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 .
Status of Claims
Claims 30, 38, 42, 47, and 53 are currently amended.
Claims 1-29 are cancelled.
Response to Arguments
Applicant’s arguments, see page 8, filed 2/27/2026, with respect to 35 U.S.C. 112 rejection have
been fully considered and are persuasive. The 35 U.S.C. 112 rejection of claims 30, 38, 42, and 53 has been withdrawn.
35 U.S.C. 112:
The applicant has amended the above claims to recite “the at least partially distally facing
openings” to “at least partially distally facing openings.” Therefore, the claims no longer lacks improper antecedent basis and the 35 U.S.C. 112 rejection is overcome.
Applicant's arguments, see pages 16-17, filed 2/27/2026, have been fully considered but they
are not persuasive.
Double Patenting:
Regarding the double patenting rejection, the applicant argues that a terminal disclaimer has
been filed. The office has not received the terminal disclaimer. Therefore, the double patenting rejection is maintained.
Applicant’s arguments, see pages 8-16, filed 2/27/2026, with respect to the rejection(s) of
claim(s) 30-59 under 35 U.S.C. 102 and 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 Therefore, the rejection has been withdrawn.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 Ciulla.
Regarding independent claims 30, 38, 47, and 53, applicant argues that Mogi, alone or in
combination with the prior art, does not teach “wherein the supply lumen is configured to introduce a liquid jet from an external liquid source into the evacuation lumen at a position adjacent to the one or more at least partially distally facing openings to create a vacuum at the one or more at least partially distally facing openings to remove at least the portion of the biological object from the location internal to the subject.” After further search and consideration, the examiner argues that Mogi teaches this limitation, but does not teach “to introduce a liquid jet from an external liquid source.” In [243], Mogi discloses “having multiple assistive jet channels inside of the aspiration lumen can constrict or narrow the flow area of the aspiration lumen, which can create a fluid dynamics advantage called the Venturi effect. The Venturi effect can increase the flow velocity of the blood through the constricted portion of the aspiration lumen to increase the suction force exerted on the thrombus that is broken down at the aspiration opening.” Furthermore, in [fig. 24-25; paragraph 193-201], Mogi teaches the assistive jet generates a pressure gradient, through the venturi effect, to draw the material from the higher-pressure surgical site toward (proximal to distal end of supply lumen 312) the lower pressure evacuation lumen 332 (toward proximal end of evacuation lumen). This effect is shown by the curved arrow in figure 24 and 25. Lastly, without conceding the previous rejection, Mogi further teaches that (fig. 32; paragraph 227-228) a reflector 467 may reflect assistive jet liquid into the evacuation lumen 432 to generate a pressure gradient.
However, Mogi does not teach “to introduce a liquid jet from an external liquid source.” After further search and consideration, the examiner will refer to Ciulla to teach this limitation (fig. 1; paragraph 20-22). It is disclosed that a fluid supply assembly 140 may be external to the catheter/tube as shown in figure 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid source Mogi with the external fluid supply assembly from Ciulla for the benefit of reducing the risk of catheter-associated urinary tract infections and improving patient’s safety.
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.
Claims 30-31, 36, 39, 42, 47-48 and 52-53 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1, 3, 6, 8, 12-13, and 20 of U.S. Patent No. 12419656. Although the claims at issue are not identical, they are not patentably distinct from each other because, despite the claim recitations are merely reworded to recite the same limitation in different language and some of the limitations have been grouped in a slightly different manner, the instant claims are broader than and thus anticipated by the patent claims. Additionally independent system claims 47 and 53 of the current application is also anticipated over independent claims 1 and 20 of U.S. Patent No. U.S. 12419656. Further dependent claims 31, 36, 42, 48, and 52 recite limitations that are similar to the dependent claims (3, 6, 8, 12-13, 20, and 25) of U.S. Patent No. U.S. 12419656.
INSTANT APPLICATION 19335480
U.S. PATENT NUMBER: 12419656
Claim 30. A system for use in a removal procedure of a biological object from a location internal to a subject, the system comprising:
Claim 1. A system for use in a removal procedure of a biological object from a urinary tract, the system comprising:
a catheter body comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body comprising one or more at least partially distally facing openings located at a distal end face of the catheter body, wherein the one or more at least partially distally facing openings are configured to receive at least a portion of the biological object;
a catheter body comprising a proximal end and a distal end configured to be inserted into the urinary tract, the catheter body comprising one or more openings at least partially facing an axial direction of the catheter body, wherein the one or more openings are configured to receive at least a portion of the biological object;
an evacuation lumen extending within the catheter body, wherein the evacuation lumen is configured to be in fluid communication with the one or more at least partially distally facing openings;
an evacuation lumen positioned at least partially within the catheter body, wherein the evacuation lumen is in fluid communication with the one or more openings and wherein the evacuation lumen is configured to receive an ablation device;
And a supply lumen extending along the catheter body and terminating at a position proximal to a distal end of the catheter body, wherein the supply lumen is configured to introduce a liquid jet into the evacuation lumen at a position adjacent to the one or more of the at least partially distally facing openings to create a vacuum at the one or more distally facing openings to remove at least the portion of the biological object from the location internal to the subject.
And a supply lumen positioned entirely within the catheter body and configured to transport a liquid from a liquid source to the distal end of the catheter body, the supply lumen configured to eject the liquid as a liquid jet outside the supply lumen and create a vacuum at the one or more openings via a Venturi effect, wherein the vacuum created via the Venturi effect is configured to attract the biological object toward the one or more openings and the system is configured to remove a plurality of fragments of the biological object from the urinary tract through the evacuation lumen toward the proximal end of the catheter body with a regulated fluid flow.
And one or more vent port openings in fluid communication with the evacuation lumen, wherein the one or more vent port openings are configured to resupply at least some liquid introduced into the evacuation lumen into the location internal to the subject.
and a plurality of vents formed in the catheter body and fluidically connected to the evacuation lumen, the plurality of vents configured to resupply into the urinary tract at least some of the liquid ejected from the supply lumen and aspirated by the evacuation lumen.
Claim 31. wherein the vacuum is created via a Venturi effect.
Claim. 12 wherein the vacuum created by the Venturi effect is configured to attract the biological object toward the one or more openings.
Claim 36. wherein the supply lumen comprises a first portion that directs a liquid flow from a proximal end of the supply lumen toward a distal end of the supply lumen and a second portion that redirects the liquid flow into the evacuation lumen toward the proximal end of the evacuation lumen.
Claim 3. wherein the supply lumen comprises a first portion that directs a flow of the liquid from the proximal end of the catheter body toward the distal end of the catheter body and a second portion that redirects the flow of the liquid toward the proximal end of the catheter body.
Claim 42. wherein the source of vacuum is configured to supply vacuum at the first vacuum level to regulate fluid flow in the evacuation lumen.
Claims 6 and 13. further comprising a vacuum source in fluid communication with the evacuation lumen to regulate fluid flow through the evacuation lumen.
