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 § 101
Claims 1-7,9-17,19,20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-10 are for an apparatus, and claims 11-20 are for a method. Thus, the claims are for statutory subject matter.
Step 2A, prong 1
Claim 1 includes a processor which is configured to present on a display EGMs, identify a subset of the EGMs, analyze the EGMs, and graphically interconnect the EGMs to present arrhythmogenic activity. Such steps are considered to be abstract ideas in the form of mental processes in that they can be performed in the user’s head or with pencil and paper. Further, the nominal recitation of a generic processor does not take the claim limitation out of a mental process category since the claimed steps can be fairly performed in the user’s head. Further, graphically interconnecting can be performed with pencil and paper or with a generic computer. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). See MPEP 2106.04(a).
Claim 11 recites the steps of identifying, analyzing, and graphically interconnecting. Such steps, as mentioned supra, can be performed in the human mind or with pencil and paper, and thus are abstract ideas in the form of a mental process. Further, graphically interconnecting can be performed with pencil and paper or with a generic computer.
Step 2A, prong 2
Re claim 1, the other element of the claim, except for the abstract idea, is a display device. A display device is a generic component and does not serve to integrate the abstract idea into a practical application, but is merely used as a tool to perform the abstract idea. Re claim 2, the user can identify the various characteristics in his head by observing the EGM on the display. Re claim 3, as mentioned supra, a processor is a generic component used to apply the abstract idea and thus does not serve to integrate the abstract idea into a practical application. Re claim 4, as mentioned supra, a processor is a generic component used to apply the abstract idea and thus does not serve to integrate the abstract idea into a practical application. Re claim 5, as mentioned, the processor is merely a generic component, and ‘graphically connecting’ can be performed by pencil and paper. Re claim 6, as mentioned, the processor is merely a generic component, and ‘graphically connecting’ can be performed by pencil and paper. Re claim 7, as mentioned, a processor is a generic component that is used to apply the abstract idea, but does not serve to integrate the abstract idea into a practical application. Re claim 9, the step that the processor performs includes identification, which can be performed in the user’s head. Re claim 10, having the generic processor present a type of arrhythmogenic activity is considered to be merely applying the abstract idea, and not integrating it into a practical application. Re claim 11, as mention supra, the step of presenting on a display is considered to be a manner of applying the abstract idea and does not serve to integrate it into a practical application. Re claim 12, the user can identify the various characteristics in his head by observing the EGM on the display. Re claim 13, ‘graphically interconnecting’, as mentioned supra, can be performed by pencil and paper and thus does not serve to integrate the abstract idea into a practical application. Re claim 14, the step of identifying, as mentioned supra, is a mental process. Re claim 15, ‘graphically presenting’ is considered a step of applying the abstract idea, and not an integration into a practical application. Further, the step of ‘graphically indicating’, as mentioned, is a mental step that can be done with paper and pencil. Re claim 16, the step of ‘graphically interconnecting’, as mentioned, is a mental step that can be performed with pencil and paper. Re claim 17, the step of ‘annotating’ can be done with paper and pencil, and thus is a further mental step. Re claim 19, the step of ‘identifying’ is considered to be a mental process, as mentioned supra. Re claim 20, the step of ‘presenting’ merely applies the abstract idea, and does not integrate it into a practical application.
Claims 8 and 18 include the step of ordering the electrograms on the display based on the spatiotemporal progression. This step is considered to integrate the abstract idea into a practical application, as set forth in at least ¶18 of applicant’s published application.
Step 2B
As mentioned supra, the claims include, other than the abstract idea, a display and a processor. These elements are considered to be set forth in a high degree of generality and are well understood, routine and conventional.
Claim Rejections - 35 USC § 112
Claims 9,10,19,20 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.
In claims 9,10, which depend from claim 1, ‘the EA map’ lacks antecedent basis.
In claims 19,20, which depend from claim 11, ‘the EA map’ lacks antecedent basis.
Claim Rejections - 35 USC § 102
Claim(s) 1-4,6-8,11-14,16-18 is/are rejected under 35 U.S.C. 102(a)(1),102(a)(2) as being anticipated by Zeidan et al (US Pre Grant Publication 2017/0354339).
1. A system, comprising:
a display device (see at least ¶55) and
a processor (see at least ¶35) which is configured to:
present, on the display device, intracardiac electrograms recorded over tissue of a portion of a cardiac chamber; (see at least figures 5-9 and ¶24-27)
identify a subset of the electrograms that show arrhythmogenic activity; (see at least ¶9 which teaches that the electrograms are reordered into a new group based on a particular pattern, and at least ¶13 teaches that such pattern can be reentrant activations circuits, focal source pattern, etc., which are indicative of arrhythmogenic activity in the heart, such as for AF) analyze one or more characteristics of the arrhythmogenic activity; (at least ¶54 teaches that an analysis is done on the sorted electrograms) and
graphically interconnect the electrograms in the subset to present the one or more characteristics of the arrhythmogenic activity to a user. (see at least figure 6 which show arrows 69,71 that graphically connect two electrograms that each have a rotational repetitive activation pattern)
2. The system according to claim 1, wherein the one or more characteristics comprise at least one of activation amplitudes, activation timings, spatiotemporal progression of activation, and activation patterns. (see at least ¶13 which teaches various activation patterns, and ¶9 which teaches local activation time)
3. The system according to claim 1, wherein the processor is configured to graphically interconnect the electrograms of the subset to present the one or more characteristics by using arrows. (see at least ¶57 which teaches arrows 73,75)
4, The system according to claim 1, wherein the processor is configured to identify the subset of the electrograms by using an electroanatomical (EA) map of the portion of the cardiac chamber. (see at least ¶3-10,34 which teach obtaining a MAP of the heart consisting of the individual electrograms, in order to determine ablation sites. The ablations sites are the areas of arrhythmogenic activity)
6. The system according to claim 1, wherein the processor is configured to graphically interconnect at least some of the electrograms in the subset by basing on a spatiotemporal relation between arrhythmogenic activations in the electrograms of the subset. (see at least ¶57 and figure 7 which teaches arrows that graphically connecting two electrograms 40,48 using arrows. Arrhythmogenic activations propagate along each egm)
7. The system according to claim 1, wherein the processor is further configured to annotate arrhythmogenic activations of the arrhythmogenic activity over at least one of the electrograms in the subset. (see at least ¶48)
8. The system according to claim 1, wherein the processor is further configured to present at least some of the electrograms in the subset on the display device in an order that is based on a spatiotemporal progression of the arrhythmogenic activity. (see at least ¶55 which teaches monotonic increases in LAT, and the electrograms ordered accordingly)
11. A method, comprising:
presenting on a display device intracardiac electrograms recorded over tissue of a portion of a cardiac chamber; (see figures 6-9)
identifying a subset of the electrograms that show arrhythmogenic activity; (see at least ¶9 which teaches that the electrograms are reordered into a new group based on a particular pattern, and at least ¶13 teaches that such pattern can be reentrant activations circuits, focal source pattern, etc., which are indicative of arrhythmogenic activity in the heart, such as for AF)
analyzing one or more characteristics of the arrhythmogenic activity; (at least ¶54 teaches that an analysis is done on the sorted electrograms) and
graphically interconnecting the electrograms in the subset to present the one or more characteristics of the arrhythmogenic activity to a user. (see at least figure 6 which show arrows 69,71 that graphically connect two electrograms that each have a rotational repetitive activation pattern)
12. The method according to claim 11, wherein the one or more characteristics comprise at least one of activation amplitudes, activation timings, spatiotemporal progression of activation, and activation patterns. (see at least ¶13 which teaches various activation patterns, and ¶9 which teaches local activation time)
13. The method according to claim 11, wherein graphically interconnecting the electrograms of the subset to present the one or more characteristics comprises using arrows. (see at least figure 6)
14. The method according to claim 11, wherein identifying the subset of the electrograms comprises using an electroanatomical (EA) map of the portion of the cardiac chamber. (see at least ¶3-10,34 which teach obtaining a MAP of the heart consisting of the individual electrograms, in order to determine ablation sites. The ablations sites are the areas of arrhythmogenic activity)
16. The method according to claim 11, graphically interconnecting at least some of the electrograms in the subset comprises basing on a spatiotemporal relation between arrhythmogenic activations in the electrograms of the subset. (see at least ¶57 and figure 7 which teaches arrows that graphically connecting two electrograms 40,48 using arrows. Arrhythmogenic activations propagate along each egm)
17. The method according to claim 11, and comprising annotating arrhythmogenic activations of the arrhythmogenic activity over at least one of the electrograms in the subset. (see at least ¶48)
18. The method according to claim 11, and comprising presenting at least some of the electrograms in the subset on the display device in an order that is based on a spatiotemporal progression of the arrhythmogenic activity. (see at least ¶55 which teaches monotonic increases in LAT)
Claim Rejections - 35 USC § 103
Claim(s) 9,10,19,20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeidan et al (US Pre Grant Publication 2017/0354339) and Bokan et al (US Pre Grant Publication 2015/0216438).
