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 with traverse of Species A, embodiment drawn to Figures 2A and 3A, in the reply filed on 8/3/26 is acknowledged. The traversal is on the ground(s) that the claims are generic to the subtle variations amongst species. This is not found persuasive because as the species are independent and/or distinct as disclosed, not obvious variants, and would require separate search and/or examination. The mere fact that Applicant argues the claims are generic does not preclude the election of species requirement.
The requirement is still deemed proper and is therefore made FINAL.
Currently no claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/3/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“a memory element” in claims 1, 9 17; and
“cardiac component” in claims 9 and 17.
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 Objections
Claim 2 is objected to because of the following informalities: the positive recitation of “…wherein the optical receiver positioned is further configured…” appears to contain grammatical error and/or typographical error. Appropriate correction is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Independent claims 1, 9, and 17 positively recite inter alia “…wall to be positioned at least partly in contact with a user’s skin, the housing asserting a pressure on the user’s skin…”, “…signal directed into the skin of the suer”, “…each optical signal modulated by the skin of the user…”. The scope of the claimed invention necessarily requires and includes at least a portion of a human organism, rendering the claims non-statutory subject matter.
Depending claims 2-8, 10-16, and 18-20 inherit and do not remedy the non-statutory issue. The listing above for claims 1, 9 and 17 is non-exhaustive and Applicant’ attention is respectfully directed to same throughout the claims.
For the purposes of compact prosecution, the Examiner respectfully notes for one example at least that the recitation of “…wall configured to be positioned at least partly in contact with a user’s skin…” would appear to obviate the rejection for this phrase.
Claim Rejections - 35 USC § 112
Claims 9-20 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.
Independent claims 9 and 17 positively recite “a pressure metric” in lines 22 and 27. The scope of the claims is indeterminate with respect to if the second “a pressure metric” must be or is necessarily the same as the first “a pressure metric”. One of ordinary skill in light of the Specification would not be apprised of metes and bounds of the claimed invention given the ambiguity. Depending claims 10-16 and 18-20 inherit and do not remedy the indefiniteness.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulach et al. (US 2018/0317786 A1, hereinafter Kulach).
For claim 1, Kulach discloses an electronic fitness device (10) (Figs 1-14) ([0025-0106]), comprising inter alia:
a housing (12) including a bottom wall to be positioned at least partly in contact with a user's skin (Figs 1-14) ([0025-0106]), the housing asserting a pressure on the user's skin (Figs 1-14) ([0025-0106]);
a first optical transmitter (42A1) positioned along the bottom wall and configured to emit a first optical signal having a first wavelength (Figs 1-14) ([0025-0106]), the first optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
a second optical transmitter (42A2) positioned along the bottom wall and configured to emit a second optical signal having a second wavelength (Figs 1-14) ([0025-0106]), the second optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
an optical receiver (28A) positioned along the bottom wall (Figs 1-14) ([0025-0106]), the optical receiver configured to: receive the first optical signal and the second optical signal, each optical signal modulated by the skin of the user (Figs 1-14) ([0025-0106]), and generate a first photoplethysmogram (PPG) signal resulting from the received first optical signal and a second PPG signal resulting from the received second optical signal (Figs 1-14) ([0025-0106]);
a memory element (32) (Figs 1-14) ([0025-0106]); and
a processor (34) electrically coupled with the optical receiver and the memory element (Figs 1-14) ([0025-0106]), the processor configured to: receive the first PPG signal and the second PPG signal(Figs 1-14) ([0025-0106]), determine a pressure metric value (62) based on a characteristic of a waveform of the first PPG signal and a characteristic of a waveform of the second PPG signal, and determine a pressure compensation factor (CC REF) based on the determined pressure metric value (Figs 1-14) ([0025-0106]), the first wavelength corresponding to the first optical signal and the second wavelength corresponding to the second optical signal (Figs 1-14) ([0025-0106]).
