DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is in response to the remarks filed on 02/14/2025.
The amendments filed on 02/14/2025 have been entered. Applicant has added new claims 11-20, accordingly claims 1-20 are pending. Claim 1 is presently amended.
Response to Arguments
Applicant's arguments regarding the 35 U.S.C. 112(a) new matter rejection have been fully considered but they are not persuasive. Applicant argues that Fig. 1 allegedly shows only the first array in contact with a patient’s skin and Fig. 2 shows only the second array in contact with a patient’s skin. However, depending on what part of the body the probe is used on, the curvature of the body, and the position of the patient, the probe as disclosed in the originally filed disclosure would not necessarily have only one array in contact with a patient’s skin at a time.
Applicant’s arguments regarding the 35 U.S.C. 112(b) rejection of the claims have been fully considered but they are not persuasive. While the claims have been amended to recite that a relative deposition between the first and second array ensure only one array is in contact with a patient’s skin at a time, it remains unclear what structure is responsible for this recited intended use of the probe.
Applicant's arguments with respect to the prior art rejection of the claims, regarding a deposition of the first and second ultrasound array ensuring only one array is in contact with a patient’s skin at a time have been fully considered but they are not persuasive. A recitation of the intended use of the claimed invention (i.e., only one array in contact with a patient’s skin at a time) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Woltjer teaches in paragraph [0038]: “A set of transducers, mounted in different angles [relative disposition], where every transducer is used separately”. Therefore, Woltjer does teach wherein the first ultrasound array comprises a phased array and the second ultrasound array comprises a linear array, and wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient's skin at a time.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
gripping element in claims 4, 5, 14, and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
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:
Regarding the “gripping element” the specification discloses “These gripping elements may be a softer polymer surface, or they may be an array of discrete elements formed from a softer polymer as dots or ridges, or they may be textured areas.” ([0056] of the US PG Pub. version of the specification). Therefore, the means-plus-function limitation of “gripping element” has been interpreted as a softer polymer surface, or any array of discrete elements formed from a softer polymer as dots or ridges, or textured areas or any equivalents thereof in light of the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 1-20 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.
Independent claims 1 and 11 recite the limitation “wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient's skin at a time”. However, neither the original claims, original drawings, nor the specification as originally filed provides support for this limitation. Applicant has indicated that support for this amendment is allegedly found in Figures 1-16 and paragraphs [0047]— [0053] of applicant’s published application, see page 4 of the Remarks.
However, these or other sections of the originally filed disclosure do not provide support for wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient's skin at a time. Examiner notes that depending on what part of the body the probe is used on, the curvature of the body, and the position of the patient, the probe as disclosed in the originally filed disclosure would not necessarily have only one array in contact with a patient’s skin at a time.
As such, claims 1-20 contain new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 11 recite the limitation “wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient's skin at a time”. It is unclear what structure is being used to ensure only one of the first ultrasound array or the second ultrasound array is in contact with a patient's skin at a time. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2018/0360419, December 20, 2018) in view Young et al. (US 4,869,260, September 26, 1989, hereinafter “Young”), Koblish et al. (US 2014/0081262, March 20, 2014, hereinafter “Koblish”), and Woltjer et al. (US 2017/0258386, September 14, 2017, hereinafter “Woltjer”).
