ETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/4/25 has been entered.
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.
Claim 2 is 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 2, “wherein the central electrode makes bipolar measurements…electrodes make unipolar measurements” is vague. An electrode by itself cannot make bipolar or unipolar measurements. Another electrode is needed to operate in the bipolar or unipolar mode, and some other element is necessary to make the measurements.
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 1-3, 10, and 14-23 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 subject matter which was not described is the simultaneously detecting at least one local activation signal at the central electrode and each of the surrounding electrodes, in combination with the other elements/functions in the claim(s).
The use of the term “detecting” is broad enough to refer to something other than just the electrode sensing an electrical signal. Therefore, the applicant had a general idea of performing the action/functions of simultaneously detecting from the electrodes a local activation signal, but they did not possess the specific details of how the idea is carried out when they filed the application. The disclosure only sets forth there is an electrode array as part of the system/method. No other guidance, element, amplifier, measurements system, processor, and/or display has been set forth in the disclosure as to how exactly the simultaneous detection is made from the electrodes.
Similarly, for the dependent claims, the subject matter which was not described is the element or steps in the dependent claims to the steps of: making bipolar or unipolar measurements (claim 2); eliminating both far field and near field interference from surrounding electrodes so the central electrode only detects the local activation signal (claim 3); constructing a map of cardiac electrical activity, or cardiac rhythm and tissue properties, or a trajectory of a cardiac activation wave (claims 10, 14, and 22); determining an activation time of the local signal (claim 19); calculating a velocity vector (claim 20); compiling an isochronal activation map based on the velocity vector (claim 21); and/or detecting a conduction block (claim 23); in combination with the other elements/steps/functions as set forth in the claim(s).
The applicant had a general idea of performing the actions/functions listed above for the dependent claims, but they did not possess the specific details of how the ideas are carried out when they filed the application. No element, structure, or guidance is provided as to exactly how the functions are accomplished for performing the dependent claim’s steps/functions. No specific element or structure has been set forth for how the two-dimensional array performs these steps.
An electrode is only a piece of conductive material that senses the surrounding electric field. It is unclear how the electrode array performs the steps/functions as set forth in the independent and/or dependent claims, or if some other element is performing the steps/functions as listed in the independent and/or dependent claims.
This rejection is related to the written description requirement.
Claims 1-3, 10 and 14-23 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The subject matter which was not described is the simultaneously detecting at least one local activation signal at the central electrode and each of the surrounding electrodes, in combination with the other elements/functions in the claim(s).
In addition, the subject matter which was not described is the dependent claim limitations of to the steps of: making bipolar or unipolar measurements (claim 2); eliminating both far field and near field interference from surrounding electrodes so the central electrode only detects the local activation signal (claim 3); constructing a map of cardiac electrical activity, or cardiac rhythm and tissue properties, or a trajectory of a cardiac activation wave (claims 10, 14, and 22); determining an activation time of the local signal (claim 19); calculating a velocity vector (claim 20); compiling an isochronal activation map based on the velocity vector (claim 21); and/or detecting a conduction block (claim 23); in combination with the other elements/steps/functions as set forth in the claim(s).
The disclosure fails to state or teach the independent and dependent claim functions listed above (e.g. of simultaneously detecting, determining, mapping calculating, compiling, and/or constructing a map, etc.), in combination with the other elements and steps in the claim(s). Without this disclosure, one skilled in the art cannot practice the invention without undue experimentation because of the number of operational parameters in the process/apparatus and uncertainty of the nature of the invention as to how to detect simultaneous signals or make the dependent claimed functions of determining, calculating, compiling, mapping, and/or and detecting, in combination with the other elements and steps in the claim(s).
Due to the lack of an enabling specification and lack of direction provided by the inventor for how to make the dependent claim functions of simultaneously detecting, determining, calculating, compiling, mapping, and/or constructing, several questions arise as to how to make and/or use the invention, such as:
An electrode is only a piece of conductive material that senses the surrounding electric field. Is this alone the structure that allows for simultaneously detecting the local activation signal from the electrodes, or is some other element/structure responsible for this?
Is another element such as a processor or circuit used to perform the functions of detecting the local activation signal? Such as may be done by averaging, subtracting, etc.?
What specific circuits/elements are being used for the method steps of claim 1? And dependent claims? Is only a two dimensional array necessary? Or is something else being done or used to detect the local activation signal only as it passes underneath the central electrode?
How do the additional elements function with the electrode array?
Where are they located?
Similarly, for the dependent claims 2-3, 10, and 14-23, the same questions are asked in regards to the electrode array performing those dependent claim functions. Is it the electrode array by itself that is performing the steps? Or is some other element performing the steps? What are these elements and how do they function?
One example of many showing the state of the prior art, the level of ordinary skill and predictability, and necessary detail needed to enable someone skilled in the art to make and/or use a mapping array system and method is patent publication 2017/0065198. In that publication a catheter and electrode array (e.g. figure 3—a combination of electrodes and conductors) is used with a processing system (e.g. figure 1) to simultaneously sense and detect, average and subtract the cardiac data, and map different cardiac activity.
