difference is calculated automatically using computer software accessing the measured PPI and measured pre-entrainment cycle length; accessing the measured pre-entrainment cycle length implies that the pre-pacing condition of pre-entrainment cycle was accessed from memory by computer software), wherein the anatomical structure comprises a heart (par. [0035]: map 132B shows…measurement locations in the heart); and
one or more catheters that sense electrical signals that inserted into in the heart (par. [0033]: a sensor in the tip of a mapping catheter…will automatically measure the PPI of an entrained potential reentry circuit);
one or more processors that are communicatively coupled to the memory (par. [0040]: The measured PPI may be stored in a memory… In procedure 184, the difference is calculated automatically using computer software accessing the measured PPI; measured PPI may be stored in memory and accessed by computer software on a computer processor) and the one or more catheters (par. [0036]: “It is noted that the disclosed technique can be embodied as a method as part of a software add-on utility to known software platforms used to generate electroanatomical timing maps, such as the CARTO system developed by Johnson & Johnson® and the EnSite cardiac mapping system developed by St. Jude Medical®. Such a method is described below in FIG. 8. In addition, the disclosed technique can be embodied as a system for sensing and determining the PPI of a mapping catheter and for generating an enhanced electroanatomical timing map and annotating the map as described above to generate an entrainment map.”)
wherein the one or more processors are collectively configured to:
control, during the cardiac procedure, the one or more catheters to generate a stimulating pacing signal and deliver the stimulating pacing signal (par. [0013]: …a series of…pacing impulses …is delivered via a mapping/ablation catheter,) to the anatomical structure (par. [0013]: …a series of fixed rate pacing impulses…, clm. 8: … delivering a fixed rate pacing at said at least one cardiac site…).,
capturing, during the cardiac procedure, a signal from a portion of the anatomical structure in response to the stimulating pacing signal (par. [0039]: … a post-pacing interval (herein abbreviated PPI) is measured at the at least one cardiac site; determining the PPI requires capturing a stimulating pacing signal), wherein the portion comprises a ventricle or an atria (Fig. 7 and pars. [Abstract], [0035], [0038]: …shown without colour are various regions of the heart, such as regions 134A, 134B and 134C, [0038]: The entrainment is measured at least one cardiac site within …the heart where electrical conduction times can be measured…the cardiac site can be the left atrium, right atrium, left ventricle, right ventricle…) and the stimulating pacing signal is generated by the one or more catheters (pars. [0013]: …a series of…pacing impulses …is delivered via…catheter);
detecting, during the cardiac procedure, whether the capturing was successful by measuring morphology changes of the anatomical structure between the pre-pacing conditions (Fig. 8 (180) the pre-pacing condition of tachycardia conditions measured) and conditions when the stimulating pacing was delievered by the one or more catheters (Fig. 8 (182) and par. [0039]: In a procedure 182, a post-pacing interval (herein abbreviated PPI) is measured at the at least one cardiac site. To measure a post-pacing interval, typically the pre-entrainment cycle length is measured and then fixed rate pacing is delivered at this same site at a rate faster than the pre-existing tachycardia or arrhythmia; the capture is successful in that the measurements are subsequently used to measure PPI ); and
in response to the morphology changes measured indicating that the stimulating pacing signal was successfully captured during the cardiac procedure:
in response to the measuring indicating that the capturing was successful (par. [0039]: In a procedure 182, a post-pacing interval (herein abbreviated PPI) is measured at the at least one cardiac site. To measure a post-pacing interval, typically the pre-entrainment cycle length is measured and then fixed rate pacing is delivered at this same site at a rate faster than the pre-existing tachycardia or arrhythmia…with pacing continued until capture of the local electrogram occurs ; one capture successfully occurs, PPI is measured in response, making the measurement of PPI an indication of successful capture):
determining that the portion of the anatomical structure is synchronized with the stimulating pacing signal (par. [0013]: An entrained circuit thus represents a circuit in the heart in which the rate of electrical conduction in the entrained circuit syncs up with an imposed electrical impulse from another system (such as an external pulse generator outside the heart)) using a refractory period of the anatomical structure (par. [0039]: The PPI is the distance, as typically measured in milliseconds of the time between cessation of entrainment pacing and the first electrogram recorded after the tachycardia resumes following pacing),
automatically identifying the PPI values (par. [0033] According to the disclosed technique, a sensor in the tip of a mapping catheter…will automatically measure the PPI) by determining, a time duration between the stimulating pacing signal and a subsequent response from the portion of the anatomical structure (Fig. 7 and Fig 8 (188) and pars. [0039]: The PPI is the distance, as typically measured in milliseconds of the time between cessation of entrainment pacing and the first electrogram recorded after the tachycardia resumes following pacing, [0041]: The annotation can be executed automatically via computer software. In a procedure 188, the at least one cardiac site is annotated on an electroanatomical timing map),
rendering, a visualization of the anatomical structure (Fig. 6 and [0041]: The annotation can be made on a representation of the cardiac site, such as on a computer-generated image of the heart); and
presenting, on a display, the PPI values as a map that is superimposed on the visualization during the cardiac procedure (Figs. 6 and 7 and par. [0041]: …different ranges of determined differences can be annotated on an electroanatomical timing map using different colours).