Regarding claim 1, Zhu discloses an ultrasound probe (“A single hand operation ultrasound probe array is provided. The single ultrasound probe array places individual transducers, each having different transducer characteristics, on sheaths that fit over fingers of a user.” abstract; Figs. 1-5 and corresponding descriptions) comprising:
a housing (finger sheaths 106 in Figs. 1, 4 and corresponding description; also see glove 110 in Fig. 4 and corresponding description) having a top side and a bottom side (see Fig. 3 and corresponding description; also see “back hand view of glove 110” in Fig. 4b and corresponding description and “palm view of glove 110” in Fig. 4a and corresponding description; Figs. 4A-B are reproduced below), a proximal end (“first end 106a” in Fig. 1 and corresponding description) and a distal end (“second end 106b” in Fig. 1 and corresponding description), and a longitudinal axis extending between the distal end and the proximal end (see annotated Fig. 1, re-produced below, and corresponding description),
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wherein the housing defines a finger-receiving aperture including a finger retaining element comprised of a substantially tubular wall member formed, said finger-receiving aperture extending parallel to the longitudinal axis (“each of the finger sheaths 106 is designed with a hollow cavity sized and dimensioned to fit over one or more fingers of a user. In particular, each of the finger sheaths 106 has a first end 106a and a second end 106b with the first end 106a including an opening sized and dimensioned to receive a finger of a user” [0023]; also see annotated Fig. 1, re-produced below, and corresponding description);
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a first ultrasound array disposed adjacent to the distal end (“the plurality of transducers 104 are located proximate to the second end 106b of each of the plurality of finger sheaths 106 and are configured to fire and receive ultrasonic waves in an end firing orientation, as depicted in FIG. 1B and 3B.” [0024], Fig. 3B is re-produced below); and
a second ultrasound array disposed adjacent to the distal end and proximal to the first ultrasound array, wherein the second ultrasound array is angled toward the bottom side (“the transducers 104 are located at a mid-region position of the finger sheaths 106 in an orientation such that the plurality of transducers 104 face the same direction as a palm of the user wearing the finger-mounted ultrasound probing device 100, as depicted in FIG. 3A.” [0024], Fig. 3A is re-produced below).
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Although Zhu discloses the finger-receiving aperture including a finger retaining element comprised of a substantially tubular wall member as stated above, Zhu is silent on the substantially tubular wall member being formed from an elastomeric material.
However, Young teaches, in the same field of endeavor, finger-receiving aperture including a finger retaining element comprised of a substantially tubular wall member formed from an elastomeric material (see Fig. 1, reproduced below and corresponding description; specifically see “Referring to the drawings, the numeral 10 generally refers to the fingertip Doppler transducer device of the present invention. Device 10 includes a finger receptacle 12 preferably formed from an elastomeric material such as rubber so that it can fit frictionally over the end of a human finger designated by the numeral 14 in FIG. 1.” col. 4, ll. 30-37).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with the substantially tubular wall member being formed from an elastomeric material as taught by Young in order to allow the finger-receiving aperture to frictionally fit over the finger (col. 4, ll. 30-37 of Young).
Zhu fails to disclose wherein the second ultrasound array is angled toward the bottom side about 10-50 degrees from the longitudinal axis.
However, Koblish teaches, in the same field of endeavor, a catheter 110 in Fig. 1, reproduced in part below, with three ultrasound arrays at the distal end of the catheter (see ultrasound transducers 117-119 in Fig. 1 and corresponding description). Koblish further teaches wherein the second ultrasound array is angled toward the bottom side about 10-50 degrees from the longitudinal axis (ultrasound transducer 119 in Fig. 1 and corresponding description).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Corbett with wherein the second ultrasound array is angled toward the bottom side about 10-50 degrees from the longitudinal axis as taught by Koblish in order to provide the ultrasound transducers facing in a direction according to the area required to be scanned ([0041] of Koblish). Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Koblish, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Applicant has not disclosed any criticality of this feature.
Zhu also fails to disclose wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient’s skin at a time.
However, Woltjer teaches, in the same field of endeavor, wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient’s skin at a time (“For instance, when a user is lying down, a first set of transducers may be used, providing a pulse and determination in a certain angle, and when a user is sitting up, a second set of transducers may be used, providing a pulse and determination in a second angle.” [0037]; also see “A set of transducers, mounted in different angles, where every transducer is used separately.” [0038]; also see “a contacting means for contacting the device to a skin of a person” [0039]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient’s skin at a time as taught by Woltjer in order to account for changes in posture of a patient during examination that can influence the quality of ultrasound determination and interpretation ([0037] of Woltjer).
Regarding claim 2, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above. Zhu further discloses wherein the first ultrasound array is oriented transverse to the longitudinal axis (“the plurality of transducers 104 are located proximate to the second end 106b of each of the plurality of finger sheaths 106 and are configured to fire and receive ultrasonic waves in an end firing orientation, as depicted in FIG. 1B and 3B.” [0024]; also see Figs. 1b and 3b and corresponding descriptions).
