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 .
Response to Amendment
The amendment filed August 11th, 2025 has been entered. Claims 1, 8, & 15 are amended. Claims 13, 19, & 21-60 are canceled. Claims 1-12, 14-18, & 20 remain pending.
Response to Arguments
Applicant's arguments filed August 11th, 2025 have been fully considered but they are not persuasive.
Applicant argues that the rejection of independent claims 1, 8, & 15 has been overcome by the amendments and the arguments, as Atala discloses an apparatus for delivering fluid under pressure to an interstitial cavity to promote tissue expansion, the apparatus comprising … a valve element adapted to restrict leakage of said pressurized fluid from said injection port following introduction of said fluid into the interstitial cavity and a pressure release valve for reducing fluid pressure within the interstitial cavity by releasing fluid if said pressure exceeds a predefined level, and that it is well established that proposed modification cannot render the prior art invention being modified unsatisfactory for its intended purpose or change the principle operation of the prior art invention being modified. The examiner respectfully disagrees. First, regarding independent claim 1, the examiner disagrees that the amendment to include “wherein fluid flows in only one direction toward the at least two sharpened needles” overcomes the previous rejection, as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The Fischell reference discloses the catheter system for fluid delivery to at least two sharpened needle, the catheter system comprising the injection port ([0366] & [0368]; Figure 11—element 354); the examiner is only relying on the Atala reference to provide a teaching that it is known in the art for an injection port to comprise a single check valve; Atala discloses a catheter system comprising an injection port ([Col. 6, line 7-30]; Figure 1—element 14) the injection port comprising a single check valve, the single check valve is along the central axis extending in the longitudinal direction, wherein the single check valve is in fluid communication with the fluid injection lumen, wherein the single check valve is attached to the proximal end of the injection port ([Col. 2, line 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28), Atala further discloses that the check valve “is adapted to restrict the flow of the fluid to a select direction of flow and thereby prevent back flow of fluid” and “it should be apparent to one of ordinary skill in the art that other one-way valves, check valves, and other pressure containment elements can be practiced with the present invention without departing from the scope thereof and it is considered to be within the skill of one of ordinary skill in the art to provide alternative one-way valve elements” ([Col. 2, lines 27-30], [Col. 8, lines 17-24], & [Col. 9, lines 30-36]), although the Atala reference discloses that the port can optionally include a safety release element 14a ([Col. 6, lines 7-15] & [Col. 7, lines 11-24]) this is an optional element and does not affect the structure and the functionality of the one-way valve element, the examiner is not relying on the Atala reference to teach the optional safety release element, the examiner is only relying on the Atala reference to teach that it is known in the art for a fluid injection port to include a single check valve to provide the benefit of preventing back flow of fluids through the injection port and restricting fluid flow to one direction; it is further the examiner position that including a single check valve, as taught by Atala, in the fluid injection port, as disclosed by Fischell, would not render Fischell inoperable its intended purpose, rather the modification would provide for an injection port that prevents back flow of fluids therethrough. Second, regarding independent claim 8, the examiner disagrees that the amendment to include “wherein the single check valve is the only seal of the fluid injection lumen”, overcomes the previous rejection, although Fischell does not disclose any seal in the fluid injection lumen, Atala teaches that it is known in the art to include a single check valve in a fluid injection port to prevent backflow of fluids ([Col. 2, line 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28), by providing the single check valve, as taught by Atlala, in the injection port of Fischell, it is the examiner position that the single check valve would be the only seal of the fluid injection lumen, see also the above response to arguments regarding the optional safety release element in the first argument. Third, regarding independent claim 15, the examiner disagrees that the amendment to include “wherein the injection port consists of a single port lumen”, overcomes the previous rejection, as Fischell discloses that the injection port is a single port lumen (e.g. there is only one injection port, the examiner is considering the single port lumen to be the lumen of the one/single injection portion) ([0366]; Figure 11—element 354), therefore Fischell discloses the amendment of “wherein the injection port consists of a single port lumen”.
Claim Objections
Claim 1 is objected to because of the following informalities: “wherein fluid flows in only one direction toward the at least two sharpened needles” (lines 23-24) should be –wherein fluid is configured to flow[[s]] in only one direction toward the at least two sharpened needles. Appropriate correction is required.
