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 .
Election/Restrictions
Applicant’s election of claims 1-16 in the reply filed on 13 November 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 17-26 have been cancelled.
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.
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.
“holding device” is interpreted as a headband or head cuff,” as mentioned in [0014] of the PGPUB
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 Objections
Claims 3-16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and/or cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, the claims 3-16 have not been further treated on the merits.
Claims 3-5 and 15 are objected to because of the following informalities:
“the bimorph” in line 2 of claim 3 should read as “the at least one bimorph”
“the bending” in line 2 of claim 4 should read as “the at least one bimorph bending”
“the bending” in line 2 of claim 5 should read as “the at least one bimorph bending”
“the bimorph” in line 2 of claim 15 should read as “the at least one bimorph”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6, 8, 10, 11, and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 2-5, 7, 8, 12, and 16 are further rejected due to their dependency to claim 1.
Claim 1 recites the limitation “the neutral fiber” in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear what this limitation is referring to as “neutral fiber” was not previously recited. Examiner suggests to amend the limitation to read as “a neutral fiber.”
Claim 1 recites the limitation “the bending sensor layers” in lines 7 and 8 (recited twice). There is insufficient antecedent basis for this limitation in the claim. It is unclear what this limitation is referring to was “bending sensor layers” was not previously mentioned. It is unclear if this limitation is referring to “two sensor layers” as mentioned in line 5. Clarification is requested. For examination purposes, the limitation is interpreted as “the two sensor layers.”
Regarding claims 6, 8, and 13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10, the phrase “if necessary” renders the claim indefinite because it is unclear whether the limitations following the phase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 recites the limitation “the holder” in line 2. There is insufficient antecedent basis for this limitation in the claim. “Holder” was not previously recited and it is unclear what this limitation is referring to. For examination purposes, “the holder” is interpreted as “the holding device.”
Claim 14 recites the limitation “the piezoelectric bending sensor” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear what this limitation is referring to as “piezoelectric bending sensor” was not previously recited. It is unclear if this limitation is referring to “the at least one bimorph bending sensor” as mentioned in claim 1. Clarification is requested.
Regarding claim 15, the phrase "if any" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-3, 5, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 (US Pub No. 2013/0085400 – cited by Applicant) in view of Nguyen et al. ‘998 (US Pub No. 2021/0127998, provisional application date 14 March 2017).
Regarding claim 1, Oliveira et al. ‘400 teaches a measuring device for non-invasively detecting the intracranial pressure pulsation of a patient (Title, Abstract), comprising:
a holding device which can be detachably attached to the outside of the patient's skull (Fig. 3 strap 3 and [0041]) in a force-locking and/or form-locking manner (Fig. 3 adjustment system 5 and [0041]),
at least one bimorph bending sensor which is arranged in or on the holding device (Fig. 9 strain sensor 15 and [0046]),
an analog signal amplifier for amplifying the measurement data supplied by the bimorph bending sensor (Fig. 1 signal amplifier 4 and [0037]),
an A/D converter for converting the analog measurement data into digital data (Fig. 1 A/D converter 6 and [0037]), and
a computing unit for preprocessing the data and calculating parameters from the intracranial pressure pulsation curve which correlate with vital state variables on the basis of the digital data (Fig. 1 processor 8 and [0038], [0081]).
Oliveira et al. ‘400 teaches all of the elements of the current invention as mentioned above except for the at least one bimorph bending sensor having two sensor layers with antiparallel polarity arranged symmetrically around the neutral fiber, wherein upon bending in one direction one of the bending sensor layers is stretched while the other is equally compressed, the signals adding up when the bending sensor layers are loaded in opposite directions.
Nguyen et al. ‘998 teaches a pressure sensor 10 having layers that are stacked on each other (Fig. 2A and [0044]), indicating at least two layers. Electrodes 15 may be connected to create an additive polarization from all layers of the pressure sensor 10 ([0044]). This would aid in using the device with a high degree of reliability in varying conditions of time and pressure ([0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one bimorph bending sensor of Oliveira et al. ‘400 to include having two sensor layers with antiparallel polarity arranged symmetrically around the neutral fiber, wherein upon bending in one direction one of the bending sensor layers is stretched while the other is equally compressed, the signals adding up when the bending sensor layers are loaded in opposite directions as Nguyen et al. ‘998 teaches that this will aid in using the device with a high degree of reliability in varying conditions of time and pressure.
Regarding claim 2, Oliveira et al. ‘400 teaches wherein the holding device is formed as a headband or head cuff (Fig. 2 band 3 and [0049]) and/or has a display to display a measurement curve, a calculated parameter and an associated time course (Figs. 8, 17, 18 internal display 12 and [0038]-[0039], [0086]-[0087]).
