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
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 1-20 rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 1-10 recite a method and claims 11-20 recite an apparatus.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites performing a morphology evaluation process. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite a generic implantable device for collecting and analyzing data, which encompasses the insignificant extrasolution activity of necessary data gathering (see MPEP 2106.05(g)).
The dependent claims contain elements that merely further limit the abstract idea and do not provide additional elements to bring the abstract idea into a practical application. Therefore, they are also rejected under 101.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? NO, The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)). The use of implantable devices to analyze waveform morphology is well-known in the art in view of Sharma US 2017/0043173 A1), El Arab (US 2010/0249626 A1), and Mika (US 6370430 B1).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
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.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillberg (US 6393316 B1).
Regarding claims 1 and 11, Gillberg discloses a method of performing morphology evaluation processes in an implantable device (eg. Fig. 1, ICD 100), the method comprising: a. providing instructions to said implantable device for performing a morphology evaluation process at a determined timing according to predetermined parameters (eg. Col. 2, Ln. 7-21, Col. 3, Ln. 65 – Col. 4, Ln. 11, Col. 9, Col. 14- Col. 11, Ln. 21, Col. 14, Ln. 50 – Col. 24, Ln. 4, three embodiments); b. activating said morphology evaluation process for a predetermined period of time following sensing said predetermined parameters (eg. Col. 7, Ln. 53 – Col. 8, Ln. 8, Col. 15, Ln. 9-27, Col. 16, Ln. 15-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the morphology analysis function embodiments to perform a more complete analysis on waveforms.
Claim(s) 2-3, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillberg (US 6393316 B1) in view of Stahmann (US 8718764 B2).
Regarding claims 2 and 12, Gillberg discloses the invention of claim 1, but does not disclose said predetermined parameters are one or more of a scheduled stimulation event and a tachycardia event.
Stahmann teaches an implantable cardiac device with morphological analysis that can be evoked just before a scheduled therapy (eg. Fig. 16A Col. 5, Ln. 8 – 30, Col. 19. Ln. 62- Col. 20, Ln. 2, Col. 34, Ln. 37 – Col. 35, Ln. 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Gillberg to use morphological analysis at a scheduled timing before therapy to provide the predictable result of improving contractility and therapy coordination.
Regarding claims 3 and 13, the combined invention of Gillberg and Stahmann discloses said scheduled stimulation are one or more of Cardiac contractility modulation and CRT (eg. Stahmann, Col. 18, Ln. 5-44, Col. 24, Ln. 65 – Col. 25, Ln. 46).
Claim(s) 4-10 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillberg (US 6393316 B1) in view of Stahmann (US 8718764 B2), further in view of Ghosh (US 2018/0250514 A1).
Regarding claims 4 and 14, the combined invention of Gillberg and Stahmann discloses the invention of claim 2, but does not predetermined parameters is a scheduled stimulation event, then said predetermined period of time is at least one selected form the group consisting of: a. up to 500mS; and b. up to 50mS.
Ghosh teaches an implantable device (eg. Fig. 1, device 10) that tracks a window within a certain pulse or blank interval (eg. Para. 58-59), table 1-2, Para. 62, 79).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the invention of Gillberg and Stahmann with the ms windows as taught by Ghosh to optimize CRT by compensating for tissue latency (eg. Ghosh, Para. 6-9).
Regarding claims 5 and 15, the combined invention of Gillberg, Stahmann, and Ghosh discloses tachycardia event is defined when a heart rate is above 100 beats per minute (BPM) (Tachycardia is typically classified in the art as having 100 bpm or higher).
Regarding claims 6 and 16, the combined invention of Gillberg, Stahmann, and Ghosh discloses said predetermined parameters is a tachycardia event, then said predetermined period of time is as long as said tachycardia event is sensed (eg. Gillberg, Fig. 5, Col. 8, Ln. 17-56, Col. 28-57, analyzes ongoing arrhythmias).
Regarding claims 7 and 17, the combined invention of Gillberg, Stahmann, and Ghosh discloses predetermined parameters is a tachycardia event, then said predetermined period of time is of equal or greater than 1000mS (eg. Ghosh, Para. 59 and Gillberg Col. 7, Ln. 53-Col. 8, Ln. 8, one of ordinary skill could set the time to over 1000 ms for comprehensive evaluation for longer periods as desired).
Regarding claims 8 and 18, the combined invention of Gillberg, Stahmann, and Ghosh discloses said predetermined parameters are one or more of: a. a detected atrial-ventricle (A-V) timing delay above a predetermined threshold; b. a detected right ventricle-left ventricle (V-V) timing delay above a predetermined threshold; and c. a detected P-P delay that is different from an R-R delay (eg. Ghosh, Para. 23, 33, 72, 107).
Regarding claims 9 and 19, the combined invention of Gillberg, Stahmann, and Ghosh discloses said predetermined parameters is one or more of: a. a detected atrial-ventricle (A-V) timing delay above a predetermined threshold; b. a detected right ventricle-left ventricle (V-V) timing delay above a predetermined threshold; and c. a detected P-P delay that is different from an R-R delay; then said predetermined period of time is of up to 500mS or up to 100mS (eg. Ghosh, Para. 58, 73).
Regarding claims 10 and 20, the combined invention of Gillberg, Stahmann, and Ghosh discloses a. said predetermined threshold of said atrial-ventricle (A-V) timing delay is a sensed value above 180mS; b. said predetermined threshold of said atrial-ventricle (A-V) timing delay is a change of more than 10mS from baseline measured A-V delay; c. said predetermined threshold of said right ventricle-left ventricle (V-V) timing delay is a sensed value above 10mS; d. said predetermined threshold of said right ventricle-left ventricle (V-V) timing delay is a change of more than 1mS from baseline measured V-V delay (eg. Ghosh, Para. 23, 33, 72-73, 107).
Conclusion
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/MICHAEL J LAU/ Examiner, Art Unit 3796