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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/8/26 has been entered.
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, 3-4, 6, 8-10, 12-15, 17, 19-21, and 25-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental concept of filtering/delaying/amplifying ECG to combine the ECG data to form a composite ECG signal to enhance a characteristic to detect an arrythmia. This judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements (e.g. claim 1--processor, claims 12 and 25—processor and memory, dependent claims use of an implantable medical device/IMD, etc.) that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The IMD does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim(s) as is nothing more than an attempt to generally link the system or method to a particular technological environment, and/or is just used a housing for the computer/processor or a means to gather data for the abstract idea/mental concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination do not add significantly more to the exception. For example the additional limitations only process information or store information in memory and these limitations are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of filtering/delaying/amplifying ECG to combine the ECG data to form a composite ECG signal to enhance a characteristic to detect an arrythmia, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. claim 1--processor, claims 12 and 25—processor and memory, dependent claims use of an implantable medical device/IMD, etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. The IMD does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim(s) as is nothing more than an attempt to generally link the system or method to a particular technological environment, and/or is just used a housing for the computer/processor or a means to gather data for the abstract idea/mental concept. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 12 having a memory and processor, and corresponding method claims 1 and 25) is a system having a memory and processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the ECG information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The memory and processor are recited so generically (no details whatsoever are provided other than that they are a memory and processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014). The IMD does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim(s) as is nothing more than an attempt to generally link the system or method to a particular technological environment, and/or is just used a housing for the computer/processor or a means to gather data for the abstract idea/mental concept.
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor and the memory. No element has been set forth to sense the ECG signal, and the only additional element is the memory, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/detection of an arrhythmia based on calculated data. The memory limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. The IMD does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim(s) as is nothing more than an attempt to generally link the system or method to a particular technological environment, and/or is just used a housing for the computer/processor or a means to gather data for the abstract idea/mental concept. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of filtering/delaying/amplifying ECG to combine the ECG data to form a composite ECG signal to enhance a characteristic to detect an arrythmia, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Note that claim 26 is only directed to a general “therapy” without specifically pointing out the therapy. Is it a therapy such as a cardioversion or defibrillation shock that would treat a fibrillating heart? Or is it a therapy that is not known or used to treat an arrhythmia, such as a foot massage, applying a topical cream, etc.? The administration/delivery step is not particular, and is instead merely instructions to “apply” the exception in a generic way. See MPEP 2106.04(d)(2).
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 3, 12-15, 17, 19-21 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 claim 12, the claim sets forth two elements, a memory and a processor. However, line 8 states the ECG signals are passed through “at least one the gain channel, filter, or delay”, which lacks antecedent basis, and it is unclear if the system claim is meant to further have an additional element of a gain channel, filter, or delay, or if these elements are meant to be intended/functional use recitations, and therefore the system only needing to have the capability of the signals to pass through those elements. If the gain channel, filter, or delay are meant to be positively recited, it is suggested to first state the system has those elements before they are used in a connection/function.
In claim 13, line 1, “further comprising at least one of a gain channel, filter, or delay” is vague as these elements are also used in claim 12 and it is unclear if they are the same elements or additional elements to what is set forth in claim 12.
Similarly, claim 14 and claim 3 have this problem and it is suggested to use a wherein statement, such as “wherein the at least one of the gain channel, filter, or delay comprises a plurality, and each of the plurality of ECG signals are passed through a respective gain channel…”.
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 1, 3-4, 6, 8-9, 12-15, 17, 19-20, and 25-29 are rejected under 35 U.S.C. 102a1 as being anticipated by Bennett et al (5331966). Bennett discloses the following claimed limitations:
--a subcutaneous IMD having electrodes to receive a plurality of far field ECG signals (e.g. figures 1 and 2, electrodes A, B, C, etc.)
--passing the ECG signals through respective gain/filter/delay (e.g. figure 10, amplifiers 252 and 254 which amplify (i.e. adds gain) and/or has filters 256, 258; figure 11, gain X and Y squared, etc.)
--combining two of the ECG signals to form a first composite signal to enhance a characteristic of interest (e.g. figures 4A-C, bottom graph; figure 10, figure 11; col. 16, lines 9-45, with the adding of the two ECG signals; to enhance the R wave, col. 14, lines 45-57; col. 20, lines 47-55; col 26, lines 10-12; col. 27, lines 26-38, etc.)
