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 .
This Office Action is in response to the amendments dated July 14, 2026.
Claims 1-11 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over Claim 10 of parent U.S. Patent No. 12,089,815 in view of Coyle (US PGPUB 2006/0064058 – “Coyle”). As shown in the chart below, Claim 10 of U.S. Patent 12,089,815 claims all features of Claim 1 of the current application 18/827,243, except for the feature of “a coil wound around a distal region of the catheter, the coil terminating at the distal end of the catheter and configured to prevent contact of the distal end of the catheter with patient tissue”:
Current Application 18/827,243
Parent US Patent 12,089,815
Claim 1.
Claim 10.
A catheter insertion system, comprising:
A medical system comprising:
a catheter assembly comprising:
a medical device comprising:
a catheter including a lumen extending between a proximal end and a distal end of the catheter;
an elongate probe configured for insertion into a patient body, the elongate probe including a lumen extending along the elongate probe between a proximal end and a distal end;
an optical fiber encapsulated in concentric tubing of a mesh construction with intersecting elements, wherein spacing between the intersecting elements defines a flexibility of the optical fiber; and
an optical fiber disposed within the lumen, wherein the optical fiber is encapsulated in concentric tubing that includes a mesh construction, in which a spacing between intersecting elements of the mesh construction is selected based on a degree of rigidity/flexibility desired for the medical device; and
an atraumatic tip at the distal end, the atraumatic tip including a distal tip section that has a greater flexibility in bending than a main probe section, the main probe section extending proximally away from the distal tip section, wherein the distal tip section is formed into a loop to define the atraumatic tip such that a distal end of the distal tip section is disposed adjacent the elongate probe proximal the loop; and
a coil wound around a distal region of the catheter, the coil terminating at the distal end of the catheter and configured to prevent contact of the distal end of the catheter with patient tissue; and
a console operatively coupled with the catheter assembly at the proximal end of the catheter, the console including a light source, an optical receiver, one or more processors, and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations that include at least one of projecting light away from the distal end of the elongate probe or determining a physical state of the elongate probe within the patient body.
a console operatively coupled with the medical device at the proximal end, the console including a light source, an optical receiver, one or more processors, and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations that include at least one of projecting light away from the distal end of the elongate probe or determining a physical state of the elongate probe within the patient body.
Coyle teaches a coil (Coyle FIG. 4, expandable distal portion 140 of expansion wire 135) wound around a distal region of the catheter (Coyle FIG. 4, catheter shaft 105), the coil terminating at the distal end of the catheter and configured to prevent contact of the distal end of the catheter with patient tissue (Coyle FIG. 4, sealing member 110; Coyle paragraph [0027], “Sealing member 110 is mounted adjacent the distal end of catheter shaft 105 and is radially expandable to form sealing engagement with the artery or vessel wall.” Examiner interprets Coyle’s sealing member 110 as being against the patient’s artery and away from the outer sheath of the catheter shaft 105, such that contact between the distal end of the outer sheath of the catheter shaft 105 and the patient artery/tissue is prevented.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Coyle’s expandable distal portion 140 with the invention described in Claim 10 of parent US Patent 12,089,815. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a catheter insertion system having an expandable distal end that selectively contacts the patient without the distal end the catheter shaft contacting the patient’s tissue (see Coyle FIG. 14).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-3, 5, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth et al. (US Patent 7,532,920 - “Ainsworth”) in view of Kinoshita et al. (US PGPUB 2012/0289779 – “Kinoshita”) and Coyle (US PGPUB 2006/0064058 – “Coyle”).
