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 Arguments
Applicant's arguments filed 2/25/2026 have been fully considered but they are not persuasive.
The applicant argued on page 15 that the terms “heat detector” and “pulse monitor” should not be interpreted under 35 USC 112(f). However, in order for the claim to not be interpreted under 35 USC 112(f), the applicant only has two options, as outlined in the previous office action and in MPEP 2181: (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.
In this case, the applicant did not amend the claim limitations, so option (1) is moot. The applicant also did not point out “that the claims limitation recite sufficient structure to perform the claimed function.” Instead, the applicant states that the claim limitations “connote sufficiently definite structure to a person of ordinary skill in the art.” However, this is not the standard. An implication of suggestion of structure is not the same as RECITING sufficient structure. In fact, the whole point of means-plus-functions recitations is to allow an applicant to connote structure that is disclosed in the specification without actually reciting the structure. This is exactly what the applicant is admitting to here. They are requesting that the Examiner read the structural limitations of the specification into the claim, which is ONLY possible if the claims recite a means-plus-function limitation. As admitted by the applicant, there are MANY different structural ways to detect a level of heat, and the claimed “heat detector” does not recite any specific way. The same is true of the “pulse monitor.” Furthermore, the applicant is pointing to the specification to show the sufficient structure, none of which is recite din the claim. The limitations are properly interpreted as means-plus-function limitations.
Regarding the art rejections, the applicant argues on page 12 that Bae does not disclose a “synergy that leads to action based on any specific combination of temperature and amplitude change.” The Examiner respectfully disagrees. The claim merely require raising an alarm on OCCURRENCE of one of the following combinations. However, the claims 1) do not recite that the earplug actually determines the occurrence of the combination(s), or deduces a change in value, or monitors a baseline, etc. and 2) do not define a specific type of alarm. All the claim requires is that IF/WHEN one of the combinations occurs, some sort of output/alarm occurs. As described in the previous rejection and again below, Bae continuously detects heat and monitors the pulse, and the outputs are continuously visually displayed. The visual display is considered an alarm. Since the heat detection and pulse monitoring is continuous, IF/WHEN any of the claimed combinations occurs, the heat value and pulse value will inherently be displayed, that output being a type of alarm, thus reading on the claim.
The rejections are still considered proper.
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:
“heat detector” in claim 1, such that the specification discloses the heat detector is a semiconductor temperature sensor, and its equivalents.
“pulse monitor” in claim 1, such that the specification discloses the pulse monitor to be a photoplethysmography sensor, a ballistocardiography sensor, and their equivalents.
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
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.
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bae et al. (US 2004/0225207, hereinafter Bae).
Regarding claims 1 and 4, Bae discloses an earplug 500 as seen in figure 5B (par. 0055). The earplug includes a heat detector 510 for obtaining an indication of the level of heat in the air of the ear canal and a PPG pulse monitor 520 configured to obtain a pulse and heart rate, such that the heat detector and pulse monitor are configured to be operated at the same time, if so desired by a user (par. 0055-0056). The outputs from the heat detector and the pulse monitor are sent to display unit 590, such that the display will visually present any occurrences of increases or decreases in the ear canal temperature and the pulse amplitude to the patient and/or physician for remote examination, the visual output constituting an “alarm” as currently claimed (fig. 6, 7, 15A, par. 0055, 0057, 0059, 0076). The claim does not require actual detection of the increases and/or decreases, nor does it require the increases and/or decreases to occur simultaneously.
Regarding claims 5 and 6, as seen in figure 5, when inserted into the ear canal, the pulse monitor 520 is in a depression on a surface of an extension that directly contacts the ear canal wall, in order to best read light absorption in the tissue. Conversely, the heat detector 510 does not abut the wall and thus is further from the wall than the pulse monitor because the heat detector needs to have a clear, open path to the tympanic membrane in order to collect and sense infrared emissions (par 0023).
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Bae in view of Cross et al. (US 2019/0117155, hereinafter Cross).
Regarding claims 2 and 3, Bae, as described above, discloses the applicant’s basic invention, including utilizing infrared heat sensors to provide an indication of the air temperature in an ear canal. However, Bae is silent as to using two, spaced semiconductor temperature sensors and determining a temperature gradient between the sensors. Cross discloses utilizing using two, spaced semiconductor temperature sensors and determining a temperature gradient between the sensors, such that the use of these sensors is an improvement over infrared sensors (par. 0050-0051, 0064, 0142). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Bae to utilize the spaced semiconductor temperature sensors and determining a temperature gradient between the sensors, as taught by Cross, such that the use of these sensors is an improvement over infrared sensors (par. 0050-0051 for motivation).
Conclusion
THIS ACTION IS MADE FINAL. 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 Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796