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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 4-6, 9, 11, 13-16, 25, 29, 67, 69, and 70 are objected to because of the following informalities:
There are numerous instances of limitations being introduced as “the” structure and therefore lacking antecedent basis (see for example claim 1 “the circumference,” “the axial length,” “the outer diameter”) that need correction
In claim 25, line 14: “the inflation lumen inflates” should be “the one or more inflation lumens inflate”
Appropriate correction is required.
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.
Claims 1, 2, 4-6, 9, 11, 25, and 67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gencheff et al (US 5256141).
Regarding claim 1, Gencheff discloses:
A device (Fig. 1) comprising: (a) a catheter (10) comprising: (i) a proximal end (12) and a distal end (20); (ii) a delivery lumen (28) that runs from the proximal end (12) of the catheter to a delivery port (50; Fig. 4) proximal to the distal end (20) of the catheter (10) (Col. 8:41-49); (iv) an elongate conductor (126) that runs from the proximal end (12) of the catheter to a lead (connection point within segment 16) proximal to the distal end (20) of the catheter (10) (Col. 6:41-58); and (v) an inflation lumen (132) that runs from the proximal end (12) of the catheter to an inflation port (port to balloon 18) proximal to the distal end (20) of the catheter (10); (b) a distal balloon (18) disposed about the catheter (10) over the distal inflation port and distal to the delivery port (50), wherein distal airflow through the inflation lumen (132) inflates the distal balloon (18) (Col. 6:65-68); and (c) an electrode (52) disposed about the catheter (10) proximal to the balloon (18), wherein the electrode (52) is connected to the lead (Col. 8:26-40).
Regarding claim 2, Gencheff discloses:
The device of claim 1, wherein the catheter further comprises: (iv) a bypass lumen (134) that runs from the proximal end (12) of the catheter (10) through the distal end (20) of the catheter (Col. 7:60-65).
Regarding claim 4, Gencheff discloses:
The device of claim 1, whereupon application of a voltage to the electrode generates an electric field and a corresponding current that flows radially relative to the catheter (Col. 8:25-35 – electrode 52 produces an electric current or field using power originating from input 26 along the conductor 126).
Regarding claim 5, Gencheff discloses:
The device of claim 1, wherein the electrode (52) is a mesh (Col. 8:28), a spiral, or a combination thereof.
Regarding claim 6, Gencheff discloses:
The device of claim 1, wherein the axial length of the electrode is from two-fold to 20-fold the outer diameter of the catheter (see Fig. 1).
Regarding claim 9, Gencheff discloses:
The device of claim 1, wherein the distal balloon (18) comprises an elastic material (Col. 7:5-10 – highly compliant polyethylene blended polymer).
Regarding claim 11, Gencheff discloses:
The device of claim 1, wherein the axial length of the distal balloon (18) is from one-fold to ten-fold the outer diameter of the catheter (Fig. 4).
Regarding claim 25, Gencheff discloses:
A device (Fig. 1) comprising: (a) a catheter (10) comprising: (i) a proximal end (12) and a distal end (20); (ii) a delivery lumen (28) that runs from the proximal end (12) of the catheter to a delivery port (50; Fig. 4) proximal to the distal end (20) of the catheter (Col. 8:41-49); (iv) an elongate conductor (126) that runs from the proximal end (12) of the catheter to a lead (connection point within segment 16) proximal to the distal end (20) of the catheter (Col. 6:41-49); and (v) one or more inflation lumens (130, 132) that run from the proximal end (12) of the catheter to a proximal inflation port (port to balloon 14) proximal to the delivery port (50) and a distal inflation port (port to balloon 18) distal to the delivery port (50), wherein the distal inflation port (port to balloon 18) is proximal to the distal end (20) of the catheter; (b) a proximal balloon (14) disposed about the catheter (10) over the proximal inflation port; (c) a distal balloon (18) disposed about the catheter (10) over the distal inflation port, wherein distal airflow through the inflation lumen (132) inflates the distal balloon (18); and (d) an electrode (52) disposed about the catheter (10) proximal to the balloon (18), wherein the electrode (52) is connected to the lead (Col. 8:26-40).
Regarding claim 67, Gencheff discloses:
A method of delivering an agent to a target cell in a hollow tissue (Col. 8:13-20, Col. 9:37-55), the method comprising: (a) providing a device (Fig. 1) comprising: (i) a catheter (10) comprising: a proximal end (12) and a distal end (20); a delivery lumen (28) that runs from the proximal end (12) of the catheter to a delivery port (50; Fig. 4) proximal to the distal end (20) of the catheter (10) (Col. 8:41-49); an elongate conductor (126) that runs from the proximal end (12) of the catheter to a lead (connection point within segment 16) proximal to the distal end (20) of the catheter (10) (Col. 6:41-58); and one or more inflation lumens (130, 132) that run from the proximal end (12) of the catheter to a proximal inflation port (port to balloon 14) proximal to the delivery port (50) and a distal inflation port (port to balloon 18) distal to the delivery port (50), wherein the distal inflation port (port to balloon 18) is proximal to the distal end (20) of the catheter; (ii) a proximal balloon (14) disposed about the catheter (10) over the proximal inflation port; (iii) a distal balloon (18) disposed about the catheter (10) over the distal inflation port; and (iv) an electrode (52) disposed about the catheter (10) proximal to the balloon (18), wherein the electrode (52) is connected to the lead (Col. 8:26-40); (b) positioning the electrode (52) within the hollow tissue (Col. 6:35-40), wherein the region of the hollow tissue radially adjacent to the electrode (52) comprises the target cell (Col. 6:35-40); (c) flowing an inflation medium distally through the one or more inflation lumens (130, 132) to inflate the proximal balloon (14) and the distal balloon (18) such that each of the proximal balloon (14) and distal balloon (18) contacts the hollow tissue (Col. 6:59-68); (d) introducing the agent through the delivery lumen (28) and the delivery port (50) such that the agent contacts the region of the hollow tissue radially adjacent to the electrode (Col. 8:15-25); and (e) while the proximal and distal balloons (14, 18) are inflated, transmitting electrical energy through the electrode (52) at conditions suitable for electrotransfer of the agent into the target cell (Col. 5:38-55, Col. 9:29-45).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gencheff in view of Cartledge et al (US 2003/0120206).
Regarding claim 13, Gencheff discloses the device of claim 1 but is silent regarding “the distal balloon is a thin-walled polyurethane tube running from a proximal step down in the catheter to a distal step up in the catheter, wherein the outer diameter of the deflated distal balloon is substantially flush with the outer diameter of the catheter.” However, Cartledge teaches a balloon catheter device (Figs. 2-7), thus being in the same field of endeavor, with a balloon (18) made from polyurethane (¶0025). The balloon (18) spans from a proximal step down (32) to a distal step up (34) of the catheter body (12). The resulting structure of the balloon results in a deflated balloon (18; Fig. 2) that is flush with the with the outer diameter of the catheter (¶0032). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the balloon of Gencheff to comprise a polyurethane material and to be formed to result in a flush deflated balloon as taught by Cartledge in order to reduce tissue trauma during insertion and withdrawal of the device, as recognized by Cartledge (¶0032).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gencheff in view of Nazarova et al (US 2001/0019762).
Regarding claim 14, Gencheff discloses the device of claim 1 but is silent regarding “the distal balloon comprises a lubricious coating.” However, Nazarova teaches a balloon catheter device (Fig. 1), thus being in the same field of endeavor, with a lubricious coating (15) on the outside of the balloon (14) to reduce friction to more easily insert the device into a patient’s vessels (¶0025). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the balloon of Gencheff to incorporate a lubricious coating as taught by Nazarova in order to more easily insert the device into a patient’s vessels, as recognized by Nazarova.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gencheff in view of Stone et al (US 2015/0327836).
Regarding claim 15, Gencheff discloses the device of claim 1 but is silent regarding “a pressure sensor.” However, Stone teaches a balloon catheter device (200; Fig. 2), thus being in the same field of endeavor, that uses pressure sensors (206, 210) to sense the fluid pressure around the balloon during inflation (¶0036) and thereby monitor the pressure exerted by the balloon during use (¶0037). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the balloon of Gencheff to incorporate a pressure sensor as taught by Stone to provide sufficient structure to monitor the balloon during inflation, as recognized by Stone.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gencheff in view of Gerrans et al (US 2012/0259215).
Regarding claim 16, Gencheff discloses the device of claim 1 but is silent regarding “the catheter comprises an inner tube and an outer tube, wherein one or more inner lumens are disposed within the inner tube and one or more outer lumens are disposed between the outer wall of the inner tube and the inner wall of the outer tube.” However, Gerrans teaches a balloon catheter device (Figs. 2A, 2B), thus being in the same field of endeavor, with an inner tube (26) and an outer tube (24) with lumens (40, 44) disposed within the inner tube (26) and other lumens (36) disposed between the inner tube (26) and outer tube (24) in order to apply precise control over fluid delivery in the device (¶0055). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the balloon of Gencheff to incorporate an inner tube and an outer tube with inner lumens disposed in and between them as taught by Gerrans in order to provide sufficient structure to apply precise control over fluid delivery in the device, as recognized by Gerrans.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gencheff in view of Hagness et al (US 2020/0030602).
Regarding claim 29, Gencheff discloses the device of claim 25 but is silent regarding “a single inflation lumen that runs to both the proximal inflation port and the distal inflation port.” However, Hagness teaches a balloon catheter device (Fig. 3), thus being in the same field of endeavor, with a single inflation lumen (36) that runs to a proximal balloon (38b) and a distal balloon (38a) (¶0041). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter of Gencheff to have a single inflation lumen as taught by Hagness in order to provide sufficient structure to simplify the number of lumens needed in the device.
Claims 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Gencheff in view of Mann et al (US 5922687).
Regarding claim 69, Gencheff discloses the method of claim 67 but is silent regarding “the agent is a nucleic acid vector.” However, Mann teaches a balloon catheter device (Fig. 4B), thus being in the same field of endeavor, that delivers a nucleic acid solution (340) to a target area (334) enclosed between two balloons (332A, 332B) (Col. 7:39-53) in order to alter the functioning of a target cell (Col. 3:24-26). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Gencheff to incorporate a nucleic acid vector as the agent as taught by Mann in order to provide a therapy that alters the function of a target cell, as recognized by Mann.
Regarding claim 70, Gencheff in view of Mann discloses the method of claim 69, wherein the nucleic acid vector is expressed in the hollow tissue (Mann; Col. 3:24-40).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
