DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 5th, 2026 has been entered.
Response to Amendment
The amendment filed February 5th, 2026, has been entered. Claim 1 is amended. Claims 21 & 22 are new. Claims 14, & 17 are canceled. Claims 1-13, 15-16, & 18-22 remain pending; claims 6-13 are withdrawn from further consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-13, 15-16, & 18-22 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; as necessitate by amendment.
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.
Claims 1, 15, 18, & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig et al. (previously presented-US 20080081950 A1), hereinafter “Koenig”, in view of Neerken et al. (US 20090118670 A1), hereinafter “Neerken”.
Regarding claim 1, Koenig discloses a dilator used in performing a transseptal puncture comprising: a hub with an opening at a proximal end ([0088]; Figure 2A—elements 2’/2’’; the examiner is considering the hub to be the proximal end of housing 2 including cover 2’ and tube 2’’); a shaft, connected to a distal end of the hub, comprising a lumen running along a length of the shaft defining an inner wall within the shaft ([0083]; Figure 2A—element 2; the examiner is considering the shaft to be the housing 2 and the lumen to be the lumen of housing 2); an optical fiber for insertion into the lumen of the shaft ([0083]; Figure 2A—element 4), the optical fiber comprising a proximal end portion for sealing the opening of the hub ([0083], [0085], & [0088]; the optical fiber 4 and all lines leading to the distal end of the shaft 2 are guiding in a vacuum-tight manner via the hub 2’ & 2’’; the examiner is considering the proximal end to be the portion of optical fiber 4 located within hub 2’ & 2’’), the optical fiber having a length for running along a length of the lumen ([0083] & [0085]; Figure 2A—elements 2 & 4), wherein a tip of the optical fiber is recessed from a tip of the dilator ([0083] & [0085]; Figure 2A—elements 3 & 4); wherein the optical fiber is configured to, in a simultaneous or alternating fashion: propagate a laser beam with an ultrafast pulse duration that is generated by an ultrafast laser for performing a puncture of the septum ([0006], [0018], [0020], [0032]-[0034], [0070], [0071], & [0080]; Figure 1—element 31; the invention permits precise cutting of biological material by means of femtosecond laser radiation with an adjustable focal plane to cut at various target depths; the invention is suitable for use in “heart surgery”; it is the examiner’s position that the device/optical fiber would be capable of performing a puncture of the septum, as the device is capable of cutting tissue and is suitable for heart surgery); and propagate light for obtaining visualization information from the light interacting with neighboring surfaces in the heart using optical coherence tomography ([0005], [0071], [0075], [0079], [0111], & [0112]); to select a location to perform the puncture using the ultrafast laser beam ([0006], [0018], [0020], [0032]-[0034], [0070], [0071], & [0080])
Koenig does not disclose using the optical coherence tomography to distinguish between scar tissue and healthy tissue at the target location through differentiation of tissue densities as an indicator of the health of tissues, thereby detecting scar tissue, to select a location to perform the puncture based on the health of tissues that avoids the scar tissue.
