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 B of Invention II, which encompasses claims 27-31, in the reply filed on 04/01/2026 is acknowledged. Claims 1-26 have been withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/07/2024 was considered by the examiner.
Claim Objections
Claims 30 and 31 are objected to because of the following informalities:
Claim 30, line 12: “both a location” should be replaced with –both the location–;
Claim 30, line 14: “both a location” should be replaced with –both the location–;
Claim 30, line 16: –one or more– should be inserted before “alignment guides”;
Claim 30, line 17: –one or more– should be inserted before “alignment guides”;
Claim 31, line 1: –one or more– should be inserted before “alignment”; and
Claim 31, line 2: –one or more– should be inserted before “alignment guides”.
Appropriate correction is required.
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.
No limitations were interpreted under 35 U.S.C. §112(f).
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 27 and 29-31 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 27 recites “determining which of the first or second oxygen saturation measurement is better” in line 9. The determination of a better measurement is facially subjective and renders the claim indefinite. See MPEP 2173.05(b)(IV). The determination is subjective because an oxygen saturation measurement that is better according to one person or standard might not be better according to another person or standard. Although the specification includes examples of how a better signal is determined (¶¶ [0087], [0090], [0093] of the published application), the examples and the rest of the specification do not provide a reasonably clear and exclusive definition or standard for the determination of the better oxygen saturation measurement. Claims 29-31 are rejected by virtue of their dependence from claim 27. Claim 28 provides definite guidance for determining the better oxygen saturation measurement, so claim 28 is not being rejected under 35 U.S.C. §112(b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi).
With regards to claim 27, Tang teaches a method to measure oxygen saturation (¶ [0058] discloses measuring SpO2), comprising: generating a first signal of a subject using a first optical sensor of a torso sensor device (¶¶ [0058], [0061] and Figs. 3A-3B depict an optical system 60 of an optical sensor 36 comprising an array of six photodetectors 62 which each detect reflected radiation); generating a second signal of the subject using a second optical sensor of the torso sensor device (¶¶ [0058], [0061] and Figs. 3A-3B depict an optical system 60 of an optical sensor 36 comprising an array of six photodetectors 62 which each detect reflected radiation), the second optical sensor spaced apart from the first optical sensor such that the first and second signals are generated from different locations of the subject (Figs. 3A-3B depict the photodetectors being spaced apart such that they would produce different signals); generating an oxygen saturation measurement of the subject based on the first and/or second signal (¶ [0058] discloses the determination of an SpO2 based on the reflected radiation), and outputting the oxygen saturation measurement (¶ [0052] discloses calculating vital signs including SpO2 and transmitting the data)
Tang is silent regarding generating a first oxygen saturation measurement of the subject based on the first signal; generating a second oxygen saturation measurement of the subject based on the second signal; determining which of the first or second oxygen saturation measurements is better; and outputting the better oxygen saturation measurement.
In a system relevant to the problem of selecting an optimal signal for determining oxygen saturation, Choi teaches generating a first oxygen saturation measurement of the subject based on a first signal (¶¶ [0023], [0068] discloses a processor 130 which determines oxygen saturation of each channel; Fig. 1 and ¶ [0042] depict a pulse wave sensor 110 and a processor 130; Fig. 2 and ¶ [0046] depict a first channel and a second channel); generating a second oxygen saturation measurement of the subject based on a second signal (¶¶ [0023], [0068] discloses a processor 130 which determines oxygen saturation of each channel; Fig. 1 and ¶ [0042] depict a pulse wave sensor 110 and a processor 130; Fig. 2 and ¶ [0046] depict a first channel and a second channel); determining which of the first or second oxygen saturation measurements is better (¶¶ [0023], [0074] discloses the processor 130 selecting, as the channel to be used for estimating bio-information, the channel having the greatest oxygen saturation within a predetermined time interval); and using the better oxygen saturation measurement (¶ [0074] discloses using the greatest oxygen saturation to select the channel to be used in estimating bio-information). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of oxygen saturation of Tang to incorporate generating a first oxygen saturation measurement of the subject based on the first signal; generating a second oxygen saturation measurement of the subject based on the second signal; determining which of the first or second oxygen saturation measurements is better; and outputting the better oxygen saturation measurement, as taught by Choi. The motivation would have been to select a channel which best corresponds with an object of interest (see ¶ [0073] of Choi), thereby improving the signal accuracy.
With regards to claim 28, the above combination teaches or suggests determining which of the first or second oxygen saturation measurements is better comprises: determining which of the first oxygen saturation measurement or the second oxygen saturation measurement is greater (¶¶ [0023], [0074] of Choi discloses the processor 130 selecting, as the channel to be used for estimating bio-information, the channel having the greatest oxygen saturation within a predetermined time interval); and selecting as the better oxygen saturation measurement the first oxygen saturation measurement or the second oxygen saturation measurement that is greater of the two (¶ [0074] of Choi discloses using the greatest oxygen saturation).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi), as applied to claim 27 above, and further in view of US 2002/0042558 A1 (Mendelson)
With regards to claim 9, the above combination teaches attaching the torso sensor device to the subject’s torso (¶ [0058] of Tang teaches the optical sensor measures signals from the patient’s chest, which indicates that the optical sensor 36 is attached to the chest).
The above combination is silent regarding whether the attachment includes: locating an intercostal space (ICS) of the subject; positioning at least one of the first optical sensor or the second optical sensor over the ICS of the subject; and coupling the torso sensor device to the subject’s torso with at least one of the first optical sensor or the second optical sensor positioned over the ICS of the subject.
In the same field of endeavor of pulse oximeters applied to the chest, Mendelson teaches attaching a sensor to a subject’s torso (¶ [0092] discloses a photodetector ring mounted to a chest) including: positioning at least one of the first optical sensor or the second optical sensor over the ICS of the subject; and coupling the torso sensor device to the subject’s torso with at least one of the first optical sensor or the second optical sensor positioned over the ICS of the subject (¶ [0092] discloses a sensor comprising a continuous photodetector ring mounted on a chest, a portion of the photodetector ring lies over a rib, and the remaining part of the photodetector is positioned over the intercostal space). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for attaching the torso sensor device to the subject’s chest of the above combination to incorporate that it includes: locating an intercostal space (ICS) of the subject; positioning at least one of the first optical sensor or the second optical sensor over the ICS of the subject; and coupling the torso sensor device to the subject’s torso with at least one of the first optical sensor or the second optical sensor positioned over the ICS of the subject as taught by Mendelson. It would have been the simple substitution of one known equivalent method for attaching a pulse oximetry device to a chest for another to obtain predictable results. See [0058] of Tang; ¶ [0092] of Mendelson.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0029833 A1 (Tang)(cited by Applicant) in view of US 2020/0229743 A1 (Choi) and US 2002/0042558 A1 (Mendelson), as applied to claim 29 above, and further in view of US 2015/0157225 A1 (Gillberg).
With regards to claim 30, the above combination teaches or suggests the torso sensor device includes: a first surface configured to be positioned against the subject’s torso and an opposing second surface (Figs. 2A-2B and 4 of Tang depict the optical sensor 36 comprising a bottom surface and a top surface), each of the first and second optical sensors positioned at the first surface of the housing (Figs. 2B and 4 of Tang depict the circular array of photodetectors 62 being positioned at the bottom surface); a first set of one or more alignment guides on the second surface and aligned to a first sensor axis of the first optical sensor (Figs. 2A-2B and 4 of Tang depict the top of the optical sensor 36 comprising a first set of one or more markings which are aligned with an axis of at least one of the photodetectors); and a second set of one or more alignment guides on the second surface and aligned to a second sensor axis of the second optical sensor (Figs. 2A-2B and 4 of Tang depict the top of the optical sensor 36 comprising a second set of one or more markings which are aligned with an axis of at least another one of the photodetectors); the sensor axes of the first and second optical sensors are parallel (Figs. 2A and 4 of Tang depict the sensor axes being parallel); the first set of one or more alignment guides is configured to visually identify a location, alignment, or both a location and alignment, of the first sensor axis of the first optical sensor (Figs. 2B and 4 of Tang depict the markings being capable of indicating a location and/or alignment of the photodetectors because they are parallel to the sensor axes); the second set of one or more alignment guides is configured to visually identify a location, alignment, or both a location and alignment, of the second sensor axis of the second optical sensor (Figs. 2B and 4 of Tang depict the markings being capable of indicating a location and/or alignment of the photodetectors because they are parallel to the sensor axes), the method further comprises positioning the at least one of the first optical sensor or the second optical sensor over the ICS of the subject (¶ [0092] of Mendelson).
The above combination is silent regarding whether the method further comprises positioning at least one of the first set of alignment guides or the second set of alignment guides over the ICS to position the at least one of the first optical sensor or the second optical sensor over the ICS of the subject
In a system relevant to the problem of accurately positioning a sensor over a desired anatomical location, Gillberg teaches positioning at least one alignment guide over a desired location to position a sensor over the desired location (¶ [0096] discloses at least one alignment marker used to align the device to one or more anatomical features of the patient such that the sensor array is positioned in a desired location). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate positioning at least one alignment guide over a desired location to position a sensor over the desired location as taught by Gillberg to arrive at positioning at least one of the first set of alignment guides or the second set of alignment guides over the ICS to position the at least one of the first optical sensor or the second optical sensor over the ICS of the subject. The motivation would have been to ensure that the sensors are located at the desired anatomical feature.
With regards to claim 30, the above combination is silent regarding aligning at least one of the first set of alignment guides or the second set of alignment guides parallel to the ICS, or an adjacent rib of the subject to align at least one of the first sensor axis or the second sensor axis parallel to the ICS or the adjacent rib.
In a system relevant to the problem of accurately positioning a sensor over a desired anatomical location, Gillberg teaches aligning at least one alignment marker parallel to an anatomical feature such that the sensors are aligned with the desired location (¶ [0096] discloses the alignment marker is aligned with the sternum (i.e., parallel with and over the sternum). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate aligning at least one alignment marker parallel to an anatomical feature such that the sensors are aligned with the desired location as taught by Gillberg to arrive at aligning at least one of the first set of alignment guides or the second set of alignment guides parallel to the ICS, or an adjacent rib of the subject to align at least one of the first sensor axis or the second sensor axis parallel to the ICS or the adjacent rib. The Examiner notes that aligning the markings of Tang to be parallel with the intercostal space necessarily results in the sensor axes being parallel with the intercostal space. The motivation would have been to ensure that the sensors are located at the desired anatomical feature in an optimal orientation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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