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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 March 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 5, and 11. Claims 1-16 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “48” [Fig. 2], “88” [Fig. 6, appears to refer to the longitudinal axis of the guidewire tracking device 86 (Applicant’s Specification ¶0032)], “90” [Fig. 6, appears to refer to the longitudinal axis of the insertion tube 42 (Applicant’s Specification ¶0032)].
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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(s) 1 and 5 is/are objected to because of the following informalities:
The Examiner notes that the amendments to claims 1 and 5 are not considered to be in proper form, as the amendments submitted are not made in accordance with 37 CFR 1.530, which states “Any changes relative to the patent being reexamined which are made to the specification, including the claims, must include the following markings: (1) The matter to be omitted by the reexamination proceeding must be enclosed in brackets; and (2) The matter to be added by the reexamination proceeding must be underlined”. The claims filed 3 March 2026 do not include the tabbed portions to define what is included in each of the imaging system, guidewire system, and real-time sampling system in claim 1, as well as what is included in the image processor in claim 5 as previously objected to in the Non-Final Rejection dated 30 June 2025, and acknowledged and amended by the Applicant in the claims filed 24 September 2025.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (US-20170079519-A1, previously presented) in view of Mihara (JP-2006020944-A, translation previously presented) and Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented).
Regarding claim 1, Sung teaches
A system comprising:
an imaging system including:
an ultrasound probe [an ultrasound probe or other real-time imaging instrument 240 (Sung ¶0074, Figures 4A-B)];
a scope comprising a single working channel [the compressed sheath 110 may be loaded into the working channel of the bronchoscope 6 (Sung ¶0066); It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein (Sung ¶0129)]; and
a real-time sampling system including:
a handle [each lumen 216 may communicate to an actuator on a hub or handle on the proximal end (also not shown) such that the actuator may be used to deploy or retract the device disposed within the lumen 216 (Sung ¶0073), wherein the Examiner notes that any proximal portion of the catheter 210 may be considered to be a handle, as the catheter 210 is considered to be graspable and/or configurable to be gripped];
a flexible catheter couplable to the handle, the flexible catheter including a distal end including a first lumen configured to receive the ultrasound probe and a second lumen terminating in an exit ramp configured to deflect a medical tool through an exit port [an access sheath or catheter 210 is shown that includes a pair of channels or lumens 216 that extend from the proximal end of the catheter 210 (Sung ¶0073, Figures 4A-B); The first or imaging lumen 216a is sized to receive an ultrasound probe or other real-time imaging instrument 240, while the second or working lumen 216b is sized to receive a needle or other biopsy device 220, e.g., as shown in FIG. 4B (Sung ¶0074); The second lumen 216b may extend adjacent to the first lumen 216a, e.g., offset from the central axis 218, and the outlet 217b may be located on a side wall of the distal portion 214. The second lumen 216b may include a ramped surface 219b adjacent the outlet 217b, e.g., such that the second lumen 216b changes direction at a specific angle relative to the central axis 218. Thus, a biopsy device 220 deployed from the outlet 217b may extend laterally relative to the central axis 218 and the distal portion 214. The catheter 210 may be manufactured with various angulations to achieve the desired directionality of the biopsy device 220 when deployed (Sung ¶0075)].
However, while Sung discloses that the system may use guide instruments to facilitate predetermined placement of the system [the guide instrument may include one or more locatable guides, e.g., components of electromagnetic navigation systems, radio-opaque wires advanced using fluoroscopic guidance, and/or other navigation systems that may be used to guide the guide instrument to a desired location in the airway (Sung ¶0007)], Sung fails to explicitly disclose a guidewire system including: a guidewire, and the scope; and a guidewire guide disposed on an exterior surface the distal end of the flexible catheter opposite the exit port, wherein the guidewire guide is configured to slidably receive the guidewire.
Mihara discloses a system comprising a dual-lumen catheter, wherein the system further comprises a guidewire system including: a guidewire [first guidewire 25 (Mihara Figures 1-2)]; and a guidewire guide disposed at an exterior surface of a distal end of the flexible catheter opposite an exit port of a medical tool, wherein the guidewire guide is configured to slidably receive the guidewire [The sheath distal end portion 21 further includes a first guide penetrating from the opening 271 on the distal end side in the in-vivo insertion direction to the most advanced opening 272 as a passage for passing the first guide wire 25. A wire lumen 27 is provided… The first guide wire 25 is inserted in advance to the vicinity of the affected part in the living body before the catheter 1 is inserted into the living body, and is used to guide the catheter 1 to the affected part. The catheter 1 is guided to the affected area while passing the first guide wire 25 through the first guide wire lumen 27 (Mihara Translated p. 4, Figs. 1-2); Further, when the first guide wire 25 and the second guide wire 26 are used at the same time, the first guide wire 25 and the second guide wire 26 do not pass coaxially. Are not entangled by interference and have excellent operability (Mihara p. 6, Figs. 1-2)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sung to employ a guidewire system including: a guidewire; and a guidewire guide disposed on the distal end of the flexible catheter opposite the exit port, wherein the guidewire guide is configured to slidably receive the guidewire, so as to allow for the catheter to be guided to a particular location [Mihara p. 4].
However, Sung in view of Mihara fails to explicitly disclose wherein the guidewire guide is positioned relative to the exit port to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue.
Kellerman discloses a multi-lumen catheter, wherein Kellerman discloses that the catheter includes a guidewire guide [angioplasty balloon guidewire locator 47 (Kellerman Figure 21)] with a guidewire extending therethrough [Kellerman Figure 21], wherein the guidewire guide is positioned relative to an exit port of the multi-lumen catheter to bias a distal end of a multi-lumen catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for a medical tool toward target tissue [FIG. 21 shows yet another exemplary embodiment (the three lumen needle) of the extendable lumen needle 39 with the guidewire lumen 37 and second guidewire lumen, shaft 41, which may be flexible, but must have torsional stiffness, a crossing needle device hub 43, which may include automatic needle advance and/or vibration inducing element, and an angioplasty balloon 45 inflated for stabilization. An angioplasty balloon guidewire locator 47 is also provided (Kellerman Col 9:7-14, Figure 21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sung in view of Mihara to employ wherein the guidewire guide is positioned relative to the exit port to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue, so as to allow for stabilization of the catheter while using a medical tool coupled to the catheter [Kellerman Col 9:7-14, Figure 21].
Regarding claim 2, Sung in view of Mihara and Kellerman teaches
The system of Claim 1, wherein:
the real-time sampling system further includes the medical tool [a needle or other biopsy device 220 (Sung ¶0074, Figure 4B)]; and
the first lumen extends a length of the flexible catheter and is configured to slidably receive the ultrasound probe [an imaging device 240, e.g., a radial EBUS probe, may be inserted into the first lumen 216a and deployed from the outlet 217a into the body lumen 92 (Sung ¶0077, Figure 4B)]; and
the second lumen extends a length of the flexible catheter and is configured to slidably receive the medical tool [a biopsy device, e.g., biopsy needle 220, may be deployed from the outlet 217b of the second lumen 216b (Sung ¶0078, Figure 4B)].
Regarding claim 3, Sung in view of Mihara and Kellerman teaches
The system Claim 2, wherein the medical tool includes a sampling needle [Sung ¶0077, Figure 4B].
Regarding claim 4, Sung in view of Mihara and Kellerman teaches
The system of Claim 2, wherein the handle includes:
a first port and a first lumen configured to slidably receive the ultrasound probe [each lumen 216 may communicate to an actuator on a hub or handle on the proximal end (also not shown) such that the actuator may be used to deploy or retract the device disposed within the lumen 216 (Sung ¶0073)]; and
a second port and a second lumen configured to slidably receive the medical tool [Sung ¶0073].
Regarding claim 5, Sung in view of Mihara and Kellerman teaches
The system of Claim 1, wherein the imaging system further includes:
an image processor [the imaging device 240 may include a processor and display (not shown), e.g., a radial EBUS system, and the processor may analyze the images acquired by the imaging device 240 to present one or more markers on the display to indicate the location, direction, and/or orientation of the needle 220 with respect to the area of interest 94 (Sung ¶0079)]] configured to:
receive image data from the ultrasound probe [Sung ¶0079]; and
generate images responsive to the received image data [Sung ¶0079]; and
a display device in data communication with the image processor, wherein the image processor is configured to generate a display responsive to the generated images [Sung ¶0079].
Regarding claim 7, Sung in view of Mihara and Kellerman teaches
The system of Claim 1, wherein:
the guidewire guide includes a first longitudinal axis [wherein the axis defined by the length of the lumen 27 of Mihara is considered to define a first longitudinal axis (Mihara Figure 2)]; and
a portion of the flexible catheter adjacent to an attachment point with the guidewire guide includes a second longitudinal axis [central longitudinal axis 218 (Sung Figures 4A-B)],
the first longitudinal axis and the second longitudinal axis are parallel [The first guide wire lumen 27 is not coaxial with the imaging core lumen 23, and is provided separately in parallel (Mihara p. 4)].
Regarding claim 8, Sung in view of Mihara and Kellerman teaches
The system of Claim 1.
However, while Sung does disclose an anchoring mechanism [the catheter 210′ includes a balloon or other expandable member 230′ on the distal portion 214,′ e.g., proximal to the outlet 217b′ of the working lumen 216b.′ (Sung ¶0081, Figure 5A); The balloon 230′ may be expanded within an airway 92 or other body lumen, e.g., as shown in FIG. 5B, to substantially fix the distal portion 214′ within the airway 92 (Sung ¶0082, Figure 5A)], Sung in view of Mihara and Kellerman as presently modified fails to explicitly disclose wherein the guidewire includes an anchoring mechanism disposed on a distal end, the anchoring mechanism configured to secure the guidewire within an airway or similar lumen within a patient.
Kellerman discloses a guidewire that includes an anchoring mechanism disposed on a distal end [angioplasty balloon 45 (Kellerman Figure 21)], the anchoring mechanism configured to secure the guide wire within an airway or similar lumen within a patient [FIG. 21 shows yet another exemplary embodiment (the three lumen needle) of the extendable lumen needle 39 with the guidewire lumen 37 and second guidewire lumen, shaft 41, which may be flexible, but must have torsional stiffness, a crossing needle device hub 43, which may include automatic needle advance and/or vibration inducing element, and an angioplasty balloon 45 inflated for stabilization. An angioplasty balloon guidewire locator 47 is also provided (Kellerman Col 9:7-14, Figure 21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sung in view of Mihara and Kellerman to employ wherein the guidewire includes an anchoring mechanism disposed on a distal end, the anchoring mechanism configured to secure the guidewire within an airway or similar lumen within a patient, so as to allow for stabilization of the catheter while using a medical tool coupled to the catheter [Kellerman Col 9:7-14, Figure 21].
Regarding claim 9, Sung in view of Mihara and Kellerman teaches
The system of Claim 8, wherein the guidewire is coupled to the anchoring mechanism in an offset manner to bias a distal end of the flexible catheter against a tissue sidewall adjacent a target tissue [see § 103 modification of claim 8 above, wherein as depicted in Figure 21 of Kellerman, the guide wire may be considered to be coupled offset to the anchor mechanism (angioplasty balloon 45)].
Regarding claim 10, Sung in view of Mihara and Kellerman teaches
The system of Claim 9, wherein a portion the distal end of the flexible catheter distal of the exit port for the second lumen is ultrasonically transmissible [wherein outlet 217a defining an opening to allow the imaging instrument 240 to extend from the lumen 216a through to the body lumen 92 is considered to define a portion of the distal end of the flexible catheter distal of an exit port for the second lumen being ultrasonically transmissible, wherein the exit port may be considered to be port in which the ultrasound probe is inserted into via the hub on the proximal end of the catheter (see Sung ¶0073)].
Regarding claim 11, Sung teaches
An apparatus comprising:
a handle [each lumen 216 may communicate to an actuator on a hub or handle on the proximal end (also not shown) such that the actuator may be used to deploy or retract the device disposed within the lumen 216 (Sung ¶0073), wherein the Examiner notes that any proximal portion of the catheter 210 may be considered to be a handle, as the catheter 210 is considered to be graspable and/or configurable to be gripped];
a flexible catheter couplable to the handle, the flexible catheter including a distal end including a first lumen configured to receive an ultrasound probe and a second lumen terminating in an exit ramp configured to deflect a medical tool through an exit port [an access sheath or catheter 210 is shown that includes a pair of channels or lumens 216 that extend from the proximal end of the catheter 210 (Sung ¶0073, Figures 4A-B); The first or imaging lumen 216a is sized to receive an ultrasound probe or other real-time imaging instrument 240, while the second or working lumen 216b is sized to receive a needle or other biopsy device 220, e.g., as shown in FIG. 4B (Sung ¶0074); The second lumen 216b may extend adjacent to the first lumen 216a, e.g., offset from the central axis 218, and the outlet 217b may be located on a side wall of the distal portion 214. The second lumen 216b may include a ramped surface 219b adjacent the outlet 217b, e.g., such that the second lumen 216b changes direction at a specific angle relative to the central axis 218. Thus, a biopsy device 220 deployed from the outlet 217b may extend laterally relative to the central axis 218 and the distal portion 214. The catheter 210 may be manufactured with various angulations to achieve the desired directionality of the biopsy device 220 when deployed (Sung ¶0075)].
However, while Sung discloses that the system may use guide instruments to facilitate predetermined placement of the system [the guide instrument may include one or more locatable guides, e.g., components of electromagnetic navigation systems, radio-opaque wires advanced using fluoroscopic guidance, and/or other navigation systems that may be used to guide the guide instrument to a desired location in the airway (Sung ¶0007)], Sung fails to explicitly disclose wherein the apparatus further comprises a guidewire guide affixed to an exterior surface of disposed on the distal end of the flexible catheter opposite the exit port.
Mihara discloses a system comprising a dual-lumen catheter, wherein the system further comprises a guidewire system including: a guidewire [first guidewire 25 (Mihara Figures 1-2)]; and a guidewire guide affixed to an exterior surface of a distal end of the flexible catheter opposite an exit port of a medical tool [The sheath distal end portion 21 further includes a first guide penetrating from the opening 271 on the distal end side in the in-vivo insertion direction to the most advanced opening 272 as a passage for passing the first guide wire 25. A wire lumen 27 is provided… The first guide wire 25 is inserted in advance to the vicinity of the affected part in the living body before the catheter 1 is inserted into the living body, and is used to guide the catheter 1 to the affected part. The catheter 1 is guided to the affected area while passing the first guide wire 25 through the first guide wire lumen 27 (Mihara Translated p. 4, Figs. 1-2); Further, when the first guide wire 25 and the second guide wire 26 are used at the same time, the first guide wire 25 and the second guide wire 26 do not pass coaxially. Are not entangled by interference and have excellent operability (Mihara p. 6, Figs. 1-2)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sung to employ a guidewire guide affixed to an exterior surface of disposed on the distal end of the flexible catheter opposite the exit port, so as to allow for the catheter to be guided to a particular location via a guidewire [Mihara p. 4].
However, Sung in view of Mihara fails to explicitly disclose wherein the guidewire guide is positioned relative to the exit port to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue.
Kellerman discloses a multi-lumen catheter, wherein Kellerman discloses that the catheter includes a guidewire guide [angioplasty balloon guidewire locator 47 (Kellerman Figure 21)] with a guidewire extending therethrough [Kellerman Figure 21], wherein the guidewire guide is positioned relative to an exit port of the multi-lumen catheter to bias a distal end of a multi-lumen catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for a medical tool toward target tissue [FIG. 21 shows yet another exemplary embodiment (the three lumen needle) of the extendable lumen needle 39 with the guidewire lumen 37 and second guidewire lumen, shaft 41, which may be flexible, but must have torsional stiffness, a crossing needle device hub 43, which may include automatic needle advance and/or vibration inducing element, and an angioplasty balloon 45 inflated for stabilization. An angioplasty balloon guidewire locator 47 is also provided (Kellerman Col 9:7-14, Figure 21)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Sung in view of Mihara to employ wherein the guidewire guide is positioned relative to the exit port to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue, so as to allow for stabilization of the catheter while using a medical tool coupled to the catheter [Kellerman Col 9:7-14, Figure 21].
Regarding claim 12, Sung in view of Mihara and Kellerman teaches
The apparatus of Claim 11, wherein the first lumen extends a length of the flexible catheter and is configured to slidably receive an imaging device [an imaging device 240, e.g., a radial EBUS probe, may be inserted into the first lumen 216a and deployed from the outlet 217a into the body lumen 92 (Sung ¶0077, Figure 4B)]; and
the second lumen extends a length of the flexible catheter and is configured to slidably receive the medical tool [a biopsy device, e.g., biopsy needle 220, may be deployed from the outlet 217b of the second lumen 216b (Sung ¶0078, Figure 4B)].
Regarding claim 13, Sung in view of Mihara and Kellerman teaches
The apparatus of Claim 12, wherein the handle includes:
a first port and a first lumen configured to receive the imaging device [each lumen 216 may communicate to an actuator on a hub or handle on the proximal end (also not shown) such that the actuator may be used to deploy or retract the device disposed within the lumen 216 (Sung ¶0073)]; and
a second port and a second lumen configured to receive the medical tool [Sung ¶0073].
Regarding claim 14, Sung in view of Mihara and Kellerman teaches
The apparatus Claim 13, wherein the second lumen and the second port are configured to slidably receive a sampling needle [Sung ¶¶0073, 0078].
Regarding claim 15, Sung in view of Mihara and Kellerman teaches
The apparatus of Claim 13, wherein the first lumen and the first port are configured to slidably receive an ultrasound probe [Sung ¶0073, 0077].
Regarding claim 16, Sung in view of Mihara and Kellerman teaches
The apparatus of Claim 11, wherein:
the guidewire guide includes a first longitudinal axis [wherein the axis defined by the length of the lumen 27 of Mihara is considered to define a first longitudinal axis (Mihara Figure 2)];
a portion of the flexible catheter adjacent to an attachment point with the guidewire guide includes a second longitudinal axis [central longitudinal axis 218 (Sung Figures 4A-B)], and
the first longitudinal axis and the second longitudinal axis are parallel [The first guide wire lumen 27 is not coaxial with the imaging core lumen 23, and is provided separately in parallel (Mihara p. 4)].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung in view of Mihara and Kellerman, as applied to claim 1, in further view of Stigall (US-20160302762-A1, previously presented).
Regarding claim 6, Sung in view of Mihara and Kellerman teaches
The system of Claim 1, wherein the scope of the guidewire system includes:
a handle including a port and a lumen configured to receive the ultrasound probe [the compressed sheath 110 may be loaded into the working channel of the bronchoscope 6 and then the bronchoscope 6 may be introduced into the patient's body, e.g., until the shaft 7 is positioned at a desired location in the airway 92 (Sung ¶0066, Figure 2B)]; and
an insertion tube [shaft 7 (Sung Figure 2B)] couplable to the scope handle, the insertion tube including a lumen [allow at least the distal portion 114 of the sheath 110 to be introduced through a working channel of the bronchoscope 6. Once received in the bronchoscope 6, the distal portion 114 may extend from the shaft 7 of the bronchoscope 6 or may be disposed within the working channel, e.g., adjacent the distal end of the shaft 7 (Sung ¶0065, Figure 2B)].
However, while Sung is generally directed towards catheters configured to access body lumens including the cardiovascular system [It should be noted that these exemplary embodiments of the catheter 210, 210′ and associated devices may be introduced into an airway 92 to access adjacent parenchyma. However, such catheters may also be used to access an area of interest in any area of the body that is adjacent to a lumen, for example, a lumen within the gastrointestinal system, biliary system, pancreas, and cardiovascular system (Sung ¶0086)], Sung in view of Mihara and Kellerman fails to explicitly disclose wherein the port and lumen of the handle of the scope may receive the guidewire separately and interchangeably with the ultrasound probe; and wherein the insertion tube has an outer diameter less than 3.2 mm.
Stigall discloses catheters for accessing vascular systems, wherein Stigall discloses a scope having a handle with a port and lumen configured to receive a guidewire [FIG. 5 shows a dual lumen imaging apparatus support 303 with a first guidewire lumen 301 and a second guidewire lumen 302 with a first guidewire 201 and a second guidewire 203 disposed therein (Stigall ¶0059); The proximal portion of the catheter may terminate at a hub such as a Y-arm, with, for instance, entry ports for the first and second catheter (Stigall ¶0065)]; and wherein Stigall discloses that catheters configured to access vascular systems have outer diameters in the range from 1 French to 12 French [Catheter bodies intended for intravascular introduction will typically have a length in the range from 50 cm to 200 cm and an outer diameter in the range from 1 French to 12 French (0.33 mm: 1 French) (Stigall ¶0042)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scope of Sung in view of Mihara and Kellerman to employ the guidewire being individually received by the port and lumen of the handle, so as to allow for insertion of the guidewire to a particular position as operated through the scope as an application of a known technique [a handle of a scope receiving a guidewire] to a known device (methods, or products) ready for improvement to yield predictable results [allowing for the handle of the guidewire system of Sung in view of Mihara and Kellerman to receive the guidewire] [MPEP § 2143(I)(D)]. Wherein based on the above modification, the guidewire being receivable by the port and lumen of the scope of the guidewire system is considered to read on being received separately and interchangeably with the ultrasound probe.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer diameter of the insertion tube of Sung in view of Mihara and Kellerman to be 3.2 mm or less, since it has been held that “[i]n cases where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, the Applicant appears to have not placed any criticality on the claimed range of the outer diameter of the insertion tube [The bronchoscope 22 may include a 3.0 mm distal-end outer diameter with a 1.7 mm working channel, thereby facilitating deep access into the lung. Other types of endoscopes may be used such as an endoscope with an outer diameter less than 4.0 mm, less than 3.5 mm, less than 3.2 mm, less than 3.0 mm, and the like (Applicant’s Specification ¶0021)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 3 March 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection to claim 5 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6-8, with respect to the rejection(s) of claim(s) 1 and 11 under § 103 as being obvious over Sung in view of Mihara have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sung (US-20170079519-A1, previously presented) in view of Mihara (JP-2006020944-A, translation previously presented) and Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented).
The Applicant asserts that the amendment to claim 1 to recite “wherein the guidewire guide is positioned relative to the exit port to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue” distinguishes the instant invention from any obvious combination of Sung and Mihara. The Applicant notes that the guidewire 25 of Mihara, which runs through guide wire lumen 27 is used for stent delivery purposes and thus Mihara fails to teach a guidewire positioned relative to the exit port to bias the distal end of a flexible catheter against a tissue sidewall. The Applicant also notes that the guidewire lumen of Mihara is an internal passage parallel to and within the same catheter body as the imaging core lumen [Mihara ¶0025], whereas the instant guidewire guide is attached to an outer surface of the catheter and defines its own channel for receiving a guidewire. The Examiner notes that Applicant’s arguments with respect to claim(s) 1 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. The Examiner notes that Mihara is still considered relevant, as while one use of Mihara is to deliver a stent [Mihara p. 6] as argued by the Applicant, Mihara in general discloses a catheter including a distal end including a first lumen configured to receive an ultrasound probe [As shown in FIG. 2, the transducer unit 41 includes an ultrasonic transducer 411 that transmits and receives ultrasonic waves, and an ultrasonic transducer housing 412 that houses the ultrasonic transducer 411 (Mihara p. 3, Fig. 2)] and a second lumen terminating in an exit ramp configured to deflect a medical tool through an exit port [As shown in FIG. 2, the opening 281 includes a deflecting unit 282 that deflects the traveling direction of the second guide wire 26 in a direction away from the major axis direction of the catheter 1 (Mihara p. 4, Fig. 2)]. Furthermore, in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the instant guidewire guide is attached to an outer surface of the catheter”, emphasis applied) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner notes that Mihara teaches a guidewire guide disposed on an exterior surface of the distal end of the flexible catheter opposite the exit port, wherein the guidewire guide is configured to slidably receive the guidewire [wherein as depicted in Mihara Fig. 2, lumen 27 defining the guidewire guide is formed on an exterior surface of catheter 1 opposite opening 281 (exit port); and wherein even in arguendo claim 1 were amended to read “attached to”, the lumen 27 as formed on the catheter 1 of Mihara is considered to read on the BRI of “attached to” based on the plain definition of “attached” meaning connected or joined to something (https://www.merriam-webster.com/dictionary/attached); and with respect to claim 11 using the language “affixed to”, a similar interpretation of Mihara is considered to be applicable mutatis mutandis based on the plain definition of “affix” meaning to attach in any way (https://www.merriam-webster.com/dictionary/affixed)]. Moreover, regarding the amended limitation “wherein the guidewire guide is positioned relative to the exit port to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue”, the Examiner notes that Sung in view of Mihara is further modified by Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented), as Kellerman discloses a guidewire guide of a multi-lumen catheter positioned relative to an exit port for a medical tool to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein, thereby positioning the exit port for the medical tool toward target tissue [FIG. 21 shows yet another exemplary embodiment (the three lumen needle) of the extendable lumen needle 39 with the guidewire lumen 37 and second guidewire lumen, shaft 41, which may be flexible, but must have torsional stiffness, a crossing needle device hub 43, which may include automatic needle advance and/or vibration inducing element, and an angioplasty balloon 45 inflated for stabilization. An angioplasty balloon guidewire locator 47 is also provided (Kellerman Col 9:7-14, Figure 21)], wherein as the angioplasty balloon 45 comprises a guidewire, the guidewire guide of Kellerman functions to bias the distal end of the flexible catheter against a tissue sidewall when a guidewire is received therein. As such, Sung in view of Mihara and Kellerman are considered to teach the argued limitation.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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