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 1-12, 14-18, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (previously presented-US 20190076186 A1), hereinafter “Fischell”, in view of Atala (previously presented-US 5858003 A), hereinafter “Atala”.
Regarding claim 1, Fischell discloses a catheter system for fluid delivery to a volume of tissue outside of an inside wall of a target vessel in a human body comprising: a catheter ([0299]; Figure 2—element 100) comprising: a catheter body ([0299]; Figure 2 & 3—element 102 & 104) comprising a catheter fluid injection lumen ([0316]; Figure 3—element 133); a central axis extending in a longitudinal direction ([0299]; Figure 2 & 3—element 100; with said central axis being the longitudinal/center axis defined by catheter 100); a distal portion comprising at least two guide tubes ([0299]; Figure 2 & 3—element 115), wherein each of the at least two guide tubes comprises a distal end ([0299]; Figures 2-4—element 115; with the distal end being the distal end of the guide tubes 115 containing radiopaque markers 122), the at least two guide tubes configured to be outwardly expandable in the radial direction beyond the outer surface of the catheter body with the distal end in proximity to the inside wall of the target vessel ([0229], [0307], & [0308]; Figures 2-4, 8, & 9—element 115; Figure 8 portrays retracted guide tubes 115 and Figure 9 portrays advanced/expanded guide tubes 115); at least two sharpened needles ([0299]; Figure 2 & 3—element 116/119), each of the at least two sharpened needles comprising a needle fluid injection lumen in fluid communication with the catheter fluid injection lumen ([0316]; the lumens of the needles 116 are in fluid communication with the lumen 133 of the catheter); a proximal handle ([0363]; Figure 1—element 300) comprising an injection port in fluid communication with the catheter fluid injection lumen ([0366] & [0368]; Figure 3—element 133; port 354 allows injection of ablative fluid into lumen 133), wherein the injection port is along the central axis extending in the longitudinal direction ([0366] & [0368]; Figure 11—element 354; the injection port 354 is shown as extending along the central axis in a longitudinal direction), wherein the injection port comprises a distal end and a proximal end ([0366] & [0368]; Figure 11—element 354; with said distal end being the portion of port 354 closest to/facing the handle 300 and catheter body 100 and said proximal end being the portion of port 354 facing away from handle 300 and catheter body), wherein the port is in fluid communication with each needle fluid injection lumen of the at least two sharpened needles ([0366]; Figure 3 & 11—elements 116/119, 133, & 354; injection port 354 allows injection of ablative fluid into catheter lumen 133 which is in fluid communication with the lumens of the injector tube 116 which are in fluid communication with the needle distal openings 117), wherein the at least two needle fluid injection lumens have equal flow volume ([0071], [0318], & [0329]); the flow rate between the two or more injector tubes/needles is equalized), the proximal handle comprising a movement mechanism configured to advance and retract the at least two guide tubes and the at least two sharpened needles ([0339] & [0350]; mechanisms at the proximal end control the motion of the injector tubes to limit or adjust the penetration depth of the needles), wherein fluid flows toward the at least two sharpened needles ([0136]), and a vial of ablative fluid and a syringe ([0145], [0168], [0169], & [0212]; the kit can include one or more vials of ablative fluid and one or more syringes), wherein a predetermined amount of ablative fluid is configured to be withdrawn from the vial of ablative fluid into the syringe by a user of the catheter system ([0144], [0145], [0369], [0378]; the syringe may be connected to the port 354 and a desired volume of ablative fluid may be injected; it is the examiners position that a user is capable of withdrawing a predetermined amount of ablative fluid from the vial into the syringe).
Fischell does not disclose the injection port comprising a single check valve, the single check valve is along the central axis extending in the longitudinal direction, wherein the single check valve is in fluid communication with the fluid injection lumen, wherein the single check valve is attached to the proximal end of the injection port, wherein fluid flows in only one direction.
