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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/05/2025 and 05/27/2025 has been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-15 in the reply filed on 03/20/2026 is acknowledged. The traversal is on the ground(s) that Groups I, II, and III inventions are sufficiently related to allow for examination of these inventions together. This is not found persuasive. Although there may be some overlap of the search for Groups I, II, and III, there is nothing to indicate that the search would be coextensive. Furthermore, the office action dated 03/11/2026 explains why Groups I, II, and III do not overlap the scope (See MPEP § 806.05 and CTRS dated 03/11/2026). Therefore, the extra search and/or examination burden for addressing Groups I, II, and III poses a serious burden to the examiner which makes the restriction requirement proper.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over House et al. (US 20120089022 A1, published April 12, 2012) in view of Rankin et al. (US 20130172742 A1, published July 4, 2013), hereinafter referred to as House and Rankin, respectively.
Regarding claim 1, House teaches a medical device (Fig. 2 and 4A) comprising:
a central lumen extending from a proximal end to a distal end of the medical device, and configured to receive a probe (Fig. 2 and 4A; see para. 0035 – “The acoustic transducer lumen 400 [of interior lumen 406, central lumen] also provides a conduit for the electrical data wire that transmits the signals produced by the transducer 206 to the proximal end of the delivery catheter 202.”),
wherein a distal portion of the probe includes a transducer configured to perform ultrasound imaging, and wherein the transducer is positioned at a fixed location relative to the medical device in a configuration in which the probe is received by the central lumen (Fig. 2, ultrasonic transducer 206 at distal end 201; see para. 0031 – “…the ultrasonic transducer 206 provides forward-looking imaging of target tissue to determine the position of the medical device relative to the target tissue.”); and
a flushing lumen extending from the proximal end of the medical device to a distalmost opening of the flushing lumen (see para. 0037 – “The flush lumen 404, when provided, provides a conduit for the delivery of saline or other suitable fluid to the cavity 216 between the acoustic transducer 206 and the acoustic window 210. A user injects saline into the flush lumen 404 at the proximal end of the flush lumen.”),
wherein the flushing lumen is in fluid communication with a fluid source at the proximal end of the medical device (see para. 0037 – “A user injects saline into the flush lumen 404 at the proximal end of the flush lumen.”), and
wherein the distalmost opening is proximal of the fixed location such that a flow of fluid received from the fluid source and expelled by the flushing lumen via the distalmost opening at least partially radially surrounds the transducer (see para. 0037 – “Optionally, a flush lumen 404 is located within the delivery catheter 202. The flush lumen 404, when provided, provides a conduit for the delivery of saline or other suitable fluid to the cavity 216 between the acoustic transducer 206 and the acoustic window 210. A user injects saline into the flush lumen 404 at the proximal end of the flush lumen. The interior space 406 of the deliver catheter 202 that is not occupied by other lumens provides a return for the saline flush.”).
House teaches a flushing lumen, but does not explicitly teach where the flushing lumen is disposed radially outward of the central lumen.
Whereas, Rankin, in an analogous field of endeavor, teaches wherein the flushing lumen is disposed radially outward of the central lumen (Fig. 2; see para. 0048 – “In the embodiment of FIG. 2, the ablation electrode tip 28 has an open irrigated configuration including a number of irrigation ports 30 used to deliver cooling fluid to cool the tip 28 and the surrounding tissue.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a flushing lumen, as disclosed in House, by having the flushing lumen disposed radially outward of the central lumen, as disclosed in Rankin. One of ordinary skill in the art would have been motivated to make this modification in order to minimize interference of the irrigation fluid with the transmission of ultrasonic waves from the ultrasonic imaging sensors, as taught in Rankin (see para. 0053).
Furthermore, regarding claim 2, House further teaches wherein the flushing lumen is a first flushing lumen extending from the proximal end of the medical device to a first distalmost opening proximal from the fixed location (see para. 0037 – “Optionally, a flush lumen 404 [first flushing lumen] is located within the delivery catheter 202. The flush lumen 404, when provided, provides a conduit for the delivery of saline or other suitable fluid to the cavity 216 between the acoustic transducer 206 and the acoustic window 210. A user injects saline into the flush lumen 404 at the proximal end of the flush lumen.”), and the medical device further comprises:
a second flushing lumen extending from the proximal end of the medical device to a second distalmost opening of the second flushing lumen (see para. 0037 – “Optionally, a separate lumen [second flushing lumen] can be provided as a return for the flush.”), and
wherein the second flushing lumen is in fluid communication with the fluid source at the proximal end of the medical device, and the second distalmost opening is proximal from the fixed location (see para. 0037 – “Optionally, a separate lumen can be provided as a return for the flush. As the user continues to inject saline into the flush lumen 404, cavity 216 fills with saline and injection of saline is continued until saline fills the interior space 406 of the delivery conduit 204 such that saline exits the proximal end of the delivery catheter 202.”), and
Rankin further teaches a flushing lumen is disposed radially outward of the central lumen (Fig. 2; see para. 0048 – “In the embodiment of FIG. 2, the ablation electrode tip 28 has an open irrigated configuration including a number of irrigation ports 30 used to deliver cooling fluid to cool the tip 28 and the surrounding tissue.”).
Furthermore, regarding claim 3, House further teaches wherein the central lumen is in fluid communication with the fluid source at the proximal end of the medical device, and wherein the central lumen is further configured to provide a flow of fluid received from the fluid source to the distal end of the medical device through the central lumen (see para. 0037 – “Optionally, a separate lumen can be provided as a return for the flush. As the user continues to inject saline into the flush lumen 404, cavity 216 fills with saline and injection of saline is continued until saline fills the interior space 406 [central lumen] of the delivery conduit 204 such that saline exits the proximal end of the delivery catheter 202.”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over House in view of Rankin, as applied to claim 1 above, and in further view of Cragg et al. (US 20130211443 A1, published August 15, 2013), hereinafter referred to as Cragg.
Regarding claim 4, House in view of Rankin teaches all of the elements disclosed in claim 1 above.
House in view of Rankin teaches a medical device comprising a sheath, a central lumen, and a flushing lumen, but does not explicitly teach an outer sheath and inner sheath, where the central lumen is a lumen of the inner sheath, and the flushing lumen is between the inner sheath and the outer sheath.
Whereas, Cragg, in an analogous field of endeavor, teaches wherein the medical device (Fig. 17, delivery system 100) comprises:
an outer sheath (outer catheter 108 as outer sheath); and
an inner sheath that is positioned within and extends distally from the outer sheath (inner catheter 106 as inner sheath within outer catheter 108),
wherein the central lumen is a lumen of the inner sheath (inner catheter lumen 102 as central lumen of inner sheath), and
wherein the flushing lumen is between the inner sheath and the outer sheath (see para. 0068 – “…an outer lumen 104 for injection of a fluid such as saline which is used to disrupt blood flow at the aneurysm neck 92.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a sheath, a central lumen, and a flushing lumen, as disclosed in House in view of Rankin, by having an outer sheath and inner sheath, where the central lumen is a lumen of the inner sheath, and the flushing lumen is between the inner sheath and the outer sheath, as disclosed in Cragg. One of ordinary skill in the art would have been motivated to make this modification in order to create a low turbulence or “peaceful” fluid environment within the aneurysm which allows improved filling of the aneurysm with the embolic material, as taught in Cragg (see para. 0067).
Claims 5-15 are rejected under 35 U.S.C. 103 as being unpatentable over House in view of Rankin, as applied to claim 1 above, and in further view of Talbot et al. (US 20220096156 A1, published March 31, 2022), hereinafter referred to as Talbot.
Regarding claim 5, House in view of Rankin teaches all of the elements disclosed in claim 1 above, and
House further teaches wherein the medical device comprises: a multi-lumen catheter including a first portion of the central lumen and a first portion of the flushing lumen (Fig. 2 and 4A; see para. 0035 – “The acoustic transducer lumen 400 [of interior lumen 406, central lumen] also provides a conduit for the electrical data wire that transmits the signals produced by the transducer 206 to the proximal end of the delivery catheter 202.”; see para. 0037 – “The flush lumen 404, when provided, provides a conduit for the delivery of saline or other suitable fluid to the cavity 216 between the acoustic transducer 206 and the acoustic window 210. A user injects saline into the flush lumen 404 at the proximal end of the flush lumen.”).
House in view of Rankin teaches a multi-lumen catheter comprising a central lumen and a flushing lumen, but does not explicitly teach a cap coupled to the multi-lumen catheter.
Whereas, Talbot, in an analogous field of endeavor, teaches a cap coupled to the multi-lumen catheter, the cap including a second portion of the central lumen and a second portion of the flushing lumen to extend the flushing lumen to the distalmost opening (Fig. 3E-3F; see para. 0040 – “For example, embodiments many include an endcap 340 disposed on the distal end of the dual-lumen catheter 308. Further, the endcap 340 may align with each lumen in catheter 308…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a multi-lumen catheter comprising a central lumen and a flushing lumen, as disclosed in House in view of Rankin, by including a cap coupled to the multi-lumen catheter, as disclosed in Talbot. One of ordinary skill in the art would have been motivated to make this modification in order to improve the efficiency, accuracy, and/or reliability with which therapies, such as ablation, can be performed, as taught in Talbot (see para. 0040).
Furthermore, regarding claim 6, Talbot further teaches wherein the medical device further comprises: an articulation wire coupled to the cap, wherein the articulation wire is configured to articulate a distal portion of the medical device (see para. 0044 – “As illustrated in FIG. 3F, dual-lumen catheter 308 may include a tubular member 354 with two lumens, a layer of braid 360 [coupled to endcap 340], and a layer of reflow 361 over the braid 360…In several embodiments, the braid 360 [articulation wire] may provide torsional strength to the dual-lumen catheter. In several such embodiments, the torsional strength provided by the braid 360 may enable rotation of the handle to translate into rotation of the distal end.”).
Furthermore, regarding claim 7, Talbot further teaches wherein the multi-lumen catheter further includes an articulation lumen, wherein the articulation wire extends through the articulation lumen, and wherein a distal end of the articulation wire extends distal to a distalmost end of the articulation lumen (Fig. 3F; see para. 0044 – “In several embodiments, the braid 360 may provide torsional strength to the dual-lumen catheter. In several such embodiments, the torsional strength provided by the braid 360 may enable rotation of the handle to translate into rotation of the distal end.”); and
wherein the cap further includes an articulation cavity aligned with the articulation lumen, wherein the articulation cavity receives the distal end of the articulation wire, and wherein the distal end of the articulation wire is secured to the cap (see para. 0040 – “For example, embodiments many include an endcap 340 disposed on the distal end of the dual-lumen catheter 308. Further, the endcap 340 may align with each lumen in catheter 308...”; see para. 0044 – “As illustrated in FIG. 3F, dual-lumen catheter 308 may include a tubular member 354 with two lumens, a layer of braid 360 [proximal to endcap 340], and a layer of reflow 361 over the braid 360…In several embodiments, the braid 360 [articulation wire] may provide torsional strength to the dual-lumen catheter. In several such embodiments, the torsional strength provided by the braid 360 may enable rotation of the handle to translate into rotation of the distal end.”).
Furthermore, regarding claim 8, Talbot further teaches wherein at least a distal portion of the multi-lumen catheter and the cap form an articulation region, and wherein the distal portion of the multi-lumen catheter comprises a first material that is more flexible than a second material of which a proximal portion of the multi-lumen catheter is comprised (see para. 0044 – “As illustrated in FIG. 3F, dual-lumen catheter 308 may include a tubular member 354 with two lumens, a layer of braid 360 [proximal to endcap 340], and a layer of reflow 361 over the braid 360…In various embodiments, the braid 360 may be woven stainless steel or nitinol.”).
Furthermore, regarding claim 9, Talbot further teaches wherein the multi-lumen catheter and the cap coupled to the multi-lumen catheter is a first device (Fig. 3A; see para. 0040 – “For example, embodiments many include an endcap 340 disposed on the distal end of the dual-lumen catheter 308 [first device]. Further, the endcap 340 may align with each lumen in catheter 308...”), and
wherein the medical device further comprises a second device including: a single-lumen catheter; and the probe, wherein the probe is received within a lumen of the single-lumen catheter, wherein the single-lumen catheter is configured to be received by and extended through the central lumen of the first device, such that a distal portion of the single-lumen catheter including the transducer extends distally past the first device (Fig. 3A; see para. 0040 – “Further, the endcap 340 may align with each lumen in catheter 308 [first device], enabling therapeutic device 316-1 to exit side port 320 and ultrasound transducer 316-2 to utilize imaging window 322 and marker 344 [of second device, single lumen catheter].”).
Furthermore, regarding claim 10, Talbot further teaches wherein, in a configuration in which the transducer is active, the distal portion of the single-lumen catheter is positioned such that the distalmost opening of the flushing lumen of the first device is positioned at a predefined distance proximal to the transducer (Fig. 1; see para. 0031 – “The flush port [flush lumen] may facilitate fluid to be provided proximate the distal end 145 [where transducer 316-2 of Fig. 3A is located], such as via the lumen of tool 116-2.”).
Furthermore, regarding claim 11, Talbot further teaches wherein the multi-lumen catheter is coupled to a proximal end of the cap (Fig. 3A; see para. 0040 – “Further, the endcap 340 may align with each lumen in catheter 308…”), and
wherein the medical device further comprises: a single-lumen catheter coupled to and extending distally from a distal end of the cap to the distal end of the medical device, the single-lumen catheter including a third portion of the central lumen, wherein, when the probe is received by the central lumen, the fixed location at which the transducer is positioned is within the single-lumen catheter (Fig. 3A; see para. 0040 – “Further, the endcap 340 may align with each lumen in catheter 308, enabling therapeutic device 316-1 to exit side port 320 and ultrasound transducer 316-2 to utilize imaging window 322 and marker 344.”).
Furthermore, regarding claim 12, Talbot further teaches wherein the medical device comprises: a multi-lumen catheter including a first portion of the central lumen and a first portion of the flushing lumen; and an overmolded component attached distally to the multi-lumen catheter (see para. 0041 – “Referring to FIG. 3A, probe 302 may include endcap 340 coupled to dual-lumen catheter 308 (e.g., via overmolding and/or bonding by reflowing.”).
Furthermore, regarding claim 13, Talbot further teaches wherein the overmolded component comprises: a proximal portion including a second portion of the central lumen and a second portion of the flushing lumen to extend the flushing lumen to the distalmost opening; and a distal portion including a third portion of the central lumen (Fig. 3E-3F; see para. 0040 – “For example, embodiments many include an endcap 340 disposed on the distal end of the dual-lumen catheter 308. Further, the endcap 340 may align with each lumen in catheter 308…”).
Furthermore, regarding claim 14, Talbot further teaches wherein, when the probe is received by the central lumen, the fixed location at which the transducer is positioned is within the distal portion of the overmolded component (Fig. 3A; see para. 0040 – “For example, embodiments many include an endcap 340 disposed on the distal end of the dual-lumen catheter 308. Further, the endcap 340 may align with each lumen in catheter 308, enabling therapeutic device 316-1 to exit side port 320 and ultrasound transducer 316-2 to utilize imaging window 322 and marker 344.”).
Furthermore, regarding claim 15, Talbot further teaches an articulation wire integrated with the multi-lumen catheter and the proximal portion of the overmolded component, wherein the articulation wire is configured to articulate a distal portion of the medical device (see para. 0044 – “As illustrated in FIG. 3F, dual-lumen catheter 308 may include a tubular member 354 with two lumens, a layer of braid 360 [proximal to endcap 340, overmolded component], and a layer of reflow 361 over the braid 360…In several embodiments, the braid 360 [articulation wire] may provide torsional strength to the dual-lumen catheter. In several such embodiments, the torsional strength provided by the braid 360 may enable rotation of the handle to translate into rotation of the distal end.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Falwell et al. (US 20150157401 A1, published June 11, 2015) discloses the tip assembly includes a first and second fluid delivery lumens and. The first fluid delivery lumen is disposed within the central lumen of the catheter, while the second fluid delivery lumen is embedded within the core of the catheter.
Phan (US 20030078644 A1, published April 24, 2003) discloses the includes electrode cooling inlet and outlet lumens that are connected to one another by way of a connector lumen formed in the tip member apparatus.
Fenech et al. (US 20200146757 A1, published May 14, 2020) discloses a vision probe includes multiple fluid ports used for delivering drugs, e.g., for numbing, before vision probe is removed from catheter and replaced with a biopsy probe.
Dresher (US 20170238786 A1, published August 24, 2017) discloses irrigation lumens may be configured to deliver fluids, e.g., gas or liquids, from fluid source to tissue adjacent the distal region of endoscope, or configured to suction fluid from a work site back into fluid source.
Nierich (EP 2265182 B1, published May 7, 2014) discloses the catheter has a main lumen for filling the inflatable member with the ultrasonic transmission fluid and the stylet is arranged in the main lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
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