DETAILED ACTION
Applicant’s preliminary amendment filed 02/21/2024 has been entered.
Claims 8-12 are hereby the present claims under consideration.
Examiner’s Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2024/0180435 A1.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
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”) in a claim creates a rebuttable presumption that the claim limitation is not 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 not 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 function without reciting sufficient structure, material or acts to entirely perform the recited 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.
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 pulse wave acquisition unit of claim 8
A blood pressure value measurement unit of claim 8
A pulse wave reproduction information generation unit of claim 8
An arrhythmia detection unit of claim 9
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.
A pulse wave acquisition unit of claim 8 is interpreted as the blood pressure cuff, air tube, and body including the control unit as described in paragraph 0033 and its equivalents.
A blood pressure value measurement unit of claim 8 is interpreted as the particular algorithm for carrying out the recited function of calculating a blood pressure value. The specification does not explicitly describe an algorithm for carrying out the recited function. In particular, the specification recites that any known method of blood pressure calculation may be performed such as the oscillometric method or Korotkoff method in paragraphs 0017 and 0043. Such a description is insufficient to satisfy the description requirements of limitations interpreted under 35 USC 112(f). The method being utilized including each of the steps required to transform the input into the output have not been disclosed.
A pulse wave reproduction information generation unit of claim 8 is interpreted as the particular algorithm for carrying out the recited function of generating pulse wave reproduction information. The specification describes the pulse wave reproduction information generation unit in paragraph 0045 and describes its operation as the generation of blinking timing by acquiring peak positions of the amplitude of the pulse signal. Paragraphs 0046-0047 and Figs. 3A-C further describe the effect of the pulse wave reproduction information generation unit and the produced pulse wave reproduction information. The specification does not describe the particular method steps carried out the produce the recited information. In particular, the steps of acquiring peak positions and determining timing information recited in paragraph 0046 are not considered sufficient because theses steps are functional and only recite the intended outputs of the steps and not how the steps are carried out to produce the final product of the unit.
An arrhythmia detection unit of claim 9 is interpreted as the particular algorithm for carrying out the recited function of detecting an arrhythmia. The specification describes the arrhythmia detection unit in functional language in paragraph 0044. The specification does not describe the particular algorithm used to detect an arrhythmia from the pulse signal.
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(b)
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 8-12 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.
Claim limitations “a blood pressure value measurement unit” and “a pulse wave reproduction information generation unit” of claim 8 and “an arrhythmia detection unit” of claim 9 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In particular, as described in the above presented claim interpretation section. The particular algorithms for carrying out the functions of each of the recited units has not been fully disclosed. 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.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 8 recites “an output unit” in line 12 but it is unclear if this limitation is the same as, related to, or different from “a display unit” of claim 8 line 11. For the purposes of this examination, the limitations will be interpreted as referring to the same display.
Claim 8 recites “wherein the output unit is configured to output the pulse wave reproduction information at the time of calculation of the blood pressure value when the blood pressure value stored in the storage unit is displayed at the display unit” but it is unclear what time of output this limitation is meant to convey. In particular, the recitation “at the time of calculation of the blood pressure value when the blood pressure value stored in the storage unit is displayed at the display unit” reads as though the calculated blood pressure information is being determined from stored data and the pulse wave reproduction information is only output when the device is operating on stored data. However, the recitations of lines 1-10 appear to indicate that the pulse wave signal is measured from the user rather than gathered from a stored database. It is unclear if this recitation is meant to convey that the measured data is saved to the storage unit and then immediately analyzed or if the system is operating on data drawn from storage device rather than measured data. For the purposes of this examination, the limitation will be interpreted as the device operating based on the measured data and the measured data also being stored. Thus the “time of calculation of the blood pressure value when the blood pressure value stored in the storage unit is displayed at the display unit” is any time where blood pressure is being calculated from the measured data and the measured data being stored.
Claims 9-12 are rejected by virtue of their dependence on claim 8.
Claim 11 recites “wherein the display unit also serves as the output unit” but it is unclear if this limitation is meant to convey that the display unit is the same device as the output unit, if the output unit is a sub-set of the display unit, or if some other relationship is present between these two components. For the purpose of this examination, the limitation will be interpreted as the display and output units referring to the same component.
Claim 12 recites “wherein the output unit includes a vibrating member” but claim 11 from which claim 12 depends recites that the display unit serves as the output unit. It is unclear if this limitation is meant to convey that the display unit further comprises a vibrating member, that the output unit is no longer part of the display and is instead a vibrating member, or some other relationship between these components. It is further noted that “a display unit” is interpreted as a generic display. Such displays are not considered to include a “vibrating member” if the claim is amended to clarify the scope as the display including a vibrating member then an interpretation under 35 USC 112f may be necessitated since the claims indicate that the display has a particular structure due to its particular components not generally associated with a display. For the purpose of this examination, the limitation is interpreted as the output unit including a vibrating member separate from the display unit.
Claim Rejections - 35 USC § 112(a)
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 8 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim limitations “a blood pressure value measurement unit” and “a pulse wave reproduction information generation unit” of claim 8 and “an arrhythmia detection unit” of claim 9 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In particular, as described in the above presented claim interpretation section. The particular algorithms for carrying out the functions of each of the recited units has not been fully disclosed. Therefore, the claim lacks sufficient written description and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chang US Patent Application Publication Number US 2009/0062664 A1 hereinafter Chang
Regarding claim 8, Chang teaches a blood pressure measurement device (Abstract) comprising:
a pulse wave acquisition unit configured to acquire a pulse wave of a human body (Paragraph 0060: the main body, cuff, and associated hose; Fig. 5A references 502 and 504; Paragraph 0092: the cuff inflates and the device detects heart pulses);
a blood pressure value measurement unit configured to calculate a blood pressure value based on the pulse wave (Paragraphs 0031 and 0092: the measured blood pressure);
a pulse wave reproduction information generation unit configured to generate pulse wave reproduction information, the pulse wave reproduction information being dynamic information reproducing pulse wave intervals of the pulse wave at a time of calculation of the blood pressure value (Paragraph 0030: the heart rate value; Paragraph 0092: the device detects heart pulses and beeps for each one detected;);
a storage unit configured to store the blood pressure value and the pulse wave reproduction information (Paragraphs 0029: the storage component; previous measurements may be compared so the measured data is recorded);
a display unit configured to display the blood pressure value (Paragraph 0061: the display unit); and
an output unit configured to output the pulse wave reproduction information (Paragraph 0061: the display unit, speaker, and/or flashing indicators; Paragraph 0068: the output of a heart rate value; Paragraph 0092: the beeping with each pulse),
wherein the output unit is configured to output the pulse wave reproduction information at the time of calculation of the blood pressure value when the blood pressure value stored in the storage unit is displayed at the display unit (Paragraphs 0092 and 0068: the heartbeat indicator and the device may beep with each measured heartbeat. These operations occur with blood pressure measurement; Paragraph 0030: both current and previous data may be displayed. The name of the heartbeat indicator in combination with the teachings of paragraphs 0068, 0079, 0084-0085, and 0091 drawn towards the optional beeping of the heartbeat sound indicator when each heartbeat is detected is considered sufficient to at least suggest that the heartbeat indicator on the display may be configured to flash with each detected heartbeat to indicate its detection.).
Regarding claim 9, Chang teaches the blood pressure measurement device according to claim 8. Chang further teaches the device further comprising an arrhythmia detection unit configured to detect an arrhythmia when the arrhythmia is present in the pulse wave acquired (Paragraph 0068: arrhythmia detection),
An obvious variation of Chang would be to configure the device wherein the output unit outputs the pulse wave reproduction information only when the blood pressure value calculated based on the pulse wave at a time of detection of the arrhythmia is displayed at the display unit. Such a variation would be obvious because Chang teaches the detection of arrhythmia (Paragraph 0068) and the output of pulse reproduction information (Paragraphs 0092 and 0068), but appears to be directed towards always presenting the pulse reproduction information when blood pressure is being determined. An obvious variation of such a presentation of the pulse reproduction information would be to only display it when arrhythmia is detected because there are a finite number of identified, predictable solutions, with a reasonable expectation of success. Thus it would be obvious to try configuring the device to only present the pulse reproduction information (the flashing of the heartbeat indicator and/or the beeping) only when arrhythmia is detected. There are a finite number of predictable solutions including presenting the indicators all the time when detecting pulses, not presenting them at all, presenting them only when no issues are detected, presenting them when any issue is detected, and presenting them when only certain issues are detected. The claim is directed towards presenting the indicators when only certain issues (only arrhythmia) are detected which is considered an obvious variation of Chang because such a configuration would be obvious to try and does not produce a surprising technical effect.
Regarding claim 10, Chang teaches the blood pressure measurement device according to claim 9. Chang further teaches the device wherein the display unit and/or the output unit output/outputs information indicating presence of the arrhythmia when the blood pressure value calculated based on the pulse wave at the time of detection of the arrhythmia is displayed at the display unit (Paragraph 0068: the measurement error indicator turns on when arrhythmia is detected during blood pressure determination; Fig. 6 references 614, 616, and 626).
Regarding claim 11, Chang teaches the blood pressure measurement device according to claim 8. Chang further teaches the device wherein the display unit also serves as the output unit, and the pulse wave reproduction information is output at least as a moving image (Fig. 6 reference 628; Paragraph 0068: the heartbeat indicator is present on the display and may be the output unit as described in the rejection of claim 8 above).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chang US Patent Application Publication Number US 2009/0062664 A1 hereinafter Chang as applied to claim 8 above and further in view of Brumfield US Patent Application Publication Number US 2014/0364750 A1 hereinafter Brumfield further in view of Thomson US Patent Application Publication Number US 2015/0018660 A1 hereinafter Thomson
Regarding claim 12, Chang teaches the blood pressure measurement device according to claim 11. Chang further teaches the device, wherein the pulse wave reproduction information is output as blinking of an icon (Paragraphs 0092 and 0068: the heartbeat indicator and the device may beep with each measured heartbeat. The name of the heartbeat indicator in combination with the teachings of paragraphs 0068, 0079, 0084-0085, and 0091 drawn towards the optional beeping when each heartbeat is detected is considered sufficient to at least suggest that the heartbeat indicator on the display may be configured to flash with each detected heartbeat to indicate its detection)
Chang fails to further teach the device wherein the blinking is in synchronization with peak positions of an amplitude of the pulse wave at the display unit and including a vibrating member which outputs vibrations and stops of the blood pressure measurement device in synchronization with the peak positions of the amplitude of the pulse wave at the vibrating member.
Brumfield teaches a method for identifying cardiac bradiacardia behavior may include acquiring pulse volume wave data from a sensor associated with a patient, and calculating metrics associated with peaks detected therein (Abstract). Thus, Brumfield is reasonably pertinent to the problem at hand.
Brumfield teaches that blood pressure cuffs may be used to capture pulse waveforms (Paragraph 0020). Brumfield further teaches that pulse waves may be identified by their peaks and the peaks used for timing purposes (Paragraphs 0051-0056).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Chang to detect pulse waves by their peaks as taught by Brumfield and to synchronize the heartbeat indicator and beeping with those peaks as the peaks serve as the peaks are used to determine when a pulse wave is detected because utilizing the peaks of pulse waves to detect the pulse wave and determine timing metrics provides a consistent metric for determinations of arrhythmia and pulse rate metrics which may improve accuracy since the timing of each wave is determined in a consistent manner.
Chang in view of Brumfield fails to teach the device further including a vibrating member which outputs vibrations and stops of the blood pressure measurement device in synchronization with the peak positions of the amplitude of the pulse wave at the vibrating member.
Thomson teaches devices, systems, and methods for measuring and monitoring biometric or physiological parameters in a user-friendly and convenient manner (Abstract). Thus, Thomson falls within the same field of endeavor as Applicant’s invention.
Thomson teaches a tactile feedback mechanism for providing feedback to the user (Paragraph 0329).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate a tactile feedback mechanism as taught by Thomson into the device of Chang in view of Brumfield because such a mechanism provides an additional avenue to provide feedback to the user and may be more convenient than the visual and/or auditory feedback taught by Chang in some instances. Furthermore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the vibration feedback mechanism to pulse in synchronization with the heartbeat similar to the visual heartbeat indicator and auditory beeping of Chang because such a vibration mechanism would provide the user with an additional way of tracking when heartbeats are detected and may be more user-friendly than the beeping and/or visual display taught by Chang in some circumstances.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791