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 Applicant’s remarks, filed on 12/15/2025. The amendments to claim(s) 1, 5, 8 and 16 have been entered. Accordingly, claim(s) 1-16 remain pending for examination on the merits.
Response to Arguments
Applicant’s arguments, see p. 5-9, with respect to the rejection of claim(s) 1-16 have been fully considered.
After review of the Applicant’s remarks and amendments regarding the objections to claim(s) 1, 5, 8 and 16, Examiner respectfully agrees with Applicant and the objections to the claims are withdrawn.
After review of the remarks and the amendments to the claim(s), Examiner respectfully agrees with the Applicant’s remarks and the 35 USC § 112 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New grounds of rejection are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of pertinent, eligible prior art; and/or different interpretation of the previously applied references.
Examiner respectfully notes that Applicant’s arguments only address independent claim(s) 1 and 16, and no remarks regarding the subject matter of the dependent claim(s) have been presented. Accordingly, the rejections to dependent claims 2-15 are modified to address Applicant’s amendments and the new rejection to independent claim(s) 1 and 16 and are sustained. The rejections of claim(s) 1-16 under 35 U.S.C. § 103 are maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 and 12-16 is/are rejected under as being unpatentable under 35 U.S.C. 103 over Ahmed et al. (US20060074318A1, 2006-04-06; hereinafter “Ahmed”), or alternatively over Ahmed in view of Corl et al. (US5059851A, 1991-10-22; hereinafter “Corl”).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Ahmed teaches an intraluminal sensing device (“A guide wire assembly,” [clm 9]; “This invention is particularly suitable for making pressure measurements in coronary arteries of human beings.” [0002]; [0044-0054], [fig. 2-3]), comprising:
a flexible elongate member comprising a distal portion and a proximal portion and configured to be positioned within a body lumen of a patient (“a flexible elongate member having a proximal end and a distal end, a lumen extending therebetween, and an outer wall;” [clm 9]; “by having both the ultrasound transducer 101 and the pressure sensor 104 near its distal end, the combination sensor tip 100 is capable of being positioned further distally in a vessel or the body” [0047]; [0044-0054], [fig. 2-3]);
a sensor configured to obtain physiological data while positioned within the body lumen, wherein the sensor comprises a proximal surface and an opposite, distal surface (“a combination sensor housing coupled to the distal end of the flexible elongate tubular member, having an outer wall and a distal end and a proximal end, and a lumen extending therebetween; […] a flow sensor disposed within the lumen of the combination sensor housing towards the distal end of the housing,” [clm 9]; “The combination sensor tip 100 includes a flow sensor 101, for example an ultrasound transducer, a Doppler flow sensor or any other suitable flow sensor, disposed at or in close proximity to the distal end 102 of the combination sensor tip 100 […] Conductors (not shown) may be secured to the front and rear sides of the ultrasound transducer 101” [0044]; The combination sensor tip comprises a pressure sensor and ultrasound transducer, wherein the ultrasound transducer possesses front and rear sides [0044-0054], [fig. 2-3; see fig. 2 reproduced below]);
an acoustic matching layer disposed on the distal surface of the sensor (Acoustic matching layer at the distal end 102 is disposed distal to transducer 101 within the sensor housing 103 [0044-0054], [fig. 2-3; see fig. 2 reproduced below]); and
a housing positioned at the distal portion of the flexible elongate member and terminating at a distal end, wherein the housing comprises a hollow interior with a distally-facing planar surface (“a combination sensor housing coupled to the distal end of the flexible elongate tubular member, having an outer wall and a distal end and a proximal end, and a lumen extending therebetween;” [clm 9]; “the sensor housing 103 preferably includes a lumen surrounded by housing walls” [0045]; “the combination sensor tip 100 incorporates a sensor housing 103 designed to enclose both the ultrasound transducer 101 and the pressure sensor 104.” [0046]; “The transducer 304 is simply slid into place in the lumen 310 and bonded” [0050]; The sensor housing has a lumen (i.e., hollow interior), wherein the distal end is counterbored to have a wider diameter distally and smaller inner diameter proximally [0044-0054], [fig. 2-3; see fig. 2 reproduced below]);
wherein the sensor is positioned within the hollow interior of the housing wherein the proximal surface of the sensor is disposed on the planar surface of the hollow interior, and wherein the distal surface of the sensor faces distally and is perpendicular to a longitudinal axis of the housing (“a flow sensor disposed within the lumen of the combination sensor housing towards the distal end of the housing,” [clm 9]; “The combination sensor tip 100 includes a flow sensor 101, for example an ultrasound transducer, a Doppler flow sensor or any other suitable flow sensor, disposed at or in close proximity to the distal end 102 of the combination sensor tip 100.” [0044]; The ultrasound transducer is disposed within the sensor housing lumen distal to counterbored section of the distal end [0044-0054], [fig. 2-3; see fig. 2 reproduced below]), and
wherein a thickness of the acoustic matching layer is equal to a distance between the distal surface of the sensor and the distal end of the housing (The acoustic matching layer is disposed distal to the sensor and sits flush (i.e., equal to a distance) with the distal end of the sensor housing [0044-0054], [fig. 2-3; see fig. 2 reproduced below]).
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Acoustic matching layer and ultrasound transducer 101 at distal end of counterbored sensor housing 103 within the lumen of the flexible elongate member (Ahmed [fig. 2], annotated)
Although Ahmed teaches all the limitations of claim 1 as shown above, if in an interpretation, one argues (or interprets differently) that Ahmed does not explicitly disclose the ‘acoustic matching layer’, the following reference is provided for an alternative rejection in supplementation to the above teachings.
In the same field of endeavor, Corl teaches an intraluminal sensing device (“A guidewire” [clm 1]; [col.1-5, ln.66-2], [fig. 1-2]), comprising:
a flexible elongate member comprising a distal portion and a proximal portion and configured to be positioned within a body lumen of a patient (“a flexible elongate member having a distal extremity” [clm 1]; [fig. 1-2]);
a sensor configured to obtain physiological data while positioned within the body lumen, wherein the sensor comprises a proximal surface and an opposite, distal surface (“an ultrasonic transducer” [clm 1]; “wherein the transducer has front and back sides” [clm 2]; The transducer has front (i.e., distal surface) and back (i.e., proximal surface) surfaces [col.2-4, ln.4-2], [fig. 1-2]);
an acoustic matching layer disposed on the distal surface of the sensor (“wherein the transducer has front and back sides together with a matching layer disposed on the front side” [clm 2]; A matching layer is provided on the front side of the transducer [col.2-4, ln.4-2], [fig. 1-2; see fig. 2 reproduced below]); and
a housing positioned at the distal portion of the flexible elongate member and terminating at a distal end, wherein the housing comprises a hollow interior with a distally-facing planar surface (“A guidewire as in claim 1 together with a cylindrical member mounted on the distal extremity of the flexible elongate member and housing the transducer” [clm 3]; “wherein said cylindrical member is provided with a cup-shaped recess” [clm 5]; “the guide wire 11 is comprised of a flexible elongate member 12 in the form of a stainless steel tube, typically called a hypo tube” [col.2, ln.9-12]; The guidewire has a cylindrical member tube with a distal cup shaped recess having a distally facing planar surface [col.2-3, ln.4-8], [fig. 1-2; see fig. 2 reproduced below]);
wherein the sensor is positioned within the hollow interior of the housing, and wherein the distal surface of the sensor faces distally and is perpendicular to a longitudinal axis of the housing (“said cylindrical member is provided with a cup-shaped recess and wherein said transducer is mounted in said cup-shaped recess” [clm 5]; “An ultrasonic transducer 28 is mounted in the cup-shaped recess 26. […] the transducer 28 is recessed within the cup a suitable distance as, for example, 0.0018 inches so that a matching layer 36 can be provided.” [col.2, ln. 36-54]; The ultrasound transducer is disposed within the cup-shaped recess of the flexible elongate member [col.2-3, ln.4-8], [fig. 1-2; see fig. 2 reproduced below]), and
wherein a thickness of the acoustic matching layer is equal to a distance between the distal surface of the sensor and the distal end of the housing (“wherein the transducer has front and back sides together with a matching layer disposed on the front side” [clm 2]; “wherein said matching layer is disposed in said cup-shaped recess” [clm 6]; “The matching layer 36 can have a suitable thickness as, for example, one quarter of the wavelength frequency for the transducer 28. The matching layer 36 can be formed in a number of ways. It can be provided by filling the space in front of the front surface 31 of the transducer 28 […] it is ground so that it has a surface which is parallel to the front surface 31 of the transducer crystal 28” [col.2, ln.54-64]; The transducer and matching layer are disposed within the cup shaped recess at the distal end of the flexible elongate member, wherein the matching layer is flush with the end [col.2-3, ln.4-8], [fig. 1-2; see fig. 2 reproduced below]).
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The ultrasound transducer 28 is recessed within the cup at the distal end of the flexible elongate member to accommodate the matching layer 36, wherein the thickness of the matching layer is sized to be parallel to the recess (Corl [fig. 2])
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the acoustic matching layer as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). An improvement of the present invention over current designs that use separate pressure sensor and ultrasound transducer housings is a smoother transition from the elongate tubular member to the combination sensor tip 100 (Ahmed [0051]). The use of the matching layer ensures efficient coupling of the energy from the transducer into the surrounding liquid medium (e.g., blood) (Corl [col.4, ln.25-28]).
Regarding claim 2, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Corl further teaching wherein a distal end of the acoustic matching layer is flush with the distal end of the housing (“wherein the transducer has front and back sides together with a matching layer disposed on the front side” [clm 2]; “wherein said matching layer is disposed in said cup-shaped recess” [clm 6]; “The matching layer 36 can have a suitable thickness as, for example, one quarter of the wavelength frequency for the transducer 28. The matching layer 36 can be formed in a number of ways. It can be provided by filling the space in front of the front surface 31 of the transducer 28 […] it is ground so that it has a surface which is parallel to the front surface 31 of the transducer crystal 28” [col.2, ln. 54-64]; [col.2-3, ln.4-8], [fig. 1-2], [see claim 1 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the acoustic matching layer as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). The use of the matching layer ensures efficient coupling of the energy from the transducer into the surrounding liquid medium (e.g., blood) (Corl [col.4, ln.25-28]).
Regarding claim 3, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Corl further teaching wherein the acoustic matching layer comprises an adhesive (“The matching layer 36 can be formed in a number of ways. It can be provided by filling the space in front of the front surface 31 of the transducer 28 with a suitable epoxy material, such as a two part epoxy material […] After the PC 12 adhesive has cured, it is ground so that it has a surface which is parallel to the front surface 31 of the transducer crystal 28” [col.2, ln.54-64]; Epoxy is an adhesive [col.2-3, ln.4-8]; [fig. 1-2], [see claim 1 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the acoustic matching layer as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). The use of the matching layer ensures efficient coupling of the energy from the transducer into the surrounding liquid medium (e.g., blood) (Corl [col.4, ln.25-28]).
Regarding claim 4, Ahmed and Corl teach the intraluminal sensing device of claim 3,
Ahmed further teaching wherein the sensor further comprises a side surface, and wherein the adhesive is disposed on the side surface of the sensor (“the lumen 310 of the housing is counterbored so that the lumen 310 has a smaller inner diameter at the proximal end of the tubular member 306. […] In addition, a flow sensor (not shown) may be placed in the sensor tip 302 instead of the weld, braze, epoxy or adhesive to provide a combo sensor tip” [0049]; “The transducer 304 is simply slid into place in the lumen 310 and bonded (adhesive or epoxy) where the sides meet the proximal 0.010″ inner diameter 314.” [0050]; The flow transducer (i.e., sensor) may replace the sensor tip and possesses sides which meet the counterbored inner diameter of the sensor housing lumen [0044-0054], [fig. 2-3], [see claim 1 rejection]).
Ahmed discloses the claimed invention except for explicitly stating that an adhesive bonds the flow sensor (i.e., ultrasound transducer) to the lumen housing; however, Ahmed clearly teaches the use of adhesive for bonding the pressure transducer to the counterbored lumen wall at a side of the transducer, and also that the sensor tip may be comprised of an adhesive. It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to replace the bonding method of the flow transducer and the pressure transducer, since it has been held that rearranging parts of an invention involves only routine skill in the art [In re Japikse, 86 USPQ 70], and since it has been held to be within the general skill of a worker in the art to select a known material (e.g., an adhesive for bonding two components) on the basis of its suitability for the intended use as a matter of obvious design choice [In re Leshin, 125 USPQ 416].
Although Ahmed appears to teach the limitations of claim 4 as shown above, if in an interpretation, one argues (or interprets differently) that Ahmed does not explicitly disclose that an adhesive bonds the flow sensor, the following reference is provided for an alternative rejection in supplementation to the above teachings.
In the same field of endeavor, Corl teaches the sensor further comprises a side surface, and wherein the adhesive is disposed on the side surface of the sensor (“wherein said cylindrical member is provided with a cup-shaped recess and wherein said transducer is mounted in said cup-shaped recess together with adhesive means for retaining said transducer in said cup-shaped recess” [clm 5]; “The transducer 28 is mounted within the cup-shaped recess 26 in a suitable manner such as by a medical grade adhesive such as FMD 14 adhesive” [col.2, ln.42-45]; “Assuming, by way of example, that it is desired that the screw tip 31 have an outside diameter of 0.018 inches and that the wall thickness of the screw tip forming the cup-like recess 26 is a minimum of 0.0005 inches which must be multiplied by 2 for the thickness of both walls. At a minimum the crystal would have a diameter of 0.0168 inches (0.018-0.001 and 0.0002 for the adhesive) and dividing this in half to obtain the proper aspect ratio” [col.3, ln.57-65]; [col.2-4, ln.4-19], [fig. 1-2], [see claim 1 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the adhesive as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). An improvement of the present invention over current designs that use separate pressure sensor and ultrasound transducer housings is a smoother transition from the elongate tubular member to the combination sensor tip 100 (Ahmed [0051]). By utilizing these criteria, it has been found that it is possible to produce a micro-miniature ultrasound high frequency efficiency transducer and a guidewire utilizing the same (Corl [col.4, ln.20-23]).
Regarding claim 5, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Ahmed further teaching wherein the proximal surface of the sensor is planar and the sensor is positioned within the housing wherein the proximal surface is parallel with the planar surface along the entire planar surface (“a flow sensor disposed within the lumen of the combination sensor housing towards the distal end of the housing,” [clm 9]; “The combination sensor tip 100 includes a flow sensor 101, for example an ultrasound transducer, a Doppler flow sensor or any other suitable flow sensor, disposed at or in close proximity to the distal end 102 of the combination sensor tip 100.” [0044]; [0044-0054], [fig. 2-3], [see claim 1 rejection]).
Regarding claim 6, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Ahmed further teaching wherein the hollow interior comprises a counterbore, wherein the counterbore comprises a thru-hole extending through the planar surface (“the lumen 310 of the housing is counterbored so that the lumen 310 has a smaller inner diameter at the proximal end of the tubular member 306. For example, the housing may be constructed in the counterbore fashion with a 0.010″ inner diameter at the proximal end 314 and a 0.012″ inner diameter at the distal end 312. […] In addition, a flow sensor (not shown) may be placed in the sensor tip 302” [0049]; The ultrasound transducer is mounted in a counterbored housing and communicates with the lumen (i.e., thru-hole through planar surface) which extends through the housing [0044-0054], [fig. 2-3; see fig. 2 reproduced below], [see claim 1 rejection]).
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The ultrasound transducer 101 is slid into the counterbored distal end of the sensor housing, wherein the lumen of the sensor housing communicates with counterbored section (Ahmen [fig. 2])
Regarding claim 7, Ahmed and Corl teach the intraluminal sensing device of claim 6,
wherein at least a portion of the thru-hole is proximal of the planar surface (“the lumen 310 of the housing is counterbored so that the lumen 310 has a smaller inner diameter at the proximal end of the tubular member 306. For example, the housing may be constructed in the counterbore fashion with a 0.010″ inner diameter at the proximal end 314 and a 0.012″ inner diameter at the distal end 312. […] In addition, a flow sensor (not shown) may be placed in the sensor tip 302” [0049]; [0044-0054], [fig. 2-3], [see claim 6 rejection]).
Regarding claim 12, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Ahmed further teaching wherein the sensor comprises a flow sensor (“a flow sensor disposed within the lumen of the housing towards the distal end of the housing,” [clm 9]; [0044-0054], [fig. 2-3], [see claim 1 rejection]).
Regarding claim 13, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Ahmed further teaching further comprising a wire assembly coupled to the sensor and extending through a portion of the hollow interior proximal of the planar surface (“a combination sensor housing coupled to the distal end of the flexible elongate tubular member, having an outer wall and a distal end and a proximal end, and a lumen extending therebetween; […] a plurality of electrical connectors extending longitudinally from the flow sensor to substantially the proximal end of the flexible elongate member.” [clm 9]; “signals from the ultrasound transducer 101 and the pressure sensor 104 may be carried by fine wire conductors 107 passing through the guide wire to conductive bands 108 a-e near the proximal end 110 of the guide wire. […] The conductive bands transmit the electrical signals from the conductors via a mating connector (or contact housing as described herein with respect to a connector of the present invention) to an instrument, such as, e.g., a physiology monitor, that converts the signals into pressure and velocity readings that are displayed to the user. In addition algorithms such as Coronary Flow Reserve (CFR) and Fractional Flow Reserve (FFR) are calculated.” [0052]; Electrical conductors (i.e., wire assembly) communicate electrical signals from the ultrasound transducer with a physiology monitor via a mating connector [0044-0054], [fig. 2-5], [see claim 1 rejection]).
Regarding claim 14, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Corl teaching further comprising an adhesive positioned between the sensor and the housing and configured to secure the sensor to the housing (“wherein said cylindrical member is provided with a cup-shaped recess and wherein said transducer is mounted in said cup-shaped recess together with adhesive means for retaining said transducer in said cup-shaped recess” [clm 5]; “The transducer 28 is mounted within the cup-shaped recess 26 in a suitable manner such as by a medical grade adhesive such as FMD 14 adhesive” [col.2, ln.42-45]; “Assuming, by way of example, that it is desired that the screw tip 31 have an outside diameter of 0.018 inches and that the wall thickness of the screw tip forming the cup-like recess 26 is a minimum of 0.0005 inches which must be multiplied by 2 for the thickness of both walls. At a minimum the crystal would have a diameter of 0.0168 inches (0.018-0.001 and 0.0002 for the adhesive) and dividing this in half to obtain the proper aspect ratio” [col.3, ln.57-65]; [col.2-4, ln.4-19], [fig. 1-2], [see claim 4 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the acoustic matching layer as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). By utilizing these criteria, it has been found that it is possible to produce a micro-miniature ultrasound high frequency efficiency transducer and a guidewire utilizing the same (Corl [col.4, ln.20-23]).
Regarding claim 15, Ahmed and Corl teach the intraluminal sensing device of claim 14,
Corl further teaching wherein the adhesive comprises a first material and the acoustic matching layer comprises a different, second material (“The transducer 28 is mounted within the cup-shaped recess 26 in a suitable manner such as by a medical grade adhesive such as FMD 14 adhesive” [col.2, ln.42-45]; “The matching layer 36 can be formed in a number of ways. It can be provided by filling the space in front of the front surface 31 of the transducer 28 with a suitable epoxy material, such as a two part epoxy material” [col. 2, ln.57-61]; [col.2-4, ln.4-19], [fig. 1-2]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the acoustic matching layer as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). By utilizing these criteria, it has been found that it is possible to produce a micro-miniature ultrasound high frequency efficiency transducer and a guidewire utilizing the same (Corl [col.4, ln.20-23]).
Regarding claim 16, Ahmed teaches an intravascular flow-sensing device (“A guide wire assembly,” [clm 9]; “This invention is particularly suitable for making pressure measurements in coronary arteries of human beings.” [0002]; [0044-0054], [fig. 2-3]), comprising:
a guidewire comprising a distal portion and a proximal portion and configured to be positioned within a blood vessel of a patient (“A guide wire assembly, comprising: a flexible elongate member having a proximal end and a distal end, a lumen extending therebetween, and an outer wall;” [clm 9]; “by having both the ultrasound transducer 101 and the pressure sensor 104 near its distal end, the combination sensor tip 100 is capable of being positioned further distally in a vessel or the body” [0047]; [0044-0054], [fig. 2-3]);
a flow sensor configured to obtain intravascular flow data while positioned within the blood vessel, wherein the flow sensor comprises a proximal surface and an opposite, distal surface (“a combination sensor housing coupled to the distal end of the flexible elongate tubular member, having an outer wall and a distal end and a proximal end, and a lumen extending therebetween; […] a flow sensor disposed within the lumen of the combination sensor housing towards the distal end of the housing,” [clm 9]; “The combination sensor tip 100 includes a flow sensor 101, for example an ultrasound transducer, a Doppler flow sensor or any other suitable flow sensor, disposed at or in close proximity to the distal end 102 of the combination sensor tip 100 […] Conductors (not shown) may be secured to the front and rear sides of the ultrasound transducer 101” [0044]; [0044-0054], [fig. 2-3], [see claim 1 rejection]);
an acoustic matching layer disposed on a distal surface of the flow sensor (Acoustic matching layer at the distal end 102 is disposed distal to transducer 101 within the sensor housing 103 [0044-0054], [fig. 2-3], [see claim 1 rejection]); and
a housing positioned at the distal portion of the guidewire and terminating at a distal end, wherein the housing comprises a hollow interior defined by a counterbore, wherein the counterbore comprises a planar surface and a thru-hole, and wherein the distal surface of the flow sensor faces distally and is perpendicular to a longitudinal axis of the housing (“a combination sensor housing coupled to the distal end of the flexible elongate tubular member, having an outer wall and a distal end and a proximal end, and a lumen extending therebetween;” [clm 9]; “the sensor housing 103 preferably includes a lumen surrounded by housing walls” [0045]; “the combination sensor tip 100 incorporates a sensor housing 103 designed to enclose both the ultrasound transducer 101 and the pressure sensor 104.” [0046]; “the lumen 310 of the housing is counterbored so that the lumen 310 has a smaller inner diameter at the proximal end of the tubular member 306. For example, the housing may be constructed in the counterbore fashion with a 0.010″ inner diameter at the proximal end 314 and a 0.012″ inner diameter at the distal end 312. […] In addition, a flow sensor (not shown) may be placed in the sensor tip 302” [0049]; [0044-0054], [fig. 2-3], [see claim 1, 6 rejections]).
wherein the flow sensor is positioned within the housing wherein the proximal surface of the flow sensor is disposed on the planar surface of the counterbore and a thickness of the acoustic matching layer is equal to a distance between the distal surface of the flow sensor and the distal end of the housing (“a flow sensor disposed within the lumen of the combination sensor housing towards the distal end of the housing,” [clm 9]; “The combination sensor tip 100 includes a flow sensor 101, for example an ultrasound transducer, a Doppler flow sensor or any other suitable flow sensor, disposed at or in close proximity to the distal end 102 of the combination sensor tip 100.” [0044]; [0044-0054], [fig. 2-3], [see claim 1 rejection]).
Although Ahmed teaches all the limitations of claim 1 as shown above, if in an interpretation, one argues (or interprets differently) that Ahmed does not explicitly disclose the ‘acoustic matching layer’, the following reference is provided for an alternative rejection in supplementation to the above teachings.
In the same field of endeavor, Corl teaches an intravascular flow-sensing device (“a flexible elongate member having a distal extremity” [clm 1]; [fig. 1-2]), comprising:
a flow sensor configured to obtain intravascular flow data while positioned within the blood vessel, wherein the flow sensor comprises a proximal surface and an opposite, distal surface (“an ultrasonic transducer” [clm 1]; “wherein the transducer has front and back sides” [clm 2]; [col.2-4, ln.4-2], [fig. 1-2], [see claim 1 rejection]);
an acoustic matching layer disposed on a distal surface of the flow sensor (“wherein the transducer has front and back sides together with a matching layer disposed on the front side” [clm 2]; [col.2-4, ln.4-2], [fig. 1-2], [see claim 1 rejection]); and
a housing positioned at the distal portion of the guidewire and terminating at a distal end, wherein the housing comprises a hollow interior defined by a counterbore, wherein the counterbore comprises a planar surface and a thru-hole, and wherein the distal surface of the flow sensor faces distally and is perpendicular to a longitudinal axis of the housing (“A guidewire as in claim 1 together with a cylindrical member mounted on the distal extremity of the flexible elongate member and housing the transducer” [clm 3]; “wherein said cylindrical member is provided with a cup-shaped recess” [clm 5]; “the guide wire 11 is comprised of a flexible elongate member 12 in the form of a stainless steel tube, typically called a hypo tube” [col.2, ln.9-12]; [col.2-3, ln.4-8], [fig. 1-2], [see claim 1 rejection]),
wherein the flow sensor is positioned within the housing wherein the proximal surface of the flow sensor is disposed on the planar surface of the counterbore and a thickness of the acoustic matching layer is equal to a distance between the distal surface of the flow sensor and the distal end of the housing (“wherein the transducer has front and back sides together with a matching layer disposed on the front side” [clm 2]; “said cylindrical member is provided with a cup-shaped recess and wherein said transducer is mounted in said cup-shaped recess” [clm 5]; “wherein said matching layer is disposed in said cup-shaped recess” [clm 6]; “An ultrasonic transducer 28 is mounted in the cup-shaped recess 26. […] the transducer 28 is recessed within the cup a suitable distance as, for example, 0.0018 inches so that a matching layer 36 can be provided.” [col.2, ln. 36-54]; “The matching layer 36 can have a suitable thickness as, for example, one quarter of the wavelength frequency for the transducer 28. The matching layer 36 can be formed in a number of ways. It can be provided by filling the space in front of the front surface 31 of the transducer 28 […] it is ground so that it has a surface which is parallel to the front surface 31 of the transducer crystal 28” [col.2, ln.54-64]; [col.2-3, ln.4-8], [fig. 1-2], [see claim 1 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed with the acoustic matching layer as taught by Corl. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). An improvement of the present invention over current designs that use separate pressure sensor and ultrasound transducer housings is a smoother transition from the elongate tubular member to the combination sensor tip 100 (Ahmed [0051]). The use of the matching layer ensures efficient coupling of the energy from the transducer into the surrounding liquid medium (e.g., blood) (Corl [col.4, ln.25-28]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed and Corl as applied to claim 1 above, further in view of Lim (EP 3150115 A1; 2017-04-05, hereinafter “Lim”).
Regarding claim 8, Ahmed and Corl teach the intraluminal sensing device of claim 1,
Ahmed further teaching the housing including a hollow interior [see claim 1 rejection];
but Ahmed and Corl fail to teach the housing comprises a plurality of layers formed atop one another.
However, in the same field of endeavor, Lim teaches an intraluminal sensing device (“A catheter apparatus comprising: […] a diagnostic assembly (7000) on the distal portion,” [clm 1]; “The catheter of the present invention has an optical sensor integrated into it possessing a light emitting means and light receiving means. The optical sensor is adapted to generate optical sensing data depending on the received light.” [0095]; [fig. 25]);
Lim further teaching wherein the housing comprises a plurality of layers formed atop one another such that the plurality of layers defines a continuous surface, wherein the hollow interior is defined by the continuous surface (“the diagnostic assembly can include an insert, typically placed in the catheter or a catheter lumen for delivery to the diagnostic location.” [0143]; “For ease and cheap cost of manufacturing- optic fibers can be inserted into 3D printed part. […] a 3D printed part may be prepared with the relevant lumens and exit ports.” [0183]; The catheter is manufactured with insert comprising lumens (i.e., housing with hollow interior) for the optical fibers of the diagnostic sensing assembly, wherein the insert may be manufactured using 3D printing techniques (i.e., continuous) [fig. 25; see fig. 25 reproduced below]).
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The insert for holding fiber optics of the catheter may be 3D printed (Lim [fig. 25])
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed and Corl with the housing comprising a plurality of layers as taught by Lim. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). Providing a 3D printed part allows for ease of manufacturing, and controls the fiber optic manufacturing to prevent breakage. An insert that holds the fiber optics (whether 3D printed or otherwise) can also provide for ease of rotation of the sensing assembly, and avoid fiber optic twisting or breakage (Lim [0183]).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed and Corl as applied to claim 1 above, further in view of Belt et al. (US20190133553A1; 2019-05-09, hereinafter “Belt”).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 9, Ahmed and Corl teach the intraluminal sensing device of claim 1, but Ahmed and Corl fail to teach the insulating layer.
However, in the same field of endeavor, Belt teaches an intraluminal sensing device (“An ultrasound device comprising a transducer arrangement” [clm 1]; “such an ultrasound probe may form part of a catheter for invasive imaging or treatment, […] Non-limiting examples of such probes include transesophageal echocardiogram (TEE) probes, intravascular probes such as intracardiac echo catheters, and so on.” [0072]; [fig. 1-2, 4]);
Belt further teaching wherein the sensor further comprises an insulating layer (“The inner layer 151 may comprise any suitable electrically insulating material such as an electrically insulating polymer, e.g. elastomer, to electrically insulate the transducer array from the elastomer layer 153.” [0059]; The acoustic window of the ultrasound device has an inner layer (i.e., insulating layer) arranged between the elastomer layer and the ultrasound transducer tiles [clm 13], [0037-0076], [fig. 1-2, 4]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed and Corl with the insulating layer as taught by Belt. ICE devices are necessarily small as they have to travel to the chambers of the heart via blood vessels. There is a need for a new and improved ultra miniature pressure and flow sensor, as well as a guide wire and apparatus for utilizing the same (Ahmed [0004]); additionally, there is a need for an ultrasonic transducer which has a high efficiency even though it has been reduced to a micro miniature size (Corl [col.1, ln.18-20]). It is well-known that operation of CMUT elements in collapse mode enhances the acoustic capabilities of the transducer array at the cost of reduced lifetime of the CMUT elements; therefore the ability to disable the power supply to CMUT elements where the generation of ultrasound waves would not yield the desired result due to the poor quality contact between the transducer array and the body (or where the transducer elements risk being damaged by overheating) is particularly advantageous as it results in an elongated lifetime of the CMUT elements (Belt [0025]). The polybutadiene layer used as materials for the inner layer may improve acoustic wave transmission (lower attenuation) for the entire acoustic window, in particular when the transducer elements are CMUT elements (Belt [0061]).
Regarding claim 10, Ahmed, Corl and Belt teach the intraluminal sensing device of claim 9,
Belt further teaching wherein the acoustic matching layer is disposed on the insulating layer (“said window comprising an elastomer layer having conductive particles dispersed in the elastomer,” [clm 1]; “the elastomer layer has an acoustic impedance that is matched to the acoustic impedance of a body to be exposed to the ultrasound waves produced by the ultrasound device and/or to the acoustic impedance of the transducer arrangement.” [clm 2]; “the acoustic window 150 further comprises an inner layer 151 arranged such that the inner layer 151 is arranged between the elastomer layer 153 and the ultrasound transducer tiles 100.” [0050]; The elastomer layer (i.e., acoustic matching layer) may be disposed on top of the inner layer in the acoustic window [0037-0076], [fig. 1-2, 4; see fig. 1 reproduced below], [see claim 9 rejection]).
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The elastomer layer 153 (i.e., acoustic matching layer) is disposed over the inner layer 151 (i.e., insulating layer) in the acoustic window 150 of ultrasound device (Belt [fig. 1])
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed and Corl with the insulating layer as taught by Belt. It is well-known that operation of CMUT elements in collapse mode enhances the acoustic capabilities of the transducer array at the cost of reduced lifetime of the CMUT elements; therefore the ability to disable the power supply to CMUT elements where the generation of ultrasound waves would not yield the desired result due to the poor quality contact between the transducer array and the body (or where the transducer elements risk being damaged by overheating) is particularly advantageous as it results in an elongated lifetime of the CMUT elements (Belt [0025]). The polybutadiene layer used as materials for the inner layer may improve acoustic wave transmission (lower attenuation) for the entire acoustic window, in particular when the transducer elements are CMUT elements (Belt [0061]).
Regarding claim 11, Ahmed, Corl and Belt teach the intraluminal sensing device of claim 9,
Belt further teaching wherein the insulating layer comprises a first material and the acoustic matching layer comprises a different, second material (“The elastomer provides an electrically insulating matrix for the conductive particles.” [0039]; “Any suitable elastomer may be used as the elastomer for the elastomer layer 153. For example, the elastomer may be a polyolefin, a diene polymer or a polysiloxane, a co-polymer or block-copolymer comprising a polyolefin, a diene polymer or a polysiloxane or a blend thereof” [0044]; “Any suitable conductive particle may be used in the elastomer layer 153. For example, the conductive particles may comprise at least one of carbon particles, e.g. graphite or graphene particles, carbon composite particles, ceramic particles, metal particles, metal alloy particles, composite metal particles and conductive metal oxide particles” [0045]; “The inner layer 151 may comprise any suitable electrically insulating material such as an electrically insulating polymer, e.g. elastomer, to electrically insulate the transducer array from the elastomer layer 153.” [0059]; “the inner layer 151 may comprise polybutadiene or butyl rubber.” [0061]; The inner layer may be polybutadiene and the elastomer layer may be a polyolefin matrix with conductive particles (e.g., carbon, metal, ceramic, etc.) [0037-0076], [fig. 1-2, 4], [see claim 9 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the intraluminal sensing device as taught by Ahmed and Corl with the insulating layer as taught by Belt. It is well-known that operation of CMUT elements in collapse mode enhances the acoustic capabilities of the transducer array at the cost of reduced lifetime of the CMUT elements; therefore the ability to disable the power supply to CMUT elements where the generation of ultrasound waves would not yield the desired result due to the poor quality contact between the transducer array and the body (or where the transducer elements risk being damaged by overheating) is particularly advantageous as it results in an elongated lifetime of the CMUT elements (Belt [0025]). The polybutadiene layer used as materials for the inner layer may improve acoustic wave transmission (lower attenuation) for the entire acoustic window, in particular when the transducer elements are CMUT elements (Belt [0061]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ahmed et al. (US20130030303A1, 2013-01-31) teaches an improved combination sensor tip that includes an ultrasound transducer and a pressure sensor both disposed at or in close proximity to the distal end of the combination sensor tip, featuring an improved connector to couple a guide wire to a physiology monitor that reduces torsional resistance when maneuvering the guide wire [abst].
Dausch et al. (US20100168583A1, 2010-07-01) teaches a method of generating an enhanced receive signal from a piezoelectric ultrasound transducer, specifically generating enhanced flexure mode signals by piezoelectric transducers and ultrasound imaging probes [abst], [0001].
Tenhoff et al. (US5984871A, 1999-11-16) teaches an ultrasound transducer having an extended focus for enabling an ultrasound imaging catheter to image features at a distance from the transducer with a high resolution and a high penetration depth [abst].
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 James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797