--analyzing the COI for detecting an arrhythmia (i.e. abstract, bradyarrhythmia and tachyarrhythmia pacer, cardioverter, defibrillator, col. 13, lines 38-53, incorporated documents, etc.; figure 6, element 150; e.g. abstract; col. 20, lines 20-55, col. 22, lines 1-13; col. 24, lines 34-45; col. 27, lines 26-38, etc.)
--for claim 25, automatically recording the ECG signals in memory in response to detecting the arrhythmia (e.g. col. 16, line 59 to col. 17, line 25; col. 18, lines 3-18; col. 22, lines 1-14, etc.).
For claims 1, 6, 12, 17, and 25, the system and method of Bennett uses a computer implemented method and system using a memory and processor in the IMD (e.g. figure 6, col. 20, lines 56-68; col. 21, lines 33-68, figure 5, etc.). For claim 26, Bennett delivers brady pacing, tachy, or cardioversion/defibrillation upon detecting the arrhythmia (e.g. abstract; col. 13, lines 38-53, incorporated documents. etc.; figure 6, element 150; e.g. abstract; col. 20, lines 20-55, col. 22, lines 1-13; col. 24, lines 34-45; col. 27, lines 26-38). For claims 27 and 29, as Bennett does have an enhanced characteristic of interest, such as the enhanced Rwave (e.g. figures 4A-C, lower graph, etc.), this will result in reducing false declarations of arrhythmia based on oversensing/undersensing of the Rwave since the Rwave is easier to detect. For claim 28, Bennett also discloses that the P wave can be picked up and enhanced (e.g. figures 4A-C, lower graph, col. 13, lines 23-37, etc.) and therefore this will result in reducing false declarations of arrhythmia based on oversensing/undersensing of P waves since the Pwave is easier to detect. For claims 9 and 20, Bennett also discloses combining two of the plurality of ECG signals to form a second composite signal different than the first composite ECG signal since Bennett continually combines the signals—i.e. this results in the second composite signal different than the first-- and/or since he combines signals from A and B in one amplifier 252 to result in a differential composite signal and also combines electrodes B and C in another differential amplifier 254 (e.g. figure 10, etc.).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6, 8-10, 12-14, 17, 19-20, 25, and 27-29 are rejected under 35 U.S.C. 102(a1) as anticipated by Cao et al (6699200) or, in the alternative, under 35 U.S.C. 103 as obvious over Cao et al (6699200) in view of Bennett et al. Cao discloses the following claimed elements:
--a processor and memory running software/algorithm (e.g. figure 5, abstract, col. 4, lines 16-24, etc.) located in an IMD (e.g. figures 2, 5, etc.) that has a plurality of far-field electrodes at different locations (e.g. figure 2, elements 3, etc.)
--that are used to receive ECG signals that are then combined to form a composite signal (e.g. figure 4, col. 6, lines 43-67, etc.) to enhance a characteristic of interest, such as a R/QRS and R-T peak ratio (e.g. col. 7, lines 1-5, etc.)
--that are put into an arrhythmia detector 39 to detect the arrhythmia to trigger the storage of the ECG (e.g. figure 5, col. 7, lines 12-30, etc.).
For claims 27 and 28, since Cao enhances the R wave and R-T ratio (e.g. column 7, lines 1-11, etc.), this therefore will result in reducing false declarations of arrhythmia based on at least one of oversensing or undersensing since the enhanced R wave or R-T ratio will make it easier to detect. For claims 3 and 14, note that the claims only claim “one” respective gain channel, not a gain channel for each respective ecg (in the alternative, see the 103 rejection below). For claims 9-10, and 20, Cao discloses the computer implemented method or processor does combine the ECG signals to form a second combined signal different than the first combined signal to determine the better signal quality--i.e. using 2 vectors instead of 3 vectors (e.g. col. 6, line 42 to col. 7, line 11, etc.). Under a different interpretation, Cao also continually combines the ECG vectors using different sensing electrodes, therefore providing a different composite/combination signal upon each combination (in the alternative, see the 103 rejection below).
--As to the new limitation of the gain/filter/delay before passing the signals to be combined, Cao’s system also has an amplifier/gain (e.g. element 38, figure 5, etc.) for input of each ECG signal. The definition of an “amplifier” is to make a signal larger or more intense, and therefore there is a gain/amplification. The basic output equation of a differential amplifier can be summarized Vout = A (V2-V1) with A as the gain and V2 and V1 as the input signals, or as Vout = R3/R1 (V2-V1), where R3 and R1 are the resistors providing the gain, and V2 – V1 is the difference between the inputted ECG signals. In addition, a differential amplifier amplifies the voltage difference between two inputs while rejecting common-mode signals, such as noise, interference, or hum present on both lines. This process is known as Common-Mode Rejection (CMRR), which effectively filters out unwanted noise.
In the alternative, for the independent claims use of a gain/filter/delay before passing the signals for combining, Bennett discloses that it is known to use a gain/amplifier and/or filter (e.g. figures 10, 11, addressed above in the 102 rejection, etc.) before passing the signals to be combined so that the signals are large enough to act on and/or to filter out any high or low frequency noise in the signals. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Cao, with the use of a gain/amplifier and/or filter before passing the signals to be combined, as taught by Bennett, since it would provide the predictable results of amplifying the ECG signals so that they are large enough to act on and/or to filter out any high or low frequency noise in the signals so as to not interfere with the detection of arrhythmias.
Claims 4, 15, 21, and 26, and in the alternative claims 3, 9, 10, 14, and 20-21, are rejected under 35 U.S.C. 103 as being unpatentable over Cao. Cao discloses that the signals are combined and that multiple different combined signals are used to determine the best signal quality to use for the R wave or RT ratio, but does not state the combination of ECG signals is done by adding the two signals together (e.g. claims 4 and 15) or that the different combined signals are done automatically/by the processor to determine the best signal quality, such as R, RT ratio, P or T wave (e.g. claim 21), between the two different combined ECGs. Cao also discloses that the software system can be part of a web-based expert system to trigger an appropriate therapy (e.g. col. 4, lines 25-34, etc.), but does not specifically state that upon detection of the arrhythmia the system and method delivers a therapy (claim 26). In addition or in the alternative, Cao does not state that a separate gain channel is used for each ECG signal (e.g. claims 3 and 14), and that the computer/processor is causing the system to use a second combined ECG different than the first combined ECG and to determine the which of the two has a better R/T peak ratio or P or T wave. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Cao, with the: combination of ECG signals being done by adding the two signals together; that the different combined signals are done automatically/by the processor to determine the best signal quality, such as R, RT ratio, P or T wave, between the two different combined ECGs; delivery of therapy once the arrhythmia was detected; and in the alternative, a separate gain channel is used for each ECG signal (e.g. claims 3 and 14), and that the computer/processor is causing the system to use a second combined ECG different than the first combined ECG and to determine the which of the two has a better R/T peak ratio or P or T wave, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of: combining the signals to better accentuate the features of interest, such as an R, P or T wave; allowing the system to automatically and quickly determine the best combined ECG signal to use that provides the best R, P, or T wave so that a user does not have to interact with the system and method; treating the patient’s heart condition when an arrhythmia is determined so the patient can function normally and/or does not die; and in the alternative, allowing the system and method to use separate amplifiers/gains on each ECG so that each ECG channel can be adjusted separately, such as to better amplify the lower ECG signal without over amplifying a different higher level ECG signal; and allowing the system to automatically run through all the different ECG electrode combinations to select the best ECG combinations that provide the best R, P, or T wave or R-T ratio for processing to determine an arrhythmia. In addition for claims 9, 10, 20, and 21, it has been held that providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
101
The argument that when it is a “close call” the Examiner should only make a rejection when it is more likely than not that the claim is ineligible under 101 is persuasive, and that is why the claims are still rejected under 101.
The claims only contain generic computer elements—a memory and processor--to process data and are directed to an abstract idea without significantly more. They do not contain any element to actually sense the data, such as electrodes, and they do not contain any element to provide the result to a user to diagnose the patient or to deliver specific therapy to revert the arrhythmia. Lacking such, the claims are directed to the abstract idea and do not contain any post solution activity that practically integrates the mental concept/abstract idea into a complete system or method.
The argument that the claims cannot be practically performed in the human mind is not persuasive. The human mind contains memory, instructions, and processes data, which is exactly what the claims recite. The argument that a human is not mentally capable of coupling to a memory or processor, and the claims contain additional elements or specific use of the claimed circuitry, is not persuasive as the Supreme Court in the Alice decision specifically pointed out that the method claims, which simply require generic computer implementations, fail to transform the abstract idea into a patent-eligible invention. Similarly, the system claims are no different in substance from the method claims, reciting a handful of generic computer components configured to implement the same idea.
The claims only set forth that data/signals are received, not that electrodes are sensing the signals. The data/signals then are filtered, delayed, and/or amplified and combined to provide a characteristic of interest (e.g. R wave) that is analyzed to determine an arrhythmia. This sort of process has been done for decades by physicians reading ECG displays or paper graphs. The simple use of “combining” is later claimed as a simple addition or subtraction of signals, which also can be done in the mind. In addition, as set forth by the examiner in the previous 101 rejection, even if a physical aid is used, such as paper and pencil, calculator, or slide rule, this does not negate the mental nature of the claimed limitations. Note that no time limit is given/claimed on when this combining and analyzing are done.
The argument that the claims recite a particular prophylaxis is not persuasive as the MPEP in 2106.04(d)(2) calls for the claims to affirmatively recite an action that effects a particular treatment/prophylaxis, which the claims do not contain. For example, a step or structure configured for “delivering cardioversion therapy to revert the tachycardia” would overcome the 101 (if there is support for this limitation). In addition, while the claims call for “analyzing” the COI for detecting an arrhythmia, nothing is done with this analysis in claims 1 and 12, and then only the ECG data is stored in memory in claim 25. This amounts to just a simple processing of data and storing the results in your mind, or paper, or through verbal utterances. Note that claim 26 is only directed to a general “therapy” without specifically pointing out the therapy. Is it a therapy such as a cardioversion or defibrillation shock that would treat a fibrillating heart? Or is it a therapy that is not known or used to treat an arrhythmia, such as a foot massage, applying a topical cream, etc.? The administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. See MPEP 2106.04(d)(2).
The argument that a human mind cannot receive a plurality of ECG signals from a subcutaneous IMD is not persuasive as the claims do not set forth how this data is received and do not positively recite the subcutaneous IMDs. The claims do not impose any limits on how the ECG information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device, by the person looking at ECG graph paper, or by looking at an ECG screen.
102
The argument that Cao does not combine signals and only identifies a single ECG is not persuasive. Cao specifically calls out “combination circuits” that “at any given moment in instantaneous time” takes the maximum signal from the three vectors to provide a combined and composite signal.
For instance, if from 0-1 seconds, Vector A-B is the largest signal of 5 volts, but then drops down in magnitude to 1 volt, then from 1-2 seconds Vector C-A is the largest signal of 6 volts, the combination circuits provide the combination/composite signal of Vector A-B of 5 volts during 0-1 seconds, then Vector C-A of 6 volts from 1-2 seconds as the output. This is a composite/combination signal.
Note that while the applicant may combine the signals in a different way than Cao, such as shown in figure 2B of their specification, the independent claims do not claim this specific combination. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The arguments regarding the gain/filtering/delay are not persuasive and are addressed above in the prior art rejections. The argument that a differential “amplifier” does not provide gain is not persuasive. The definition of an “amplifier” is to make a signal larger or more intense, and therefore there is a gain/amplification. The basic output equation of a differential amplifier can be summarized Vout = A (V2-V1) with A as the gain and V2 and V1 as the input signals, or as Vout = R3/R1 (V2-V1), where R3 and R1 are the resistors, and V2 – V1 is the difference between the inputted ECG signals. Even if it is a “unity gain” amplifier, there still is a gain. In addition, a differential amplifier amplifies the voltage difference between two inputs while rejecting common-mode signals, such as noise, interference, or hum present on both lines. This process is known as Common-Mode Rejection (CMRR), which effectively filters out unwanted noise. In the alternative, a 103 rejection was provided.
103
The arguments regarding the 103 rejections are not persuasive. The argument that the only teaching of adding two signals together is from the applicant’s own specification is not persuasive. The examiner provided two pieces of evidence in the final rejection showing the well-known, common knowledge in the art elements, such as Lian and/or Bennett, that disclose the use of automatically adding signals together to form a composite signal. The composite signal is used to find a characteristic of interest in order to evaluate the patient’s heart and provide another or substitute way to quickly combine signals to better detect a signal characteristic to determine the condition of the patient. It is noted that the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The argument that Cao does not provide a composite signal or multiple composite signals are addressed above in the 102 rejections and the response to the arguments. The argument that Cao teaches away from combining two ECG signals to form a composite ECG signal since Cao selects only one signal for use is not persuasive as addressed above. Cao specifically chooses the largest signal “at any instantaneous time” to use and output to form the combined/composite signal. The argument regarding the well-known in the art elements is not persuasive as the examiner previously provided evidence of these well-known elements (e.g. Bennett, Lian, etc.).
It does not matter that Cao only uses one signal at a time to form the claimed “composite signal” since the claims contain no such negative limitation or exclusionary proviso against forming the composite signal in such a manner.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and shows some of the well-known in the art elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 1/27/26