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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-7, 12, 14-17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) in view of Mogi et al. (US 20180338770 A1).
Regarding claim 1, Griep embodiment of Fig 1-6, hereinafter Griep-1, discloses a method of removing a biological object (blood clot, Col 4, lines 20-26) from an anatomical structure (blood vessel, claim 1), the method comprising: creating a vacuum (vacuum 19, Fig 6; Col 4, lines 20-26) with a catheter (catheter 1, Fig 1) in the anatomical structure (blood vessel, claim 1), the catheter (Catheter 1, Fig 1) including a proximal end (1001, Annotated Fig 1) and a distal end (1002, Annotated Fig 1), an aspiration lumen (discharge channel 4, Fig 6) positioned in a catheter body (catheter body 2, Fig 6) of the catheter (1), and a supply lumen (pressure channel 3, Fig 6) configured to transport a liquid (contrast fluid; Col. 4, lines 33-37) from a liquid source (reservoir 6, Fig 1) to the distal end of the catheter (1002, Annotated Fig 1), the supply lumen (3) comprising a first portion (1003, Annotated Fig 1) extending at least between the proximal end (1001, Annotated Fig 1) and the distal end (1002, Annotated Fig 1) of the catheter body (2) of the catheter (1) and a second portion (1004, Annotated Fig 1) at the distal end (1002, Annotated Fig 1) of the catheter body (2) of the catheter (1) that redirects a flow of the liquid (contrast fluid; Col. 4, lines 33-37) at least partially toward the proximal end (1001, Annotated Fig 1) of the catheter body (2), wherein the vacuum (19) is created at one or more distal openings (inlet opening 9, Fig 1) in the catheter body (2) to attract the biological object (blood clot, Col 4, lines 20-26) toward the one or more distal openings (9), the vacuum (19) being created by transporting the liquid (contrast fluid; Col. 4, lines 33-37) through the supply lumen (3) and ejecting the liquid into the aspiration lumen (4) (Col. 4, lines 41-45); and aspirating at least a portion of the biological object (blood clot, Col 4, lines 20-26) through the aspiration lumen (4) towards the proximal end (1001, Annotated Fig 1) of the catheter (1).
Griep is silent regarding an opening positioned at a distal end of the supply lumen, wherein the vacuum is created at one or more distal openings in the catheter body positioned distal to the opening of the supply lumen.
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Mogi teaches a method of removing a biological object (thrombus T, [0228]) from an anatomical structure (blood vessel, [0126]), the method comprising an opening (opening 445 of the assistive channel lumen 442, Fig 30) positioned at a distal end of the supply lumen (jet channel lumen 444, Fig 30), wherein the vacuum is created at one or more distal openings (aspiration opening 430, Fig 30) in the catheter body (catheter body 412, Fig 30) positioned distal to the opening (445) of the supply lumen (444)(Fig 30).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the position of the aspiration opening and distal opening of the supply lumen of the method of Griep with similar distal positions as taught by Mogi for the purpose of preventing blockage of the aspiration lumen and increase the suction force ([0288]; [0243]).
Regarding claim 2, Griep-1/Mogi discloses the method of claim 1. Griep-1 is silent regarding further comprising breaking the biological object into a plurality of fragments with ablation.
Mogi teaches a method comprising breaking the biological object (thrombus T, Fig 31) into a plurality of fragments (Fig 31) with ablation (hydraulic ablation via jet; [0288])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the position of the aspiration opening and distal opening of the supply lumen of the method of Griep with similar distal positions as taught by Mogi for the purpose of preventing blockage of the aspiration lumen ([0288]).
Regarding claim 4, Griep-1/Mogi discloses the method of claim 1. Griep-1 is silent regarding further comprising applying negative pressure to the proximal end of the catheter to aspirate the portion of the biological object.
Griep embodiment of Fig 7-8, hereinafter Griep-7, discloses applying negative pressure (negative pressure applied by syringe 40, Fig 7) to the proximal end of the catheter (25) to aspirate the portion of the biological object (Col. 4, lines 48-54).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar syringe as taught by Griep-7 for the purpose of controlling the blocking of the discharge channel (Col. 5, lines 12-15)
Regarding claim 5, Griep-1/Mogi discloses the method of claim 1. Griep-1 discloses further comprising regulating fluid flow through the aspiration lumen (Col. 4, lines 41-47; self-regulating effect).
