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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pressure assembly, the purge fluid supply, the beam director being adjacent to and coaxial with the optical fiber, the optical pressure transducer being arranged coaxial with the beam director and the optical fiber and positioned distal to the beam director, the tube heat shrunk around the first and second torque wires must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "500" and "501" have both been used to designate the adjustable restriction element. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "492" and "482" have both been used to designate the expandable tube. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “482” has been used to designate both the transducer and the expandable tube. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “497” has been used to designate both the restriction and the restricting device. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “492” has been used to designate both the restriction and the restricting element. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “500” has been used to designate both the adjustable restriction and the adjustable fluid restricting element. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “501” has been used to designate both the adjustable restriction and the adjustable restricting element. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 4 objected to because of the following informalities: for reciting in the preamble “The system of claim 2 further comprising…” which should be amended to recite “The system of claim 2, further comprising…”. Appropriate correction is required.
Claims 5-16 and 18 are also objected to for reciting the same as outlined above.
Claim 13 objected to because of the following informalities: for claiming dependency on later claim 14. Appropriate correction is required.
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
Further, the limitation “wherein the fluid control device is selected from the group consisting of a restriction, an adjustable restriction, an expandable tube, and an expandable tube disposed in an expansion limiter” should be amended to recite “wherein the fluid control device is at least one /or an expandable tube disposed in an expansion limiter”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“pressure assembly” in claims 2-4, 10, 16-17 described in paragraph [0023] of the PG pub as having an optical pressure transducer which is coaxial with the beam director and optical fiber, and positioned distal to the beam director, the optical pressure transducer configured to modulate light of the second wavelength band; in [0040], [0041] of the specification as being a pressure transducer, the pressure transducer is in fluid communication with the fluid delivery channel; and a valve; in [0052], [0056] the pressure assembly is configured to measure pressure at one or more predetermined locations in a vessel; in [0053] the pressure assembly can include an optical pressure transducer which is orientated coaxial with the beam director and the optical fiber, and positioned distal to the beam director, the optical pressure transducer configured to modulate light of the second wavelength band; and in [0054] the pressure assembly comprises a pressure transducer disposed within a pocket disposed in the wall; in [0056] the pressure assembly is used to measure a pressure value at one or more predetermined locations in the vessel; in [0058] the pressure assembly is a pressure transducer in fluid communication with a purge port of a catheter disposed in the vessel and wherein the pressure value is measured at a predetermined location near the purge port.
“beam director” in claims 3, 9 described in [0013] of the specification as being an angled fiber.
"optical pressure transducer" in claim 3 described in paragraph [0120] of the specification as being a Fabry-Perot cavity, such that pressure changes are detected as a modulation of the spectrum of the reflected light, or alternatively being configured as a mirror whose reflectance at a specific wavelength depends on the applied pressure. Therefore, for the purposes of examination, the optical pressure transducer under the broadest reasonable interpretation has been interpreted as a Fabry-Perot type sensor.
“biasing element” in claim 8 described in paragraph [0048] of the specification as being, along with a plug, an adjustable restriction apparatus, and the biasing element slidably disposed relative to the plug; in [0030], [0054] of the specification describes the biasing element and a slidable member defining a hole as being included in the adjustable fluid restricting device; in [0162]-[0163] of the specification describes the biasing element as being a spring compressed purge solution from a supply.
“fluid supply” in claim 12 described in paragraph [0040], [0045] of the specification as being included in a purge port/system; in [0046] of the specification as being included in pressure a measuring catheter apparatus; in [0054] of the specification as being included in a purge assembly; in [0130], [0143], [0145] of the specification as being a syringe configured to dispense a purge solution such as water, saline, or other fluids and is in fluid communication with one or more fluid flow restricting or fluid flow controlling elements.
“fluid delivery channel” in claim 13 described in paragraph [0041] of the specification as being included in the pressure measuring apparatus; in [0049], [0054] of the specification as being included in a purge system and configured to transport the purge solution to a data collection probe having a purge port; in [0055] of the specification as being configured to transport the purge solution to a purge port defined by a wall of the probe.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitations "the fluid control device" and "the group" in lines 1-2. There is insufficient antecedent bases for these limitations in the claim. The claim does not prior recite, nor parent claim 14, nor claim 2 via claim 14, prior recite a fluid control device nor a group.
Further it is unclear what functionally meaning applicant meant impar on the fluid control device when reciting that the “fluid control device” as being “ selected” from the group consisting of “a restriction, an adjustable restriction, an expandable tube, and an expandable tube disposed in an expansion limiter”. For example, it is unclear how and by what mechanism the function of a “selection” is made and it is unclear what structural device or component of a device is defined as a “restriction”, “an adjustable restriction”, and “an expansion limiter”; and how the “restriction” is structurally different from the “adjustable restriction”.
The term “about” in claim 14 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the length of the second torque wire in relation to the length of the first torque wire has been rendered indefinite by the use of the term “about”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2, 4-5, 10, 15-18, and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Tearney et al. (US20110137140, hereafter “Tearney”), in view of Dick et al (US20090018393, hereafter “Dick”).
Regarding claims 2 and 17-19, Tearney discloses data collection system comprising:
a pressure assembly configured to measure pressure at one or more predetermined locations in a vessel ([0028], [0035], flow information is used in conjunction with geometrical information/ more predetermined locations about the vessel wall to derive intraluminal pressure measurements, the geometrical information is from the arterial wall is provided in the form of an exemplary two-dimensional image (cross-sectional image) or a three dimensional image, with the pressure measurement value by optical means); but does not explicitly disclose a first torque wire having a first outer diameter and defining a first lumen and a second torque wire having a second outer diameter and defining a second lumen, the second outer diameter being greater than the first outer diameter, wherein a proximal-most end of the first torque wire is joined to a distal-most end of the second torque wire by a collar that surrounds a portion of the first outer diameter, and wherein a length of the first torque wire is shorter than a length of the second torque wire.
However, in the same field of endeavor, Dick teaches a first torque wire having a first outer diameter and defining a first lumen and a second torque wire having a second outer diameter and defining a second lumen, the second outer diameter being greater than the first outer diameter ([0003], [0032], [0050], [0054], [0055] FIG. 10b, a portion of the hypotube metal shaft/ second torque wire is concentrically or coaxially engaged or fitted to a portion of the stranded hollow core/first torque wire, illustrating that the diameter of the hypotube metal shaft/second torque wire is larger than the diameter of the stranded hollow core shaft/first torque wire),
wherein a proximal-most end of the first torque wire is joined to a distal-most end of the second torque wire by a collar that surrounds a portion of the first outer diameter ([0003], [0032], [0050], [0054], [0055], FIG. 10a a hypotube metal/ second torque wire on a proximal portion of the rotary drive shaft or on the entire proximal section, or the rotary drive shaft includes a stranded hollow core shaft extending a substantial length of the rotary drive shaft used with a stranded hollow core shaft by butt-joining/joining the distal end of the hypotube metal shaft/second torque wire to the proximal end of the stranded hollow core shaft/first torque wire), and
wherein a length of the first torque wire is shorter than a length of the second torque wire ([0003], [0032], [0050], [0054], [0055] a longer section of the hypotube metal shaft/second torque wire is used proximal to the rotary drive shaft to achieve a greater reduction in NURD (non-uniform rotational distortion), therefore the second torque wire is longer than the first torque wire at this position).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by with the first torque wire having a first outer diameter and defining a first lumen and the second torque wire having a second outer diameter and defining a second lumen, the second outer diameter being greater than the first outer diameter, the proximal-most end of the first torque wire is joined to a distal-most end of the second torque wire by a collar that surrounds a portion of the first outer diameter, and the length of the first torque wire is shorter than a length of the second torque wire. taught by Dick in order to make the length of the proximal shaft longer than the length of the distal shaft of the two shafts ([0055] of Dick).
With specific regard to claims 2 and 18, Tearney discloses an imaging assembly, the imaging assembly comprising an optical fiber, wherein the optical fiber passes through the first lumen and the second lumen ([0052] at least one of the inner cores or cables can be rotated and/or translated along to provide a one dimensional or two dimensional scan through distal optics by an optical beam directed to an anatomical sample or structure, the inner core of the cable can be placed in a transparent outer tube that can accommodate a guide wire).
And claim 2 specifically requiring an imaging probe which is disclosed by Tearney (see [0054] OCT imaging probe).
Regarding claims 2 and 19, Tearney discloses wherein the imaging assembly is an optical coherence tomography assembly ([0004], [0054] the imaging element of the catheter is an optical Coherence Tomography (“OCT”), including Fourier Domain OCT (including but not limited to Optical Frequency Domain Imaging (OFDI) imaging assembly).
