DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below. Regarding Applicant’s arguments with respect to positioning the blood detector of Shaw on the tapered end, the Examiner respectfully disagrees. The rejection has been updated to clarify the design choice motivation for the positioning, but the grounds of rejection with respect to said positioning are unchanged. Shaw sets forth that the side port 98 is “typically” located 5 cm from the distal tip. This does not teach away from moving the opening to be on the tapered portion, and provides no criticality as to why it must be located on a non-tapered portion at the claimed distance. Regarding Applicant’s arguments with respect to claim 24, the detection and flushing ports are taught by Ginn and are not defined in terms of their function. They are openings into the dilator and can be used to detect blood, but can also be used to flush the dilator as they’re fully capable of receiving any type of fluid for any desired function. The claim only requires the structure of two sets of openings, which are known from Ginn. Furthermore, the openings of Ginn are considered to be positioned at alternating circumferential locations around an exterior as claimed and as depicted by Ginn in Figure 10 as they are spaced around the circumference of the dilator and are offset axially. Regarding Applicant’s arguments as to amended claim 27, the Examiner respectfully disagrees. Previously, the claim was being examined wherein the graduated markings were sensors. However, the claim, as amended, has removed the connection to the control unit. The scope of the claim now requires graduated markings on the outer surface of the sheath to be connected to a control unit. However, the only disclosed use of the graduated markings in the instant specification is for visual inspection of insertion depth (see ¶¶ [0066]-[0067] of the instant specification). There is no disclosed connection means to any control unit or any structure which would allow the markings to be connected to any system at all. They are only disclosed as visual markings. For this reason, the claim now lacks written description support, and is now considered indefinite as it is unclear how visual markings could be connected to a control unit at all. Regarding the location of the flushing ports of claim 27, it is clear from Ginn that both sets of ports are “adjacent” a distal end of the dilator. The claim sets forth no specific distance which might further limit the term “adjacent” and as both sets of ports are to be inserted during use, they are on the working distal end of the dilator and are therefore considered adjacent. Regarding claims 38 and 39, the Examiner thanks applicant for pointing out the typographical error in the rejection statement to leave off Ginn as a cited reference (though it is noted that it is included in the body of the rejection). It has been resolved below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 27, 38, and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 27 has been amended to state that “each graduated marking of the linear array of graduated markings is connected to the control unit….” There is no disclosure of connecting the graduated markings to any control system. The markings are only disclosed (see e.g., instant ¶¶ [0066] and [0067]) as being markings on the outer surface of the sheath. The disclosure therefore has support for visual markings (e.g., printed or etched as is known in the art) and makes no mention of how they could conceivably be connected to a control system as claimed. Therefore, the limitation lacks written description support as one of ordinary skill would have no basis for how this might be achieved given the disclosure. Claims 38 and 39 are rejected due to their dependence upon claim 27.
Claims 27, 38, and 39 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.
As above, the amended claim attempts to connect visual markings to a control unit and provides no means for accomplishing such a connection. The disclosure fails to provide any support for such a system and such a connection would not be understood by one of ordinary skill given the disclosure. For this reason, the scope of the claim is indefinite as it is not clear how such a connection is made or what structure is required to achieve such a connection. Claims 38 and 39 are rejected due to their dependence upon claim 27. For the purposes of examination, the claims will be examined as if there is a opening forming the blood detector as per claim 1, and that the monitoring steps can be performed without a control system (e.g., by visual inspection).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 4, 9-10, 13-14, 23, 41, and 46-47 is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Shaw (US 5,431,639) in view of Gregersen (US 2009/0192435) in view of Huber (US 2,748,769), and further in view of Nance et al. (US 2008/0215008).
