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 .
Election/Restrictions
Applicant’s election without traverse of Species Embodiment A, Fig 2, in the reply filed on February 16, 2026 is acknowledged.
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 data acquisition unit, a data collection and conversion module, and pulse oximetry module, in claims 1 and 13; a reflective module, an electrocardiogram (ECG) module, a bioimpedance module, a motion module, a blood oxygen module, a perfusion index module, a pulse wave module, a respiration module, a blood pressure module, a body temperature module, an cardiac output module, a photoplethysmography module, a phonocardiogram module, an impedance cardio graphic module, a respiration impedance module, a peripheral venous pressure module, a peripheral arterial pressure module, in claims 2 and 14 and repeated in other dependent claims; a data storage module, data transmission module, a power management module, and charging module in claims 8 and 19; and a data analysis unit in claims 10 and 11. The claims use the words unit and module throughout and these are generic placeholders that are coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
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 11-12 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 11 recites the limitation "the data analysis unit" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 10 recites “a data analysis unit” and claim 11 is dependent on claim 8; therefore, it appears it should be dependent on claim 10 and not claim 8 and the examiner will examine the claims as if it were dependent on claim 10 in favor of compact prosecution.
Claim 12 recites the limitation "the computational hardware" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 10 recites “the computational hardware” and claim 11 is dependent on claim 8; therefore, it appears it should be dependent on claim 10 and not claim 8 and the examiner will examine the claims as if it were dependent on claim 10 in favor of compact prosecution.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Banet (US 2019/0290134 A1) in view of Chou (US 2018/0014741 A1)
Regarding claim 1, Banet discloses a non-invasive and portable device for monitoring hemodynamics (e.g. Figs 2 and 9), comprising: a data acquisition unit (e.g. [0056]-[0057]; Fig 1:30) comprising: a host machine (e.g. [0056]-[0057]; Fig 9/10:36); a body surface lead (e.g. [0060] Fig 9/10:38); and a photoelectric ear clip (e.g. [0064]; [0067] Fig 9/10:50); wherein the host machine comprises a signal interface and a data collection and conversion module (e.g. [0057]); wherein one end of the body surface lead is configured to connect to an electrode or electrode pad attached to the body surface of a person in need and the other end of the body surface lead is configured to connect with the lead interface located in the host machine (e.g. [0060] Fig 9/10:35/37); wherein the data collection and conversion module comprises a pulse oximetry module (e.g. [0031]; [0064]; [0067]); and wherein the photoelectric clip comprises a reflective photoelectric sensor (e.g. [0064]; [0067] Fig 9/10:50).
Banet is silent regarding utilizing a photoelectric earplug.
However, Chou discloses a wearable physiological monitoring device wherein the structure of the photoelectric sensor can be implemented in the form of an ear-clamp (or clip) (e.g. [0066] Fig 7a) or implemented in the form of an ear-plug (e.g. [0066] Fig 7B) in order to contact the inner structure of the ear such as the canal or inferior concha.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Banet to incorporate the teachings of Chou wherein the ear clip utilized in Banet is substituted with the earplug of Chou for the purpose of utilizing a known substitute for the photoelectric device of the system.
Regarding claim 13, Banet discloses a non-invasive and portable device for monitoring hemodynamics(e.g. Figs 2 and 9), comprising: a data acquisition unit (e.g. [0056]-[0057]; Fig 1:30) comprising: a host machine (e.g. [0056]-[0057]; Fig 9/10:36) comprising: a signal interface (e.g. [0057]); and a data collection and conversion module (e.g. [0057]); a body surface lead (e.g. [0060] Fig 9/10:38); a photoelectric ear clip comprising a reflective photoelectric sensor (e.g. [0064]; [0067] Fig 9/10:50); a data analysis unit comprising a computational hardware and a mathematical algorithm(e.g. [0057]; [0086]); wherein one end of the body surface lead is configured to connect to an electrode or electrode pad attached to the body surface of a person in need and the other end of the body surface lead is connected with the lead interface located in the host machine (e.g. [0060] Fig 9/10:35/37); wherein the data collection and conversion module comprises a pulse oximetry module (e.g. [0031]; [0064]; [0067]); and wherein the computational hardware comprises a computer, a mobile device, a cloud server, or a combination thereof (e.g. [0058] Fig 12).
Banet is silent regarding utilizing a photoelectric earplug.
However, Chou discloses a wearable physiological monitoring device wherein the structure of the photoelectric sensor can be implemented in the form of an ear-clamp (or clip) (e.g. [0066] Fig 7a) or implemented in the form of an ear-plug (e.g. [0066] Fig 7B) in order to contact the inner structure of the ear such as the canal or inferior concha.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Banet to incorporate the teachings of Chou wherein the ear clip utilized in Banet is substituted with the earplug of Chou for the purpose of utilizing a known substitute for the photoelectric device of the system.
Regarding claims 2 and 14, modified Banet discloses wherein the data collection and conversion module comprises at least an additional data collection and conversion module selected from a group consisting of a reflective photoelectric module, an electrocardiogram (ECG) module (e.g. Banet [0013]; [0022]-[0024]; [0028]-[0029]; [0057] ), a bioimpedance module, a motion module (e.g. Banet [0032]-[0033], a blood oxygen module, a perfusion index module, a pulse wave module, a respiration module, a blood pressure module (e.g. Banet [0011]; [0030]-[0031]), a body temperature module, an cardiac output module (e.g. Banet abstract [0003]), a photoplethysmography module, a phonocardiogram module, an impedance cardio graphic module, a respiration impedance module (e.g. Banet [0004]; [0033]; [0040]; [0080]-[0081] Figs 6A/B), a peripheral venous pressure module, a peripheral arterial pressure module, and a combination thereof.
Regarding claims 3 and 15, modified Banet discloses wherein the additional data collection and conversion module is an electrocardiogram (ECG) module (e.g. Banet [0013]; [0022]-[0024]; [0028]-[0029]; [0057]).
Regarding claims 4 and 16, modified Banet discloses wherein the electrocardiogram (ECG) module comprises a combined respiration module (an ECG and respiration module) (e.g. Banet [0004]; [0033]; [0040]; [0080]-[0081] Figs 6A/B).
Regarding claims 5 and 17, modified Banet discloses wherein the additional data collection and conversion module is an impedance detection module (e.g. Banet [0022]; [0029]; [0033]; [0060]).
Regarding claims 6 and 18, modified Banet discloses wherein the additional data collection and conversion module is a motion monitoring module (e.g. Banet [0032]-[0033]; [0057]).
Regarding claim 7, modified Banet discloses wherein the host machine comprises a digital signal processing module (e.g. Banet [0057] Fig 10:62).
Regarding claims 8 and 19, modified Banet discloses wherein the host machine comprises support modules including a data storage module (e.g. Banet [0059] Fig 11:23), a data transmission module (e.g. Banet Fig 10:66), a power management module and a rechargeable battery and charging module (e.g. Banet [0059] Fig 1:32).
Regarding claim 9, modified Banet discloses wherein the digital signal processing module is configured to connect with the data collection and conversion modules and with the supporting module to control said modules and process and transmit data among said modules (e.g. Banet [0057] Fig 10:62).
Regarding claim 10, modified Banet discloses further comprising a data analysis unit, wherein the data analysis unit comprises a computational hardware and a mathematical algorithm to process and analyze data collected by the host machine (e.g. Banet [0057]; [0086]).
Regarding claim 11, modified Banet discloses wherein the data analysis unit and the host machine are connected in wired or wireless manner (e.g. Banet [0086] the necklace and computer can be wired or wireless)
Regarding claim 12, modified Banet discloses wherein the computational hardware comprises a computer, a mobile device, a cloud server (e.g. Banet [0058] Fig 12).
Regarding claim 20, modified Banet discloses wherein the data analysis unit is connected, in wired or wireless manner (e.g. Banet [0086] the necklace and computer can be wired or wireless), with the data collection and conversion modules of the host machine and with the supporting modules of the host machine to control said modules, transmit data among said modules, and process and analyze the data collected by the host machine (e.g. Banet [0057] Fig 10:62).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough March 21, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights