DETAILED ACTION
This action is responsive to the “AMENDMENT & RESPONSE UNDER 37 C.F.R. § 1.111” filed 14 July 2026. The Examiner acknowledges the amendments to claims 1, 5, and 11. Claims 1-16 are pending.
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 handle including a port and a lumen configured to separately and interchangeably receive the ultrasound probe and the guidewire” of the scope of the guidewire system [of claim 6] must be shown or the feature(s) canceled from the claim(s) [The Examiner notes that the handle of the guidewire system, as presently claimed, is a separate handle from the handle of the real-time sampling system (of claim 1, from which claim 6 depends from)]. 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.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Line 6 of claim 1 should be tabbed once to the right [see previously presented claim objections on p. 3 of the Non-Final Rejection dated 16 April 2026 and corresponding 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 Panzenbeck (US-20190261946-A1) in view of Yamaguchi (US-20050101870-A1) and Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented).
Regarding claim 1, Panzenbeck teaches
A system comprising:
an imaging system including:
an ultrasound probe [The radial ultrasound system 16 includes a signal processor 24, a display device 18 and a radial ultrasound probe 22 (Panzenbeck ¶0034, Fig. 1); a radial ultrasound probe is positioned within the cap portion 42, the radial ultrasound probe is able to produce a 360° image (Panzenbeck ¶0041)];
a scope comprising a single working channel [a bronchoscope system 10 includes a bronchoscope 12 with an insertion tube 14, a radial ultrasound system 16 and an access device 20 (Panzenbeck ¶0034, Fig. 1)]; and
a real-time sampling system including:
a handle [The radial ultrasound probe 22 and a medical device 30, such as a needle for sampling and/or medicant delivery, are received within the bronchoscope 12 via a handle component of the access device 20 (Panzenbeck ¶0034, Fig. 1), wherein any graspable portion of the bronchoscope 12, including at least the portion of the bronchoscope 12 where the access device 20 is coupled to, may define a handle based on the broadest reasonable interpretation of a “handle”];
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, the distal end further including one or more orientation pins adjacent the first lumen and positioned on a same half of the distal end as the exit port [an example system includes a flexible catheter portion (Panzenbeck ¶0004); FIGS. 2-8 show an example of a distal end of the access device 20. The access device 20 includes a catheter portion 40 and a cap portion 42 at a distal end of the catheter portion 40. The catheter portion 40 extends from a handle portion (not shown). The catheter portion 40 includes a radial ultrasound lumen 44, a second lumen 46, a third lumen 50 and a fourth lumen 50′… The radial ultrasound lumen 44 is sized to slidably receive a radial ultrasound probe (not shown). The second lumen 46 is sized to receive a medical device 48, such as a needle (Panzenbeck ¶0037, Fig. 3); The distal end of the second lumen 60 of the cap portion 42 includes a side port 70 and a ramp 68. The ramp 68 causes the medical device 48 to deflect and exit the cap portion 42 through the side port 70 (Panzenbeck ¶0040); As shown in FIGS. 3, 4, 7 and 8, the cap portion 42 includes a first lumen 54, a second lumen 60, a third lumen 62 and a fourth lumen 62′. A first orientation pin 80 and a second orientation pin 80′ each include a proximal end and a distal end. The proximal ends of the pins 80 and 80′ are at least partially received within the third and fourth lumens 50 and 50′ of the catheter portion 40 (Panzenbeck ¶0038, Figs. 4-5), wherein as depicted in Panzenbeck Fig. 5, the lumens 50, 50’ for the orientation pins 80, 80’ are depicted as being positioned adjacent to the first lumen (lumen 44) and on a same half of the cross-sectional face as lumen 46, which based on Fig. 3 terminates in an exit port (side port 70)].
However, Panzenbeck fails to explicitly disclose a guidewire system including: a guidewire; and a guidewire guide comprising a tubular structure attached to and protruding from an exterior surface of the distal end of the flexible catheter, the tubular structure defining a guidewire passage separate from any lumen within the flexible catheter, wherein the guidewire guide is configured to receive the guidewire.
Yamaguchi discloses a system comprising an imaging tubular structure [imaging core lumen 23 (Yamaguchi Fig. 1-2)], wherein the system further comprises a guidewire system including: a guidewire [guide wire 25 (Yamaguchi Fig. 1-2)]; and a guidewire guide comprising a tubular structure attached to and protruding from an exterior surface of the catheter [guide wire lumen 26 (Yamaguchi Fig. 1-2); The first guide wire lumen 27 is provided on the distal end side, in the direction of insertion of the ultrasound catheter 1 into an organism, and the second guide wire lumen 28 is provided on the proximal end side, namely on the side of the proximal end of the ultrasound catheter 1 (Yamaguchi ¶0045)], the guidewire guide tubular structure defining a guidewire passage separate from any lumen within the catheter [In a first method of producing the sheath distal end portion 21, first, as shown on the left side in FIG. 5, a monolayer tube 26a for constituting the guide wire lumen 26 and a monolayer tube 23a for constituting the imaging core lumen 23 are prepared. Then, as shown on the right side in FIG. 5, parts of the outer peripheries of the monolayer tube 26a and the monolayer tube 23a are adhered to each other, whereby the guide wire lumen 26 and the imaging core lumen 23 substantially parallel to each other can be obtained (Yamaguchi ¶0065, Fig. 5), wherein defining separate tubular structures for each of the guidewire guide (guidewire lumen 26) and the catheter (imaging core lumen 23) that are adhered together is considered to read on the tubular structure defining a guidewire passage being separate from any lumen within the catheter], wherein the guidewire guide is configured to slidably receive the guidewire [Therefore, the guide wire 25 can pass through the guide wire lumen 26 rectilinearly without bending (Yamaguchi ¶0045)]. Yamaguchi discloses that the guidewire guide [guide wire lumen 26] is employed to enable the guidewire [guide wire 25] to guide the imaging tubular structure to an intended location [The guide wire 25 is preliminarily inserted into the vicinity of a diseased part in an organism before the insertion of the ultrasound catheter 1 into the organism to be used for guiding the ultrasound catheter 1 to the diseased part. The ultrasound catheter 1 is guided to the diseased part while fitting the guide wire lumen 26 over the guide wire 25 (Yamaguchi ¶0046)].
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 Panzenbeck to employ a guidewire system including: a guidewire; and a guidewire guide comprising a tubular structure attached to and protruding from an exterior surface of the distal end of the flexible catheter, the tubular structure defining a guidewire passage separate from any lumen within the flexible catheter, wherein the guidewire guide is configured to slidably receive the guidewire, so as to facilitate guiding of the catheter to an intended location.
However, Panzenbeck in view of Yamaguchi fails to explicitly disclose wherein the guidewire guide is attached to and protrudes from an exterior surface of the distal end of the flexible catheter opposite the exit port and the one or more orientation pins, as well as 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 disposed at a position opposite an exit port for a medical tool, and wherein the guidewire guide is positioned relative to the exit port to bias a distal end of a multi-lumen catheter against a tissue sidewall when a guidewire is received therein via an anchoring mechanism disposed on a distal end of the guidewire, 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 Panzenbeck in view of Yamaguchi to employ wherein the guidewire guide is attached to and protrudes from an exterior surface of the distal end of the flexible catheter opposite the exit port and the one or more orientation pins, as well as 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, Panzenbeck in view of Yamaguchi and Kellerman teaches
The system of Claim 1, wherein:
the real-time sampling system further includes the medical tool [Panzenbeck ¶0037, Fig. 3]; and
the first lumen extends a length of the flexible catheter and is configured to slidably receive the ultrasound probe [Panzenbeck ¶0037, Fig. 3]; and
the second lumen extends a length of the flexible catheter and is configured to slidably receive the medical tool [Panzenbeck ¶0037, Fig. 3].
Regarding claim 3, Panzenbeck in view of Yamaguchi and Kellerman teaches
The system Claim 2, wherein the medical tool includes a sampling needle [Panzenbeck ¶0037, Fig. 3].
Regarding claim 4, Panzenbeck in view of Yamaguchi 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 [The lumens 44, 46, 50, 50′ are all accessible via a distal face of the catheter portion 40. The lumens 44, 46 extend to proximal ports (not shown) located at the handle portion, a port on a handle of the bronchoscope or other scope device, or at a position accessible by an operator (Panzenbeck ¶0037)]; and
a second port and a second lumen configured to slidably receive the medical tool [Panzenbeck ¶0037].
Regarding claim 5, Panzenbeck in view of Yamaguchi and Kellerman teaches
The system of Claim 1, wherein the imaging system further includes:
an image processor configured to:
receive image data from the ultrasound probe [The display device 18 is in wired or wireless signal communication with the bronchoscope 12 and/or the signal processor 24. The display device 18 presents images generated based on information received from the bronchoscope 12 and/or the signal processor 24 that receives image information from a radial ultrasound transducer at the distal end of the radial ultrasound probe 22 (Panzenbeck ¶0035, Fig. 1)]; and
generate images responsive to the received image data [Panzenbeck ¶0035, Fig. 1]; 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 [Panzenbeck ¶0035, Fig. 1].
Regarding claim 7, Panzenbeck in view of Yamaguchi and Kellerman teaches
The system of Claim 1, wherein:
the guidewire guide includes a first longitudinal axis; and
a portion of the flexible catheter adjacent to an attachment point with the guidewire guide includes a second longitudinal axis,
the first longitudinal axis and the second longitudinal axis are parallel [See § 103 modification of claim 1 above; Yamaguchi Fig. 1-2, 5].
Regarding claim 8, Panzenbeck in view of Yamaguchi and Kellerman teaches
The system of Claim 1, 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 [See § 103 modification of claim 1 above; Kellerman Col 9:7-14, Figure 21].
Regarding claim 9, Panzenbeck in view of Yamaguchi 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 1 above; Kellerman Col 9:7-14, Figure 21, wherein as depicted in Fig. 21 of Kellerman, the guide wire may be considered to be coupled offset to the anchor mechanism (angioplasty balloon 45)].
Regarding claim 10, Panzenbeck in view of Yamaguchi 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 [When a radial ultrasound probe is positioned within the cap portion 42, the radial ultrasound probe is able to produce a 360° image. The 360° image includes reflections of the orientation pins 80, 80′. Because the orientation pins 80, 80′ are located on the same half of the first lumen 54, then any medical device passed through the second lumen 60 and out the side port 70 will interact with tissue visually located on the 360° image between the shortest arced distance between the reflections of the orientation pins 80, 80′. This is show by the example image of FIG. 9 (Panzenbeck ¶0041, Fig. 9), wherein the cap portion 42 enabling ultrasound imaging therethrough is considered to read on a portion of the distal end of the flexible catheter distal of the exit port being ultrasonically transmissible].
Regarding claim 11, Panzenbeck teaches
An apparatus comprising:
a handle [The radial ultrasound probe 22 and a medical device 30, such as a needle for sampling and/or medicant delivery, are received within the bronchoscope 12 via a handle component of the access device 20 (Panzenbeck ¶0034, Fig. 1)];
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, the distal end further including one or more orientation pins adjacent the first lumen and positioned on a same half of the distal end as the exit port [an example system includes a flexible catheter portion (Panzenbeck ¶0004); FIGS. 2-8 show an example of a distal end of the access device 20. The access device 20 includes a catheter portion 40 and a cap portion 42 at a distal end of the catheter portion 40. The catheter portion 40 extends from a handle portion (not shown). The catheter portion 40 includes a radial ultrasound lumen 44, a second lumen 46, a third lumen 50 and a fourth lumen 50′… The radial ultrasound lumen 44 is sized to slidably receive a radial ultrasound probe (not shown). The second lumen 46 is sized to receive a medical device 48, such as a needle (Panzenbeck ¶0037, Fig. 3); The distal end of the second lumen 60 of the cap portion 42 includes a side port 70 and a ramp 68. The ramp 68 causes the medical device 48 to deflect and exit the cap portion 42 through the side port 70 (Panzenbeck ¶0040); As shown in FIGS. 3, 4, 7 and 8, the cap portion 42 includes a first lumen 54, a second lumen 60, a third lumen 62 and a fourth lumen 62′. A first orientation pin 80 and a second orientation pin 80′ each include a proximal end and a distal end. The proximal ends of the pins 80 and 80′ are at least partially received within the third and fourth lumens 50 and 50′ of the catheter portion 40 (Panzenbeck ¶0038, Figs. 4-5), wherein as depicted in Panzenbeck Fig. 5, the lumens 50, 50’ for the orientation pins 80, 80’ are depicted as being positioned adjacent to the first lumen (lumen 44) and on a same half of the cross-sectional face as lumen 46, which based on Fig. 3 terminates in an exit port (side port 70)].
However, Panzenbeck fails to explicitly disclose a guidewire guide comprising a tubular structure attached to and protruding from affixed to an exterior surface of the distal end of the flexible catheter, the tubular structure defining a guidewire passage separate from any lumen within the flexible catheter.
Yamaguchi discloses a system comprising an imaging tubular structure [imaging core lumen 23 (Yamaguchi Fig. 1-2)], wherein the system further comprises a guidewire system including: a guidewire [guide wire 25 (Yamaguchi Fig. 1-2)]; and a guidewire guide comprising a tubular structure attached to and protruding from an exterior surface of the catheter [guide wire lumen 26 (Yamaguchi Fig. 1-2); The first guide wire lumen 27 is provided on the distal end side, in the direction of insertion of the ultrasound catheter 1 into an organism, and the second guide wire lumen 28 is provided on the proximal end side, namely on the side of the proximal end of the ultrasound catheter 1 (Yamaguchi ¶0045)], the guidewire guide tubular structure defining a guidewire passage separate from any lumen within the catheter [In a first method of producing the sheath distal end portion 21, first, as shown on the left side in FIG. 5, a monolayer tube 26a for constituting the guide wire lumen 26 and a monolayer tube 23a for constituting the imaging core lumen 23 are prepared. Then, as shown on the right side in FIG. 5, parts of the outer peripheries of the monolayer tube 26a and the monolayer tube 23a are adhered to each other, whereby the guide wire lumen 26 and the imaging core lumen 23 substantially parallel to each other can be obtained (Yamaguchi ¶0065, Fig. 5), wherein defining separate tubular structures for each of the guidewire guide (guidewire lumen 26) and the catheter (imaging core lumen 23) that are adhered together is considered to read on the tubular structure defining a guidewire passage being separate from any lumen within the catheter], wherein the guidewire guide is configured to slidably receive the guidewire [Therefore, the guide wire 25 can pass through the guide wire lumen 26 rectilinearly without bending (Yamaguchi ¶0045)]. Yamaguchi discloses that the guidewire guide [guide wire lumen 26] is employed to enable the guidewire [guide wire 25] to guide the imaging tubular structure to an intended location [The guide wire 25 is preliminarily inserted into the vicinity of a diseased part in an organism before the insertion of the ultrasound catheter 1 into the organism to be used for guiding the ultrasound catheter 1 to the diseased part. The ultrasound catheter 1 is guided to the diseased part while fitting the guide wire lumen 26 over the guide wire 25 (Yamaguchi ¶0046)].
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 Panzenbeck to employ a guidewire guide comprising a tubular structure attached to and protruding from affixed to an exterior surface of the distal end of the flexible catheter, the tubular structure defining a guidewire passage separate from any lumen within the flexible catheter, so as to facilitate guiding of the catheter to an intended location.
However, Panzenbeck in view of Yamaguchi fails to explicitly disclose wherein the guidewire guide is attached to and protrudes from an exterior surface of the distal end of the flexible catheter opposite the exit port and the one or more orientation pins, 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 disposed at a position opposite an exit port for a medical tool, and wherein the guidewire guide is positioned relative to the exit port to bias a distal end of a multi-lumen catheter against a tissue sidewall when a guidewire is received therein via an anchoring mechanism disposed on a distal end of the guidewire, 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 Panzenbeck in view of Yamaguchi to employ wherein the guidewire guide is attached to and protrudes from an exterior surface of the distal end of the flexible catheter opposite the exit port and the one or more orientation pins, 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, Panzenbeck in view of Yamaguchi 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 [Panzenbeck ¶0037, Fig. 3]; and
the second lumen extends a length of the flexible catheter and is configured to slidably receive the medical tool [Panzenbeck ¶0037, Fig. 3].
Regarding claim 13, Panzenbeck in view of Yamaguchi 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 [The lumens 44, 46, 50, 50′ are all accessible via a distal face of the catheter portion 40. The lumens 44, 46 extend to proximal ports (not shown) located at the handle portion, a port on a handle of the bronchoscope or other scope device, or at a position accessible by an operator (Panzenbeck ¶0037)]; and
a second port and a second lumen configured to receive the medical tool [Panzenbeck ¶0037].
Regarding claim 14, Panzenbeck in view of Yamaguchi and Kellerman teaches
The apparatus Claim 13, wherein the second lumen and the second port are configured to slidably receive a sampling needle [Panzenbeck ¶0037, Fig. 3].
Regarding claim 15, Panzenbeck in view of Yamaguchi and Kellerman teaches
The apparatus of Claim 13, wherein the first lumen and the first port are configured to slidably receive an ultrasound probe [Panzenbeck ¶0037, Fig. 3].
Regarding claim 16, Panzenbeck in view of Yamaguchi and Kellerman teaches
The apparatus of Claim 11, wherein:
the guidewire guide includes a first longitudinal axis;
a portion of the flexible catheter adjacent to an attachment point with the guidewire guide includes a second longitudinal axis, and
the first longitudinal axis and the second longitudinal axis are parallel [See § 103 modification of claim 1 above; Yamaguchi Fig. 1-2, 5].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Panzenbeck in view of Yamaguchi and Kellermann, as applied to claim 1 above, in further view of Stigall (US-20160302762-A1, previously presented).
Regarding claim 6, Panzenbeck in view of Yamaguchi 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 [handle component of the access device 20 (Panzenbeck ¶0034)]
an insertion tube couplable to the scope handle, the insertion tube including a lumen [Panzenbeck ¶0034, Fig. 1].
However, Panzenbeck 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 Panzenbeck in view of Yamaguchi 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 to a known device (method, or product) ready for improvement to yield predictable results [a handle of a scope receiving a 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. 8, filed 14 July 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The objections for reference character(s) not mentioned in the description have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 8, with respect to the previously presented claim objections have been fully considered but they are not entirely persuasive.
The Examiner notes that not all of the previously presented objections to claims 1 and 5 have been overcome. See above for maintained rejections.
Applicant’s arguments, see Applicant’s Remarks p. 8-11, with respect to the rejection(s) of claim(s) 1, 11, and those dependent therefrom under § 103 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 Panzenbeck (US-20190261946-A1) in view of Yamaguchi (US-20050101870-A1) and Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented).
The Applicant asserts that the previously applied interpretation of Mihara to read on the guidewire guide “attached to” the catheter is now unreasonable in view of the amended claim language referring to a guidewire guide that is a discrete “tubular structure attached to and protruding from an exterior surface” of the catheter and that defines “a guidewire passage separate from any lumen within the flexible catheter”, wherein the Applicant notes that the internal passage formed within the catheter wall, such as lumen 27 of Mihara [Mihara ¶¶0025, 0032, 0034, 0042], is neither a structure protruding from an exterior surface” nor a passage “separate from any lumen within the flexible catheter”. However, the Examiner notes Applicant’s arguments with respect to claim(s) 1 and 11 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 Panzenbeck (US-20190261946-A1) in view of Yamaguchi (US-20050101870-A1) and Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented) is presently applied in the § 103 rejections of claim 1 and 11, wherein Yamaguchi is considered to disclose a guidewire guide that is a discrete “tubular structure attached to and protruding from an exterior surface” of the catheter and that defines “a guidewire passage separate from any lumen within the flexible catheter” [Yamaguchi ¶0065, Fig. 5].
The Applicant further asserts that amended claim 1 [and claim 11 due to similar language] recites “one or more orientation pins adjacent the first lumen and positioned on a same half of the distal end as the exit port” with the guidewire guide disposed “opposite the exit port and the one or more orientation pins”, wherein the Applicant notes that none of Sung, Mihara, Kellerman, or Stigall teaches or suggests orientation pins as claimed. However, the Examiner notes Applicant’s arguments with respect to claim(s) 1 and 11 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 Panzenbeck (US-20190261946-A1) in view of Yamaguchi (US-20050101870-A1) and Kellerman (US-12121235-B1, effective filing date 15 December 2020, previously presented) is presently applied in the § 103 rejections of claim 1 and 11, wherein Panzenbeck is considered to disclose “one or more orientation pins adjacent the first lumen and positioned on a same half of the distal end as the exit port” [Panzenbeck ¶0038, Figs. 4-5], wherein based on the disclosure of Kellerman [Kellerman Col 9:7-14, Figure 21], Panzenbeck in view of Yamaguchi and Kellerman is considered to render obvious wherein the guidewire guide is disposed “opposite the exit port and the one or more orientation pins”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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, Charles Marmor II can be reached at (571) 272-4730. 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.
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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