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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered but are not found persuasive with respect to the rejection under 35 USC 101. In addition, an updated grounds of rejection is presented below, necessitated by amendment.
Applicant proposes that the amended claim language of collecting cardiac activity signals and impedance data over a series of cardiac cycles and then processing, analyzing, comparing, and performing operations are performed concurrently – cannot be done on a printed sheet of paper. The examiner notes that the claims are clear in that the performing step is based on the previous comparison of the baseline pocket stability state, which occurs only after determining a pocket stability state, which is only accomplished after the waveform is generated. These are functional steps which build on each other and are dependent on the result/performance of the prior step, and do not appear capable of being performed concurrently. Accordingly, these steps can be performed repeatedly in order, concurrently (at the same time) as the data is being collected – because the claims do not require that the data that is being collected – the physical data points are being analyzed in real time at the exact same time as the arguments appear to be alluding to. For example, an individual can start examining the data and be on dataset #1 while the data collecting is now on the 10th cardiac cycle data set. Both steps of the claims are being accomplished concurrently.
Applicant draws a parallel to Example 42 of the 2019 Revised Patent Subject Matter Eligibility Guidance and provides a table as a roadmap to the similarities found in independent claims 1 and 7. Applicant contends that based on this comparison, the claims have as much or more detail regarding each element as compared to claim 1 of example 42. The examiner respectfully disagrees.
Applicant maps sections a and b of the claim in Example 42 to the method steps of obtaining base-line impedance waveform…collecting cardiac activity…collecting impedance data. These sections of the present application claim are purely data gathering steps. Section a of example 42 is a data gathering step, but section b is very clear that the “users can update the information…in the collection…in real time through a graphical user interface…in a non-standardized format” – which is not just a data collection step but an active step where a specific non-standardized format of data is being entered in real time and is critical to the novelty and reason why this claim has elements which amount to significantly more than the abstract idea.
Applicant maps sections c and d to the processing and analyzing steps of the present invention. Sections c and d describe converting the above data from non-standardized format to the standardized format and storing it appropriately. In contrast, the processing step in the present application is taking obtained data (not entered in real time, or in a specialized format) and manipulating the data into an impedance waveform format and analyzing a characteristic of that waveform. These are quite different steps – one can simply take data and plot it as a waveform manually and then analyze a characteristic of the waveform by hand.
Applicant maps section e to the comparison step – these are different steps involving generating a message related to the data entered (in a non-standardized format) after it is updated – but the comparison step of the present invention is looking at the determined pocket stability state based on a characteristic and comparing it to historical data to determine a change. This is a difference between generating a message based on the updated information from a novel conversion that was performed vs the present application is comparing current data to historical data to determine if a change has occurred. The examiner maintains the position that these are very different steps.
Lastly, step f is compared to the “performing at least one of” step. Step f is transmitting a message in real time. The present invention’s claim does not transmit. The step is “performing at least one of…” either discarding or ignoring the signal, or recording an indication of the stability state, or providing an indication. Simply discarding a signal is clearly not a transformative or actively responsive step equivalent to transmitting. Recording or providing an indication may simply be flagging data in the data set (i.e. circling an out of threshold or unexpected data point on the graph so that it is “indicated”) – also not on the same detail and requirements as transmitting a message in real time. Performing one of these 3 operations concurrently with collecting the CA signals and impedance data is still something that manually can be performed as one can “collect data” printed on a sheet of paper with these parameters while discarding or ignoring the data concurrently.
Applicant further maps the independent claims of the present invention to claim 1 of the Cardionet case. The examiner will not dissect each section of the claims as above as it does not appear necessary. The Cardionet claims are recognized as achieving a technological improvement for analyzing cardiac activity in a very specific manner and as a result generate an event when the variability is identified as relevant. Applicant describes how the present claims determine when the ICM has shifted or is unstable with a pocket. It is further contended that the claims follow Fig. 4B which illustrates how after determining and forming the baseline IW and pocket stability, the system is used to determine changes in pocket stability and used to minimize and prevent mis-diagnosis as a result of changes in pocket stability, followed by a plurality of specific examples from the disclosure.
The examiner maintains that the independent claims do not require the specific details of analysis which would follow the potential technological improvements to align with or be relative to the Cardionet case. In addition, the result of this analysis does not tie back into an active step – simply performing at least one of a plurality of three steps as discussed above, is not an equivalent parallel to the Cardionet claims.
Applicant further proposes a plurality of scenarios where the performing step in the independent claim is beneficial (i.e. Fig. 4B, ¶¶ 52-65); however, the examiner maintains that informing a clinician to prevent unneeded tests, reasons for false data to indicate an improper condition or medical issue, are extra solution steps which are not claimed and even if they were, performing the step of providing an indication of this is not transformative, and does not provide enough to amount to significantly more than the abstract idea. Again, one could say that circling a plurality of points on a graph could be an indication to the clinician – which can help in a plurality of proposed ways , none of which would be significantly more than the abstract idea.