Neerken discloses a device for puncturing tissue ([0046]) configured to obtain visualization information using optical coherence tomography ([0047] & [0048]; Figure 1—element 108 & 110), and using the optical coherence tomography to distinguish between scar tissue and healthy tissue at the target location through differentiation of tissue densities as an indicator of the health of tissues, thereby detecting scar tissue, to select a location to perform the puncture based on the health of tissues that avoids the scar tissue ([0015], [0047], [0048], [0050], [0054], & [0055]; the detection system 110 performs signal processing of signals obtained by acquisition module 108 (which may be realized by the means of Optical Coherence Tomography), the control unit 112 processes the data obtained from the detection system 110 and analyzes whether the tissue is suitable for punctuation by a tissue analysis means which detects skin irregularities (e.g. scars) that are not suitable for cannulation).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the optical fiber for obtaining visualization information using optical coherence tomography, as disclosed by Koenig, to further include using the optical coherence tomography to distinguish between scar tissue and healthy tissue at the target location through differentiation of tissue densities as an indicator of the health of tissues, thereby detecting scar tissue, to select a location to perform the puncture based on the health of tissues that avoids the scar tissue, as taught by Neerken, as both references and the claimed invention are directed toward surgical systems for cutting tissue and obtaining visualization information using optical coherence tomography. As disclosed by Neerken, the imaging system may use optical coherence tomography to analyze tissue in order to detect irregularities such as scars that are not suitable for cannulation, these parts of tissue are normally unsuitable for puncturing such that avoiding these portions of the body increases safety of the puncturing system ([0015], [0047], [0048], [0050], [0054], & [0055]). A person of ordinary skill in the art would have been motivated to modify the optical fiber for obtaining visualization information using optical coherence tomography, as disclosed by Koenig, to further include using the optical coherence tomography to distinguish between scar tissue and healthy tissue at the target location through differentiation of tissue densities as an indicator of the health of tissues, thereby detecting scar tissue, to select a location to perform the puncture based on the health of tissues that avoids the scar tissue, as taught by Neerken, as such a modification would increase safety of the puncturing system.
Regarding claim 15, Koenig in view of Neerken disclose all of the limitations of claim 1, as described above.
Koenig further discloses wherein the inner wall of the shaft and the optical fiber, once inserted into the shaft, define an interior space in the lumen between the optical fiber and the inner wall of the shaft ([0083]; Figure 2A—elements 2 & 4).
Regarding claim 18, Koenig in view of Neerken disclose all of the limitations of claim 1, as described above.
Koenig further discloses wherein the optical fiber is a dual-core optical fiber, and wherein the laser beam is propagated in a first core of the dual-core fiber, and wherein the light is propagated in a second core of the dual-core fiber ([0027] & [0104]).
Regarding claim 19, Koenig in view of Neerken disclose all of the limitations of claim 1, as described above.
Koenig further discloses wherein the laser beam is a Gaussian beam ([0026], [0033], & [0073]).
Claims 2 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig in view of Neerken and Giba et al. (previously presented-US 5876373 A), hereinafter “Giba”.
Regarding claim 2, Koenig in view of Neerken disclose all of the limitations of claim 1, as described above.
Koenig in view of Neerken further disclose a kit used in the performance of a transseptal puncture comprising: the dilator as defined in claim 1 (see above rejection of claim 1).
Koenig does not disclose a sheath comprising: a shaft of the sheath; a pull-wire assembly comprising one or more pull wires connected to a distal end of the shaft of the sheath; a steering mechanism connected to the one or more pull wires for causing tension to be applied to or diminished from one or more of the one or more pull wires for steering the shaft of the sheath; and an opening in the sheath for providing access to a space for receiving the dilator.