Regarding claim 1, Shaw discloses (Figure 3) a medical device comprising: A medical device comprising: a sheath (90) having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end (Figure 3); and a removable dilator (88) having a distal end and a proximal end comprising a dilator hub (on the proximal end), the dilator having at least one blood inlet opening (98) disposed on the distal end of the dilator, the dilator comprising at least one opening at the distal tapered end (lumen 110 passes through the tapered distal tip of the dilator for passing the guidewire therethrough as depicted in Figure 6; guidewire 105 extends from the distal tip of the dilator and through the proximal hub 80) the lumen (110 into port 80; Figure 3) in fluid communication with a port (80) in the dilator hub (at the proximal end of the dilator; Figure 3), whereby liquid is transferable between the opening in the distal tapered end of the dilator and the port in the dilator hub (the lumen 110, which provides a path for the guidewire to locate the dilator at the target site, is fully capable of conveying fluid therethrough as it is open along the entire length of the device), wherein the lumen (110) extends the entire length of the dilator (Figures 3 and 6; it can be seen that the lumen extends from the distal tip through the top hub portion to provide a path for the guidewire from outside the dilator through the distal tip of the device) and is adapted for tracking over a guide wire (Col. 12, lines 21-44), wherein the blood inlet opening is in fluid communication with a blood outlet at the proximal end of the dilator (e.g., through connected lumen 112 and out 82 at the proximal end; Col. 12, lines 44-50), and the dilator is positionable within the sheath such that a tapered portion of the distal end of the dilator extends through the opening in the distal end of the sheath (e.g., Figures 1b or 3), the proximal end of the dilator extends through the opening in the proximal end of the sheath (Figures 1b and 3), and at least a portion of the at least one blood inlet opening is adjacent to the distal end of the sheath (e.g., Figure 3, it can be seen to be positioned on the distal end of the device), the tapered portion further comprising a skive disposed distally of the blood inlet opening (the opening is formed by a skived cut and will therefore comprise a portion distal of the opening as claimed as per Col. 12, lines 59-64). Shaw fails to explicitly disclose the elliptical cross-section, the blood inlet opening on the tapered distal portion, and the luer connector comprising two connection sites (Shaw does teach that hub 80 comprises a luer connector; see Col. 12, lines 37-41).
Gregersen teaches (Figures 3d and 3c) a medical tubing comprising a skived opening (44) having an elliptical shaped cross- section (¶¶ [0044], [0054], and [0064]) and at least one opening (32b) on the distal end of the tubing in communication with an internal lumen of the medical device (¶ [0049], the device comprises an opening for the guidewire to extend therefrom).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the circular cross section of Shaw by providing the elliptical cross-section of Gregersen so as to control the flow dynamics of fluid entering or exiting the opening as taught by Gregersen. Gregersen further teaches that such a method and shape of forming an opening, via a skived cut, in tubular medical device is known in the art of medical catheters for providing fluid access to individual lumens during multi-lumen catheter manufacture.
Regarding the location of the blood inlet opening, Shaw places it proximal of the distal tip as depicted in Figure 3, and does not locate the opening on the tapered distal tip section.
Huber teaches a medical device (needle 10) comprising a blood inlet opening (at 16, Figure 2, blood is able to flow into the opening) formed on a tapered distal section of the needle body (Figure 2; Col. 3, lines 14-19).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dilator of Shaw to comprise the blood inlet opening on the tapered distal tip section of the dilator so as to provide a means for allowing fluid communication between the piercing end of the dilator and the proximal hub of the dilator. Such a modification allows for the visibility of flashback into the needle to indicate early positioning of the dilator within the vasculature (via the opening being on the tip rather than axially offset), while providing the utility of delivering a fluid through the distal tip section if desired. Huber further teaches that a primary lumen also passes through the distal end tip for performing desired procedural tasks (e.g., Col. 3, lines 7-19)
As above, Shaw/Gregersen/Honda fail to explicitly disclose the dilator comprising a luer connection (though Col. 12, lines 37-40 disclose each hub has a luer connection) having two connection sites and at least one valve for controlling flow passing through the at least one of the two connection sites for providing fluid insertion and extraction through the dilator (e.g., for providing a saline flush as per ¶ [0094]).
Nance teaches (Figure 19) a sheath-dilator assembly (1918, 1916) comprising a plurality of three-way stopcock valves (1920) connected to a proximal end of the sheath and comprising two connection sites (the three-way valves comprise two inlets and one outlet) for controlling fluid flow through the assembly, as well as a valve (unlabeled) connected to the dilator (1916).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dilator of Shaw/Gregersen to provide one of the three-way stopcock assemblies of Nance so as to allow for additional connections for flushing or instrument insertion through the dilator as taught by Nance (e.g., ¶ [0090]). In this manner, the flash chamber of Shaw/Gregersen could be connected through one of the stopcock ports to maintain its intended function, with the additional utility of being able to flush the dilator before or after a procedure as taught by Nance (see e.g., ¶¶ [0098]-[0099]).