Since there are numerous questions as to how the invention is made and/or used, since no amount of direction or guidance was presented, since other catheter and electrode array mapping systems and methods describe in detail how to provide the processing of the sensed data, and/or since one skilled in the art cannot practice the invention without undue experimentation (as seen by the above questions) because of the number of operational parameters in the process/apparatus that are needed to know the exact way of how to make the simultaneous detection of the local activation signal by the electrodes, in combination with the other steps and elements in the claim(s), in addition to the dependent claim functions of determining, calculating, compiling, and mapping, in combination with the other elements and steps in the claim(s), one skilled in the art to which it pertains is not enabled to make and/or use the invention of the subject matter presented in the claims.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-3, 10 and 14-20 are rejected under 35 U.S.C. 102a1 as being anticipated by Ruppersberg (2017/0065198). Ruppersberg discloses the following claimed limitations:
--using a two dimensional electrode array in a patient’s heart (e.g. figures 2 and 3, etc.) where the array has electrodes distributed across the array at known locations separated by known distances (e.g. figure 3, para. 17; uses conventional mapping catheters such as Boston Scientific Constellation as set forth in para. 69 –brochure attached; or Biosense Webster Pentaray in para. 41; etc.; Note that the claim does not state that the catheter is rigid/inflexible or that the known spacing/locations do not change, only that they are “known:” which they are known before use)
--simultaneous measurements of heart signals (e.g. para. 69, etc.) using the basket electrode or 8x8 array (e.g. figure 3, 5(d), paras. 41, 68, 69, etc., which necessarily has a central electrode surrounded by surrounding electrodes and shows it as a series of nine electrodes in three rows; Constellation brochure—Note that the claim is an open-ended “comprising” claim and does not preclude other electrodes in the basket).
For claim 2, it is unclear how the central electrode and other electrodes “make bipolar” or “unipolar” measurements as the electrodes are just pieces of conductive material, which Ruppersberg discloses. Ruppersberg also discloses that the processing system can make unipolar and bipolar measurements (e.g. para. 46, etc.).
For claim 3, Ruppersberg also discloses the signals from all the electrodes are averaged (e.g. paras. 105, 114, etc.) and then the average subtracted from each individual electrode/electrogram (e.g. paras. 105, 114, etc., which would include the central electrode) and therefore it meets the claim limitation of having the “central electrode detects only the local activation signal as the local activation signal passes under the central electrode” since this is the exact same way the applicant states in their disclosure that this claim limitation is performed--i.e. by generating a common mode rejection signal for the central electrode by averaging each surrounding electrode and subtracting the average from the central electrode.
Ruppersberg also discloses determining the activation times, maps of cardiac electrical activity and times of the activation signal (e.g. paras. 107-109, etc.), velocity vector maps from the local activation signal and determining conduction blocks and fibrosis/scarring (i.e. and therefore the electrode array would be positioned within and outside a scar region, figure 9, e.g. abstract, paras. 31, 8, 9, 70-75, 107, figures 5g, 7-10, etc.), mapping the trajectory of a cardiac activation wave and tissue properties to detect conduction blocks/fibrosis/rotors (e.g. paras. 107-109, figures 5, 7-10 etc.) and the spatial context/maps for each electrode signal (e.g. abstract, paras. 9, 70, etc.). Note that the electrodes are microelectrodes as they have a size in microns.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ruppersberg. As discussed above, Ruppersberg discloses the claimed invention and detecting conduction blocks, mapping trajectory, and calculating the spatial context, but does not disclose compiling an isochronal map based on the velocity vector for each electrode of the array. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed (and is admitted prior art as the applicant has not previously pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Ruppersberg, with compiling an isochronal map based on the velocity vector for each electrode of the array, as is well known and common knowledge in the art (mpep 2144), since it would provide the predictable results of showing contour lines of equal arrival times of cardiac signals to indicate how close the electrode array is to a site of tachycardia origin.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive, and are moot in view of the new grounds of rejection necessitated by amendment.
The argument regarding the 112(a) rejection for written description and enablement are not persuasive as it is unclear how an electrode, by itself, simultaneously detects the local activation signal using the electrodes, in addition to the dependent claims steps of calculating, mapping, detecting, etc..
It is noted that the applicant and/or attorney have argued in different dated responses to the Examiner’s office actions, that different elements are used to generate the different steps and it is unclear if the electrode array by itself is performing these steps, the physician, or some other element/structure.
In the response of 1/4/24 it was argued the array itself and array circuitry performs the generation of the CMR/method steps. Similarly, in the response of 4/19/24 it was argued the center electrode and surrounding electrodes of the array perform the generation of the CMR/method steps. The response of 8/20/24 states that the electrode array acts as circuitry to generate the CMR/method steps. Also, the applicant/attorney is arguing that the catheter generates the CMR/method steps with some other additional circuity.
These multiple different responses as to what actually is generating the CMR/method steps is further evidence that the written description was/is lacking as no guidance was provided in the disclosure to what is actually generating the CMR/method steps and how it functions with the catheter and array to perform all the functions/steps listed in the claims.
The argument that the catheter of Ruppersburg is flexible and conforms to the cardiac cavity is not persuasive and the claims only contain limitations to having the catheter electrode locations and spacing being known, which Ruppersburg does disclose as set forth in the 102 rejection. Note that the claim does not state that the electrode locations/spacings stay constant when in the heart, or that the catheter is not flexible. In addition, is the applicant stating that their own catheter is a solid rigid structure that does not deform or is not flexible?
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 1/24/26