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 § 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 1-18 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 1, line 5, receive “patient ECG signals” is vague as this term has been used in line 2 and it is unclear if these elements are the same element or different. If they are the same, then “receive the patient ECG signals” should be used in line 5.
In claim 2, the next to last line, “treatment” is vague as this term is also used in claim 1. If they are the same, then “the treatment” should be used. If they are different, then a modifier such as “an additional treatment” should be used.
Similarly, claim 4 has this problem.
In claim 6, the next to last line, “a refibrillation indicator model” is inferentially included and vague. It is unclear if the claim is positively reciting/claiming the model, or if this is meant as an intended/functional use. If the model is meant to be positively recited, it is suggested to first state an element to provide the model before it is used to put the parameters into the input. As claim 8 further limits the model, it is suggested to positively recite the model in claim 6.
In claim 8, “a treatment” is vague as this term is also used in claim 1.
In claim 9, line 1, “a defibrillation shock” is vague as this term is also used in claim 6 and it is unclear if they are the same element. In addition, “one or more samples”, “one or more parameters” and “a refibrillation indicator model” are vague as they have been previously recited in claim 6.
In claim 10, “the one or more parameters” is vague as this term is used in claims 9 and 6, one after a shock and one before a shock, and it is unclear which is being discussed.
In claims 11 and 13, “a treatment” and “a flag” are vague as these terms have been used previously in claim 1 and claim 8.
In claim 12, both occurrences of “a flag” are vague and in the last line “CPR treatment” is vague as these terms have been used previously.
In claim 14-17, “a treatment” is vague as this term has been used previously. In claims 15, 17, and 18, “a flag” is vague as this term has been used previously.
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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the written description is how the ECG signals are analyzed to generate an ECG refibrillation indicator representing a likelihood of refibrillation, and how to choose a treatment using the refibrillation indicator, in combination with the other elements/structure in the claim(s).
The inventors/applicants had a general idea of performing these functions, but they did not possess the specific details of how these functions are carried out when they filed the application.
The inventors/applicants list a multitude of different parameters that may be used to determine the refibrillation indicator (e.g. paras. 20, 30, 31, etc.) but go in to no specific details or examples of how the parameters are used to determine the indicator. For example, the parameters could be a frequency domain, wavelet parameter, or ECG signal sample minimum amplitude, but the disclosure goes no further in discussing what is done with those parameters. What specifically is examined in those indicators? And when a refibrillation index is produced, what does that refibrillation index mean?
This appears to be a black box, where ECG details are gathered and input into the black box, then an indicator is presented on the output of the black box without explaining how the indicator is actually produced.
In addition, no guidance is given as to what the indicator means and then how to choose a specific treatment (e.g. shock, CPR, etc.) to meet that given indicator’s value.
Claims 14-16 and 19-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The disclosure fails to state or teach one of ordinary skill in the art the exact way to analyze a patient impedance signal to generate at least one impedance fibrillation indicator representing a likelihood of refibrillation, and to choose a treatment using the impedance indicator, in combination with the other elements/steps of the claim(s). Without this disclosure, one skilled in the art cannot practice the invention without undue experimentation because of the number of operational parameters in the process/apparatus and uncertainty of the nature of the invention as to how analyze a patient impedance signal to generate at least one impedance fibrillation indicator representing a likelihood of refibrillation, and to choose a treatment using the impedance indicator.
Due to the lack of an enabling specification and lack of direction provided by the inventor for analyzing a patient impedance signal to generate at least one impedance fibrillation indicator representing a likelihood of refibrillation, and to choose a treatment using the impedance indicator, several questions arise as to how to make and/or use the invention, such as:
The disclosure states that system/method may measure with patient electrodes one or more parameters of the one or more impedance waveforms which may comprise an amplitude of a peak of an impedance waveform or a width of a peak of an impedance waveform (e.g. para. 45, etc.) or breath of a patient.
Where exactly are the patient electrodes located?
Is the measured impedance directed to the contact impedance, breath impedance, or some other impedance (e.g. transthoracic? Cardiac tissue? etc.).
As the impedance waveform contains many peaks and widths, exactly what peak or width is measured? Are the peaks and widths only drawn to an electrode contact impedance waveform, a cardiac impedance waveform, or can it also be a peak or width from a breath impedance waveform?
How is a refibrillation indicator formed from the impedance peak, width, or breath? What values will this index have? Zero to one, or just a number? What equation is used to determine this refibrillation indicator from the impedance signal? When does the refibrillation indicator indicate the likelihood that refibrillation will occur?
How do you determine what therapy to deliver from the impedance indicator? What specific values indicate one treatment (e.g. defibrillation shock) over a different treatment (e.g. CPR)?
How is the impedance refibrillation indicator combined with the other determined ECG refibrillation indexes? How do you determine what treatment to deliver with the combined refibrillation indicator?
One example of many showing the state of the prior art, the level of ordinary skill and predictability, and necessary detail needed to enable someone skilled in the art to make and/or use a refibrillation index system and method is publication number 2003/0191403 (Zhou et al), which shows how to use electrical ECG signals, using specific equations to determine a score (e.g. paras. 52-62, etc.) to provide therapy. However, impedance is never discussed in Zhou.
Since there are numerous questions as to how the invention is made and/or used, since no amount of direction or guidance was presented, since other refibrillation systems and methods describe in detail how to provide a refibrillation index and score, and/or since one skilled in the art cannot practice the invention without undue experimentation (as seen by the above questions) because of the number of operational parameters in the process/apparatus that are needed to analyze a patient impedance signal to generate at least one impedance fibrillation indicator representing a likelihood of refibrillation, and to choose a treatment using the impedance indicator, in combination with the other elements/steps of the claim(s), one skilled in the art to which it pertains is not enabled to make and/or use the invention of the subject matter presented in the claims.
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 1-18 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 or mathematical equation of receiving ECG data to analyze to determine an indicator of refibrillation to choose a treatment. This judicial exception is not integrated into a practical application because the combination of additional elements (e.g. ECG analysis system/processor, and input) fails to integrate the judicial exception into a practical application. The generically recited computer elements (e.g. input and analysis/processor system) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. 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. The additional limitations only receive and process data and these 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 receiving ECG data to analyze to determine an indicator of refibrillation to choose a treatment, 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. input, analysis/processor system, 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. 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 1 having an input and analysis/processor system) is a system having a 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 besides through an input, 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 input and analysis system/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).
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 input. No element has been set forth to sense the ECG signal, and the only additional element is the input, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/choice of treatment. The input limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim and/or it is only receiving data to be used in the abstract mental process. 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 receiving ECG data to analyze to determine an indicator of refibrillation to choose a treatment, 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.
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 1-4, 6-11, and 17-18 are rejected under 35 U.S.C. 102a1 as being anticipated by Zhou et al (2003/0191403). Zhou discloses the claimed limitations as follows:
--an input to receive ECG signals (e.g. paras. 10, 19, figure 2, implantable or external defibrillator, etc.)
--an ECG analysis system to receive the ECG signal (e.g. figure 2, element 224, paras. 10, 36-42, etc.; processing unit, microcontroller, etc.) to generate an ECG refibrillation indicator representing a likelihood of refibrillation (e.g. figure 3, element 500/430, paras. 41-42 , etc.) to choose treatment (e.g. figure 3, element 440, para. 44, etc.).
For claims 2-4, 6, 8, 9, and 11, Zhou discloses that a refibrillation indicator is determined before a shock and also after delivery of the defibrillation shock (e.g. para. 40, figure 3, block 415, etc.), where the indicators can be weighted/combined/aggregated to compare to a threshold or template/model (e.g. abstract, paras. 9-12, etc.). Note that the claim is also an open-ended “comprising” claim and does not preclude having previous shocks before a claimed limitation such as “before delivery of a defibrillation shock”. For claims 7 and 10, Zhou uses time domain parameters and R-R intervals (e.g. HRV) to determine the refibrillation indicator.
Conclusion
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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/George R Evanisko/Primary Examiner, Art Unit 3792 5/1/26
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