For claim 2, Kulach discloses the electronic fitness device of claim 1, further comprising a third optical transmitter (42A3) positioned along the bottom wall and configured to emit a third optical signal having a third wavelength (Figs 1-14) ([0025-0106]), the third optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]); wherein the optical receiver positioned is further configured to receive the third optical signal (Figs 1-14) ([0025-0106]), the third optical signal modulated by the skin of the user (Figs 1-14) ([0025-0106]); and wherein the processor is further configured to determine: a physiological metric (52) for the user (Figs 1-14) ([0025-0106]), the physiological metric based on characteristics of the waveform of the third PPG signal and one of the first PPG signal and the second PPG signal (Figs 1-14) ([0025-0106]), and a pressure-compensated physiological metric (CC2 - CCn) as a function of the determined physiological metric and the determined pressure compensation factor (Figs 1-14) ([0025-0106]).
For claim 3, Kulach discloses the electronic fitness device of claim 1, wherein the characteristic of the waveform of the first PPG signal is an AC component of the waveform of the first PPG signal and a DC component of the waveform of the first PPG signal ([0025-0035]), and wherein the characteristic of the waveform of the second PPG signal is an AC component of the waveform of the second PPG signal and a DC component of the waveform of the second PPG signal ([0025-0035]).
For claim 4, Kulach discloses the electronic fitness device of claim 3, wherein determining the pressure metric value includes: determining a first AC component to DC component ratio of the waveform of the first PPG signal ([0025-0035]), determining a second AC component to DC component ratio of the waveform of the second PPG signal ([0025-0035]), and determining a ratio of the first AC component to DC component ratio to the second AC component to DC component ratio ([0025-0035]).
For claim 5, Kulach discloses the electronic fitness device of claim 1, wherein the processor is further configured to determine a pressure-compensated physiological metric (CC, cardiac component) based on the determined pressure compensation factor (Figs 1-14) ([0025-0106]).
For claim 6, Kulach discloses the electronic fitness device of claim 1, wherein the determined pressure metric value, a value of the first wavelength corresponding to the first optical signal, a value of the second wavelength corresponding to the second optical signal, and the determined pressure metric value are stored in the memory element in association with the identified pressure compensation factor (Figs 1-14) ([0025-0106]).
For claim 7, Kulach discloses the electronic fitness device of claim 1, wherein the first wavelength ranges from approximately 900 nanometers to approximately 980 nanometers ([0033-0041, 0067-0071]).
For claim 8, Kulach discloses the electronic fitness device of claim 1, wherein the second wavelength ranges from approximately 820 nanometers to approximately 900 nanometers ([0033-0041, 0067-0071]).
For claim 9, Kulach discloses an electronic fitness device (10) (Figs 1-14) ([0025-0106]), comprising inter alia:
a housing (12) including a bottom wall to be positioned at least partly in contact with a user's skin (Figs 1-14) ([0025-0106]);
a first optical transmitter (42A1) positioned along the bottom wall and configured to emit a first optical signal having a first wavelength (Figs 1-14) ([0025-0106]), the first optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
a second optical transmitter (42A2) positioned along the bottom wall and configured to emit a second optical signal having a second wavelength (Figs 1-14) ([0025-0106]), the second optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
a third optical transmitter (42A3) positioned along the bottom wall and configured to emit a third optical signal having a third wavelength (Figs 1-14) ([0025-0106]), the third optical signal to be directed into the skin of the user (Figs 1-14) ([0025-0106]);