Regarding claims 4 and 14, Fishel discloses the method of claim 1 and the system of claim 11 respectively, wherein the time duration comprises an impediment value (Fig. 5 and par. [0014]: …the PPI, as shown by an arrow 96B, is 388 ms which is 153 ms longer than the tachycardia cycle length of 235 ms, as shown by an arrow 94B. This indicates a region of entrainment pacing that is very poor and represents a site very far removed from the actual reentrant circuit causing the arrhythmia).
Regarding claim 22, Fishel discloses the method of claim 1, wherein the heart is influenced by the stimulating pacing signal to cause activity of the heart to synchronize with the stimulating pacing signal (par. [0013]: An entrained circuit thus represents a circuit in the heart in which the rate of electrical conduction in the entrained circuit syncs up with an imposed electrical impulse from another system (such as an external pulse generator outside the heart)).
Regarding claim 24, Fishel discloses the method of claim 1, wherein the time duration comprises a post pacing interval automatically determined after the stimulating pacing signal is delivered (par. [0013]: The measurement of the amount of time it takes to see the next beat of tachycardia after the cessation of overdrive pacing occurs is termed in the art as the post-pacing interval (herein abbreviated PPI)).
Regarding claim 25, Fishel discloses the method of claim 1, wherein an electrophysiological procedure is applied to the ventricle or the atria of the heart based on the presenting (Fig. 7 (132A) and par. [0038]: Once the entire heart has been mapped, the operator can then return to the recorded locations of the active reentry circuit or circuits and ablate them…).
Regarding claim 26:
A non-transitory computer readable storage medium storing instructions, the instructions when executed by a processor of a surgical console, (par. [0036]: “It is noted that the disclosed technique can be embodied as a method as part of a software add-on utility to known software platforms used to generate electroanatomical timing maps” and par. [0040]: “In procedure 184, the difference is calculated automatically using computer software accessing the measured PPI and measured pre-entrainment cycle length”; the technique being a part of a software add-on utility implies a memory storying instructions that are executed by a computer (i.e. a processor of a surgical console), cause the surgical console to perform the method according to claim 1 (see rejection to claim 1 above)
Claims 3, 7, 8, 10, 13 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fishel in view of Boveja et al. (US 2014/0058246 A1, hereinafter “Boveja”, cited by Applicant) as evidenced by International Business Machines (IBM, “Big Data Analytics“, Website: https://www.ibm.com/analytics/big-data-analytics, hereinafter “IBM”).
Regarding claims 3 and 13, while Fishel discloses the method of claim 1 and the system of claim 11, comprising one or more catheters (par. [0033]: a sensor in the tip of a mapping catheter ), Fishel does not disclose wherein the catheter includes a coronary sinus catheter stationed within the anatomical structure.