Regarding claim 3, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above. Zhu further discloses wherein the second ultrasound array is oriented parallel to the longitudinal axis (“In accordance with an example embodiment of the present invention, the plurality of transducers 104 are located proximal to a mid-region (between the first end 106a and the second end 106b) of each of the finger sheaths 106 and is configured to fire and receive ultrasonic waves in a side firing orientation, as depicted in FIG. 1A and 3A. In particular, the transducers 104 are located at a mid-region position of the finger sheaths 106 in an orientation such that the plurality of transducers 104 face the same direction as a palm of the user wearing the finger-mounted ultrasound probing device 100, as depicted in FIG. 3A.”; also see Figs. 1b and 3b and corresponding descriptions).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Young, Koblish, and Woltjer as applied to claim 1 above and further in view of Takano et al. (US 4,898,177, February 6, 1990, hereinafter “Takano”).
Regarding claims 4-5, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1, as stated above but fails to disclose wherein the housing further comprises a left side and a right side, and wherein the left and right sides each comprises a gripping element, wherein the gripping elements are positioned adjacent to the distal end.
However, Takano teaches, in the same field of endeavor, wherein the housing (adapter 50 in Fig. 3, re-produced below with annotations, and corresponding description) further comprises a left side and a right side (see annotated Fig. 3 below), and wherein the left and right sides each comprises a gripping element (grip portions 52 in Fig. 3 and corresponding description), wherein the gripping elements are positioned adjacent to the distal end (e.g. see Figs. 3 and 8 and corresponding description).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with wherein the housing further comprises a left side and a right side, and wherein the left and right sides each comprises a gripping element, wherein the gripping elements are positioned adjacent to the distal end as taught by Takano in order to allow a user to hold the device with a relatively large number of support points (col. 8, ll. 47-62 of Takano).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Young, Koblish, and Woltjer as applied to claim 1 above and further in view of Mills et al. (US 2020/0281525, corresponding PCT filed September 11, 2018, hereinafter “Mills”).
Regarding claim 6, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above but fails to disclose wherein the finger retaining element further comprises a deformable gripping member having a cross-sectional form which forms an M or W shape.
However, Mills teaches, in an analogous field of endeavor (e.g. finger sensors, e.g. see Abstract), wherein the finger retaining element further comprises a deformable gripping member (“he aperture 202 of the ring 200 comprises a resiliently deformable pad 208, opposing the sensing portion, in some embodiments, an apex 209 of the substantially V-shaped portion 204 of the sensing portion. The resiliently deformable pad 208 may comprise silicone rubber, although it will be appreciated that other elastomers and resiliently deformable materials may be used. Alternatively, the pad may be made from a non-resilient or substantially rigid material. In some embodiments, the resiliently deformable pad 208 comprises a plurality of projections 210 for contacting the finger.” [0129]; also see Figs. 2-6 and corresponding descriptions).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with wherein the finger retaining element further comprises a deformable gripping member as taught by Mills in order to provide better contact with the finger ([0131] of Mills).
Although Mills further teaches the deformable pad 208 can be provided in varying sizes and shapes ([0134]-[0135]), Corbett modified by Mills fails to explicitly disclose the deformable gripping member having a cross-sectional form which forms an M or W shape. However, it would have been an obvious matter of design choice to provide the gripping member with a cross-sectional form which forms an M or W shape, since such a modification would have involved a mere change in the form or shape of a component. The motivation for providing a particular cross-sectional form shape would provide a better fit according to different finger sizes ([0135] of Mills). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. Applicant has not disclosed any criticality in this feature. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Young, Koblish, and Woltjer as applied to claim 1 above and further in view of Flesch et al. (US 2005/0085730, April 21, 2005, hereinafter “Flesch”).
Regarding claim 7, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-40 degrees from the longitudinal axis.
