DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species C in the reply filed on 01/09/2026 is acknowledged.
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 5-20 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. Claim 5 recites the limitation “at least one flexible member that projects from the cross member”, however, the specification lacks a written description of what the at least one flexible member represents. Paragraphs 0047-0049 recite eflection portion 812 comprises a pair of deflection side rails 824 and 826 that project proximally from cross member 818 parallel to side rails 814 and 816. Consistent with one implementation, and as shown in FIG. 13, deflection side rails 824/826 may project at a relaxed angular orientation θ1 relative to side rails 814/816. One exemplary angle θ1 may be approximately 10° although any suitable relaxed orientation in a range of approximately 0° to 15° may be provided. A deflection cross member 830 connects the proximal ends of deflection side rails 824 and 826. The examiner questions which element of the drawings represent the flexible member? and If the deflection portion as a whole is referred to as the flexible member?
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 15-16 and 23 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 15 recites the limitation “wherein the proximal portion of the rigid guidance portion projects rearwardly relative to the cross member to form a probe face engagement portion configured to engage a front face of the ultrasound probe” it is unclear how the proximal/ upper portion of the rigid guidance portion can engage a front face of the ultrasound probe? The examiner interprets the limitation as the distal portion of the rigid guidance portion projects rearwardly to engage a front face of the ultrasound probe.
Claim 16 is rejected based on its dependency from claim 15.
Claim 23 recites the limitation “puncture device guide mounting structure secured to the patient facing surface” it is unclear how the puncture device guide mounting structure is secured to the patient facing surface (probe acoustic window) and how would it be possible to obtain an image of the patient with the puncture device guide mounting structure being in between the acoustic window and the patient skin. The examiner interprets the limitation as the mounting being adjacent to the patient facing surface (probe body).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-14, 17, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cermak et al. (US 2020/0113596).
Regarding claim 1, Cermak teaches a puncture device guide for use with an ultrasound probe having a probe body and a probe face at a distal end of the probe body, the probe face being configured to be placed proximate an outer surface of a patient, the ultrasound probe forming a scan plane perpendicular to the probe face, the puncture device guide comprising (figs. 10-11, paras. 0017 and 0071; an imaging transducer for providing a signal representing an image of an internal portion of the body of a patient for visualization by a user of the imaging transducer. . A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.):
a fixed portion configured to attach directly or indirectly to the probe body (fig. 10, element 44, para. 0071; The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B. The front portion of the body member 44 includes an arcuate recess or cavity 60, as best seen in FIG. 8, which is configured to accommodate the barrel member 56. The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.); and
a deflection portion connected to the fixed portion by at least one spring or living hinge (fig. 10, element 46, paras. 0071-0072; Each ear includes a short slot terminating in a circular hole 54 for accommodating a respective pivot pin of a cylindrically shaped barrel member 56 (to be described shortly) forming a portion of the needle holder subassembly 46. The bottom edge portion of the barrel member includes a pair of pivot pins 72 projecting outward therefrom. The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).),
wherein the deflection portion comprises at least one groove configured to support a puncture device therein (para. 0072; The barrel member 56 is an elongated generally tubular member having a centrally located front slot 66 extending parallel to the central longitudinal axis 78 of the barrel member. ), and
wherein outward pressure on the at least one groove causes the deflection portion to rotate outwardly relative to the fixed portion to support the puncture device in a range of angular orientations relative to the fixed portion (para. 0072; he bottom edge portion of the barrel member includes a pair of pivot pins 72 projecting outward therefrom. The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).).
Regarding claim 2, Cermak teaches the puncture device guide of claim 1, wherein the fixed portion and the deflection portion are manufactured as a single part (para. 0071; the details of the needle guide assembly 22 will now be described. To that end, it basically comprises a body or base member 44, a needle holder subassembly 46 and a slide member 48. Each is molded of a suitable plastic material. The examiner notes that the fixed and deflection portions are manufactured as a single unit as can be seen in figure 2.).
Regarding claim 3, Cermak teaches the wherein the fixed portion and the deflection portion are formed of a flexible material (para. 0071; the details of the needle guide assembly 22 will now be described. To that end, it basically comprises a body or base member 44, a needle holder subassembly 46 and a slide member 48. Each is molded of a suitable plastic material.).