Regarding claim 6, Griep-1/Mogi discloses the method of claims 1. further comprising ejecting the liquid (liquid; Col. 4, lines 32-33) from the supply lumen (3) through a plurality of vent port openings (leakage openings 10, 11; Fig 6) formed in the catheter body (2).
Regarding claim 7, Griep-1/Mogi discloses the method of claim 1. Griep-1 discloses wherein creating the vacuum (19) at the one or more distal openings (9) comprises transporting the liquid (contrast fluid; Col. 4, lines 33-37) through the supply lumen (3) at a first flow rate (flow rate at proximal end of supply) and ejecting the liquid from the supply lumen (3) into the catheter body (2), wherein the catheter body (2)comprises another liquid (fluid entering through 9, Fig 6) flowing at a second flow rate (flow rate at lumen 4 )higher than the first flow rate (flow rate at aspiration lumen 4 is higher because of narrow section at the end of supply lumen 3 causes a Venturi effect; Col. 4, lines 20-27).
Regarding claim 12, embodiment of Fig 1-6 of Griep, hereinafter Griep-1, discloses a method of removing a biological object (blood clot, Col 4, lines 20-26) from an anatomical structure (blood vessel, claim 1), the method comprising: creating a vacuum (vacuum 19, Fig 6; Col 4, lines 20-26) with a catheter (catheter 1, Fig 1) in the anatomical structure (blood vessel, claim 1), the catheter (1) including (1001, Annotated Fig 1) and a distal end (1002, Annotated Fig 1), an aspiration lumen (discharge channel 4, Fig 6) positioned in a catheter body (catheter body 2, Fig 6), and a supply lumen (pressure channel 3, Fig 6) positioned in the aspiration lumen (4) (distal portion of supply lumen is inserted in aspiration lumen; See Fig 2-6), the vacuum (19) being created at one or more distal openings (inlet opening 9, Fig 1) in the catheter body (2) to attract a biological object (blood clot, Col 4, lines 20-26) toward the one or more distal openings (9) by ejecting a liquid (contrast fluid; Col. 4, lines 33-37) from an end (1005, Annotated Fig 1) of the supply lumen (3) into the aspiration lumen (4); and aspirating the biological object (blood clot, Col 4, lines 20-26) through the one or more distal openings (9) in the catheter body and transporting the biological object (blood clot, Col 4, lines 20-26) along the aspiration lumen (4) toward the proximal end (1001, Annotated Fig 1) of the catheter (1).
Griep-1 is silent regarding emitting energy from an energy source positioned in the aspiration lumen to break the biological object into a plurality of fragments; and aspirating at least some of the plurality of fragments of the biological object through the one or more distal openings in the catheter body and transporting at least some of the plurality of fragments of the biological object along the aspiration lumen toward the proximal end of the catheter.
Mogi teaches a method of removing a biological object (thrombus T, [0228]) from an anatomical structure (blood vessel, [0126]), the method comprising an opening (opening 445 of the assistive channel lumen 442, Fig 30) positioned at a distal end of the supply lumen (jet channel lumen 444, Fig 30); emitting energy (kinetic energy is give off being converted partially into frictional elastic energy upon contact with target )from an energy source (fluid jet; [0288]) positioned in the aspiration lumen (432) to break the biological object (T) into a plurality of fragments (Fig 31); and aspirating at least some of the plurality of fragments of the biological object (T)through the one or more distal openings (430) in the catheter body (412) and transporting at least some of the plurality of fragments of the biological object (fragments of T, Fig 31) along the aspiration lumen (432) toward the proximal end of the catheter (Fig 31).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the position of the aspiration opening and distal opening of the supply lumen of the method of Griep with similar distal positions as taught by Mogi for the purpose of preventing blockage of the aspiration lumen and ablate the thrombus into smaller particles via jet action ([0288]).
Regarding claim 14, Griep-1/Mogi discloses the method of claim 12. Griep-1 discloses further comprising ejecting the liquid (contrast fluid; Col. 4, lines 33-37) from the catheter body (2) through one or more of a plurality of vent port openings (leakage openings 10, 11; Fig 6) formed in the catheter body (2).
