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 Group IV (claim 24) in the reply filed on 12 Jan 2026 is acknowledged.
Additionally in the reply filed on 12 Jan 2026, claims 1-23 have been cancelled, claims 25-30 have been amended to depend on elected claim 24, and new claims 31-49 have been added. Claims 24-49 are currently under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09 Jul 2024, 16 Jul 2024, 16 Oct 2025, and 26 Nov 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Drawings
The drawings are objected to because in Fig. 10B, the label “Transducer 620” and the unlabeled arrow within reference “650” should be connected for clarity.
The drawings are also objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference number 625 is absent in the drawings. 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. 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.
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, 1) varying both the orientation and the lateral position of the ultrasound transducer as recited in claims 27, 29, and 46; 2) the “locking means” recited in claims 26-27 and 38-39; 3) “scale” recited in claims 28 and 40-41; and 4) “reference sensor” recited in claim 45 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.
Specification
The disclosure is objected to because of the following informalities:
“. . ” should read “.” ([0113]); and
“As shown in the figure” should read “As shown in the figures (or FIGS. 10A-10D)” ([0113]).
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informality:
“the absence of an external applied force” should read “an absence of an externally applied force”.
Appropriate correction is required.
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.
Claim 26 recites the limitations “a locking means for releasably locking at least one of the suitable orientation and the suitable lateral position of said ultrasound transducer relative to said housing” and “actuating the locking means”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 26 and its dependent claim 27 have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
[0178] Additionally or alternatively, a releasable locking means or mechanism may be provided to facilitate the locking of the orientation and/or lateral position of the ultrasound transducer assembly. It will be understood that a wide variety of locking mechanisms may be employed, such as, but not limited to, locking screws/knobs, clamping collars and other clamping mechanisms, latches, and other suitable fixation mechanisms. The locking means may be actuated after determining, based on the detection or monitoring of Doppler ultrasound signals, that the ultrasound transducer is aligned on a vessel of interest.
For purposes of the examination, the Examiner will interpret “locking means” as screws/knobs, clamping collars, latches, or equivalents thereof.
Claim 38 recites the limitation “an orientation locking means for releasably locking the orientation of said ultrasound transducer relative to said housing”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 38 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
[0178] Additionally or alternatively, a releasable locking means or mechanism may be provided to facilitate the locking of the orientation and/or lateral position of the ultrasound transducer assembly. It will be understood that a wide variety of locking mechanisms may be employed, such as, but not limited to, locking screws/knobs, clamping collars and other clamping mechanisms, latches, and other suitable fixation mechanisms. The locking means may be actuated after determining, based on the detection or monitoring of Doppler ultrasound signals, that the ultrasound transducer is aligned on a vessel of interest.
For purposes of the examination, the Examiner will interpret “orientation locking means” as screws/knobs, clamping collars, latches, or equivalents thereof.
Claim 39 recites the limitation “a position locking means for releasably locking the lateral position of said ultrasound transducer relative to said housing”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 38 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
[0178] Additionally or alternatively, a releasable locking means or mechanism may be provided to facilitate the locking of the orientation and/or lateral position of the ultrasound transducer assembly. It will be understood that a wide variety of locking mechanisms may be employed, such as, but not limited to, locking screws/knobs, clamping collars and other clamping mechanisms, latches, and other suitable fixation mechanisms. The locking means may be actuated after determining, based on the detection or monitoring of Doppler ultrasound signals, that the ultrasound transducer is aligned on a vessel of interest.
For purposes of the examination, the Examiner will interpret “position locking means” as screws/knobs, clamping collars, latches, or equivalents thereof.
Claim 44 recites the limitation “an encoding mechanism for encoding at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 44 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
[0181] In some example implementations, an encoding mechanism may be employed to facilitate encoding of the angle and/or lateral position of the ultrasound transducer assembly. For example, an optical encoder or electrical encoder (e.g. conductive or potentiometer based) may be employed. The encoding mechanism may include an encoding interface, such as a reflective interface or conductive interface with a set of markings or conductive features, and an encoding sensor, such as an optical emitter/detector or a conductivity/resistance detection circuit, where the encoding sensor moves relative to the encoding interface, or vice versa. The signal from the encoder sensor may be employed and processed by control and processing circuitry to determine an angle and/or lateral position of the ultrasound transducer assembly relative to the housing.
For purposes of the examination, the Examiner will interpret “encoding mechanism” as an optical encoder, an electrical encoder, an encoding interface, an encoding sensor, or equivalents thereof.
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure(s), material(s), or act(s) and clearly links them to the function so that one of ordinary skill in the art would recognize what structure(s), material(s), or act(s) perform the claimed function, applicant should clarify the record by either: (1) amending the written description of the specification such that it expressly recites the corresponding structure(s), material(s), or act(s) to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (2) stating on the record what the corresponding structure(s), material(s), or act(s), which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. See 37 CFR 1.75(d) and MPEP §608.01(o) and §2181.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27, 29, and 44-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 27 recites the limitation “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing, and wherein the locking means is configured for releasably locking both the orientation and the lateral position of the ultrasound transducer assembly relative to the frame, the method further comprising: after varying both the orientation and lateral position of the ultrasound transducer assembly to determine the suitable orientation and the suitable lateral position of the ultrasound transducer that is associated with detection of blood flow within the blood vessel, actuating the locking means to lock both the orientation and the lateral position of the ultrasound transducer assembly”. A review of the specification does not disclose 1) “varying both the orientation and lateral position of said ultrasound transducer assembly”; and 2) “wherein the locking means is configured for releasably locking both the orientation and the lateral position of the ultrasound transducer assembly relative to the frame” and “actuating the locking means to lock both the orientation and the lateral position of the ultrasound transducer assembly”. A review of the original specification discloses in varying the orientation of an ultrasound transducer assembly (Fig. 10A-D) in one embodiment and varying the lateral position of an ultrasound transducer assembly (Fig. 11-13) in another embodiment. Specifically, the original specification discloses varying the orientation of an ultrasound transducer assembly by “a ball and socket joint” (Fig. 10A-D and [0162]) and varying the lateral position of an ultrasound transducer assembly by “a slider” (Fig. 11-13 and [0171]), but does not disclose a single embodiment encompassing varying both the orientation and the lateral position of an ultrasound transducer assembly. In [0175] of the original specification, Applicant even admits that “the figures and preceding description refer to example implementations in which the ultrasound device is configured to facilitate either rotation or lateral translation of the ultrasound transducer assembly relative to the housing”. Applicant merely notes in [0175] that “it will be understood that other example implementations may combine such features, such that the ultrasound device is configured to facilitate both rotation and lateral translation of the ultrasound transducer assembly relative to the housing” but does not disclose in sufficient detail an embodiment combining both, for example, “a ball and socket joint” and “a slider” to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention. Furthermore, the original specification does not disclose in sufficient detail a locking means that are configured to lock both the orientation and the lateral position of the ultrasound transducer assembly to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention. Therefore, the limitations are not supported by the scope of written description.
Claim 29 recites the limitation “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing”. Similar to claim 27 above, a review of the original specification discloses in varying the orientation of an ultrasound transducer assembly (Fig. 10A-D) in one embodiment and varying the lateral position of an ultrasound transducer assembly (Fig. 11-13) in another embodiment. Specifically, the original specification discloses varying the orientation of an ultrasound transducer assembly by “a ball and socket joint” (Fig. 10A-D and [0162]) and varying the lateral position of an ultrasound transducer assembly by “a slider” (Fig. 11-13 and [0171]), but does not disclose a single embodiment encompassing varying both the orientation and the lateral position of an ultrasound transducer assembly. Applicant merely notes in [0175] that “it will be understood that other example implementations may combine such features, such that the ultrasound device is configured to facilitate both rotation and lateral translation of the ultrasound transducer assembly relative to the housing” but does not disclose in sufficient detail an embodiment combining both, for example, “a ball and socket joint” and “a slider” to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention. Therefore, the limitation is not supported by the scope of written description.
Claim 44 recites the limitation “wherein said control circuitry is configured to process a signal from an encoding sensor associated with said encoding mechanism to determine at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing”. A review of the specification of the original specification, however, does not disclose in sufficient detail the algorithm (e.g., the necessary steps and/or flowcharts) for the control circuitry in “process(ing) a signal from an encoding sensor associated with said encoding mechanism to determine at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing”. See MPEP 2161.01.I.
Claim 45 recites the limitation “wherein said control circuitry is configured to process a signal from said reference sensor to determine when said ultrasound transducer assembly resides at the reference angle or the reference lateral position”. A review of the specification of the original specification, however, does not disclose in sufficient detail the algorithm (e.g., the necessary steps and/or flowcharts) for the control circuitry in “process(ing) a signal from said reference sensor to determine when said ultrasound transducer assembly resides at the reference angle or the reference lateral position”. See MPEP 2161.01.I.
Claim 46 recites the limitation “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation and the lateral position of said ultrasound transducer assembly”. Similar to claims 27 and 29 above, a review of the original specification discloses in varying the orientation of an ultrasound transducer assembly (Fig. 10A-D) in one embodiment and varying the lateral position of an ultrasound transducer assembly (Fig. 11-13) in another embodiment. Specifically, the original specification discloses varying the orientation of an ultrasound transducer assembly by “a ball and socket joint” (Fig. 10A-D and [0162]) and varying the lateral position of an ultrasound transducer assembly by “a slider” (Fig. 11-13 and [0171]), but does not disclose a single embodiment encompassing varying both the orientation and the lateral position of an ultrasound transducer assembly. Applicant merely notes in [0175] that “it will be understood that other example implementations may combine such features, such that the ultrasound device is configured to facilitate both rotation and lateral translation of the ultrasound transducer assembly relative to the housing” but does not disclose in sufficient detail an embodiment combining both, for example, “a ball and socket joint” and “a slider” to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention. Therefore, the limitation is not supported by the scope of written description.
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 24-49 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 24 recites the limitation “wherein said housing is configured to generate a frictional force as a result of contact with said ultrasound transducer assembly”. The antecedent basis for “said ultrasound transducer assembly” is unclear. It is unclear whether “said ultrasound transducer assembly” is referring to “ultrasound transducer” in claim 24 or the ultrasound transducer device of claim 24, or otherwise. Claims 25-49 inherit the deficiency by the nature of their dependency on claim 24. For purposes of the examination, “said ultrasound transducer assembly” in the limitation as well as any further recitation of “ultrasound transducer assembly” in claim 24 and dependent claims 25-49 are being given a broadest reasonable interpretation as “the ultrasound transducer”.
Claim 24 recites the limitation “wherein the frictional force is sufficiently low to permit manual actuation thereof and sufficiently high to maintain said ultrasound transducer assembly in a fixed orientation in the absence of an external applied force”. The terms “sufficiently low” and “sufficiently high” are relative terms which render the claim indefinite. The terms “sufficiently low” and “sufficiently high” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, “to permit manual actuation thereof” and “maintain said ultrasound transducer assembly in a fixed orientation in the absence of an external applied force” do not suggest any standard for ascertaining the requisite degrees of “sufficiently low” and “sufficiently high”, respectively: for example, the manual actuation can be permitted by a various amount of frictional force, and the ultrasound transducer assembly can be in a fixed orientation in an absence of an externally applied force even momentarily. Claims 25-49 inherit the deficiency by the nature of their dependency on claim 24. For purposes of the examination, the limitation is being given a broadest reasonable interpretation a “wherein the ultrasound transducer is configured to be manually actuated within the housing and be in a fixed orientation in an absence of an externally applied force”.
Claim 25 recites the limitation “employing the Doppler ultrasound signals to determine at least one of a suitable orientation and a suitable lateral position of the ultrasound transducer assembly that is associated with detection of blood flow within a blood vessel”. The terms “suitable orientation” and “suitable lateral position” are relative terms which render the claim indefinite. The terms “suitable orientation” and “suitable lateral position” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 26-30 inherit the deficiency by the nature of their dependency on claim 25. For purposes of the examination, the limitation in claim 25 is being given a broadest reasonable interpretation as “employing the Doppler ultrasound signals to determine at least one of a fixed orientation and a fixed lateral position of the ultrasound transducer that is associated with detection of blood flow within a blood vessel”, and any further recitations of “the suitable orientation and the suitable lateral position of said ultrasound transducer assembly” or “the suitable orientation and the suitable lateral position of said ultrasound transducer” in claim 25 and its dependent claims 26-30 are being given a broadest reasonable interpretation as “the fixed orientation and fixed lateral position of said ultrasound transducer”.
Claim 27 recites the limitation “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing, and wherein the locking means is configured for releasably locking both the orientation and the lateral position of the ultrasound transducer assembly relative to the frame, the method further comprising: after varying both the orientation and lateral position of the ultrasound transducer assembly to determine the suitable orientation and the suitable lateral position of the ultrasound transducer that is associated with detection of blood flow within the blood vessel, actuating the locking means to lock both the orientation and the lateral position of the ultrasound transducer assembly”. As noted above in the 35 U.S.C. 112(a) rejection for lack of scope of written description, the metes and bounds of the limitation are unclear when the original specification lacks support for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation or lateral position of said ultrasound transducer assembly relative to said housing, and wherein the locking means is configured for releasably locking the orientation or lateral position of the ultrasound transducer assembly relative to the frame, the method further comprising: after varying the orientation or lateral position of the ultrasound transducer to determine the fixed orientation or fixed lateral position of the ultrasound transducer that is associated with detection of blood flow within the blood vessel, actuating the locking means to lock the orientation or lateral position of the ultrasound transducer”.
Claim 29 recites the limitation “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing, the method further comprising: employing the Doppler ultrasound signals to determine the suitable orientation and the suitable lateral position of said ultrasound transducer assembly such that said longitudinal axis is substantially perpendicular to an axis of the blood vessel”. As noted above in the 35 U.S.C. 112(a) rejection for lack of scope of written description, the metes and bounds of the limitation are unclear when the original specification lacks support for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein said ultrasound transducer and said housing are configured such that said ultrasound transducer is moveable, relative to said housing, for varying the orientation or lateral position of said ultrasound transducer relative to said housing, the method further comprising: employing the Doppler ultrasound signals to determine the fixed orientation or fixed lateral position of said ultrasound transducer such that said longitudinal axis is substantially perpendicular to an axis of the blood vessel”.
Claim 46 recites the limitation “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation and the lateral position of said ultrasound transducer assembly”. As noted above in the 35 U.S.C. 112(a) rejection for lack of scope of written description, the metes and bounds of the limitation are unclear when the original specification lacks support for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation or lateral position of said ultrasound transducer assembly”.
Claim Rejections - 35 USC § 102
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 24, 31-32, 34, 38, 40, and 46-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chandraratna et al. (US Patent No. 5598845) – hereinafter referred to as Chandraratna.
Regarding claim 24, Chandraratna discloses an ultrasound device (at least Fig. 3, 5-6) comprising:
a housing (Fig. 3, 5-6: ring portion 14) configured for attachment to a skin surface (Fig. 3-6: skin surface 21; Fig. 3, 5-6 and Col 5, lines 5-8: assembled device 1, including ring portion 14, is adhered to skin surface 21 of the patient);
an ultrasound transducer (Fig. 3, 5-6: acoustic transducer means 16) supported relative to said housing (Fig. 3, 5-6: ring portion 14) such that said ultrasound transducer is moveable, relative to said housing, for varying an orientation of said ultrasound transducer relative to said housing (Fig. 3, 5-6 and Col 4, line 66 - Col 5, line 4: ring portion 14 holds transducer enclosure 6 in position without further movement, after the enclosure position has been manually adjusted for scanning the patient; Col 4, lines 19-26: acoustic transducer means 16 mounted inside the bottom of enclosure 6); and
wherein said housing (Fig. 3, 5-6: ring portion 14) is configured to generate a frictional force as a result of contact with said ultrasound transducer assembly (Col 4, line 66 - Col 5, line 4: ring portion 14 provides a friction engagement with outside surface of transducer enclosure 6; Col 4, lines 19-26: acoustic transducer means 16 mounted inside the bottom of enclosure 6),
wherein the frictional force is sufficiently low to permit manual actuation thereof and sufficiently high to maintain said ultrasound transducer assembly in a fixed orientation in the absence of an external applied force (Fig. 3, 5-6 and Col 4, line 66 - Col 5, line 4: ring portion 14 holds transducer enclosure 6 in position without further movement, after the enclosure position has been manually adjusted for scanning the patient).
Regarding claim 31, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
a coupling component (Fig. 3, 5-6: transducer enclosure 6) for coupling ultrasound energy between said ultrasound transducer and the skin surface (Fig. 3: ultrasound scanning beam emitted from transducer means 16 through enclosure 6 into skin surface 21; Col 3, lines 34-37),
wherein said coupling component is in acoustic communication with said ultrasound transducer (Fig. 3: ultrasound scanning beam emitted from transducer means 16 through enclosure 6 into skin surface 21; Col 3, lines 34-37), and
wherein a distal portion of said coupling component is configured to contact and apply pressure to the skin surface when said housing is secured to the skin surface (Fig. 3, 5-6: transducer enclosure 6 coupled to skin surface 21; Col 4, line 51 - Col 5, line 4: holding pad comprising adhesive layer 5 and ring portion 14, and transducer enclosure 6 held in position relative to skin surface 21 by ring portion 14 of holding pad).
Regarding claim 32, Chandraratna discloses all limitations of claim 31, as discussed above, and Chandraratna further discloses:
wherein said ultrasound transducer assembly is supported, relative to said housing, such that a constant pressure is maintained between said distal portion of said coupling component and the skin surface when said ultrasound transducer assembly is moved relative to said housing (Fig. 5-6: transducer enclosure 6 maintaining contact with skin surface 21 during orientation change within ring portion 14; Col 5, lines 34-67: enclosure 6 to swivel with one side downwards inside the ring portion 14, placing the face of the transducer means 16 at an angle to the patient's chest surface and thereby adjusting the area scanned by the transducer means).
Regarding claim 34, Chandraratna discloses all limitations of claim 32, as discussed above, and Chandraratna further discloses:
wherein said housing (Fig. 3, 5-6: ring portion 14) comprises a socket (Fig. 3, 5-6),
wherein at least a distal portion of said ultrasound transducer assembly (Fig. 3, 5-6: transducer enclosure 6 comprising round sides that contact with ring portion 14) is spherical in shape (Fig. 3, 5-6 and Col 4, lines 19-26: spherical shaped, hollow enclosure 6) and resides within said socket, thereby forming a ball and socket joint (Fig. 3, 5-6: transducer enclosure 6 within ring portion 14; Col 4, lines 55-58: inner surface of ring portion 14 is curved and sized in diameter to fit closely over the outside surface of the transducer enclosure 6),
said socket comprising a distal aperture through which said ultrasound transducer assembly projects (Fig. 3, 5-6 and Col 4, lines 51-59: circular hole at center of cloth portion 4 to which ring portion 14 is attached), such that said distal portion of said coupling component contacts and applies pressure to the skin surface when housing is secured to the skin surface, and such that the constant pressure is maintained between said coupling component and the skin surface during rotation of said ultrasound transducer assembly (Fig. 3, 5-6: transducer enclosure 6 in contact with skin surface 21 during orientation change relative to ring portion 14; Col 4, lines 55-58: inner surface of ring portion 14 is curved and sized in diameter to fit closely over the outside surface of the transducer enclosure 6; Col 5, lines 34-67: enclosure 6 to swivel with one side downwards inside the ring portion 14, placing the face of the transducer means 16 at an angle to the patient's chest surface and thereby adjusting the area scanned by the transducer means).
