DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/2/2026 has been entered.
Claims 1-8 and 10-12 remain pending and under prosecution.
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 .
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:
Light blocking feature in claim 10-11 – disclosed as black tape
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 § 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)(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, 3, and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by LeBoeuf et al (US Pub No. 20220313098).
In regard to Claim 1, LeBoeuf et al disclose a pulse oximeter device, comprising:
a first light emitting element 112a capable and thus configured to emit red light as would be well-known in the art, best seen in Figure 13A – “Although just two wavelengths were provided in this example, the invention could employ a plurality of PPG waveforms over a plurality of optical wavelengths beyond just two” (0164);
a second light emitting element 112b configured to emit green light or near infrared (NIR) light, best seen in Figure 13A (0055, 0164); and
a sensor element 114 configured to detect red and green light or detect red and NIR light, best seen in Figure 13A (0198),
wherein the sensor element has a circular geometry, best seen in Figure 13A,
the first light emitting element and the second light emitting element each have a block arc-shaped geometry, best seen in Figure 13A – each ring of the first and second light emitting elements 112a-b comprise a block arc shape as indicated by the left and right rectangular annotations in annotated Figure 13A below, and
wherein the sensor element is positioned between the first light emitting element and the second light emitting element, as shown by the annotated drawing below – the sensor element 114 is between the left light emitting element 112a block arc indicated by the left annotated rectangle and the right emitting element 112b black arc indicated by the right annotated rectangle:
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3. LeBoeuf et al disclose the pulse oximeter device of claim 1, wherein the first light emitting element 112a comprises a first light emitting diode, best seen in Figure 13A (0102),
wherein the second light emitting element 112b comprises a second LED, best seen in Figure 13A (0102), and wherein the sensor element includes a photodetector 114, best seen in Figure 13A (0200).
8. LeBoeuf et al disclose the pulse oximeter device of claim 1, wherein the sensor element 114 is configured to detect light reflected by tissue containing blood, e.g. PPG measurement (0102, 0198).
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.
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.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Arias et al (US Pub No. 20170156651 – cited by applicant) in view of LeBoeuf et al (US Pub No. 20220313098).
In regard to Claim 1, Arias et al disclose a pulse oximeter device, comprising:
a first light emitting element 20 configured to emit red light, best seen in Figure 1;
a second light emitting element 15 configured to emit green light or near infrared (NIR) light, best seen in Figure 1; and
a sensor element 25 configured to detect red and green light or detect red and NIR light, best seen in Figure 1 (0040-0041).
However, Arias et al do not expressly disclose the sensor element has a circular geometry, the first light emitting element and the second light emitting element each have a block arc-shaped geometry, and wherein the sensor element is positioned between the first light emitting element and the second light emitting element.
It is noted that while Arias et al disclose a specific orientation of the sensor and light emitting elements, best seen in Figure 1 – the OLEDs are in the center and surrounded by the detector sensor array, Arias et al expressly disclose the sensors (comprising the sensor and light emitting elements) can be made in “new shapes” (0111).
LeBoeuf et al teach that it is well-known in the art to provide an analogous pulse device for PPG (0102) with a sensor element 114 with a circular geometry, best seen in Figure 13A, and
a first light emitting element 112a and a second light emitting element 112b each with a block arc-shaped geometry, best seen in Figure 13A – each ring of the first and second light emitting elements 112a-b comprise a block arc shape as indicated by the left and right rectangular annotations in annotated Figure 13A below. Additionally, each block arc-shape is such that the sensor element is positioned between the first light emitting element and the second light emitting element, as shown by the annotated drawing below – the sensor element 114 is between the left light emitting element 112a block arc indicated by the left annotated rectangle and the right emitting element 112b black arc indicated by the right annotated rectangle:
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LeBoeuf et al teach that the concentric ring configuration providing the block arc-shapes for the first and second emitting elements “optimizes the signal-to-noise ratio, such that periodic biometric parameters can be accurately monitored during motion, and... optimizes the total PPG signal resolution, such that waveform biometric parameters can be accurately assessed (predominantly during resting conditions)” (0198).
It is noted that LeBoeuf et al also teach that the configuration of the light emitting elements and the sensor element can be “swapped” – “an outer ring of emitters 112 concentric with at least one optical detector 114 or with an outer ring of optical detectors 114 concentric with at least one optical emitter 112” to a configuration similar to that of Arias et al (0201).
Since Arias et al as well as LeBoeuf et al disclose variability with the shape of the overall sensor (which includes the first and second light emitting elements and the sensor element), it would have been obvious to one of ordinary skill in the art at the time of filing to modify Arias et al such that the sensor element has a circular geometry, the first light emitting element and the second light emitting element each have a block arc-shaped geometry, and wherein the sensor element is positioned between the first light emitting element and the second light emitting element, as taught by LeBoeuf et al as an equally as effective configuration for the light emitting elements and sensor that is a natural alternative given the teaching in Arias et al and LeBoeuf et al for other desirable configurations/shapes and that also provides benefits such as optimized signal-to-noise ratio and optimized PPG signal resolution, to accurately assess the desired results as taught by LeBoeuf et al above.
2. Arias et al disclose the pulse oximeter device of claim 1, wherein a spacing between the sensor element 25 and each of the first light emitting element 20 and the second light emitting element 15 is between about 2 mm and about 6 mm – Arias et al disclose the detector used on a 9 mm finger; thus a distance of 2 mm and about 6 mm can be inferred between the sensor element and each of the first and second light emitting elements, as shown in Figure 1 (0037).
3. Arias et al disclose the pulse oximeter device of claim 1, wherein the first light emitting element comprises a first light emitting diode (LED) 20, best seen in Figure 1 (0005),
wherein the second light emitting element comprises a second LED 15, best seen in Figure 1, and wherein the sensor element includes a photodetector 25, best seen in Figure 1 (0040).
4. Arias et al disclose the pulse oximeter device of claim 3, wherein each of the first 20 and second 15 LEDs comprises an organic LED – OLED (organic light emitting diode), best seen in Figure 1 (0005), and wherein the photodetector comprises an organic photodiode – OPD (organic polymer photodiode), best seen in Figure 1 (0005).
5. Arias et al disclose the pulse oximeter device of claim 1, further comprising a flexible substrate 105, wherein the first light emitting element 20, the second light emitting element 15 and the sensor element 25 are formed on the flexible substrate, best seen in Figure 3 (abst, 0044).
6. Arias et al disclose the pulse oximeter device of claim 5, wherein the flexible substrate 105 comprises polyethylene napthalate (PEN) (0044).
7. Arias et al disclose the pulse oximeter device of claim 1, wherein the sensor element 25 is configured to detect light transmitted through tissue containing blood, e.g. blood oxygenation measurement – “The sensor element is configured to detect the emitted red and green light transmitted through tissue containing blood” (abst).
8. Arias et al disclose the pulse oximeter device of claim 1, wherein the sensor element 25 is configured to detect light reflected by tissue containing blood, e.g. PPG measurement – “By creating a printed sensor on a flexible substrate that can make reflectance measurements as opposed to only transmission measurements” (0085, 0108, claim 7).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Arias et al in view of LeBoeuf et al as applied to claim 1 above, and further in view of Genoe et al (US Pub No. 20080312517).
Arias et al in combination with LeBoeuf et al disclose the invention above but do not expressly disclose a light blocking feature positioned between the sensor element and at least one of the first light emitting element or the second light emitting element.
Genoe et al teach that it is well-known in the art to provide an analogous pulse oximeter device comprising a light blocking feature 13 that is positioned between the sensor element 12 and at least one light emitting element 11, best seen in Figure 5, to effectively “prevent incident light that has not been scattered in the skin tissue” (0041), which is undesirable.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Arias et al as modified by LeBoeuf et al to include a light blocking feature as taught by Genoe et al to effectively prevent incident light that has not been scattered in the skin tissue, wherein it would have been obvious to a skilled artisan to have the light blocking feature positioned between the sensor element and both the first light emitting element and the second light emitting element to effectively prevent undesirable light passing between each element of the pulse oximeter device.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Arias et al in view of LeBoeuf et al, and Genoe et al as applied to claim 10 above, and further in view of Young et al (US Pat No. 5368025).
Arias et al in combination with LeBoeuf et al and Genoe et al disclose the invention above but do not expressly disclose the light blocking feature includes a black tape.
Young et al teach that it is well-known in the art to use black tape 14 as a light blocking feature in an analogous pulse oximeter device (Col.4: 57-Col.5: 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify over Arias et al as modified by LeBoeuf et al and Genoe et al such that the light blocking feature includes a black tape as taught by Young et al, as an effective form for said light blocking feature of Genoe et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) above have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. the sensor element placement relative to light emitting elements may differ or that the shapes of the individual sensor and light emitting elements of the medical device "can be made in 'new shapes" as alleged
It is noted that while applicant contends that “A block arc is generally known to one skilled in the art as a partial donut shape, e.g., a chunk of a donut with a curve shape having a length and a thickness within a plane. Also, a block arc geometry is clearly not the same as or similar to a circular geometry (where every point of the perimeter of the circle is equidistant from the center point)” (Remarks pg. 8), this is not persuasive because the term “block arc” does not appear to refer to any standardized or routine and conventional geometry in the art. Additionally, applicant’s disclosure appears to merely define the term as a “continuous” or “single integrated” geometry that surrounds the OPD in Figure 2C – “Circular geometry (C), where the OLEDs are shaped as block arcs and placed around a substantially circular OPD” (0030 filed spec). Applicant also echoes this in the remarks – “singular light emitting elements that itself has an arc-shape” (Remarks pg. 9).
Lastly, applicant contends that Arias et al does not teach “the sensor element placement relative to light emitting elements may differ or that the shapes of the individual sensor and light emitting elements of the medical device "can be made in 'new shapes" as alleged” (Remarks pg. 8). However, this is not persuasive because it is submitted that the disclosure of Arias et al to have the sensors in “new shapes” implies modification to the configuration and individual sensor and light emitting elements as well. Regardless, LeBoeuf et al is also set forth to teach variability in the configuration and shape/geometry (0201).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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