Regarding claim 3, Oliveira et al. ‘400 teaches wherein the bimorph bending sensor is a piezoelectric bimorph bending sensor ([0036], Claim 5).
Regarding claim 5, Oliveira et al. ‘400 teaches wherein the bending sensor is arranged at or in a middle section of a C-shaped holder (Fig. 9 lid 7 and [0043]; A cross-section of the lid 7 is C-shaped.) arranged between two end sections (Fig. 4 shows that the lid 7 is arranged between two end sections of sensor box base 9.).
Regarding claim 12, Oliveira et al. ‘400 teaches wherein the measuring device comprises a data logger connected to the A/D converter or the computing unit (Fig. 1 digital memory 10 and [0038]-[0039]).
Regarding claim 13, Oliveira et al. ‘400 teaches wherein the holding device arranged as a headband comprises an energy storage device, preferably a battery or a rechargeable battery ([0037]; “battery”).
Regarding claim 14, Oliveira et al. ‘400 teaches wherein the piezoelectric bending sensor and/or the analog signal amplifier and/or the A/D converter are connected to a transmitting device or a transmitting-receiving device for wireless data transmission ([0047]; “wireless communication technologies”).
Regarding claim 15, Oliveira et al. ‘400 teaches wherein the bimorph bending sensor and the analog signal amplifier and the A/D converter and/or the transmitting device, if any, and/or the transmitting-receiving device for wireless data transmission ([0047]; “wireless communication technologies”), if any, and/or the battery or rechargeable battery ([0037]; “battery”), if any, are integrated in a single component (Fig. 1 and [0035]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Naser ‘979 (US Patent No. 4,233,979).
Regarding claim 4, Oliveira et al. ‘400 teaches wherein the bending sensor is arranged like a rocker on a support which can be attached to the outside of the patient's skull (Figs. 6-10 pin 16 and [0046]).
Oliveira et al. ‘400 in view of Nguyen et al. ‘998 teaches all of the elements of the current invention as mentioned above except for wherein the bending sensor is movable about a pivot point.
Naser ‘979 teaches a pivot pin to measure pressure in a cranium (Column 1 Lines 6-10) to manage depth control during a screw-in operation on a human skull (Column 1 Lines 36-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bending sensor of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 to include being movable about a pivot point as Naser ‘979 teaches that this will aid in managing depth control during a screw-in operation on a human skull.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Abdul-Hafiz et al. ‘520 (US Pub No. 2020/0113520).
Regarding claim 6, Oliveira et al. ’400 teaches wherein the holding device designed as a headband (Fig. 2 band 3 and [0049]) has a device for generating and adjusting a pretensioning force acting on the patient's skull (Fig. 3 adjustment system 5 and [0041]).
Oliveira et al. ‘400 in view of Nguyen et al. ‘998 teaches all of the elements of the current invention as mentioned above except for the device preferably having a force sensor or a strain sensor.
Abdul-Hafiz et al. ‘520 teaches a headband with one or more indicators and/or limiters that can assist a wearer and/or caregiver in applying the headband. The one or more indicators and/or limiters can help the wearer and/or caregiver stretch the headband an appropriate amount to achieve a desired and/or optimal pressure and/or force to the sensor and/or portion of the wearer's body underneath, adjacent, and/or proximate the sensor ([0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 to include preferably having a force sensor or a strain sensor as Abdul-Hafiz et al. ‘520 teaches that this will aid in assisting a wearer and/or caregiver in applying the headband.
Regarding claim 7, Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Abdul-Hafiz et al. ‘520 teaches all of the elements of the current invention as mentioned above except for wherein the device for generating the pretensioning force comprises an indicator for the pretensioning force or a voltage associated therewith.
Abdul-Hafiz et al. ‘520 teaches a headband with one or more indicators and/or limiters that can assist a wearer and/or caregiver in applying the headband. The one or more indicators and/or limiters can help the wearer and/or caregiver stretch the headband an appropriate amount to achieve a desired and/or optimal pressure and/or force to the sensor and/or portion of the wearer's body underneath, adjacent, and/or proximate the sensor ([0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Abdul-Hafiz et al. ‘520 to include an indicator for the pretensioning force or a voltage associated therewith as Abdul-Hafiz et al. ‘520 teaches that this will aid in assisting a wearer and/or caregiver in applying the headband.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Abdul-Hafiz et al. ‘520 further in view of Damadian et al. ‘310 (US Patent No. 9,766,310).