However Boveja, in the same field of endeavor: system and methods for real-time cardiac mapping, discloses the one or more catheters includes a coronary sinus catheter stationed within the anatomical structure ((Figs. 1B and 16 (64) (183) and pars. [0053], [0169]: As pacing is performed from the CS 183 catheter, the software is configured and programmed such that the measurement of time from the pacing spike (CS catheter) to the ABL 182 signal recording will be measured by the software and displayed on the screen) to provide the benefit of checking a post ablation line of block in such a way to make the procedure go faster and smoother (par. [0169]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to incorporate in the method and system containing a catheter of Fishel, a coronary sinus catheter, of Boveja, in order to check a post ablation line of block in such a way to make the procedure go faster and smoother.
Regarding claims 7, 8, 17 and 18, Fishel discloses the method of claim 1 and the system of claim 11 respectively, except wherein the pacing comprises a train of sequential signals with the stimulating pacing signal being at an end of the train; and
wherein the subsequent response from the portion of the anatomical structure comprises a next natural event of activity.
Boveja discloses the pacing comprises a train of sequential signals with the stimulating pacing signal being at an end of the train (Fig. 15 and par. [0166]: …the catheter is …paced at a cycle length (CL)…The first escape interval after the last paced beat is measured); and
wherein the subsequent response from the portion of the anatomical structure comprises a next natural event of activity (Fig. 15 (201); in Fig. 15, TCL 201 is the next natural event after First escape beat 199) to provide the benefit of checking a post ablation line of block in such a way to make the procedure go faster and smoother (par. [0169]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to incorporate in the method and system of an entrained circuit that syncs with the pacing pulse of Fishel, a pacing signal at the end of a train sequence followed by a natural, tachycardia event, of Boveja, in order to check a post ablation line of block in such a way to make the procedure go faster and smoother.
Regarding claims 10, Fishel discloses the method of claim 1, except further comprising: determining the accuracy of the time duration based on previously collected data.
Boveja discloses further comprising:
determining the accuracy of the time duration (Fig. 29 (220) par. [0151]: The computer 17 of the mapping system also comprises the software which is configured for data analysis and processing…; software data analysis can constitute big data analysis) for the purpose of providing real-time propagation mapping (par. [0147]).
Boveja teaches software configured for data analysis using data from sensors, but does not explicitly teach big data analysis. However, IBM provides a definition of big data as "data sets whose size or type is beyond the ability of traditional relational databases to capture, manage and process the data with low latency…the different types of data originate from sensors, devices…generated in real time and at a very large scale." Therefore, the data in Boveja constitutes big data as is evidenced by IBM teachings.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to incorporate in the method and system of an entrained circuit that syncs with the pacing pulse of Fishel, big data software analysis beyond traditional analysis, of Boveja, in order to provide real-time propagation mapping.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fishel in view of Takahashi et al. (Publication No. US 20170010253 A1).
Regarding claim 23, Fishel discloses the method of claim 1, except wherein the use of the refractory period comprises detecting a difference between an order, a direction, or a morphology of waves of the anatomical structure and an order, a direction, or a morphology of the stimulating pacing signal that clears, during the pacing, the anatomical structure.
However, Takahashi, in the same field of endeavor: live tissue analysis, discloses the use of the refractory period comprises detecting a difference between an order, a direction, or a morphology of waves of the anatomical structure and an order, a direction, or a morphology of the stimulating pacing signal that clears, during the pacing, the anatomical structure (par. [0020]: …the refractory period calculation unit can calculate a refractory period of the cardiomyocytes, on the basis of two or more pieces of wave information having different phase differences) for the benefit of ensuring a sufficient number of data as the observation range becomes larger while using techniques suitable for long term measurement (par. [0013]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to incorporate in the method and system of an entrained circuit that syncs with the pacing pulse of Fishel, a refractory period calculation comprising the difference between wave phases, of Takahashi, in order to ensuring a sufficient amount of data as the observation range becomes larger while using techniques suitable for long term measurement.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEBASTIAN X LUKJAN whose telephone number is (571)270-7305. The examiner can normally be reached Monday - Friday 9:30AM-6PM.
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, NIKETA PATEL can be reached at 571-272-4156. 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.
SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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