Regarding Claim 1, Ainsworth discloses:
A catheter insertion system (Ainsworth FIG. 12, guidewire-based treatment system 100 coupled to data processing system 105), comprising:
a catheter assembly (Ainsworth FIG. 12, guidewire-based treatment system 100) comprising:
a catheter (Ainsworth FIG. 1, apparatus 1) including a lumen (Ainsworth FIG. 1, lumen 23 extending through apparatus 1) extending between a proximal end and a distal end of the catheter;
an optical fiber (Ainsworth FIG. 12, optical fiber 30 within guidewire-based treatment system 100 / apparatus 1); and
a console (Ainsworth FIG. 12, data processing system 105), operatively coupled (Ainsworth FIG. 12, connector 104) with the catheter assembly at the proximal end of the catheter, the console including a light source (Ainsworth FIG. 12, laser 106), an optical receiver (Ainsworth FIG. 12, optical fiber 31), one or more processors, and a non-transitory computer-readable medium having stored thereon logic (Ainsworth FIG. 12, computer 112) that, when executed by the one or more processors, causes operations that include at least one of projecting light away from the distal end of the elongate probe (Ainsworth col. 10 lines 44-48, “a data processing system is generally operated to transmit (or send) a plurality of light radiation signals via the optical fiber to the specified location in the vasculature or determining a physical state of the elongate probe within the patient body”).
Ainsworth does not explicitly disclose an optical fiber encapsulated in concentric tubing of a mesh construction with intersecting elements, wherein spacing between the intersecting elements defines a flexibility of the optical fiber.
Kinoshita an optical fiber (Kinoshita FIG. 2, light guide (LG) 13 within insertion portion 31 of endoscope 1C) encapsulated in concentric tubing of a mesh construction (Kinoshita FIG. 8, endoscope 1C having a mesh layer 17) with intersecting elements (Kinoshita paragraph [0086], “a net-like tube (mesh 17)), wherein spacing between the intersecting elements defines a flexibility of the optical fiber (Kinoshita paragraph [0080], “insertion portion 31 of the endoscope 1C includes…a mesh 17…and an inside of the insertion portion 31 is a hollow to which, e.g., the LG 13 is inserted.” Examiner interprets the flexibility of the LG 13 to be defined by the flexibility of the insertion portion 31 (including the mesh layer 17) within which it is inserted.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kinoshita’s flexible tubing with the catheter insertion system disclosed by Ainsworth. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an insertion portion that accommodates the flexibility of the optical fiber itself (see Kinoshita paragraph [0030]).
Ainsworth in view of Kinoshita does not explicitly teach a coil wound around a distal region of the catheter, the coil terminating at the distal end of the catheter and configured to prevent contact of the distal end of the catheter with patient tissue.
Coyle teaches a coil (Coyle FIG. 4, expandable distal portion 140 of expansion wire 135) wound around a distal region of the catheter (Coyle FIG. 4, catheter shaft 105), the coil terminating at the distal end of the catheter and configured to prevent contact of the distal end of the catheter with patient tissue (Coyle FIG. 4, sealing member 110; Coyle paragraph [0027], “Sealing member 110 is mounted adjacent the distal end of catheter shaft 105 and is radially expandable to form sealing engagement with the artery or vessel wall.” Examiner interprets Coyle’s sealing member 110 as being against the patient’s artery and away from the outer sheath of the catheter shaft 105, such that contact between the distal end of the outer sheath of the catheter shaft 105 and the patient artery/tissue is prevented.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Coyle’s expandable distal portion 140 with the catheter taught by Ainsworth in the catheter insertion system taught by Ainsworth in view of Kinoshita. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a catheter insertion system having an expandable distal end that selectively contacts the patient without the distal end the catheter shaft contacting the patient’s tissue (see Coyle FIG. 14).
Regarding Claim 2, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Ainsworth further discloses wherein a distal end of the optical fiber is attached to the distal end of the catheter (Ainsworth FIG. 1, showing optical fiber 30 connected to tip 17 of apparatus 1).
Regarding Claim 3, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Coyle further teaches the coil has a round cross-sectional shape (Coyle FIG. 14, showing expandable distal portion 140 in contact with a circular artery 310; see also Coyle paragraph [0029], “Expansion wire 135 may have a cross-sectional shape, such as circular”).
Regarding Claim 5, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Coyle further teaches wherein:
the catheter (Coyle FIG. 4, catheter shaft 105) includes an actuator (Coyle FIG. 4, actuation assembly 115) adjacent the proximal end,
the actuator is operatively coupled with the distal region (Coyle FIG. 4, showing actuation assembly 115 coupled to expandable distal portion 140 by expansion wire lumen 125), and
the actuator is configured to laterally deflect the distal region between a first shape (Coyle FIG. 11, showing collapsed distal portion 140) and a second shape (Coyle FIG. 13, showing expanded distal portion 140) different from the first shape.
Regarding Claim 10, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Ainsworth further discloses wherein the optical fiber comprises one or more illuminating core fibers, each of the one or more illuminating core fibers configured to receive illuminating light from the console at the proximal end and project the illuminating light away from the distal end (Ainsworth FIG. 12, optical fiber 30 within guidewire-based treatment system 100 receiving illuminating light from laser 106 within system 105 via connecting optical fiber 31).
Regarding Claim 11, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 10, as described above.
Ainsworth further discloses wherein the optical fiber further comprises one or more imaging core fibers (Ainsworth col. 3 lines 42-44, “optical fiber 30 filament is made of at least two concentrically arranged elements: a central core and a cladding surrounding the core”), each of the one or more imaging core fibers configured to receive imaging light at the distal end (Ainsworth col. 3 lines 57-61, “Light radiation signals reflected back by various structures or elements, e.g. blood particles, present in the vasculature are then transmitted via the optical fiber back to a detector in a laser/data processing system.”) and propagate the imaging light along the optical fiber from the distal end to the console (Ainsworth col. 3 lines 53-54, “the core of the optical fiber 30 transmits light radiation signals from a light source”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth et al. (US Patent 7,532,920 - “Ainsworth”) in view of Kinoshita et al. (US PGPUB 2012/0289779 – “Kinoshita”), Coyle (US PGPUB 2006/0064058 – “Coyle”), and Engelson (US Patent 5,599,492 – “Engelson”).
Regarding Claim 4, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Ainsworth further discloses:
the distal region of the catheter comprises a varying flexibility along a length of the distal region (Ainsworth FIG. 1, flexible coil 15 and distal cord section 12 are made from different materials; Ainsworth col. 6 lines 26-31, “the distal core section 12 is preferably made of a pseudoelastic alloy material, such as Nickel-Titanium (Ni--Ti) alloy (e.g., Nitinol)”…In one embodiment, the Ni--Ti alloy material consisting essentially of about 30 to about 52% titanium and the balance nickel and up to 10% of one or more other alloying elements”; Ainsworth col. 7 lines 46-48; “Coil 15 may be composed of a 90% Pt-10% Ni wire with a diameter of about 0.0025 in.”; Examiner interprets these different materials as having different physical properties, including different levels of flexibility), and
the varying flexibility comprises a first flexibility adjacent a proximal end of the distal region (Ainsworth FIG. 1, flexibility of proximal cord section 12) and a second flexibility adjacent a distal end of the distal region (Ainsworth FIG. 1, flexibility of distal flexible coil 15).
Ainsworth in view of Kinoshita and Coyle does not explicitly teach that the second flexibility is greater than the first flexibility.
Engelson teaches the second flexibility is greater than the first flexibility by disclosing in Engelson FIG. 6 a catheter guidewire 74 accommodated in a sleeve 76 made of proximal sleeve section 78 and distal sleeve section 80. The sleeve sections may be formed of high-density polyethylene and low-density polyethylene, respectively, such that the flexibility increases towards the distal end of the sleeve (see Engelson col. 6 lines 43-49, “Another embodiment of the invention is shown at 74 in FIG. 6. Here the guidewire sleeve, indicated at 76, is composed of a proximal sleeve section 78 formed of a polymer having a selected flexibility, and a distal sleeve section 80 formed of a more flexible polymer material. By way of example, the proximal and distal sections may be formed of high- and low-density polyethylene, respectively.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distal tip section taught by Ainsworth in view of Kinoshita and Coyle with the material flexibility taught by Engelson for the benefit of selectively varying flexibility and column strength properties along the length of the distal region of the guidewire (see Engelson col. 6 lines 59-63, “This embodiment further illustrates the ability to selectively vary flexibility and column strength properties along the length of the distal region of the guidewire by varying (a) flexibility of the material forming the sleeve, (b) thickness of the sleeve, and (c) depth and width of the grooves formed in the sleeve.”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth et al. (US Patent 7,532,920 - “Ainsworth”) in view of Kinoshita et al. (US PGPUB 2012/0289779 – “Kinoshita”), Coyle (US PGPUB 2006/0064058 – “Coyle”), and Landey et al. (US PGPUB 2018/0289243 – “Landey”).
Regarding Claim 6, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Coyle further teaches the second transition shape (Coyle FIG. 13, showing expanded distal portion 140) is different from the first transition shape (Coyle FIG. 11, showing collapsed distal portion 140).
However, Ainsworth in view of Kinoshita and Coyle does not explicitly teach wherein:
the distal region of the catheter includes a shape memory material having a shape transition temperature between 20 ℃ and 37 ℃, and
the distal region of the catheter defines a first transition shape below the shape transition temperature and a second transition shape above the shape transition temperature.
Analogous art Landey (biopsy needles), teaches the distal region (Landey FIG. 1A, needle 120) of the catheter (Landey FIG. 1A, needle assembly 100) includes a shape memory material having a shape transition temperature between 20 ℃ and 37 ℃, and the distal region of the catheter defines a first transition shape below the shape transition temperature and a second transition shape above the shape transition temperature (Landey paragraph [0055], needle 120 can be formed from Nitinol…Nitinol, the superelastic material of the needle 120 can assume an interpenetrating simple cubic structure (referred to as the austenite phase) and can be set in this phase in the straight, tubular shape shown in FIG. 1A. When Nitinol in the austenite phase is subject to exterior forces in a temperature range from about −20° C. to +60° C., the Nitinol can undergo a phase transformation to the martensite phase as well as changing shape “).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Landey’s Nitinol when constructing Ainsworth’s apparatus 1 in the catheter insertion system taught by Ainsworth in view of Kinoshita and Coyle. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of catheter that can change flexibility using temperature (see Landey paragraph [0056]).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth et al. (US Patent 7,532,920 - “Ainsworth”) in view of Kinoshita et al. (US PGPUB 2012/0289779 – “Kinoshita”), Coyle (US PGPUB 2006/0064058 – “Coyle”), and Messerly (US PGPUB 2018/0289927 – “Messerly”).
Regarding Claim 7, Ainsworth in view of Kinoshita and Coyle teaches the features of Claim 1, as described above.
Ainsworth further discloses:
the optical fiber includes one or more core fibers extending along a longitudinal length of the optical fiber (Ainsworth FIG. 1, core of optical fiber 30).
However, Ainsworth in view of Kinoshita and Coyle does not explicitly teach:
each of the one or more core fibers including a plurality of sensors distributed along the longitudinal length and
each sensor of the plurality of sensors being configured to
(i) reflect a light signal of a different spectral width based on received incident light at proximal end, and
(ii) change a characteristic of the reflected light signal based on condition experienced by the optical fiber.
Messerly is analogous art in the field of optical systems that teaches:
each of the one or more core fibers including a plurality of sensors distributed along the longitudinal length; and each sensor of the plurality of sensors being configured to (i) reflect a light signal of a different spectral width based on received incident light at proximal end, and (ii) change a characteristic of the reflected light signal based on condition experienced by the optical fiber (Messerly FIGs. 1 and 4; Messerly teaches a system catheter 72 including an optical fiber 140 within a lumen 216. The optical fiber 140 has strain sensors 204 positioned longitudinally along the length of the fiber and which return optical signals. The sensors 204 are provided as fiber Bragg grating- type sensors for detecting strain on the optical fiber at the sensor location to enable shape and movement of the corresponding optical fiber and catheter tube 150 of the catheter 72, thus causing the characteristic of the reflected light signal to change based on the detected bending of the optical fiber 140; see Messerly paragraphs [0047] – [0048]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Messerly’s strain gauges with the Ainsworth’s optical fiber 30 in the catheter insertion system taught by Ainsworth in view of Kinoshita and Coyle. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of enabling the advancement of a catheter distal tip toward its intended destination (see Messerly paragraph [0048]).
Regarding Claim 8, Ainsworth in view of Kinoshita, Coyle, and Messerly teaches the features of Claim 7, as described above.
Ainsworth further discloses:
wherein the operations include determining the physical state, comprising:
providing an incident light signal to the optical fiber (Ainsworth: the data processing system transmits light radiation signals via the optical fiber to a specific location in the vasculature; see Ainsworth col 10 lines 44-48);
receiving reflected light signals of different spectral widths of the incident light by one or more of the plurality of sensors (Ainsworth: reflected signals transmitted by optical fiber 30 further transmits reflected signals to a detector for processing via the optical fiber 31); and processing the reflected light signals associated with the one or more of core fibers to determine the physical state (Ainsworth: reflected signals are further transmitted for processing by the optical fiber 31 as shown in Ainsworth FIG. 12; see also Ainsworth col 3 lines 53-61, “the core of the optical fiber 30 transmits light radiation signals from a light source, for example a laser, to the distal tip of the optical fiber and then into the vasculature of a patient. The distal tip of the optical fiber core is generally exposed to, or in optical contact with the vasculature of a patient. Light radiation signals reflected back by various structures or elements, e.g. blood particles, present in the vasculature are then transmitted via the optical fiber back to a detector in a laser/data processing system.”; and Ainsworth col 9 lines 62-64, “The laser source is typically chosen based on the light wavelengths and light source power that facilitate the detection of the particular physical characteristic or variable.”).
Regarding Claim 9, Ainsworth in view of Kinoshita, Coyle, and Messerly teaches the features of Claim 8, as described above.
Messerly further teaches wherein the physical state includes one or more of a three-dimensional (3D) shape of the elongate probe (Messerly FIG. 4, strain gauges 204 that measure the 3D shape of catheter tube 150), a temperature experienced by the elongate probe, a pressure exerted on the elongate probe, and a fluid flow adjacent the elongate probe.
Response to Arguments
Applicant’s arguments, see page 5, filed July 14, 2026, with respect to the rejection of Claim 6 under 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the present amendments. The rejection of Claim 6 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments, see pages 5-6, filed July 14, 2026, with respect to the rejection of Claim 1 under 35 U.S.C. 103, and Claims 2-11 that depend on Claim 1, have been fully considered but they are not persuasive. Specifically, Applicant asserts that Coyle (US PGPUB 2006/0064058 – “Coyle”) fails to teach a coil that terminate at the distal end of the catheter. First, Examiner notes that Applicant’s FIG. 5C shows the coil 530 wrapping around the distal tip section 123, which includes all of the portion of the elongate probe 120 around which the coil is wrapped. As such, a broadest reasonable interpretation of “the coil terminating at the distal end of the catheter” is for the coil to be wrapped around the distal portion of the catheter shaft (as shown by coil 140 surrounding the distal end of catheter shaft 105). This interpretation is further supported by Applicant’s FIG. 5C, which shows the coil 530 terminating at the distal most end 522A of the distal tip section 123. Claim 1 does not claim the coil terminating at the distal most end of the catheter, but rather claims the coil terminating at the distal end of the catheter, which is identified by Applicant in paragraph [0091] as “distal tip section 123”. Furthermore, wire distal end 141, which is an integral component of expandable distal portion 140 of expansion wire 135, terminates at the end of catheter shaft 105 in Coyle FIG. 4.
Applicant's arguments, see pages 6-7, filed July 14, 2026, with respect to the double patenting rejection of Claim 1 on the ground of obviousness-type nonstatutory double patenting over Claim 10 of US Patent No. 12,089,815 in view of Coyle (US PGPUB 2006/0064058 – “Coyle”) have been fully considered but they are not persuasive. Applicant’s position appears to be that since Coyle does not teach the cited features in Claim 1, then Coyle cannot be used in an obviousness-type nonstatutory double patenting rejection. For reasons stated above, Examiner believes that Coyle teaches the feature of a coil wound around a distal region of the catheter, the coil terminating at the distal end of the catheter and configured to prevent contact of the distal end of the catheter with patient tissue, and thus the double patenting rejection of Claim 1 is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/02/26
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