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 .
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 25-26, 28-30 and 34 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 25-26, 28-30 and 34 each recite a broad recitation immediately followed by a narrower statement of the limitation which is introduced by the term “namely” (claim 29 has two such recitations; see list below). The format each time is “[broad limitation], namely [narrower limitation].” The actual recitations are as follows:
Claim 25
“the relative spatial information, namely the order of the electrodes”
Claim 26
“the analysis routine, namely in the classification routine”
Claim 28
“the relative spatial information, namely the order of the electrodes”
Claim 29
“a quality indicator, namely a signal- to-noise ratio”
“the spatial information, namely the order of the electrodes”
Claim 30
“a comparison of neighboring channels, namely waveforms of activations or activation candidates of neighboring channels”
Claim 34
“a peak morphology, namely a minimum and/or maximum peak angle”
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
It appears that in each of these instances, Applicant is intending to claim the narrower limitation. As such, there is no reason to also claim the broader limitation. Proper clarity and definiteness can be achieved by simply omitting the broader limitations. For instance, in claim 26, when it recites “wherein, in the analysis routine, namely in the classification routine,” it appears that this should simply recite “wherein, in the classification routine, …”
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 16-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 16-37 are directed either to a method/process or to a system/machine.
Step 2A, Prong One: The claims recite a mental process including steps, e.g. in claim 16 all of the remaining limitations beginning at the phrase “in an analysis routine” are steps which could be performed by the human mind and/or by a human with a physical aid such as pen and paper.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the step of “the intracardiac electrogram has been recorded … the catheter comprises multiple electrodes … multiple channels … have been recorded … the multiple electrodes have a fixed order of placement” is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process. Furthermore, merely carrying out mental steps using generic computing technology such as “a control system” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection components (specifically the “control system” and the catheter). The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. Examples of both the control system and catheter can be seen in US 2017/0181655 A1 cited with this action. The catheter is referred to both in that reference, and by Applicant here in the specification, as being a LASSO® catheter which is a well-understood, routine and conventional circular mapping catheter by Biosense Webster. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
All of claims 17-37 follow the same analysis above since they do not introduce any other additional elements, and merely expand on the mental process itself and/or expand on the insignificant pre-solution activity.
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.
Claims 16-37 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2017/0181655 A1 to El Haddad (hereinafter “El Haddad”).
Regarding Claim 16, El Haddad teaches a method for analysing an intracardiac electrogram for detecting a pulmonary vein isolation status (see title), wherein:
the intracardiac electrogram has been recorded at a target region via a catheter inserted into a human body (see e.g. Paras. 3, 73, 114, 117 137, 141; a circular mapping catheter (CMC) such as the LASSO® catheter is used);
the catheter comprises multiple electrodes (see e.g. Paras. 3, 73, 114, 117 137, 141; a circular mapping catheter (CMC) such as the LASSO® catheter is used);
multiple channels of the intracardiac electrogram have been recorded by the multiple electrodes (see e.g. Paras. 3, 73, 114, 117 137, 141; a circular mapping catheter (CMC) such as the LASSO® catheter is used; also see e.g. FIGS. 2-3 and Para. 118);
the multiple electrodes have a fixed order of placement (see e.g. Paras. 3, 73, 114, 117 137, 141; a circular mapping catheter (CMC) such as the LASSO® catheter is used);
in an analysis routine, a control system determines an electrical status of the target region by analysing at least three of the multiple channels (see e.g. FIGS. 2-3, 8-9 and Para. 118),
the order of the multiple electrodes is provided to the control system or saved in a memory of the control system (see e.g. FIGS. 2-3 and Para. 118);
in the analysis routine, the control system determines the electrical status of the target region based on relative spatial information including the order of placement of the multiple electrodes (see e.g. FIGS. 8-9);
in the analysis routine, the control system identifies activation candidates in at least three of the multiple channels (see e.g. FIGS. 8-9);
in the analysis routine the control system performs a classification routine for at least some of the activation candidates by classifying the activation candidates into groups (see e.g. FIGS. 8-9), the groups comprising at least one group assigned to local activations and/or at least one group assigned to far field interference (see e.g. Para. 6: “a distinction is made in accordance with a decision algorithm between the case where the electrogram data comprises both pulmonary vein potentials and far field potentials, e.g. where the pulmonary vein is not electrically isolated, and the case where the electrogram data contains only far field potentials, e.g. where the pulmonary vein is electrically isolated”; also see e.g. Para. 67); and
in the classification routine the control system identifies a timing sequence and/or a timing difference (see e.g. Paras. 32, 88) between at least two activation candidates of different of the multiple channels based on the spatial information to differentiate between local activations and far field interference (see e.g. Para. 6: “a distinction is made in accordance with a decision algorithm between the case where the electrogram data comprises both pulmonary vein potentials and far field potentials, e.g. where the pulmonary vein is not electrically isolated, and the case where the electrogram data contains only far field potentials, e.g. where the pulmonary vein is electrically isolated”; also see e.g. Para. 67).
Regarding Claim 17, El Haddad further teaches wherein: the intracardiac electrogram has been recorded during a surgical procedure without electrical mapping of an atrium with a localization system based on the recorded electrogram (there appears to be no indication in El Haddad to the contrary); and/or in the analysis routine, the control system determines the electrical status by analysing concurrently measured channels of the electrogram at the target region without using electrogram channels measured after repositioning of the catheter (see e.g. FIGS. 2-3, 8-9).
Regarding Claim 18, El Haddad further teaches wherein the multiple channels have been measured concurrently over at least partially the same time period and/or wherein the relative spatial information is passive relative spatial information that has not been measured over time (see e.g. FIGS. 2-3 and 8-9).
Regarding Claim 19, El Haddad further teaches wherein the catheter is an ablation catheter selected from the group consisting of a cryoballoon catheter and a spiral catheter (see e.g. Paras. 3, 73, 114, 117 137, 141; a circular mapping catheter (CMC) such as the LASSO® catheter is used; circular and spiral are being considered synonymous here since the CMC forms a spiral-like shape, and/or because Applicant has indicated in the specification that the LASSO® catheter qualifies).
Regarding Claim 20, El Haddad further teaches wherein the electrical status is an electrical isolation status (see e.g. Para. 6: “a distinction is made in accordance with a decision algorithm between the case where the electrogram data comprises both pulmonary vein potentials and far field potentials, e.g. where the pulmonary vein is not electrically isolated, and the case where the electrogram data contains only far field potentials, e.g. where the pulmonary vein is electrically isolated”; also see e.g. Para. 67).
Regarding Claim 21, El Haddad further teaches wherein the target regions are located inside a pulmonary vein and the electrical isolation status is an electrical isolation status of the pulmonary vein (see e.g. Para. 6: “a distinction is made in accordance with a decision algorithm between the case where the electrogram data comprises both pulmonary vein potentials and far field potentials, e.g. where the pulmonary vein is not electrically isolated, and the case where the electrogram data contains only far field potentials, e.g. where the pulmonary vein is electrically isolated”; also see e.g. Para. 67).
Regarding Claim 22, El Haddad further teaches wherein the intracardiac electrogram has been recorded after an isolation of the pulmonary vein inside the isolated pulmonary vein such that in the analysis routine the control system determines the pulmonary vein isolation status (see e.g. FIGS. 2-3 and 8-9; see e.g. Para. 6: “a distinction is made in accordance with a decision algorithm between the case where the electrogram data comprises both pulmonary vein potentials and far field potentials, e.g. where the pulmonary vein is not electrically isolated, and the case where the electrogram data contains only far field potentials, e.g. where the pulmonary vein is electrically isolated”; also see e.g. Para. 67).
Regarding Claim 23, El Haddad further teaches wherein in the analysis routine the control system performs the classification routine for at least some of the activation candidates by classifying the activation candidates into at least one group assigned to noise (see e.g. Paras. 16, 29, 76, 107).
Regarding Claim 24, El Haddad further teaches wherein, in the classification routine, the control system differentiates between local activations and far field interference by identifying a propagation sequence along the order of the electrodes and classifying activation candidates as local activations when the control system identifies a propagation sequence and/or as far field interference when the control system does not identify a propagation sequence (see e.g. FIGS. 2-3 and 8-9; see e.g. Para. 6: “a distinction is made in accordance with a decision algorithm between the case where the electrogram data comprises both pulmonary vein potentials and far field potentials, e.g. where the pulmonary vein is not electrically isolated, and the case where the electrogram data contains only far field potentials, e.g. where the pulmonary vein is electrically isolated”; also see e.g. Para. 67).
Regarding Claim 25, El Haddad further teaches wherein, in the analysis routine, the control system determines the electrical status based on a set of features determined from an analysis of the multiple channels independently and a set of features determined from the analysis based on the relative spatial information, namely the order of the electrodes (see e.g. FIGS. 2-3, 8-9 and Para. 118).
Regarding Claim 26, El Haddad further teaches wherein, in the analysis routine, namely in the classification routine, the control system determines the electrical status based on a local activation time difference between neighboring channels based on the order of the electrodes (see e.g. Paras. 32, 88).
Regarding Claim 27, El Haddad further teaches wherein the local activation time is measured in relation to a coronary activation and is measured by a coronary sinus electrode and/or is an atrial activation (see e.g. Paras. 32, 88).
Regarding Claim 28, El Haddad further teaches wherein, in the classification routine, the control system determines the electrical status and/or the classification of an activation candidate based on a change of an activation or activation candidate over its spatial propagation whereby the spatial propagation is determined based on the relative spatial information, namely the order of the electrodes, and the timing of the activation or activation candidate (see e.g. FIGS. 8-9).
Regarding Claim 29, El Haddad further teaches, in a quality estimation routine the control system estimates a quality indicator, namely a signal-to-noise ratio, of a channel based on the spatial information, namely the order of the electrodes (see e.g. Paras. 16, 29, 76, 107).
Regarding Claim 30, El Haddad further teaches wherein in the quality estimation routine, the control system estimates the quality indicator based on a comparison of neighboring channels, namely waveforms of activations or activation candidates of neighboring channels, and/or wherein the control system, in the analysis routine, uses only a subset of the multiple channels selected based on the quality indicator to determine the electrical status of the target region (see e.g. Paras. 16, 29, 76, 107).
Regarding Claim 31, El Haddad further teaches wherein, in the analysis routine, the control system analyzes a morphology of the local activations to determine the electrical isolation status of the target region (see “morphology” throughout El Haddad, such as in Paras 76-80).
Regarding Claim 32, El Haddad further teaches wherein, in the analysis routine, the control system classifies the local activations into morphology groups and determines the electrical isolation status based on the distribution of local activations across the morphology groups (see “morphology” throughout El Haddad, such as in Paras 76-80).
Regarding Claim 33, El Haddad further teaches wherein, in the analysis routine, the control system classifies the local activations into the morphology groups based on a number of characteristic peaks of the local activation (see e.g. Para. 16: “In a device according to embodiments of the present invention, the processing means may be adapted for determining a number of peaks above a predetermined noise threshold and determining the morphology classification may take into account the determined number of peaks.”; also see e.g. Para. 76)
Regarding Claim 34, El Haddad further teaches wherein the control system classifies a peak with at least a predetermined amplitude and/or with at least a predetermined slope and/or with at most a predetermined slope and/or with at least a predetermined minimum peak distance and/or with at most a predetermined maximum peak distance and/or based on a peak morphology, namely a minimum and/or maximum peak angle, as a characteristic peak (see e.g. Paras. 32, 76, 88)
Regarding Claim 35, El Haddad further teaches wherein the morphology groups comprise a group for local activations with a single characteristic peak and/or exactly two characteristic peaks and/or exactly three characteristic peaks and/or more than three characteristic peaks and/or at least two characteristic peaks separated by a predetermined time (see e.g. Para. 76; see “peaks” through El Haddad)
Regarding Claim 36, El Haddad further teaches a control system configured to perform the method according to claim 16, wherein the control system is configured to receive and/or measure the intracardiac electrogram (see e.g. “processing means” throughout El Haddad; see 202 in FIG. 10).
Regarding Claim 37, El Haddad further teaches the control system according to claim 36, wherein the control system is connectable to the catheter (see 201 in FIG. 10 and Para. 98)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792