Claim 47. A system for use in a removal procedure of a biological object from a location internal to a subject, the system comprising:
Claim 20. A system for use in a removal procedure of a biological object from a urinary tract, the system comprising:
a catheter body comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body comprising one or more at least partially distally facing openings located at a distal end face of the catheter body, wherein the one or more at least partially distally facing openings are configured to receive at least a portion of the biological object;
a catheter body comprising a proximal end and a distal end configured to be inserted into the urinary tract, the catheter body comprising one or more openings at least partially facing an axial direction of the catheter body, wherein the one or more openings are configured to receive the biological object;
an evacuation lumen extending within the catheter body, wherein the evacuation lumen is configured to be in fluid communication with the one or more at least partially distally facing openings;
an evacuation lumen positioned at least partially within the catheter body in fluid communication with the one or more openings, wherein the evacuation lumen is configured to aspirate a plurality of fragments of the biological object and transport the plurality of fragments of the biological object from the one or more openings toward the proximal end of the catheter body
a supply lumen extending along the catheter body and terminating at a position proximal to a distal end of the catheter body, wherein the supply lumen is configured to introduce a liquid jet into the evacuation lumen at a position adjacent to the one or more at least partially distally facing openings to create a vacuum at the one or more at least partially distally facing openings to remove at least the portion of the biological object from the location internal to the subject;
a supply lumen positioned entirely within the catheter body and configured to transport a liquid to the distal end of the catheter body, the supply lumen comprising a first portion that directs a flow of the liquid from the proximal end of the catheter body toward the distal end of the catheter body and a second portion that redirects the flow of the liquid toward the proximal end of the catheter body, wherein the second portion is configured to eject the liquid outside the supply lumen and create vacuum at the one or more openings via a Venturi effect to facilitate attracting the biological object at the one or more openings;
And one or more vent port openings in fluid communication with the evacuation lumen, wherein the one or more vent port openings are configured to resupply at least some liquid introduced into the evacuation lumen into the location internal to the subject.
and a plurality of vents formed in the catheter body and fluidically connected to the evacuation lumen, the plurality of vents configured to resupply into the urinary tract at least some of the liquid ejected from the supply lumen and aspirated by the evacuation lumen.
Claim 39. wherein the vacuum is created via a Venturi effect.
Claim. 12 wherein the vacuum created by the Venturi effect is configured to attract the biological object toward the one or more openings.
Claim 48. wherein the vacuum is created via a Venturi effect.
Claim. 12 wherein the vacuum created by the Venturi effect is configured to attract the biological object toward the one or more openings.
Claim 52. wherein the one or more vent port openings are configured to resupply at least some liquid introduced into the evacuation lumen into the location internal to the subject to maintain a fluid balance and a pressure balance in the location internal to the subject.
Claim 8. further comprising a plurality of vent port openings formed in the catheter body and fluidically connected to the evacuation lumen, the plurality of vent port openings configured to resupply into the urinary tract at least some of the liquid ejected from the supply lumen to maintain a fluid balance and pressure balance in the urinary tract.
Claim 53. A system for use in a removal procedure of a biological object from a location internal to a subject, the system comprising:
Claim 20. A system for use in a removal procedure of a biological object from a urinary tract, the system comprising
a catheter body comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body comprising one or more at least partially distally facing openings located at a distal end face of the catheter body, wherein the one or more at least partially distally facing openings are configured to receive at least a portion of the biological object;
a catheter body comprising a proximal end and a distal end configured to be inserted into the urinary tract, the catheter body comprising one or more openings at least partially facing an axial direction of the catheter body, wherein the one or more openings are configured to receive the biological object;
an evacuation lumen extending within the catheter body, wherein the evacuation lumen is configured to be in fluid communication with the one or more at least partially distally facing openings;
an evacuation lumen positioned at least partially within the catheter body in fluid communication with the one or more openings, wherein the evacuation lumen is configured to aspirate a plurality of fragments of the biological object and transport the plurality of fragments of the biological object from the one or more openings toward the proximal end of the catheter body;
a supply lumen comprising a first portion extending along the catheter body, and a second portion extending into the evacuation lumen and at least partially facing a proximal direction, wherein the first portion is configured to direct a flow of a liquid from a proximal end of the supply lumen to a distal end of the supply lumen and the second portion is configured to redirect the flow of the liquid toward the proximal end of the evacuation lumen and introduce the liquid into the evacuation lumen at a position adjacent to the one or more distally facing openings to create a vacuum at the one or more distally facing openings to remove the portion of the biological object from the location internal to the subject.
a supply lumen positioned entirely within the catheter body and configured to transport a liquid to the distal end of the catheter body, the supply lumen comprising a first portion that directs a flow of the liquid from the proximal end of the catheter body toward the distal end of the catheter body and a second portion that redirects the flow of the liquid toward the proximal end of the catheter body, wherein the second portion is configured to eject the liquid outside the supply lumen and create vacuum at the one or more openings via a Venturi effect to facilitate attracting the biological object at the one or more openings
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.
Claims 30-41, 43, and 53-59 are rejected under 35 U.S.C. 103 as being unpatentable by
MOGI et al. US Pub.: US 20180338770 A1, hereinafter Mogi in view of Ciulla et al. US Pub.: US 20160166320 A1, hereinafter Ciulla.
Regarding claim 30, Mogi teaches a system (300) for use in a removal procedure of a biological
object from a location internal to a subject, the system comprising (fig. 18-25; paragraph 193-196):
a catheter body (312) comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body (312) comprising one or more at least partially distally facing openings (330) located at a distal end face of the catheter body, wherein the one or more at least partially distally facing openings (330) are configured to receive at least a portion of the biological object (fig. 18-25; paragraph 193-196);
an evacuation lumen (332) extending within the catheter body, wherein the evacuation lumen (332) is configured to be in fluid communication with the one or more at least partially distally facing openings (fig. 18-25; paragraph 193-196);
and a supply lumen (344) extending along the catheter body (312) and terminating at a position proximal to a distal end of the catheter body (312), wherein the supply lumen is configured to introduce a liquid jet into the evacuation lumen (332) at a position adjacent to the one or more at least partially distally facing openings to create a vacuum at the one or more distally facing openings (330) to remove at least the portion of the biological object from the location internal to the subject (fig. 18-25; paragraph 193-201).
However, Mogi does not teach to introduce a liquid jet from an external liquid source.
Ciulla, in the same field of endeavor, teaches to teach to introduce a liquid jet from an external liquid source (fig. 1; paragraph 20-22). It is disclosed that a fluid supply assembly 140 may be external to the catheter/tube as shown in figure 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid source Mogi with the external fluid supply assembly from Ciulla for the benefit of reducing the risk of catheter-associated urinary tract infections and improving patient’s safety.
Regarding claim 31, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches a wherein the vacuum is created via a Venturi effect (fig. 18-25; paragraph 240-245).
Regarding claim 32, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches a wherein the location internal to the subject is selected from the group consisting of a blood vessel, a colon, a duodenum, an ear canal, a gallbladder, a gland, a heart, an ileum, an intestine, a jejunum, a kidney, a liver, a lung, a lymph node, a mouth, a nasal cavity, an ovary, a pancreas, a spleen, a urethra, a urinary bladder, a urinary tract, a uterus, and other body cavities (fig. 18-25; paragraph 126); The surgical site of the patient may comprise a blood vessel.
Regarding claim 33, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the evacuation lumen is configured to receive an energy source (512) configured to fragment the biological object into one or more portions (fig. 5; paragraph 50 and 55). The nozzle outputs a water jet (from the energy source 512) and is operated to dislodge or otherwise divide the resected material into smaller fragments to promote evacuation.
Regarding claim 34, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the energy source (102) is configured to provide light-based energy, acoustic-based energy, mechanical-based energy, electromagnetic-based energy, or thermal-based energy (fig. 1; paragraph 154). A pressurized fluid pump equates to mechanical-based energy source.
Regarding claim 35, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the energy source (102) is selected from the group consisting of a laser fiber, an ultrasonic instrument, an electrohydraulic instrument, a pneumatic instrument, a cryogenic instrument, a radio-frequency instrument, a waterjet, and morcellation blades (fig. 1; paragraph 154). A waterjet is disclosed.
Regarding claim 36, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the supply lumen comprises a first portion that directs a liquid flow from a proximal end of the supply lumen (344) toward a distal end of the supply lumen (344) and a second portion that redirects the liquid flow into the evacuation lumen (332) toward the proximal end of the evacuation lumen (fig. 18-25; paragraph 193-201). The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream. The jet generates a pressure gradient, through the venturi effect, to draw the material from the higher-pressure surgical site toward (proximal to distal end of supply lumen) the lower pressure evacuation lumen (toward proximal end of evacuation lumen).
Regarding claim 37, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches further comprising a closed loop control system configured to maintain a fluid balance and pressure balance in the location internal to the subject (fig. 18-25; paragraph 193-201). The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream in a closed loop system. The jet generates a pressure gradient. This is done internal to the subject.
Regarding claim 38, Mogi teaches a system (300) for use in a removal procedure of a biological
object from a location internal to a subject, the system comprising (fig. 1-4; paragraph 20-23):
a catheter body (312) comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body (312) comprising one or more at least partially distally facing openings (330) located at a distal end face of the catheter body (312), wherein the one or more at least partially distally facing openings (330) are configured to receive at least a portion of the biological object (fig. 18-25; paragraph 193-196);
an evacuation lumen (332) extending within the catheter body (312), wherein the evacuation lumen (332) is configured to be in fluid communication with the one or more at least partially distally facing openings at a distal end of the evacuation lumen (332) and configured to be in fluid communication with a vacuum source (102) at a proximal end of the evacuation lumen (332), wherein the vacuum source (102) is configured to supply vacuum at a first vacuum level (fig. 1 and 18-25; paragraph 154 and 193-196);
and a supply lumen (344) extending along the catheter body (312) and terminating at a position proximal to a distal end of the catheter body (312), wherein the supply lumen (344) is configured to introduce a liquid jet into the evacuation lumen (332) at a position adjacent to the one or more at least partially distally facing openings to create a vacuum at a second vacuum level at the one or more distally facing openings to remove at least the portion of the biological object from the location internal to the subject (fig. 1 and 18-25; paragraph 154 and 193-196). The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream. The jet generates a pressure gradient, through the venturi effect, to draw the material from the higher-pressure surgical site toward the lower pressure evacuation lumen.
However, Mogi does not teach to introduce a liquid jet from an external liquid source.
Ciulla, in the same field of endeavor, teaches to teach to introduce a liquid jet from an external liquid source (fig. 1; paragraph 20-22). It is disclosed that a fluid supply assembly 140 may be external to the catheter/tube as shown in figure 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid source Mogi with the external fluid supply assembly from Ciulla for the benefit of reducing the risk of catheter-associated urinary tract infections and improving patient’s safety.
Regarding claim 39, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the vacuum at the second vacuum level is created via a Venturi effect (fig. 18-25; paragraph 240-245).
Regarding claim 40, Mogi in view of Ciulla teaches the claimed invention and Mogi
Further teaches wherein the location internal to the subject is selected from the group consisting of a blood vessel, a colon, a duodenum, an ear canal, a gallbladder, a gland, a heart, an ileum, an intestine, a jejunum, a kidney, a liver, a lung, a lymph node, a mouth, a nasal cavity, an ovary, a pancreas, a spleen, a urethra, a urinary bladder, a urinary tract, a uterus, and other body cavities (fig. 18-25; paragraph 126); The surgical site of the patient may comprise a blood vessel.
Regarding claim 41, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches further comprising a closed loop control system configured to maintain a fluid balance and pressure balance in the location internal to the subject (fig. 18-25; paragraph 193-201). The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream in a closed loop system. The jet generates a pressure gradient. This is done internal to the subject.
Regarding claim 43, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the vacuum source is configured to create negative pressure at the proximal end of the evacuation lumen (fig. 1 and 18-25; paragraph 154 and 240-245). The pump connects to the supply lumen 344 to output a waterjet stream, which is positioned in the lumen to optimize the venturi effect. This effect creates a suction force with negative pressure at the proximal end of the evacuation lumen.
Regarding claim 53, Mogi teaches a system (300) for use in a removal procedure of a biological
object from a location internal to a subject, the system comprising (fig. 1-4; paragraph 20-23):
a catheter body (312) comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body (312) comprising one or more at least partially distally facing openings (330) located at a distal end face of the catheter body (312), wherein the one or more at least partially distally facing openings (330) are configured to receive at least a portion of the biological object (fig. 18-25; paragraph 193-196);
an evacuation lumen (332) extending within the catheter body (312), wherein the evacuation lumen (332) is configured to be in fluid communication with the one or more at least partially distally facing openings (fig. 1 and 18-25; paragraph 154 and 193-196);
and a supply lumen (344) comprising a first portion extending along the catheter body (312), and a second portion extending into the evacuation lumen and at least partially facing a proximal direction, wherein the first portion is configured to direct a flow of a liquid from a proximal end of the supply lumen (344) to a distal end of the supply lumen (344) and the second portion is configured to redirect the flow of the liquid toward the proximal end of the evacuation lumen (332) and introduce the liquid into the evacuation lumen (332) at a position adjacent to the one or more distally facing openings (330) to create a vacuum at the one or more distally facing openings (330) to remove the portion of the biological object from the location internal to the subject (fig. 1 and 18-25; paragraph 154 and 193-196); The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream. The jet generates a pressure gradient, through the venturi effect, to draw the material from the higher-pressure surgical site toward (proximal to distal end of supply lumen) the lower pressure evacuation lumen (toward proximal end of evacuation lumen).
However, Mogi does not teach to introduce a liquid jet from an external liquid source.
Ciulla, in the same field of endeavor, teaches to teach to introduce a liquid jet from an external liquid source (fig. 1; paragraph 20-22). It is disclosed that a fluid supply assembly 140 may be external to the catheter/tube as shown in figure 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid source Mogi with the external fluid supply assembly from Ciulla for the benefit of reducing the risk of catheter-associated urinary tract infections and improving patient’s safety.
Regarding claim 54, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the vacuum is created via a Venturi effect (fig. 18-25; paragraph 240-245).
Regarding claim 55, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the location internal to the subject is selected from the group consisting of a blood vessel, a colon, a duodenum, an ear canal, a gallbladder, a gland, a heart, an ileum, an intestine, a jejunum, a kidney, a liver, a lung, a lymph node, a mouth, a nasal cavity, an ovary, a pancreas, a spleen, an urethra, a urinary bladder, a urinary tract, a uterus, and other body cavities (fig. 18-25; paragraph 126); The surgical site of the patient may comprise a blood vessel.
Regarding claim 56, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the second portion is positioned proximal to a distal end of the catheter body (fig. 18-25; paragraph 193-196 and 240-245). The second portion is shown to be positioned proximal to a distal end of the catheter body below.
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Regarding claim 57, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the first portion extends linearly along the catheter body (fig. 18-25; paragraph 193-196 and 240-245). The first portion of supply lumen 344 is extending linearly towards the distal end of the catheter body.
Regarding claim 58, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the second portion is U-shaped (fig. 18-25; paragraph 193-196 and 240-245). The distal portion and fluid flow of the supply lumen 344 is shown to be U-shaped at the distal end of the catheter body.
Regarding claim 59, Mogi in view of Ciulla teaches the claimed invention and Mogi further
teaches wherein the distal end of the supply lumen terminates proximal to the distal end of the catheter body (fig. 18-25; paragraph 193-196 and 240-245). This is shown in the annotated figure above.
Claims 42 and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Mogi in view
of Ciulla in view of Bonette et al. US Pub.: US 20010051811 A1, hereinafter Bonette.
Regarding claim 42, Mogi in view of Ciulla does not explicitly teach wherein the source of
vacuum is configured to supply vacuum at the first vacuum level to regulate fluid flow in the evacuation lumen.
Bonette, in the same field of endeavor, teaches wherein the source of vacuum is configured to
supply vacuum at the first vacuum level to regulate fluid flow in the evacuation lumen (paragraph 58). The exhaust regulation means can regulate exhaust at a predetermined or user-adjustable flow rate which can be correlated with or independent of the rate of flow of the pressurized fluid flowing along the high pressure tubular means.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum source of Mogi in view of Ciulla with the peristaltic pump and regulation means from Bonette for the benefit of increasing, decreasing, limiting, or adjusting the rate of flow of fluid and thrombus or other unwanted material debris along the exhaust tubular means.
Regarding claim 44, Mogi in view of Ciulla does not explicitly teach wherein the first vacuum
level is less than the second vacuum level.
Bonette, in the same field of endeavor, teaches wherein the first vacuum level is less than the
second vacuum level (paragraph 58). The exhaust regulation means can regulate exhaust at a predetermined or user-adjustable flow rate which can be correlated with or independent of the rate of flow of the pressurized fluid flowing along the high pressure tubular means.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum source of Mogi in view of Ciulla with the peristaltic pump and regulation means from Bonette for the benefit of increasing, decreasing, limiting, or adjusting the rate of flow of fluid and thrombus or other unwanted material debris along the exhaust tubular means.
Regarding claim 45, Mogi in view of Ciulla does not explicitly teach wherein the vacuum source
is a peristaltic pump.
Bonette, in the same field of endeavor, teaches wherein the vacuum source is a peristaltic
Pump (paragraph 58). Peristaltic pump is disclosed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum source of Mogi in view of Ciulla with the peristaltic pump and regulation means from Bonette for the benefit of increasing, decreasing, limiting, or adjusting the rate of flow of fluid and thrombus or other unwanted material debris along the exhaust tubular means.
Regarding claim 46, Mogi in view of Ciulla does not explicitly teach wherein the vacuum source
is configured to slow a volumetric flow through the evacuation lumen.
Bonette, in the same field of endeavor, teaches wherein the vacuum source is configured to
slow a volumetric flow through the evacuation lumen (paragraph 58). The exhaust regulation means can regulate exhaust at a predetermined or user-adjustable flow rate which can be correlated with or independent of the rate of flow of the pressurized fluid flowing along the high pressure tubular means.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum source of Mogi in view of Ciulla with the peristaltic pump and regulation means from Bonette for the benefit of increasing, decreasing, limiting, or adjusting the rate of flow of fluid and thrombus or other unwanted material debris along the exhaust tubular means.
Claims 47-52 are rejected under 35 U.S.C. 103 as being unpatentable over Mogi in view of
Ciulla in view of Harrah et al. US Pat.: US 11382693 B2, hereinafter Harrah.
Regarding claim 47, Mogi teaches a system (300) for use in a removal procedure of a biological
object from a location internal to a subject, the system comprising (fig. 1-4; paragraph 20-23):
a catheter body (312) comprising a proximal end and a distal end configured to be delivered to the location internal to the subject, the catheter body (312) comprising one or more at least partially distally facing openings (330) located at a distal end face of the catheter body (312), wherein the one or more at least partially distally facing openings (330) are configured to receive at least a portion of the biological object (fig. 18-25; paragraph 193-196);
an evacuation lumen (332) extending within the catheter body (312), wherein the evacuation lumen (332) is configured to be in fluid communication with the one or more at least partially distally facing openings (fig. 1 and 18-25; paragraph 154 and 193-196);
a supply lumen (344) extending along the catheter body (312) and terminating at a position proximal to a distal end of the catheter body (312), wherein the supply lumen (344) is configured to introduce a liquid jet into the evacuation lumen (332) at a position adjacent to the one or more at least partially distally facing openings (330) to create a vacuum at the one or more at least partially distally facing openings to remove at least the portion of the biological object from the location internal to the subject (fig. 1 and 18-25; paragraph 154 and 193-196). The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream. The jet generates a pressure gradient, through the venturi effect, to draw the material from the higher-pressure surgical site toward the lower pressure evacuation lumen.
Mogi does not teach one or more vent port openings in fluid communication with the evacuation lumen, wherein the one or more vent port openings are configured to resupply at least some liquid introduced into the evacuation lumen into the location internal to the subject; introduce a liquid jet from an external liquid source.
Ciulla, in the same field of endeavor, teaches to teach to introduce a liquid jet from an external liquid source (fig. 1; paragraph 20-22). It is disclosed that a fluid supply assembly 140 may be external to the catheter/tube as shown in figure 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid source Mogi with the external fluid supply assembly from Ciulla for the benefit of reducing the risk of catheter-associated urinary tract infections and improving patient’s safety.
Harrah, in the same field of endeavor, teaches one or more vent port openings in fluid communication with the evacuation lumen, wherein the one or more vent port openings are configured to resupply at least some liquid introduced into the evacuation lumen into the location internal to the subject (fig. 3A-B; col. 6-7, lines 41-68 and 1-56). Multiple side ports of different sizes are disclosed. These ports may act as vents to resupply at least some liquid introduced into the evacuation lumen.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the catheter of Mogi to add multiple vent ports from Harrah for the benefit of assisting in pushing fragments towards the vacuum and into the catheter body.
Regarding claim 48, Mogi in view of Ciulla in view of Harrah teaches the claimed invention and
Mogi further teaches wherein the vacuum is created via a Venturi effect (fig. 18-25; paragraph 240-245).
Regarding claim 49, Mogi in view of Ciulla in view of Harrah teaches the claimed invention and
Mogi further teaches wherein the location internal to the subject is selected from the group consisting of a blood vessel, a colon, a duodenum, an ear canal, a gallbladder, a gland, a heart, an ileum, an intestine, a jejunum, a kidney, a liver, a lung, a lymph node, a mouth, a nasal cavity, an ovary, a pancreas, a spleen, a urethra, a urinary bladder, a urinary tract, a uterus, and other body cavities (fig. 18-25; paragraph 126); The surgical site of the patient may comprise a blood vessel.
Regarding claim 50, Mogi in view of Ciulla does not teach wherein the one or more vent port
openings are positioned along a side wall of the catheter body.
Harrah, in the same field of endeavor, teaches wherein the one or more vent port openings are
positioned along a side wall of the catheter body (fig. 3A-B; col. 6-7, lines 41-68 and 1-56). Multiple side ports of different sizes are disclosed. These ports be positioned along the catheter body as shown.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the catheter of Mogi in view of Ciulla to add multiple vent ports from Harrah for the benefit of assisting in pushing fragments towards the vacuum and into the catheter body.
Regarding claim 51, Mogi in view of Ciulla does not teach, wherein the one or more vent port
openings are positioned along a side wall of the evacuation lumen.
Harrah, in the same field of endeavor, teaches wherein the one or more vent port openings are
positioned along a side wall of the evacuation lumen (fig. 3A-B; col. 6-7, lines 41-68 and 1-56). Multiple side ports of different sizes are disclosed. These ports may be place along the evacuation lumen of the catheter body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the catheter of Mogi in view of Ciulla to add multiple vent ports from Harrah for the benefit of assisting in pushing fragments towards the vacuum and into the catheter body.
Regarding claim 52, Mogi in view of Ciulla in view of Harrah teaches the claimed invention and
Mogi further teaches wherein the one or more vent port openings are configured to resupply at least some liquid introduced into the evacuation lumen into the location internal to the subject to maintain a fluid balance and a pressure balance in the location internal to the subject (fig. 18-25; paragraph 193-201). The supply lumen is configured to house an assistive jet aspiration configured to emit a high-pressure fluid stream in a closed loop system. The jet generates a pressure gradient. This is done internal to the subject.
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 THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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