Regarding claim 4, Cermak teaches the puncture device guide of claim 1, wherein the fixed portion comprises a first side rail and a second side rail joined to the first side rail by a cross member (fig. 10, para. 0071, The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B. A pair of triangularly shaped flanged ears 52A and 52B project rearwardly from the bottom portions of the sides 50A and 50B, respectively. Each ear includes a short slot terminating in a circular hole 54 for accommodating a respective pivot pin of a cylindrically shaped barrel member 56 (to be described shortly) forming a portion of the needle holder subassembly 46. The examiner notes that the pair of sides 50A/52A and 50B/52B are the rails and they are joined by the pivoting member and holes).
Regarding claim 5, Cermak teaches the puncture device guide of claim 4, wherein the deflection portion comprises at least one flexible member that projects from the cross member (fig. 10, element 56, paras. 0071-0072, the needle guide assembly 22 will now be described. To that end, it basically comprises a body or base member 44, a needle holder subassembly 46 and a slide member 48. Each is molded of a suitable plastic material. The barrel member 56 is an elongated generally tubular member having a centrally located front slot 66 extending parallel to the central longitudinal axis 78 of the barrel member. A pair of triangular ears 68 project outward from the barrel member 56 on opposite sides of the slot 66. Each ear includes a linear slot or track 70 (only one of which can be seen in the figures) which extends at an acute angle, e.g., 15°, from the longitudinal axis of the barrel member, and oriented upward and outward as shown in FIGS. 2 and 8-12. The bottom edge portion of the barrel member includes a pair of pivot pins 72 projecting outward therefrom. The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. The examiner notes that the barrel member made of flexible plastic material projects from the pivot member connected to the fixed portion.).
Regarding claim 6, Cermak teaches the puncture device guide of 5, wherein the first side rail and the second side rail project perpendicularly from opposing ends of the cross member, and wherein the at least one flexible member of the deflection portion projects between the first side rail and the second side rail (figs. 10-12, paras. 0071-0072; The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B. A pair of triangularly shaped flanged ears 52A and 52B project rearwardly from the bottom portions of the sides 50A and 50B, respectively. Each ear includes a short slot terminating in a circular hole 54 for accommodating a respective pivot pin of a cylindrically shaped barrel member 56 (to be described shortly) forming a portion of the needle holder subassembly 46. The examiner notes that the long sides of the body member project from opposing ends of the pivot member when the pivot member is connected to the holes, where the sides of the body member comprise a cavity for accommodating the barrel member.).
Regarding claim 7, Cermak teaches the puncture device guide of claim 6, wherein the at least one flexible member comprises a first deflection side rail and a second deflection side rail joined to the first deflection side rail by a deflection cross member (fig. 10, para. 0072; The barrel member 56 is an elongated generally tubular member having a centrally located front slot 66 extending parallel to the central longitudinal axis 78 of the barrel member. A pair of triangular ears 68 project outward from the barrel member 56 on opposite sides of the slot 66. Each ear includes a linear slot or track 70 (only one of which can be seen in the figures) which extends at an acute angle, e.g., 15°, from the longitudinal axis of the barrel member, and oriented upward and outward as shown in FIGS. 2 and 8-12. The bottom edge portion of the barrel member includes a pair of pivot pins 72 projecting outward therefrom. The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. Examiner notes: see annotated figure 10 below).
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Regarding claim 8, Cermak teaches the puncture device guide of claim 7, wherein the at least one groove comprises: a first groove formed in the cross member configured to face outward from the probe body when installed (figs. 10-11, para. 0072; The barrel member 56 is an elongated generally tubular member having a centrally located front slot 66 extending parallel to the central longitudinal axis 78 of the barrel member. Examiner notes: see annotated figure bellow.); and a second groove formed in the deflection cross member configured to face inward from the probe body when installed, wherein the first groove is aligned with the second groove (figs 10-11, paras. 0072-0073; The insert 74 has a slot 76 extending parallel to the central longitudinal axis 78 of the insert from one end of the insert to the other.).
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Regarding claim 9, Cermak teaches the puncture device guide of claim 8, wherein the deflection cross member comprises a hook portion adjacent the second groove the hook portion providing an access opening to the second groove to allow the puncture device guide to be removed from a puncture device inserted in the first groove and the second grooves groove without withdrawing the puncture device from the patient (fig. 11, para. 0075; the upper or entrance end of the slot 76 is chamfered or tapered to facilitate the axial introduction of the needle therein, i.e., the tapered or chamfered surface directs the distal end of the needle towards the slot when the needle is introduced axially. The examiner notes that above the second groove is a chamfered entrance end that facilitate the entrance of the needle into the first and second grooves.).
Regarding claim 10, Cermak teaches the puncture device guide of claim 7, wherein the flexible member projects at a relaxed angular orientation relative to the first side rail and the second side rail (para. 0072; When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).).
Regarding claim 11, Cermak teaches the puncture device guide of claim 10, wherein the relaxed angular orientation comprises an angular orientation in the range of 0° to 15° (para. 0072; When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).).
Regarding claim 12, Cermak teaches the puncture device guide of claim 7, further comprising: a rigid guidance portion projecting from the cross member between the first deflection side rail and the second deflection side rail, wherein the at least one groove comprises an outwardly facing groove formed in the rigid guidance portion (fig. 11, element 74, para. 0073; That member is best seen in FIGS. 10 and 11. It is in the form of an elongated cylindrical needle holder or insert 74. The insert is molded of any suitable plastic material and is configured to be disposed within the barrel member 46 to directly hold the needle 12 therein. Moreover, as will be seen and described later, the insert 74 is configured to be rotated about the central axis 78 of the barrel member between an open position, such as shown in FIG. 12, and a closed position, such as shown in FIG. 2, and vice versa. The insert 74 has a slot 76 extending parallel to the central longitudinal axis 78 of the insert from one end of the insert to the other. The examiner notes that the insert is projecting between the deflection side rails and has a slot.).
Regarding claim 13, Cermak teaches the puncture device guide of claim 12, wherein the rigid guidance portion projects at an angular orientation relative to the first side rail and the second side rail (para. 0072; When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9). The examiner notes that the insert projects at an angular orientation relative to the side rails same as the barrel.).
Regarding claim 14, Cermak teaches the puncture device guide of The puncture device guide of wherein the rigid guidance portion includes a distal portion that projects distally from the cross member and a proximal portion that projects proximally from the cross member (fig. 12, the examiner notes that the distal portion of the insert projects distally from the barrel/body pivot cross member and the proximal portion extends upwards/proximally from the barrel/body pivot cross member), and wherein the distal portion of the rigid guidance portion includes groove walls, such that a depth of the outwardly facing groove in the proximal portion is greater than the depth of the outwardly facing groove in the distal portion (figure 11, para. 0075; the upper or entrance end of the slot 76 is chamfered or tapered to facilitate the axial introduction of the needle therein, i.e., the tapered or chamfered surface directs the distal end of the needle towards the slot when the needle is introduced axially. The examiner notes that the proximal portion has a groove with an increased depth relative to the depth of the slot).
Regarding claim 17, Cermak teaches the puncture device guide of claim 5, wherein the first side rail and the second side rail are generally planar (para. 0071; The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B.).
Regarding claim 19, Cermak teaches the puncture device guide of claim 17, wherein the first side rail and the second side rail are configured to be received within corresponding slots in a puncture device guide mounting sleeve coupled to or integrated with the probe body or a sterile cover placed over the probe body (para. 0071; The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.).
Regarding claim 20, Cermak teaches the puncture device guide of The puncture device guide of wherein the first side rail and the second side rail, have a three-dimensional configuration (para. 0071; The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B. A pair of triangularly shaped flanged ears 52A and 52B project rearwardly from the bottom portions of the sides 50A and 50B. The examiner notes that the side rails comprise a flat planer configuration and 3D configuration), and wherein the first side rail and the second side rail are configured to be received within corresponding side rail receiving elements in a puncture device guide mounting structure coupled to or integrated with the probe body or a sterile cover placed over the probe body (para. 0071; The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.).
Regarding claim 21, Cermak teaches the puncture device guide system, comprising:
an ultrasound probe cover (para. 0086; The adaptor bracket 200 is best seen in FIGS. 13-17 and enables a needle guide of this invention to be indirectly mounted on the prior art imaging transducer 10. The adaptor bracket 200 basically comprises a hollow housing 202 made of any suitable material, e.g., a plastic. The housing is hollow and shaped to accommodate the lower portion of whatever prior art imaging transducer it is to be used on.);
a puncture device guide mounting structure secured to the ultrasound probe cover (para. 0087; In order to enable a needle guide device constructed in accordance with this invention on the adaptor bracket 200, the front portion of the housing 202 includes a coupling member 216.); and
a puncture device guide comprising (para. 0071; the needle guide assembly 22):
a fixed portion configured to attach directly or indirectly to an ultrasound probe body(fig. 10, element 44, para. 0071; The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B. The front portion of the body member 44 includes an arcuate recess or cavity 60, as best seen in FIG. 8, which is configured to accommodate the barrel member 56. The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.); and
a deflection portion connected to the fixed portion by at least one spring or living hinge (fig. 10, element 46, paras. 0071-0072; Each ear includes a short slot terminating in a circular hole 54 for accommodating a respective pivot pin of a cylindrically shaped barrel member 56 (to be described shortly) forming a portion of the needle holder subassembly 46. The bottom edge portion of the barrel member includes a pair of pivot pins 72 projecting outward therefrom. The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).),
wherein the fixed portion is configured to be attached to the puncture device guide mounting structure during use (para. 0071; The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.),
wherein the deflection portion comprises at least one groove configured to support a puncture device therein (para. 0072; The barrel member 56 is an elongated generally tubular member having a centrally located front slot 66 extending parallel to the central longitudinal axis 78 of the barrel member.), and
wherein outward pressure on the at least one groove causes the deflection portion to rotate outwardly relative to the fixed portion to support the puncture device in a range of angular orientations relative to the fixed portion (para. 0072; The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak et al. (US 2020/0113596) in the view of Furia et al. (US 2002/0123689).
Regarding claim 15, Cermak teaches the puncture device guide of claim 14, however, fails to explicitly teach wherein the proximal portion of the rigid guidance portion projects rearwardly relative to the cross member to form a probe face engagement portion configured to engage a front face of the ultrasound probe.
Furia, in the same field of endeavor, teaches portion of the rigid guidance portion projects rearwardly relative to the cross member to form a probe face engagement portion configured to engage a front face of the ultrasound probe (para. 0096; A slot-like aperture 509 is provided on the front head side 9 turned toward the probe 1 and lying over the open side of the extension of the groove 702, coincident with said extension, which aperture extends transversely all along the engagement hole 409 of the front head 9. Further, at said end side 109, the front head 9 has an extension 609 toward the probe 1 which is designed to be engaged in a complementary recess 501 formed in the case of the probe 1).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the distal end of the deflection portion of Cermak with the tapered distal end of the deflection portion of Furia to provide rigid guidance portion projects rearwardly relative to the cross member to form a probe face engagement portion configured to engage a front face of the ultrasound probe because it will eliminate forming a step between the distal end and the probe and create a connection in a harmonic manner as disclosed within Furia in para. 0096.
Regarding claim 16, Cermak teaches the puncture device guide of claim 15, however, fails to explicitly teach wherein the probe face engagement portion is angled relative to the first side rail and the second side rail to conform to the front face of the ultrasound probe.
Furia, in the same field of endeavor, disclose wherein the probe face engagement portion is angled relative to the first side rail and the second side rail to conform to the front face of the ultrasound probe (para. 0096; A slot-like aperture 509 is provided on the front head side 9 turned toward the probe 1 and lying over the open side of the extension of the groove 702, coincident with said extension, which aperture extends transversely all along the engagement hole 409 of the front head 9. Further, at said end side 109, the front head 9 has an extension 609 toward the probe 1 which is designed to be engaged in a complementary recess 501 formed in the case of the probe 1).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the distal end of the deflection portion of Cermak with the tapered distal end of the deflection portion of Furia to provide probe face engagement portion is angled relative to the first side rail and the second side rail to conform to the front face of the ultrasound probe because it will eliminate forming a step between the distal end and the probe and create a connection in a harmonic manner as disclosed within Furia in para. 0096.
Claim(s) 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak et al. (US 2020/0113596) in the view of Pruter et al. (US 7,837,627).
Regarding claim 18, Cermak teaches the puncture device guide of claim 17, wherein the first side rail and the second side rail are configured to adhere to one of the probe body or a sterile cover placed over the probe body via an adhesive.
Pruter, in the same field of endeavor, disclose needle guide is configured to adhere to one of the probe body or a sterile cover placed over the probe body via an adhesive (col 2, line 52 to col 3, line 2; Needle guide 102 is coupled to sterile sheath 104 by exterior adhesive 106. Sterile sheath 104 can be a latex sheath or other material known for use with sheaths and sterile sheaths for medical imaging transceivers. Exterior adhesive 106 can be a contact adhesive applied to sterile sheath 104 or needle guide 102, or it may be adhesive tape.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the connection method of the needle guide to the probe of Cermak with the method of connecting the needle guide to the probe using adhesive of Pruter to provide first side rail and the second side rail are configured to adhere to one of the probe body or a sterile cover placed over the probe body via an adhesive because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 22, Cermak teaches the puncture device guide system of claim 21, however, fails to explicitly teach wherein an inside surface of the ultrasound probe cover comprises an adhesive layer for facilitating securing of the ultrasound probe cover to an ultrasound probe.
Pruter, in the same field of endeavor, disclose wherein an inside surface of the ultrasound probe cover comprises an adhesive layer for facilitating securing of the ultrasound probe cover to an ultrasound probe (col 3, line 3-39; ow referring to FIG. 3, there is shown an exploded view of the needle guide system of FIG. 1, which includes an internal adhesive material 312 disposed on the inside of sterile sheath 104. Medical imaging device 103 is inserted into sterile sheath 104. Elongated adhesive cover removing pull 108 is pulled to expose internal adhesive material 312. Internal adhesive material 312 is then pressed against medical imaging device 103. Needle guide 102, which has been previously attached to sterile sheath 104 via exterior adhesive 106 or other means, can be used for normal clinical activities.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the attachment mechanism of the probe cover to the probe of Cermak with the adhesive attachment mechanism of the probe cover to the probe of Pruter to provide ultrasound probe cover comprises an adhesive layer for facilitating securing of the ultrasound probe cover to an ultrasound probe because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Cermak et al. (US 2020/0113596) in the view of Lindekugel et al. (US 7,837,627).
Regarding claim 23, Cermak teaches a puncture device guide system, comprising:
a puncture device guide mounting structure secured to the patient facing surface (para. 0087; in order to enable a needle guide device constructed in accordance with this invention on the adaptor bracket 200, the front portion of the housing 202 includes a coupling member 216.)
a puncture device guide comprising (para. 0071; the needle guide assembly 22):
a fixed portion configured to attach directly or indirectly to an ultrasound probe body(fig. 10, element 44, para. 0071; The body member 44 comprises a generally flat panel having a pair of long sides 50A and 50B. The front portion of the body member 44 includes an arcuate recess or cavity 60, as best seen in FIG. 8, which is configured to accommodate the barrel member 56. The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.); and
a deflection portion connected to the fixed portion by at least one spring or living hinge (fig. 10, element 46, paras. 0071-0072; Each ear includes a short slot terminating in a circular hole 54 for accommodating a respective pivot pin of a cylindrically shaped barrel member 56 (to be described shortly) forming a portion of the needle holder subassembly 46. The bottom edge portion of the barrel member includes a pair of pivot pins 72 projecting outward therefrom. The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).),
wherein the fixed portion is configured to be attached to the puncture device guide mounting structure during use (para. 0071; The back wall 58 includes a slot or channel 62 extending from one side of the back wall to the other and is open to the back surface of the back wall from the ear 52A to a point adjacent the ear 52B. A central opening 64 is located in the front surface of the back wall and is shaped to accommodate the top portion 16A of the transducer coupling member 16 to releasably secure the needle guide device to the transducer.),
wherein the deflection portion comprises at least one groove configured to support a puncture device therein (para. 0072; The barrel member 56 is an elongated generally tubular member having a centrally located front slot 66 extending parallel to the central longitudinal axis 78 of the barrel member.), and
wherein outward pressure on the at least one groove causes the deflection portion to rotate outwardly relative to the fixed portion to support the puncture device in a range of angular orientations relative to the fixed portion (para. 0072; The pins 72 are diametrically opposed and axially aligned, and each pin is configured to be disposed within a respective hole 54 in the body member 44. When so located the barrel member is able to pivot with respect to the body member about the axis of the aligned holes and pins to enable the barrel to assume any desired angular position with respect to the body member from 0° (as shown in FIG. 8) to 40° (as shown in FIG. 9).).
However, Cermak fails to explicitly teach an ultrasound probe interface pad comprising: a probe-facing surface and patient facing surface.
Lindekugel, in the same field of endeavor, disclose an ultrasound probe interface pad comprising: a probe-facing surface and patient facing surface (para. 0068; spacer component 118 includes a skin contact surface 126 that defines two spacer elements 120 and a concavity 122 disposed therebetween. The spacer component includes 118 a compliant material, such as hydrogel in one embodiment, though it is appreciated that other suitable materials can also be employed).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the cover of Cermak with the cover with ultrasound interface pad of Lindekugel to provide an ultrasound probe interface pad comprising a probe-facing surface and patient facing surface because it will provide acoustic path between the acoustic surface and the patient without requiring the use of flowable gel as disclosed within Lindekugel in para. 0068.
Conclusion
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797