The dependent claims do not further limit these final steps or the abstract idea in a manner that would amount to significantly more than the abstract idea in ways that would equate the claims to either example proposed in the remarks. Accordingly, the rejection is maintained.
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 and 23-26 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1 and 7 are directed to statutory subject matter as the claim(s) recite(s) a system and method for analyzing impedance data.
Step 2A, Prong One
Claims 1 and 7 recite the following steps or instructions for/to “obtain(ing) a base-line impedance waveform…”, “collect(ing) cardiac activity (CA) signals…”, “collect(ing) impedance data…”, “process(ing) impedance data…”, “analyze(ing) a characteristic of interest…”, “compare(ing) the pocket stability state...”, “perform(ing) at least one of….discard(ing) or ignore(ing) a potential false pause or asystole…record(ing) an indication…or provid(ing) an indication…..to a clinician…” which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and/or mathematical concept in MPEP 2106.04(a)(2)(I).
For example, these limitations concern data collection (obtain and collect steps), data analysis (process and analyze steps) and altering the data based on the analysis (discard step) or indicating an issue in the data (providing an indication) which could be done mentally or by hand with pen and paper by a medical professional analyzing previously recorded data for any irregularity, or outlier, evaluating the pocket stability and comparing it to previously recorded historical data to determine any changes, and discarding or ignoring data or providing an indication of an issue with the data as a result. These are accomplished via performing concepts in a human mind or by a human using a pen and paper and mathematical concepts.
As to the claim amendments specifying: “the processing, analyzing, comparing, and performing operations are performed….concurrently with the collecting the CA signals and the impedance data”, the examiner notes that as the data (i.e. a single parameter) is being obtained, it still can be processed, analyzed (via a plot) and compared in real time, mentally or by hand as each individual data point can be processed and analyzed/compared in real time as the data is obtained.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claims 1 and 7 recite additional elements of “an implantable cardiac monitor (ICM)”, “housing”, “one or more processors”, and “electrodes”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claims 1 and 7 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 7), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional elements of: “one or more processors” as recited in independent claims 1 and 7 (and their respective dependent claims) are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 7 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g., “one or more processors” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 7 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 7 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, although claims 1 and 7 recite processors in the body of the claim, 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)).
With respect to the ICM of claim 7, the examiner notes that this element is not tied directly to the abstract idea and simply serves as an extrasolution / presolution data gathering step, that can be accomplished by any generic ICM well known in the art.
Claims 1 and 7 do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
These claims also require the additional elements of: “an implantable cardiac monitor (ICM)”, “one or more processors”, “housing”, and “electrodes”.
The above-identified “one or more processors” are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
The above-identified “implantable cardiac monitor (ICM)”, “one or more processors”, “housing”, and “electrodes” are described in the disclosure as known components of a subcutaneous cardiac device comprising of housings with processors and electrodes all of which are generic and conventionally used and known in the art as described in applicant’s disclosure. [¶¶ 30-37 – published app]. There is nothing in these components which would distinguish over a generic monitor/module/implant, nor do the claims provide any details or specificity as to what aspects of these components perform or accomplish different from a generic implant.
Accordingly, in light of Applicant’s specification, “an implantable cardiac monitor (ICM)”, “housing”, “one or more processors”, and “electrodes” and their function are considered well-understood routine and conventional in the art, performing presolution activities that are merely data gathering steps for the abstract idea in Claim 1.
Additionally, the claimed term “one or more processors”, is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for “one or more processors”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1 and 7 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the methods and systems of claims 1 and 7 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 7 (and their respective dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Regarding dependent claims 2-6, 8-20, and 23-26, the limitations of these claims further define limitations directed to the abstract idea.
As such, claim 1-20 and 23-26 when analyzed as a whole, do not appear to be patent eligible for the reasons set forth above.
Claim Rejections - 35 USC § 112
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 1-20 and 23-26 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. In claims 1 and 7, the claims have been amended to recite “…operations are performed by the one or more processors concurrently, with the collecting….over the series of cardiac cycles”, in combination with the other elements and steps of the claims, fails to be supported by the disclosure as originally filed. ¶¶ 27 of the published application states “certain operations may be performed concurrently” and ¶¶ 74 of the published application states “…processors collect impedance data over cardiac cycles” – these are the only two places where the words “concurrently” and “cardiac cycles” are used. This combination of this language, where a plurality of steps are performed concurrently with collecting, over the series of cardiac cycles, is a combination not supported by the disclosure and outside the scope of the invention. Additionally, the claims are clear in that the performing step is based on the previous comparison of the baseline pocket stability state, which occurs only after determining a pocket stability state, which is only accomplished after the waveform is generated. These are functional steps which build on each other and are dependent on the result/performance of the prior step, and do not appear capable of being performed concurrently.
Claims 2-6, 8-20, and 23-26 are rejected under the same rationale as being dependent upon claims 1 and 7 and their limitations.
Allowable Subject Matter
Claims 1-20 and 23-26 avoid the prior art of record, but remain rejected under 101 and 112, as indicated above.
Conclusion
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796