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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/30/2026 has been entered.
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) “light source module configured to irradiate” in claim 76.
b) “processing module configured to determine” in claim 76.
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) The specification does not ever explicitly defines nor even clearly exemplifies the structure of the module at any point; however the specification at [0452]-[0454] (citing paragraph numbers from PGPUB US20240130620A1; hereafter merely the specification) states that an optical fiber can be the structure which performs this same function of irradiating the tissue and therefore there is implicit disclosure for the light source module to be or comprise an optical fiber and/or any related structure capable of the function.
b) The specification states that all modules including the processing module may be a processor or memory, or other hardware, or software or similar structures in [0656]-[0657]. Therefore, the processing module is being interpreted as any processor, memory, hardware, software, or combination thereof that could perform the claimed functions.
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.
This application includes one or more claim limitations that use the word “means” or “step” or an analog thereto such as “module” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
a) “acquisition module … to obtain T output light intensities” in claim 76 because this is declared to comprise a structure of “M photosensitive surfaces” and because a photosensitive surface could perform the function of “obtain … light intensities”.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 76, and 163 are rejected under 35 U.S.C. 102(a)(1) as anticipated by NPL reference A Single LED Photoplethysmography-based Noninvasive Glucose Monitoring Prototype System by Hina et al. (hereafter Hina).
Regarding claim 1, Hina teaches: 1. A method of measuring a tissue element (see Hina’s Abstract), comprising:
irradiating a measurement region with incident light having a single predetermined wavelength, wherein each beam of the incident light passes through the measurement region to form at least one beam of exit light exited from at least one exit position, and a number of incident positions of the incident light is at least one (see Hina’s page 1 noting that the abstract and Introduction both cover as much with the Abstract being exemplary and stating: “This paper presents a novel non-invasive continuous blood glucose monitoring system based on a single wavelength near-infrared (NIR) spectroscopy.” Additionally or alternatively, see the Proposed Glucose Monitoring System section’s Fig. 1 which likewise shows the input and output of the light through the tissue);
obtaining a light intensity value corresponding to each beam of the exit light acquired by M photosensitive surfaces, so as to obtain T output light intensities, wherein each of the T output light intensities is obtained by processing the light intensity value of the exit light acquired by one or more of the M photosensitive surfaces, and each of the M photosensitive surfaces is configured to acquire the light intensity value of the exit light exited from the exit position corresponding to the photosensitive surface, each photosensitive surface is continuous, a ratio of an area of each photosensitive surface to a circumference of the photosensitive surface is greater than or equal to a ratio threshold, wherein the ratio threshold is greater than or equal to 0.04 mm, the circumference of the photosensitive surface represents an edge portion of the photosensitive surface, the area of the photosensitive surface represents a non-edge portion of the photosensitive surface, where 1<=T<=M (see Hina’s Fig. 1 noting the reception of at least one signal from at least one location as depicted. For the remaining limitations. See Hina’s PPG Analog Front End section on page 2 which states in salient part that: “The FGA10 (Thorlabs photodiode) is used to detect the transmitted light since” one of ordinary skill in the art would therefore readily understand that the light intensity is obtained from a single continuous photosensitive surface of diameter 1 mm (though to preclude any argument and compact prosecution to the utmost, the data sheet for the FGA10 is included in the examiner’s 892 form and cited below in the conclusion section), such that we are left with (PI*r^2)/(2*Pi*r) which simplifies to r/2, where r=0.5 mm which gives a ratio of 0.25 mm); and
determining a concentration of a detected tissue element according to at least one output light intensity corresponding to the predetermined wavelength (see Hina’s Glucose Estimation Digital Backend on pages 3-5 for a full rundown of all of the calculations that go into determining the blood glucose concentration, or simply see any of Fig. 8 which illustrates the concentration being measured in mg/dL, or the Implementation Results and Discussion section which iterates that the levels are successfully determined or the Conclusion section which iterates in summary form that the detection is accomplished by the system, any of which would teach the limitation in various levels of detail).
Regarding claim 76, Hina teaches: 76. A device of measuring a tissue element (see Hina’s Abstract or Fig. 1), comprising:
a light source module configured to irradiate a measurement region with incident light having a single predetermined wavelength, wherein each beam of the incident light passes through the measurement region to form at least one beam of exit light exited from at least one exit position, and a number of incident positions of the incident light is at least one (see Hina’s page 1 noting that the abstract and Introduction both cover as much with the Abstract being exemplary and stating: “This paper presents a novel non-invasive continuous blood glucose monitoring system based on a single wavelength near-infrared (NIR) spectroscopy.” Additionally or alternatively, see the Proposed Glucose Monitoring System section’s Fig. 1 which likewise shows the input and output of the light through the tissue and shows a module (e.g. LED));
an acquisition module comprising M photosensitive surfaces, wherein each of the M photosensitive surfaces is configured to acquire a light intensity value of the exit light exited from the exit position corresponding to the photosensitive surface, the acquisition module is configured to obtain a light intensity value corresponding to each beam of the exit light acquired by the M photosensitive surfaces, so as to obtain T output light intensities, and each of the T output light intensities is obtained by processing the light intensity value of the exit light acquired by one or more of the M photosensitive surfaces, each photosensitive surface is continuous, a ratio of an area of each photosensitive surface to a circumference of the photosensitive surface is greater than or equal to a ratio threshold, wherein the ratio threshold is greater than or equal to 0.04 mm, the circumference of the photosensitive surface represents an edge portion of the photosensitive surface, the area of the photosensitive surface represents a non-edge portion of the photosensitive surface, and wherein 1≤T≤M (see Hina’s Fig. 1 noting the reception of at least one signal from at least one location as depicted and where the photodiode is a module that measures light intensity. For the remaining limitations. See Hina’s PPG Analog Front End section on page 2 which states in salient part that: “The FGA10 (Thorlabs photodiode) is used to detect the transmitted light since” one of ordinary skill in the art would therefore readily understand that the light intensity is obtained from a single continuous photosensitive surface of diameter 1 mm (though to preclude any argument and compact prosecution to the utmost, the data sheet for the FGA10 is included in the examiner’s 892 form and cited below in the conclusion section), such that we are left with (PI*r^2)/(2*Pi*r) which simplifies to r/2, where r=0.5 mm which gives a ratio of 0.25 mm); and
a processing module (see Hina’s Fig. 7 noting the computer, PCB, and FPGA which are the structures for processing) configured to determine a concentration of a detected tissue element according to at least one output light intensity corresponding to the predetermined wavelength (see Hina’s Glucose Estimation Digital Backend on pages 3-5 for a full rundown of all of the calculations that go into determining the blood glucose concentration, or simply see any of Fig. 8 which illustrates the concentration being measured in mg/dL, or the Implementation Results and Discussion section which iterates that the levels are successfully determined or the Conclusion section which iterates in summary form that the detection is accomplished by the system, any of which would teach the limitation in various levels of detail).
Regarding claim 163, Xu teaches: 163. A wearable apparatus (the examiner notes that it is inherent that things can be worn, thus the invention of Hina is fully capable of as much. Likewise the examiner notes at least that: this does not recite any structure to effectuate being wearable and that even if the mention of such a structure was made explicit in a later amendment it would likely be proper to do so only in the body of the claims as per MPEP 2111.02 as currently being "wearable" only relates to the intended use as per MPEP 2111.02(II). As such and for compact prosecution purposes the applicant is urged to amend the claim to recite structure limitations in the body of the claim if they are of the opinion that the claim is intended to confer any additional limitation on the structure of the invention set forth in Claim 76. Lastly and for compact prosecution purposes and despite having no related claim limitation as currently drafted the examiner notes that Hina also directly teaches as much, see Fig. 7, noting that this is worn on the finger in use), comprising the device of measuring the tissue element according to claim 76 (see the rejection of claim 76 above which is incorporated herein by reference to teach this limitation).
Response to Arguments
Applicant’s arguments, see page 21, filed 06/30/2026, with respect to the 112 rejections of the previous office action have been fully considered and are persuasive. The associated rejections have been withdrawn.
Applicant’s arguments with respect to the prior art rejection of claim(s) 1, 76, and 163 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
InGaAs Photodiode FGA10 by THORLABS is a data sheet showing the particulars of the FGA10 photodiode. Notably the active area diameter being 1 mm is textually stated on page 1 and depicted in the drawing on page 3.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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