However, Flesch teaches, in the same field of endeavor, wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-40 degrees from the longitudinal axis (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0042]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-40 degrees from the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Providing the specific claimed angled placements of the ultrasound arrays would allow a particular field of view of the probe according to a particular imaging protocol ([0097] of Flesch). Applicant has not disclosed any criticality of this feature.
Regarding claim 8, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the first ultrasound array is angled between 80-85 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-30 degrees from the longitudinal axis.
However, Flesch teaches, in the same field of endeavor, wherein the first ultrasound array is angled between 80-85 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-30 degrees from the longitudinal axis (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the first ultrasound array is angled between 80-85 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-30 degrees from the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Providing the specific claimed angled placements of the ultrasound arrays would allow a particular field of view of the probe according to a particular imaging protocol ([0097] of Flesch). Applicant has not disclosed any criticality of this feature.
Regarding claim 9, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the second ultrasound array is angled between 105-155 degrees away from the first ultrasound array.
However, Flesch teaches, in the same field of endeavor, wherein the second ultrasound array is angled between 105-155 degrees away from the first ultrasound array (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the second ultrasound array is angled between 105-155 degrees away from the first ultrasound array. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Providing the specific claimed angled placements of the ultrasound arrays would allow a particular field of view of the probe according to a particular imaging protocol ([0097] of Flesch). Applicant has not disclosed any criticality of this feature.
Regarding claim 10, Zhu modified by Young, Koblish, and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis.
However, Flesch teaches, in the same field of endeavor, wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Providing the specific claimed angled placements of the ultrasound arrays would allow a particular field of view of the probe according to a particular imaging protocol ([0097] of Flesch). Applicant has not disclosed any criticality of this feature.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Koblish and Woltjer.
Regarding claim 11, Zhu discloses an ultrasound probe (“A single hand operation ultrasound probe array is provided. The single ultrasound probe array places individual transducers, each having different transducer characteristics, on sheaths that fit over fingers of a user.” abstract; Figs. 1-5 and corresponding descriptions) comprising:
a housing (finger sheaths 106 in Figs. 1, 4 and corresponding description; also see glove 110 in Fig. 4 and corresponding description) having a top side and a bottom side (see Fig. 3 and corresponding description; also see “back hand view of glove 110” in Fig. 4b and corresponding description and “palm view of glove 110” in Fig. 4a and corresponding description; Figs. 4A-B are reproduced below), a proximal end (“first end 106a” in Fig. 1 and corresponding description) and a distal end (“second end 106b” in Fig. 1 and corresponding description), and a longitudinal axis extending between the distal end and the proximal end (see annotated Fig. 1, re-produced below, and corresponding description),
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wherein the housing defines a finger-receiving aperture extending parallel to the longitudinal axis (“each of the finger sheaths 106 is designed with a hollow cavity sized and dimensioned to fit over one or more fingers of a user. In particular, each of the finger sheaths 106 has a first end 106a and a second end 106b with the first end 106a including an opening sized and dimensioned to receive a finger of a user” [0023]; also see annotated Fig. 1, re-produced below, and corresponding description);
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a first ultrasound array disposed adjacent to the distal end (“the plurality of transducers 104 are located proximate to the second end 106b of each of the plurality of finger sheaths 106 and are configured to fire and receive ultrasonic waves in an end firing orientation, as depicted in FIG. 1B and 3B.” [0024], Fig. 3B is re-produced below); and
a second ultrasound array disposed adjacent to the distal end and proximal to the first ultrasound array, wherein the second ultrasound array is angled toward the bottom side (“the transducers 104 are located at a mid-region position of the finger sheaths 106 in an orientation such that the plurality of transducers 104 face the same direction as a palm of the user wearing the finger-mounted ultrasound probing device 100, as depicted in FIG. 3A.” [0024], Fig. 3A is re-produced below).
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Zhu fails to disclose wherein the second ultrasound array is angled toward the bottom side about 10-50 degrees from the longitudinal axis.
