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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “one or more electrodes” (claim 12, line 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
In line 1, “The disclosed technology” should be changed to “A disclosed technology”
In line 3, “each manifold” should be changed to “each manifold of the plurality of manifolds”
In line 4, “each fluid passageway” should be changed to “each fluid passageway of the plurality of fluid passageways”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 10, 12, and 14 are objected to because of the following informalities:
In regards to claim 1, line 7, “each manifold” should be changed to “each manifold of the plurality of manifolds”.
In regards to claim 1, line 9, “each fluid passageway” should be changed to “each fluid passageway of the plurality of fluid passageways”.
In regards to claim 10, line 5, “comprising;” should be changed to “comprising:”.
In regards to claim 10, line 10, “the distal end” should be changed to “the distal end of the flow diverter”.
In regards to claim 10, line 11, “each manifold” should be changed to “each manifold of the plurality of manifolds”.
In regards to claim 10, line 13, “each fluid passageway” should be changed to “each fluid passageway of the plurality of fluid passageways”.
In regards to claim 12, line 2, “the electrodes” should be changed to “the one or more electrodes”.
In regards to claim 12, line 3, “ablation” should be changed to “the tissue ablation”.
In regards to claim 14, line 2, “the distal” should be changed to “the distal end”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 9, line 1 recites “silicone”. Claim 9 depends upon claim 8. Claim 8, line 1 recites “an elastomeric material”. It is unclear whether the two recitations are related or different.
In regards to claim 20, line 1 recites “silicone”. Claim 20 depends upon claim 19. Claim 19, line 1 recites “an elastomeric material”. It is unclear whether the two recitations are related or different.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 10-12, 15-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daniel et al (US 2020/0197082).
In regards to claim 1, Daniel et al teaches a flow diverter (Figures 5A-6B) comprising:
a proximal end (40) and a distal end (42)
a lumen (50) extending along a longitudinal axis from the proximal end to the distal end of the flow diverter
a plurality of annular ridges (48P/70/48D) disposed around the lumen between the proximal end and the distal end
a plurality of manifolds (44), each manifold being disposed between adjacent annular ridges of the plurality of annular ridges and comprising a plurality of fluid passageways (56), each fluid passageway extending from the lumen to an exterior of the flow diverter
In regards to claim 2, Daniel et al teaches wherein the distal end comprises a distal aperture (Figures 5A-6B), the distal aperture configured to form a seal around an outer circumference of an end effector disposed through the lumen (Figure 6A).
In regards to claim 3, Daniel et al teaches wherein the plurality of annular ridges comprises a proximal annular ridge (48P), a second annular ridge, a third annular ridge (paragraph [0087] states “the sidewall 61 of the post 44 of the support member 22 is configured with one or more raised portions 70 extending outwardly in the radial direction… with N plurality of bands 70, N+1 plurality of separate chambers 54 can be formed within the distal assembly 15 between the post 44 and the flex circuit 20” from which it is understood that Daniel et al teaches two raised portions 70 anticipating a second annular ridge and a third annular ridge), and a distal annular ridge (48D).
In regards to claim 4, Daniel et al teaches wherein the plurality of manifolds comprises a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge (paragraph [0087] states “the sidewall 61 of the post 44 of the support member 22 is configured with one or more raised portions 70 extending outwardly in the radial direction… with N plurality of bands 70, N+1 plurality of separate chambers 54 can be formed within the distal assembly 15 between the post 44 and the flex circuit 20” from which it is understood that Daniel et al teaches two raised portions 70 anticipating a second annular ridge and a third annular ridge, in addition to proximal annular ridge 48P and distal annular ridge 48D. Daniel et al teaches a plurality of manifolds 44, each manifold between adjacent annular ridges; thus, it is understood that with 4 annular ridges, there are 3 manifolds 44).
In regards to claim 10, Daniel et al teaches a catheter (Figures 1A-1B, 5A-6B) comprising:
an insertion shaft (14/81) extending along a longitudinal axis
an end effector (21 or 58) disposed at a distal end of the insertion shaft
a sheath (84) disposed around the insertion shaft
a flow diverter (Figures 5A-6B) disposed at a distal end of the sheath, the flow diverter comprising;
a proximal end (40) and a distal end (42)
a lumen (50) extending along the longitudinal axis from the proximal end to the distal end of the flow diverter
a plurality of annular ridges (48P/70/48D) disposed around the lumen between the proximal end and the distal end
a plurality of manifolds (44), each manifold being disposed between adjacent annular ridges of the plurality of annular ridges and comprising a plurality of fluid passageways (56), each fluid passageway extending from the lumen to an exterior of the flow diverter
In regards to claim 11, Daniel et al teaches wherein the plurality of manifolds diverts irrigation fluid from the lumen to the exterior of the flow diverter to distribute the irrigation fluid radially about the end effector (paragraph [0078]).
In regards to claim 12, Daniel et al teaches wherein the end effector comprises one or more electrodes (21) configured for tissue ablation (paragraph [0090]), and wherein the irrigation fluid cools the electrodes during ablation (paragraph [0089]).
In regards to claim 15, Daniel et al teaches wherein the plurality of annular ridges comprises a proximal annular ridge (48P), a second annular ridge, a third annular ridge (paragraph [0087] states “the sidewall 61 of the post 44 of the support member 22 is configured with one or more raised portions 70 extending outwardly in the radial direction… with N plurality of bands 70, N+1 plurality of separate chambers 54 can be formed within the distal assembly 15 between the post 44 and the flex circuit 20” from which it is understood that Daniel et al teaches two raised portions 70 anticipating a second annular ridge and a third annular ridge), and a distal annular ridge (48D).
In regards to claim 16, Daniel et al teaches wherein the plurality of manifolds comprises a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge (paragraph [0087] states “the sidewall 61 of the post 44 of the support member 22 is configured with one or more raised portions 70 extending outwardly in the radial direction… with N plurality of bands 70, N+1 plurality of separate chambers 54 can be formed within the distal assembly 15 between the post 44 and the flex circuit 20” from which it is understood that Daniel et al teaches two raised portions 70 anticipating a second annular ridge and a third annular ridge, in addition to proximal annular ridge 48P and distal annular ridge 48D. Daniel et al teaches a plurality of manifolds 44, each manifold between adjacent annular ridges; thus, it is understood that with 4 annular ridges, there are 3 manifolds 44).
In regards to claim 18, Daniel et al teaches wherein the distal end of the flow diverter comprises a distal aperture (Figures 5A-6B), the distal aperture forming a seal about an outer circumference of the end effector (58) disposed through the lumen (Figure 6A).
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 5-7, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al, as applied to claims 3-4, 10, and 15 above, and further in view of Sievers et al (US 2006/0142702).
In regards to claim 5, Daniel et al teaches wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge comprise a distal surface and a proximal surface (paragraph [0087] states “the sidewall 61 of the post 44 of the support member 22 is configured with one or more raised portions 70 extending outwardly in the radial direction… with N plurality of bands 70, N+1 plurality of separate chambers 54 can be formed within the distal assembly 15 between the post 44 and the flex circuit 20” from which it is understood that Daniel et al teaches two raised portions 70 anticipating a second annular ridge and a third annular ridge, in addition to proximal annular ridge 48P, each having a distal surface and a proximal surface); however, Daniel et al does not teach wherein each of the proximal surfaces are substantially convex and each of the distal surfaces are substantially concave, as Daniel et al instead teaches wherein the proximal surface of the proximal annular ridge is flat, the distal surface of the proximal annular ridge is substantially convex (Figures 5B-6B), the proximal surface of the second annular ridge is substantially convex, the distal surface of the second annular ridge is substantially convex (Figures 5B-6B), the proximal surface of the third annular ridge is substantially convex, and the distal surface of the third annular ridge is substantially convex (it is understood that the third annular ridge would have the same substantially convex distal and proximal surfaces as the second annular ridge 70 shown in Figures 5B-6B). Sievers et al teaches a flow diverter (Figures 1-2b) wherein each of a proximal annular ridge (11), a second annular ridge (21), and a third annular ridge (31) comprise a distal surface and a proximal surface, wherein each of the proximal surfaces are substantially convex and each of the distal surfaces are substantially concave (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the flow diverter, of Daniel et al, with each of the proximal surfaces are substantially convex and each of the distal surfaces are substantially concave, as taught by Sievers et al, as such will mean that in each case a portion of the fluid flowing out of the distal aperture will be redirected from the basic flow and led off to the side which reduces the rate of flow and causes a whirling motion to take place, wherein some of the outflowing fluid still passes through the fluid passageways directed towards the distal aperture along the basic direction of flow, but the stepwise separation of partial quantities of the flowing fluid at the annular ridges also achieves a rate reduction in the portion still flowing in the basic direction of flow (paragraph [0009]) to address the problems that can occur during the delivery of fluid, in particular blood, into the aortic arch or another vessel of the human body by the fluid emerging in a directed manner at a very high speed (paragraph [0002]).
In regards to claim 6, in the modified flow diverter of Daniel et al and Sievers et al, Daniel et al teaches wherein the distal annular ridge comprises a distal surface and a proximal surface (Figures 5B-6B); however, Daniel et al does not teach wherein both the distal surface and the proximal surface of the distal annular ridge are substantially convex, as Daniel et al instead teaches wherein the distal surface of the distal annular ridge is substantially concave and the proximal surface of the distal annular ridge is substantially convex (Figures 5B-6B). Sievers et al teaches a flow diverter (Figure 3) wherein both a distal surface and a proximal surface of a distal annular ridge (41) are substantially convex (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify both the distal surface and the proximal surface of the distal annular ridge, of the modified flow diverter of Daniel et al and Sievers et al, to be substantially convex, as taught by Sievers et al, as such will ensure that on the introduction of the flow diverter into a vessel, the risk of damage to the inner wall of the vessel is further reduced (paragraph [0040]).
In regards to claim 7, Daniel et al teaches wherein a diameter (D1) of the proximal annular ridge is greater than a diameter (DR) of the second annular ridge (Figures 5A-6B); however, Daniel et al does not teach the diameter of the second annular ridge is greater than a diameter of the third annular ridge, and the diameter of the third annular ridge is greater than a diameter of the distal annular ridge, as Daniel et al instead teaches the diameter of the second annular ridge is the same as a diameter of the third annular ridge (it is understood that the third annular ridge would have the same diameter DR as the second annular ridge 70 shown in Figures 5A-6B), and the diameter (DR) of the third annular ridge is less than a diameter (D1) of the distal annular ridge (Figures 5A-6B). Sievers et al teaches a flow diverter (Figures 1-2b) wherein a diameter of a second annular ridge (21) is greater than a diameter of a third annular ridge (31), and the diameter of the third annular ridge is greater than a diameter of a distal annular ridge (41) (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the flow diverter, of Daniel et al, with the diameter of the second annular ridge is greater than a diameter of the third annular ridge, and the diameter of the third annular ridge is greater than a diameter of the distal annular ridge, as taught by Sievers et al, as such will mean that in each case a portion of the fluid flowing out of the distal aperture will be redirected from the basic flow and led off to the side which reduces the rate of flow and causes a whirling motion to take place, wherein some of the outflowing fluid still passes through the fluid passageways directed towards the distal aperture along the basic direction of flow, but the stepwise separation of partial quantities of the flowing fluid at the annular ridges also achieves a rate reduction in the portion still flowing in the basic direction of flow (paragraph [0009]) to address the problems that can occur during the delivery of fluid, in particular blood, into the aortic arch or another vessel of the human body by the fluid emerging in a directed manner at a very high speed (paragraph [0002]).
In regards to claim 14, Daniel et al does not teach wherein a diameter of each annular ridge of the plurality of annular ridges decreases relative to one another from the proximal end to the distal of the flow diverter, as Daniel et al instead teaches wherein a diameter (DR) of the second annular ridge decreases relative to a diameter (D1) of the proximal annular ridge (Figures 5A-6B), a diameter of the third annular ridge is the same as the diameter of the second annular ridge (it is understood that the third annular ridge would have the same diameter DR as the second annular ridge 70 shown in Figures 5A-6B), and a diameter (D1) of the distal annular ridge is greater than the diameter (DR) of the third annular ridge (Figures 5A-6B). Sievers et al teaches a catheter (Figures 1-2b) wherein a diameter of each annular ridge of a plurality of annular ridges (11/21/31/41) decreases relative to one another from a proximal end to a distal of a flow diverter (1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify a diameter of each annular ridge of the plurality of annular ridges, of the catheter of Daniel et al, to decrease relative to one another from the proximal end to the distal of the flow diverter, as taught by Sievers et al, as such will mean that in each case a portion of the fluid flowing out of the distal aperture will be redirected from the basic flow and led off to the side which reduces the rate of flow and causes a whirling motion to take place, wherein some of the outflowing fluid still passes through the fluid passageways directed towards the distal aperture along the basic direction of flow, but the stepwise separation of partial quantities of the flowing fluid at the annular ridges also achieves a rate reduction in the portion still flowing in the basic direction of flow (paragraph [0009]) to address the problems that can occur during the delivery of fluid, in particular blood, into the aortic arch or another vessel of the human body by the fluid emerging in a directed manner at a very high speed (paragraph [0002]).
In regards to claim 17, Daniel et al teaches wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge comprise a distal surface and a proximal surface (paragraph [0087] states “the sidewall 61 of the post 44 of the support member 22 is configured with one or more raised portions 70 extending outwardly in the radial direction… with N plurality of bands 70, N+1 plurality of separate chambers 54 can be formed within the distal assembly 15 between the post 44 and the flex circuit 20” from which it is understood that Daniel et al teaches two raised portions 70 anticipating a second annular ridge and a third annular ridge, in addition to proximal annular ridge 48P, each having a distal surface and a proximal surface); however, Daniel et al does not teach wherein each of the proximal surfaces are substantially convex and each of the distal surfaces are substantially concave, as Daniel et al instead teaches wherein the proximal surface of the proximal annular ridge is flat, the distal surface of the proximal annular ridge is substantially convex (Figures 5B-6B), the proximal surface of the second annular ridge is substantially convex, the distal surface of the second annular ridge is substantially convex (Figures 5B-6B), the proximal surface of the third annular ridge is substantially convex, and the distal surface of the third annular ridge is substantially convex (it is understood that the third annular ridge would have the same substantially convex distal and proximal surfaces as the second annular ridge 70 shown in Figures 5B-6B). Sievers et al teaches a catheter (Figures 1-2b) wherein each of a proximal annular ridge (11), a second annular ridge (21), and a third annular ridge (31) comprise a distal surface and a proximal surface, wherein each of the proximal surfaces are substantially convex and each of the distal surfaces are substantially concave (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter, of Daniel et al, with each of the proximal surfaces are substantially convex and each of the distal surfaces are substantially concave, as taught by Sievers et al, as such will mean that in each case a portion of the fluid flowing out of the distal aperture will be redirected from the basic flow and led off to the side which reduces the rate of flow and causes a whirling motion to take place, wherein some of the outflowing fluid still passes through the fluid passageways directed towards the distal aperture along the basic direction of flow, but the stepwise separation of partial quantities of the flowing fluid at the annular ridges also achieves a rate reduction in the portion still flowing in the basic direction of flow (paragraph [0009]) to address the problems that can occur during the delivery of fluid, in particular blood, into the aortic arch or another vessel of the human body by the fluid emerging in a directed manner at a very high speed (paragraph [0002]).
Claims 8-9 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al, as applied to claims 1 and 18 above, and further in view of McClurken (US 7,311,708).
In regards to claim 8, Daniel et al does not teach wherein the flow diverter comprises an elastomeric material, as Daniel et al instead teaches wherein the flow diverter comprises plastic (paragraph [0006]). McClurken teaches a flow diverter (Figures 9-16) wherein the flow diverter comprises an elastomeric material (column 29, lines 54-58: silicone). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the flow diverter, of Daniel et al, to comprise an elastomeric material, as taught by McClurken, as such will conduct RF energy through a thickness and surface to the tissue to be treated by virtue of conductive fluid contained therewithin (column 29, lines 66-67, to column 30, lines 1-3).
In regards to claim 9, in the modified flow diverter of Daniel et al and McClurken, Daniel et al does not teach wherein the flow diverter comprises silicone, as Daniel et al instead teaches wherein the flow diverter comprises plastic (paragraph [0006]). McClurken teaches wherein the flow diverter comprises silicone (column 29, lines 54-58). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified flow diverter, of Daniel et al and McClurken, to comprise silicone, as taught by McClurken, as such will conduct RF energy through a thickness and surface to the tissue to be treated by virtue of conductive fluid contained therewithin (column 29, lines 66-67, to column 30, lines 1-3).
In regards to claim 19, Daniel et al does not teach wherein the seal comprises an elastomeric material, as Daniel et al instead teaches wherein the seal comprises plastic (paragraph [0006]). McClurken teaches a catheter (Figures 9-16) wherein a seal (26) comprises an elastomeric material (column 29, lines 54-58: silicone). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the seal, of the catheter of Daniel et al, to comprise an elastomeric material, as taught by McClurken, as such will conduct RF energy through a thickness and surface to the tissue to be treated by virtue of conductive fluid contained therewithin (column 29, lines 66-67, to column 30, lines 1-3).
In regards to claim 20, in the modified catheter of Daniel et al and McClurken, Daniel et al does not teach wherein the seal comprises silicone, as Daniel et al instead teaches wherein the seal comprises plastic (paragraph [0006]). McClurken teaches wherein the seal comprises silicone (column 29, lines 54-58). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the seal, of the modified catheter of Daniel et al and McClurken, to comprise silicone, as taught by McClurken, as such will conduct RF energy through a thickness and surface to the tissue to be treated by virtue of conductive fluid contained therewithin (column 29, lines 66-67, to column 30, lines 1-3).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al, as applied to claim 11 above, and further in view of Brucker et al (US 6,017,338).
In regards to claim 13, Daniel et al does not teach wherein the end effector is a guidewire, as Daniel et al instead teaches wherein the end effector is a tip electrode 21 or a flow director 58. Brucker et al teaches a catheter (Figure 1) wherein an end effector is a guidewire (42). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the end effector, of the flow diverter of Daniel et al, to be a guidewire, as taught by Brucker et al, as such will allow for ease of entry of the catheter into the heart or vascular system (column 8, lines 5-7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin C Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights