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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/2025 has been entered.
Response to Amendment
This office action is in response to the remarks filed on 11/26/2025.
The amendment filed 11/26/2025 has been entered. Claims 34-40, 42-54, and 83-84 remain pending in the application, claims 40 and 46-51 have been previously withdrawn, and claims 35 and 41 has been cancelled.
The 112(b) rejections have been withdrawn in light of claim amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 34, 36-39, 44, 52, 54, and 83-84 are rejected under 35 U.S.C. 103 as being unpatentable over Tokumoto (US 20060020211 A1, hereinafter “Tokumoto”, of record) in view of Sandrin et al. (US 20080058644 A1, hereinafter "Sandrin"), and Tchang et al. (US 20180263597 A1, hereinafter “Tchang”)
Regarding claim 34, Tokumoto teaches a guide (a base unit 14 and a holder 16 [0053]) for guiding pivotal movement of an ultrasound transducer relative to a volume to be imaged (the probe 10 which is held by the holder 16 also rotates or pivots), the guide comprising:
a body (60) configured to couple to an end of the ultrasound transducer (10) that includes a transducer array (The holder 16 includes a housing portion 60 for receiving the probe 10. The housing portion 60 has an upper opening and a lower opening, and the wave transmitting and receiving surface of the probe 10 projects (is exposed) through the lower opening, as already described with reference to FIGS. 1 and 2 [0065]) and first (32) and second protrusions (34) respectively located at first and second ends of the body such that (the base unit 14 includes a seat 30 which further includes a pair of leg portions 32, 34 [0057]:
the first (32) and second protrusions (34) respectively located at first and second ends of the body such that (the base unit 14 includes a seat 30 which further includes a pair of leg portions 32, 34 [0057]:
Tokumoto, however, does not teach:
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Fig. 2 of Tokumoto reproduced above
each of the first and second protrusions comprising a curved patient-contacting surface contactable with a patient to be imaged;
wherein the curved patient-contacting surfaces of the first and second protrusions are shaped to be positionable between a pair of adjacent ribs of the patient when in contact with the patient and configured to indent skin of the patient between the pair of adjacent ribs when pressed against the skin of the patient;
wherein curvatures of the curved patient-contacting surfaces of the first and second protrusions are shaped to define a pivot axis about which the ultrasound transducer coupled to the body is pivotable by pivotal contact between the curved patient-contacting surfaces and the skin of the patient;
wherein the curved patient-contacting surfaces extend a distance forwardly relative to a front surface of the transducer array through which the ultrasound transducer emits acoustic energy when coupled to the body and each of the curved patient-contacting surfaces have a radius of curvature substantially equal to the distance. thereby aligning the pivot axis with the front surface of the transducer array.
Sandrin is considered analogous to the instant application as an ultrasound system for an intercostal space is disclosed ([0010]-[0011]). Sandrin teaches: each of the first and second protrusions (two locating posts 9 [0050]; fig. 4 shows the first and second protrusions 9) comprising a curved patient-contacting surface contactable with a patient to be imaged (the said locating posts 9 are of rounded shape so that, when the measuring instrument 1 is pressed against the thoracic cage, they cause no injury to the patient);
wherein the curved patient-contacting surfaces of the first and second protrusions are shaped to be positionable between a pair of adjacent ribs (2) of the patient when in contact with the patient (the positioning and the retention of the distal end 5 of the transducer 4 between two adjacent ribs [0046]; the locating posts 9 advantageously have transverse dimensions that allow them to be pressed against the ribs 2 between which they are positioned [0056]; fig. 2 shows the adjacent ribs, both labeled 2, with the protrusion 9 in-between) and configured to indent skin of the patient between the pair of adjacent ribs pressed against the skin of the patient (the height of the locating posts 9 is determined so that they should be in contact with the skin when the pressure exerted is sufficient in order to allow correct transmission of the low-frequency waves through the skin of the patient, and therefore in order to allow the examination to be performed [0055]; fig.2 depicts the indent on the surface of the skin against the protrusion 9 and the adjacent ribs 2).;
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Fig. 4 and fig. 2 of Sandrin reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Tokumoto, by including each of the first and second protrusions comprising a curved patient-contacting surface contactable with a patient to be imaged, wherein the curved patient-contacting surfaces of the first and second protrusions are shaped to be positionable between a pair of adjacent ribs of the patient when in contact with the patient and configured to indent skin of the patient between the pair of adjacent ribs when pressed against the skin of the patient, as taught by Sandrin. This would allow for the instrument to be pressed against the thoracic cage, and cause no injury to the patient, as suggested by Sandrin ([0057]).
The combined invention still does not teach:
wherein curvatures of the curved patient-contacting surfaces of the first and second protrusions are shaped to define a pivot axis about which the ultrasound transducer coupled to the body is pivotable by pivotal contact between the curved patient-contacting surfaces and the skin of the patient;
wherein the curved patient-contacting surfaces extend a distance forwardly relative to a front surface of the transducer array through which the ultrasound transducer emits acoustic energy when coupled to the body and each of the curved patient-contacting surfaces have a radius of curvature substantially equal to the distance. thereby aligning the pivot axis with the front surface of the transducer array.
Tchang is considered analogous to the instant application as an ultrasound device is disclosed (abstract). Tchang teaches:
wherein curvatures of the curved patient-contacting surfaces (165) of the first and second protrusions (first and second protrusions 165 shown in fig. 10a; A bottom side of the legs 165 of the base 101 comprise a contact surface area 101 b configured to be brought into contact with a patient's skin when using the device 100 [0125]) are shaped to define a pivot axis about which the ultrasound transducer coupled to the body is pivotable by pivotal contact between the curved patient-contacting surfaces and the skin of the patient (The base module 102 further comprises adjusting means 150 arranged for adjusting the position of the ultrasound probe 200 held by the base module 102 [0123]; the contact legs comprise a base and a distal end, the base arranged for being coupled with the device, the distal end having a surface contact area configured for being in contact with a patient's skin so as to provide support for the device, wherein the distal end is pivotally connected with the base [0048]);
wherein the curved patient-contacting surfaces extend a distance forwardly relative to a front surface of the transducer array (curved patient-contacting surfaces 165 are positioned forward relative to the ultrasound transducer as shown in fig. 11a and fig. 10a) through which the ultrasound transducer emits acoustic energy (ultrasound probe for medical application [0050]) when coupled to the body and each of the curved patient-contacting surfaces have a radius of curvature substantially equal to the distance, thereby aligning the pivot axis with the front surface of the transducer array (Fig. 10a, reproduced below, depicts an outline of the transducer in a tilted position and in a straight position, in the tilted position, the curved patient-contacting 165 go extend forwardly to the bottom of the transducer, the bottom of the transducer in the straight position outlined in a dashed line below; the probe can be tilted/pivot as described in [0038], the radius of curvature of the patient-contacting is substantially equal to the distance between the front surface of the transducer to the bottom of the patient-contacting, the distance is between the two annotated lines in fig. 10a below ).
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Fig. 10a of Tchang reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Tokumoto, by including wherein curvatures of the curved patient-contacting surfaces of the first and second protrusions are shaped to define a pivot axis about which the ultrasound transducer coupled to the body is pivotable by pivotal contact between the curved patient-contacting surfaces and the skin of the patient, and wherein the curved patient-contacting surfaces extend a distance forwardly relative to a front surface of the transducer array through which the ultrasound transducer emits acoustic energy when coupled to the body and each of the curved patient-contacting surfaces have a radius of curvature substantially equal to the distance. thereby aligning the pivot axis with the front surface of the transducer array, as taught by Tchang. Doing so would allow for displacement along a longitudinal direction of a member of the device towards or away from a patient's body, during use, allows the adjustment of the height/depth of the receiver and hence the ultrasound probe with respect to the patient's body, as suggested by Tchang ([0038]).
Regarding claim 36, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches the pivot axis is in an imaging plane of the transducer array (With the rotation of the holder 16, the probe 10 which is held by the holder 16 also rotates or pivots, which further causes the scan plane generated by the probe 10 to also pivot. It is therefore possible to set the rotation angle of the holder 16 at a desired position, thereby allowing the setting of the scan plane at a desired position (at a desired inclined angle) within the subject. [0055]; Referring to FIG. 3, the scan plane generated when the probe 10 is inclined by the greatest amount toward one side is represented as S1 and the scan plane generated when the probe 10 is inclined by the greatest amount toward the other side is represented as S2 [0061]).
Regarding claim 37, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches the body is removably attachable and detachable from the ultrasound transducer (the holder is a member which detachably holds the probe while directing a wave transmitting and receiving surface of the probe toward a subject [0017]).
Regarding claim 38, modified Tokumoto teaches the guide according to claim 37, as discussed above. Tokumoto further teaches wherein the body defines a cavity shaped to receive the end of the ultrasound transducer (The holder 16 is a component which holds the probe 10 [0054]; holder 16, depicted in fig. 5 below, shows a cavity that holds the transducer 10) that includes the transducer array (The housing portion 60 has an upper opening and a lower opening, and the wave transmitting and receiving surface of the probe 10 projects (is exposed) through the lower opening, as already described with reference to FIGS. 1 and 2), the cavity having an opening aligned with the transducer array when the transducer is inserted into the cavity (as the holder 16 is shaped as a rectangle, the user would inherently align the rectangular shaped transducer within the cavity).
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Fig. 5 of Tokumoto reproduced above
Regarding claim 39, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches the cavity is formed to provide a stop the transducer array, has a desired alignment with the pivot axis (A stopper 80 which is rotatably supported at the axis of rotation 82 is provided on the back side of the base unit 14 … Specifically, a portion of the holder 16 strikes against the stopper 80 and further rotation of the holder 16 is restricted [0064]).
Regarding 44, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches the first and second protrusions are each mounted to pivot relative to the body (The moving mechanism 26 allows the holder 16 to rotate about a predetermined horizontal axis of rotation. With the rotation of the holder 16, the probe 10 which is held by the holder 16 also rotates or pivots, which further causes the scan plane generated by the probe 10 to also pivot [0055]; first protrusion 32 and second protrusion 34 have holes which allow for rotation, the axis of rotation is inherently formed from the discs that go within them, the pivot axis is seen in annotated fig. 4 below, and the pivoting motion is shown in fig 8, reproduced below).
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Annotated Fig.4 and Fig. 8 of Tokumoto reproduced above
Regarding claim 52, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches the first and second protrusions are detachably mounted to the body (The base unit 14 will be described first. The base unit 14 includes side plates 40 and 42… The side plates 40 and 42 have slots 48 and 50 formed therein [0063]; slots 40 and 50 are on first and second protrusions 32 and 34 as seen in [fig. 4] the slots allow for the detachable mounting to body 16).
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Fig. 4 of Tokumoto reproduced above
Regarding claim 54, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches Tokumoto teaches the first and second protrusions have dimensions in a direction parallel to the pivot axis (The moving mechanism 26 allows the holder 16 to rotate about a predetermined horizontal axis of rotation. With the rotation of the holder 16, the probe 10 which is held by the holder 16 also rotates or pivots, which further causes the scan plane generated by the probe 10 to also pivot [0055]; first protrusion 32 and second protrusion 34 have holes which allow for rotation, the axis of rotation is inherently formed from the discs that go within them, the pivot axis is seen in annotated fig. 4 below)
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Fig. 4 of Tokumoto with annotations reproduced above.
Tokumoto is silent regarding where the dimensions are in the range between ½ cm to 2 cm.
Sandrin, however, discloses the first and second protrusions being dimensioned such that allow them to be allow them to be pressed against the ribs between which they are positioned ([0056]), and adjusting the height/dimensions protrusions/locating posts 9 to fit within the intercostal space of the patient being examined ([0049]).
Before the effective filing date, it would have been obvious to one of ordinary skill in the art, through routine optimization, to change the first and second protrusions such that the dimensions are in the range between ½ cm to 2 cm, in order to optimize the shape of the protrusions/location posts 9, such that it can be pressed against the thoracic cage, and cause no injury to the patient, as suggested by Sandrin ([0056]-[0057]). See MPEP 2144.05.
Regarding claim 83, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto further teaches guide according in combination with the ultrasound transducer (Within the tip portion 20 of the probe 10, a 1D array transducer (not shown) formed by a plurality of transducer elements arranged in an arc shape is provided in this embodiment [0054]).
Regarding claim 84, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto, however, does not teach: wherein the curved patient- contacting surfaces of the first and second protrusions are shaped such that when the ultrasound transducer is pressed against the skin of the patient, the pivot axis is maintained in a fixed location between the pair of adjacent ribs as the ultrasound transducer pivots about the pivot axis.
Sandrin, however, teaches: wherein the curved patient-contacting surfaces of the first and second protrusions (locating posts 9 [0055]) are shaped such that when the ultrasound transducer is pressed against the skin of the patient (Since locating posts 9 are also intended to prevent this pressure from being borne only by the transducer 4, the height of the locating posts 9 is determined so that they should be in contact with the skin when the pressure exerted is sufficient …In addition, the locating posts 9 advantageously have transverse dimensions that allow them to be pressed against the ribs 2 between which they are positioned [0055]-[0056]) the pivot axis is maintained in a fixed location between the pair of adjacent ribs as the ultrasound transducer pivots about the pivot axis (allow the pivoting of the imagery transducer in the cavity [0030]; imagery transducer 12 is one of the single-element type. In order to allow the formation of echographic images, such a transducer is hinged onto the said instrument 1 on the transverse pivotal axis AA1 [0067]; pivoting of the imagery transducer 12 [0071]; teaches the transducer hinges/pivots about an axis when the transducer/probe is placed within the ring 8 with the protrusions 9, as seen in figs 2 and 4, and figs. 6 and 7 depict the pivoting motion).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tokumoto, to include, wherein the curved patient- contacting surfaces of the first and second protrusions are shaped such that when the ultrasound transducer is pressed against the skin of the patient, the pivot axis is maintained in a fixed location between the pair of adjacent ribs as the ultrasound transducer pivots about the pivot axis, as taught by Sandrin. This would allow for the instrument to be pressed against the thoracic cage, and cause no injury to the patient, as suggested by Sandrin ([0057]).
Claims 42-43, 45 are rejected under 35 U.S.C. 103 as being unpatentable over Tokumoto (US 20060020211 A1, hereinafter “Tokumoto”, of record) and Sandrin et al. (US 20080058644 A1, hereinafter "Sandrin"), in view of Lokhandwalla et al. (US 20050113684 A1, hereinafter "Lokhandwalla").
Regarding claim 42, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto, however, is silent in regards to the guide, wherein the radius of curvature is in the range of 0.5 cm to 1 cm.
Sandrin, however, discloses the first and second protrusions being dimensioned such that allow them to be allow them to be pressed against the ribs between which they are positioned ([0056]), and adjusting the height/dimensions protrusions/locating posts 9 to fit within the intercostal space of the patient being examined ([0049]).
Before the effective filing date, it would have been obvious to one of ordinary skill in the art, through routine optimization, to change the first and second protrusions such that the dimensions are in the range between ½ cm to 2 cm, in order to optimize the shape of the protrusions/location posts 9, such that it can be pressed against the thoracic cage, and cause no injury to the patient, as suggested by Sandrin ([0056]-[0057]). See MPEP 2144.05.
Regarding claim 43, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto, however does not teach the curved patient-contacting surfaces of the first and second protrusions each comprises a cylindrical configuration.
Lokhandwalla, however, teaches wherein the curved patient-contacting surfaces of the first and second protrusions each comprises a cylindrical configuration (rollers/spheres 28 proximate to a probe face 30 [0022]; as half the spheres are outside of the device, seen in fig. 2 below, forms a “cylindrical configuration”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tokumoto, to include wherein the patient-contacting surfaces of the first and second protrusions each comprises a cylindrical configuration, as taught while Lokhandwalla, in order to reduce variation in attenuation and refraction effects that could otherwise affect overall image quality, as suggested by Lokhandwalla ([0022]).
Regarding claim 45, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto, however, does not teach guide according wherein each of the first and second protrusions comprises a roller mounted to rotate about the pivot axis.
Lokhandwalla, however, teaches wherein each of the first and second protrusions comprises a roller mounted (rollers/spheres 28 proximate to a probe face 30 [0022]) to rotate about the pivot axis(the articulated mounting platform 26 and the rollers/spheres 28 allow the probe face to conformably tilt and/or move along a longitudinal axis Z [0022]).
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Fig. 2 and of Lokhandwalla
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tokumoto, to include wherein each of the first and second protrusions comprises a roller mounted to rotate about the pivot axis, as taught by Lokhandwalla, in order to reduce variation in attenuation and refraction effects that could otherwise affect overall image quality, as suggested by Lokhandwalla ([0022]).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Tokumoto Tokumoto (US 20060020211 A1, hereinafter “Tokumoto”, of record) and Sandrin et al. (US 20080058644 A1, hereinafter "Sandrin") in view of Burns et al (US 20130263438 A1, hereinafter "Burns").
Regarding claim 53, modified Tokumoto teaches the guide according to claim 34, as discussed above. Tokumoto, however, does not teach a mechanism for adjusting a distance by which the curved patient-contacting surface of at least one of the first and second protrusions is located forwardly of the pivot axis.
Burns is considered analogous to the instant application as “Ergonomic Grip Assemblies and Handles for Ultrasound Transducers” is disclosed (title). Burns teaches,
a mechanism for adjusting a distance (include an adjustment screw 218 [0033]) by which the curved patient-contacting surface of at least one of the first and second protrusions is located (elongate extensions 120 a and 120 b [0022]) forwardly of the pivot axis (Further tightening or advancement of the adjustment screw 218 may bias against the casing 106 and serve to finely adjust the position of the transducer 102 with respect to the interface plate 118 [0033])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tokumoto, to include a mechanism for adjusting a distance by which the curved patient-contacting surface of at least one of the first and second protrusions is located forwardly of the pivot axis, as taught by Burns, in order to easily align the transducer.
Response to Arguments
Applicant’s arguments on remarks filed 11/26/2025 have been considered but are moot.
With regards to the 35 USC §103 rejection of claim 34, applicant argues on pages 8-19, that the prior art, specifically, Tokumoto, Sandrin, and Lokhandwalla, does not the limitations regarding the pivot axis and the radius of curvature of claim 34. These arguments are moot in view of new grounds of rejection which relies upon Tchang et al. (US20180263597A1) to teach these amendments. Accordingly, the argument is moot.
Applicant arguments on page 19 are premised upon the assertion that remaining dependent claims rejected under 35 USC §103 are allowable due to dependency on an allowable independent claim. This argument is not persuasive for the reasons discussed above.
Conclusion
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798