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 .
DETAILED ACTION
The Amendment filed on December 29, 2025 is acknowledged and entered. Claims 1, 3-4, 9 and 11-12 are amended. Claims 2 and 10 are canceled. Claims 1, 3-9 and 11-20 are pending and under examination in this Office action.
Examiner’s Notes I.
The rejection under 35 U.S.C. 101 presented in the previous Office action is identified to contain a typographic error in the header, and on p.6, the second (ii) bullet should have been noted to be referring to claim 18 but was unintentionally omitted. As analyzed in the rejection, claims 1-20 were all rejected. On pp.3-5 of the previous Office action, claims 1, 9 and 17 were analyzed and determined to be patent ineligible. On p.6, claims 2-8, 10-16 and 18-20 were analyzed and determined to be patent ineligible. Hence, claims 1-20 were rejected. The header of the rejection and the second (ii) bullet are now corrected in this Office action. No new rejection nor new analysis is introduced. This Office action hence is a final Office action.
Response to Amendment
Claims 2 and 10 are previously noted as not rejected under prior arts. As claims 2 and 10 are incorporated in to claims 1 and 9, respectively, the rejections under 35 U.S.C. 102(a)(1) to claims 1, 3, 5, 7, 9, 11, 13 and 15 are now withdrawn. The rejections under 35 U.S.C. 103 to claims 6, 8, 14 and 16 area also withdrawn.
The rejection to claims 4 and 12 under 35 U.S.C. 112(b) is now withdrawn in view of the claim amendment.
The provisional double patenting rejection is now withdrawn in view of the terminal disclaimer filed and approved on December 29, 2025.
In regard to the rejection under 35 U.S.C. 101, as noted above, in the previous Office action, claims 1-20 were rejected, yet the heading of the rejection has a typographical error, which states that claims 1-9 and 12-19 are rejected. The rejection is maintained with the typographical error corrected. Th analysis is also modified to address the amendment to claims 1 and 9.
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, 3-9 and 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1, 3-8 and 17-20 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claims 9 and 11-16 are drawn to a “system” which describes one of the four statutory categories, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1, 9 and 17 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: calculating a peripheral blood pressure index based on a steepness of a rising edge of the PPG signal; estimating the magnitude of the blood pressure based on the peripheral blood pressure index, and the steepness includes information regarding a width of a first peak during a single cardiac cycle in a waveform of a velocity PPG signal that is a first derivative of the PPG signal”.
In claims 1, 9 and 17, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, the PPG signal in a single cardiac cycle, either in a printout or an electronic format, he/she would be able to calculate the first derivative of the PPG signal, that may be defined as a velocity PPG signal. He/she may identify the first peak in the first derivative, identify its width, identify the slope that is a steepness of a rising edge and also the first derivative of the PPG signal. He/she would further be able to derive an index based on the slope or the steepness, and call it a peripheral blood pressure index. He or she would be able to further estimate the magnitude of the blood pressure based on the index, according to a relationship between the slope of the PPG signal and the blood pressure or a look up table that is known in the field of art. There is nothing recited in the claim to suggest an undue level of complexity in how the magnitude of the blood pressure is estimated. Therefore, a person would be able to perform the calculation and the estimation mentally or with a generic computer.
Prong Two: Claims 1, 9 and 17 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) acquiring a PPG signal via a PPG sensor; and (2) a biological data measurement system and a signal processing device for performing the method steps.
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The step in (2) represents merely well-known, routine and conventional tools for data acquisition and processing (see below Step IIB for further details).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated magnitude of the blood pressure is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 9 and 17 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) acquiring a PPG signal via a PPG sensor; and (2) a biological data measurement system and a signal processing device for performing the method steps. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The PPG signal is acquired by a PPG sensor, and the acquired data is processed by the biological data measurement system and a signal processing device, i.e., a processor or its equivalence. These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of PPG signal-based blood pressure estimation, as evidenced by Elgendi et al., “The use of photoplethysmography for assessing hypertension”. npj Digital Medicine 2:60 (2019). Elgendi teaches the measurement of blood pressure is performed by PPG technology, which includes a PPG sensor for acquiring the PPG signals, and a computation system for processing the PPG signals for estimating the blood pressure.
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Further describing the steepness of the PPG signal (claims 3-4 and 11-12)
Further describing the PPG signal (claim 19)
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
Further describing the PPG sensor, its configuration and operation (claims 5-8, 13-16 and 20)
Further describing the well-known routine and conventional tool that is already addressed in Step 2B (claim 18)
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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
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:
Claim 9: the claim limitation of “a signal processing device configured to calculate a peripheral blood pressure index” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “to calculate” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
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 review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 9: “a signal processing device” refers to the specification, PG Pub US 2019/0053768 A1, [0056]: the control device is an arithmetic processing device such as a central processing unit (CPU) or a field-programmable gate array (FPGA).
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Examiner’s Notes II.
Claims 1, 3-9 and 11-20 are not rejected under prior arts.
The limitation recited in claims 1, 9 and 17 in regard to the features of “the steepness includes information regarding a width of a first peak during a single cardiac cycle in a waveform of a velocity plethysmographic signal that is a first derivative of the photoplethysmographic signal", in combination with the other claimed elements, is not taught or disclosed in the prior arts.
Dependent claims 3-8, 11-16 and 18-20 are not rejected under prior arts by virtue of their respective dependency upon claims 1, 9 and 17.
Response to Arguments
As noted in the above Examiner’s Note I., and the response to the amendment, the rejection under 35 U.S.C. 101 is maintained. Though in the header claim 10 is not listed as being rejected, it is determined to be a typographical error since claim 10 is clearly determined to be patent ineligible (i.e., rejected under 35 U.S.C. 101) on page 6 of the non-final Office action, Section 4.i. (line 7 of page 6: “i. Further describing the steepness of the PPG signal (claims 2-4 and 10-12)”). Further, the limitation of claims 2 and 10 is recited in claim 17, and has been analyzed in Step 2B, Prong 2 to be considered as a mental process. Hence, in the previous Office action, claims 2 and 10 have not been indicated as patent eligible except for the typographical error in the header of the rejection that is now corrected. The Step 2B, Prong 1 analysis also has been elaborated to address the amended feature, though the previous analysis for claim 17 that the amended feature is already recited within is considered proper and sufficient.
Based on the above consideration, claims 1, 3-9 and 11-20 remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YI-SHAN YANG/Primary Examiner, Art Unit 3798