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
This office action is responsive to the amendment filed on 05/19/2026. As directed by the amendment: claims 1, 4, 12, 14 have been amended; claims 3, 13 have been canceled; and new claims 21-22 have been added. Thus, claims 1-2, 4-12, 14-22 are presently pending in this application.
Response to Arguments
Applicant’s argument pages 6-7 of the remarks filed 05/19/2026 that Potter fails to disclose the amended limitation in claim 1. Applicant’s argument has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection has been made, as seen below.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, 10, 12, 14, 18, 20-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Farnan et al. (US 2023/0116038).
Regarding claim 1, Farnan discloses
A catheter (100, figs. 1-5, 7-10, pars. 0088-0168) comprising:
a control handle (300, fig. 1 and par. 0090);
a catheter shaft (102) coupled to the control handle (300) and extending from the control handle (see fig. 1 and par. 0090), the catheter shaft (102) having a proximal end (104) coupled to the control handle (300) and a distal end (106) located opposite the proximal end (104, see fig. 1);
a pull wire band (216/222) coupled to the catheter shaft (102, see fig. 2), wherein at least a portion of the pull wire band is exposed to an environment outside of the catheter shaft (see fig. 2); and
a pull wire (212/214/218/220, fig. 5) extending from the control handle (300, figs. 7-8 and par. 0096) and through the catheter shaft (102) to the pull wire band (216/222);
wherein a portion of the pull wire band (216/222) is embedded in the catheter shaft (102, see figs. 2 and 5).
Regarding claim 4, Farnan discloses
The catheter of claim 1, wherein the portion of the pull wire band (216/222, fig. 5) that is exposed to the environment outside of the catheter shaft (102, fig. 5) is radially recessed relative to an outer surface of the catheter shaft (see fig. 5), and defines a radially outermost portion of the catheter at a location of the pull wire band (see fig. 5).
Regarding claim 5, Farnan discloses
The catheter of claim 1, wherein the pull wire band (216/222) includes an additional layer (outer layer of 216/222) having an outer surface that is substantially flush with an outer surface of the catheter shaft (see fig. 5).
Regarding claim 6, Farnan discloses
The catheter of claim 5, wherein the additional layer (outer layer of 216/222) is formed of the same material as a remainder of the pull wire band (216/222, fig. 5).
Regarding claim 10, Farnan discloses
The catheter of claim 1, wherein the pull wire band (216/222) is coupled to the distal end of the catheter shaft (see figs. 1 and 5 for 216 and 222 located at the distal end 106 of the catheter shaft 102).
Regarding claim 12, Farnan discloses
The catheter of claim 11, wherein the pull wire band (216/222) is part of a steering system for deflecting and steering the distal end of the catheter (pars. 0094-0096), wherein the steering system includes the pull wire band (216/222), the pull wire (212/214/218/220), and an actuating mechanism (304/306) at the control handle (300).
Regarding claim 14, Farnan discloses
The catheter of claim 12, wherein the actuating mechanism (304/306) includes a control knob (304/306), wherein the control knob is coupled to the pull wire (212/214/218/220, fig. 8) such that when the control knob is rotated, the pull wire is tensioned, and the distal end of the catheter flexes (see figs. 1, 5, 7-9 and pars. 0106-0107).
Regarding claim 18, Farnan discloses
The catheter of claim 1, wherein the catheter (100) is a delivery catheter (via lumen 120).
Regarding claim 20, Farnan discloses
The catheter of claim 1, wherein the catheter shaft is a flexible polymer shaft (pars. 0101-0102).
Regarding claim 21, Farnan discloses
A catheter (100, figs. 1-5, 7-10, pars. 0088-0168) comprising:
a control handle (300, fig. 1 and par. 0090);
a catheter shaft (102) coupled to the control handle (300) and extending from the control handle (see fig. 1 and par. 0090), the catheter shaft (102) having a proximal end (104) coupled to the control handle (300) and a distal end (106) located opposite the proximal end (104, see fig. 1);
a pull wire band (216/222) coupled to the catheter shaft (102, see fig. 2), wherein at least a portion of the pull wire band is exposed to an environment outside of the catheter shaft (see fig. 2); and
a pull wire (212/214/218/220, fig. 5) extending from the control handle (300, figs. 7-8 and par. 0096) and through the catheter shaft (102) to the pull wire band (216/222);
wherein the pull wire band (216/222) includes an additional layer (outer layer of 216/222) having an outer surface that is substantially flush with an outer surface of the catheter shaft (see fig. 5), and wherein the additional layer (outer layer of 216/222) is formed of the same material as a remainder of the pull wire band (216/222, fig. 5).
Regarding claim 22, Farnan discloses
A catheter (100, figs. 1-5, 7-10, pars. 0088-0168) comprising:
a control handle (300, fig. 1 and par. 0090);
a catheter shaft (102) coupled to the control handle (300) and extending from the control handle (see fig. 1 and par. 0090), the catheter shaft (102) having a proximal end (104) coupled to the control handle (300) and a distal end (106) located opposite the proximal end (104, see fig. 1);
a pull wire band (216/222) coupled to the catheter shaft (102, see fig. 2), wherein at least a portion of the pull wire band is exposed to an environment outside of the catheter shaft (see fig. 2); and
a pull wire (212/214/218/220, fig. 5) extending from the control handle (300, figs. 7-8 and par. 0096) and through the catheter shaft (102) to the pull wire band (216/222);
wherein the portion of the pull wire band (216/222, fig. 5) that is exposed to the environment outside of the catheter shaft (102, fig. 5) is radially recessed relative to an outer surface of the catheter shaft (see fig. 5), and defines a radially outermost portion of the catheter at a location of the pull wire band (see fig. 5)
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.
Claim(s) 2, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 2023/0116038).
Regarding claim 2, Farnan discloses the catheter of claim 1, as set forth above, except for wherein between 60% to 90% of an outer surface of the pull wire band is exposed to the environment outside of the catheter shaft.
Farnan only discloses that the outer surface of the pull wire band (216/222, fig. 5) being exposed to the environment outside of the catheter shaft (see fig. 5).
There is no evidence of record that establishes that changing the exposed outer surface of the pull wire band would result in a difference in function of the Farnan device. Further, a person having ordinary skill in the art, being faced with modifying the exposed outer surface of the pull wire band would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed percentage.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the exposed outer surface of the pull wire band to be between 60% to 90% as an obvious matter of design choice within the skill of the art.
Regarding claim 8, Farnan discloses the catheter of claim 5, as set forth above, except for wherein the additional layer extends between 20% to 30% around a circumference of the catheter shaft.
Farnan only discloses that the outer surface of the pull wire band (216/222, fig. 5) extending around a circumference of the catheter shaft (see fig. 5).
There is no evidence of record that establishes that changing the outer surface of the pull wire band would result in a difference in function of the Farnan device. Further, a person having ordinary skill in the art, being faced with modifying the outer surface of the pull wire band would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed percentage.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the outer surface of the pull wire band to extend between 20% to 30% as an obvious matter of design choice within the skill of the art.
Claim(s) 7, 9, 11, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 2023/0116038) in view of Potter (US 2009/0163915).
Regarding claim 7, Farnan discloses the catheter of claim 6, as set forth above, except for wherein the additional layer is formed at least in part from an electrically conductive material.
However, Potter teaches a pull wire band (25a) with an additional layer (31a) formed at least in part from an electrically conductive material (par. 0028).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan’s pull wire band to have electrically conductive material, as taught by Potter, for the purpose of providing treatment to the tissue as needed (par. 0005 of Potter).
Regarding claim 9, Farnan discloses the catheter of claim 1, as set forth above, except for wherein the pull wire band includes openings spaced circumferentially apart.
However, Potter teaches a pull wire band (30) including openings (36) spaced circumferentially apart (see fig. 2 and par. 0024).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan’s pull wire band to include openings, as taught by Potter, for the purpose of allowing fluid flow therefrom (par. 0024 of Potter).
Regarding claim 11, Farnan discloses the catheter of claim 1, as set forth above, except for wherein the pull wire band is an electrode.
However, Potter teaches a pull wire band (25a) with an electrode (par. 0028)
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan’s pull wire band to be an electrode, as taught by Potter, for the purpose of providing treatment to the tissue as needed (par. 0005 of Potter).
Regarding claim 15, Farnan discloses the catheter of claim 1, as set forth above, except for further comprising an electrode wire coupled to the pull wire.
However, Potter teaches an electrode wire (fig. 1, par. 0031, claim 28) coupled to the pull wire (26).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan’s pull wire band to be an electrode and having pull wires, as taught by Potter, for the purpose of providing energy to provide treatment to the tissue as needed (par. 0005 of Potter).
Regarding claim 16, Farnan discloses the catheter of claim 15, as set forth above, except for wherein the electrode wire is coupled to the pull wire within the control handle.
However, Potter teaches an electrode wire (fig. 1, par. 0031, claim 28) coupled to the pull wire (26) within the control handle (par. 0031 and claim 28).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan’s pull wire band to be an electrode and having pull wires, as taught by Potter, for the purpose of providing energy to provide treatment to the tissue as needed (par. 0005 of Potter).
Regarding claim 17, Farnan discloses the catheter of claim 1, as set forth above, except for wherein the pull wire band is formed at least in part from an electrically conductive material.
However, Potter teaches a pull wire band (25a) formed at least in part from an electrically conductive material (par. 0028).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan’s pull wire band to have electrically conductive material, as taught by Potter, for the purpose of providing treatment to the tissue as needed (par. 0005 of Potter).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan et al. (US 2023/0116038) in view of Subramaniam et al. (US 2021/0031006).
Regarding claim 19, Farnan discloses the catheter of claim 18, as set forth above, except for wherein the delivery catheter includes a stopcock.
However, Subramaniam teaches a delivery catheter including a stopcock (pars. 0021 and 0026).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Farnan by adding a stopcock, as taught by Subramaniam, for the purpose of allowing the operator to open and close the fluid pathway as needed (par. 0026 of Subramaniam).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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