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 .
Specification
The disclosure is objected to because of the following informalities. Appropriate correction is required.
The acronyms “VSD” and “ASD” used in paragraphs [0069] and [0071] are not defined in the specification.
Drawings
The drawings are objected to for the following reasons (Examiner notes that remarks regarding the drawings are directed to the drawings provided with the label “REPLACEMENT SHEET”):
FIG. 1
The text inside the boxes is illegible.
FIG. 2
The titles, axis labels, and axis numbers are illegible.
It is unclear where the title of the figure in row 1, column 5 ends.
It is unclear where the title of the figure in row 1, column 6 begins.
FIGS. 3-4
The title of the first spectrogram is blocked by the bottom portion of the captured heart sound.
The axis labels of the spectrograms and the captured heart sound are illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
Claims 1-15 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 re claim 1,
There is insufficient antecedent basis for the limitation “the heart murmur condition”, for examination purposes the first instance of “the heart murmur condition” in claim 1 will be interpreted as “a heart murmur condition”.
There is insufficient antecedent basis for the limitation “the user”, for examination purposes the limitation “the user” will be interpreted as “a user”.
Examiner notes that dependent claims 2-9 and 15 inherit the same deficiencies.
In re claim 4, there is insufficient antecedent basis for the limitation “the classified heart murmur details”. Additionally, it is unclear what applicant means by “the classified heart murmur details”, as this limitation is not mentioned in claim 1. For examination purposes, as best understood the limitation “storing the captured heart signature along with the classified heart murmur details of the patient memory associated with the computing device” will be interpreted as requiring the claim to store the captured heart signature along with the benign or pathological heart murmur classification of the patient.
In re claim 6, the limitation “a portable smart device of a user” in combination with claim 1 raises a clarity concern. Specifically, it is unclear if “a user” from claim 6 is the same user described in claim 1 or a second different user. For examination purposes the limitation “a portable smart device of a user” will be interpreted as referring to the user from claim 1. In other words, the limitation “a portable smart device of a user” will be interpreted as “a portable smart device of the user”.
In re claim 8, see above (In re claim 6).
In re claim 10, see above (In re claim 1 (i)).
Examiner notes that dependent claims 11-14 inherit the same deficiencies.
In re claim 13, see above (In re claim 4).
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 1-15 are rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claim 1 and 10 are directed to a method of classifying heart murmurs in patients. Thus, the claims are directed to a statutory category of invention (Step 1: Yes).
Step 2A, Prong 1:
Claims 1 and 10 recite the following limitations:
“in a signal processing step, processing the captured heart signature using a fast Fourier transformation to identify a plurality of frequency component waveforms” (mathematical calculations and/or mental process)
“for each component frequency waveform, determining a power value of the component frequency waveform” (mathematical calculations)
“classifying the component frequency waveform as: i. a primary frequency waveform, being the component frequency waveform with the largest power value; ii. harmonic frequency waveforms, being any component frequency waveforms that factor with the same denominator as the primary frequency waveform; and iii. non-harmonic frequency waveforms, being any component frequency waveforms that do not factor with the same denominator as the primary frequency waveform;” (mathematical calculations and/or mental process).
“calculating: i. a composite power value, being the total of the power values for all of the component frequency waveforms; ii. a harmonic power value, being the total of the power values for all of the harmonic frequency waveforms; and iii. a non-harmonic power value, being the total of the power values for all of the non-harmonic frequency waveforms;” (mathematical calculations)
“classifying the heart murmur of the patient by determining a harmonic ratio being the harmonic ratio of the harmonic power value as a portion of the composite power value, wherein: i. if the harmonic ratio exceeds a defined benign threshold value the heart murmur condition of the patient is classified as benign; and ii. if the harmonic ratio does not reach the defined benign threshold value the heart murmur condition of the patient is classified as pathologic;” (mathematical calculations and/or mental process).
Dependent claims 2, 3, 11, and 12 recite the following limitations:
wherein the defined threshold value is the ratio of the non-harmonic power value as a portion of the composite power value (mathematical calculations).
“wherein the power value of each component frequency waveform is determined by rendering a power spectrograph of said component frequency waveform as isolated from the captured heart signature and calculating the power value based on the rendered power spectrograph” (mathematical calculations).
The above limitations are directed to mathematical calculations and mental processes. Regarding the limitations directed to mathematical calculations, under the broadest reasonable interpretation a mathematical calculation is a mathematical operation or an act of calculating using mathematical methods to determine a variable or number. see MPEP 2106.04(a)(2)(I). Examiner notes, as discussed in MPEP 2106.04(a)(2)(I), the claim does not need to recite the word “calculating” in order to be considered a mathematical calculation. Therefore, under BRI “processing using a fast Fourier transform”, “determining a power value”, “calculating a i. composite power value…ii. a harmonic power value…and iii. a non-harmonic power value”, and “determining a harmonic ratio”, are examples of mathematical calculations.
Regarding the limitations directed to a mental process, Examiner asserts that “processing the captured heart signal”, “classifying the component frequency waveform…” and “classifying the heart murmur of a patient” are examples of mental processes (observations, evaluations, judgements, and opinions) that can be performed in the human mind, or by a human using a physical aid. Examiner notes that the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III).
For the reasons described above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea (Step 2A, Prong 1: Yes).
Step 2A, Prong 2:
Claim 1 recites the following additional elements:
“capturing a digitized acoustic heart signature of the patient, being the captured heart signature;” (insignificant extra pre-solution activity).
“in an interface display step, providing an interface indication to the user of the computing device of the benign or pathologic heart murmur classification of the patient” (insignificant extra post-solution activity).
The above additional elements are examples of insignificant extra solution activity. Specifically, the limitation “capturing a digitized acoustic heart signature of the patient, being the captured heart signature;”, is directed to pre-solution activity (I.e., mere data gathering). Similarly, the limitation “in an interface display step, providing an interface indication to the user of the computing device of the benign or pathologic heart murmur classification of the patient”, is directed to post-solution activity related to outputting information. These additional elements fail to provide significantly more because they are insignificant extra-solution activity.
Claims 1 and 10 recite the following additional elements:
“a computing device” (generic computer element)
“processor” (generic computer element)
“memory” (generic computer element)
“human interface device” (generic computer element)
“cardiac capture hardware” (generic computer element)
“cardiac classification software component” (generic computer element)
The above additional elements are merely examples of generic computer elements. These additional elements fail to provide significantly more because they amount to merely applying the abstract idea using generic computer elements.
Dependent claims 4-9, 13, 14, and 15 recite the following additional elements:
“storing the captured heart signature along with the classified heart murmur details of the patient to memory” (insignificant extra post-solution activity)
“captures the digitized acoustic heart signature of the patient from a connected digital stethoscope” (insignificant extra pre-solution activity)
“wherein the computing device comprises a standard personal computer or a portable smart device” (generic computer element)
“processor” (generic computer element)
“memory” (generic computer element)
“data interface” (generic computer element)
“human interface display” (generic computer element)
“software” (generic computer element)
“wherein the device comprises a standard personal computer or a portable smart device” (generic computer element)
“digital stethoscope” (insignificant extra pre-solution activity)
“cardiac classification software component” (generic computer element)
The additional elements listed in the dependent claims fail to provide significantly more because they amount to no more than insignificant extra solution activity and applying the abstract idea using generic computer elements (Step 2A, Prong 2: NO).
Step 2B:
The claims do not include any additional elements that amount to significantly more than the judicial exception.
Regarding the limitations “captures the digitized acoustic heart signature of the patient from a connected digital stethoscope” and “digital stethoscope” see Ravindran (US 2009/0192401), which discloses using a digital stethoscope to capture a digitized acoustic heart signature of a patient (FIG. 2; [0023]). Thus, the limitations “captures the digitized acoustic heart signature of the patient from a digital stethoscope” and “digital stethoscope” are well-understood, routine and conventional (as evidenced by Ravindran).
As discussed above, in Step 2A Prong 2 the remaining additional elements amount to no more than applying the abstract idea using generic computer components and insignificant extra solution activity.
Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C 101. (Step 2B: NO).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Polyschuck et al. (US 2005/0222515) discloses a method of analyzing a patient’s heart sounds for detection, identification, and prognostication of heart disease (abstract).
Pretorius et al. (US 2013/0226019) discloses a method for classifying a heart murmur as normal or pathological using a diagnostic decision network (FIG. 1; abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796