Atala teaches a catheter system for fluid delivery to a volume of tissue ([Col. 2, lines 22-33] & [Col. 6, lines 7-30]; Figure 1—element 12), the catheter system comprising fluid injection lumen ([Col. 6, lines 7-30]; Figure 1—element 12A), a syringe for delivering fluid to the catheter system ([Col. 6, lines 7-30]; Figure 1—element 16/16A), an injection port in fluid communication with the catheter fluid injection lumen, wherein the injection port is along the central axis extending in the longitudinal direction and comprises a distal end and a proximal end ([Col. 6, lines 7-30]; Figure 1—element 14; with said distal end being the end/portion of the port 14 facing catheter body 12 and said proximal end being the end/portion of the port 14 facing away from the catheter body and facing toward syringe 16), the injection port comprising a single check valve, the single check valve is along the central axis extending in the longitudinal direction, wherein the single check valve is in fluid communication with the fluid injection lumen, wherein the single check valve is attached to the proximal end of the injection port, wherein fluid flows in only one direction ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28; the port 14 includes a valve element 28 which is configured to restrict the flow of fluid to a select direction of flow to thereby prevent back flow of fluid; Figure 1 portrays at least a portion of the valve 28 attached at the proximal end of the port 14 and the valve 28 extending along the central axis of the catheter system).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port, as disclosed by Fischell, to include a single check valve along the central axis, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the port may comprise a valve that is adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port, wherein the valves can be one-way valves, check valve, and/or other pressure containment elements that are considered to be within the skill of one of ordinary skill in the art to provide alternative one-way valves ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]). 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 proximal end of the injection port, as disclosed by Fischell, to include a single check valve along the central axis, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 2, Fischell in view of Atala disclose all of the limitations of claim 1, as described above.
Fischell further discloses the at least two guide tubes comprising three guide tubes and the at least two sharpened needles comprising three sharpened needles ([0231], [0299], & [0316]; Figures 2 & 3—elements 115 & 116/119).
Regarding claim 3, Fischell in view of Atala disclose all of the limitations of claim 1, as described above.
Fischell further discloses wherein the each of the at least two sharpened needles comprise a fluid egress and wherein the catheter fluid injection lumen is in fluid communication with each fluid egresses of the at least two sharpened needles ([0366]; Figure 2 & 3—element 117).
Regarding claim 4, Fischell in view of Atala disclose all of the limitations of claim 1, as described above.
Fischell further discloses the proximal handle includes at least one indicia associated with the state of the catheter ([0370]; Figure 11—element 300; the handle 300 may include markings) selected from the group consisting of: a. the position of the movement mechanism wherein the at least two guide tubes and the at least two sharpened needles are both retracted, b. the position of the movement mechanism wherein the at least two guide tubes are advanced but the at least two sharpened needles are retracted, and c. the position of the movement mechanism wherein the at least two guide tubes and the at least two injector tubes are both advanced ([0370]; the handle includes a gap adjustment cylinder that when rotated adjusts the penetration depth of the injection needles, the gap adjustment cylinder could be accessible to the user of the PTAC with markings on the handle to indicate the distance that will be achieved).
Regarding claim 5, Fischell in view of Atala disclose all of the limitations of claim 1, as described above.
Fischell does not disclose wherein the single check valve is integrated with the proximal handle and configured to prevent the ablative fluid from flowing back out of the injection port.
Atala further teaches wherein the single check valve is integrated with the proximal handle and configured to prevent the ablative fluid from flowing back out of the injection port ([Col. 3, lines 53-57]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle and configured to prevent the ablative fluid from flowing back out of the injection port, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the valve that is integrally formed with the port and adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], ([Col. 3, lines 53-57], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle and configured to prevent the ablative fluid from flowing back out of the injection port, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 6, Fischell in view of Atala disclose all of the limitations of claim 1, as described above.
Fischell does not disclose wherein the single check valve is integrated with the proximal handle and configured to prevent air from entering the catheter fluid injection lumen.
Atala further teaches wherein the single check valve is integrated with the proximal handle and configured to prevent air from entering the catheter fluid injection lumen ([Col. 3, lines 53-57] & [Col. 8, lines 9-23]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle and configured to prevent air from entering the catheter fluid injection lumen, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the valve that is integrally formed with the port and may be configured to form a fluid seal around the syringe to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], ([Col. 3, lines 53-57], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle and configured to prevent air from entering the catheter fluid injection lumen, as taught by Atala, as such a modification would form a fluid seal around the syringe and restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe to thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 7, Fischell in view of Atala disclose all of the limitations of claim 1, as described above.
