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
The amendments filed 7th August 2025 have been entered. Claims 1-20 are pending. Applicant’s amendments to the claims have overcome each and every objection to the claims, and every rejection under 35 U.S.C. § 112(b) that was previously applied in the office action dated 7th May 2025.
Response to Arguments
Applicant argues that Schmitt does not disclose the ‘chamber is defined by the flexible membrane and the part of the inner sheath nested within the part of the outer sheath’, as recited in amended Claims 1 and 5. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. The citations of the previous action discloses the recited limitation by noting the items within the citation that contribute to defining a perimeter for the structure for the chamber.
Applicant argues that the cited art fails to disclose or fairly suggest a ‘flexible membrane arranged on a side opening of the outer sheath perpendicular to the longitudinal axis’, as recited in independent Claim 17. The cited art refers to Fig. 2, item 132 flexible membrane and item 134 opening of Ludoph. The rejection notes the membranes orientation being perpendicular to the longitudinal axis and its arrangement on item 132 opening on the side of the sheath. This reference is combined with Schmitt, and is merely the rearrangement of parts, as is known to be within the scope of ability of one skilled in the art, as previously stated in the last action.
Applicant further argues that the cited art fails to disclose or fairly suggest ‘receiving a first signal from light reflected or scattered by the flexible membrane and by the inner sheath; receiving a second signal from light reflected or scattered by the flexible membrane and by the inner sheath’ receiving a second signal from light reflected or scattered by the vessel while the imaging core is rotated and/or pullback with respect to the inner sheath and the outer sheath; generating an image of the vessel based on the second signal; and calculating a pressure parameter based on the first signal’, as further recited in amended Claim 17. The citations applied in the previous action teach all of the recited limitations in the argument and as originally claimed, cited and shown in the rejection below for Claim 17. Note: The citations are shown here, meeting the limitations by receiving a first signal (acquisition of pressure measurement) and second signal (acquisition of OCT images) from light reflected by the flexible membrane (Schmitt: Para. [0061] ‘acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure trandsucer’; Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations’) while the imaging core is rotated (Schmitt: Para. [0077] ‘rotates inside the catheter sheath 218’; Note: the optical fiber mounts inside the lumen of torque wire that rotates inside the catheter sheath, rotation is only active while in image mode.); and/or pullback with respect to the inner sheath and the outer sheath (Schmitt: Para. [0073] ‘automated pullback mechanism (part of the standard FD-OCT probe interface’; Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer’; Note: the pullback mechanism translates the core longitudinally within the sheath over the stenotic tissue and is controlled by the computer.).
Applicant argues that the art fails to disclose ‘the chamber has no fluid communication with the lumen of the inner sheath’ of Claim 2 (and Claim 6 by extension). Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. The prior art does teach the recited limitation. To clarify, the chamber as cited is part of a basic Fabry-Perot pressure transducer, and as is known in the art, Fabry-Perot pressure transducers isolate pressure introduced to the exterior diaphragm of the transducer, but no fluid is introduced. With respect to the lumen of the inner sheath, the optical fiber only communicates with the Fabry-Perot pressure transducer via light exchanged from the optical fiber and reflected by the Fabry-Perot cavity reflective surface (Schmitt: Para. [0016]). The cited liquid seal at the proximal end between the optical fiber and the non-rotating shell over the body of the fiber-optic connector prevents the escape of fluid into the probe interface.
Applicant's arguments that newly amended Claims 10 and 18 clarifies separate operations in a pressure detection zone and in a lumen imaging zone, citing Para. 52 of the specification and the pullback mechanism have been fully considered but they are not persuasive. Schmitt discloses the amended limitations as currently claimed, shown in the art rejections below.
Claim Objections
Claim objected to because of the following informalities:
Claim 5, line 10 ‘the at least part the inner sheath’, should likely read ‘the at least part of the inner sheath’ as best understood by the disclosure.