an optical receiver (28A) positioned along the bottom wall (Figs 1-14) ([0025-0106]), the optical receiver configured to: receive the first optical signal, the second optical, and the third optical signal (Figs 1-14) ([0025-0106]), each optical signal modulated by the skin of the user (Figs 1-14) ([0025-0106]), and generate a first photoplethysmogram (PPG) signal resulting from the received first optical signal (Figs 1-14) ([0025-0106]), a second PPG signal resulting from the received second optical signal (Figs 1-14) ([0025-0106]), and a third PPG signal resulting from the received third optical signal (Figs 1-14) ([0025-0106]), each received optical signal including a cardiac component of the user (Figs 1-14) ([0025-0106]);
a memory element (32) configured to store a plurality of pressure compensation factors (CC REF) (Figs 1-14) ([0025-0106]), each pressure compensation factor associated with a pressure metric value (Figs 1-14) ([0025-0106]), the first optical signal having the first wavelength and the second optical signal having the second wavelength (Figs 1-14) ([0025-0106]); and
a processor (34) electrically coupled with the memory element (Figs 1-14) ([0025-0106]) and configured to: receive the first PPG signal, the second PPG signal, and the third PPG signal (Figs 1-14) ([0025-0106]), determine a pressure metric value (62) based on a characteristic of a waveform of the first PPG signal and a characteristic of a waveform of the second PPG signal (Figs 1-14) ([0025-0106]), identify, and retrieve from the memory element, one of the plurality of pressure compensation factors based on the determined pressure metric value (Figs 1-14) ([0025-0106]), and determine a pressure-compensated physiological metric (CC2 - CCn) based on characteristics of the waveform of the third PPG signal and the identified pressure compensation factor (Figs 1-14) ([0025-0106]).
For claim 10, Kulach discloses the electronic fitness device of claim 9, wherein the first wavelength ranges from approximately 900 nanometers to approximately 980 nanometers ([0033-0041, 0067-0071]).
For claim 11, Kulach discloses the electronic fitness device of claim 9, wherein the second wavelength ranges from approximately 820 nanometers to approximately 900 nanometers ([0033-0041, 0067-0071]).
For claim 12, Kulach discloses the electronic fitness device of claim 9, wherein the third wavelength ranges from approximately 500 nanometers to approximately 800 nanometers ([0033-0041, 0067-0071]).
For claim 13, Kulach discloses the electronic fitness device of claim 9, wherein the characteristic of the waveform of the first PPG signal is an AC component of the waveform of the first PPG signal and a DC component of the waveform of the first PPG signal ([0025-0035]), the characteristic of the waveform of the second PPG signal is an AC component of the waveform of the second PPG signal and a DC component of the waveform of the second PPG signal ([0025-0035]), and the characteristic of the waveform of the third PPG signal is an AC component of the waveform of the third PPG signal and a DC component of the waveform of the third PPG signal ([0025-0035]).
For claim 14, Kulach discloses the electronic fitness device of claim 9, wherein determining the pressure metric value includes determining a first AC component to DC component ratio of the waveform of the first PPG signal ([0025-0035]), determining a second AC component to DC component ratio of the waveform of the second PPG signal ([0025-0035]), and determining a ratio of the first AC component to DC component ratio to the second AC component to DC component ratio ([0025-0035]).
For claim 15, Kulach discloses the electronic fitness device of claim 9, wherein the determined pressure- compensated physiological metric is a pressure-compensated pulse oximetry for the user ([0025-0035]), the pressure-compensated pulse oximetry being a function of a product of the identified pressure compensation factor and a ratio of: the first AC component to DC component ratio of the waveform of the first PPG signal, and the third AC component to DC component ratio of the waveform of the third PPG signal ([0025-0035]).
For claim 16, Kulach discloses the electronic fitness device of claim 9, wherein the determined pressure- compensated physiological metric is a pressure-compensated pulse oximetry for the user ([0025-0035]), the pressure-compensated pulse oximetry being a function of a sum of the identified pressure compensation factor and a ratio of: the first AC component to DC component ratio of the waveform of the first PPG signal, and the third AC component to DC component ratio of the waveform of the third PPG signal ([0025-0035]).