However, Koblish teaches, in the same field of endeavor, a catheter 110 in Fig. 1, reproduced in part below, with three ultrasound arrays at the distal end of the catheter (see ultrasound transducers 117-119 in Fig. 1 and corresponding description). Koblish further teaches wherein the second ultrasound array is angled toward the bottom side about 10-50 degrees from the longitudinal axis (ultrasound transducer 119 in Fig. 1 and corresponding description).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Corbett with wherein the second ultrasound array is angled toward the bottom side about 10-50 degrees from the longitudinal axis as taught by Koblish in order to provide the ultrasound transducers facing in a direction according to the area required to be scanned ([0041] of Koblish). Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Koblish, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Applicant has not disclosed any criticality of this feature.
Zhu also fails to disclose wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient’s skin at a time.
However, Woltjer teaches, in the same field of endeavor, wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient’s skin at a time (“For instance, when a user is lying down, a first set of transducers may be used, providing a pulse and determination in a certain angle, and when a user is sitting up, a second set of transducers may be used, providing a pulse and determination in a second angle.” [0037]; also see “A set of transducers, mounted in different angles, where every transducer is used separately.” [0038]; also see “a contacting means for contacting the device to a skin of a person” [0039]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with wherein a deposition of the first ultrasound array relative to the second ultrasound array ensures only one of the first ultrasound array or the second ultrasound array is in contact with a patient’s skin at a time as taught by Woltjer in order to account for changes in posture of a patient during examination that can influence the quality of ultrasound determination and interpretation ([0037] of Woltjer).
Regarding claim 12, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above. Zhu further discloses wherein the first ultrasound array is oriented transverse to the longitudinal axis (“the plurality of transducers 104 are located proximate to the second end 106b of each of the plurality of finger sheaths 106 and are configured to fire and receive ultrasonic waves in an end firing orientation, as depicted in FIG. 1B and 3B.” [0024]; also see Figs. 1b and 3b and corresponding descriptions).
Regarding claim 13, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above. Zhu further discloses wherein the second ultrasound array is oriented parallel to the longitudinal axis (“In accordance with an example embodiment of the present invention, the plurality of transducers 104 are located proximal to a mid-region (between the first end 106a and the second end 106b) of each of the finger sheaths 106 and is configured to fire and receive ultrasonic waves in a side firing orientation, as depicted in FIG. 1A and 3A. In particular, the transducers 104 are located at a mid-region position of the finger sheaths 106 in an orientation such that the plurality of transducers 104 face the same direction as a palm of the user wearing the finger-mounted ultrasound probing device 100, as depicted in FIG. 3A.”; also see Figs. 1b and 3b and corresponding descriptions).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Koblish and Woltjer as applied to claim 11 above and further in view of Takano et al. (US 4,898,177, February 6, 1990, hereinafter “Takano”).
Regarding claims 14-15, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1, as stated above but fails to disclose wherein the housing further comprises a left side and a right side, and wherein the left and right sides each comprises a gripping element, wherein the gripping elements are positioned adjacent to the distal end.
However, Takano teaches, in the same field of endeavor, wherein the housing (adapter 50 in Fig. 3, re-produced below with annotations, and corresponding description) further comprises a left side and a right side (see annotated Fig. 3 below), and wherein the left and right sides each comprises a gripping element (grip portions 52 in Fig. 3 and corresponding description), wherein the gripping elements are positioned adjacent to the distal end (e.g. see Figs. 3 and 8 and corresponding description).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with wherein the housing further comprises a left side and a right side, and wherein the left and right sides each comprises a gripping element, wherein the gripping elements are positioned adjacent to the distal end as taught by Takano in order to allow a user to hold the device with a relatively large number of support points (col. 8, ll. 47-62 of Takano).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Koblish and Woltjer as applied to claim 1 above and further in view of Mills et al. (US 2020/0281525, corresponding PCT filed September 11, 2018, hereinafter “Mills”).
Regarding claim 16, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above but fails to disclose wherein the finger retaining element further comprises a deformable gripping member having a cross-sectional form which forms an M or W shape.
However, Mills teaches, in an analogous field of endeavor (e.g. finger sensors, e.g. see Abstract), wherein the finger retaining element further comprises a deformable gripping member (“he aperture 202 of the ring 200 comprises a resiliently deformable pad 208, opposing the sensing portion, in some embodiments, an apex 209 of the substantially V-shaped portion 204 of the sensing portion. The resiliently deformable pad 208 may comprise silicone rubber, although it will be appreciated that other elastomers and resiliently deformable materials may be used. Alternatively, the pad may be made from a non-resilient or substantially rigid material. In some embodiments, the resiliently deformable pad 208 comprises a plurality of projections 210 for contacting the finger.” [0129]; also see Figs. 2-6 and corresponding descriptions).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Zhu with wherein the finger retaining element further comprises a deformable gripping member as taught by Mills in order to provide better contact with the finger ([0131] of Mills).
Although Mills further teaches the deformable pad 208 can be provided in varying sizes and shapes ([0134]-[0135]), Corbett modified by Mills fails to explicitly disclose the deformable gripping member having a cross-sectional form which forms an M or W shape. However, it would have been an obvious matter of design choice to provide the gripping member with a cross-sectional form which forms an M or W shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. The motivation for providing a particular cross-sectional form shape would provide a better fit according to different finger sizes ([0135] of Mills). A change in form or shape is generally recognized as being within the level of ordinary skill in the art. Applicant has not disclosed any criticality in this feature. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Koblish and Woltjer as applied to claim 1 above and further in view of Flesch et al. (US 2005/0085730, April 21, 2005, hereinafter “Flesch”).
Regarding claim 17, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-40 degrees from the longitudinal axis.
However, Flesch teaches, in the same field of endeavor, wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-40 degrees from the longitudinal axis (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-40 degrees from the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Applicant has not disclosed any criticality of this feature.
Regarding claim 18, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the first ultrasound array is angled between 80-85 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-30 degrees from the longitudinal axis.
However, Flesch teaches, in the same field of endeavor, wherein the first ultrasound array is angled between 80-85 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-30 degrees from the longitudinal axis (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the first ultrasound array is angled between 80-85 degrees from the longitudinal axis; and wherein the second ultrasound array is angled between 20-30 degrees from the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art Providing the specific claimed angled placements of the ultrasound arrays would allow a particular field of view of the probe according to a particular imaging protocol ([0097] of Flesch). Applicant has not disclosed any criticality of this feature. Regarding claim 19, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the second ultrasound array is angled between 105-155 degrees away from the first ultrasound array.
However, Flesch teaches, in the same field of endeavor, wherein the second ultrasound array is angled between 105-155 degrees away from the first ultrasound array (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the second ultrasound array is angled between 105-155 degrees away from the first ultrasound array. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Applicant has not disclosed any criticality of this feature.
Regarding claim 20, Zhu modified by Koblish and Woltjer discloses the limitations of claim 1 as stated above. Zhu fails to explicitly disclose wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis.
However, Flesch teaches, in the same field of endeavor, wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis (“the bi-plane transducer is mounted on the probe at an angle between 30 and 60 degrees [second ultrasound array] with respect to the longitudinal axis of the probe [...] a first [second ultrasound array] said bi-plane transducer and a second [first ultrasound array] said bi-plane transducer mounted in the vicinity of the first said bi-plane transducer, and the second bi-plane transducer is rotated with respect to the second bi-plane array transducer through an angle of between 30 and 60 degrees.” [0043]-[0043]; examiner notes that the second [claimed first] bi-plane array transducer can be angled between 30 and 60 degrees from the first [claimed second] bi-plane transducer which is an additional 30-60 degrees from the first transducers 30-60 degrees not the horizontal, i.e. 60-120 degrees as also explained in e.g. [0108]).
Zhu discloses the claimed invention except wherein the first ultrasound array is angled between 75-90 degrees from the longitudinal axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to dispose the arrays at particular angles from the longitudinal axis as taught by Flesch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Providing the specific claimed angled placements of the ultrasound arrays would allow a particular field of view of the probe according to a particular imaging protocol ([0097] of Flesch). Applicant has not disclosed any criticality of this feature.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./ Examiner, Art Unit 3797
/ANNE M KOZAK/Supervisory Patent Examiner, Art Unit 3797