Claim 5, lines 10-11 ‘part of the outer sheath are each other,’ should likely read ‘part of the outer sheath,’. as best understood by the disclosure.
Claim 17, line 21 ‘receiving a second an image signal’ should likely read ‘receiving a second signal’ as best understood by the disclosure.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190343409 A1 to Schmitt et al. (hereinafter, Schmitt).
Regarding Claim 1, Schmitt discloses an imaging catheter (Schmitt: Para. [0023] ‘a combination OCT/pressure probe catheter’ ) comprising:
An imaging core (Schmitt: Fig. 1 & Fig. 10 Optical Fiber 26),
An inner sheath enclosing the imaging core (Schmitt: Fig. 1, Bonding Material encloses the Optical Fiber 26),
an outer sheath surrounding the inner sheath (Schmitt: Fig. 1 The portion of the Sensor Body 22 surrounding the Bonding Material)
a flexible membrane arranged on the outer sheath (Schmitt: Fig. 1 Diaphragm 18 arranged on the outer surface of the Sensor Body 22 ) and configured to deflect in response to intravascular pressure (Schmitt: Para. [0049] ‘the pressure transducer includes a Diaphragm that deflects under pressure’; Fig. 1 Diaphragm 18) ; and
a chamber (Schmitt: Fig. 1 Fabry-Perot Cavity 14 and the Diaphragm 18, connected to the Sensor Body 22 )
wherein the outer sheath coaxially surrounds at least a part of the inner sheath such that at least part of the inner sheath nests within a part of the outer sheath (Schmitt: Fig. 1 Bonding Material & Sensor Body 22; Note: Sensor body shown to coaxially surround Bonding material)
wherein the chamber is defined by the flexible membrane and the part of the inner sheath nested within the part of the outer sheath (Schmitt: Fig. 1 The chamber is defined by the Diaphragm 18, the outer sheath in Fig. 1, Sensor Body 22 and the inner sheath Bonding Material); (Examiner’s Note: The chamber is defined by the Diaphragm 18, the Fabry-Perot cavity 14, and the inner Bonding Material & outer Sensor Body 22 sheaths in totality, by defining the perimeter of the chamber.),
wherein the chamber provides an empty space into which the flexible membrane is deflected (Schmitt: Fig. 1 Fabry-Perot Cavity 14 is an empty space provided and defined by the Sensor Body 22 for the Diaphragm 18 to deflect in response to intravascular pressure).
Regarding Claim 2, Schmitt discloses the invention as discussed above in Claim 1.
Schmitt further discloses:
wherein a predetermined distance separates the part of the inner sheath that is surrounded by the part of the outer sheath (Schmitt: Fig. 1 Bonding Material & Sensor Body 22; Note: Sensor body shown to coaxially surround Bonding material. Any distance between the Bonding Material & the portion of the Sensor Body 22 that surrounds the Bonding Material would be considered predetermined), and
wherein the chamber has no fluid communication with the lumen of the inner sheath (Schmitt: Para. [0016] ‘an optical fiber located within the bore, the optical fiber having a first end and a second end; an optical pressure transducer located within the bore and in optical communication with the first end of the optical fiber; and a fiber optic connector, located at the second end of the body and in optical communication with the second end of the optical fiber, where the body further defines at least one opening from the bore to the environment by which pressure from the environment is transmitted to the optical pressure transducer’; Only pressure and light are permitted communication between the lumen of the inner sheath and the chamber as explained in the arguments section above.; Para. [0072] ‘A liquid seal at the proximal end between the optical fiber and the non-rotating shell over the body of the fiber-optic connector prevents the escape of fluid into the probe interface.’)
Regarding Claim 3, Schmitt discloses the invention as discussed above in Claim 1.
Schmitt further discloses:
wherein the flexible membrane is arranged on a side opening formed in a portion of the outer sheath (Schmitt: Fig. 1 Diaphragm 18 is arranged on a side opening Fabry-Perot Cavity 14 of the Sensor Body 22);
wherein the imaging core is arranged inside the inner sheath (Schmitt: Fig. 1 Optical Core 26 arranged within the Bonding Material),
the outer sheath arranged to coaxially overlap at least a distal portion of an inner sheath. (Schmitt: Fig. 1 Sensor Body 22 arranged to coaxially overlap the distal portion of the Bonding Material enclosing the Optical Fiber 26)
and wherein the chamber is formed by a space between the distal portion of the inner sheath (Schmitt: Fig. 1 Bonding Material) overlapped by the portion of the outer sheath (Schmitt: Fig. 1 Sensor Body 22 portion overlapping Bonding Material) to which the flexible membrane is attached (Schmitt: Fig. 1 Diaphragm 18 attached to the Sensor Body 22); Examiner’s Note: The chamber is defined by the Diaphragm 18, the Fabry-Perot cavity 14, and the inner Bonding Material & outer Sensor Body 22 sheaths in totality, by defining the perimeter of the chamber. Further, “a space” has been interpreted to be any distance between the limitations.),
Regarding Claim 5, Schmitt discloses
a system comprising: an imaging catheter (Schmitt: Para. [0023] ‘a combination OCT/pressure probe catheter’)
and a processor (Schmitt: Para. [0062] the processor) configured to acquire intravascular image data (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer’) and intravascular pressure data from a vessel in a vasculature of a patient (Schmitt: Para. [0048] ‘configured in a specific manner, permits a user to make an intravascular blood pressure measurement’);
the imaging catheter comprising: an imaging core (Schmitt: Fig. 1 Optical Fiber 26),
an inner sheath enclosing the imaging core (Schmitt: Fig. 1 Optical Core 26 arranged within the Bonding Material)
an outer sheath surrounding the inner sheath, such that the inner and outer sheath are nested within each other (Schmitt: Fig. 1 The portion of the Sensor Body 22 surrounding the Bonding Material).
and a flexible membrane (Schmitt: Fig. 1 Diaphragm 18)
the flexible membrane arranged on an outer sheath (Schmitt: Fig. 1 Diaphragm 18 arranged on the outer surface of the Sensor Body 22 ) and configured to deflect in response to intravascular pressure (Schmitt: Para. [0048] ‘the Diaphragm 18 flexes in response to external pressure variations.’)
wherein the outer sheath coaxially surrounds at least a part of the inner sheath such that at least part of the inner sheath nests within a part of the outer sheath (Schmitt: Fig. 1 Bonding Material & Sensor Body 22; Note: Sensor body shown to coaxially surround Bonding material)
a chamber (Schmitt: Fig. 1 Fabry-Perot Cavity 14 and the Diaphragm 18, connected to the Sensor Body 22 )
wherein the chamber is defined by the flexible membrane and the part of the inner sheath nested within the part of the outer sheath (Schmitt: Fig. 1 The chamber is defined by the Diaphragm 18, the outer sheath in Fig. 1, Sensor Body 22 and the inner sheath Bonding Material); (Examiner’s Note: The chamber is defined by the Diaphragm 18, the Fabry-Perot cavity 14, and the inner Bonding Material & outer Sensor Body 22 sheaths in totality, by defining the perimeter of the chamber.),
wherein the chamber provides an empty space into which the flexible membrane is deflected (Schmitt: Fig. 1 Fabry-Perot Cavity 14 is an empty space provided and defined by the Sensor Body 22 for the Diaphragm 18 to deflect in response to intravascular pressure); and
wherein the processor is configured to: control the imaging core to scan the flexible membrane by transmitting a light beam through the inner sheath and the chamber (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
The processor scanning the membrane through the chamber to calculate pressure based on reflected light (Schmitt: Para. [0061] ‘simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer’)
Regarding Claim 6, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the chamber has no fluid communication with the lumen of the inner sheath or with fluids in the vessel (Schmitt: Para. [0016] ‘an optical fiber located within the bore, the optical fiber having a first end and a second end; an optical pressure transducer located within the bore and in optical communication with the first end of the optical fiber; and a fiber optic connector, located at the second end of the body and in optical communication with the second end of the optical fiber, where the body further defines at least one opening from the bore to the environment by which pressure from the environment is transmitted to the optical pressure transducer’; Only pressure and light are permitted communication between the lumen of the inner sheath and the chamber as explained in the arguments section above.; Para. [0072] ‘A liquid seal at the proximal end between the optical fiber and the non-rotating shell over the body of the fiber-optic connector prevents the escape of fluid into the probe interface.’)
Regarding Claim 7, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
the flexible membrane being arranged on a side opening of the outer sheath (Schmitt: Fig. 1 Diaphragm 18 is arranged on a side opening Fabry-Perot Cavity 14 of the Sensor Body 22);.
wherein the imaging core is arranged inside the inner sheath (Schmitt: Fig. 1, Bonding Material encloses the Optical Fiber 26),
and configured to transmit the light beam at an angle with respect to the longitudinal axis (Schmitt: Para. [0077] ‘angle-polished end 202 of the fiber segment 26′ … reflect light… transmit light’)
wherein the processor is operatively coupled to the imaging core (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
and configured to: control the imaging core to scan the flexible membrane with the light beam that is transmitted through the inner sheath, through the chamber, and through the side opening of the outer sheath, calculate an amount of deflection of the flexible membrane based upon the light reflected or scattered by the flexible membrane and by the inner sheath (Schmitt: Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations. When the sensor 10 is excited by a laser, the optical signals returning from the cavity 14 through the optical fiber 26 combine and generate a common-mode interference signal. An FD-OCT system, configured according to the present invention, performs the functions required to record these interference signals.’)
and generate intravascular pressure data based on the calculated amount of deflection (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
Regarding Claim 8, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein a predetermined distance separates the part of the inner sheath that is surrounded by the part of the outer sheath (Schmitt: Fig. 1 Bonding Material & Sensor Body 22; Note: Sensor body shown to coaxially surround Bonding material. Any distance between the Bonding Material & the portion of the Sensor Body 22 that surrounds the Bonding Material would be considered predetermined) and
the processor is further configured to: calculate an amount of deflection of the flexible membrane based upon the light reflected or scattered by the flexible membrane and by the inner sheath (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
and wherein the processor calculates the intravascular pressure based on the amount of deflection of the flexible membrane (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
wherein the amount of deflection is equal a difference between the predetermined distance and a mean position of a surface of the flexible membrane calculated spatially across an area deflected towards the inner sheath in response to the intravascular pressure (Schmitt: Fig. 1 Diaphragm 18 deflects toward the inner sheath (Bonding Material) in response to intravascular pressure, the average position of the Diaphragm 18 being deflected may be determined as claimed.)
Regarding Claim 9, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the processor is further configured to: calculate the intravascular pressure (Schmitt: Para. [0002] ‘Intravascular pressure measurement, particularly in the coronary arteries’)
at a first location distal to a stenosis (Schmitt: Para. [0002] ‘distal to … a lesion’)
and at second location proximal to the stenosis of the vessel (Schmitt: Para. [0002] ‘proximal to a lesion’)
and calculate a fractional flow reserve (FFR) based on the intravascular pressure calculated at the first and second locations (Schmitt: Para. [0002] ‘(FFR), defined as the ratio of the blood pressures measured distal to and proximal to a lesion after injection of a vasodilating drug, exceeds a certain clinically defined threshold ‘).
Regarding Claim 10, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the processor is further configured to: calculate intravascular pressure based on the light reflected or scattered when the imaging core is positioned in a pressure detection zone (Schmitt: Para. [0023] ‘inserting a combination OCT/pressure probe catheter into the blood vessel; setting the OCT/pressure probe system to measure pressure; determining the pressure drop across a putative stenotic region of the vessel’; Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.‘ ; Note: The pressure detection zone is the putative stenotic region while the device is set to pressure);
initiate a pullback operation of the imaging core from the pressure detection zone to a lumen imaging zone (Schmitt: Para. [0053] ‘A motorized translation stage in the probe interface 74 enables the fiber-optic core of the catheter (82, 28, 90) inserted into a vessel to pull back with a constant speed. ’; Note: The pressure detection zone is the putative stenotic region while the device is set to pressure, and the lumen imaging zone is the putative stenotic region while the device is set to image); and
perform optical coherence tomography (OCT) imaging based upon the light reflected or scattered when the imaging core is positioned in the lumen imaging zone (Schmitt: Para. [0023] ‘setting the OCT/pressure probe system to image; and taking an OCT image of the putative stenotic region.’; Note: The lumen imaging zone is the putative stenotic region while the device is set to image.).
Regarding Claim 11, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the processor (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’) is further configured to: generate an optical coherence tomography (OCT) image based upon the light reflected or scattered by the flexible membrane and by the inner sheath (Schmitt: Para. [0061] ‘enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer); Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’).
Regarding Claim 12, Schmitt discloses the invention as discussed above in Claim 11.
Schmitt further discloses:
wherein the processor (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
is further configured to: calculate an amount of deflection of the flexible membrane based upon peak signals in the OCT image corresponding to the light reflected or scattered by the flexible membrane and by the inner sheath (Schmitt: Para. [0061] ‘enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer’; Para. [0049] ’Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’)
and wherein the amount of deflection is proportional to a distance between a first signal shown in the OCT image corresponding to light reflected or scattered by the inner sheath (Schmitt: Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.)
a second signal shown in the OCT image based on the light reflected or scattered by the flexible membrane deflected towards the inner sheath in response to the intravascular pressure (Schmitt: Fig. 9E Mean Pressure in vessel; Para. [0049] ‘When the sensor 10 is excited by a laser, the optical signals returning from the cavity 14 through the optical fiber 26 combine and generate a common-mode interference signal.).
Regarding Claim 13, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the processor (Schmitt: Para. [0008] ‘computer’) is further configured to: control rotation and pullback of the imaging core (Schmitt: Para. [0008] ‘catheter control)
such that the imaging core first irradiates the flexible membrane by transmitting the light beam through the inner sheath and through the chamber, and control subsequent scan of the vessel by transmitting the light beam only through the inner sheath (Schmitt: Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’).
Regarding Claim 14, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the processor (Schmitt: Para. [0008] ‘computer’) is further configured to control the imaging core to irradiate the flexible membrane and the inner sheath with the light beam while rotating the imaging core prior to initiating a pullback (Schmitt: Para. [0008] ‘catheter control’)
and control the imaging core to scan the vessel wall with the light beam in a helicoidally oriented path while the imaging core is rotated (Schmitt: Para. [0077] ‘rotates inside the catheter sheath 218’) and pullback (Schmitt: Para. [0073] automated pullback mechanism (part of the standard FD-OCT probe interface; Para. [0008] ‘…processing, catheter control, and parameter and image display are controlled by software executing on the same computer’)
Regarding Claim 15, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
wherein the processor (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.)
is further configured to: generate a first optical coherence tomography (OCT) image based upon the light reflected or scattered by the flexible membrane and by the inner sheath while the imaging core is rotated without being pullback (Schmitt: Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.)
and generate a second OCT image based upon light reflected or scattered by the vessel wall while the imaging core is rotated and pullback (Schmitt: Para. [0061] ‘enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer’; Para. [0046] ‘FIGS. 14 (a, b) show an example of dynamic pressure readings obtained from an optical pressure sensor during pullback’).
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.
Claim(s) 4, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190343409 A1 to Schmitt et al. (hereinafter, Schmitt) in view of US 20150223707 A1 to Ludoph.
Regarding Claim 4, Schmitt discloses the invention as discussed above in Claim 1.
Schmitt further discloses:
a circular
wherein the flexible membrane is held by a cylindrical frame (Schmitt: Fig. 1 Fabry-Perot Cavity 14 and Diaphragm 18 and Pressure Transducer 10; Para. [0079] ‘the main Fabry-Perot cavity famed (sic) (should read “framed”) by the diaphragm and the body of the (sic) (should read “sensor”) in the optical pressure transducer’).
wherein the cylindrical frame has a top flat surface with a circular opening and an arcuate bottom surface attached to an external surface of the outer sheath (Schmitt: Fig. 1 Fabry-Perot Cavity 14 and Diaphragm 18 and Pressure Transducer 10; Para. [0079] ‘the main Fabry-Perot cavity famed (sic) (should read “framed”) by the diaphragm and the body of the (sic) (should read “sensor”) in the optical pressure transducer; Examiner’s note: As the frame is cylindrical, it contains an arcuate bottom surface as claimed.),
wherein the circular
and wherein the chamber includes a space between the inner sheath and the outer sheath and a space between the membrane and the inner sheath (Schmitt: Fig. 1 The chamber is defined by the Diaphragm 18, the outer sheath (Schmitt: Fig. 1 The portion of the Sensor Body 22 surrounding the Bonding Material) and the inner sheath (Bonding Material); Examiner’s Note: The chamber is defined by the Diaphragm 18, the Fabry-Perot cavity 14, and the inner Bonding Material & outer Sensor Body 22 sheaths in totality, by defining the perimeter of the chamber. Further, “a space” has been interpreted to be any distance between the limitations),
Schmitt does not explicitly disclose:
wherein the flexible membrane is a circular silicone membrane,
Ludoph further teaches:
Wherein the flexible membrane is a circular silicone membrane (Ludoph: Para. [0105] ‘a silicone membrane’; Fig. 2 cross-sectional view of membrane item 132).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify Schmitt’s combined system to include a silicone membrane as the material for the diaphragm of Schmitt as taught by Ludoph, motivated by the need for precise pressure calculations using material properties that are known in the art. Ludoph’s membrane design allows accurate pressure measurement, reducing flow disruption and improving applicability for narrow vessels (Ludoph: Para. [0005] ‘to accurately measure the pressure on the distal side of a flow restriction’).
Regarding Claim 16, Schmitt discloses the invention as discussed above in Claim 5.
Schmitt further discloses:
a circular membrane (Schmitt: Fig. 1 Diaphragm 18 is implied to be circular due to the structure shown in Fig. 1 and the implementation of the Pressure Transducer as a whole shown in Fig. 9A/B)
wherein the flexible membrane is held by a cylindrical frame (Schmitt: Fig. 1 Fabry-Perot Cavity 14 and Diaphragm 18 and Pressure Transducer 10); Para. [0079] ‘the main Fabry-Perot cavity famed (sic) (should read “framed”) by the diaphragm and the body of the (sic) (should read “sensor) in the optical pressure transducer’).
wherein the cylindrical frame has a top flat surface with a circular opening and an arcuate bottom surface attached to an external surface of the outer sheath (Schmitt: Fig. 1 Fabry-Perot Cavity 14 and Diaphragm 18 and Pressure Transducer 10; Para. [0079] the main Fabry-Perot cavity famed (sic) (should read “framed”) by the diaphragm and the body of the (sic) (should read “sensor) in the optical pressure transducer );(Examiner’s note: As the frame is cylindrical, it contains an arcuate bottom surface as claimed.),
wherein the circular membrane is arranged on the top flat surface substantially tangential to the external surface of the outer sheath (Schmitt: Fig. 1 Diaphragm 18 shown to be tangent to the outer surface of the Sensor Body 22),
and wherein the chamber includes the space between the inner sheath and the outer sheath and the space between the silicon membrane and the inner sheath (Schmitt: Fig. 1 The chamber is defined by the Diaphragm 18, the outer sheath (Schmitt: Fig. 1 The portion of the Sensor Body 22 surrounding the Bonding Material) and the inner sheath (Bonding Material); (Examiner’s Note: The chamber is defined by the Diaphragm 18, the Fabry-Perot cavity 14, and the inner Bonding Material & outer Sensor Body 22 sheaths in totality, by defining the perimeter of the chamber. Further, “a space” has been interpreted to be any distance between the limitations),
Schmitt does not explicitly disclose:
wherein the flexible membrane is a circular silicone membrane,
However, Ludoph teaches:
Wherein the flexible membrane is a circular silicon membrane (Ludoph: Para. [0105] ‘a silicone membrane’; Fig. 2 cross-sectional view of membrane item 132).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify Schmitt’s combined system to include a silicone membrane as the material for the diaphragm of Schmitt as taught by Ludoph, motivated by the need for precise pressure calculations using material properties that are known in the art. Ludoph’s membrane design allows accurate pressure measurement, reducing flow disruption and improving applicability for narrow vessels (Ludoph: Para. [0005] ‘to accurately measure the pressure on the distal side of a flow restriction’).
Regarding Claim 17, Schmitt discloses:
A method for simultaneously acquiring intravascular image data and intravascular pressure data (Schmitt: Para. [0023] ‘a combination OCT/pressure probe catheter’)
the method comprising: inserting an imaging catheter into a vessel of a patient's vasculature (Schmitt: Para. [0022] ‘inserting a catheter having an optical pressure transducer into a vessel’)
the imaging catheter comprising an outer sheath having lumen along a longitudinal axis and a flexible membrane arranged on a side opening of the outer sheath (Schmitt: Fig. 1 Sensor Body 22 portion surrounding the Bonding Material interpreted as the outer sheath, having a lumen along a longitudinal axis, and a Diaphragm 18 arranged on a side opening of the outer sheath)
an inner sheath inserted into the lumen of the outer sheath such that the inner sheath and the outer sheath are coaxial to each other (Schmitt: Fig. 1 Bonding Material & Sensor Body 22 coaxial to each other),
and an imaging core arranged inside the inner sheath and configured to transmit light at an angle with respect to the longitudinal axis (Schmitt: Para. [0077] ‘the optical fiber mounts inside the lumen of torque wire 214 that rotates inside the catheter sheath 218’; Para. [0077] ‘angle-polished end 202 of the fiber segment 26′ … reflect light… transmit light)
controlling, using a processor operatively coupled to the imaging core (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
the imaging core arranged inside the inner sheath to scan the flexible membrane with light transmitted through the inner sheath (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.)
and through the side opening of the outer sheath at an angle with respect to the longitudinal axis (Schmitt: Fig. 1 shows the opening Fabry-Perot cavity at an angle with respect to the longitudinal axis)
calculating intravascular pressure based upon light reflected or scattered by the flexible membrane and by the inner sheath (Schmitt: Para. [0061] ‘enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer’; Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’)
controlling the imaging core to irradiate the flexible membrane and a vessel wall of the vessel (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’; Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’)
receiving a first signal from light reflected or scattered by the flexible membrane and by the inner sheath (Schmitt: Para. [0061] ‘enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer’; Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’)
receiving a second an image signal from light reflected or scattered by the vessel while the imaging core is rotated (Schmitt: Para. [0077] ‘rotates inside the catheter sheath 218’) and/or pullback with respect to the inner sheath and the outer sheath (Schmitt: Para. [0073] ‘automated pullback mechanism (part of the standard FD-OCT probe interface’; Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer’).
generating an image of the vessel based on the second signal (Schmitt: Para. [0023] ‘setting the OCT/pressure probe system to measure pressure; determining the pressure drop across a putative stenotic region of the vessel; setting the OCT/pressure probe system to image; and taking an OCT image of the putative stenotic region’)
and calculating a pressure parameter based on the first signal (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’).
Schmitt does not explicitly disclose:
the flexible membrane arranged on a side opening of the outer sheath perpendicular to the longitudinal axis.
However, Ludoph teaches:
the imaging catheter comprising an outer sheath having lumen along a longitudinal axis and a flexible membrane arranged on a side opening of the outer sheath perpendicular to the longitudinal axis (Ludoph: Fig. 2 item 132 flexible membrane, 134 opening, shows the membrane located perpendicular to the longitudinal axis of the outer sheath).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify Schmitt’s OCT/pressure probe catheter by incorporating Ludoph’s flexible membrane arranged on the outer sheath. Ludoph’s membrane location and design allows accurate pressure measurement without requiring the sensor to pass through a stenosis, reducing flow disruption and improving applicability for narrow vessels (Ludoph: Para. [0012] ‘a pressure transfer tube…does not have to be guided past the flow constriction…the sensor dimensions are not limiting the applicability of the pressure sensor catheter’).
Regarding Claim 18, Schmitt in view of Ludoph discloses the invention as discussed above in Claim 17.
Schmitt further discloses:
wherein the processor is further configured to: calculate intravascular pressure based on the light reflected or scattered when the imaging core is positioned in a pressure detection zone (Schmitt: Para. [0023] ‘inserting a combination OCT/pressure probe catheter into the blood vessel; setting the OCT/pressure probe system to measure pressure; determining the pressure drop across a putative stenotic region of the vessel’; Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.‘ ; Note: The pressure detection zone is the putative stenotic region while the device is set to pressure);
initiate a pullback operation of the imaging core from the pressure detection zone to a lumen imaging zone (Schmitt: Para. [0053] ‘A motorized translation stage in the probe interface 74 enables the fiber-optic core of the catheter (82, 28, 90) inserted into a vessel to pull back with a constant speed. ’; Note: The pressure detection zone is the putative stenotic region while the device is set to pressure, and the lumen imaging zone is the putative stenotic region while the device is set to image); and
perform optical coherence tomography (OCT) imaging based upon the light reflected or scattered when the imaging core is positioned in the lumen imaging zone (Schmitt: Para. [0023] ‘setting the OCT/pressure probe system to image; and taking an OCT image of the putative stenotic region.’; Note: The lumen imaging zone is the putative stenotic region while the device is set to image.).
Regarding Claim 19, Schmitt in view of Ludoph discloses the invention as discussed above in Claim 17.
Schmitt further discloses:
wherein calculating the pressure parameter includes: calculating the intravascular pressure at a first location distal to a stenosis and at second location proximal to the stenosis of the vessel (Schmitt: Para. [0071] ‘measurement of pressure both distal and proximal to the stenosis.’)
and calculating a fractional flow reserve (FFR) based on the intravascular pressure calculated at the first and second locations (Schmitt: Para. [0002] ‘fractional flow reserve (FFR), … the ratio of the blood pressures measured distal to and proximal to a lesion after injection of a vasodilating drug).
Regarding Claim 20, Schmitt in view of Ludoph discloses the invention as discussed above in Claim 17.
Schmitt further discloses:
further comprising: generating, using the processor (Schmitt: Para. [0008] ‘processing, catheter control, and parameter and image display are controlled by software executing on the same computer.’)
a first optical coherence tomography (OCT) image based upon the light reflected or scattered by the flexible membrane and by the inner sheath while the imaging core is rotated without being pullback (Schmitt: Para. [0049] ‘Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations.’)
and generating, using the processor, a second OCT image based upon light reflected or scattered by the vessel wall while the imaging core is rotated and pullback (Schmitt: Para. [0061] ‘enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer’; Para. [0046] ‘FIGS. 14 (a, b) show an example of dynamic pressure readings obtained from an optical pressure sensor during pullback’).
Conclusion
(i) 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.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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