Giba teaches a dilator comprising a shaft and an optical fiber ([Col. 10, lines 28-37] & [Col. 15, line 50 – Col. 16, line 8]; Figure 1 & 5—element 116), wherein the optical fiber is configured to propagate a laser beam and aid in obtaining visualization information ([Col. 15, lines 3-25]), further comprising a sheath comprising: a shaft of the sheath ([Col. 8, lines 7-49]; Figure 1 & 3—elements 100, 106, & 118); a pull-wire assembly comprising one or more pull wires connected to a distal end of the shaft of the sheath ([Col. 9, lines 23-34]; Figure 3—elements 118 & 122); a steering mechanism connected to the one or more pull wires for causing tension to be applied to or diminished from one or more of the one or more pull wires for steering the shaft of the sheath ([Col. 9, lines 23-34] & [Col. 13, lines 12-25]; Figure 1—elements 102 & 156); and an opening in the sheath for providing access to a space for receiving the dilator ([Col. 9, lines 1-9] & [Col. 15, lines 10-20]; Figure 1 & 3—element 116).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the dilator kit, as disclosed by Koenig, to include the sheath and pull wire assembly for receiving the dilator, as taught by Giba, as both references and the claimed invention are directed toward surgical devices configured for delivering laser energy to remove and cut tissue in the heart. As disclosed by Giba, the dilator including the laser delivery device can be slidably disposed within a steerable catheter sheath that includes a pull wire assembly to cause deflection of the distal tip of the steerable catheter sheath, the inclusion of the steerable catheter allows for the laser delivery device to be steered and maneuvered through vasculature to the heart chamber, allows for the laser delivery device to be controlled and stabilized within the target treatment site so as to ensure proper positioning of the laser delivery device for treatment of tissue, and allows for the laser delivery device to be retracted within the steerable catheter so as to prevent accidental injury to a patient while navigating to the target treatment site ([Col. 2 lines 35-50], [Col. 9, lines 1-9], [Col. 9, lines 23-34], & [Col. 14, lines 1-9]). A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the dilator kit, as disclosed by Koenig, to include the sheath and pull wire assembly for receiving the dilator, as taught by Giba, as such a modification would aid in steering and maneuvering the laser delivery device through vasculature to the target treatment site within the heart while preventing accidentally injury to a patient and would aid in controlling and stabilizing the laser delivery device within the target treatment site so as to ensure proper positioning for treatment of tissue.
Regarding claim 20, Koenig in view of Neerken and Giba disclose all of the limitations of claim 2, as described above.
Giba further teaches wherein the sheath includes, at or near the proximal end of the sheath, a hemostatic valve body comprising the opening of the sheath at a proximal end of the hemostatic valve body ([Col. 13, lines 35-49]; Figure 12 & 14A—element 170; a Tuohy-Borst type adapter 170 for releasably coupling to the laser delivery means 116 is located at the proximal end of the steerable catheter 100).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the dilator kit, as disclosed by Koenig, to include the steerable sheath with a hemostatic valve body for receiving the dilator, as further taught by Giba, as both references and the claimed invention are directed toward surgical devices configured for delivering laser energy to remove and cut tissue in the heart. As disclosed by Giba, the steerable catheter sheath comprises a Tuohy-Borst type adapter at the proximal end for releasably coupling to the dilator, the Tuohy-Borst adapter prevents fluids from escaping past the adapter around the dilator, the steerable catheter sheath allows for the dilator and laser delivery device to be: steered and maneuvered through vasculature to the heart, controlled and stabilized within the target treatment site so as to ensure proper positioning of the dilator device for treatment of tissue, and retracted within the steerable catheter so as to prevent accidental injury to a patient while navigating to the target treatment site ([Col. 2 lines 35-50], [Col. 9, lines 1-9], [Col. 9, lines 23-34], [Col. 13, lines 35-49], & [Col. 14, lines 1-19]). A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the dilator kit, as disclosed by Koenig, to include the steerable sheath with a hemostatic valve body for receiving the dilator, as further taught by Giba, as such a modification would provide for a steerable sheath that aids in steering and maneuvering the laser delivery device through vasculature to the target treatment site while preventing accidentally injury to a patient, aids in controlling and stabilizing the laser delivery device within the target treatment site so as to ensure proper positioning for treatment of tissue, and provides a connection that prevents backflow of fluids.
Claims 3 & 4 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig in view of Neerken, Giba, and Feldman et al. (previously presented-US 20190133688 A1), hereinafter “Feldman”.
Regarding claim 3, Koenig in view of Neerken and Giba disclose all of the limitations of claim 2, as described above.
Koenig further discloses a system for performing a transseptal puncture comprising: the kit as defined in claim 2 (see above rejection of claim 2), wherein the ultrafast laser comprises one or more light sources for generating the laser beam and the light; a power source for powering the light source ([0071]; Figure 1—element 31); and a controller ([0075]; Figure 1—element 37) configured to: receive, at least periodically during the transseptal puncture, the light information and perform optical coherence tomography using the light information to obtain the visualization information ([0005], [0074], [0075], [0076], [0095], [0107], & [0112]).