Regarding claim 15, Griep-1/Mogi discloses the method of claim 12. Griep-1 discloses wherein the liquid (contrast fluid; Col. 4, lines 33-37) is ejected from the distal end (1005, Annotated Fig 1) of the supply lumen (3) into the aspiration lumen (4).
Regarding claim 16, Griep-1/Mogi discloses the method of claim 12. Griep-1 discloses wherein ejecting the liquid (contrast fluid; Col. 4, lines 33-37) comprises ejecting the liquid at least partially toward the proximal end (1001, Annotated Fig 1) of the catheter body (2) (Fig 6; ejection of liquid towards the proximal end causes venturi effect; Col. 4, lines 20-27).
Regarding claim 17, Griep-1/Mogi discloses the method of claim 12. Griep-1 is silent further comprising applying negative pressure to the proximal end of the catheter to aspirate at least some of the plurality of fragments the portion of the biological object
Mogi teaches comprising applying negative pressure to the proximal end of the catheter to aspirate at least some of the plurality of fragments the portion of the biological object (syringe applies negative pressure to the proximal end of catheter to aspirate [0035], Fig 31).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar connection of a syringe to the proximal end of aspiration lumen of the catheter as taught by Mogi for the purpose of providing aspiration means ([0265]).
Regarding claim 23, Griep-1/Mogi discloses the method of claim 14. Griep-1 is silent wherein aspirating at least some of the plurality of fragments of the biological object through one or more of the plurality of vent port openings improves visibility of the anatomical structure.
Mogi teaches wherein aspirating at least some of the plurality of fragments of the biological object (fragments of T, Fig 31) through one or more of the plurality of vent port openings (aspiration opening 430, Fig 31) improves visibility of the anatomical structure (removal of thrombus will improve visibility of the blood vessel).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep with similar distal positions of the apertures as taught by Mogi for the purpose of preventing blockage of the aspiration lumen and increase the suction force ([0288]; [0243]).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) in view of Mogi et al. (US 20180338770 A1) in further view of Holochwost et al. (US 20160135829 A1).
Regarding claim 3, Griep-1/Mogi discloses the method of claim 1. Griep-1/Mogi are silent regarding discloses wherein the vacuum creates a vortex within the aspiration lumen adjacent to the one or more distal openings
Holochwost teaches a method of removing a biological object (claim 3: thrombus) from an anatomical structure (blood vessel, [0044]), wherein the vacuum creates a vortex within the aspiration lumen adjacent to the one or more distal openings ([0031]; Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar dual-friction surfaces at as taught by Holochwost to generate an enhanced vortex flow that captures and removes undesirable materials ([0031]).
Claims 8-9, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) in view of Mogi et al. (US 20180338770 A1) in further view of Aljuri et al. (US 20170232273 A1).
Regarding claim 8, Griep-1/Mogi discloses the method of claim 1. Griep-1 discloses further comprising irrigating the anatomical structure (blood vessel, claim 1), via an irrigation lumen (lumen of leakage openings 10, 11; Fig 6). Griep-1 is silent wherein the irrigation lumen is in fluid communication with a second liquid source.
Aljuri discloses a method comprising a first liquid source (aquablation system, Fig 4A) and a second liquid source (saline bag, Fig 4A) wherein the irrigation lumen (lumen of irrigation port; [0093]) is in fluid communication with a second liquid source (saline bag, Fig 4A; [0093]: “The saline bag is coupled to the irrigation port as described herein)”.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with a second fluid source in communication with the irrigation lumen as taught by Aljuri for the purpose of maintain pressure based on the height of the saline bag ([0095])
Regarding claim 9, Griep-1/Mogi/Aljuri discloses the method of claim 8. Griep-1 is silent wherein the second liquid source provides a gravity fed pressure to the irrigation lumen.
Aljuri discloses a method wherein the second liquid source (saline bag, Fig 4A) provides a gravity fed pressure to the irrigation lumen ([0095]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi/Aljuri with a second fluid source in communication with the irrigation lumen as taught by Aljuri for the purpose of maintain pressure based on the height of the saline bag ([0095]).
Regarding claim 18, Griep-1/Mogi discloses the method of claim 12. Griep-1 discloses further comprising irrigating the anatomical structure (blood vessel, claim 1) via an irrigation lumen (lumen of leakage openings 10, 11; Fig 6). Griep-1 is silent regarding in fluid communication with a second liquid source.