Regarding claim 4, Shaw further discloses (Figure 3) wherein the sheath (90) further comprises one or more depth indicators (92) affixed thereto.
Regarding claim 9, Shaw further discloses (Figure 3) wherein the sheath (90) further comprises a hub (e.g., handle portion 86) at the proximal end of the sheath, the sheath hub releasably engaged with the dilator hub (e.g., the sheath or plug is left inside and the dilator removed as per Col. 8, lines 59-62).
Regarding claim 10, Shaw further discloses wherein the blood outlet is in the dilator hub (Col. 12, lines 44-50 disclose the blood inlet opening being connected to lumen 112 to reach indicator 108 in the hub).
Regarding claim 13, Shaw further discloses wherein the depth indicators include graduation marks (92; Figure 3).
Regarding claim 14, Shaw/Gregersen/Huber/Nance teach a luer connector (disclosed by Shaw for port 80) extending from the port in the dilator hub, the luer connector extending from the port in the dilator hub, the luer connector creating a fluid pathway between the port and at least one of a 2 and 3 way tap (in the cited combination, the three-way stopcock of Nance would be attached to either port 80 or 82 of the hub of Shaw thereby providing means for connecting various devices to either port or to provide flow means for flushing the dilator or sheath before or after use as set forth above for claim 1).
Regarding claim 23, Shaw further discloses the use of radiopaque markers on the dilator (Col. 17, lines 42-44 disclose that radiopaque markers can be used for positioning or confirmation).
Regarding claim 41, Shaw further discloses wherein the dilator hub (114) provides fluid communication between a reservoir and the dilator (e.g., through adapter at proximal end of 80), and wherein the sheath hub provides fluid communication between a fluid source and the sheath (the proximal end of the sheath is open and as such can provide fluid communication as claimed).
Regarding claim 46, the modified device of Shaw/Huber comprises a blood inlet opening on the tapered section of the distal tip (e.g., Figure 2 of Huber) which enters the same lumen as the outlet (Figure 2). Therefore, the combination presents a single lumen providing for inflow through an opening as well as a primary use as an outlet. The guidewire function of the device of Shaw would be maintained within the primary lumen with the additional utility of allowing flashback through the lumen to indicate proper positioning of the dilator within the vasculature.
Regarding claim 47, The oval opening of the cited combination is considered to meet this limitation as it is currently set forth since any direction of the opening can be considered aligned in a circumferential direction as claimed. The claim does not require the major axis to extend along an axis orthogonal to the longitudinal axis of the dilator or some other reference point.
Claim 16-18, 21, and 44 is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Shaw in view of Gregersen in view of Huber in view of Nance, and further in view of Malek (US 2009/0287118).
Regarding claim 16, Shaw/Gregersen/Huber/Nance teach the claimed invention substantially as set forth above for claim 14, but fail to explicitly disclose the linear array of sensors.
Malek teaches a medical device for insertion into a tissue of a patient which comprises an array of pressure sensors (114, ¶¶ [0025] and [0026]; the cited paragraphs set forth an electromechanical sensor array as the pressure measuring device) connected via fiber optic cables along the outer surface of the device (the cited paragraphs disclose the sensors on the device and the fiber optic cable passing through the lumen as claimed).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the sheath of Shaw to comprise a linear array of sensors along its length so as to allow a user to sense physical parameters via the outer surface of the sheath during use as taught by Malek (¶¶ [0025] and [0026]).
Regarding claim 17, Shaw further discloses wherein the sheath hub includes an interface connectable to an endovascular device (the sheath hub is considered fully capable of being connectable to an endovascular device as claimed since it simply comprises a sheath body and proximal handle/hub assembly).
Regarding claim 18, Shaw further discloses wherein the endovascular device is a closure device (the endovascular device is not positively recited and all the claim requires is the ability of the sheath hub to receive any desired endovascular device, which it is fully capable of doing). Furthermore, in accordance to MPEP § 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e., the embedding of the sensors in the outer surface of the sheath, does not depend on its method of production, i.e., via extrusion. See In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
Regarding claim 21, Shaw/Gregersen/Huber/Nance teach the claimed invention as set forth above for claim 1, and Malek teaches a linear array of sensors located along an outer surface of the sheath (114, ¶¶ [0025] and [0026]; the cited paragraphs set forth an electromechanical sensor array as the pressure measuring device) connected via fiber optic cables along the outer surface of the device (the cited paragraphs disclose the sensors on the device and the fiber optic cable passing through the lumen as claimed); wherein the linear array of sensors is an array of tissue type pressure sensors (¶ [0020] discloses the sensors as pressure sensors and it’s used within an intervertebral disc as per ¶ [0046] which represents a tissue type though it’s understood that it is fully capable of use in any tissue).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the sheath of Shaw to comprise a linear array of sensors along its length so as to allow a user to sense physical parameters via the outer surface of the sheath during use as taught by Malek (¶¶ [0025] and [0026]).
Regarding claim 44, Malek further teaches wherein each sensor of the linear array of sensors is capable of detecting blood flow (they’re pressure sensors and are therefore capable of sensing any pressure applied thereto, from any source, including blood).
Claim 24 and 48 is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Ginn (US 7,144,411) in view of Malek.
Regarding claim 24, Ginn discloses (Figures 10 and 11) a medical device comprising: a sheath (212) having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end (Figures 10-11); and a removable dilator (214) having a distal end and a proximal end, the dilator being positionable within the sheath such that the tapered portion of the distal end of the dilator extends through the opening in the distal end of the sheath (Figure 11), the proximal end of the dilator extends through the opening in the proximal end of the sheath (Figure 11), wherein the dilator further includes a plurality of flushing ports (253; the ports are fully capable of being used for flushing) disposed adjacent the distal end of the sheath when the dilator is positioned within the sheath, and a plurality of detector ports (249; Col. 9, lines 1-6) being disposed distally from the plurality of flushing ports (Figure 10, flushing ports 253 are proximal to the detector ports 249), separate from the flushing ports, and wherein the plurality of flushing ports and plurality of detector ports are positioned at alternating circumferential locations around an exterior circumference of the removable dilator (ports 253 extend around the circumference of the dilator as seen in Figure 10; they can be considered to alternate either axially or radially relative to the circumference of the dilator). Ginn fails to explicitly disclose a linear array of sensors.
Malek teaches a medical device for insertion into a tissue of a patient which comprises a linear array of pressure sensors (114, ¶¶ [0025] and [0026]; the cited paragraphs disclose the sensor as an electromechanical sensor array wherein at least two sensors will be spaced from each other to form the array) and wherein the linear array of sensors are calibrated with respect to each other such that a distance between adjacent sensors is known, and such that changes in sensor readings associated with penetrating the skin of a patient may be referenced with respect to other sensors to indicate the depth of penetration into an artery (it appears as if the claim is attempting to claim a method of use of a structure within a device claim; there is no structure claimed which might perform the reading of the pressure values such as a processor or control system to make the depth determination, and for this reason, all that is required by the claim is the presence of a linear array of sensors which is known from Malek; it applicant wishes to limit the linear array to perform the claimed function, it should be set forth as: “…a processor configured detect changes in sensor readings associated with penetrating the skin…”; absent such language, the claim only requires the structure of the linear array of sensors, and the distance between adjacent sensors would be known for forming the array before installing on the catheter).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the sheath of Ginn to comprise a linear array of sensors along its length so as to allow a user to sense physical parameters via the outer surface of the sheath during use as taught by Malek (¶¶ [0025] and [0026]). Furthermore, the electromechanical sensor array of Malek would have been fully capable of being calibrated as the array is disclosed as being used as a pressure sensor. It would be routine to ensure that all elements of the sensor array are working within the desired specification during design and testing of the sensor array before it is installed on the medical device. This allows the user confidence that the sensor array is providing accurate pressure readings which are essential to the proper performance of a medical procedure.
Regarding the location of the detection ports on the tapered portion of the distal end, it would have been obvious to locate the detector ports on a tapered portion of the distal end of the dilator (see e.g., portion 232 which is tapered as claimed) since Ginn teaches the location of the side ports along the shaft and it would therefore be obvious to one of ordinary skill in the art to position them on the tapered portion if desired for a procedure. There is no evidence of record that establishes that placing the detection ports on the tapered end of the dilator would have any effect on the function of the device of Ginn. Furthermore, a person having ordinary skill in the art 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 location. Finally, applicant has not disclosed that the claimed location of the detector ports on a tapered distal end of the dilator would solve any stated problem, indicating that the ports “are suitable for blood detection in view of their location on the tapered section…” (see e.g., ¶ [0069]). The disclosure provides no unexpected reason or statement defining the necessity of the location beyond the location being suitable, and therefore there appears to be no criticality placed on the location as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to place the detector ports on the distal tapered end of the dilator as an obvious matter of design choice within the skill of the art.
Regarding claim 48, Ginn discloses the claimed plurality of flushing and detector ports, and further depicts three of each in Figure 10, but fails to explicitly disclose that there are exactly three of each port. Regarding the number of ports, it would have been obvious to utilize exactly three openings for the detector ports and flushing ports. There is no evidence of record that establishes that such a number of ports would have any effect on the function of the device of Ginn. Furthermore, a person having ordinary skill in the art 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 location. Finally, applicant has not disclosed that the claimed number of ports would solve any stated problem, indicating that the ports “having distinct blood inlet hole configurations…two holes…three holes…or four holes” (see e.g., ¶ [0076]). Therefore, there appears to be no criticality placed on the number of holes as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to use three flushing ports and three detector ports, as an obvious matter of design choice within the skill of the art.
Claim 27 is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Shaw in view of Ginn, and further in view of Elkins et al. (US 2005/0245892).
Regarding claim 27, Shaw discloses (Figures 6a-6d) a method of positioning a medical device at an arteriotomy puncture site (it’s an insertion at the femoral artery; Col. 6, lines 25-28), comprising: inserting a distal end of a dilator (88) releasably engaged with a sheath (90) having depth indicators (92) thereon into an artery of a patient (e.g., femoral artery as disclosed in Col. 6, lines 25-28), the dilator including at least one blood detector (98) positioned on the distal end of the dilator (Figure 6), the depth indicators comprising graduated markings disposed on an outer surface of the sheath arranged in a linear array (92, Col. 12, lines 3-15 disclose the array of markings for determining the depth of insertion of the dilator and sheath); the at least one blood detector comprising: a first blood detector (the same detector 98); extending the distal end of the dilator a required distance through an opening in the distal end of the sheath (Figure 6a; Col. 14, lines 56-62), the required distance being gauged by referencing the graduated markings (Col. 15, lines 13-27); monitoring the first blood detector for a signal indicating entry of the first blood detector into the artery contemporaneously with inserting the dilator into the artery (Col. 14, lines 56-62); referencing the position of the sheath with respect to the artery based on the location of the sheath and based on the graduated markings with respect to the patient upon generation of the signal indicating entry of the blood detector into the artery (Col. 14, lines 56-62 disclose inserting the device until blood flows through the side port indicating the dilator is located in the vessel; Col. 15, lines 13-20 disclose the use of the depth marks for determining the measurement of the skin level to the vessel wall); and disengaging the dilator from the sheath (see e.g., Figure 6c; Col. 15, lines 49-53). Shaw fails to explicitly disclose the blood detector being on a tapered distal end of the dilator, the plurality of flushing ports for flushing the dilator, the second blood detector, and the monitoring steps determining entry into the puncture site via the second blood detector.
Ginn et al. (henceforth Ginn) teaches a dilator member (214, Figure 10) comprising a blood detector formed as a first blood detector (one of 249) and a second blood detector (one of ports 253) located proximally from the first blood detector (Figure 10); flushing ports (others of 249) on a distal end thereof (Figure 10), and further discloses the step of flushing the sheath device with saline (Col. 7, lines 7-9 disclose using the flush port to flush the sheath of blood or bodily fluid; Col. 8, lines 23-26 disclose using a flush line to communicate with lumen 216 of the sheath); monitoring the first blood detector (one of 249) for a signal indicating entry of the first blood detector into the artery contemporaneously with inserting the dilator into the artery (Col. 9, lines 6-10 disclose placing the first detector into the vessel and receiving a visual indication while the second detector is not in the vessel; Figures 12-13); monitoring the second blood detector (one of 253) for a signal indicating entry of the second blood detector and further indicating that the distal end of the sheath is positioned at the puncture site (Col. 9, lines 1-13 disclose using first and second detectors, aligned with ports 242, 250 for observing the insertion depth of the device into the vessel via visual inspection of “backbleed” which will only occur at one of the detectors or both depending on the depth as depicted in Figures 12-13).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dilator of Shaw to comprise the plurality of flushing ports taught by Ginn so as to allow a means of providing a fluid conduit through the dilator for receiving fluid during a procedure as taught by Ginn. In addition, it would have been obvious to one of ordinary skill in the art to utilize the monitoring method of Ginn so as to provide feedback to a user, during an insertion procedure, that the device is properly placed, at the desired depth, via observed flashback of blood through the detector ports as taught by Ginn.
Shaw/Ginn fail to explicitly disclose flushing the dilator during a procedure.
Elkins et al. (henceforth Elkins) teaches a sheath dilator system comprising a sheath (110) and a dilator (102, 106, 116), and wherein the dilator is flushed during a procedure with a flush port (¶ [0109] discloses flushing saline through the dilator (stiff tube is element 106 of dilator) during a procedure; see also ¶¶ [0104]-[0105] which disclose the saline flush).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Shaw/Ginn to provide a flushing means to the dilator, as taught by Elkins, so as to provide a means of flush the dilator to ensure the system is operating as intended and is free of any unwanted material before insertion during a procedure as taught by Elkins.
Claims 38 and 39 is/are rejected under pre-AlA35 U.S.C. 103(a) as being unpatentable over Shaw in view of Ginn in view of Elkins, and further in view of Willard et al. (US 5,219,335).
Regarding claim 38, Shaw/Ginn/Elkins teach the claimed invention substantially as set forth above for claim 27, but fail to explicitly disclose the use of marker bands formed from iridium.
Willard et al. (henceforth Willard) teaches a catheter assembly (Figure 1) comprising marker bands (33) which are formed from iridium for imaging the catheter end during use (Col. 4, lines 3-12).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the depth markers on the shaft of Shaw/Ginn/Elkins to comprise iridium bands swaged onto the shaft as Willard teaches that such elements and method of attachment are sufficient for installing marker bands on a catheter device for use in a procedure so as to reference the location of the shaft during said procedure. Furthermore, in a method of use of a device, in accordance to MPEP § 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e., a dilator comprising an iridium marker band, does not depend on its method of production, i.e., the bands being swaged onto the outer surface of the sheath. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
Regarding claim 39, Shaw/Ginn/Elkins/Willard teach the claimed invention substantially as set forth above for claim 38, but fail to explicitly disclose the spacing and width of the markers. There is no evidence of record that establishes that changing the width or spacing of the prior art markers would result in a difference in function of the cited prior art device. Furthermore, one of ordinary skill in the art being faced with modifying the dilator of Shaw/Ginn/Elkins/Willard would have a reasonable expectation of success in making such a modification and it appear the device would function as intended being given the claimed width and spacing of the markings. Lastly, applicant has not disclosed that the claimed width or spacing solves any stated problem (apart from being designed to allow a user to determine the depth of penetration, which is the same intended use of the markings of the prior art) indicating that “the markers may have a width of 3mm” (see ¶ [0085]) or that the spacing is used only to allowing an operator to advance the sheath a specific distance such as 20 mm as per ¶¶ [0066]-[0067]). Therefore, there appears to be no criticality placed on the width or distance of the markers beyond their intended use which is identical to that of the prior art. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to space the markers at the claimed distance of about 3 mm and space the markers a distance of 20 mm as an obvious matter of design choice based upon the end procedural use of the device within the skill of the art.
Claim 45 is/are rejected under pre-AlA35 U.S.C. 103(a) as being unpatentable over Shaw in view of Gregersen in view of Nance, and further in view of Weaver et al. (US 6,770,066).
Regarding claim 45, Regarding claim 45, Shaw/Gregersen/Nance disclose the lumen as an internal guidewire lumen (Col. 12, lines 39-50), and a first lumen (112) disposed on a first side of the internal guidewire lumen (Figure 3a), but fail to explicitly disclose the second lumen on an opposite side.
Weaver et al. (henceforth Weaver) teaches (Figure 15) a multi-lumen medical device comprising a central guidewire lumen (55), a first lumen (57) disposed on a first side of the internal guidewire lumen, and a second lumen (58) disposed on an opposite side of the internal guidewire lumen (Figure 15; Col. 11, lines 49-62 disclose the three lumen).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sheath dilator system of Shaw/Gregersen/Nance to comprise an additional lumen on an opposite side of the guidewire lumen so as to provide additional utility to the dilator device such as allowing for the infusion of a fluid through the lumen as taught by Weaver. It is noted that Weaver discloses that lumen 58 is used for inflation fluid, however, the lumen may be used for the passage of any fluid through the shaft and need not be connected to an inflatable member to provide the additional utility.
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.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783