Regarding claim 38, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
wherein said housing (Fig. 3, 5-6: ring portion 14) is configured to facilitate variation of the orientation of said ultrasound transducer assembly relative to said housing (Fig. 5-6 and Col 4, lines 55-58: inner surface of ring portion 14 is curved and sized in diameter to fit closely over the outside surface of the transducer enclosure 6; Col 5, lines 34-67: enclosure 6 to swivel with one side downwards inside the ring portion 14, placing the face of the transducer means 16 at an angle to the patient's chest surface and thereby adjusting the area scanned by the transducer means), and
wherein at least one said housing and said ultrasound transducer assembly comprises an orientation locking means (Fig. 5-6: actuating pins 24) for releasably locking the orientation of said ultrasound transducer relative to said housing (Fig. 5-6 and Col 5, lines 55-60: pushing down at least one of the actuating pins 24 causes the enclosure 6 to swivel with one side downwards inside the ring portion 14, thus not pushing down at least one of the actuating pins would lock the orientation of the transducer enclosure 6).
Regarding claim 40, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
wherein said housing (Fig. 3, 5-6: ring portion 14) is configured to facilitate variation of the orientation of said ultrasound transducer assembly relative to said housing (Fig. 5-6 and Col 4, lines 55-58: inner surface of ring portion 14 is curved and sized in diameter to fit closely over the outside surface of the transducer enclosure 6; Col 5, lines 34-67: enclosure 6 to swivel with one side downwards inside the ring portion 14, placing the face of the transducer means 16 at an angle to the patient's chest surface and thereby adjusting the area scanned by the transducer means), and
wherein at least one of said housing and said ultrasound transducer assembly comprises an orientation scale that permits visual determination of the orientation of said ultrasound transducer relative to said housing (Fig. 5-6: actuating pins 24 that are depressed vs. non-depressed; Col 5, lines 55-60: one or two of the actuating pins 24 pushed down indicating swiveled enclosure 6, placing face of the transducer means 16 at an angle to the patient).
Regarding claim 46, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
wherein said ultrasound transducer assembly (Fig. 3, 5-6: acoustic transducer means 16) and said housing (Fig. 3, 5-6: ring portion 14) are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation or the lateral position of said ultrasound transducer assembly (Fig. 3, 5-6 and Col 4, line 66 - Col 5, line 4: ring portion 14 holds transducer enclosure 6 in position without further movement, after the enclosure position has been manually adjusted for scanning the patient; Col 4, lines 19-26: acoustic transducer means 16 mounted inside the bottom of enclosure 6).
Regarding claim 47, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
wherein said ultrasound transducer is a single element ultrasound transducer (Col 4, lines 36-39: acoustic transducer means 16 comprising a mechanical scanned single element).
Regarding claim 48, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
wherein said ultrasound transducer comprises a plurality of ultrasound transducer elements (Col 4, lines 36-39: acoustic transducer means 16 comprising a phased array or an annular array).
Regarding claim 49, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna further discloses:
a flexible substrate (Fig. 3, 5-6: cloth portion 4) that is attachable to the skin surface for indirectly supporting said housing relative to the skin surface (Fig. 3, 5-6 and Col 4, lines 50-56: cloth portion having adhesive layer 5 affixed underside; Col 5, lines 5-8: assembled device 1 is adhered to skin surface 21).
Claims 24, 31-37, 39, 41, 43, 46, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura et al. (US PG Pub No. 2017/0156695) – hereinafter referred to as Nakamura.
Regarding claim 24, Nakamura discloses an ultrasound device (at least Fig. 2, 7, 10-11) comprising:
a housing (Fig. 2, 10: fixation section 3) configured for attachment to a skin surface (Fig. 2, 10: living body A; [0067]: fixation section 3 is fixed to the body surface of the living body A);
an ultrasound transducer (Fig. 2, 10: ultrasonic device 22) supported relative to said housing such that said ultrasound transducer is moveable, relative to said housing, for varying an orientation of said ultrasound transducer relative to said housing (Fig. 10 and housing 21 comprising ultrasonic device 22 rotates relatively to the fixation section 3) or a lateral position of said ultrasound transducer relative to said housing (Fig. 2 and [0068]: position of ultrasonic device 22 can be adjusted along the X direction with respect to the fixation section 3); and
wherein said housing is configured to generate a frictional force as a result of contact with said ultrasound transducer assembly (Fig. 2 and [0102]: contact surface 211B of housing 21 is a surface having contact with the probe-opposed surface 33 of the fixation section 3; Fig. 10 and [0151]: contact surface 211D of housing 21 and probe-opposed surface 33 of the fixation section 3 keep having contact with each other),
wherein the frictional force is sufficiently low to permit manual actuation thereof (Fig. 2 and [0123]-[0125]: manually moving pressing part 242A forward and backward to move ultrasonic device 22 along X direction; Fig. 10-11 and [0147]: manually rotating probe-side magnet 23 for rotating probe-side magnet 23 relatively to the house 21) and sufficiently high to maintain said ultrasound transducer assembly in a fixed orientation in the absence of an external applied force (Fig. 2 and [0076]: relative position between the fixation section-side magnet 31 and the probe-side magnet 23 attracting each other with magnetic force is uniquely determined, and thus, the ultrasonic probe 2 is fixed to the fixation section 3).
Regarding claim 31, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
a coupling component (Fig. 2, 7, 10-11: acoustic lens 44) for coupling ultrasound energy between said ultrasound transducer and the skin surface ([0097]: acoustic lens 44 efficiently propagates the ultrasonic wave emitted from the ultrasonic transducers 45 to the living body A as the measurement object, and further propagate the ultrasonic wave, which has been reflected in the living body A, to the ultrasonic transducers 45 with efficiency),
wherein said coupling component is in acoustic communication with said ultrasound transducer ([0097]: acoustic lens 44 is set to have an acoustic impedance intermediate between the acoustic impedance of the ultrasonic transducers 45 of the element substrate 41 of the ultrasonic device 22 and the acoustic impedance of the living body), and
wherein a distal portion of said coupling component is configured to contact and apply pressure to the skin surface when said housing is secured to the skin surface (Fig. 2, 7, 10-11 and [0072]: acoustic lens 44 in contact with body surface via acoustic matching material 35 when the ultrasonic probe 2 is fixed to the fixation section 3).
