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.
Claim 11 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention and thus fails as eligible subject matter. Claim 11 characterizes the invention as a “computer-readable recording medium…”. A broadest reasonable interpretation of this language typically covers forms of non-transitory tangible media and transitory propagating signals per se, which are not patentable under 35 U.S.C. 101. Claims that cover both statutory and non-statutory embodiments under the broadest reasonable interpretation of the claims when read in light of the specification and in view of one skilled in the art, embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. The claim is considered to be broad enough to cover a transitory propagating signal that carries a programmed instruction set. Furthermore, even when the claim is directed to one of the four statutory categories of invention, the claim must not be wholly directed to subject matter encompassing a judicially recognized exception without a particular practical application. In the instant case, in addition to failing to fall within one of the four statutory categories of invention, the claim recites only instructions, i.e. an algorithm that is not limited to a particular practical application. It is suggested to add “non-transitory” to the claim.
Claims 1-11 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 receiving ECG data to convert with a Hilbert transform and calculating an ECG axial deviation based on the Hilbert transformed ECG. This judicial exception is not integrated into a practical application because the combination of additional elements (e.g. a reception unit, converter, control unit, etc.; or a processor performing acting as those elements [pages 18 and 19 of the specification]) fails to integrate the judicial exception into a practical application. The generically recited computer elements 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, calculate and process the 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 convert with a Hilbert transform and calculating an ECG axial deviation based on the Hilbert transformed ECG, 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. a reception unit, converter, control unit, etc.; or a processor [pages 18 and 19 of the specification]) 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 a processor, or a reception unit, converter, and a control unit, and corresponding method claim 10) is a system having a processor, or a reception unit, converter, and control unit, wherein the processor/control unit 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 processor, or reception unit, converter, and control unit, 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, or the reception unit, converter, and control unit. No element has been set forth to sense the ECG signal, and the only additional element is the reception unit and converter, where the processor/control unit performs the necessary software tasks so that the result of the abstract mental process is just data/calculated ECG axial deviation. The reception unit and converter limitations represent extra-solution activity because they are mere nominal or tangential additions to the claim, they only receive and calculate data for the mental concept, and are nothing more than an attempt to generally link the system to a particular technological environment. 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 convert with a Hilbert transform and calculating an ECG axial deviation based on the Hilbert transformed ECG, 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 § 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 1-11 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 3, “the measured ECG signal” lacks antecedent basis. It is suggested to use “a measured ECG signal” (note that line 1 of the claim measures the deviation, not the ECG). In line 6, “an” electrocardiography … is vague as this term is also used in line 1 and it is unclear if the two are the same element or not. It is suggested to use “the” electrocardiography in line 6.
Similarly, claim 10 has these problems.
In claim 4, a peak value of “the envelope in the Nyquis diagram” lacks antecedent basis. Claim 3 has not set forth that it determines an envelope in the Nyquist diagram (also Nyquis is spelled wrong).
Similarly, claims 8 and 9 have this problem in regards to the envelope.
In claim 7, “which is obtained by adding…” is vague as it is unclear what element is performing this function. It is suggested to state “wherein the control unit calculates it by adding…”.
In claim 11, “in which a program for executing…” seems to be misworded. It is suggested to use something similar to “A non-transitory computer-readable recording medium containing instructions that, when executed by a processor, perform the method as set forth in claim 10”.
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, 10, and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for calculating an ECG axial deviation based on the created Nyquist diagram having a real value and the Hilbert transformed ECG imaginary value, does not reasonably provide enablement for calculating the ECG axial deviation based solely on the Hilbert transformed ECG. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Note that claim 2 and its dependents are not included in this rejection as the specification does enable any person skilled in the art to make and/or use the invention commensurate in scope with these claims.
The disclosure fails to state or teach one of ordinary skill in the art the exact way to calculate an ECG axial deviation based on, at the minimum, the Hilbert transformed ECG signal. 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 to calculate an ECG axial deviation based on, at the minimum, the Hilbert transformed ECG signal.
Due to the lack of an enabling specification and lack of direction provided by the inventor to calculate an ECG axial deviation based on, at the minimum, the Hilbert transformed ECG signal, several questions arise as to how to make and/or use the invention, such as:
At the minimum as set forth in the claims, how does the control unit calculate an ECG axial deviation based on the Hilbert transformed ECG signal?
As seen in figure 2b, numeral 202, of the applicant’s disclosure, the Hilbert transformed ECG signal represents imaginary ECG values, how are these values used solely by the control unit to calculate the ECG axial deviation?
Are there other procedures that are necessary for the control unit to determine the ECG axial deviation based on the Hilbert transformed ECG signal? Such as creating a Nyquist diagram with the real ECG value and imaginary Hilbert value where the control unit determines the ECG axial deviation from the Nyquist diagram (e.g. page 9, first, second and third full paragraph, etc.)?
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 an ECG axial deviation system and method is patent number 11291379 to Paak which describes the extracted parameters of a Poincare map analysis to determine axial tilt (e.g. col. 26, etc.).
Since there are numerous questions as to how the invention is made and/or used, since no amount of direction or guidance was presented as to how to calculate an ECG axial deviation based on, at the minimum, the Hilbert transformed ECG signal, since other axial tilt systems and methods describe in detail how to provide an axial tilt determination system and method, 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 calculate an ECG axial deviation based on, at the minimum, the Hilbert transformed ECG signal 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.
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 9/30/25