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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The instant Figures, especially Fig. 11-14, 17-21, 23 seem to require color; especially since the instant specification refers to color within these drawings; see instant specification [00125] “FIG. 17 shows an example of the phase of the various locations on the chamber surface at an instant in time (time 0.0010) represented in visual format. Blue indicates activation (depolarization), light blue/green shows that tissue is refractory (unable to be activated), yellow/gold (partially repolarized) indicates that activation may be able to occur although propagation is expected to be slow. Red shows fully repolarised regions that will support the normal spread of electrical activation. This information is rendered as a color map across the left atria surface that "predicts" the spread of activation. A moving wave of activation (blue) cannot enter refractory regions (green) and spreads via regions that are repolarized (red).” and [00184] “With respect to figure 23, it can be utilitarian to only ablate the area in red or around the red area and not treat the green areas even though the green areas may be as extensive as the red areas, but the green areas are not as intense as the red areas with respect to the time averaged maximum phase gradient values and thus it may be sufficient to only "process" the tissue that shows up as red. Conversely, the extensive nature of the areas in green with respect to spatial location could be tissue that serves as a greater block to the electrical signals then the tissue in red.”
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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(s) 8 is/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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “abating” in claim 8 is used by the claim to mean “ablating,” while the accepted meaning is “to decrease in force or intensity”. The term is indefinite because the specification does not clearly redefine the term. For examination purposes below, it will be assumed that this is a typo and should be “ablating” which would be consistent with the instant specification.
Claim 8 does not end in a period. Each claim can only be one sentence (see MPEP 608.01(m)) and so a suggested edit is to include a period at end of claim to mark end of sentence.
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.
Claim(s) 1-7, 13-16, 19-20, 24-25, 27-28, 32, 41-46, 49-52 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite the collection and analyzing of data. More specifically, independent claims 1, 14, 24, and their dependents (except for claims 8, 21, 47, 48) are directed to the mental process (i.e. abstract idea) of collecting and processing health data.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim(s) to a process, machine, manufacture or composition of matter?
Yes, independent claim 1, 14, 24 and dependents are to a process (method).
Step 2A (Prong 1): Does the claim(s) recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim(s) recite an abstract idea of data collection and usage. The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology; please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016).
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim(s) does not recite additional elements that integrate the judicial exception into a practical application because the claim(s) merely use sensor(s) to collect data with already well-known technology. The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). The fundamental data collection and processing steps performed by Applicant's claimed invention could theoretically be carried out manually by a person. Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, in addition to the relevant discussion in Step 2A (Prong 2) above, please note, as explained in MPEP § 2106.05(I) (A), limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include those listed therein.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements are well- known, routinely-used generic devices/technologies.
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.
Claim(s) 1-8, 13-14, 19-21, 24-25, 27-28, 32, 41-42, 44, 46, 48-51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubois (US 20140088395 A1; 3/27/2014).
Regarding claim 1, Dubois teaches a method, comprising:
obtaining heart phase data for a plurality of activation cycles of a living human afflicted with atrial fibrillation (Fig. 8-14; Fig. 17; [0003] “atrial…fibrillation”; [0033]; [0036] “atrial fibrillation”; [0072]; [0078]; [0081]); and
analyzing the heart phase data to identify specific heart tissue locations where there are repeated and consistent temporal discrepancies of electrical activation relative to other tissue locations (Fig. 8; Fig. 21-23; [0072]; [0078]; [0081]-[0083]; [0105]; [0113]-[0115]; [0117]).
Regarding claim 2, Dubois teaches the action of analyzing the heart phase data includes implementing a statistical analysis on the heart phase data (Fig. 8; Fig. 12; [0076] “averaged over time”; [0078] “statistics”; [0081] “statistics”).
Regarding claim 3, Dubois teaches the action of analyzing the heart phase data includes implementing time averaging analysis on the heart phase data ([0076] “averaged over time”).
Regarding claim 4, Dubois teaches wherein the action of analyzing the heart phase data includes:
for a plurality of spatial locations on an interior surface of the heart, which spatial locations include the identified specific heart tissue locations, identifying respective maximum phase gradients for respective locations of the plurality of spatial locations over a length of time (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”);
time averaging the respective maximum phase gradients for the respective locations ([0076] “averaged over time”); and
identifying corresponding locations where the time averaged results are statistically aberrant and/or are not statistically aberrant, wherein the identified corresponding locations of the time average results that are statistically aberrant are the identified specific heart tissue locations and/or the identified corresponding locations of the time average results that are not statistically aberrant are not the identified specific heart tissue locations ([0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]).
Regarding claim 5, Dubois teaches the respective maximum phase gradients are the respective maximum phase gradients between the respective locations and a plurality of proximate locations on the surface of the heart (Fig. 12-17; Fig. 23; [0076]-[0078]; [0082]; [0105]; [0107]; [0117]).
Regarding claim 6, Dubois teaches wherein the proximate locations are effectively North- South-East-West adjacent locations (Fig. 12-17; Fig. 23; [0076]-[0078]; [0082]; [0105]; [0107]; [0117]; adjacent locations as taught by reference are effectively surrounding the phase singularity and so meet the claim limitation).
Regarding claim 7, Dubois teaches wherein the proximate locations are the locations immediately surrounding the respective location (Fig. 12-17; Fig. 23; [0076]-[0078]; [0082]; [0105]; [0107]; [0117]; adjacent locations as taught by reference are effectively surrounding the phase singularity and so meet the claim limitation).
Regarding claim 8, Dubois teaches ablating a surface of the heart based at least on the identified specific heart tissue locations (Fig. 12; [0085]; [0114] “ablating the tissue where the rotor core occurs”).
Regarding claim 13, Dubois teaches wherein the action of analyzing the heart phase data includes:
for a plurality of spatial locations on an interior surface of the heart, which spatial locations include the identified specific heart tissue locations, identifying respective maximum phase gradients for respective locations of the plurality of spatial locations over a length of time (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”);
time averaging the respective maximum phase gradients for the respective locations ([0076] “averaged over time”); and
identifying corresponding locations where the time averaged results are non-zero and/or statistically zero, wherein the identified corresponding locations of the time average results that are non-zero are the identified specific heart tissue locations and/or the identified corresponding locations of the time average results that are statistically zero are not the identified specific heart tissue locations ([0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]).
Regarding claim 14, Dubois teaches a method, comprising:
developing a time-varying electrical potential map of a surface of a cavity of a beating heart (Fig. 1-5; Fig. 8-14; Fig. 17; [0003] “atrial…fibrillation”; [0033]; [0036] “atrial fibrillation”; [0072]; [0078]; [0081]; [0095]);
developing a time-varying phase map of the surface of the cavity based on the developed time-varying electrical potential map (Fig. 8-14; Fig. 17; [0003] “atrial…fibrillation”; [0033]; [0036] “atrial fibrillation”; [0072]; [0078]; [0081]); and
identifying repeating phase signatures for respective locations on the surface of the atrial cavity from the time-varying phase map that repeat in a statistically aberrant manner relative to other phase signatures at other respective locations (Fig. 8; Fig. 21-23; [0072]; [0078]; [0081]-[0083]; [0105]; [0113]-[0115]; [0117]).
Regarding claim 19, Dubois teaches the action of developing a time-varying electrical potential map of a surface of a cavity of a beating heart is based at least in part on time-varying readings from electrodes located in the cavity ([0088] “sensors may also be located on the device 156 that is inserted into the patient’s body”; [0089] “invasively”); and
the action of identifying the repeating phase signatures is executed within 20 minutes of the electrodes being removed from the chamber ([0031] “real time”; [0042] “minutes”).
Regarding claim 20, Dubois teaches the action of developing a time-varying electrical potential map of a surface of a cavity of a beating heart is based at least in part on invasive readings taken while a human in which the beating heart resides is in an operating room (Fig. 12; [0031]; [0088] “sensors may also be located on the device 156 that is inserted into the patient’s body”; [0089] “invasively”; it is inherent that delivery of invasive therapy to heart occurs in operating room); and
the action of identifying the repeating phase signatures is executed before the human leaves the operating room (Fig. 12; [0031] “real time”; [0042] “minutes”).
Regarding claim 21, Dubois teaches executing a medical procedure targeted at tissue of the heart corresponding to at least some of the respective locations identified as having the repeating phase signatures that repeat in the statistically aberrant manner before the human leaves the operating room (Fig. 12; [0031]; [0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]).
Regarding claim 24, Dubois teaches a method, comprising:
developing data including at least X spatial locations and at least Y respective phase gradients for the respective spatial locations of the X spatial locations (Fig. 5; Fig. 8-19; Fig.22-23; [0038]; [0070]; [0087]);
statistically analyzing the developed data (Fig. 8; Fig. 12; [0072]; [0076] “averaged over time”; [0078] “statistics”; [0081] “statistics; [0082]-[0083]; [0105]; [0113]-[0115]; [0117]); and
identifying locations of the respective locations that are indicative of tissue influencing atrial fibrillation based on the statistical analysis ([0003] “atrial…fibrillation”; [0033]; [0036] “atrial fibrillation”; [0072]; [0078]; [0081]), wherein
X is at least 64 and Y is at least 50 ([0038] “2000 locations or more”; [0070] “2000 or more”; [0087] “greater than 200 electrodes”).