Regarding claim 32, Nakamura discloses all limitations of claim 31, as discussed above, and Nakamura further discloses:
wherein said ultrasound transducer assembly is supported, relative to said housing, such that a constant pressure is maintained between said distal portion of said coupling component and the skin surface when said ultrasound transducer assembly is moved relative to said housing (Fig. 2, 7, 10-11 and [0076]: relative position between the fixation section-side magnet 31 and the probe-side magnet 23 attracting each other with magnetic force is uniquely determined, and thus, the ultrasonic probe 2 is fixed to the fixation section 3; [0130]: relative position of the probe-side magnet 23 to the fixation section-side magnet 31 does not change since the fixation section-side magnet 31 and the probe-side magnet 23 attract each other with the magnetic force when the ultrasonic device 22 is displaced toward the -X direction relatively to the fixation section 3).
Regarding claim 33, Nakamura discloses all limitations of claim 32, as discussed above, and Nakamura further discloses:
wherein said housing (Fig. 10: fixation section 3) is configured to permit rotation of said ultrasound transducer assembly (Fig. 10: ultrasonic device 22) about a rotation axis (Fig. 10 and [0151]: rotating the probe-side magnet 23 counterclockwise relatively to the housing 21, since the probe-side magnet 23 and the fixation section-side magnet attract each other, the housing 21 rotates clockwise relatively to the fixation section 3 while the curved contact surface 211D and a part of the probe-opposed surface 33 of the fixation section 3 keep having contact with each other), and
wherein a distal surface of said coupling component comprises a circular shape (Fig. 10: acoustic lens 44) in a plane perpendicular to said rotation axis such that the constant pressure is maintained between said coupling component and the skin surface during rotation of said ultrasound transducer assembly (Fig. 10 and [0151]: rotating the probe-side magnet 23 counterclockwise relatively to the housing 21, since the probe-side magnet 23 and the fixation section-side magnet attract each other, the housing 21 rotates clockwise relatively to the fixation section 3 while the curved contact surface 211D and a part of the probe-opposed surface 33 of the fixation section 3 keep having contact with each other).
Regarding claim 34, Nakamura discloses all limitations of claim 32, as discussed above, and Nakamura further discloses:
wherein said housing (Fig. 11: probe-contact surface 33A of fixation section 3A) comprises a socket (Fig. 11 and [0160]: probe-contact surfaces 33A of fixation section 3A each having the same curvature formed in the probe-opposed surface 33 of the fixation section 3A),
wherein at least a distal portion of said ultrasound transducer assembly is spherical in shape (Fig. 11: curved contact surface 22D of ultrasonic device 22) and resides within said socket, thereby forming a ball and socket joint (Fig. 11 and [0160]: probe-contact surfaces 33A have the same curvature radius as that of the contact surface 211D of the ultrasonic probe 2A),
said socket comprising a distal aperture (Fig. 11 and [0162]: opening part (the space in the frame) of the fixation section 3A in which acoustic matching material 35 is provided) through which said ultrasound transducer assembly projects, such that said distal portion of said coupling component contacts and applies pressure to the skin surface when housing is secured to the skin surface, and such that the constant pressure is maintained between said coupling component and the skin surface during rotation of said ultrasound transducer assembly (Fig. 10-11 and [0151]: rotating the probe-side magnet 23 counterclockwise relatively to the housing 21, since the probe-side magnet 23 and the fixation section-side magnet attract each other, the housing 21 rotates clockwise relatively to the fixation section 3 while the curved contact surface 211D and a part of the probe-opposed surface 33 of the fixation section 3 keep having contact with each other).
Regarding claim 35, Nakamura discloses all limitations of claim 32, as discussed above, and Nakamura further discloses:
wherein said housing comprises a slot (Fig. 11 and [0162]: opening part (the space in the frame) of the fixation section 3A in which acoustic matching material 35 is provided) configured to permit lateral translation of said ultrasound transducer assembly relative to said housing in a direction parallel to the skin surface, and such that the constant pressure is maintained between said coupling component and the skin surface during lateral translation of said ultrasound transducer assembly (Fig. 2, 7 and [0076]: relative position between the fixation section-side magnet 31 and the probe-side magnet 23 attracting each other with magnetic force is uniquely determined, and thus, the ultrasonic probe 2 is fixed to the fixation section 3).
Regarding claim 36, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
wherein housing (Fig. 2, 7: fixation section 3A) is configured to permit lateral translation of said ultrasound transducer assembly relative to said housing in a translation direction that is parallel to the skin surface ([0067]: fixation section 3 is fixed to the body surface of living body A and then the ultrasonic probe 2 is fixed to the fixation section 3; [0130]: relative position of the probe-side magnet 23 to the fixation section-side magnet 31 does not change since the fixation section-side magnet 31 and the probe-side magnet 23 attract each other with the magnetic force when the ultrasonic device 22 is displaced toward the -X direction relatively to the fixation section 3), and
wherein said ultrasound transducer (Fig. 2, 10: ultrasonic device 22) comprises a one-dimensional array of ultrasound elements (Fig. 4 and [0068]: ultrasonic device 22 has a one-dimensional array structure having a plurality of ultrasonic transducer groups 45A),
the one-dimensional array of ultrasound elements being disposed along a longitudinal axis that is parallel to the translation direction (Fig. 2, 7 and [0066]: fixing the ultrasonic probe 2 to the body surface of the living body A via the fixation section 3 to transmit (perform a transmission process of) an ultrasonic wave, and then receive (perform a reception process of) the ultrasonic wave reflected by the part in the living body A).
Regarding claim 37, Nakamura discloses all limitations of claim 36, as discussed above, and Nakamura further discloses:
wherein the one-dimensional array of ultrasound elements are angled relative to the skin surface (Fig. 2: ultrasonic device 22 relative to living body A along the X direction).
Regarding claim 39, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
wherein said housing (Fig. 2: fixation section 3) is configured to facilitate variation of the lateral position of said ultrasound transducer assembly relative to said housing (Fig. 2 and [0068]: position of ultrasonic device 22 can be adjusted along the X direction with respect to the fixation section 3), and
wherein at least one of said housing and said ultrasound transducer assembly comprises a position locking means (Fig. 2: biasing section 241 and pressing section 242) for releasably locking the lateral position of said ultrasound transducer relative to said housing (Fig. 2, 7 and [0123]-[0125]: a biasing section 241 for biasing the probe-side magnet 23 toward the −X direction, and a pressing section 242 for pressing the probe-side magnet 23 toward the +X direction, thus not moving pressing part 242 would lock the lateral position of the ultrasonic device 22).
