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(s) (IDS) submitted on 9/1/2023 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Specification
The disclosure is objected to because of the following informalities: prior to allowance, the first paragraph of the specification should be updated to indicate the present status of all applications referred to therein.
Appropriate correction is required.
Claim Objections
Claims 12 and 13 are objected to because of the following informalities:
In claim 12, line 1, it is believed the phrase “wherein the processor configured to” should read “wherein the processor is configured to”.
In claim 13, line 1, it is believed the phrase “wherein the processor configured to” should read “wherein the processor is configured to”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to provide adequate written description for the invention as it is presently claimed. As presently claimed, independent claims 1 and 11 do not require pacing of the heart as part of the process steps, rather only requiring detecting a period of electrophysiological repolarization and measuring an activity pattern. However, the specification fails to describe these elements in the absence of the explicit pacing. The specification at paragraphs [0060]-[0066] describes what appears to be the intended claimed invention, however, the claims lack those elements as described in the specification, specifically lacking that described in paragraph [0064] of “the plurality of pulses can be paced together and at the same time (e.g., in unison) the area 512 of the left atria 511 (e.g., at a same specified focal point). It is possible to pace all locations of the area 512 of the left atria 511 or just an isolated section of the area 512 of the left atria 511 based on how the diagnosis system selects and groups the plurality of electrodes” which results in the claimed “the pacing of the heart tissue by the catheter generates a region of the heart tissue where waves, other than the plurality of pulses, are prohibited from entering until after the period of electrophysiological repolarization to enable the measuring of the activity pattern”. Because the claims fail to require this pacing, they are directed to a separate invention from that of paragraphs [0060]-[0066], and are directed to an invention that was not described in the specification in sufficient detail to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 4-7, 9, and 11-20 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.
Claims 4 and 14 recite the limitation "a coverage of plurality of electrodes". The metes and bounds of the limitation are unclear as it is unknown if it is referring to the previously-recited plurality of electrodes or a different plurality of electrodes. Furthermore, it is unknown what is meant by “coverage” in the context of the claim.
Claims 5 and 15 recite “wherein each electrode of the plurality of electrodes of the catheter provides the pacing of the heart tissue by providing a corresponding pulse of the plurality of pulses”. Wherein statements are used to further define previously set forth elements. In this case, a wherein statement is used to further define an element that was not previously, positively set forth, which makes it unclear if the recited element is required by the claimed method or apparatus.
Claims 6 and 16 recite the limitation "the region of the heart tissue where the plurality of pulses are a unified or near unified" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it appears that either the claim is unfinished or there is an extra word. It is unclear if the phrase “a unified” should rather be “unified” or if there should be a word that follows “near unified”.
Claims 7 and 17 recite “wherein each pulse of the plurality of pulses are paced together and at a same time”. Wherein statements are used to further define previously set forth elements. In this case, a wherein statement is used to further define an element that was not previously, positively set forth, which makes it unclear if the recited element is required by the claimed method or apparatus.
Claims 9 and 19 recite “wherein each of a number or a location of the plurality of pulses is varied to manipulate the period of electrophysiological repolarization”. Wherein statements are used to further define previously set forth elements. In this case, a wherein statement is used to further define an element that was not previously, positively set forth, which makes it unclear if the recited element is required by the claimed method or apparatus.
Claim 11 recites the limitation "a plurality of electrodes of a catheter" in line 7. It is unclear if this is referring to the same or a different catheter and plurality of electrodes as that recited in line 2 of the claim.
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 1-9 and 11-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Niederer et al. (U.S. 2019/0298213, cited by Applicant), herein Niederer. Regarding claim 1, Niederer discloses a method comprising: detecting, by a plurality of electrodes of a catheter, a period of electrophysiological repolarization for a heart tissue caused by a pacing of the heart tissue by the catheter with a plurality of pulses (see step 12..6 in Figure 12); measuring, by the plurality of electrodes of the catheter, an activity pattern of returning electrical signals propagating from the heart tissue after the period of electrophysiological repolarization (see step 12.8 in Figure 12 and paragraph [0047]). It is respectfully submitted that the recitation “wherein the pacing of the heart tissue by the catheter generates a region of the heart tissue where waves, other than the plurality of pulses, are prohibited from entering until after the period of electrophysiological repolarization to enable the measuring of the activity pattern” describes a response of the body to the pacing rather than further limiting any aspect of the method as claimed.
Regarding claim 2, Niederer discloses isolating and analyzing focal points of interest within the heart tissue based on the activity pattern of returning electrical signals (“Once the activation data 1066 has been obtained, it may then be post-processed for each local region by an activation data processor unit 110… The apparatus is further provided with a visual display 118, arranged to display any images of tissue activation maps that are generated”, paragraph [0048]).
Regarding claim 3, Niederer discloses measuring an electrical signal within the heart tissue after the period of electrophysiological repolarization and before the measuring of the activity pattern (“bipolar recordings are taken from the other pairs of electrodes 12, 14, 18, and 19, as the pacing signals are conducted through the atrial heart tissue local to the catheter. The individual bipolar pairs of electrodes 12, 14, 18, and 19 are essentially recording, as electrocardiographic data, whether the local atrial tissue cells have been activated by the pacing signals applied at the central pair 16, and the relative times with respect to the application of the pacing signals to the central pair 16 that activation occurs”, paragraph [0044], where the first sensed signal is considered the claimed “an electrical signal within the heart tissue after the period of electrophysiological repolarization and before the measuring of the activity pattern” and the subsequent signals are considered the claimed “activity pattern”).
Regarding claim 4, Niederer discloses that the period of electrophysiological repolarization provides a time window for measuring the returning electrical signals propagating from within or from outside a coverage of plurality of electrodes (“The individual bipolar pairs of electrodes 12, 14, 18, and 19 are essentially recording, as electrocardiographic data, whether the local atrial tissue cells have been activated by the pacing signals applied at the central pair 16, and the relative times with respect to the application of the pacing signals to the central pair 16 that activation occurs”, paragraph [0044]).
Regarding claim 5, it is respectfully submitted that the recitation “each electrode of the plurality of electrodes of the catheter provides the pacing of the heart tissue by providing a corresponding pulse of the plurality of pulses” fails to further define the claimed invention over that of the prior art because it further limits something, the pacing of the heart tissue, that has not been previously positively recited. The claims do not require the delivery of pacing, rather only being directed to the detection and measurement that occurs subsequent to the pacing. As such, further limiting how the pacing occurs fails to further limit the method, as it is directed to an aspect that occurs prior to the performance of the method.
Regarding claim 6, it is respectfully submitted that the recitation “the pacing of the heart tissue by the catheter generates the region of the heart tissue where the plurality of pulses are a unified or near unified” describes a response of the body to the pacing rather than further limiting any aspect of the method as claimed.
Regarding claim 7, it is respectfully submitted that the recitation “each pulse of the plurality of pulses are paced together and at a same time” fails to further define the claimed invention over that of the prior art because it further limits something, the pacing of the heart tissue, that has not been previously positively recited. The claims do not require the delivery of pacing, rather only being directed to the detection and measurement that occurs subsequent to the pacing. As such, further limiting how the pacing occurs fails to further limit the method, as it is directed to an aspect that occurs prior to the performance of the method.
Regarding claim 8, Niederer discloses that the period of electrophysiological repolarization comprises a time period when the heart tissue is in a refractory period (“From the electrocardiographic data activation time measurements can then be calculated, and from the activation time measurements conduction velocity (CV) and effective refractory periods (ERP) of the local atrial tissue can be subsequently found”, paragraph [0044]).
Regarding claim 9, Niederer discloses that each of a number or a location of the plurality of pulses is varied to manipulate the period of electrophysiological repolarization (“If a different local region of the heart is then required to be measured, the catheter may then be relocated on the heart tissue of the different local region, and the process repeated. Once all of the pacing protocols have been applied and the resulting activation data from the bipolar electrode pairs recorded for every local region desired to be measured”, paragraph [0047]).
Regarding claim 11, Niederer discloses an apparatus comprising: a catheter 10 comprising a plurality of electrodes e1-10 (see Figure 2); and a cardiac pacing and diagnosis device 100/110 comprising a memory 106/119 storing processor executable instructions of cardiac pacing and diagnosis software, and a processor 104/114 configured to execute the processor executable instructions of the cardiac pacing and diagnosis software (see Figures 10 and 11) to cause the apparatus to: detect, by a plurality of electrodes of a catheter, a period of electrophysiological repolarization for a heart tissue caused by a pacing of the heart tissue by the catheter with a plurality of pulses (see step 12..6 in Figure 12); measure, by the plurality of electrodes of the catheter, an activity pattern of returning electrical signals propagating from the heart tissue after the period of electrophysiological repolarization (see step 12.8 in Figure 12 and paragraph [0047]). It is respectfully submitted that the recitation “wherein the pacing of the heart tissue by the catheter generates a region of the heart tissue where waves, other than the plurality of pulses, are prohibited from entering until after the period of electrophysiological repolarization to enable the measuring of the activity pattern” describes a response of the body to the pacing rather than further limiting any aspect of the method as claimed.
Regarding claim 12, Niederer discloses that the processor configured to execute the processor executable instructions of the cardiac pacing and diagnosis software to cause the apparatus to: isolate and analyze focal points of interest within the heart tissue based on the activity pattern of returning electrical signals (“Once the activation data 1066 has been obtained, it may then be post-processed for each local region by an activation data processor unit 110… The apparatus is further provided with a visual display 118, arranged to display any images of tissue activation maps that are generated”, paragraph [0048]).
Regarding claim 13, Niederer discloses that the processor configured to execute the processor executable instructions of the cardiac pacing and diagnosis software to cause the apparatus to: measure an electrical signal within the heart tissue after the period of electrophysiological repolarization and before the measuring of the activity pattern (“bipolar recordings are taken from the other pairs of electrodes 12, 14, 18, and 19, as the pacing signals are conducted through the atrial heart tissue local to the catheter. The individual bipolar pairs of electrodes 12, 14, 18, and 19 are essentially recording, as electrocardiographic data, whether the local atrial tissue cells have been activated by the pacing signals applied at the central pair 16, and the relative times with respect to the application of the pacing signals to the central pair 16 that activation occurs”, paragraph [0044], where the first sensed signal is considered the claimed “an electrical signal within the heart tissue after the period of electrophysiological repolarization and before the measuring of the activity pattern” and the subsequent signals are considered the claimed “activity pattern”).
Regarding claim 14, Niederer discloses that the period of electrophysiological repolarization provides a time window for measuring the returning electrical signals propagating from within or from outside a coverage of plurality of electrodes (“The individual bipolar pairs of electrodes 12, 14, 18, and 19 are essentially recording, as electrocardiographic data, whether the local atrial tissue cells have been activated by the pacing signals applied at the central pair 16, and the relative times with respect to the application of the pacing signals to the central pair 16 that activation occurs”, paragraph [0044]).
Regarding claim 15, it is respectfully submitted that the recitation “each electrode of the plurality of electrodes of the catheter provides the pacing of the heart tissue by providing a corresponding pulse of the plurality of pulses” fails to further define the claimed invention over that of the prior art because it further limits something, the pacing of the heart tissue, that has not been previously positively recited. The claims do not require the delivery of pacing, rather only being directed to the detection and measurement that occurs subsequent to the pacing. As such, further limiting how the pacing occurs fails to further limit the invention, as it is directed to an aspect that occurs prior to the performance of the invention.
Regarding claim 16, it is respectfully submitted that the recitation “that the pacing of the heart tissue by the catheter generates the region of the heart tissue where the plurality of pulses are a unified or near unified” describes a response of the body to the pacing rather than further limiting any aspect of the invention as claimed.
Regarding claim 17, it is respectfully submitted that the recitation each pulse of the plurality of pulses are paced together and at a same time” fails to further define the claimed invention over that of the prior art because it further limits something, the pacing of the heart tissue, that has not been previously positively recited. The claims do not require the delivery of pacing, rather only being directed to the detection and measurement that occurs subsequent to the pacing. As such, further limiting how the pacing occurs fails to further limit the invention, as it is directed to an aspect that occurs prior to the performance of the invention.
Regarding claim 18, Niederer discloses that the period of electrophysiological repolarization comprises a time period when the heart tissue is in a refractory period (“From the electrocardiographic data activation time measurements can then be calculated, and from the activation time measurements conduction velocity (CV) and effective refractory periods (ERP) of the local atrial tissue can be subsequently found”, paragraph [0044]).
Regarding claim 19, Niederer discloses that each of a number or a location of the plurality of pulses is varied to manipulate the period of electrophysiological repolarization (“If a different local region of the heart is then required to be measured, the catheter may then be relocated on the heart tissue of the different local region, and the process repeated. Once all of the pacing protocols have been applied and the resulting activation data from the bipolar electrode pairs recorded for every local region desired to be measured”, paragraph [0047]).
Claims 1, 4, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kane et al. (U.S. 2017/0072202), herein Kane. Regarding claim 1, Kane discloses a method comprising: detecting, by a plurality of electrodes 114/114’ of a catheter (“In some instances, some or all of electrodes 114 may be spaced from housing 120 and connected to housing 120 and/or other components of LCP 100 through connecting wires. In such instances, the electrodes 114 may be placed on a tail (not shown) that extends out away from the housing 120.”, paragraph [0056]), a period 514 of electrophysiological repolarization for a heart tissue caused by a pacing of the heart tissue by the catheter with a plurality of pulses (see Figure 5 and “ Upon detection of a cardiac electrical event 511, LCP 100 may initiate a time delay, such as time delay 514.”, paragraph [0094] and “These timings may, in some cases, ensure that sensing periods 512a-512d occur after repolarization of the heart during a cardiac cycle”, paragraph [0095]); measuring, by the plurality of electrodes of the catheter, an activity pattern of returning electrical signals propagating from the heart tissue after the period of electrophysiological repolarization (“Upon expiration of time delay 514, LCP 100 may initiate sensing periods 512a-512d, during which LCP 100 may sense one or more of signals 504, 506, 508 and 510.”, paragraph [0094]). It is respectfully submitted that the recitation “wherein the pacing of the heart tissue by the catheter generates a region of the heart tissue where waves, other than the plurality of pulses, are prohibited from entering until after the period of electrophysiological repolarization to enable the measuring of the activity pattern” describes a response of the body to the pacing rather than further limiting any aspect of the method as claimed.
Regarding claim 4, Kane discloses that the period of electrophysiological repolarization provides a time window for measuring the returning electrical signals propagating from within or from outside a coverage of plurality of electrodes (“for a paced cardiac electrical event, time delay 514 may be longer than for an intrinsic cardiac electrical event.”, paragraph [0096]).
Regarding claim 11, Kane discloses an apparatus comprising: a catheter comprising a plurality of electrodes 114/114’ (“In some instances, some or all of electrodes 114 may be spaced from housing 120 and connected to housing 120 and/or other components of LCP 100 through connecting wires. In such instances, the electrodes 114 may be placed on a tail (not shown) that extends out away from the housing 120.”, paragraph [0056]); and a cardiac pacing and diagnosis device 100 comprising a memory storing processor executable instructions of cardiac pacing and diagnosis software, and a processor configured to execute the processor executable instructions of the cardiac pacing and diagnosis software (“Processing module 110, in additional embodiments, may include a memory circuit and processing module 110 may store information on and read information from the memory circuit. In other embodiments, LCP 100 may include a separate memory circuit (not shown) that is in communication with processing module 110, such that processing module 110 may read and write information to and from the separate memory circuit. The memory circuit, whether part of processing module 110 or separate from processing module 110, may be volatile memory, non-volatile memory, or a combination of volatile memory and non-volatile memory.”, paragraph [0070]) to cause the apparatus to: detect, by a plurality of electrodes of a catheter, a period 514 of electrophysiological repolarization for a heart tissue caused by a pacing of the heart tissue by the catheter with a plurality of pulses (see Figure 5 and “ Upon detection of a cardiac electrical event 511, LCP 100 may initiate a time delay, such as time delay 514.”, paragraph [0094] and “These timings may, in some cases, ensure that sensing periods 512a-512d occur after repolarization of the heart during a cardiac cycle”, paragraph [0095]); measure, by the plurality of electrodes of the catheter, an activity pattern of returning electrical signals propagating from the heart tissue after the period of electrophysiological repolarization (“Upon expiration of time delay 514, LCP 100 may initiate sensing periods 512a-512d, during which LCP 100 may sense one or more of signals 504, 506, 508 and 510.”, paragraph [0094]). It is respectfully submitted that the recitation “wherein the pacing of the heart tissue by the catheter generates a region of the heart tissue where waves, other than the plurality of pulses, are prohibited from entering until after the period of electrophysiological repolarization to enable the measuring of the activity pattern” describes a response of the body to the pacing rather than further limiting any aspect of the method as claimed.
Regarding claim 14, Kane discloses that the period of electrophysiological repolarization provides a time window for measuring the returning electrical signals propagating from within or from outside a coverage of plurality of electrodes (“for a paced cardiac electrical event, time delay 514 may be longer than for an intrinsic cardiac electrical event.”, paragraph [0096]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Niederer (U.S. 2019/0298213, cited above) in view of Swanson (U.S. 2002/0183638, cited by Applicant). Niederer discloses the invention substantially as claimed, but fails to disclose that the catheter comprises a mesh, balloon, or spoon catheter and the plurality of electrodes comprises at least forty electrodes. Swanson teaches a system for conducting electrophysiological testing that includes a pacing module 48 and a sensing module 32 and a mesh, balloon, or spoon catheter (electrode structure 20 in Figures 1 and 2 is considered both a mesh and balloon catheter, electrode structure 128 in Figures 12A and 12B is considered both a mesh and balloon catheter, electrode structure 129 in Figure 13 A is considered both a mesh and balloon catheter, electrode structure 162 in Figures 15-21 is considered a balloon catheter, electrode structure 206 in Figure 22 is considered a balloon catheter, electrode structure 214/252 in Figures 23-27 is considered a spoon catheter, and electrode structure 358 in Figure 39 is considered both a mesh and balloon catheter), wherein the plurality of electrodes comprises at least forty electrodes (see paragraphs [0099], [0100], and [0147] which describe that each spline of the mesh/balloon catheter carries eight electrodes and there are at least eight splines, resulting in at least 64 electrodes) It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Niederer such that the catheter comprises a mesh, balloon, or spoon catheter and the plurality of electrodes comprises at least forty electrodes, as taught by Swanson, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. V. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796