Koenig does not disclose wherein the controller configured to at least periodically adapt, during the transseptal puncture, one or more properties of the laser beam as a function of the visualization information, the properties of the laser beam including pulse duration, wavelength, light source of the laser beam, and turning on or off a light source of the one or more light sources that generates the laser beam.
Feldman teaches a dilator comprising a shaft ([0046]; Figure 1 & 3—element 100/110), a controller ([0045]; Figure 1—element 200), and an optical fiber laser delivery device configured propagate a laser beam and propagate light for obtaining visualization information ([0012], [0047], & [0049]; Figure 3—element 131 & 141), the controller configured to at least periodically adapt, during the transseptal puncture, one or more properties of the laser beam as a function of the visualization information, the properties of the laser beam including pulse duration, wavelength, light source of the laser beam, and turning on or off a light source of the one or more light sources that generates the laser beam ([0019], [0020], [0049], & [0059]; knowledge obtained from the OCT image may be used to control (increase or decrease) the pulsed laser (e.g. the wavelength, pulse repetition rate, pulse duration, etc.); the examiner notes the rest are in the alternative).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller and the laser beam, as disclosed by Koenig, to include the controller configured to at least periodically adapt one or more properties of the laser beam as a function of the visualization information, as taught by Feldman, as both references and the claimed invention are directed toward surgical devices for delivering laser energy to cut tissue within the heart. As disclosed by Feldman, based on the composition of tissue obtained from the OCT image the laser pulse energy may be increased or decreased in order to be capable of cutting through the tissue ([0059]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller and the laser beam, as disclosed by Koenig, to include the controller configured to at least periodically adapt one or more properties of the laser beam as a function of the visualization information, as taught by Feldman, as such a modification would allow for the laser pulse energy to be increased or decreased based on the composition of the tissue in order to accurately cut through the tissue.
Regarding claim 4, Koenig in view of Neerken, Giba, and Feldman disclose all of the limitations of claim 3, as described above.
Koenig further discloses wherein the hub of the dilator further comprises a vacuum port for connecting the dilator to a vacuum source ([0089]; Figure 2A—element 9).
Koenig does not disclose the vacuum port for creating a vacuum in a vacuum lumen of the dilator or via a side port of the dilator, and wherein the system further comprises the vacuum source that is adapted to cause an adherence of a septum to the tip of the dilator through suction.
Feldman further teaches wherein a hub of the dilator ([0045]; Figure 1—element 200) further comprising a vacuum port for connecting the dilator to a vacuum source ([0050]; Figure 1—element 250); the vacuum port for creating a vacuum in a vacuum lumen of the dilator or via a side port of the dilator ([0050]; Figure 5—element 160), and wherein the system further comprises the vacuum source that is adapted to cause an adherence of a septum to the tip of the dilator through suction ([0050] & [0056], & [0065]; Figure 5—element 160; the vacuum lumen 160 allows for debris to be removed; it is the examiners position that the vacuum lumen would be capable of adhering to tissue if so positioned).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the vacuum port and connection of the vacuum source, as disclosed by Koenig, to further include a vacuum port for creating a vacuum in a vacuum lumen of the dilator or via a side port of the dilator, as taught by Feldman, as both references and the claimed invention are directed toward surgical devices for delivering laser energy to cut tissue within the heart. As disclosed by Feldman, the dilator may further include a vacuum lumen so that tissue that is cut can be removed from the site which can reduce temperature increases in the region ([0056] & [0065]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the vacuum port and connection of the vacuum source, as disclosed by Koenig, to further include a vacuum port for creating a vacuum in a vacuum lumen of the dilator or via a side port of the dilator, as taught by Feldman, as such a modification would provide for an arrangement that assists in removing cut tissue and debris from the surgical site which can reduce temperature increases in the surgical site.
Claims 3 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig in view of Neerken, Giba, and Pesach et al. (previously presented-US 20060122583 A1), hereinafter “Pesach”.
Regarding claims 3 & 5, Koenig in view of Neerken and Giba disclose all of the limitations of claim 2, as described above.
Koenig further discloses a system for performing a transseptal puncture comprising: the kit as defined in claim 2 (see above rejection of claim 2), wherein the ultrafast laser comprises one or more light sources for generating the laser beam and the light; a power source for powering the light source ([0071]; Figure 1—element 31); and a controller ([0075]; Figure 1—element 37) configured to: receive, at least periodically during the transseptal puncture, the light information and perform optical coherence tomography using the light information to obtain the visualization information ([0005], [0074], [0075], [0076], [0095], [0107], & [0112]) (claim 3).
Koenig does not disclose wherein the controller configured to at least periodically adapt, during the transseptal puncture, one or more properties of the laser beam as a function of the visualization information, the properties of the laser beam including pulse duration, wavelength, light source of the laser beam, and turning on or off a light source of the one or more light sources that generates the laser beam (claim 3); wherein the controller is further configured to detect, using the visualization information, when the septum has been traversed, and to shut off a light source of the one or more light sources that generates the laser beam (claim 5).
Pesach teaches a laser dilator system comprising a shaft ([0062]; Figure 1A, 1B, & 3A—element 32) and an optical fiber disposed within the shaft ([0063]; Figure 1B & 3A—element 38) configured to propagate a laser beam to ablate tissue and propagate light for obtaining visualization information ([0063], [0065], & [0079]); wherein the controller configured to at least periodically adapt, during the transseptal puncture, one or more properties of the laser beam as a function of the visualization information, the properties of the laser beam including pulse duration, wavelength, light source of the laser beam, and turning on or off a light source of the one or more light sources that generates the laser beam ([0008], [0066], [0069], [0087], & [0088]; the controller is configured to automatically terminate the ablation when the desired hole depth or tissue thickness is reached; wherein the thickness or hole depth can be monitored using OCT or signals from acoustic detectors; the examiner notes the rest are in the alternative) (claim 3); wherein the controller is further configured to detect, using the visualization information, when the septum has been traversed, and to shut off a light source of the one or more light sources that generates the laser beam ([0008], [0066], [0069], [0087], & [0088]; the controller is configured to automatically terminate the ablation when the desired hole depth or tissue thickness is reached; wherein the thickness or hole depth can be monitored using OCT or signals from acoustic detectors; it is the examiner position that the controller would be capable of determining if a septum has been traversed based on the desired hole depth or tissue thickness) (claim 5).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the controller and the laser beam, as disclosed by Koenig, to include the controller configured to at least periodically adapt one or more properties of the laser beam as a function of the visualization information and wherein the controller is further configured to detect, using the visualization information, when the septum has been traversed, and to shut off a light source of the one or more light sources that generates the laser beam, as taught by Pesach, as both references and the claimed invention are directed toward dilators comprising optical fibers for cutting tissue within the heart and propagating light for obtaining visualization information. As disclosed by Pesach, the controller can automatically terminate the ablation when the desired tissue thickness/surgical affect is achieved based on the visualization information and prevent unintended damage to the tissue ([0008], [0069], [0087], & [0088]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller and the laser beam, as disclosed by Koenig, to include the controller configured to at least periodically adapt one or more properties of the laser beam as a function of the visualization information and wherein the controller is further configured to detect, using the visualization information, when the septum has been traversed, and to shut off a light source of the one or more light sources that generates the laser beam, as taught by Pesach, as such a modification would provide for automatic control of the dilator based on the visualization information and allow the controller to terminate the ablation when the desired tissue thickness/surgical affect is achieved, therefore preventing unintended damage to the tissue.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Koenig in view of Neerken and Appling et al. (previously presented-US 20040010248 A1), hereinafter “Appling”.
Regarding claim 16, Koenig in view of Neerken disclose all of the limitations of claim 1, as described above.
Koenig does not disclose wherein the proximal end portion for sealing the opening of the hub has a luer configuration that interacts with a sealing portion at the proximal end of the hub.
Appling teaches a dilator comprising a hub with an opening at a proximal end ([0057]; Figure 6—element 73), a shaft ([0056]; Figure 6—element 71), an optical fiber for insertion into the lumen of the shaft ([0062]; Figure 8—element 3/13), the optical fiber comprising a proximal end portion for sealing the opening of the hub ([0062]; Figure 8—element 103), wherein the proximal end portion for sealing the opening of the hub has a luer configuration that interacts with a sealing portion at the proximal end of the hub ([0058] & [0062]; Figure 6 & 8—element 83, 93, & 103).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the connection of the proximal end of the optical fiber to the hub, as disclosed by Koenig, to include wherein the proximal end portion for sealing the opening of the hub has a luer configuration that interacts with a sealing portion at the proximal end of the hub, as taught by Appling, as both references and the claimed invention are directed toward dilators comprising optical fibers configured to be inserted through a shaft. As disclosed by Appling, the optical fiber may comprise a male luer connector that is connectable to a female luer connector located in the hub, this configuration provides a secure but releasable connection between the optical fiber and the hub ([0058], [0062], [0063], & [0084]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connection of the proximal end of the optical fiber to the hub, as disclosed by Koenig, to include wherein the proximal end portion for sealing the opening of the hub has a luer configuration that interacts with a sealing portion at the proximal end of the hub, as taught by Appling, as such a modification would provide for a known connection between a shaft and optical fiber and would provide for a secure but releasable connection between the optical fiber and the shaft.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Koenig in view of Neerken and Doi et al. (US 4971034 A), hereinafter “Doi”.
Regarding claim 21, Koenig in view of Neerken disclose all of the limitations of claim 1, as described above.
Koenig further discloses using the optical coherence tomography (see above rejection of claim 1).
Koenig does not disclose further comprising a vacuum lumen surrounding the optical fiber and defined in the shaft, for providing a vacuum created by a vacuum source, and for removing fluid between the tip of the dilator and the neighboring surfaces in the heart to improve light penetration.
Doi teaches a dilator comprising a shaft ([Col. 9, lines 9-47]; Figure 2—element 22) and an optical fiber ([Col. 8, lines 55-65]; Figure 2—element 14) comprising a vacuum lumen surrounding the optical fiber and defined in the shaft, for providing a vacuum created by a vacuum source, and for removing fluid between the tip of the dilator and the neighboring surfaces in the heart to improve light penetration ([Col. 6, lines 44-61] & [Col. 9, lines 9-47]; Figures 1 & 2—element 23 & 27; the vacuum lumen is configured to remove debris; it is the examiners position that removing debris would be capable of improving light penetration).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the dilator, as disclosed by Koenig, to include a vacuum lumen surrounding the optical fiber and defined in the shaft, for providing a vacuum created by a vacuum source, as taught by Doi, as both references and the claimed invention are directed toward electrosurgical devices configured to deliver laser energy to tissue. As disclosed by Doi, the laser may be surrounded by a vacuum lumen, such that the vacuum lumen may remove debris from the treatment region ([Col. 6, lines 44-61] & [Col. 9, lines 9-47]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the dilator, as disclosed by Koenig, to include a vacuum lumen surrounding the optical fiber and defined in the shaft, for providing a vacuum created by a vacuum source, as taught by Doi, as such a modification would assist in removing debris from the treatment site.
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Accordingly, claims 1-5,15-16,18-21 are rejected; claim 22 is objected to as being dependent upon a rejected base claim.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kleen et al. (US 20050148836 A1) discloses using optical coherence tomography to distinguish between healthy tissue and scar tissue within the heart ([0010] & [0012]). Maschke (US 20090076375 A1) discloses using optical coherence tomography to distinguish between healthy tissue and scar tissue within the heart ([0016])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794