Regarding claim 4, Tearney substantially discloses all the limitations of the claimed invention, specifically, Tearney discloses further comprising a processor in communication with the optical coherence tomography assembly and the pressure assembly ([0028], FIG. 1A, OCT system includes a processor as part of the system, therefore the processor is in communication with the optical coherence tomography assembly and the pressure assembly as they are part of the same system), the processor configured to execute a program ([0010] processor includes a program) to calculate a corrected fractional flow reserve for the vessel ([0030] the program being a method to determine the flow information) in response to the geometry at one or more of the predetermined locations within the vessel ([0030] information obtained from measuring a signal from the at least one of fluid within the lumen of the vessel and the vessel wall) and the pressure measured at one or more predetermined locations in the vessel ([0031] the flow information is be obtained and plotted synchronously with exemplary pressure information).
Regarding claim 5, Tearney substantially discloses all the limitations of the claimed invention, specifically, Tearney discloses wherein the processor is configured to execute the program to correct an initial fractional flow reserve ([0013] determine at least one characteristic of the fluid as a function of the interference which comprises particular parameters which include fractional flow reserve) using hydrodynamic equations ([0034] ) using flow equations or fluid dynamic modeling equations such as the Navier-Stokes equations, known in the flow dynamic arts to be hydrodynamic equations) and the geometry of the vessel measured with the optical coherence tomography assembly ([0035] and using vessel geometry measured with the OFDI catheter).
Regarding claim 10, Tearney, in view of Dick, substantially discloses all the limitations of the claimed invention, specifically, Dick discloses further comprising:
a wall of the probe ([0053], FIG. 9a, a solid wall extending substantially the entire longitudinal length of the central lumen of the rotary drive shaft 40); and
a lumen defined by the wall ([0053], FIG. 9a, see the central lumen defined by a solid wall extending substantially the entire longitudinal length of the central lumen),
wherein the optical coherence tomography assembly comprises a rotatable optical fiber disposed within the lumen ([0029], FIG. 1, optical fiber 50, see in lumen as illustrated) and wherein the pressure assembly comprises a pressure transducer disposed within a pocket* disposed in the wall ([0036], FIG. 2a, see protection bearing 70 housing acoustics, as cited in claim 16 above).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation to mean any shape in any dimension in an inward direction within or toward the central lumen from the outer periphery of the wall of the probe.
Regarding claim 15, Tearney, in view of Dick substantially discloses all the limitations of the claimed invention, specifically, Dick discloses wherein the first torque wire abuts the second torque wire and the first and the second torque wires are located within and held together by a tube heat shrunk around the first and second torque wires ([0051] the stranded hollow core shaft 500 comprising both the first torque wire and the second torque wire are coated with a biocompatible material, such as PTFE or similar polymers to provide lubricity within the monolithic catheter sheath, with PTFE as known in the catheter arts to be used as heat-shrink tubing, therefore the cited disclosures reads on the limitation as presently claimed).
Regarding claim 16, Tearney, in view of Dick, substantially discloses all the limitations of the claimed invention, specifically, Dick discloses wherein the probe comprises a catheter having a wall defining a lumen ([0044] sheath 20 having a lumen filled with fluid), and a purge port ([0047] flushing port 250 in FIG. 7a) and further comprising
a fluid supply ([0044] the central lumen of the outer catheter sheath is filled with fluid that is provided to other components of the catheter); and
a three-way valve ([0047] luer connection system consisting of round male and female interlocking tubes, slightly tapered to hold together) having a first port in communication with the lumen ([0047] standard way of attaching catheter lumen), a second port in communication with the fluid supply ([0047] IV tubes, fluid supply) and a third port in communication with the pressure assembly, wherein the pressure assembly is a pressure transducer ([0036], [0082] the distal end includes acoustics/transducers for measuring acoustic impedance which is determined by measuring pressure via the acoustics), wherein when in the first position the valve connects the fluid supply with the lumen ([0047] luer connections as known in the art of luer locking systems would recognized that the luer connecting valves have two-three positions which each correspond to a different connection, therefore, under the broadest reasonable interpretation, the cited disclosure reads on the limitation as presently claimed), and wherein when in the second position the valve connects the lumen and the pressure transducer ([0047] luer connections as known in the art of luer locking systems would recognized that luer connecting valves have two-three positions which each correspond to a different connection, therefore, under the broadest reasonable interpretation, the cited disclosure reads on the limitation as presently claimed, where the third position may be the same as the second position).
Claims 7-8 and 11-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Tearney, in view of Dick, as applied to claim 2 above, further in view of Pfeiffer et al. (US20070142729, hereafter “Pfeiffer”).
Regarding claim 7, Tearney substantially discloses all the limitations of the claimed invention, but does not explicitly disclose further comprising a purge assembly comprising a fluid restricting device and a purge fluid supply, the fluid restricting device in fluid communication with a purge port defined by a wall of the probe.
However, in the same field of endeavor, Pfeiffer teaches further comprising a purge assembly ([0052]-[0058], see as illustrated in FIG. 2) comprising a fluid restricting device ([0052]-[0058] see stop cock 28, lever 34 and element 31) and a purge fluid supply ([0052] see fluid reservoir 4), the fluid restricting device in fluid communication with a purge port defined by a wall of the probe ([0049], [0058], FIG. 2, the control valve 12 formed to the lumen of the fluid channel/wall within/of the catheter).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Tearney with the purge assembly comprising a fluid restricting device and a purge fluid supply, the fluid restricting device in fluid communication with a purge port defined by a wall of the probe as taught by Pfeiffer in order to provide a releasably coupling the fluid transfer unit to the catheter such that the rinsing fluid can flow from the fluid transfer unit to the catheter ([0051] of Pfeiffer).
Regarding claim 8, Tearney, in view of Pfeiffer, substantially discloses all the limitations of the claimed invention, specifically, Pfeiffer discloses wherein the fluid restricting device is adjustable and comprises a biasing element ([0047], [0062], the valve control element 31 in form of the bellow such that the bellow is squeezed) and a slidable member* defining a hole ([0047], [0060]-[0062] pivotable/slidable inner member 34 is provided with a lever is connected to biasing element 31, and biasing element 31 is in turn connected to 12 having a hole via a structure 18 and when the bellow of biasing element 31 is mechanically activated, the valve/hole 12 activates/opens within the main flow path 33 results in that the flexible tube/hole 32 opens allowing the rinsing fluid to flow through the catheter), the hole positioned to received* purge fluid from the purge fluid supply and the biasing element configured to apply a biasing force upon the slidable member ([0060]-[0062] when the bellow of biasing element 31 is squeezed and an overpressure in the pneumatic signal activation line 18 is obtained, once the overpressure within line 18 is released, the main flow path 33 results in that the flexible tube/hole 32 opens allowing the rinsing fluid to flow through the catheter that is supplied by the reservoir 4).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation to mean any structure known in the medical catheter arts to be movable in relation to and of which motion defines an opening or hole.
Regarding claim 11, Tearney, in view of Dick, substantially discloses all the limitations of the claimed invention, specifically, Dick discloses wherein the pressure transducer is separated from the lumen by a liquid positioned within the pocket ([0044] the central lumen of the outer catheter sheath is filled with a fluid that could serve to (a) provide lubrication within the lumen which extends down to the pocket), but does not explicitly disclose discloses gel positioned within the pocket.
However, in the same field of endeavor, Pfeiffer teaches discloses wherein the pressure transducer is separated from the lumen by a gel positioned within the pocket ([0084], [0093] pressure sensor 13 arranged with a pressure channel/pocket is provided that is connected to a tube 32 filled with liquid or gel).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Tearney with the pressure transducer is separated from the lumen by a gel positioned within the pocket as taught by Pfeiffer in order to provide a fluid transfer system according to present invention allows a continuous measurement of a blood pressure of a patient ([0018] of Pfeiffer).
Regarding claim 12, Tearney, in view of Dick, substantially discloses all the limitations of the claimed invention, specifically, Dick discloses further comprising a fluid supply configured to deliver a purge solution ([0047] the monolithic catheter sheath uses standard luer connections at the proximal end of the catheter sheath 200 to provide the flushing fluid/purge solution); but does not explicitly disclose a check valve in fluid communication with the fluid supply; a fluid flow control device in fluid communication with the check valve; and a fluid delivery channel configured to transport the purge solution to a purge port defined by a wall of the probe.
However, in the same field of endeavor, Pfeiffer teaches a check valve in fluid communication with the fluid supply;
a fluid flow control device in fluid communication with the check valve ([0028] a syringe is provided which is connected to the fluid flow means between the stop cock and the flow control unit for supply a bolus into the fluid flow means for flush rinsing); and
a fluid delivery channel configured to transport the purge solution to a purge port defined by a wall of the probe ([0053]-[0054] first rinsing position the reservoir 4 is connected to the fluid flow means 24 such that the injectate fluid flows via the fluid flow means and the connector 15).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Tearney with the check valve in fluid communication with the fluid supply; the fluid flow control device in fluid communication with the check valve; and the fluid delivery channel configured to transport the purge solution to a purge port defined by a wall of the probe as taught by Pfeiffer in order to provide a fluid transfer system according to present invention allows a continuous measurement of a blood pressure of a patient ([0018] of Pfeiffer).
Claims 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Tearney, in view of Dick, as applied to claim 2 above, further in view of Salmon et al. (US5503155, hereafter “Salmon”).
Regarding claim 14, Tearney substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the length of the second torque wire is about ten times the length of the first torque wire.
However, in the same field of endeavor, Salmon teaches wherein the length of the second torque wire is about ten times the length of the first torque wire (column 4, lines 45-58, the outer second coil having a diameter in the range from 0.015 to 0.15 cm, specifically from 0.03 to 0.1 cm and has a pitch which may vary from 8 to 400 turns/cm, more usually being in the range from about 25 to 100 turns/cm, the inner first coil 0.01 to 0.125 cm, specifically, from about 0.02 to 0.05 cm and has a pitch which may vary from 8 to 400 turns/cm; therefore, as the outer second coil having a wider diameter than the inner first coil, with both coils having the same pitch of turns/cm, the length of the outer second coil may be 0.1 cm x 25 turns/cm = 2.5 turns length, whereas the inner first coil may be 0.01 cm x 25 turns/cm = 0.25 turns in length).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Tearney with the length of the second torque wire is about ten times the length of the first torque wire as taught by Salmon in order to provide for uniform torque-transmission along the entire length of the drive cable (column 2, lines 21-23 of Salmon).
Claims 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Tearney, in view of Dick and Salmon, as applied to claim 14 above, further in view of Pfeiffer.
Regarding claim 13, Tearney substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the fluid control device is selected from the group consisting of a restriction, an adjustable restriction, an expandable tube, and an expandable tube disposed in an expansion limiter.
However, in the same field of endeavor, Pfeiffer teaches wherein the fluid control device is selected* from the group consisting of a restriction ([0058], FIG. 2, see fluid control unit having capillary 21 which restricts the flow to a predetermined flow rate e.g. of 3 ml/h).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Tearney with fluid control device is selected from the group consisting of a restriction the as taught by Pfeiffer in order to provide a releasably coupling the fluid transfer unit to the catheter such that the rinsing fluid can flow from the fluid transfer unit to the catheter at rate that does not exceed a threshold pressure ([0069] of Pfeiffer).
*For the purposes of examination, the limitation is interpreted in the alternative, requiring the fluid control device is selected from the group consisting of a restriction; or requiring the fluid control device is selected from the group consisting of an adjustable restriction; or requiring the fluid control device is selected from the group consisting of an expandable tube; or requiring the fluid control device is selected from the group consisting of an expandable tube disposed in an expansion limiter.
Allowable Subject Matter
Claim 3, 6, and 9 are allowed.
Regarding claims 3, 6, and 9, Tearney, Dick, Pfeiffer, and Salmon, individually or in combination, do not disclose or reasonably suggest all of the corresponding elements and the remaining limitations as claimed, in combination and taken together as a whole. Thus, for at least the foregoing reasons, the Office finds no reason to reject the claims herein. Accordingly, the claims are held to be allowable.
Specifically, regarding claim 3, Tearney substantially discloses all the limitations of the claimed invention, specifically, Tearney discloses wherein the optical coherence tomography assembly comprises a beam director ([0029], FIG. 1A, distal optics 115 provide one- or two-dimensional scanning by an optical beam 110 directed to an anatomical sample or structure) adjacent to and coaxial with the optical fiber ([0028], FIG. 1A, see distal optics 115 are coaxial with the optical fiber 75), the beam director configured to reflect light ([0028], [0029], FIG. 1A, optical beam 115 is light redirected to the distal end from the arrangement 50) of the first wavelength band (abstract, the first radiation), wherein the pressure assembly comprises an optical pressure transducer ([0015] an additional arrangement can be provided for measuring pressure), coaxial with the beam director and the optical fiber (see FIGS. 6A-6B), and positioned distal to the beam director (see FIGS. 6A-6B), the optical fiber configured to transmit light of a first wavelength band and a second wavelength band (abstract, [0013], a first radiation and a second radiation having different wavelengths that can vary over time), but is silent on the optical pressure transducer configured to modulate light of the second wavelength band. Dick, Pfeiffer, and Salmon, do not disclose this feature.
Claim 9 is allowable by nature of dependency on claim 3 allowable as outlined above.
Specifically, regarding claim 6, Tearney, Dick, Pfeiffer, and Salmon, individually or in combination, do not disclose or reasonably suggest wherein the processor is configured to execute the program to output a myocardial damage index as a ratio of a measured pressure drop to an expected pressure drop.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights