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 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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitations is/are:
“a cuff pressure adjustment unit configured to increase or decrease a cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user;” (Claim 1)
“a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal superimposed on a cuff pressure signal detected in a process of increasing or decreasing the cuff pressure;” (Claim 1)
“an information acquisition unit configured to acquire, for an individual blood pressure measurement, pulse wave feature information representing a feature amount of a pulse wave from the pulse wave signal superimposed on the cuff pressure signal detected in the blood pressure measurement;” (Claim 1)
“a storing unit configured to store pulse wave feature information acquired for the individual blood pressure measurement;” (Claim 1)
“a pulse number determination unit configured to determine the number of pulse waves having a feature amount represented by pulse wave feature information for the individual blood pressure measurement;” (Claim 1) / “the pulse number determination unit is configured to determine the number of pulse waves for the individual blood pressure measurement by excluding, from the pulse wave feature information for the individual blood pressure measurement, pulse wave feature information corresponding to a blood pressure measurement in which an elapsed time from when the blood pressure measurement is performed is equal to or greater than a threshold value” (Claim 2) / “the pulse number determination unit is configured to determine the number of pulse waves for the individual blood pressure measurement by excluding pulse wave feature information corresponding to a pulse wave in which an amplitude of a pulse wave having a feature amount represented by the pulse wave feature information for the individual blood pressure measurement is equal to or less than a threshold value” (Claim 5)
“a total number determination unit configured to determine whether a total number of pulse waves obtained by integrating pulse waves for individual blood pressure measurements has reached a predetermined number;” (Claim 1) / “the total number determination unit is configured to determine whether the total number of pulse waves obtained by integrating pulse waves and determined by the pulse number determination unit for one or more blood pressure measurements after a previous determination of atrial fibrillation has reached the predetermined number” (Claim 1)
“an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave based on the pulse wave feature information corresponding to the integrated pulse waves in the storing unit every time the total number is determined to have reached a predetermined number,” (Claim 1)
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“a cuff pressure adjustment unit configured to increase or decrease a cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user;” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the cuff pressure adjustment unit: “Based on the pulse wave signal superimposed on the cuff pressure signal indicating the cuff pressure detected by a pressure sensor 22, the blood pressure measurement unit 220 adjusts the cuff pressure using the components illustrated in Figure 2, which will be described later, in accordance with an instruction indicated by a user operation performed on the blood pressure measurement unit that measures the user's blood pressure and the blood pressure monitor. Specifically, the blood pressure measurement unit 220 drives a pump 23 via a pump drive circuit 26 and controls the valve 24 via a valve drive circuit 27. The valve 24 is controlled to open and close to adjust the cuff pressure by discharging or sealing air in the fluid bag.” Or equivalents thereof.
“a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal superimposed on a cuff pressure signal detected in a process of increasing or decreasing the cuff pressure” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the blood pressure determination unit: “Referring to Figure 3, the blood pressure monitor 20 includes, as main functional components, a blood pressure measurement unit 220, an AF determination unit 230, an output control unit 240 that controls output of information, and a storing control unit 250 that controls reading and writing of information from and to a storage unit 36. These units are realized by, for example, the processor 30 of the blood pressure monitor 20 reading a program stored in a storage such as a hard disk drive (HDD) 35 to be described later, expanding the read program in a memory 33 to be described later, and executing the program. Some or all of these units may be configured to be realized by hardware circuits including an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).” Or equivalents thereof.
“an information acquisition unit configured to acquire, for an individual blood pressure measurement, pulse wave feature information representing a feature amount of a pulse wave from the pulse wave signal superimposed on the cuff pressure signal detected in the blood pressure measurement;” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the information acquisition unit: ‘Referring to Figure 3, the blood pressure monitor 20 includes, as main functional components, a blood pressure measurement unit 220, an AF determination unit 230, an output control unit 240 that controls output of information, and a storing control unit 250 that controls reading and writing of information from and to a storage unit 36. These units are realized by, for example, the processor 30 of the blood pressure monitor 20 reading a program stored in a storage such as a hard disk drive (HDD) 35 to be described later, expanding the read program in a memory 33 to be described later, and executing the program. Some or all of these units may be configured to be realized by hardware circuits including an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).’ ‘The interval calculation unit 221 included in the blood pressure measurement unit 220 calculates an interval between adjacent pulse waves in the time series pulse waves constituting the pulse wave information.’ ‘The interval calculation unit 221 is an example of an "information acquisition unit" that acquires a feature amount of a pulse wave.’ Or equivalents thereof.
“a storing unit configured to store pulse wave feature information acquired for the individual blood pressure measurement;” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the storing unit: “Referring to Figure 3, the blood pressure monitor 20 includes, as main functional components, a blood pressure measurement unit 220, an AF determination unit 230, an output control unit 240 that controls output of information, and a storing control unit 250 that controls reading and writing of information from and to a storage unit 36. These units are realized by, for example, the processor 30 of the blood pressure monitor 20 reading a program stored in a storage such as a hard disk drive (HDD) 35 to be described later, expanding the read program in a memory 33 to be described later, and executing the program. Some or all of these units may be configured to be realized by hardware circuits including an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).” Or equivalents thereof.
“a pulse number determination unit configured to determine the number of pulse waves having a feature amount represented by pulse wave feature information for the individual blood pressure measurement;” (Claim 1) / “the pulse number determination unit is configured to determine the number of pulse waves for the individual blood pressure measurement by excluding, from the pulse wave feature information for the individual blood pressure measurement, pulse wave feature information corresponding to a blood pressure measurement in which an elapsed time from when the blood pressure measurement is performed is equal to or greater than a threshold value” (Claim 2) / “the pulse number determination unit is configured to determine the number of pulse waves for the individual blood pressure measurement by excluding pulse wave feature information corresponding to a pulse wave in which an amplitude of a pulse wave having a feature amount represented by the pulse wave feature information for the individual blood pressure measurement is equal to or less than a threshold value” (Claim 5): As identified by the Specification, the following is recognized as the corresponding structure to the pulse number determination unit: “Referring to Figure 3, the blood pressure monitor 20 includes, as main functional components, a blood pressure measurement unit 220, an AF determination unit 230, an output control unit 240 that controls output of information, and a storing control unit 250 that controls reading and writing of information from and to a storage unit 36. These units are realized by, for example, the processor 30 of the blood pressure monitor 20 reading a program stored in a storage such as a hard disk drive (HDD) 35 to be described later, expanding the read program in a memory 33 to be described later, and executing the program. Some or all of these units may be configured to be realized by hardware circuits including an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).” “In the AF determination process performed by the AF determination unit 230, a pulse number determination unit 232 analyzes the interval information 362 stored in the storage unit 36 and determines whether or not the number of pulse waves corresponding to the interval information 362 has reached a predetermined number based on the analysis result.” Or equivalents thereof.
“a total number determination unit configured to determine whether a total number of pulse waves obtained by integrating pulse waves for individual blood pressure measurements has reached a predetermined number;” (Claim 1) / “the total number determination unit is configured to determine whether the total number of pulse waves obtained by integrating pulse waves and determined by the pulse number determination unit for one or more blood pressure measurements after a previous determination of atrial fibrillation has reached the predetermined number” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the pulse number determination unit: “Referring to Figure 3, the blood pressure monitor 20 includes, as main functional components, a blood pressure measurement unit 220, an AF determination unit 230, an output control unit 240 that controls output of information, and a storing control unit 250 that controls reading and writing of information from and to a storage unit 36. These units are realized by, for example, the processor 30 of the blood pressure monitor 20 reading a program stored in a storage such as a hard disk drive (HDD) 35 to be described later, expanding the read program in a memory 33 to be described later, and executing the program. Some or all of these units may be configured to be realized by hardware circuits including an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).” “In the AF determination process performed by the AF determination unit 230, a pulse number determination unit 232 analyzes the interval information 362 stored in the storage unit 36 and determines whether or not the number of pulse waves corresponding to the interval information 362 has reached a predetermined number based on the analysis result.” “In the blood pressure monitor described above, the pulse number determination unit is further configured to determine whether or not the total number of pulse waves corresponding to the pulse wave feature information for the individual blood pressure measurement in the storing unit reaches the predetermined number.” Or equivalents thereof.
“an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave based on the pulse wave feature information corresponding to the integrated pulse waves in the storing unit every time the total number is determined to have reached a predetermined number,” (Claim 1): As identified by the Specification, the following is recognized as the corresponding structure to the atrial fibrillation determination unit: “Referring to Figure 3, the blood pressure monitor 20 includes, as main functional components, a blood pressure measurement unit 220, an AF determination unit 230, an output control unit 240 that controls output of information, and a storing control unit 250 that controls reading and writing of information from and to a storage unit 36. These units are realized by, for example, the processor 30 of the blood pressure monitor 20 reading a program stored in a storage such as a hard disk drive (HDD) 35 to be described later, expanding the read program in a memory 33 to be described later, and executing the program. Some or all of these units may be configured to be realized by hardware circuits including an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 1, the term “a cuff pressure adjustment unit configured to increase or decrease a cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user” should be replaced with -- a cuff pressure adjustment unit configured to increase or decrease a cuff pressure, the cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user-- for grammatical clarity.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
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.
Claim 1 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1, the term “a cuff pressure signal" in line 8 renders the claim indefinite because it is unclear if this is referring to the “cuff pressure signal” of line 5 or refers to a second “cuff pressure signal.” Appropriate changes would include -- a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal superimposed on [[a]] the cuff pressure signal, the pulse wave signal detected in a process of increasing or decreasing the cuff pressure --.
Regarding Claim 1, the term “a pulse number determination unit configured to determine the number of pulse waves having a feature amount represented by pulse wave feature information for the individual blood pressure measurement;” renders the claim indefinite because it is unclear if the claim is referring to determining a number of pulse waves by determining all “pulse waves” in the individual blood pressure measurement with all pulse waves “having a feature amount represented by pulse wave feature information” or if determining a number of pulse waves is performed by determining all “pulse waves” in the individual blood pressure that meet a conditional metric, the conditional metric being “having a feature amount represented by pulse wave information.” In view of the Specification and the claim 3, the feature amount seems to be an inherent characteristic of the pulse waves (i.e. a pulse wave interval) and therefore Examiner will be interpreting the claim as the former. Appropriate changes would include --a pulse number determination unit configured to determine the number of pulse waves within the pulse wave signal superimposed on the cuff pressure signal for the individual blood pressure measurement;--.
Regarding Claim 1, the term “a total number determination unit configured to determine whether a total number of pulse waves obtained by integrating pulse waves for individual blood pressure measurements has reached a predetermined number;” because it is unclear if the claim is if the term “integrating” refers to the mathematical step or if “integrating” refers to appending datasets of pulse waves from different individual blood pressure measurements.” If the former, it is also unclear how you can find a total number of pulse waves from integrating said pulse waves. From reviewing the Specification, Examiner believes the latter interpretation of “integrating” is the correct interpretation and suggests amending the claim to read “a total number determination unit configured to determine whether a total number of pulse waves obtained by combining pulse waves of each [[for]] individual blood pressure measurements has reached a predetermined number.”
Regarding Claim 1, the term “an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave based on the pulse wave feature information corresponding to the integrated pulse waves in the storing unit every time the total number is determined to have reached a predetermined number,” renders the claim indefinite because the phrasing “an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave… every time the total number is determined to have reached a predetermined number” can indicate a positive determination of atrial fibrillation is always output upon a total number of pulse waves reaching a predetermined number. Alternatively, it can indicate a capability of making determination of atrial fibrillation upon a total number of pulse waves reaching a predetermined number. Examiner will be interpreting the claim as the latter and suggests amending the claim to read “an atrial fibrillation determination unit configured to determine whether atrial fibrillation is present in a pulse wave, based on the pulse wave feature information corresponding to the combined pulse waves in the storing unit, every time the total number is determined to have reached a predetermined number,--"
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 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “a pulse number determination unit configured to determine the number of pulse waves having a feature amount represented by pulse wave feature information for the individual blood pressure measurement;
a total number determination unit configured to determine whether a total number of pulse waves obtained by integrating pulse waves for individual blood pressure measurements has reached a predetermined number; and
an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave based on the pulse wave feature information corresponding to the integrated pulse waves in the storing unit every time the total number is determined to have reached a predetermined number, wherein
the total number determination unit is configured to determine whether the total number of pulse waves obtained by integrating pulse waves and determined by the pulse number determination unit for one or more blood pressure measurements after a previous determination of atrial fibrillation has reached the predetermined number.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a cuff pressure adjustment unit configured to increase or decrease a cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user;
a cuff pressure detector configured to detect a cuff pressure signal indicating the cuff pressure;
a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal superimposed on a cuff pressure signal detected in a process of increasing or decreasing the cuff pressure;
an information acquisition unit configured to acquire, for an individual blood pressure measurement, pulse wave feature information representing a feature amount of a pulse wave from the pulse wave signal superimposed on the cuff pressure signal detected in the blood pressure measurement;
a storing unit configured to store pulse wave feature information acquired for the individual blood pressure measurement;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, cuff pressure adjustment units, cuff pressure detectors, blood pressure measurement units, information acquisition units, storing units are general field of use and determination units are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining atrial fibrillation in a pulse wave based on pulse wave feature information after determining that the total number of pulse waves obtained from blood pressure measurements has reached a predetermined number and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-5 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2017/0135585) (“Liu”) in view of Minamino et al (US 2021/0161412) (“Minamino”) as noted in Applicant IDS dated 1/17/2025.
Regarding Claim 1, while Liu teaches a blood pressure monitor (Abstract, Fig. 1, [0026]) comprising
a cuff attached to a measurement site of a user (Fig. 1, [0026]);
a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal (Fig. 1, [0025]-[0026] conventional blood pressure monitors may be used to gather heart rhythm data, where one such blood pressure monitor includes a blood pressure cuff, [0036] the steps of the invention may be applied by adding the cardiovascular monitoring module to existing blood pressure monitors, i.e. a blood pressure cuff);
an information acquisition unit configured to acquire pulse wave feature information representing a feature amount of a pulse wave from the pulse wave signal ([0028] heartbeats acquired from blood pressure monitor, where heartbeat acquisition is described by way of PPG, but reiterates that other methods may be used, i.e. a traditional blood pressure cuff, [0029]-[0034] pulse wave feature information is heartbeat interval and its variation);
a storing unit configured to store pulse wave feature information ([0013], [0035] stored program for calculation process and for values of known symptomatic heartbeat variations);
a pulse number determination unit configured to determine the number of pulse waves within the pulse wave signal ([0029] the cardiovascular health condition monitoring module detects the number of heartbeat counts in a preset time period);
a total number determination unit configured to determine whether a total number of pulse waves, obtained by combining pulse waves, has reached a predetermined number ([0028]-[0029] heartbeats captured for a preset time period and processed, [0030]-[0032] if after processing the blood pressure measurement, there are more heartbeats than a predetermined number, the atrial fibrillation determination may continue); and
an atrial fibrillation determination unit configured to determine whether atrial fibrillation is present in a pulse wave based on the pulse wave feature information corresponding to the combined pulse waves every time the total number is determined to have reached a predetermined number ([0029]-[0032], [0034] atrial fibrillation determination when a sufficient amount of heartbeats are provided and a new measurement of blood pressure would need to fulfill the same condition to be recognized as atrial fibrillation. Thus every time the total number of pulse waves is determined to have reached a predetermined number in a new measurement, atrial fibrillation could be determined. And atrial fibrillation is determined from patient’s heartbeat interval);
the total number determination unit is configured to determine whether the total number of pulse waves obtained by combining pulse waves and determined by the pulse number determination unit for one or more measurements after a previous determination of atrial fibrillation has reached the predetermined number ([0028]-[0029] heartbeats captured for a preset time period and processed, [0030]-[0032] if after processing, there are more heartbeats than a predetermined number determined for the one measurement session, the atrial fibrillation determination may continue. This process will be reset and applied equivalently for a subsequent measurement, determining whether the total number of pulse waves combined for the next measurement has reached the predetermined number and that the determination of atrial fibrillation can continue for this subsequent measurement),
Liu fails to teach
a cuff pressure adjustment means configured to increase or decrease a cuff pressure, the cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user;
a cuff pressure detector configured to detect a cuff pressure signal indicating the cuff pressure;
a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal superimposed on the cuff pressure signal, the pulse wave signal detected in a process of increasing or decreasing the cuff pressure;
an information acquisition unit configured to acquire pulse wave feature information from the pulse wave signal superimposed on the cuff pressure signal detected in the blood pressure measurement;
wherein the pulse wave feature information is acquired, stored, and determined from an individual blood pressure measurement;
a storing unit configured to store pulse wave feature information acquired for the individual blood pressure measurement;
a pulse number determination unit configured to determine the number of pulse waves within the pulse wave signal superimposed on the cuff pressure signal;
an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave based on the pulse wave feature information corresponding to the combined pulse waves in the storing unit, wherein
the total number determination unit is configured to determine whether the total number of pulse waves obtained by integrating pulse waves and determined by the pulse number determination unit for one or more blood pressure measurements after a previous determination of atrial fibrillation has reached the predetermined number.
However Minamino teaches a blood pressure monitor (Abstract, Fig. 1) comprising
a cuff pressure adjustment unit configured to increase or decrease a cuff pressure, the cuff pressure indicating an internal pressure of a cuff attached to a measurement site of a user ([0053] cuff pressure is controlled to acquire a sequence of pulse waves, indicating the presence of a cuff pressure adjustment unit);
a cuff pressure detector configured to detect a cuff pressure signal indicating the cuff pressure ([0053] pulse wave detection unit 104 acquires a pulse wave from the cuff pressure signal);
a blood pressure measurement unit configured to measure a blood pressure of the user based on a pulse wave signal superimposed on the cuff pressure signal, the pulse wave signal detected in a process of increasing or decreasing the cuff pressure ([0053]);
an information acquisition unit configured to acquire, for an individual blood pressure measurement, pulse wave feature information representing a feature amount of a pulse wave from the pulse wave signal superimposed on the cuff pressure signal detected in the blood pressure measurement ([0061], [0063] spectrum generation unit 108 of the calculation unit 102 acts as the information acquisition unit acquiring pulse wave feature information in the form of a frequency spectrum of the pulse signal waveform for the individual blood pressure measurement);
a storing unit configured to store pulse wave feature information acquired for the individual blood pressure measurement ([0059] storage unit 114 includes results of the processing);
an atrial fibrillation determination unit configured to determine atrial fibrillation in a pulse wave based on the pulse wave feature information corresponding to the combined pulse waves in the storing unit ([0064] atrial fibrillation found by frequency spectrum characteristics, [0089] where the combined pulse waves of multiple measurements must be considered before a patient is identified with atrial fibrillation),
wherein determining the feature amount of a pulse within the pulse wave signal superimposed on the cuff pressure signal for the individual blood pressure measurement is also performed within a predetermined condition ([0017] preset time period);
wherein a total measurement determination is made by determining whether the determination of atrial fibrillation in one or more blood pressure measurements has reached a predetermined number ([0089] two of three separate measurements must show atrial fibrillation before determining a patient has atrial fibrillation),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to recognize that utilizing a blood pressure cuff as the means for detecting pulse wave as taught in Liu would require a cuff pressure adjustment unit, a cuff pressure detector, and measuring a pulse wave signal superimposed on the cuff pressure signal as taught in Minamino as this is a traditional way to utilize a blood pressure cuff to acquire pulse wave, implied in Liu. Correspondingly, it would be obvious to consider that the pulse waves superimposed on the cuff pressure signal in an individual blood pressure measurement, e.g. Minamino’s Fig. 2, has sufficient pulse waves to meet the conditions of Liu with a monitoring time period between 5 second and 10 minutes and with over 6 pulse waves in the waveform. Thus the information acquisition, storing, and pulse determinations can be performed on the pulse wave signal superimposed on the cuff pressure signal detected in the individual blood pressure measurements. Finally, applying Minamino’s teaching regarding the use of repeated determinations of atrial fibrillation to increase confidence in the final determination ([0089]) could equivalently be applied in Liu and would essentially reflect a determination of whether the total number of pulse waves obtained by combining pulse waves of more than one measurement has reached the predetermined number in view of previous determinations (i.e. the pulse waves number condition would be satisfied to lead to the first atrial fibrillation determination and the new pulse waves number must be that number and between six to ten more pulse waves to satisfy that same condition in the new measurement).
Regarding Claim 3, Liu and Minamino teach the blood pressure monitor according to claim 1, and Liu teaches wherein the feature amount of the pulse wave represented by the pulse wave feature information includes an interval between pulse waves represented by the pulse wave signal superimposed on the cuff pressure signal detected in the blood pressure measurement (See Claim 1 Rejection, [0031] heartbeat intervals identified from the pulse waves used to identify atrial fibrillation).
Regarding Claim 4, while Liu and Minamino teach the blood pressure monitor according to claim 3, and Liu wherein the interval between pulse waves includes a time interval between maximum values of amplitudes in adjacent pulse waves for a non-cuff based heartbeat interval ([0028] RR interval used to find heartbeat interval in PPG, indicating a peak-based identification of a pulse like that of an ECG RR interval), their combined efforts fail to explicitly teach wherein the interval between pulse waves includes a time interval between maximum values of amplitudes in adjacent pulse waves for a cuff measurement.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the use of peak-based intervals of a PPG waveform in Liu could equivalently be applied to peaks due to pulsation in the equivalent sensing devices of a blood pressure cuff and a piezoelectric component device (Liu [0026]) as a standardization step of pulse identification, ensuring consistency across applications of the invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Minamino and further in view of Frick et al (US 2016/0228017) (“Frick”) as noted in Applicant IDS dated 1/17/2025.
Regarding Claim 2, while Liu and Minamino teach the blood pressure monitor according to claim 1, their combined efforts fail to teach wherein the pulse number determination unit is configured to determine the number of pulse waves for the individual blood pressure measurement by excluding, from the pulse wave feature information for the individual blood pressure measurement, pulse wave feature information corresponding to a blood pressure measurement in which an elapsed time from when the blood pressure measurement is performed is equal to or greater than a threshold value.
However Frick teaches an atrial fibrillation monitor (Abstract) comprising determine the number of pulse waves for the individual blood pressure measurement by excluding, from the pulse wave feature information for the individual blood pressure measurement, pulse wave feature information corresponding to a blood pressure measurement in which an elapsed time from when the blood pressure measurement is performed is equal to or greater than a threshold value ([0014]-[0023], [0064]-[0065] pulse waves of a blood pressure measurement are analyzed as by sequences, where a sequence is limited to a predetermined time to determine a presence of atrial fibrillation in as short a time as possible, where secondary sequences of predetermined time are only performed if the first sequence indicates the presence of atrial fibrillation. For a blood pressure measurement without atrial fibrillation, the elapsed time threshold will be 15 seconds. For a patient with atrial fibrillation, the measurement of blood pressure is extended and an elapsed time threshold proportional to the number of sequences is utilized).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the elapsed time threshold of Frick for the pulse waves of Liu and Minamino as a way to minimize monitoring time as taught by Frick ([0023]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Minamino and further in view of Geddes et al (US 5,916,239) (“Geddes”).
Regarding Claim 5, while Liu and Minamino teach the blood pressure monitor according to claim 4, their combined efforts fail to teach wherein the pulse number determination unit is configured to determine the number of pulse waves for the individual blood pressure measurement by excluding pulse wave feature information corresponding to a pulse wave in which an amplitude of a pulse wave having a feature amount represented by the pulse wave feature information for the individual blood pressure measurement is equal to or less than a threshold value.
However Geddes teaches a closed loop atrial fibrillation monitioring (Abstract) where a determination of the number of pulse waves is performed by excluding pulse wave feature information corresponding to a pulse wave in which an amplitude of a pulse wave having a feature amount represented by the pulse wave feature information for the individual blood pressure measurement is equal to or less than a threshold value (Col. 8, L. 62 – Col. 9, L. 42, pulses waves identified with a certain amplitude equal to or less than a threshold value as absent, the number of pulse waves recognized as present in a predefined period is evaluated to identify pulse deficit, a characteristics of atrial fibrillation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to exclude pulse wave peaks under a certain amplitude as taught by Geddes in the pulse wave of Liu and Minamino as a way to identify pulse deficit, a characteristic of atrial fibrillation. Identifying pulse deficit along with evaluating heartbeat intervals will increase confidence in the occurrence of atrial fibrillation in a subject.
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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