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 .
Election/Restrictions
Claims 5-11, 14-16, 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 13, 2026.
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, 2 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altman et al (6,086,582).
Regarding claim 1, Altman et al provide a system comprising a catheter (14, 20, 22) including a portion configured to deliver ablation therapy to an area of interest (i.e. via electrode (114) and an aperture (116,118,120,122) configured to deliver a therapeutic agent to the area of interest. There is also a workstation (26) coupled to the catheter (Figure 1a) including a therapy ablation source coupled to the catheter (via leads 34 and 28) coupled to the catheter, and a fluid source (16) also coupled to the workstation and coupled to the apertures of the catheter. The workstation includes a controller including a memory configured to generate and deliver ablation energy when appropriate (col. 6, lines 4-9) and to deliver a therapeutic agent to the area of interest (col. 6, lines 9-14).
Regarding claim 2, the ablation therapy source may be an RF energy source (Abstract, for example).
Regarding claim 17, Altman et al provide a method comprising applying an ablation therapy to an area if interest (Abstract, for example) and delivering a therapeutic agent to the area of interest (Abstract) via an aperture (116, for example) defined on a distal portion of the catheter. The aperture is in fluid communication with a fluid source (16) as seen in Figure 1a.
Claims 1, 2, 4 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nardella (5,342,357).
Regarding claim 1, Nardella provides a system comprising a catheter (30) including a portion (32,34) configured to deliver ablation therapy to tissue, and an aperture (36) configured to deliver a therapeutic agent to the area of interest. There is a workstation (100 – Figure 11) including an ablation therapy source (102) and a fluid source (shown in Figure 12) the work station including a memory and processor to control the delivery of RF energy to tissue and to control the delivery of the therapeutic agent to tissue. See, for example, column 7, lines 24-45.
Regarding claim 2, Nardella provides an RF generator (102 – Figure 11). Regarding claim 4, the interior portion of the catheter provides a lumen defining a cooling channel which is connected to the fluid source (Figure 12).
Regarding claim 17, Nardella provides a method comprising applying ablation energy (i.e. RF energy) to an area of interest, the ablation therapy delivered by a portion of the catheter coupled to the RF source. Nardella also provides the step of delivering a therapeutic agent (i.e. coolant) to the area of interest via an aperture (36) in communication with the fluid source.
Claims 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falwell et al (8,961,509).
Regarding claim 17, Falwell et al provide a method of treating tissue comprising delivering ablation energy to an area of interest (see Ablation Energy Generator in Figure 1), the ablation energy delivered by a portion of the catheter (144). Falwell et al also disclose delivering a therapeutic agent to the area of interest via an aperture (4620, 4650 – Figure 56, for example) where the aperture is in communication with the fluid source. See, also, columns 37 and 38 which discusses the delivery of fluids, including drugs, to the tissue area.
Regarding claim 18, Falwell disclose delivering a therapeutic agent to the area of interest through the aperture where the therapeutic agent delivery tube (4710) is disposed on an outer surface of the catheter. See, for example, Figures 57-59 and column 38, lines 22-38.
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 3, 12, 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nardella (5,342,357) in view of the teaching of Falwell et al (8,961,509).
Nardella provides a system including a catheter and a workstation to control the delivery of energy and the delivery of fluid to a tissue site. Nardella provides an interior channel to deliver a therapeutic agent (i.e. cooling fluid), but fail to disclose a tube on an exterior surface of the catheter for delivery of a therapeutic agent.
Falwell et al discloses another catheter system including an electrode for treating tissue and means to deliver a therapeutic agent to tissue. In particular, Falwell et al specifically teach that the tube for delivering a therapeutic agent may be located on the external surface of the catheter (Figures 57-59 as addressed previously). It is noted that Falwell et al expressly teach that the external delivery tube may be used in conjunction with internal tubes that also deliver a fluid to tissue. See, for example, column 38, lines 22-38.
To have provided the Nardella device with a lumen on an external surface of the catheter for providing a therapeutic agent to tissue would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Falwell et al fairly teach the use of a therapeutic agent delivery lumen on the external surface of an energy delivery catheter that may also be used in conjunction with an internal fluid delivery lumen of the energy delivery catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. LePivert (2010/0274178) discloses another catheter device having an external lumen for delivery of a therapeutic agent. See, for example, Figures 4A and 4B. Sanders et al (7,708,733) discloses another system comprising a catheter having an electrode at the distal end and an external tube (239 – Figure 4) for providing a fluid to the treatment area. Sanders et al also disclose a controller to control energy and fluid delivery. Rittman, III et al (6,575,969) provide another device comprising a cooling channel and a distal energy delivery element, the system including a controller that controls the delivery of the coolant and the delivery of energy. See Figure 6 and associated discussion. Altman et al (6,416,510) discloses another catheter device to delivery RF energy and a therapeutic agent to tissue and is substantially similar to the Altman et al (‘582) reference cited in the rejection above. Panescu et al (5,735,846) disclose another system comprising a catheter with a distal electrode to treat tissue and a means to circulate a cooling fluid, the system including a controller to control the delivery of energy and the cooling fluid.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/July 23, 2026
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