9. The system according to claim 1, wherein the processor is further configured to identify on the EA map one of a regional focal source and rotor types of arrhythmogenic activity. (see at least figures 6-9 of Zeidan which shows a map of the heart; left side of display. Zeidan is silent as to either a regional focal source or rotor type. Bokan teaches rotors and in a map using a color-coded scale to indicate type, see at least figures 13-15, and ¶113. It would have been obvious to show the rotors as shown in Borkan, with the device of Zeidan, since it would give the user a better picture of the patient’s heart condition in a predictable manner)
10. The system according to claim 1, wherein the processor is further configured to present the type of the arrhythmogenic activity on the EA map by presenting one of a regional focal source and rotor types of arrhythmogenic activity. (see at least figures 6-9 of Zeidan which shows a map of the heart; left side of display. Zeidan is silent as to either a regional focal source or rotor type. Bokan teaches rotors and in a map using a color-coded scale to indicate type, see at least figures 13-15, and ¶113. It would have been obvious to show the rotors as shown in Borkan, with the device of Zeidan, since it would give the user a better picture of the patient’s heart condition in a predictable manner)
19. The method according to claim 11, and comprising identifying on the EA map one of a regional focal source and rotor types of arrhythmogenic activity. (see at least figures 6-9 of Zeidan which shows a map of the heart; left side of display. Zeidan is silent as to either a regional focal source or rotor type. Bokan teaches rotors and in a map using a color-coded scale to indicate type, see at least figures 13-15, and ¶113. It would have been obvious to show the rotors as shown in Borkan, with the device of Zeidan, since it would give the user a better picture of the patient’s heart condition in a predictable manner)
20. The system according to claim 11, and comprising presenting the type of the arrhythmogenic activity on the EA map by presenting one of a regional focal source and rotor types of arrhythmogenic activity. (see at least figures 6-9 of Zeidan which shows a map of the heart; left side of display. Zeidan is silent as to either a regional focal source or rotor type. Bokan teaches rotors and in a map using a color-coded scale to indicate type, see at least figures 13-15, and ¶113. It would have been obvious to show the rotors as shown in Borkan, with the device of Zeidan, since it would give the user a better picture of the patient’s heart condition in a predictable manner)
Claim(s) 5,15 is/are rejected under 35 U.S.C. 103 as being patentable over Zeidan et al (US Pre Grant Publication 2017/0354339) and Donahue (US Pre Grant Publication 2022/0167907).
5. The system according to claim 4, wherein the processor is further configured to present on the display device the EA map, to graphically indicate the type of the arrhythmogenic activity on the EA map, and to graphically connect the activity on the EA map to at least one of the electrograms in the subset. (at least figure 6 of Zeidan shows an EA map. Zeidan is silent as to graphically connecting arrhythmogenic activity on a map to an electrogram. At least figure 4c of Donahue shows a map with color coding indicating where on the map an electrogram corresponds with it, see at least ¶23. It would have been obvious to use color coding on the map of Zeidan, as shown in Donohue, to correspond with color coded EGMs so that the EGMs can be quickly located that correspond to the relevant area of the patient’s heart, thus improving diagnosis in a predictable manner)
15. The method according to claim 14, and comprising presenting on the display device the EA map, graphically indicating the type of the arrhythmogenic activity on the EA map, and graphically connecting the activity on the EA map to at least one of the electrograms in the subset. (at least figure 6 of Zeidan shows an EA map. Zeidan is silent as to graphically connecting arrhythmogenic activity on a map to an electrogram. At least figure 4c of Donahue shows a map with color coding indicating where on the map an electrogram corresponds with it, see at least ¶23. It would have been obvious to use color coding on the map of Zeidan, as shown in Donohue, to correspond with color coded EGMs so that the EGMs can be quickly located that correspond to the relevant area of the patient’s heart, thus improving diagnosis in a predictable manner)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792