Regarding claim 25, Dubois teaches the statistical analysis is time averaging ([0076] “averaged over time”).
Regarding claim 27, Dubois teaches the action of identifying locations includes identifying locations where averaging of the maximum phase gradients yields a statistically meaningful non-zero value (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”; [0078] “statistics”; [0081] “statistics”; [0112]-[0114]; [0117]).
Regarding claim 28, Dubois teaches the action of identifying locations includes identifying other locations where averaging of the maximum phase gradients of at least a majority of the Y phase gradients yields a statistically zero value (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “lower…thresholds”; [0083]; [0078] “statistics”; [0081] “statistics”; [0112]-[0114]; [0117]; reference is teaching finding rotor cores via integration and statistics and analyzing over the various surface locations of the heart and so it is inherent that there will be statistically zero values to contrast with the identified rotor cores).
Regarding claim 32, Dubois teaches the statistical analysis of the developed data identifies statistically consistent patterns of electrical activity that repeat in a statistically meaningful manner over time ([0069] “temporal and spatial consistency”; [0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]).
Regarding claim 41, Dubois teaches wherein the plurality of spatial locations includes at least 24 locations (Fig. 5; Fig. 8-19; Fig.22-23; [0038]; [0070]; [0087]); and
there are at least 36 temporally spaced respective maximum phase gradients for the respective locations (Fig. 5; Fig. 8-19; Fig.22-23; [0038]; [0070]; [0087]).
Regarding claim 42, Dubois teaches obtaining respective plurality of temporally spaced electrical potentials for respective electrodes of at least 24 electrodes of a catheter located in a heart chamber at a first location in the heart chamber (Fig. 12, 156; [0038] “contact electrodes on a basket catheter”; [0087] “greater than 200 electrodes”; [0088] “sensors may also be located on the device 156 that is inserted into the patient’s body”; [0089] “invasively”);
converting the obtained respective plurality of temporally spaced electrical potentials to the heart phase data, thereby obtaining the heart phase data ([0072]; [0078]; [0081]-[0083]; [0105]; [0113]-[0115]; [0117]), wherein
the actions of identifying respective maximum phase gradients (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”), time averaging ([0076] “averaged over time”), identified corresponding locations where the time average results are statistically aberrant and/or not statistically aberrant ([0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]), are based on the obtained respective plurality of temporally spaced electrical potentials for the catheter located at the first location (Fig. 12; [0031]; [0088] “sensors may also be located on the device 156 that is inserted into the patient’s body”; [0089] “invasively”).
Regarding claim 44, Dubois teaches the action of obtaining heart phase data and analyzing is executed in real time vis-a-vis a catheter located in a heart chamber (Fig. 12; [0031] “real time”; [0038] “contact electrodes on a basket catheter”; [0087] “greater than 200 electrodes”; [0088] “sensors may also be located on the device 156 that is inserted into the patient’s body”; [0089] “invasively”).
Regarding claim 46, Dubois teaches the actions of developing a time-varying electrical potential map, developing the time- varying phase map, and identifying the repeating phase signatures are executed within a period of no more than 20 minutes ([0031] “real time”; [0042] “minutes”).
Regarding claim 48, Dubois teaches the medical procedure is ablation of the targeted tissue (Fig. 12; [0085]; [0114] “ablating the tissue where the rotor core occurs”).
Regarding claim 49, Dubois teaches the action of identifying locations includes identifying locations where the statistical analysis of the developed data indicates non-random activation of respective heart tissue cells at the identified locations ([0072]; [0076] “averaged over time”; [0078] “statistics”; [0081] “statistics; [0082]-[0083]; [0105]; [0113]-[0115]; [0117]; it is inherent that the reference’s analysis to identify rotor core is non-random activation).
Regarding claim 50, Dubois teaches the action of identifying locations includes identifying locations where averaging of the maximum phase gradients of at least a majority of the Y phase gradients yields a statistically meaningful non-zero value (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”; [0078] “statistics”; [0081] “statistics”; [0112]-[0114]; [0117]); and
the action of identifying the locations includes further statistically analyzing the values of the non-zero values (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”; [0078] “statistics”; [0081] “statistics”; [0112]-[0114]; [0117]).
Regarding claim 51, Dubois teaches X is at least 300 and Y is at least 75 ([0038] “2000 locations or more”; [0070] “2000 or more”; [0087] “greater than 200 electrodes”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15, 16, 43, 45, 47, 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubois as applied to claims 14, 21, 24, 42 above.
Regarding claim 15, Dubois does not explicitly teach the electrical potential map has at least 500 electrical potential spatial locations and at least respective 5,000 temporal potential values for the respective potential spatial locations;
the phase map has at least 400 phase spatial locations and at least respective 4,000 temporal phase values for respective phase locations.
However, Dubois does teach “2000 locations or more” ([0038]; [0070]) as well as “greater than 200 electrodes” ([0087]) and so it would be obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, Dubois does not explicitly teach respective electrical potential locations of the at least 500 electrical potential locations have respective phase locations of the at least 500 phase locations. However, Dubois does teach “2000 locations or more” ([0038]; [0070]) as well as “greater than 200 electrodes” ([0087]) and so it would be obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 43, Dubois does not teach obtaining respective second plurality of temporally spaced electrical potentials for respective electrodes of at least 64 electrodes of the catheter located in the heart chamber at a second location in the heart chamber different from the first chamber. However, Dubois does teach obtaining respective second plurality of temporally spaced electrical potentials for respective electrodes of at least 64 electrodes of the catheter located in the heart chamber (Fig. 12, 156; [0038] “contact electrodes on a basket catheter”; [0087] “greater than 200 electrodes”; [0088] “sensors may also be located on the device 156 that is inserted into the patient’s body”; [0089] “invasively”) and also teaches measuring over entire surface of heart which would include a second location in heart chamber (Fig. 5; Fig. 8-19; Fig.22-23). As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s). See MPEP 2144.05(II)(A)("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation")(citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCCPA 1955)).
Dubois teaches converting the obtained respective second plurality of temporally spaced electrical potentials to second heart phase data (Fig. 12, note the loop; [0072]; [0078]; [0081]-[0083]; [0105]; [0113]-[0115]; [0117]);
for a plurality of second spatial locations on the interior surface of the heart, which second spatial locations include the identified specific heart tissue locations, identifying respective second maximum phase gradients for respective second locations of the plurality of second spatial locations over second length of time (Fig. 5; Fig. 8-19; Fig.22-23; [0033]; [0074]; [0082] “upper…thresholds”; [0083]; [0107] “computed phase is greater”);
second time averaging the second respective maximum phase gradients for the second respective locations ([0076] “averaged over time”); and
identifying corresponding second locations where the time averaged second results are statistically aberrant and/or not statistical aberrant ([0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]), wherein the identified corresponding second locations of the second time average results that are statistically aberrant are included in the identified specific heart tissue locations and/or the identified corresponding second locations of the time second average results that are not statistically aberrant are not included in the identified specific heart tissue locations ([0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]).
Regarding claim 45, Dubois does not explicitly teach the electrical potential map has at least 500 electrical potential locations and at least respective 20,000 temporal locations for respective potential locations of the 500 potential locations;
the phase map has at least 500 phase locations and at least respective 20,000 temporal locations for respective phase locations of the 500 phase locations.
However, Dubois does teach “2000 locations or more” ([0038]; [0070]) as well as “greater than 200 electrodes” ([0087]) and so it would be obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 47, Dubois does not explicitly teach after executing the medical procedure, developing second time-varying electrical potential map of the surface of the cavity of the beating heart. However, Dubois does teach a loop in which therapy is applied and measurements and analysis are used to further guide therapy (Fig. 12) as well as measuring over cardiac cycles developing time-varying electrical potential map of the surface of the cavity of the beating heart (Fig. 8; Fig. 9; Fig. 17; [0080]-[0083]). As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s).
Dubois teaches developing second time-varying phase map of the surface of the cavity based on the second developed time-varying electrical potential map (Fig. 12, note the loop; [0072]; [0078]; [0081]-[0083]; [0105]; [0113]-[0115]; [0117]); and
evaluating whether and/or how many repeating phase signatures for respective locations on the surface of the atrial cavity from the second time-varying phase map that repeat in a statistically aberrant manner relative to other phase signatures at other respective locations, and based on the evaluation, evaluation whether the medical procedure was successful (Fig. 12; [0031]; [0078] “statistics”; [0081] “statistics”; [0082]-[0083]; [0112]-[0114]; [0117]).
Regarding claim 52, Dubois teaches X is at least 1,000 ([0087] “greater than 200 electrodes”). Dubois does not teach and Y is between 60 and 1,000, inclusive. However, Dubois does teach “2000 locations or more” ([0038]; [0070]) as well as “greater than 200 electrodes” ([0087]) and so it would be obvious to one having ordinary skill in the art before the effective filing date of the invention to use the instant claim's range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792
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