Regarding claim 41, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
wherein said housing (Fig. 2: fixation section 3) is configured to facilitate variation of the lateral position of said ultrasound transducer assembly relative to said housing (Fig. 2 and [0068]: position of ultrasonic device 22 can be adjusted along the X direction with respect to the fixation section 3), and
wherein at least one of said housing and said ultrasound transducer assembly comprises a lateral position scale that permits visual determination of the lateral position of said ultrasound transducer relative to said housing (Fig. 2, 6-7 and [0123]-[0125]: expanded vs. contracted coil spring of biasing section 241 along the X direction and pressing section 242 moved forward vs. backward along the X direction providing a visual determination of the lateral position of the ultrasonic device 22 relative to fixation section 3).
Regarding claim 43, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
at least one motor operably coupled to said ultrasound transducer assembly ([0125]: stepping motor for moving pressing part 242A forward and backward along the X direction; [0147]: stepping motor controlling the rotational amount of rotating the probe-side magnet 23 relatively to the housing 21); and
control circuitry configured to control actuation of said at least one motor for controlling of at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing ([0125]: stepping motor for translation controlled by control device 5; [0147]: rotational amount controlled by stepping motor based on the control by the control device 5).
Regarding claim 46, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
wherein said ultrasound transducer assembly (Fig. 2, 10: ultrasonic device 22) and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation (Fig. 10 and housing 21 comprising ultrasonic device 22 rotates relatively to the fixation section 3) and the lateral position of said ultrasound transducer assembly (Fig. 2 and [0068]: position of ultrasonic device 22 can be adjusted along the X direction with respect to the fixation section 3).
Regarding claim 48, Nakamura discloses all limitations of claim 24, as discussed above, and Nakamura further discloses:
wherein said ultrasound transducer (Fig. 2, 10: ultrasonic device 22) comprises a plurality of ultrasound transducer elements (Fig. 4 and [0068]: ultrasonic device 22 having a plurality of ultrasonic transducer groups 45A).
Claims 24-27, 29-30, 38-39, 43, 46, and 48-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bar-Zion et al. (US PG Pub No. 2017/0105700) – hereinafter referred to as Bar-Zion.
Regarding claim 24, Bar-Zion discloses an ultrasound device (at least Fig. 5A-C, 6) comprising:
a housing (Fig. 5A,C and 6: enclosure 205) configured for attachment to a skin surface (Fig. 5A-C, 6 and [0124]-[0125]: enclosure 205 attaches to adhesive patch 201 and adhesive patch 201 holds ultrasound measurement assembly 200 to a skin surface);
an ultrasound transducer (Fig. 6: ultrasound transducer 230) supported relative to said housing such that said ultrasound transducer is moveable, relative to said housing, for varying at least one of: an orientation of said ultrasound transducer relative to said housing; and a lateral position of said ultrasound transducer relative to said housing (Fig. 5A-C, 6 and [0129]: axial knob 210 and tilt knob 208 rotated to axially rotate and tilt the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, respectively); and
wherein said housing is configured to generate a frictional force as a result of contact with said ultrasound transducer assembly (Fig. 6 and [0129]: axial knob 210 and tilt knob 208 rotated by the user to axially rotate and tilt the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, respectively; [0137]: Tilt axis 234, tilt knob 208, and ultrasound transducer 230, together with rotatable enclosure section 205a and tilt actuator 236, are rotatable about axial rotation axis 232, thus frictional force generated between fixed enclosure section 205b and ultrasound transducer 230),
wherein the frictional force is sufficiently low to permit manual actuation thereof and sufficiently high to maintain said ultrasound transducer assembly in a fixed orientation in the absence of an external applied force (Fig. 6 and [0129]: axial knob 210 and tilt knob 208 rotated by the user to axially rotate and tilt the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, respectively; [0124]: enclosure seat 207 with fixed enclosure section 205b hold ultrasound measurement device 204 at a fixed position and orientation relative to adhesive patch 201).
Regarding claim 38, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
wherein said housing (Fig. 5A,C and 6: enclosure 205) is configured to facilitate variation of the orientation of said ultrasound transducer assembly relative to said housing (Fig. 5A-C, 6 and [0129]: axial knob 210 and tilt knob 208 rotated to axially rotate and tilt the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, respectively), and
wherein at least one said housing and said ultrasound transducer assembly comprises an orientation locking means (Fig. 5A, C and 6: tilt knob 208) for releasably locking the orientation of said ultrasound transducer relative to said housing (Fig. 5A-C, 6 and [0129]: tilt knob 208 rotated by a user to tilt the enclosed ultrasound transducer relative to fixed enclosure section 205b, thus not rotating the tilt knob 208 would lock the orientation of ultrasound transducer 230).
Regarding claim 39, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
wherein said housing (Fig. 5A,C and 6: enclosure 205) is configured to facilitate variation of the orientation of said ultrasound transducer assembly relative to said housing (Fig. 5A-C, 6 and [0129]: axial knob 210 and tilt knob 208 rotated to axially rotate and tilt the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, respectively), and
wherein at least one of said housing and said ultrasound transducer assembly comprises a position locking means for releasably locking the lateral position of said ultrasound transducer relative to said housing (Fig. 5A-C, 6 and [0129]: axial knob 210 rotated to axially rotate the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, thus not rotating the axial knob 210 would lock the lateral position of ultrasound transducer 230).
Regarding claim 43, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
at least one motor operably coupled to said ultrasound transducer assembly ([0140]: ultrasound transducer 230 electrically controlled by axial actuator 238 and tilt actuator 236, which each includes a motor); and
control circuitry configured to control actuation of said at least one motor for controlling of at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing ([0138]: device 240 controls operation of axial actuator 238 and tilt actuator 236; [0140]: ultrasound transducer 230 electrically controlled by axial actuator 238 and tilt actuator 236, which each includes a motor).
Regarding claim 46, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying the orientation and the lateral position of said ultrasound transducer assembly (Fig. 5A-C, 6 and [0129]: axial knob 210 and tilt knob 208 rotated to axially rotate and tilt the enclosed ultrasound transducer 230 relative to fixed enclosure section 205b, respectively).
Regarding claim 48, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
wherein said ultrasound transducer comprises a plurality of ultrasound transducer elements ([0143]: ultrasound transducer 230 includes a two-dimensional array of ultrasonic transducer elements 14).
