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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/26/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country. Specifically, during examination of the instant application, the examiner became aware of TW 657804 U which claims priority to TW 113201508 U, which has a filing date of 2/07/2024, that is before the US filing date of 4/29/2024.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the display or speaker on the holding device as recited in claim 6 and the embodiment described in claim 7 “wherein a quantity of the at least one accelerometer is two or more, wherein the accelerometers are disposed on the holding device and spaced apart from each other by a predetermined distance, such that the accelerometers are simultaneously and respectively in contact with and attached to the outer skin of the left side of the skull and the outer skin on the right side of the skull when the user wears the bone-conduction transcranial cerebral pressure monitoring device” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
“holding device” in claims 1 and 4-8;
“output device” in claims 1-4 and 7-10;
“power supply device” in claims 1-10;
“biasing structure” in claim 3;
“wired transmission module” and “wireless transmission module” in claim 5; .
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.
These terms are interpreted as follows:
“holding device” is interpreted as a headband and a main body as described in paragraph [0036], or equivalents thereof.
“output device” is interpreted as “a wired transmission device”, “a wireless transmission device”, or a display as described in paragraph [0032], or equivalents thereof.
“power supply device” is interpreted as a wired power source, a wireless power source, a battery, or other existing power supply devices as described in paragraph [0033], or equivalents thereof.
“biasing structure” is interpreted as a headband, shrinkable adhesive, or any form capable of applying the main body (accelerometer) biased toward the head of the user as described in paragraph [0037], or equivalents thereof.
“wired transmission module” is interpreted as wires for transmitting an electric signal as described in paragraph [0032], or equivalents thereof.
“wireless transmission module” is interpreted as any structure or transmission method such as Bluetooth, Zigbee, WI-FI or any remote communication method as described in paragraph [0032], or 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.
(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 1, 3, 5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lovoi et al (US 2022/0395226 A1).
Regarding claims 1, 3, 5, 7 and 8; Lovoi discloses a bone-conduction transcranial cerebral pressure monitoring device (wherein the examiner notes that the extracted accelerometer data is indicative of cerebral pressure and thus meets the BRI of cerebral pressure monitoring device; element 100, element 8; figures 1a,c,d and 2a,b), comprising:
a holding device (combined headset elements 112 and 114 of figure 1a; element 8 of figure 2a,b));
at least one accelerometer (elements 110 or 10), wherein the at least one accelerometer is disposed on the holding device (figures 1a and 2a,b), and is exposed from a surface of the holding device for contacting an outer skin of a skull of a user, so as to sense a transcranial cerebral pressure acceleration wave of the user for formation of a first monitoring signal (paragraph [0039]-[0043]; figures 1a-2c);
an output device (elements 126, 128), wherein the output device is disposed on the holding device (within element 112 if figure 1 embodiment or on headband element 8 of figure 2 embodiment) , and is communicatively connected to the at least one accelerometer, so as to output the first monitoring signal (paragraphs [0037]-[0043]; figures 1a-2c); and
a power supply device (element 130), wherein the power supply device is disposed on the holding device, and is electrically connected to the at least one accelerometer and the output device, so as to supply power to the at least one accelerometer and the output device (paragraphs [0037]-[0043]; figures 1a-2c);
wherein, when the user wears the bone-conduction transcranial cerebral pressure monitoring device (figures 1a and 2a,b), the at least one accelerometer (elements 110 and 10) is configured to be in contact with and attached to the outer skin of the skull of the user by the holding device (paragraphs [0037]-[0043]; figures 1a-2c).
Further regarding claim 3; Lovoi discloses the holding device further includes a biasing structure (holding device element 114 and 8 are biased to places accelerometer against head via headset); wherein, when the at least one accelerometer is attached to the outer skin of the skull of the user by the holding device, a bias directed toward the user is applied to the at least one accelerometer by the biasing structure (paragraphs [0037]-[0043]; figures 1a-2c).
Further regarding claim 5; Lovoi discloses the output device (elements 126, 128) is a signal transmission part, and includes at least one of a wired transmission module (element 126) or a wireless transmission module (element 128), so as to transmit the first monitoring signal to an external device (element 150, 160) ((paragraphs [0037]-[0043]; figures 1a-2c).
Further regarding claim 7; Lovoi discloses a quantity of the at least one accelerometer (elements 10) is two or more (embodiment of figures 2a-c includes at least 2 accelerometer elements 10); wherein the accelerometers are disposed on the holding device (element 8) and spaced apart from each other by a predetermined distance (figures 2a and b), such that the accelerometers are simultaneously and respectively in contact with and attached to the outer skin of a left side of the skull and the outer skin of a right side of the skull when the user wears the bone-conduction transcranial cerebral pressure monitoring device (paragraphs [0042]; figures 2a and b).
Further regarding claim 8; Lovoi discloses the at least one accelerometer is a capacitive accelerometer, a piezoelectric accelerometer, or a piezoresistive accelerometer (wherein Lovoi discloses 3 axis digital accelerometer utilizes 3 capacitive transducers, thus being capacitive; paragraph [0040]).
Regarding claim 9; Lovoi discloses a bone-conduction transcranial cerebral pressure monitoring device (wherein the examiner notes that the extracted accelerometer data is indicative of cerebral pressure and thus meets the BRI of cerebral pressure monitoring device; element 100, element 8; figures 1a,c,d and 2a,b), comprising:
at least one accelerometer (elements 110 or 10), wherein the at least one accelerometer is configured to contact an outer skin of a skull, so as to sense a transcranial cerebral pressure acceleration wave of the user for formation of a first monitoring signal (paragraph [0039]-[0043]; figures 1a-2c);
an output device (elements 126, 128), wherein the output device is communicatively connected to the at least one accelerometer, so as to output the first monitoring signal (paragraphs [0037]-[0043]; figures 1a-2c); and
a power supply device (element 130), wherein the power supply is electrically connected to the at least one accelerometer and the output device, so as to supply power to the at least one accelerometer and the output device (paragraphs [0037]-[0043]; figures 1a-2c).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lovoi.
Regarding claims 2; Lovoi is described in the rejection of claim 1 above. Lovoi further discloses the holding device (elements 112 and 114) further includes a hollow housing (element 112) wherein the output device and the power supply are disposed in the hollow housing (figure 1a).
However, Lovoi does not explicitly disclose the accelerometer is in the hollow housing of the holding device.
Lovoi does further discloses the embodiment of figures 1c and 1d which is an embodiment of the invention as described in paragraphs [0037]-[0040] similar to that of figure 1a. While the embodiment of figures 1c and d and the corresponding section of the specification does not explicitly describe the location of the accelerometer embodiment of figures 1c and d, it would have been clear to one of ordinary skill in the art at the time of filing that the accelerometer is located on the distal end of the arm extending from the housing to position the accelerometer against the skin in the same manner as depicted in figure 1a (see annotated figures 1c and 1d below).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to place the accelerometer inside the housing of the holding device of the embodiment depicted in figures 1c and d (see annotated figure below) in order to position the accelerometer against the skin and protect from external forces as obvious to try, choosing from a finite number of identified predictable solutions (either the accelerometer is mounted externally on the arm, or internally in a hollow portion of the arm), or in the alternative, as a mere rearrangement of parts (see MPEP 2144.04 VI).
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Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lovoi as applied to claims 1 and 9 above, and further in view of Berme et al (US 11,337,606 B1).
Lovoi is described in the rejection of claims 1 and 9 above; specifically, Lovoi further discloses a processor (controller element 124) disposed on the holding device (figures 1a and 1b) wherein head worn device is for obtaining an acceleration waveform from the accelerometers placed against the user’s skin on their head which is indicative of the accelerations experienced by the accelerometer and that the acceleration waveform is analyzed and investigated (paragraph [0039]).
However, Lovoi does not explicitly disclose the processor is configured to perform a double integral on the first monitoring signal output by the at least one accelerometer, so as to form a second monitoring signal; wherein the output device outputs at least one of the second monitoring signal or the first monitoring signal.
Berme teaches it is known to obtain a displacement signal of an accelerometer placed against the head by integrating the accelerometer signal twice in order to obtain the positional information data of the accelerometer.
Regarding claims 4 and 10; Lovoi teaches the accelerometer data represents small motion of the surface of the head produced by pulsatile cerebral blood flow and its impact on the skull. Berme teaches that displacement data of the accelerometer can be obtained by performing a double integral on the accelerometer data. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Lovoi’s processor such that it is configured to perform a double integral on the first monitoring signal output by the accelerometer as taught by Berme in order to obtain a second monitoring signal (displacement/position of the accelerometer) in order to analyze and investigate pulsatile cerebral blood flow displacement waveform.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lovoi as applied to claim 1 above, and further in view of Zwierstra et al (US 2024/0201737 A1).
Regarding claim 6; Lovoi is described in the rejection of claim 1 above; furthermore, Lovoi discloses an output device (displays of elements 150 and 160) for displaying the processed and collected data.
However, Lovoi does not explicitly disclose that the display or speaker is disposed on the holding device.
Zwierstra teaches a similar headset device for placing sensors against the head of the user wherein the headset includes electronics components in/on the housing which include user interface elements such as a graphical display, a touchscreen display, audio speakers or the like (paragraph [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Lovoi to provide a display or speakers on the headset as taught by Zwierstra in order to provide a user interface on the headset.
In the alternative, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Lovoi’s display to be on the holding device (headset) as mere rearrangement of parts (see MPEP 2144.04 VI).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2018/0296107 A1 to Harrer et al; discloses detection of heartbeat in cranial accelerometer data using independent component analysis.
US 2023/0380751 A1 to Pizur; discloses a brain impact sensor and method of using the same.
US 2023/0301523 A1 to Intrator; discloses a system for measuring physiological signal from a subject’s head.
US 2017/0172222 A1 to Morgenthau et al; discloses a sensor module for sensing forces to the heads of an individual for analysis.
US 2025/0295351 A1 to Grinnell et al; discloses a concussion sensor.
US 2017/0035350 A1 to Allessie et al; discloses a sensor module having accelerometers for placement on the head.
US 2016/0007935 A1 to Hernandez et al; discloses an apparatus for measuring physiological parameters on the head.
US 10,076,274 B2 to Lovoi et al; discloses a system and method for non-invasive detection of human cranial conditions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791