For claim 17, Kulach discloses an electronic fitness device (10) (Figs 1-14) ([0025-0106]), comprising inter alia:
a housing (12) including a bottom wall to be positioned at least partly in contact with a user's skin (Figs 1-14) ([0025-0106]);
a first optical transmitter (42A1) positioned along the bottom wall and configured to emit a first optical signal having a first wavelength (Figs 1-14) ([0025-0106]), the first optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
a second optical transmitter (42A2) positioned along the bottom wall and configured to emit a second optical signal having a second wavelength (Figs 1-14) ([0025-0106]), the second optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
a third optical transmitter (42A3) positioned along the bottom wall and configured to emit a third optical signal having a third wavelength (Figs 1-14) ([0025-0106]), the third optical signal directed into the skin of the user (Figs 1-14) ([0025-0106]);
an optical receiver (28A) positioned along the bottom wall (Figs 1-14) ([0025-0106]), the optical receiver configured to: receive the first optical signal, the second optical, and the third optical signal (Figs 1-14) ([0025-0106]), each optical signal modulated by the skin of the user (Figs 1-14) ([0025-0106]), and generate a first photoplethysmogram (PPG) signal resulting from the received first optical signal (Figs 1-14) ([0025-0106]), a second PPG signal resulting from the received second optical signal (Figs 1-14) ([0025-0106]), and a third PPG signal resulting from the received third optical signal (Figs 1-14) ([0025-0106]), each received optical signal including a cardiac component of the user (Figs 1-14) ([0025-0106]);
a memory element (32) configured to store a plurality of pressure compensation coefficients (CC REF) (Figs 1-14) ([0025-0106]), each pressure compensation coefficient associated with a pressure metric value and the first optical signal having the first wavelength and the second optical signal having the second wavelength (Figs 1-14) ([0025-0106]); and
a processor (34) electrically coupled with the optical receiver and the memory element, the processor configured to: receive the first PPG signal, the second PPG signal, and the third PPG signal (Figs 1-14) ([0025-0106]), determine a pressure metric value (62) based on a characteristic of a waveform of the first PPG signal and a characteristic of a waveform of the second PPG signal (Figs 1-14) ([0025-0106]), retrieve from the memory element pressure compensation coefficients associated with the first wavelength associated with the first optical signal and the second wavelength associated with the second optical signal (Figs 1-14) ([0025-0106]), determine a pressure compensation factor (CC REF) based on the pressure compensation coefficients, the first PPG signal, and the second PPG signal (Figs 1-14) ([0025-0106]), and determine a pressure-compensated physiological metric (CC2 – Cn) based on characteristics of the waveform of the third PPG signal and the determined pressure compensation factor (Figs 1-14) ([0025-0106]).
For claim 18, Kulach discloses the electronic fitness device of claim 17, wherein the characteristic of the waveform of the first PPG signal is an AC component of the waveform of the first PPG signal and a DC component of the waveform of the first PPG signal ([0025-0035]), the characteristic of the waveform of the second PPG signal is an AC component of the waveform of the second PPG signal and a DC component of the waveform of the second PPG signal ([0025-0035]), and the characteristic of the waveform of the third PPG signal is an AC component of the waveform of the third PPG signal and a DC component of the waveform of the third PPG signal ([0025-0035]).
For claim 19, Kulach discloses the electronic fitness device of claim 17, wherein determining the pressure metric value includes determining a first AC component to DC component ratio of the waveform of the first PPG signal, determining a second AC component to DC component ratio of the waveform of the second PPG signal, and determining a ratio of the first AC component to DC component ratio to the second AC component to DC component ratio.
For claim 20, Kulach discloses the electronic fitness device of claim 17, wherein the first wavelength ranges from approximately 900 nanometers to approximately 980 nanometers ([0033-0041, 0067-0071]), the second wavelength ranges from approximately 820 nanometers to approximately 900 nanometers ([0033-0041, 0067-0071]), and the third wavelength ranges from approximately 500 nanometers to approximately 800 nanometers ([0033-0041, 0067-0071]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for providing pressure compensated PPG signals for pulse oximetry measurements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. 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.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights