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 .
Examiner’s Note
Claims 4, 5, 7, and 8 do not possess prior art rejections.
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:
“data input” first recited in claim 1;
“signaling output” first recited in claim 1;
“pressure generating unit” first recited in claim 11.
The claim limitation “data input” uses the term “input” 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. The term “data input” is modified by functional language (e.g., “configured to obtain a pressure signal and/or a gas flow signal”). The term “data input” is not modified by sufficient structure, material, or acts for performing the claimed function. The corresponding structure for the term “data input” is “hard- and/or software… data interfaces of the processor 253” (Pages 8-9). The term “signaling output” possesses similar analysis.
The claim limitation “pressure generating unit” uses the term “unit” 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. The term “pressure generating unit” is modified by functional language (e.g., “configured to inflate a cuff that is configured to be mounted to a subject’s body part”). The term “pressure generating unit” is not modified by sufficient structure, material, or acts for performing the claimed function. The corresponding structure for the term “pressure generating unit” is “e.g. a pump” (Page 2).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 10 and respective dependent claims thereof 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.
Re. Claim 6: Claim 1 recites “…the gas flow signal indicating gas flow entering the cuff and leaving the cuff during deflation…” Applicant appears to utilize “gas flow signal” in claim 6 in a manner differing from how the term is first claimed in the independent claim. Claim 1 has a flow signal defined as entering and leaving during deflation, and does not describe steps taken during inflation.
Re. Claim 10: Claim 10 requires detection of “deflation failure,” but describes method steps involving detection of changes during inflation. It is unclear how deflation failure may be determined from “detecting a sudden large change of the cuff pressure during inflation.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites steps or instructions for ascertaining and processing data to measure a blood pressure of a mammal subject, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claims 1, 14, and 15 similarly recite limitations comprising:
a data input configured to obtain a pressure signal and/or a gas flow signal, the pressure signal indicating a cuff pressure of a cuff that is configured to be mounted to a subject's body part and to be inflated for performing a blood pressure measurement and the gas flow signal indicating gas flow entering the cuff during inflation and leaving the cuff during deflation; (additional element, extra-solution activity)
a signaling output configured to output a failure signal (additional element, extra-solution activity); and
a processor configured to detect, based on the obtained pressure signal and/or the obtained gas flow signal, a deflation failure indicating a failure to deflate the cuff after a blood pressure measurement measured by the blood pressure monitor device below a safety cuff pressure and to control the signaling output to output a failure signal indicating a deflation failure in case a deflation failure is detected (additional element, evaluation, extra-solution activity).
As indicated above, the independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
The limitations of detect, based on the obtained pressure signal and/or the obtained gas flow signal, a deflation failure indicating a failure to deflate the cuff after a blood pressure measurement measured by the blood pressure monitor device below a safety cuff pressure amounts to no more than an individual identifying what can broadly be considered a failure signal based on gathered data.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
The dependent claims merely include limitations that either further define the abstract idea (e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process) or define features necessary for extra-solution activity and thus amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because such limitations are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 1 recites the additional elements of a device comprising:
a data input;
a signaling output;
a processor.
Claims 14 recites only the additional element of a signaling output.
Claim 15 recites additional elements of a non-transitory computer-readable medium and a signaling output
The elements of a data input and signaling output are described in Applicant’s Specification (Pages 8-9) as follows:
“The data input 251 and the signaling output 252 may be implemented in hard- and/or software. For instance, they may be implemented as data interfaces of the processor 253, for receiving and outputting the respective signals or data via signal lines or in a wireless manner (e.g. via Bluetooth) from the respective sensors.”
Similarly, the element of a non-transitory machine-readable storage medium are the instructions executable by a processor (Page 3).
Such additional element are generically recited computer elements which do not improve the functioning of a computer or any other technology or technical field. The claims recite merely acquiring data and having no further operative connection to the processor executing instructions of the non-transitory machine-readable storage medium besides communication of obtained data via a data input and outputting a result of analysis thereafter via a signaling output described as encompassing an interface of a generically described processor. Thus, each action of the data input and signaling output amounts to no more than insignificant, extra-solution activity, which does not constitute an integration into a practical application.
Both the non-transitory machine-readable storage medium and processor are recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment (processing blood pressure cuff signals), such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Each additional element (a data input, a signaling output, a processor are generically described. Since Applicant describes the data input and signaling output as merely interfaces of a processor, and further states that “a separate processor or other hard- and/or software may be provided to implement the failure detection device 25,” it is clear that Applicant’s disclosure is not particular regarding the particular structure of the generically claimed data input, signaling output, or processor. No special programming or algorithms is indicated for how such generic computer components operate. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since these hardware components perform non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the medical technology industry or medical technology arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Accordingly, in light of Applicant’s specification, the claimed terms interpretable as a processor or parts thereof (i.e., data input and signaling output) are reasonably construed as a generic computing device in their claimed combination.
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Dependent claims 2-5 recite intermittent control and data gathering, which amounts to extra-solution activity.
Dependent claims 6-10 recite further details regarding the evaluation of a deflation failure, which amounts to additional steps of the abstract idea.
Dependent claim 11 recites the additional elements of:
a pressure generating unit configured to inflate a cuff that is configured to be mounted to a subject’s body part;
a valve configured to deflate the cuff;
a pressure sensor configured to measure the cuff pressure;
a processor configured to control the pressure generating unit and to determine the subject’s blood pressure based on the measured cuff pressure;
However, each of the above components is understood to be well-understood, routine, and conventional components of typical non-invasive blood pressure (NIBP) monitoring systems, as per Applicant’s description found under “BACKGROUND OF THE INVENTION” in the Specification, pages 1-2. Claim further recites the failure detection device of claim 1; however, such a requirement is understood to be no more than utilizing the abstract idea carried out by generic processing components in combination with a well-understood, routine, and conventional NIBP system.
Dependent claim 12 requires the additional element of a flow meter configured to measure gas flow entering the cuff during inflation and leaving the cuff during deflation. Applicant’s disclosure is not particular regarding the particular structure of the generically claimed flow meter. Again, no special programming or algorithms is indicated for how such generic computer components operate. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since these hardware components perform non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the medical technology industry or medical technology arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Dependent claim 13 recites components of a well-understood, routine, and conventional NIBP system, and can be analyzed akin to limitations of claim 11.
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer utilizing data obtained from known sensors. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing of sensor data). That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 9-11, 13-15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by:
Wen et al. (CN115299904A) (hereinafter – Wen) (citing Google Patents machine translation).
Re. Claims 1, 14, and 15: Wen teaches a failure detection device for a blood pressure monitoring device (Abstract; Title),
the failure detection device comprising:
a data input configured to obtain a pressure signal and/or a gas flow signal (Page 4/12: “Wherein, it can be determined whether the first valve is faulty by detecting the change of air pressure in the airbag. If the air pressure in the airbag drops quickly, it indicates that the exhaust function of the first valve is good and there is no failure; There is a glitch”),
the pressure signal indicating a cuff pressure of a cuff that is configured to be mounted to a subject’s body part and to be inflated for performing a blood pressure measurement (Page 2/12: “The present application mainly provides a fault detection method of a blood pressure detection device, a blood pressure detection device and a storage medium, which can solve the problem in the prior art that valve fault detection cannot be performed during blood pressure detection;” Page 3/12: “The fault detection method of the blood pressure detection device of the present application takes the non-invasive blood pressure detection device as the implementation subject. The non-invasive blood pressure detection needs to bind the cuff to the arm of the subject, and then inflate and deflate the cuff to obtain the patient's systolic blood pressure, Diastolic blood pressure and other blood pressure parameters”) and
the gas flow signal indicating gas flow entering the cuff and leaving the cuff during deflation;
a signaling output configured to output a failure signal (Page 2/12: “7. The method of claim 4, wherein, When it is determined that there is a fault in the first valve or the second valve, an alarm program is started. 8. The method according to claim 7, further comprising: displaying alarm information on the interface of the blood pressure detection device”); and
a processor configured to
detect, based on the obtained pressure signal and/or the obtained gas flow signal (Page 5/12: " In this step, after the first valve is opened, the change of the air pressure in the air bag is monitored in real time, so that when the air pressure in the air bag drops to a first preset pressure value, the first valve is closed to stop deflation. And record the time required for the air pressure in the air bag to reach the first preset pressure value after the first valve is opened, that is, the time required for the first valve to be closed from opening to closing;” Page 7/12: “Optionally, faults of the first valve and the second valve may be detected during each deflation stage of a blood pressure detection process”),
a deflation failure indicating a failure to deflate the cuff after a blood pressure measurement measured by the blood pressure monitor device below a safety cuff pressure (Page 5/12: see steps S24-S25; Examiner notes that the fault detection is performed during multiple detection stages of a blood pressure detection program, and thus is configured to perform fault detection after detecting certain blood pressure values; Examiner further notes that Applicant defines “safety cuff pressure” as “a cuff pressure that is not harmful to the patient;” Examiner is interpreting a pressure value at an initial inflation stage (e.g., S11 of Wen) as a “safety cuff pressure”)
and to control the signaling output to output a failure signal indicating a deflation failure in case a deflation failure is detected (Page 5/12: see step S25: outputting a warning message reminding the user of failure of the first valve).
Re. Claim 2: Wen teaches the invention according to claim 1. Wen further teaches the invention wherein the processor is configured to
detect a deflation failure based on the obtained cuff pressure signal (Page 4/12: S11: the air pressure in the airbag is monitored in real time; Page 5/12: similarly recited in S23; Page 9/12: similarly recited in S64),
control a valve of the blood pressure monitor device that is configured to deflate the cuff to intermittently deflate the cuff after the blood pressure measurement (Abstract: “… the first deflation stage is configured to deflate in a stepped manner…;” Examiner notes that the fault detection is performed during multiple detection stages of a blood pressure detection program, and thus is configured to perform fault detection after detecting certain blood pressure values),
control a pressure sensor of the blood pressure monitor device that is configured to measure the cuff pressure to measure the remaining cuff pressure in between the periods of deflation, and detect a deflation failure based on the intermittently measured remaining cuff pressure values (Examiner first notes that an initial inflation pressure is known, and the change in pressure at each deflation stage is also measured in real time in various portions of the following schema: Page 4/12: steps S12-S13: fault is detected if pressure in airbag drops quickly in stepped deflation; see also, Page 4/12-5/12: steps S21-S25; see also, Page 5/12-6/12: steps S31-S35: determination of first valve failure in second deflation stage; see also, Page 6/12-7/12: steps S41-S44: determination of first valve failure over preset time intervals to determine air pressure drop rate; see also: Page 7/12: steps S51-S56: fault determination in three preset time periods of air pressure changes; see also: any other schema involving fault detection over various deflation periods/stages).
Re. Claim 3: Wen teaches the invention according to claim 2. Wen further teaches the invention wherein the processor is configured to check, for the intermittently measured remaining cuff pressure values, if the remaining cuff pressure is below the safety cuff pressure (see citation above; since an initial inflation pressure is known, and various steps monitor the deflation of the air bag in real time, the value of the remaining cuff pressure is known, i.e., checked, to be below the safety cuff pressure, i.e., initial inflation pressure).
Re. Claim 9: Wen teaches the invention according to claim 2. Wen further teaches the invention wherein the signaling output is configured to output a failure signal indicating one or more of
an instruction to remove the cuff from the subject’s body part,
an urgency of the deflation failure, and
a strength of the deflation failure
(Page 10/12: see: “abnormality of the first valve” and “abnormality of the second valve;” Examiner notes that fault detection can occur for both valves, whereby providing both messages is an indication of the “strength” of a deflation failure – i.e., whether a single or both types of valve have failed; Examiner notes that Applicant’s Specification and claims do not further define “urgency” or “strength” as claimed).
Re. Claim 10: Wen teaches the invention according to claim 2. Wen further teaches the invention wherein the processor is configured to detect a deflation failure
by detecting a sudden large change of the cuff pressure during inflation, in particular a change of the cuff pressure exceeding a change threshold within a predetermined period, and/or
by detecting a deviation above a deviation threshold from a predicted cuff pressure that is predicted based on the obtained pressure signal and/or the obtained gas flow signal
(Page 8/12: see discussion of rate thresholds relative to air pressure drops).
Re. Claim 11: Wen teaches a blood pressure monitoring device comprising:
a pressure generating unit configured to inflate a cuff that is configured to be mounted to a subject’s body part (Abstract: “The blood pressure detection process of the blood pressure detection device comprises an inflation stage;…” Examiner notes that the existence of an inflation stage implies a pressure generating unit);
a valve configured to deflate the cuff (Abstract: “… wherein the air bag is connected to at least a first valve and a second valve…”);
a pressure sensor configured to measure the cuff pressure (Abstract: “….until the internal pressure of the air bag is consistent with the external air pressure…;” Examiner notes that such a statement implies a pressure sensor; see prior citations regarding monitoring pressure in real time in the rejection of independent claims);
a processor configured to control the pressure generating unit and the valve and to determine the subject’s blood pressure based on the measured cuff pressure (Page 4/12: “During the deflation process of the airbag, the airbag is usually deflated in stages first, and then deflated naturally until it is consistent with the external air pressure to complete a blood pressure measurement”); and
a failure detection device as claimed in claim 1 (see citations of claim 1).
Re. Claim 13: Wen teaches blood pressure monitoring system comprising:
a cuff configured to be mounted to a subject’s body part (Page 3/12: ‘The non-invasive blood pressure detection needs to bind the cuff to the arm of the subject…”); and
the blood pressure monitoring device as claimed in claim 11 (see citations of claim 11),
the blood pressure monitoring device being configured to control the cuff and non-invasively measure the subject’s blood pressure (Page 3/12: “The non-invasive blood pressure detection needs to bind the cuff to the arm of the subject, and then inflate and deflate the cuff to obtain the patient's systolic blood pressure, Diastolic blood pressure and other blood pressure parameters”).
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.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Wen et al. (CN115299904A) (hereinafter – Wen) (citing Google Patents machine translation) in view of
Woerle (US 20170238824 A1) (hereinafter – Woerle) (disclosed by Applicant).
Re. Claim 6: Wen teaches the invention according to claim 1, but does not teach the invention wherein the processor is configured to detect a deflation failure based on the obtained gas flow signal,
wherein the obtained gas flow signal indicates a first measured amount of gas entering the cuff during inflation and a second measured amount of gas leaving the cuff during deflation.
Woerle teaches analogous art in the technology of cuff-based oscillatory non-invasive blood pressure measurement (Abstract). Woerle further teaches that a possible source of error which can occur during instances of inflation and deflation is tube resistance (Paragraphs 0079). Thus, identification of an error which can occur during deflation can encompass detection of a “deflation failure.” Woerle teaches that determination of tube resistance involves measurement of air flow at inflation and deflation (Paragraph 0085).
It would have been obvious to one having skill in the art before the effective filing date to have modified Wen to include identification of tube resistance (i.e., a point of error during deflation) as taught by Woerle, the motivation being that doing so allows for the device to compensate for high volume flow rates for inflation or if relatively long and/or narrow tubing is used (Paragraph 0079), which allows for a removal of a possible source of error.
Re. Claim 12: Wen teaches the invention according to claim 11, but does not teach the invention further comprising a flow meter configured to measure gas flow entering the cuff during inflation and leaving the cuff during deflation.
Woerle teaches analogous art in the technology of cuff-based oscillatory non-invasive blood pressure measurement (Abstract). Woerle further teaches that a possible source of error which can occur during instances of inflation and deflation is tube resistance (Paragraphs 0079). Thus, identification of an error which can occur during deflation can encompass detection of what can be interpreted as “deflation failure.” Woerle teaches that determination of tube resistance involves measurement of air flow at inflation and deflation (Paragraph 0085). This implies the existence of a gas flow meter in the system to obtain such data.
It would have been obvious to one having skill in the art before the effective filing date to have modified Wen to include identification of tube resistance (and thus requiring a flow meter to measure gas entering the cuff during inflation and leaving during deflation) as taught by Woerle, the motivation being that doing so allows for the device to compensate for high volume flow rates for inflation or if relatively long and/or narrow tubing is used (Paragraph 0079), which allows for a removal of a possible source of error.
Conclusion
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/JUSTIN XU/ Examiner, Art Unit 3791