Aljuri teaches method comprising a first liquid source (aquablation system, Fig 4A) and a second liquid source (saline bag, Fig 4A) wherein the irrigation lumen (lumen of irrigation port; [0093]) is in fluid communication with a second liquid source (saline bag, Fig 4A; [0093]: “The saline bag is coupled to the irrigation port as described herein)”.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with a second fluid source in communication with the irrigation lumen as taught by Aljuri for the purpose of maintain pressure based on the height of the saline bag ([0095]).
Regarding claim 19, Griep-1/Mogi/Aljuri discloses the method of claim 18. Griep-1 is silent wherein the second liquid source provides a gravity fed pressure to the irrigation lumen.
Aljuri teaches a method wherein the second liquid source (saline bag, Fig 4A) provides a gravity fed pressure to the irrigation lumen ([0095]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi/Aljuri with a second fluid source in communication with the irrigation lumen as taught by Aljuri for the purpose of maintain pressure based on the height of the saline bag ([0095]).
Claim 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) in view of Mogi et al. (US 20180338770 A1) in further view of Harrah et al. (US 11382693 B2).
Regarding claim 10, Griep-1/Mogi discloses the method of claim 1. Griep-1 is silent regarding further comprising controlling a fluid inflow and a fluid outflow of the anatomical structure based on at least one of a sensed pressure, a sensed flow rate, or a sensed temperature.
Harrah teaches a method comprising controlling a fluid inflow and a fluid outflow of the anatomical structure based on at least one of a sensed pressure, a sensed flow rate, or a sensed temperature (Col.10, lines 35-48; fluid being irrigate to the anatomical structure is in equilibrium with the fluid aspirated out of the site by the use of pressure sensor).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar pressure sensor at the distal end or near the target area to maintain a pressure equilibrium (Col. 10, lines 46-48).
Regarding claim 20, Griep-1/Mogi discloses the method of claim 12. Griep-1 is silent regarding further comprising controlling a fluid inflow and a fluid outflow of the anatomical structure based on at least one least one of a sensed pressure, a sensed flow rate, or a sensed temperature.
Harrah teaches a method comprising controlling a fluid inflow and a fluid outflow of the anatomical structure based on at least one of a sensed pressure, a sensed flow rate, or a sensed temperature (Col.10, lines 35-48; fluid being irrigate to the anatomical structure is in equilibrium with the fluid aspirated out of the site by the use of pressure sensor).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar pressure sensor at the distal end or near the target area as taught by Harrah to maintain a pressure equilibrium (Col. 10, lines 46-48).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) in view of Mogi et al. (US 20180338770 A1) in further view of Stoller (US 5788667 A).
Regarding claim 11, Griep-1/Mogi discloses the method of claim 1. Griep-1 is silent wherein the liquid is ejected into the aspiration lumen along a helical path within the catheter body.
Stoller teaches a method comprising a liquid wherein the liquid is ejected into the aspiration lumen along a helical path within the catheter body (Col. 3, lines 63-65; liquid is ejected into lumen of aspiration port 12 along a helical path caused by swirl of the turbine).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar turbine as taught by Stoller for the purpose of adjust pressure of the fluid at a desired level (Col 4. Lines 20-22).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) of in view of Mogi et al. (US 20180338770 A1) in further view of Melsky et al. (US 20090299354 A1).
Regarding claim 22, Griep-1/Mogi discloses the method of claim 12. Griep-1 is silent wherein a portion of the distal end of the catheter body is transparent at wavelengths corresponding to visible light and wavelengths corresponding to laser energy emitted by an ablation instrument.
Melsky teaches a portion of the distal end of the catheter body (catheter body 14, Fig 2A) is transparent at wavelengths corresponding to visible light ([0109]) and wavelengths corresponding to laser energy emitted by an ablation instrument ([0064]: “The catheter body, projection balloon and inflation/ablation fluids are all preferably substantially transparent to the radiant energy at the selected wavelength to provide a low-loss transmission pathway from the ablation element 40 to the target.”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Mogi with similar transparent material of the catheter body as taught by Melsky for the purpose of to provide a low-loss transmission pathway from the ablation element to the target ([0064]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) of in view of Kadamus (WO2015148541A1).
Regarding claim 24, Griep embodiment of Fig 1-6, hereinafter Griep-1, discloses a method of removing a biological object (blood clot, Col 4, lines 20-26) from an anatomical structure (blood vessel, claim 1), the method comprising: creating a vacuum (vacuum 19, Fig 6; Col 4, lines 20-26) with a catheter (catheter 1, Fig 1) in the anatomical structure (blood vessel, claim 1), the catheter (Catheter 1, Fig 1) including a proximal end (1001, Annotated Fig 1) and a distal end (1002, Annotated Fig 1), an aspiration lumen (discharge channel 4, Fig 6) positioned in a catheter body (catheter body 2, Fig 6), and a supply lumen (pressure channel 3, Fig 6) positioned in the aspiration lumen (4) (distal portion of supply lumen is inserted in aspiration lumen; See Fig 2-6), the vacuum (19) being created at one or more distal openings (inlet opening 9, Fig 6) in the catheter body (2) to attract a biological object (blood clot, Col 4, lines 20-26) toward the one or more distal openings (9) by ejecting a liquid (contrast fluid; Col. 4, lines 33-37) from an end (1005, Annotated Fig 1) of the supply lumen (3) into the aspiration lumen (4); aspirating at least some of a plurality of fragments of the biological object (lumen 4aspirate blood clots, any fragments of it are also aspirated as well of other solid particles; Col 4, lines 23-27) and at least some of a fluid positioned within the anatomical structure (Col 4, lines 23-27) through the one or more distal openings (9) in the catheter body (2) and transporting at least some of the plurality of fragments of the biological object and the fluid along the aspiration lumen toward the proximal end of the catheter (Col 4, lines 23-27: blood clots, fluid and any fragments are aspirated proximally);
Griep-1 is silent regarding resupplying at least some of the fluid aspirated through the one or more distal openings into the anatomical structure through one or more vent port openings formed in the catheter body.
Kadamus teaches resupplying at least some of the fluid aspirated through the one or more distal openings into the anatomical structure through one or more vent port openings formed in the catheter body ([0193]; “extracted fluids are recycled, such as for subsequent delivery by at least one treatment element 165 to target tissue TT”.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1 with to allow re-supplying of fluid to the target site as taught by Kadamus for the purpose of recycling fluids to treat the target site ([0193]).
Claim 12 and 21 is rejected under 35 U.S.C. 103 as being unpatentable over Griep et al. (US 5785678 A) in view of Harrah et al. (US 11382693 B2).
Regarding claim 12, Griep embodiment of Fig 1-6 of Griep, hereinafter Griep-1, discloses a method of removing a biological object (blood clot, Col 4, lines 20-26) from an anatomical structure (blood vessel, claim 1), the method comprising: creating a vacuum (vacuum 19, Fig 6; Col 4, lines 20-26) with a catheter (catheter 1, Fig 1) in the anatomical structure (blood vessel, claim 1), the catheter (1) including (1001, Annotated Fig 1) and a distal end (1002, Annotated Fig 1), an aspiration lumen (discharge channel 4, Fig 6) positioned in a catheter body (catheter body 2, Fig 6), and a supply lumen (pressure channel 3, Fig 6) positioned in the aspiration lumen (4) (distal portion of supply lumen is inserted in aspiration lumen; See Fig 2-6), the vacuum (19) being created at one or more distal openings (inlet opening 9, Fig 1) in the catheter body (2) to attract a biological object (blood clot, Col 4, lines 20-26) toward the one or more distal openings (9) by ejecting a liquid (contrast fluid; Col. 4, lines 33-37) from an end (1005, Annotated Fig 1) of the supply lumen (3) into the aspiration lumen (4); and aspirating the biological object (blood clot, Col 4, lines 20-26) through the one or more distal openings (9) in the catheter body and transporting the biological object (blood clot, Col 4, lines 20-26) along the aspiration lumen (4) toward the proximal end (1001, Annotated Fig 1) of the catheter (1).
Griep-1 is silent regarding emitting energy from an energy source positioned in the aspiration lumen to break the biological object into a plurality of fragments; and aspirating at least some of the plurality of fragments of the biological object through the one or more distal openings in the catheter body and transporting at least some of the plurality of fragments of the biological object along the aspiration lumen toward the proximal end of the catheter.
Harrah teaches a method comprising emitting energy from an energy source (energy emitted by laser fiber) positioned in the aspiration lumen (Col. 12, lines 42-47: Ramp 752 may be used to direct a tool such as laser fiber 120 within any lumen and/or any delivery device which includes aspiration lumen) to break the biological object (kidney stone 470, Fig 4) into a plurality of fragments (Col 10, line 18); and aspirating at least some of the plurality of fragments of the biological object (Col 10. Lines 51-67) through the one or more distal openings (opening of second lumen 114, Fig 3A) in the catheter body (tube 102, Fig 3A) and transporting at least some of the plurality of fragments of the biological object (470) along the aspiration lumen (114) toward the proximal end (proximal end 106, Fig 1) of the catheter (tube 102, Fig 1)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1 with similar laser control and laser fiber as taught by Harrah for the purpose of breaking large biological objects and aspirating small particles (Col. 9, lines 60-36).
Regarding claim 21, Griep-1/Harrah discloses the method of claim 12. Griep-1 is silent regarding further comprising, with a reciprocator, axially moving an ablation instrument positioned within the aspiration lumen.
Harrah teaches further comprising, with a reciprocator (laser control 130, Fig 1), axially moving an ablation instrument (Laser fiber 120, Fig 1) positioned within the aspiration lumen (Col. 12, lines 42-47: Ramp 752 may be used to direct a tool such as laser fiber 120 within any lumen and/or any delivery device which includes aspiration lumen).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Griep-1/Harrah with similar laser fiber, control and ramp as taught by Harrah for the purpose of inserting and removing the laser fiber from any lumen of the device for breaking large biological objects and aspirating small particles (Col. 9, lines 60-36; Col. 12, lines 42-47).
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.
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Claims 1-2, 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, and 5-8 of U.S. Patent No. US 20250134538 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the present invention recite similar subject matter as claim 1 of U.S. Patent No. US 20250134538 A1 including a catheter including a proximal end and a distal end, an aspiration lumen positioned in a catheter body of the catheter, and a supply lumen configured to transport a liquid from a liquid source to the distal end of the catheter, the supply lumen comprising a first portion extending at least between the proximal end and the distal end of the catheter body of the catheter and a second portion at the distal end of the catheter body of the catheter that redirects a flow of the liquid at least partially toward the proximal end of the catheter body, and an opening positioned at a distal end of the supply lumen, the vacuum being created by transporting the liquid through the supply lumen and ejecting the liquid into the aspiration lumen; and aspirating at least a portion of the biological object through the aspiration lumen towards the proximal end of the catheter.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7 of U.S. Patent No. US 20250134538 A1 . in view of Mogi et al. (US 20180338770 A1)
With regard to claim 1, Patent No. US 20250134538 A1 claims 1, and 6-7 discloses the claimed invention except for wherein the vacuum is created at one or more distal openings in the catheter body positioned distal to the opening of the supply lumen.
Mogi teaches a method of removing a biological object (thrombus T, [0228]) from an anatomical structure (blood vessel, [0126]), the method comprising an opening (opening 445 of the assistive channel lumen 442, Fig 30) positioned at a distal end of the supply lumen (jet channel lumen 444, Fig 30), wherein the vacuum is created at one or more distal openings (aspiration opening 430, Fig 30) in the catheter body (catheter body 412, Fig 30) positioned distal to the opening (445) of the supply lumen (444)(Fig 30).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the position of the aspiration opening and distal opening of the supply lumen of the method U.S. Patent No. US 20250134538 A1 with similar distal positions as taught by Mogi for the purpose of preventing blockage of the aspiration lumen and increase the suction force ([0288]; [0243]).
The instant application reads on the U.S. Patent No. US 20250134538 A1 based on the underline portion. Please see the double patenting analysis in the table below.
Instant Application (19/373,586)
U.S. Patent No. US 20250134538 A1
Claim 2
Claim 2
Claim 4
Claim 8
Claim 5
Claim 1
Claim 6
Claim 1 and claim 5
Response to Arguments
Applicant’s arguments with respect to claims 1-12, and 14-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner reconsidered prior art Harrah et al. (US 11382693 B2). Claim 12 is being alternatively rejected in view of Harrah et al. (US 11382693 B2). Harrar teaches (Col. 12, lines 42-47: Ramp 752 may be used to direct a tool such as laser fiber 120 within any lumen and/or any delivery device which includes aspiration lumen).
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 date of this final action.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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