Fischell does not disclose wherein the single check valve is integrated with the proximal handle and configured to prevent blood from flowing back through the catheter.
Atala further teaches wherein the single check valve is integrated with the proximal handle and configured to prevent blood from flowing back through the catheter ([Col. 3, lines 53-57]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle and configured to prevent blood from flowing back through the catheter, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the valve that is integrally formed with the port and adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], ([Col. 3, lines 53-57], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port and proximal handle , as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle and configured to prevent blood from flowing back through the catheter, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 8, Fischell discloses a catheter system for fluid delivery into tissue outside of an interior wall of a target vessel of a human body, the catheter system comprising: a catheter ([0299]; Figure 2—element 100) comprising: a catheter body comprising an outer surface ([0299]; Figure 2 & 3—element 102 & 104; with said outer surface being the outer extend of catheter body 102/104), a central axis extending in a longitudinal direction([0299]; Figure 2 & 3—element 100; with said central axis being the longitudinal/center axis defined by catheter 100), and a fluid injection lumen ([0316]; Figure 3—element 133); at least two guide tubes ([0299]; Figure 2 & 3—element 115) configured to advance distally and expand outwardly toward the interior wall of the target vessel ([0229], [0307], & [0308]; Figures 2-4, 8, & 9—element 115; Figure 8 portrays retracted guide tubes 115 and Figure 9 portrays advanced/expanded guide tubes 115); a support structure ([0307]; Figure 3—element 121); at least two injector tubes ([0299]; Figure 2 & 3—element 116) with distal injection needles ([0299]; Figure 2 & 3—element 119), each of the injector tubes with distal injection needles comprising an injection lumen in fluid communication with the fluid injection lumen of the catheter body ([0316]; Figure 3—element 116/119 & 133), the at least two injector tubes with distal injection needles configured to be advanced outwardly ([0339], [0350], & [0362]; Figure 2, 3, 8, & 10—element 116/119), guided by the at least two guide tubes to penetrate the interior wall of the target vessel ([0299]; Figures 2, 3, & 10—element 115), the injection needles comprising a distal opening for fluid delivery into the tissue outside of the interior wall of the target vessel ([0299], [0366], & [0329]; Figures 2 & 3—element 117); a proximal handle ([0363]; Figure 1—element 300) comprising an injection port in fluid communication with the fluid injection lumen ([0366] & [0368]; Figure 3—element 133; port 354 allows injection of ablative fluid into lumen 133), wherein the injection port comprises a distal end and a proximal end ([0366] & [0368]; Figure 11—element 354; with said distal end being the portion of port 354 closest to/facing the handle 300 and catheter body 100 and said proximal end being the portion of port 354 facing away from handle 300 and catheter body),wherein the fluid injection lumen is along the central axis extending in the longitudinal direction ([0366] & [0368]; Figure 11—element 354; the injection port 354 is shown as extending along the central axis in a longitudinal direction), wherein the port is in fluid communication with each injection lumen of the at least two injector tubes with distal injection needles ([0366]; Figure 3 & 11—elements 116/119, 133, & 354; injection port 354 allows injection of ablative fluid into catheter lumen 133 which is in fluid communication with the lumens of the injector tube 116 which are in fluid communication with the needle distal openings 117), wherein each injection lumen of the at least two injector tubes with distal injection needles has equal flow rates ([0071], [0318], & [0329]); the flow rate between the two or more injector tubes/needles is equalized); and a vial of ablative fluid and a syringe ([0145], [0168], [0169], & [0212]; the kit can include one or more vials of ablative fluid and one or more syringes), wherein the rate of flow of infusion is slowed by an increased resistance to flow within the fluid injection lumen ([0076] & [0332]).
Fischell does not disclose a single check valve, wherein the single check valve is attached to the proximal end of the injection port, the single check valve is along the central axis extending in the longitudinal direction, wherein the single check valve is in fluid communication with the injection lumen, wherein the single check valve is the only seal of the fluid injection lumen.
Atala teaches a catheter system for fluid delivery to a volume of tissue ([Col. 2, lines 22-33] & [Col. 6, lines 7-30]; Figure 1—element 12), the catheter system comprising fluid injection lumen ([Col. 6, lines 7-30]; Figure 1—element 12A), a syringe for delivering fluid to the catheter system ([Col. 6, lines 7-30]; Figure 1—element 16/16A), an injection port in fluid communication with the catheter fluid injection lumen, wherein the injection port is along the central axis extending in the longitudinal direction and comprises a distal end and a proximal end ([Col. 6, lines 7-30]; Figure 1—element 14; with said distal end being the end/portion of the port 14 facing catheter body 12 and said proximal end being the end/portion of the port 14 facing away from the catheter body and facing toward syringe 16), and a single check valve, wherein the single check valve is attached to the proximal end of the injection port, the single check valve is along the central axis extending in the longitudinal direction, wherein the single check valve is in fluid communication with the injection lumen, wherein the single check valve is the only seal of the fluid injection lumen ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28; the port 14 includes a valve element 28 which is configured to restrict the flow of fluid to a select direction of flow to thereby prevent back flow of fluid; Figure 1 portrays at least a portion of the valve 28 attached at the proximal end of the port 14 and the valve 28 extending along the central axis of the catheter system; further it is the examiners position that including by including the single check valve in the injection port of Fischell, it would be the only seal of the fluid injection lumen, as disclosed by Fischell, as the fluid injection lumen of Fischell does not comprise any seals or valves).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port, as disclosed by Fischell, to include a single check valve along the central axis, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the port may comprise a valve that is adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port, wherein the valves can be one-way valves, check valve, and/or other pressure containment elements that are considered to be within the skill of one of ordinary skill in the art to provide alternative one-way valves ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]). 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 proximal end of the injection port, as disclosed by Fischell, to include a single check valve along the central axis, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 9, Fischell in view of Atala disclose all of the limitations of claim 8, as described above.
Fischell further discloses wherein the support structure comprises a deflection surface ([0224] & [0307]; Figure 4—element 144), the deflection surface configured to deflect the distally moving guide tubes outward to a pre-set radial distance from the outer surface of the distal portion of the catheter body ([0308]; Figure 4—element 115 & 144).
Regarding claim 10, Fischell in view of Atala disclose all of the limitations of claim 8, as described above.
Fischell further discloses the at least two guide tubes comprising three guide tubes ([0231], [0299], & [0316]; Figures 2 & 3—element 115).
Regarding claim 11, Fischell in view of Atala disclose all of the limitations of claim 8, as described above.
Fischell further discloses wherein each distal injection needle is hollow and includes fluid egress near a distal end of the injection needle, and wherein the fluid injection lumen of the catheter body is in fluid communication with the fluid egress of each injection needle ([0366]; Figure 2 & 3—element 117).
Regarding claim 12, Fischell in view of Atala disclose all of the limitations of claim 8, as described above.
Atala further teaches wherein the single check valve is located at the proximal end of the catheter body ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and the catheter body, as disclosed by Fischell, to include the single check valve located at the proximal end of the injection port and catheter body, as further taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the port may comprise a valve that is adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40]). 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 proximal end of the injection port, as disclosed by Fischell, to include the single check valve located at the proximal end of the injection port and catheter body, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 14, Fischell in view of Atala disclose all of the limitations of claim 8, as described above.
Fischell does not disclose wherein the single check valve is integral to a proximal portion of the fluid injection lumen.
Atala further teaches wherein the single check valve is integral to a proximal portion of the fluid injection lumen ([Col. 3, lines 53-57]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and injection lumen, as disclosed by Fischell, to further include the single check valve integral with the injection port and the injection lumen, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the valve that is integrally formed with the port and adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], ([Col. 3, lines 53-57], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port and injection lumen, as disclosed by Fischell, to further include the single check valve integral with the injection port and the injection lumen, as further taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 15, Fischell discloses a catheter system comprising: a catheter ([0299]; Figure 2—element 100) comprising: a catheter body ([0299]; Figure 2 & 3—element 102 & 104) comprising a fluid injection lumen ([0316]; Figure 3—element 133); two or more guide tubes ([0299]; Figure 2 & 3—element 115), each of the two or more guide tubes comprising a distal end ([0299]; Figures 2-4—element 115; with the distal end being the distal tip of the guide tubes 115 containing radiopaque markers 122), each of the two or more guide tubes moveable between a first position within the catheter body and a second position inclined away from the catheter body, wherein each guide tube is configured to be positioned with the distal end in proximity to an inside wall of a target vessel ([0229], [0307], & [0308]; Figures 2-4, 8, & 9—element 115; Figure 8 portrays retracted guide tubes 115 and Figure 9 portrays advanced/expanded guide tubes 115); two or more penetrators ([0299]; Figure 2 & 3—element 116/119), each of the two or more penetrators comprising an injection lumen in fluid communication with the fluid injection lumen of the catheter body ([0316]; the lumens of the needles 116 are in fluid communication with the lumen 133 of the catheter), each penetrator configured to penetrate the inside wall of the target vessel ([0042]); a proximal handle ([0363]; Figure 1—element 300) configured to advance and retract the two or more guide tubes and the two or more penetrators ([0339] & [0350]; mechanisms at the proximal end control the motion of the injector tubes to limit or adjust the penetration depth of the needles), wherein the proximal handle comprises an injection port, wherein the injection port consists of a single port lumen, in fluid communication with the fluid injection lumen of the catheter body ([0366] & [0368]; Figure 3—element 133; Figure 11—element 354; port 354 allows injection of ablative fluid into lumen 133; the examiner is considering the single port lumen to be the lumen of the injection port 354), wherein the injection port comprises a distal end and a proximal end ([0366] & [0368]; Figure 11—element 354; with said distal end being the portion of port 354 closest to/facing the handle 300 and catheter body 100 and said proximal end being the portion of port 354 facing away from handle 300 and catheter body), wherein the port valve is along a central axis extending in a longitudinal direction ([0366]; Figure 11—element 354; the injection port 354 is shown as extending along the central axis in a longitudinal direction), wherein fluid injected into the port flows from the single check valve to each injection lumen of the two or more penetrators ([0366]; Figure 3 & 11—elements 116/119, 133, & 354; injection port 354 allows injection of ablative fluid into catheter lumen 133 which is in fluid communication with the lumens of the injector tube 116 which are in fluid communication with the needle distal openings 117), wherein pressure is equalized between each injection lumen of the two or more penetrators ([0071], [0318], & [0329]; the flow rate between the two or more injector tubes/needles is equalized), and a vial of ablative fluid and a syringe ([0145], [0168], [0169], & [0212]; the kit can include one or more vials of ablative fluid and one or more syringes), wherein the fluid injection lumen is primed with the ablative fluid instead of saline ([0189]; the catheter may be filled with ablative fluid before insertion into the body), wherein saline dilutes the ablative fluid that follows for injection into peri-vascular tissue ([0394]).
Fischell does not disclose a single check valve in fluid communication with the fluid injection lumen of the catheter body, wherein the single check valve is attached to the proximal end of the injection port, wherein fluid injected into the single check valve flows from the single check valve to each injection lumen.
Atala teaches a catheter system for fluid delivery to a volume of tissue ([Col. 2, lines 22-33] & [Col. 6, lines 7-30]; Figure 1—element 12), the catheter system comprising fluid injection lumen ([Col. 6, lines 7-30]; Figure 1—element 12A), a syringe for delivering fluid to the catheter system ([Col. 6, lines 7-30]; Figure 1—element 16/16A), an injection port in fluid communication with the catheter fluid injection lumen, wherein the injection port is along the central axis extending in the longitudinal direction and comprises a distal end and a proximal end ([Col. 6, lines 7-30]; Figure 1—element 14; with said distal end being the end/portion of the port 14 facing catheter body 12 and said proximal end being the end/portion of the port 14 facing away from the catheter body and facing toward syringe 16), and a single check valve in fluid communication with the fluid injection lumen of the catheter body, wherein the single check valve is attached to the proximal end of the injection port, wherein fluid injected into the single check valve flows from the single check valve to each injection lumen ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28; the port 14 includes a valve element 28 which is configured to restrict the flow of fluid to a select direction of flow to thereby prevent back flow of fluid; Figure 1 portrays at least a portion of the valve 28 attached at the proximal end of the port 14 and the valve 28 extending along the central axis of the catheter system).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port, as disclosed by Fischell, to include a single check valve along the central axis in communication with the injection lumen, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the port may comprise a valve that is adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port, wherein the valves can be one-way valves, check valve, and/or other pressure containment elements that are considered to be within the skill of one of ordinary skill in the art to provide alternative one-way valves ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]). 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 proximal end of the injection port, as disclosed by Fischell, to include a single check valve along the central axis in communication with the injection lumen, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 16, Fischell in view of Atala disclose all of the limitations of claim 15, as described above.
Fischell does not disclose wherein the single check valve is integrated into the proximal handle.
Atala further teaches wherein the single check valve is integrated into the proximal handle ([Col. 3, lines 53-57]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the valve that is integrally formed with the port and adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], ([Col. 3, lines 53-57], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port and proximal handle, as disclosed by Fischell, to further include the single check valve integrated with the injection port and the proximal handle, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 17, Fischell in view of Atala disclose all of the limitations of claim 15, as described above.
Fischell does not disclose wherein the single check valve is integrated into a fluid injection port in a proximal portion of the catheter.
Atala further teaches wherein the single check valve is integrated into a fluid injection port in a proximal portion of the catheter ([Col. 3, lines 53-57]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port and injection lumen, as disclosed by Fischell, to further include the single check valve integral with the injection port and the injection lumen, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the valve that is integrally formed with the port and adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], ([Col. 3, lines 53-57], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port and injection lumen, as disclosed by Fischell, to further include the single check valve integral with the injection port and the injection lumen, as further taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Regarding claim 18, Fischell in view of Atala disclose all of the limitations of claim 17, as described above.
Fischell further discloses wherein the fluid injection port includes a non-Luer connector ([0057]; the injection port may include a customized fitting (different from a Luer fitting)).
Regarding claim 20, Fischell in view of Atala disclose all of the limitations of claim 15, as described above.
Fischell further discloses the device configured to allow ablative fluid to flow from a proximal injection port to an egress of each of the two or more penetrators ([0318] & [0366]; Figure 2—element 117; Figure 11— 354).
Fischell does not disclose wherein the single check valve is configured to allow fluid to flow in one direction from a proximal injection port to an egress of each of the two or more penetrators and prevent fluid from flowing in the opposite direction out of the proximal injection port.
Atala further teaches wherein the single check valve is configured to allow fluid to flow in one direction from a proximal injection port to an egress and prevent fluid from flowing in the opposite direction out of the proximal injection port ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], [Col. 8, lines 9-40], & [Col. 9, lines 30-36]; Figure 1—element 28).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the proximal end of the injection port, as disclosed by Fischell, to include a single check valve is configured to allow fluid to flow in one direction and prevent fluid from flowing in the opposite direction out of the proximal injection port, as taught by Atala, as both references and the claimed invention are directed toward catheter systems comprising ports configured to receive an injection of fluid via a syringe. As disclosed by Atala, the port may comprise a valve that is adapted to restrict the flow of fluid to a select direction of flow and thereby prevent back flow of fluid and fluids escaping through the injection port ([Col. 2, lines 23-32], [Col. 5, lines 28-36], [Col. 6, lines 7-30], & [Col. 8, lines 9-40]). 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 proximal end of the injection port, as disclosed by Fischell, to include a single check valve is configured to allow fluid to flow in one direction and prevent fluid from flowing in the opposite direction out of the proximal injection port, as taught by Atala, as such a modification would restrict the flow of fluid to a select direction of flow, as fluid is introduced into the catheter system by the syringe, and thereby prevent back flow of fluid and fluid escaping through the injection port.
Conclusion
Accordingly, claims 1-12, 14-18, & 20 are rejected.
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 MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794