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 without traverse of Species B (claims 6-16) in the reply filed on December 11, 2025 is acknowledged. Species A (claims 1-5) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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, an integrated ultrasonic sensing device (claim 11) comprising an ultrasonic sensing device over a flexible substrate and a piezoelectric sensor over said substrate 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 Objections
Claims 6 and 11 are each objected to because of the following informalities: the phrase “wherein flexible substrate is attached to a part of a body”, the phrase “flexible substrate” should be preceded by “the” for proper antecedence basis. 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 11-16 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.
Claim 11 recites in part, “an ultrasonic sensing device over a flexible substrate ; a piezoelectric sensor over said substrate”, however, this recitation renders the claim indefinite in view of [0009], [0019] and [0036] of the specification as filed, because an ultrasonic sensing device comprises a piezoelectric component, which can be described as an ultrasonic sensing device comprising a piezoelectric sensor, and not two different elements (i.e. sensors) as recited in claim 11. Moreover, as noted in the objection to the drawings section above, the drawings fails to show this specific configuration recited in the claim. For examination purposes only, claim 11 will be examined as reciting “an ultrasonic sensing device comprising an piezoelectric sensor, over a flexible substrate”. Claims 12-16 are likewise rejected, because they include all limitations and deficiencies of base claim 11.
Claim 10 and 16 each recite in part, the body part to which the flexible substrate is attached includes neck blood vessels, a heart, lungs, a liver and pancreas that renders the claim indefinite because in view of the specification, e.g., [0018], the flexible substrate is attached on a skin surface to monitor the said body parts and not attached to said body part. For examination purposes, it will be presumed that in claims 6 and 12 recite in part, “wherein the flexible substrate is attached to monitor a part of a body …” and claims 10 and 16 refer to “said part that is monitored”.
Claim 12 recites the limitation "a flexible substrate disposed on said second bias electrode layer; and wherein the flexible substrate is attached to a part of a body" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim considering base claim 11 also recites “a flexible substrate” in lines 3-4. It is unclear if the recitation is claim 12 is one and the same with the recitation in claim 11. For examination purposes only, it will be presumed that the flexible substrate recited in claim 12 is one and the same with the previously recited flexible substrate in claim 11.
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 6-10 and 12-15 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). Claims 6 and 12 each recite in part “wherein flexible substrate is attached to a part of a body…” amounts to inferential recitation of part of a living thing, the scope of the claim encompasses a part of a living thing (body) as the claim recites a configuration that requires a body to be present, which renders the claim non-statutory. A phrase such as -- wherein flexible substrate is adapted to be attached to a part of a body… -- is suggested to address the understood intent of the Applicant to avoid the 35 U.S.C 101 rejection. Claims 7-10 and 13-15 are likewise rejected, only because they include all limitations and therefore the deficiencies of claim 6 or 12.
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 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. US 20170231598 A1 ("Baek").
Regarding claim 6, Baek discloses an ultrasonic sensing device ([0150], [0164] - “ultrasound measuring device 600 includes ultrasonic sensor system 610”- [0167] “FIG. 6B shows an example of an exploded view of an ultrasonic sensor system” and as illustrated in Fig. 6B), comprising:
a first electrode layer ([0169] - “second transmitter electrode 26”);
an ultrasonic emitting layer configured on said first electrode layer ([0169] - “piezoelectric transmitter layer 22” );
a first bias electrode layer configured on said ultrasonic emitting layer ([0169] - “first transmitter electrode 24”);
a thin film transistor layer, configured on said first bias electrode layer, including a pixel array ([0170] - “sensor pixel circuits 32 disposed on a substrate 34 (which also may be referred to herein as a backplane … each sensor pixel circuit 32 may include one or more TFT elements” - Examiner interprets substrate 34 with pixel circuit 32 comprising TFT (i.e. Thin Film Transistor) to read on TFT layer) ;
a pixel input electrode layer configured on said thin film transistor layer ([0170] - “pixel input electrode 38”);
an ultrasonic receiving layer configured on said pixel input electrode layer ([0170] - “piezoelectric receiver layer 36”);
a second bias electrode layer configured on the ultrasonic receiving layer ([0171] - “receiver bias electrode 39”);
a flexible substrate disposed on said second bias electrode layer ([0165] - “back support 650 … implemented with flexible material” and [0171] - “platen 40”); and
wherein flexible substrate is adapted to be attached to a part of a body ([0165] - “back support 650 … implemented with flexible material so that the wearable ultrasound measuring device 600 may wrap around or otherwise conform to the surface of the subject”), said ultrasonic emitting layer emits ultrasonic waves to said part, and receiving reflected ultrasonic waves ([0169-0170]), examiner notes that the recitation “for imaging” is directed to intended use, the device of Baek is capable of receiving reflected ultrasonic waves, for the purpose of imaging.
Baek discloses in [0166] that the wearable ultrasound measuring device 600 may be configured in the form of or incorporated into a patch, however, Baek does not explicitly disclose that the embodiment of Fig. 6A-6B comprise an adhesive. Baek does teach an alternative embodiment “device 200” in [0125] that may alternatively obtain measurements via one or more ultrasonic sensors, and wherein the device 200 may be attached to the skin surface with an adhesive. In view of these teaching, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to modify the embodiment of “device 600” to include an adhesive, to enable attachment of the device on a skin surface, hence, an adhesive ultrasonic device.
Regarding claim 7, see [0160] “the processor 620 may be configured to transmit signals to the ultrasound transmitter layer 614 in order to generate a continuous or pulsed sequence of ultrasonic plane waves, which are emitted from the focusing layer 612 as one or more beams of ultrasound”.
Regarding claims 8-9, see [0166] “… the wearable ultrasound measuring device 600 may be incorporated into athletic equipment, such as helmets, racket handles, wrist or headbands, shoes, socks, handle bars, etc., and configured so that the optical sensor(s) contact the skin of a subject” i.e. Baek discloses an embodiment comprising optical sensor(s), examiner takes Official Notice in regards to optical sensors incorporated in athletic equipment include an emitter or light emitting device to emit a light and a photodetector to detect the reflected light which senses a body part.
Regarding claim 10, this recitation is directed to intended use of the ultrasonic sensing device, the device of Baek is capable of being attached on a body surface adjacent to a neck blood vessel, heart, lungs, a liver or pancreas in light of teachings in [0164] “… the wearable ultrasound measuring device 600 may wrap around or otherwise conform to the surface of the subject, such as a finger, wrist, or other limb” and [0076] “The term "limb" is used herein to refer to a finger, wrist, forearm, ankle, leg, or other body part”.
Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hussain US 20160100817 A1 in view of Baek.
Regarding claim 11, as best understood (see 35 U.S.C 112(b) rejections above, Hussain discloses an integrated ultrasonic sensing device ([0146] stethoscope and [0170] “… that includes one or more ultrasound sensors”) comprising:
an ultrasonic sensing device ([0170] “The base 13… configured for ultrasound sensing that includes one or more ultrasound sensors”; a diaphragm configured on a circuit board ([0158] “The circuit board 19 can include a microphone pickup 51 configured to facilitate sound receipt by the at least one microphone”); and a sound-insulating ring (“base 13”) forms a resonant cavity with said circuit board (see illustration Figs. 3-6).
Hussain is silent as to the structure of the ultrasonic sensing device comprising a piezoelectric sensor over a flexible substrate and wherein said piezoelectric sensor is arranged under said sound insulating ring. Baek discloses an ultrasonic sensing device ([0150], [0164] - “ultrasound measuring device 600 includes ultrasonic sensor system 610”- [0167] - ultrasonic sensor system 655 - Fig. 6B) suitable for taking measurements for estimation of blood pressure ([0150]) comprising a piezoelectric sensor ([0169-0170] ultrasonic transmitter 644 comprise a piezoelectric transmitter layer 22 and ultrasonic receiver 666 comprise a piezoelectric receiver layer 36) over a flexible substrate ([0165] - “back support 650 … implemented with flexible material” and [0171] - “platen 40”).
In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have installed the ultrasonic sensor system of Baek onto the base 13 of Hussain for the added advantage of obtaining measurements to estimate blood pressure when using the stethoscope of Hussain.
Regarding claim 12, Hussain has been modified to include the ultrasonic sensor of Baek, Baek illustration Fig. 6B discloses all features of the ultrasonic sensing device as follows:
a first electrode layer ([0169] - “second transmitter electrode 26”);
an ultrasonic emitting layer configured on said first electrode layer ([0169] - “piezoelectric transmitter layer 22” );
a first bias electrode layer configured on said ultrasonic emitting layer ([0169] - “first transmitter electrode 24”);
a thin film transistor layer, configured on said first bias electrode layer, including a pixel array ([0170] - “sensor pixel circuits 32 disposed on a substrate 34 (which also may be referred to herein as a backplane … each sensor pixel circuit 32 may include one or more TFT elements” - Examiner interprets substrate 34 with pixel circuit 32 comprising TFT (i.e. Thin Film Transistor) to read on TFT layer) ;
a pixel input electrode layer configured on said thin film transistor layer ([0170] - “pixel input electrode 38”);
an ultrasonic receiving layer configured on said pixel input electrode layer ([0170] - “piezoelectric receiver layer 36”);
a second bias electrode layer configured on the ultrasonic receiving layer ([0171] - “receiver bias electrode 39”);
a flexible substrate disposed on said second bias electrode layer ([0165] - “back support 650 … implemented with flexible material” and [0171] - “platen 40”); and
wherein flexible substrate is adapted to be attached to a part of a body ([0165] - “back support 650 … implemented with flexible material so that the wearable ultrasound measuring device 600 may wrap around or otherwise conform to the surface of the subject”), said ultrasonic emitting layer emits ultrasonic waves to said part, and receiving reflected ultrasonic waves ([0169-0170]), examiner notes that the recitation “for imaging” is directed to intended use, the modified device of Hussain is capable of receiving reflected ultrasonic waves, for the purpose of imaging.
Regarding claim 13, Hussain has been modified by to include an ultrasound sensing device of Baek, as modified by Baek, see [0160] “the processor 620 may be configured to transmit signals to the ultrasound transmitter layer 614 in order to generate a continuous or pulsed sequence of ultrasonic plane waves, which are emitted from the focusing layer 612 as one or more beams of ultrasound”.
Regarding claims 14-15, Hussain has been modified by to include an ultrasound sensing device of Baek, as modified by Baek, see [0166] “… the wearable ultrasound measuring device 600 may be incorporated into athletic equipment, such as helmets, racket handles, wrist or headbands, shoes, socks, handle bars, etc., and configured so that the optical sensor(s) contact the skin of a subject” i.e. Baek discloses an embodiment comprising optical sensor(s), examiner takes Official Notice in regards to optical sensors incorporated in athletic equipment include an emitter or light emitting device to emit a light and a photodetector to detect the reflected light which senses a body part.
Regarding claim 16, this recitation is directed to intended use of the ultrasonic sensing device, the device of Baek is capable of being attached on a body surface adjacent to a neck blood vessel, heart, lungs, a liver or pancreas in light of teachings in [0164] “… the wearable ultrasound measuring device 600 may wrap around or otherwise conform to the surface of the subject, such as a finger, wrist, or other limb” and [0076] “The term "limb" is used herein to refer to a finger, wrist, forearm, ankle, leg, or other body part”.
Conclusion
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