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 .
Election/Restrictions
Newly submitted claims 21-24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Invention I (claims 1-15 and 25) and Invention II (claims 21-24) are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design. Invention II recites a tube having a wall defining a central lumen, the wall defines a first flushing lumen and a second flushing lumen, wherein the first flushing lumen terminates at a first distal-facing distalmost opening, wherein the second flushing lumen terminates at a second distal-facing distalmost opening, and Invention I does not.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-24 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
Claims 21-25 are added, and claims 1-15 and 21-25 remain pending, with claims 21-24 withdrawn, in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 05/13/2026.
Response to Arguments
Applicant's arguments filed 08/13/2026 have been fully considered but they are not persuasive.
For claim 1, the applicant argues “House nowhere states that the "distalmost opening" of the flush lumen 404 is "proximal of the fixed location."” (see pg. 10, para. 1), and the examiner disagrees.
House teaches the distal end of the flush lumen is proximate to the transducer (fixed location) (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.”).
For claim 1, the applicant argues “the ports 30 of Rankin are not "lumens" that "extend from the proximal end of the medical device to a distalmost opening," as recited in claim 1” (see pg. 10, para. 2), and the examiner disagrees.
Rankin teaches a fluid lumen 29 (flushing lumen) that extends from the proximal to distal ends of the probe 12 (Fig. 1-2; see para. 0038 – “The probe body 20 includes an internal cooling fluid lumen 29 fluidly coupled to the fluid reservoir and pump 16, which supplies a cooling fluid, such as saline, through the probe body 20 to a number of irrigation ports 30 in the ablation electrode tip 28.”).
For claim 1, the applicant argues “Thus, Rankin further fails to disclose that "the flushing lumen is disposed radially outward of the central lumen," as recited in claim 1” (see pg. 10, para. 2), and the examiner disagrees.
Rankin teaches the ports 30 (distal end of flushing lumen, fluid lumen 29) are disposed radially outward of the central lumen (probe body 20) (Fig. 1-2; see para. 0038 – “The probe body 20 includes an internal cooling fluid lumen 29 fluidly coupled to the fluid reservoir and pump 16, which supplies a cooling fluid, such as saline, through the probe body 20 to a number of irrigation ports 30 in the ablation electrode tip 28.”).
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 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over House et al. (US 20120089022 A1, published April12, 2012) in view of Rankin et al. (US 20130172742A1, published July 4, 2013), hereinafter referred to as House and Rankin, respectively.
Regarding claim 1, House teaches a medical device (Fig. 2 and4A) 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 202that 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 centra 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, cavity216 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.").
Furthermore, regarding claim 25, Rankin further teaches wherein the distalmost opening faces distally and opens to an exterior of the medical device (Fig. 2, ports 30 (distalmost opening) facing distally and opens to exterior of medical device (ablation tip 28 of probe body 20)).
The motivation for claims 2 and 25 was shown previously in claim 1.
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 20130211443A1, publishedAugust15, 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 ofendeavor, 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 20220096156A1, 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 member354 with two lumens, a layer of braid 360 [coupled to endcap 340], and a layer of reflow 361 over the braid 360...IIn 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 catheter308. Further, the endcap 340 may align with each lumen in catheter308..."; 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 endcap340], 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 catheter308 (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 catheter308. 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 catheter308, 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 catheter308 may include a tubular member 354 with two lumens, a layer of braid 360 [proximal to endcap 340, overmolded component], and a layer of reflow361 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.").
The motivation for claims 6-15 was shown previously in claim 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wong (US 20250127515 A1, published April 24, 2025 with a priority date of October 23, 2023) discloses the catheter may include a plurality of lumens. A first lumen may be configured to allow a first fluid to be introduced and/or removed from the volume of space defined by the inner surface of the expandable occlusion element. A second lumen may be configured to receive a pressure sensor or define a fluid-filled pressure transducer. A third lumen may be configured to allow a second fluid to be removed from the volume of space
Courtney et al. (US 20190374196 A1, published December 12, 2019) discloses additional flushing or venting lumens that are in fluid communication with an interior region of the catheter to help improve image quality, such as by removing air from the distal region that can interfere with imaging.
McCaffrey et al. (US 20260174497 A1, published June 25, 2026 with a priority date of May 27, 2022) discloses introducing the fluid into a transducer lumen of an ultrasound transducer of the catheter, the ultrasound transducer being positioned radially inward of the expandable member.
Fleury et al. (US 20180242948 A1, published August 20, 2018) discloses the elongate member may include a dedicated inflation fluid delivery lumen extending between the proximal end (not shown) and distal end to place the external fluid source and interior region in fluid communication (Fig. 2A).
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 Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM 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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
