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.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of calculating a peak heart sound point time sequence based on the heart sound signal sequence; and finding a cuff pressure value at a corresponding moment in the cuff pressure time sequence as a blood pressure measurement value based on a moment of occurrence of a target peak heart sound point in the peak heart sound point time sequence.
The limitation of calculating a peak heart sound point time sequence and finding a cuff pressure value corresponding to the moment in the cuff pressure time sequence when the target heart sound point, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, “calculating” and “finding” in the context of this claim encompasses the user manually calculating a peak heart sound and finding what cuff pressure that corresponds to in the time series. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Claims 4 and 12 also specifically recite an equation that falls within the “mathematical concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of controlling a cuff bladder and collecting a heart sound signal sequence as well as a cuff pressure time sequence. The cuff and the presumed sensors for the heart sound and pressure signals involve mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a heart sound collecting unit” in claim 1 which is a piezoelectric vibration sensor, a sound sensing MEMS chip or a microphone according to ¶33; “a control module”, “a collecting module”, “a calculation module” and “a finding module” in claim 8 which does not appear to have any corresponding physical structure and is just the modules as shown in figure 6 and ¶90-92 states they can be physical or program modules but does not provide any structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2-4 and 10-12 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. It is unclear what is “intercepting a first heart sound signal sequence”. It is unclear how heart sounds are collected or intercepted before the heart sound signal sequence collected in claims 2 and 10. Similarly, if the second heart sound signal sequence is the sorted first heart sound signal sequence it is unclear how an average value of “heart sounds after the second heart sound signal sequence” is determined. It seems there would be no before or after of the second heart sound signal sequence.
There is no antecedent basis for “the noise amplitude threshold” and it is unclear when or how this is determined and used to validate the heart sound signals.
It is unclear how the vector is made from depositing. It is also unclear how the time vector is recorded. It is presumed these are the time points that correspond with the heart sounds deposited into the heart sound vector.
Claims 3-4 and 11-12 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. It is unclear if the peak detection is performed on the difference sequence and the time vector separately or are the difference sequence and the time vector combine.
Claims 4 and 12 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. It is unclear what diffpeaks +1 is indicating in the equation. It could be just the difference sequence indexed +1 or another forward difference sequence.
Claims 6 and 14 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. It is unclear if the claim is reciting that all the sub-depressurization phases are controlled at the same flow rate selected from a set or if the flow rates for each phase are assigned separately from a set of preset values.
Claim limitations “a control module”, “a collecting module”, “a calculation module” and “a finding module” in claim 8 have been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the modules do not appear to have any corresponding physical structure and is just the boxes as shown in figure 6. Furthermore, ¶90-92 states the modules can be physical components or programming components but does not provide any structure. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Du et al. US 2018/0177411.
Regarding claim 1, 8 and 9, Du discloses a blood pressure measurement method, applied to an electronic blood pressure measurement device ([FIG.1][¶41] microcomputer 5), comprising:
controlling a cuff air bladder to depressurize when the cuff air bladder is in a state of pressurization completion ([FIG.2][¶45] the device inflates the cuff to a maximum pressure then depressurizes while performing the readings);
collecting a heart sound signal sequence as well as a cuff pressure time sequence in real time by a heart sound collecting unit during a depressurization process ([FIG.2][¶45-48,75] cuff pressure is recorded from pressure sensor 2 and the sounds are collected via a sound sensor 3);
calculating a peak heart sound point time sequence based on the heart sound signal sequence ([¶65] peak value acquiring module 511 collects sound intensity peaks) and
finding a cuff pressure value at a corresponding moment in the cuff pressure time sequence as a blood pressure measurement value based on a moment of occurrence of a target peak heart sound point in the peak heart sound point time sequence ([¶75] the pressure matching unit determines the pressure at the peak sound moments).
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.
Claim(s) 2-3, 5-7, 10-11 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Du in view of Shinomiya US 5,103,830 and Hutcheson et al. US 4,889,132.
Regarding claims 2 and 10, Du discloses the step of calculating the peak heart sound point time sequence based on the heart sound signal sequence comprises: intercepting a first heart sound signal sequence N seconds before the heart sound signal sequence ([¶45] the signals are collected before the first Korotkoff sound). Du does not specifically disclose sorting the heart sound sequence or the noise threshold. Shinomiya teaches a similar Korotkoff sound detection system that sorts the first heart sound signal sequence in ascending order to obtain a second heart sound signal sequence ([FIG.10][ [Col. 7 lines 40-65] the signals are ordered based on the peak difference); obtaining valid heart sound signals from the heart sound signal sequence based on the noise amplitude threshold to be deposited into a heart sound vector, and recording a time vector corresponding to the heart sound vector; and calculating the peak heart sound point time sequence based on the heart sound vector and the time vector ([FIG.10][Col. 7 lines 21-43] the heart sounds over a noise threshold are kept for further processing. Shinomiya does not specifically teach making a vector but making a vector or bin is a common data processing technique that would have been obvious to one of ordinary skill in the art). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Du with the teachings of Shinomiya in order to determine with a probability in a certain range the correct Korotkoff signals ([Col. 5 lines 5-11]).
Du as modified by Shinomiya does not specifically teach calculating an average value of M heart sound signals after the second heart sound signal sequence to obtain a noise amplitude threshold. Hutcheson teaches a similar blood pressure monitoring system based around Korotkoff sound detection that determines a mean value of the peaks as a noise threshold ([FIG.15] AKSN and ANOISE are calculated as noise thresholds). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Du with the teachings of Hutcheson in order to alleviate errors caused by “upstream pounding” ([Col. 30 lines 43-68]).
Regarding claims 3 and 11, Shinomiya teaches the step of calculating the peak heart sound point time sequence based on the heart sound vector and the time vector comprises: performing a difference operation on all the valid heart sound signals in the heart sound vector to obtain a difference sequence; performing a peak detection on the difference sequence and the time vector based on a predetermined peak detection formula to obtain a peak point sequence and a corresponding time sequence; and determining the peak heart sound point time sequence based on the peak point sequence and the corresponding time sequence ([Col. 7 lines 40-65] the differences in the pulse signals and the sound signals with respect to time are generated like in FIG.10).
Regarding claims 5 and 13, Shinomiya teaches that the step of controlling the cuff air bladder to depressurize comprises: controlling the cuff air bladder to depressurize at a first gas flow rate during a first depressurization phase ([FIG.14,15][Col. 18 line 63 to Col. 19 line 8] the initial rapid reduction of step S264 after detecting the systolic K sound); controlling the cuff air bladder to depressurize at a second gas flow rate during a second depressurization phase when a first heart sound signal is captured by the heart sound collecting unit ([FIG.14,15][Col. 18 line 63 to Col. 19 line 8] the slower rate of reduction in step S266 between the systolic K sound and the last sound marking the diastolic); controlling the cuff air bladder to depressurize at a third gas flow rate during a third depressurization phase when the heart sound collecting unit a last heart sound signal is collected; wherein the first gas flow rate is greater than the second gas flow rate, and the third gas flow rate is greater than the first gas flow rate ([FIG.14][Col. 18 line 63 to Col. 19 line 8] the final flow which is just the release of all pressure at the end of the measurement). Shinomiya teaches these pressure release steps in a separate embodiment from FIG.10 however at the time of filing it would have been obvious to one of ordinary skill in the art to combine the embodiment of FIG.14 and the embodiment of FIG.10 as Shinomiya teaches all of its embodiments are combinable or useable together ([Col. 20 line 31-37]).
Regarding claims 6 and 14, Shinomiya teaches the step of controlling the cuff air bladder to depressurize at the second gas flow rate during the second depressurization phase comprises: dividing the second depressurization phase into a plurality of sub-depressurization phases and controlling the cuff air bladder to depressurize at a corresponding second gas flow rate selected from a set of preset second gas flow rate values in the plurality of the sub-depressurization phases ([Col. 17 line 15-30] the reduction phase, or second depressurization phase, can have its rate adjusted if the readings do not fall within the predetermined settings). Shinomiya teaches these pressure release steps in a separate embodiment from FIG.10 however at the time of filing it would have been obvious to one of ordinary skill in the art to combine the embodiment of FIG.14 and the embodiment of FIG.10 as Shinomiya teaches all of its embodiments are combinable or useable together ([Col. 20 line 31-37]).
Regarding claims 7 and 15, Shinomiya teaches the step of finding the cuff pressure value at the corresponding moment in the cuff pressure time sequence as the blood pressure measurement value based on the moment of occurrence of the target peak heart sound point in the peak heart sound point time sequence comprises: finding a cuff pressure value at a corresponding moment in the cuff pressure time sequence as a high-pressure measurement value of the blood pressure based on a moment of occurrence of a first peak heart sound point in the peak heart sound point time sequence, and finding a cuff pressure value of a corresponding moment in the cuff pressure time sequence as a low-pressure measurement value of the blood pressure based on a moment of occurrence of a last peak heart sound point in the peak heart sound point time sequence ([FIG.10][Col. 7 lines 40-65] the first heart sound corresponds to the systolic pressure and the last heart sound corresponds to the diastolic pressure reading).
Claim(s) 4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Du, Shinomiya and Hutcheson further in view of Boashash “Estimating and interpreting the instantaneous frequency of a signal. II. Algorithms and applications”.
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Regarding claims 4 and 12, Du as modified by Shinomiya teaches using the signal differences in determining the peaks but does not specifically disclose wherein the peak detection formula is expressed as:
wherein hpeaks denotes the peak point sequence, htime denotes the time sequence, diffpeaks denotes the difference sequence, and tpeaks denotes the time vector.
Boashash teaches a signal processing technique for continuous signals like those collected by Shinomiya that uses a forward finite difference formula ([pg. 542] equation 7 is the forward difference equation which comprises the diffpeaks). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the difference function of Boashash with the device of Du modified by Shinomiya as the forward difference function provides reliable estimate of discrete time providing better noise performance and is more computationally efficient ([pg. 542 Col. 1]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. KR 20180130416 which also discloses removing noise with a first reference value or threshold.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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