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 . Claims 1-5 are currently pending.
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 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 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elkins et al. US Publication 2005/0245892 (hereinafter Elkins).
Regarding claim 1, Elkins discloses a catheter sheath flushing system comprising: an elongated catheter sheath comprising a proximal end and a distal end (170), the elongated catheter sheath configured to be inserted into a patient body distal end first (Figure 13A); and a flushing portion (30) selectively detachable from the elongated catheter sheath (the sheath is detachable and attachable via 34/35), the flushing portion comprising an elongate body surrounding a lumen sized to receive a manipulable portion of a catheter therein (42 where the catheters 152, 154, 156 can all fit within in it as per Figures 2-3, 11a-14b), the lumen extending between a proximal end portion of the elongate body and a distal end portion of the elongate body (the lumen extends from the entrance opening at 40 to the distal end’s opening near 36), the distal end portion of the elongated body selectively detachable from the elongated catheter sheath at a location at least proximate the proximal end of the elongated catheter sheath (the sheath not shown in Figures 2-3, 5-6 attaches at the distal end of the elongated body at the ring 35), wherein the elongate body comprises a first port located distally from the proximal end portion of the elongate body (48) and a second port located proximally from the distal end portion of the elongate body (the opening at the end of the lumen 70 of 68 opposing 54 as per Figure 6 where it connects to the interior lumen 66), each of the first port and the second port in fluid communication with the lumen (Figure 6), wherein the first port or the second port is configured to be a fluid inlet port for fluid introduced into the flushing portion to reduce occurrences of gas present in the lumen (as the ports are in fluid communication with each other they are fully capable of allowing flushing of a gas/fluid through them without any additional structural modification), and wherein the other of the first port or the second port that is configured to be the fluid inlet port is configured to be a fluid outlet port for fluid introduced into the flushing portion to reduce occurrences of gas present in the lumen (the ports again are structurally fully capable of affording flow in either direction and can afford flushing of a fluid or gas as desired).
Regarding claim 4, Elkins discloses a transducer-based device ([0128] which details chemical sensors).
Regarding claim 5, Elkins discloses an implant (152, 154, 156, which are catheters and can be considered an implant).
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 non-obviousness.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Elkins in view of Kordis et al. US Patent 6,233,491 (hereinafter Kordis).
Regarding claim 2, Elkins discloses the catheter (152, 154, 156), but is silent on any further detail. Kordis discloses the catheter (now positively claimed, see elements 152, 154, 156 of Figures 16-17), where the manipulable portion (154) is configurable between an unexpanded configuration in which the manipulable portion is sized to be deliverable through the flushing portion (Figure 17), and an expanded configuration in which the manipulable portion is sized too large to be deliverable through the flushing portion (Figure 16). It would have been obvious to the skilled artisan before the effective filing date to utilize the catheter specifics as taught by Kordis with the system of Elkins as predictable results would have ensued (allowing the introduced catheter to ablate/sense as is known in the art).
Regarding claim 3, Elkins teaches an actuator (388) operatively coupled to the manipulable portion [of Kordis, rendered obvious above] by at least one control element (386). Kordis additionally discloses an actuator operatively coupled to the manipulable portion by at least one control element configured to transmit force from the actuator to the manipulable portion to move the manipulable portion between the expanded configuration and the unexpanded configuration (actuator 20, control element 22, manipulable portion 24, see Figure 1). It would have been obvious to the skilled artisan before the effective filing date to utilize the catheter specifics as taught by Kordis with the system of Elkins as predictable results would have ensued (allowing the introduced catheter to ablate/sense as is known in the art).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794