Regarding claim 49, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
a flexible substrate (Fig. 5A-C, 6: adhesive patch 201) that is attachable to the skin surface for indirectly supporting said housing relative to the skin surface ([0124]-[0125]: enclosure 205 held to skin surface by adhesive patch 201).
Regarding claim 25, Bar-Zion discloses all limitations of claim 24, as discussed above, and Bar-Zion further discloses:
securing the ultrasound device according to claim 24 to the skin surface of a subject (Fig. 5A-C, 6 and [0125]: adhesive patch 201 hold ultrasound measurement assembly 200 to a skin surface);
while actuating the ultrasound device to vary at least one of the orientation of said ultrasound transducer assembly relative to said housing and the lateral position of said ultrasound transducer assembly relative to said housing (Fig. 5A-C, 6 and [0140]-[0142]: axial actuator 238 and tilt actuator 236 for linear translation and orientation of the ultrasound transducer 230, respectively, and the ultrasound transducer 230 continuously modified to track a blood vessel inside the body);
detecting Doppler ultrasound signals from the ultrasound transducer ([0008]-[0009]: ultrasound transducer in Doppler mode to acquire a measurement of flow rate of blood in the target section); and
employing the Doppler ultrasound signals to determine at least one of a suitable orientation and a suitable lateral position of the ultrasound transducer assembly that is associated with detection of blood flow within a blood vessel ([0140]-[0141]: linear translation and orientation of ultrasound transducer 230 controlled by operation of axial actuator 238 and tilt actuator 236, respectively; [0146]: automatically adjust the ultrasound transducer 230 to maintain its focus on the target vessel and to aim at the blood vessel; [0008]-[0009]: ultrasound transducer in Doppler mode).
Regarding claim 26, Bar-Zion discloses all limitations of claim 25, as discussed above, and Bar-Zion further discloses:
a locking means (Fig. 5A,C, and 6: tilt actuator 236 and axial actuator 238) for releasably locking at least one of the suitable orientation and the suitable lateral position of said ultrasound transducer relative to said housing ([0136]-[0137]: axial actuator 238 and tilt actuator 236 for motorized operation; [0140]-[0142]: axial actuator 238 and tilt actuator 236 controlling linear translation and orientation of the ultrasound transducer 230, respectively),
the method further comprising: after determining at least one of the suitable orientation and the suitable lateral position that is associated with detection of blood flow within the blood vessel, actuating the locking means ([0140]-[0141]: linear translation and orientation of ultrasound transducer 230 controlled by operation of axial actuator 238 and tilt actuator 236, respectively; [0146]: automatically adjust the orientation of ultrasound transducer 230 to maintain its focus on the target vessel and to aim at the blood vessel, thus when axial actuator 238 or tilt actuator 236 is not adjusted the ultrasound transducer is locked in position).
Regarding claim 27, Bar-Zion discloses all limitations of claim 26, as discussed above, and Bar-Zion further discloses:
wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing (Fig. 5A-C, 6 and [0140]-[0142]: axial actuator 238 and tilt actuator 236 for linear translation and orientation of the ultrasound transducer 230 relative to enclosure 205b), and
wherein the locking means is configured for releasably locking both the orientation and the lateral position of the ultrasound transducer assembly relative to the frame ([0140]-[0141]: linear translation and orientation of ultrasound transducer 230 controlled by operation of axial actuator 238 and tilt actuator 236, respectively; [0146]: automatically adjust the orientation of ultrasound transducer 230 to maintain its focus on the target vessel and to aim at the blood vessel, thus when axial actuator 238 or tilt actuator 236 is not adjusted the ultrasound transducer is locked in position),
after varying both the orientation and lateral position of the ultrasound transducer assembly to determine the suitable orientation and the suitable lateral position of the ultrasound transducer that is associated with detection of blood flow within the blood vessel, actuating the locking means to lock both the orientation and the lateral position of the ultrasound transducer assembly ([0140]-[0141]: linear translation and orientation of ultrasound transducer 230 controlled by operation of axial actuator 238 and tilt actuator 236, respectively; [0146]: automatically adjust the orientation of ultrasound transducer 230 to maintain its focus on the target vessel and to aim at the blood vessel, thus when axial actuator 238 or tilt actuator 236 is not adjusted the ultrasound transducer is locked in position).
Regarding claim 29, Bar-Zion discloses all limitations of claim 25, as discussed above, and Bar-Zion further discloses:
wherein said ultrasound transducer comprises a one-dimensional array of ultrasound elements disposed along a longitudinal axis ([0143]: ultrasound transducer 230 includes a one-dimensional array of ultrasonic transducer elements 14), and
wherein said ultrasound transducer assembly and said housing are configured such that said ultrasound transducer assembly is moveable, relative to said housing, for varying both the orientation and lateral position of said ultrasound transducer assembly relative to said housing ([0140]-[0141]: linear translation and orientation of ultrasound transducer 230 controlled by operation of axial actuator 238 and tilt actuator 236, respectively; [0146]: automatically adjust the orientation of ultrasound transducer 230 to maintain its focus on the target vessel and to aim at the blood vessel, thus when axial actuator 238 or tilt actuator 236 is not adjusted the ultrasound transducer is locked in position),
the method further comprising:
employing the Doppler ultrasound signals to determine the suitable orientation and the suitable lateral position of said ultrasound transducer assembly such that said longitudinal axis is substantially perpendicular to an axis of the blood vessel ([0140]-[0141]: linear translation and orientation of ultrasound transducer 230 controlled by operation of axial actuator 238 and tilt actuator 236, respectively; [0146]: automatically adjust the ultrasound transducer 230 to maintain its focus on the target vessel and to aim at the blood vessel; [0008]-[0009]: ultrasound transducer in Doppler mode; [0055]: when the ultrasound transducer is operated in Doppler mode, the measured target section is approximately perpendicular to the ultrasound beam).
Regarding claim 30, Bar-Zion discloses all limitations of claim 25, as discussed above, and Bar-Zion further discloses:
wherein the housing is indirectly secured to the skin surface via an intermediate flexible substrate adhered to the skin surface (Fig. 5A-C, 6: adhesive patch 201; [0124]-[0125]: enclosure 205 held to skin surface by adhesive patch 201).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bar-Zion, as applied to claim 25 above, and further in view Chandraratna.
Regarding claim 28, Bar-Zion discloses al limitations of claim 25, as discussed above, and Bar-Zion further discloses:
employing a scale to record the at least one of the orientation and lateral position of said ultrasound transducer that is associated with detection of blood flow within the blood vessel ([0142]: ultrasound transducer 230 is modified to track a blood vessel inside the body; [0155]: orientation of ultrasound measurement assembly 200 is stored in a data storage unit).
Bar-Zion does not disclose:
wherein the scale permits visual determination of at least one of the orientation and lateral position of said ultrasound transducer relative to said housing.
In the same field of varying an orientation or position of an ultrasound transducer relative to a housing, Chandraratna, however, teaches:
a scale that permits visual determination of at least one of the orientation and lateral position of said ultrasound transducer relative to said housing (Fig. 5-6: actuating pins 24 that are depressed vs. non-depressed; Col 5, lines 55-60: one or two of the actuating pins 24 pushed down indicating swiveled enclosure 6, placing face of the transducer means 16 at an angle to the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bar-Zion’s method to include Chandraratna’s scale. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., modifying Bar-Zion’s knobs as Chandraratna’s pins that visually change with operation), and the combination would have yielded a reasonable expectation of success since both Bar-Zion and Chandraratna are directed to varying an orientation or position of an ultrasound transducer relative to a housing. The motivation for the combination would have been to provide a visualization of the orientation or lateral position of the ultrasound transducer enclosed in the housing (Fig. 5-6 and Col 5, lines 55-60 of Chandraratna).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna, as applied to claim 24 above, and further in view of Wetterling et al. (US PG Pub No. 2025/0134496, priority date of 13 Sep 2021) – hereinafter referred as Wetterling.
Regarding claim 42, Chandraratna discloses all limitations of claim 24, as discussed above, and Chandraratna does not disclose:
two or more marking apertures that permit marking of the skin surface after securing said housing relative to the skin surface, thereby facilitating re-alignment of said ultrasound device after detachment from the skin surface and re-attachment of said housing to the skin surface.
In the same field of coupling an ultrasound transducer to a subject, Wetterling, however, teaches:
two or more marking apertures (Fig. 25: guide holes 14) that permit marking of the skin surface after securing said housing relative to the skin surface, thereby facilitating re-alignment of said ultrasound device after detachment from the skin surface and re-attachment of said housing to the skin surface (Fig. 25 and [0197]: guide holes 14 for alignment with corresponding markers on the skin).
While Wetterling does not explicitly disclose that its guide holes are for marking, Wetterling’s guide holes are still capable of permitting marking of the skin surface, since its guide holes are for facilitating re-alignment of its ultrasound device for re-attachment of the housing to the skin surface, as explicitly recited in the claim, by visualizing the markers on the skin through the guide holes ([0197] of Wetterling).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chandraratna’s device to include Wetterling’s apertures. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing apertures on Chandraratna’s cloth portion 4, as suggested by Wetterling), and the combination would have yielded a reasonable expectation of success since both Chandraratna and Wetterling are directed to coupling an ultrasound transducer to a subject using an adhesive patch. The motivation for the combination would have been “To ensure that the transducer is periodically replaced in the same location on the torso throughout the monitoring period, the adhesive pad is provided with a plurality of guide holes 14 for alignment with corresponding markers on the skin”, as taught by Wetterling ([0197]).
Claims 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura, as applied to claim 43 above, and further in view of Eilers et al. (US PG Pub No. 2009/0192389) – hereinafter referred toa s Eilers.
Regarding claim 44, Nakamura discloses all limitations of claim 43, as discussed above, and Nakamura does not disclose:
an encoding mechanism for encoding at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing,
wherein said control circuitry is configured to process a signal from an encoding sensor associated with said encoding mechanism to determine at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing.
In the same field of varying an orientation or position of an ultrasound transducer relative to a housing, Eilers, however, teaches:
an encoding mechanism for encoding at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing (Fig 6 and [0095]-[0096]: encoder, borne by the guide track and the carriage, that allows external circuitry to sense the position of the carriage along the track),
wherein said control circuitry is configured to process a signal from an encoding sensor associated with said encoding mechanism to determine at least one of the orientation and the lateral position of said ultrasound transducer assembly relative to said housing ([0019]: controller selectively energizes an electric coil segment in proximity to a sensed position of the carriage).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nakamura’s device to include Eilers’s encoding mechanism and control circuitry. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing an encoding mechanism and modifying Nakamura’s control circuitry, as suggested by Eilers), and the combination would have yielded a reasonable expectation of success since both Nakamura and Eilers are directed to varying an orientation or position of an ultrasound transducer relative to a housing. The motivation for the combination would have been “the sensing device can provide precise position of the transducer carriage along the arc guide assembly which, in turn, allows for a precise and accurate ultrasonic scan to be made”, as taught by Eilers ([0019]).
Regarding claim 45, Nakamura discloses all limitations of claim 43, as discussed above, and Nakamura does not disclose:
a reference sensor for detecting at least one of a reference angle and a reference lateral position of said ultrasound transducer assembly relative to said housing (Fig. 6 and [0096]-[0097]: encoder, borne by the guide track and the carriage, allows external circuitry to sense the position of the carriage along the track and is based on a home position on the arc guide track),
wherein said control circuitry is configured to process a signal from said reference sensor to determine when said ultrasound transducer assembly resides at the reference angle or the reference lateral position ([0019]: controller selectively energizes an electric coil segment in proximity to a sensed position of the carriage).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nakamura’s device to include Eilers’s reference sensor and control circuitry. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a reference sensor and modifying Nakamura’s control circuitry, as suggested by Eilers), and the combination would have yielded a reasonable expectation of success since both Nakamura and Eilers are directed to varying an orientation or position of an ultrasound transducer relative to a housing. The motivation for the combination would have been “the sensing device can provide precise position of the transducer carriage along the arc guide assembly which, in turn, allows for a precise and accurate ultrasonic scan to be made”, as taught by Eilers ([0019]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hon (US Patent No. 4920966) disclosing a “ball and socket” ultrasound transducer patch (Fig. 7);
Geelan (US PG Pub No. 2020/0015780) disclosing an ultrasound transducer configured to vary orientation relative to a housing (at least Fig. 1);
Kempf (DE4131430A1, see attached machine translation relied upon) disclosing an ultrasound transducer patch
Vezina (US PG Pub No. 2010/0168577) disclosing an ultrasound transducer configured to vary in both orientation and lateral position relative to a housing (Fig. 20);
Tei et al. (US Patent No. 5381794) disclosing a “ball and socket” ultrasound transducer patch (Fig. 3-4, 9-10);
Reddall et al. (US PG Pub No. 2022/0361817) disclosing apertures for marking a position of a patch (Fig. 7A); and
Sharf et al. (US PG Pub No. 2014/0107435) disclosing a “ball and socket” ultrasound transducer patch (Fig. 7A-C).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/18/26