Regarding claim 8, Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Abdul-Hafiz et al. ‘520 teaches all of the elements of the current invention as mentioned above except for wherein the device for generating the pretensioning force is designed for automatically setting a predetermined pretensioning force and preferably comprises an electromechanical or a pneumatic mechanism.
Damadian et al. ‘310 teaches a patient handling system that incorporates one or more actuators and an actuation control unit. Actuators may be conventional electrical, electromechanical, pneumatic, hydraulic or other devices capable of imparting the desired motion to the elements of the patient handling system. The actuation control unit is linked to a control computer (such as computer 30) and to manual controls which regulate the patient handling system 106 (Column 6 Lines 46-61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Abdul-Hafiz et al. ‘520 to include generating the pretensioning force is designed for automatically setting a predetermined pretensioning force and preferably comprises an electromechanical or a pneumatic mechanism as Damadian et al. ‘310 teaches that electromechanical and pneumatic devices are conventional for imparting the desired motion of elements.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Ferguson ‘272 (US Pub No. 2017/0042272).
Regarding claim 9, Oliveira et al. ‘400 in view of Nguyen et al. ‘998 teaches all of the elements of the current invention as mentioned above except for wherein the holding device, which is in the form of the headband has pads over at least part of its length.
Ferguson ‘272 teaches a circumferential band with impact-absorbing bands (Fig. 1 impact absorbing gel pads 102, 104, 106, 108 and [0010], [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the holding device of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 to include being in the form of the headband has pads over at least part of its length as Ferguson ‘272 teaches that this will aid in distributing the force of impacts received ([0031]) and increase comfort ([0034]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of LeBoeuf et al. ‘519 (US Pub No. 2013/0131519).
Regarding claim 10, Oliveira et al. ‘400 in view of Nguyen et al. ‘998 teaches all of the elements of the current invention as mentioned above except for wherein the device comprises one or more of the following sensors: structure-borne sound sensor, acceleration sensor, position sensor, external pulse sensor, external blood pressure sensor, temperature sensor, and wherein the computing unit is designed to detect external disturbing influences or conditions detected by at least one of said sensors and, if necessary, to correct disturbing influences.
LeBoeuf et al. ‘519 teaches an accelerometer that may provide an inertial noise reference without measuring physiological information to cancel optical noise from an optical noise source as the noise may prevent a filter from working properly ([0187]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 to include one or more of the claimed sensors as LeBoeuf et al. ‘519 teaches that this will aid in cancelling optical noise as the noise may prevent a filter from working properly.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Quinn et al. ‘278 (US Pub No. 2021/0106278, foreign priority date 02 March 2018).
Regarding claim 11, Oliveira et al. ‘400 teaches the holder formed as a headband (Fig. 2 band 3 and [[0049]).
Oliveira et al. ‘400 in view of Nguyen et al. ‘998 teaches all of the elements of the current invention as mentioned above except for wherein the bending sensor is removable and replaceable from the holder.
Quinn et al. ‘278 teaches a user may also choose to replace the physiological sensors 204 with other types, such as replacing photodiode sensors with heart rate/blood pressure sensors to measure other types of physiological signals or data. Accordingly, the wearable physiological device 20 is customizable in design and the user can easily disassemble and reassemble the physiological device 20, possibly with repaired/upgraded components ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bending sensor of Oliveira et al. ‘400 in view of Nguyen et al. ‘998 to include being removable and replaceable from the holder as Quinn et al. ‘278 teaches that this will aid in customizing the device in design and the user easily disassembling and reassembling the device with repaired/upgraded components.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira et al. ‘400 in view of Nguyen et al. ‘998 further in view of Menkes et al. ‘827 (US Pub No. 2019/0289827).
Regarding claim 16, Oliveira et al. ‘400 teaches the holding device designed as a on the headband (Fig. 2 band 3 and [[0049]) and one strain sensor (Fig. 6 strain sensor 15 and [0043]).
Oliveira et al. ‘400 in view of Nguyen et al. ‘998 teaches all of the elements of the current invention as mentioned above except for wherein a plurality of piezoelectric bending sensors are arranged at the holding device.
Menkes et al. ‘827 teaches at least one piezoelectric element embedded in a band (Fig. 3A and [0036], Claim 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the at least one piezoelectric element of Menkes et al. ‘827 for the one strain sensor of Oliveira et al. ‘400 as Menkes et al. ‘827 teaches that simple substitution of one known element for another would obtain predictable results.
Examiner’s Note
It is noted that the Examiner has performed the 101 analysis on the claims. However, the analysis fails at step 2B as the bimorph bending sensor having two sensor layers with antiparallel polarity arranged symmetrically around the neutral fiber, in combination with the other structural elements, was not well-understood, routine, and conventional. As such, no 101 rejection as made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791