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 .
Response to Amendment
This Office action is responsive to the amendment filed March 18, 2026. As directed by the amendment, claims 35-48, 55, 58 and 61 have been cancelled, claims 49, 51, 56 and 59 have been amended and claims 62-63 have been added. Thus, claims 49-54, 56-57, 59-60 and 62-63 are presently pending.
The cancellation of claim 58 effectively obviates the 35 U.S.C 112(b) rejection from the previous Office action. That rejection is hereby withdrawn.
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: "ear portion configured to be received an ear ..." in claim 49.
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.
This application includes one or more claim limitations that use the word “means” or “step” 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: “... sensor means comprising at least part of an emitter and associated detector of a photoplethysmography sensor means configured to ... capture the biometric data” in claim 49.
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.
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 § 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 49-54, 56-57 and 62 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 claim 54 recite in part “a non-contact photoplethysmography sensor means directed to non-pigmented ear tissue of a medial 2/3rds of an ear-canal of said human or other animal” that amounts to inferential recitation of the human being, the scope of the claim encompasses a human being the claim recites a configuration that requires a human being present, which renders the claim non-statutory. A phrase such as -- a non-contact photoplethysmography sensor means configured to be directed to non-pigmented ear tissue of a medial 2/3rds of an ear-canal of said human or other animal -- is suggested to address the understood intent of the Applicant to avoid the 35 U.S.C 101 rejection. Claims 50-54, 56-57 and 62 are likewise rejected, only because they include all limitations and therefore the deficiencies of claim 54.
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.
(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.
Claims 49-51 and 56-63 are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Roeck et al., US 20210298670 A1 hereinafter "Roeck".
Regarding claims 49 and 59, Roeck discloses an apparatus (“100” - Fig. 1) and associated for capturing biometric data from a human or other animal ([0001], [0005], [0011-0016], [0020-0022], Figs. 1, 2, and 4-6), said apparatus comprising: an ear portion (“104”) configured to be received in an ear of said human or other animal ([0020-0022], [0024] and illustration Figs. 4-6), wherein the ear portion comprises sensor means comprising at least part of an emitter and associated detector of a non-contact photoplethysmography sensor means ([0024-0026] and illustration Fig. 2 and 4-6) directed to non-pigmented ear tissue of a medial 2/3rds of an ear-canal of said human or other animal so as to capture the biometric data from said medial 2/3rds of the ear-canal ([0022] and [0024], the ear portion comprise a dome 120 that is elastic and thus allows positioning of the ear portion either fully in the ear canal or partially and therefore the non-contact photoplethysmography sensor means is configured to be directed to a medial 2/3rds of an ear canal where non-pigmented ear tissue is to be found as this depends on positioning of the apparatus).
Regarding claim 50 and 60, the one or more sensor means is configured to capture biometric data related to blood pressure ([0001] “… the measured intensity signal over time represents a photoplethysmogram (PPG) signal, which can be processed to determine heart rate, blood pressure …”).
Regarding claims 51, 62 and 63, see [0022] and [0024], the ear portion comprise a dome 120 that is elastic and thus allows positioning of the ear portion either fully in the ear canal or partially to capture biometric data from outer(lateral) section of the ear canal, a middle ear and/or combinations thereof or to capture only biometric data from medial 2/3rds of the ear canal, as this depends on positioning of the ear portion within the ear, note as depicted in Figs. 2 and 4-6, the dome 120 will prevent illuminating an ear-drum and/or malleus of the ear ([0005]).
Regarding claim 56, see [0025-0026] the photoplethysmography sensor means is configured to emit and detect multiwavelength and/or white light.
Regarding claim 57, see [0022] the ear portion comprise a dome 120 that is elastic and is an equivalent thereof means for securely fastening the ear portion within an ear canal of the user as described in instant application printed publication in [0226].
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.
Claims 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Roeck as applied to claim 49 above, and further in view of previously cited Leboeuf et al., WO 2021046237 A1 hereinafter "Leboeuf".
Regarding claims 52-54, Roeck does not explicitly disclose wherein the apparatus is configured to further detect the biometric data from an outer ear, pinna, neck, chest, hand, or digit [claim 52]; wherein the apparatus comprises a plurality of sensor means, in which at least two sensor means of the plurality of sensor means are configured to detect the same biometric data from different parts of the ear and/or different parts of the body [claim 53]; or wherein the apparatus additionally comprises molecular spectroscopy means, at least part of which is located in the ear portion for capturing the biometric data relating to the molecular constituents of: blood passing through the ear of said human or other animal; and/or ear tissue of said human or other animal [claim 54].
However, Leboeuf discloses an analogous earpiece device with multiple sensor regions (Fig. 17B, page 14, lines 6-7) wherein the apparatus is configured to further detect the biometric data from an outer ear, pinna, neck, chest, hand, or digit (see illustration Figs. 12C, 15A-B ,17A-B regarding outer ear and/or pinna, and page 52, lines 28-31 regarding “finger press”), wherein the apparatus comprises a plurality of sensor means, in which at least two sensor means of the plurality of sensor means are configured to detect the same biometric data from different parts of the ear and/or different parts of the body (see illustration Fig. 12C two sensor means are depicted, in view of Fig. 17A, the same biometric parameter will be detected from different parts of the ear, alternatively the structure of Fig. 17B would detect same biometric parameter from different parts of the ear and/or body in view of discussion in paragraph bridging page 52-53. Additionally, see page 48, lines 12-16 regarding raw PPG waveform data taken from the same subject at the same body location); and wherein the apparatus additionally comprises molecular spectroscopy means, at least part of which is located in the ear portion for capturing the biometric data relating to the molecular constituents of: blood passing through the ear of said human or other animal; and/or ear tissue of said human or other animal (see page 73, lines 3-6, tertiary sensor 110c and page 75, lines 3-6, tertiary sensor 110c as a spectrometer such an optical spectrometer, Raman spectrometer or the like, such a sensor on the earpiece 12C is capable of capturing biometric data related to molecular constituents of blood passing through the ear or ear tissue).
In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the hearing device 100 of Roeck as taught by Leboeuf as discussed above, so to increase versatility of the device of Roeck to monitor various biometrics from a user using a single worn device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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