Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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: Pressure control unit in claim 1, 10, 11, 12; Blood pressure calculation unit in claim 1, 10, 11; and Fluid containment control unit in claim 10, 11.
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.
The limitations are interpreted as follows:
Pressure control unit is interpreted according to paragraphs 0048, 0065, 0105 which recite “the CPU 110 acts as a pressure control unit according to a program for controlling the sphygmomanometer 1 stored in the memory 51”.
Blood pressure calculation unit is interpreted according to paragraphs 0048, 0065, 0105 which recite “the CPU110 acts as a blood pressure calculation unit to calculate a blood pressure value based on the data representing the pressure Ps of the sensing cuff 21 from the first pressure sensor 30 and the data representing the pressure Pc of the pressing cuff 23 from the second pressure sensor 31”.
Fluid containment control unit is interpreted according to paragraphs 0103, 0104, 0106 which recite “the CPU 110 acts as a fluid containment control unit”.
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 1-12 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.
The term “approximate” in claims 1 and 12 is a relative term which renders the claim indefinite. The term “approximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As a result, it is not clear what range of values is encompassed by the limitation "a value approximate to the direct current component".
Claims 2-10 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claim 1, which has been rejected as indefinite.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-12 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "calculates a blood pressure value based on data representing the pressure of the sensing cuff from the first pressure sensor and data representing the pressure of the pressing cuff from the second pressure sensor in a process of changing the pressure of the pressing cuff with the pressure control unit" and “obtains a pressure at a rising start point and a pressure at a peak point indicated by the pressure pulse wave for each beat by subtracting a direct current component of data representing the pressure of the pressing cuff or a value approximate to the direct current component from data representing the pressure of the sensing cuff in the process of changing the pressure; and obtains a first time point at which the pressure at the peak point for each beat transitions between a zero level and a positive value in the process of changing the pressure, obtains the pressure of the pressing cuff at the first time point as a systolic blood pressure value, obtains a second time point at which the pressure at the rising start point for each beat transitions between the zero level and the positive value, and obtains the pressure of the pressing cuff at the second time point as a diastolic blood pressure value”. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "calculates a blood pressure value based on data representing the pressure of the sensing cuff from the first pressure sensor and data representing the pressure of the pressing cuff from the second pressure sensor in a process of changing the pressure of the pressing cuff with the pressure control unit" and “obtains a pressure at a rising start point and a pressure at a peak point indicated by the pressure pulse wave for each beat by subtracting a direct current component of data representing the pressure of the pressing cuff or a value approximate to the direct current component from data representing the pressure of the sensing cuff in the process of changing the pressure; and obtains a first time point at which the pressure at the peak point for each beat transitions between a zero level and a positive value in the process of changing the pressure, obtains the pressure of the pressing cuff at the first time point as a systolic blood pressure value, obtains a second time point at which the pressure at the rising start point for each beat transitions between the zero level and the positive value, and obtains the pressure of the pressing cuff at the second time point as a diastolic blood pressure value” are abstract ideas as they are directed to a mental process and mathematical concept as the calculations may be performed mentally or with the aid of pen and paper based on data gathered by the provided sensors, where such calculations may involve the use of mathematical transformations of the data (e.g., the subtracting of the DC component). With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “a pressing cuff having a bag shape configured to be attached around the measurement target site along a circumferential direction of the measurement target site to receive supply of a pressurization fluid and compress the measurement target site; a sensing cuff having a bag shape disposed in a portion facing an artery of the measurement target site on an inner circumferential side of the pressing cuff, the sensing cuff containing a pressure transmission fluid separately from the pressing cuff, the sensing cuff configured to compress the artery of the measurement target site via the pressure transmission fluid by using a pressure of the pressing cuff and receive a pressure pulse wave from the artery; a first pressure sensor that detects a pressure of the sensing cuff; a second pressure sensor that detects the pressure of the pressing cuff; a pressure control unit that controls the pressure of the pressing cuff by supplying the pressurization fluid to the pressing cuff or discharging the pressurization fluid from the pressing cuff; and a blood pressure calculation unit”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The detecting steps lead to the final limitation of “calculat[ing]” such that the end result of use of the system is only the generic calculation which may be any generic output, or no output at all. As this calculation is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of data relating to pressure of a pressing cuff and sensing cuff, such that the claim does not integrate the judicial exception into any practical application. Regarding “a blood pressure calculation unit”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the blood pressure calculation unit are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by using mathematical transforms of the gathered data by a person alone or with the aid of pen and paper) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “a pressing cuff having a bag shape configured to be attached around the measurement target site along a circumferential direction of the measurement target site to receive supply of a pressurization fluid and compress the measurement target site; a sensing cuff having a bag shape disposed in a portion facing an artery of the measurement target site on an inner circumferential side of the pressing cuff, the sensing cuff containing a pressure transmission fluid separately from the pressing cuff, the sensing cuff configured to compress the artery of the measurement target site via the pressure transmission fluid by using a pressure of the pressing cuff and receive a pressure pulse wave from the artery; a first pressure sensor that detects a pressure of the sensing cuff; a second pressure sensor that detects the pressure of the pressing cuff; a pressure control unit that controls the pressure of the pressing cuff by supplying the pressurization fluid to the pressing cuff or discharging the pressurization fluid from the pressing cuff; and a blood pressure calculation unit”. The limitation of “additional limitation” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding generic cuffs, sensors, and a controller or processor, which Higashimura (US 20190374115 A1) discloses these elements as well-understood, routine, or conventional in its description of “as disclosed in Patent Document 1 (Japanese Laid-Open Patent Publication No. 11-309119), conventionally known sphygmomanometer of this type has a cuff wound around a wrist that is a measurement site, and a main body integrally attached to the cuff. This sphygmomanometer includes in a strap-shaped belt a bag-shaped blood-pressure measurement cuff compressing an artery, an intervening member disposed on the outside of the blood-pressure measurement cuff, and a bag-shaped pressing cuff disposed on the outside of the intervening member, and is configured to detect a pressure in the blood-pressure measurement cuff with a pressure sensor mounted on the main body” (Paragraph 0003, 0064-0065, 0068, 0074) where such a system is controlled by a well-understood, routine, or conventional CPU (Paragraph 0064-0065, 0068, 0083-0085, 0116).. As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claim 12 is rejected for similar reasons.
Claims 2-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 12 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1: claim 2-3 recites additional limitations of the abstract idea which are thus similarly abstract; claims 2-3, 5 recite additional limitations of mere data gathering which are similarly extra-solution activity which fails to integrate the abstract idea into a practical application as described above; claim 4 and 6-11 recites additional structures of generic conduits, plates, valves, and pumps for controlling the cuffs for performing the steps of mere data gathering where these structures are additionally well-understood, routine, or conventional elements as described by Higashimura (cited above, particularly paragraphs 0003, 0064-0068, 0072-0076, 0083-0084). The limitations provide no practical application, nor do they provide meaningful limitations to the abstract idea.
Conclusion
No rejection is currently applied under 35 U.S.C. 102/103.
The prior art fails to teach and/or fairly suggest, in combination with all other limitations, “wherein the blood pressure calculation unit obtains a pressure at a rising start point and a pressure at a peak point indicated by the pressure pulse wave for each beat by subtracting a direct current component of data representing the pressure of the pressing cuff or a value approximate to the direct current component from data representing the pressure of the sensing cuff in the process of changing the pressure; and obtains a first time point at which the pressure at the peak point for each beat transitions between a zero level and a positive value in the process of changing the pressure, obtains the pressure of the pressing cuff at the first time point as a systolic blood pressure value, obtains a second time point at which the pressure at the rising start point for each beat transitions between the zero level and the positive value, and obtains the pressure of the pressing cuff at the second time point as a diastolic blood pressure value” as claimed in each of claims 1 and 12.
Higashimura (US 20190374115 A1) teaches an electronic sphygmomanometer that noninvasively measures blood pressure at a measurement target site, the electronic sphygmomanometer comprising: a pressing cuff having a bag shape configured to be attached around the measurement target site along a circumferential direction of the measurement target site to receive supply of a pressurization fluid and compress the measurement target site (Pressing cuff 23; paragraph 0053-- a flexible tube 39 is attached for supplying a pressure-transmitting fluid (air in this example) to the pressing cuff 23 or discharging the pressure-transmitting fluid from the pressing cuff 23); a sensing cuff having a bag shape disposed in a portion facing an artery of the measurement target site on an inner circumferential side of the pressing cuff (Sensing cuff 21; paragraph 0048-0049), the sensing cuff containing a pressure transmission fluid separately from the pressing cuff, the sensing cuff configured to compress the artery of the measurement target site via the pressure transmission fluid by using a pressure of the pressing cuff and receive a pressure pulse wave from the artery (Paragraph 0051-- a flexible tube 38 is attached for supplying a pressure-transmitting fluid (air in this example) to the sensing cuff 21 or discharging the pressure-transmitting fluid from the sensing cuff 21); a first pressure sensor that detects a pressure of the sensing cuff (Second pressure sensor 32); a second pressure sensor that detects the pressure of the pressing cuff (First pressure sensor 31); a pressure control unit that controls the pressure of the pressing cuff by supplying the pressurization fluid to the pressing cuff or discharging the pressurization fluid from the pressing cuff (Main CPU 100/Sub-CPU 101/Pump Drive Circuit 35; paragraph 0053); and a blood pressure calculation unit (Main CPU 100) that calculates a blood pressure value based on data representing the pressure of the sensing cuff from the first pressure sensor and data representing the pressure of the pressing cuff from the second pressure sensor in a process of changing the pressure of the pressing cuff with the pressure control unit (Paragraph 0064-0068-- CPU 100 executes various functions as the control part in accordance with a program for controlling the sphygmomanometer 1… executing the blood-pressure measurement function…), but is silent as to “wherein the blood pressure calculation unit obtains a pressure at a rising start point and a pressure at a peak point indicated by the pressure pulse wave for each beat by subtracting a direct current component of data representing the pressure of the pressing cuff or a value approximate to the direct current component from data representing the pressure of the sensing cuff in the process of changing the pressure; and obtains a first time point at which the pressure at the peak point for each beat transitions between a zero level and a positive value in the process of changing the pressure, obtains the pressure of the pressing cuff at the first time point as a systolic blood pressure value, obtains a second time point at which the pressure at the rising start point for each beat transitions between the zero level and the positive value, and obtains the pressure of the pressing cuff at the second time point as a diastolic blood pressure value.”
Goodman (US 20030036685 A1) discloses a blood pressure determination system which obtains a first time point at which the pressure at the peak point for each beat transitions between a zero level and a positive value in the process of changing the pressure and obtains the pressure of the pressing cuff at the first time point as a systolic blood pressure value (Paragraph 0169, 0198) as well as subtracting a direct current component (Paragraph 0154-0155), but is silent as to separate pressure and sensing cuffs and “obtains a second time point at which the pressure at the rising start point for each beat transitions between the zero level and the positive value, and obtains the pressure of the pressing cuff at the second time point as a diastolic blood pressure value”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/ Examiner, Art Unit 3791
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