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
The amendment filed on 07/27/26 has been entered in the case. Claims 1-4, 6-12, 16-20 & 22 are pending for examination and claims 5, 13-15, 21 & 23 are cancelled.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “the outer surface” (of the tip member) in line 23 lacks antecedent basis. Appropriate correction is required.
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.
Claims 1, 4, 6-12, 16-20 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shimogami et al. (US 2010/0094258) in view of Whitman et al. (US 9,055,971), Plassman et al. (US 2015/0258306) and Kelly (US 5,879,342).
Regarding claim 1, Shimogami discloses a catheter, comprising:
an elongate shaft body 10 extending from a proximal end 14 to a distal end 48 and defining an inner lumen 16; the shaft body 10 including a liner 32, a braid member 38, a multi-layer coil member 40a-40b & 51 surrounding at least a portion of the liner 32 and the braid member 38; and an outer polymer cover 28 surrounding the multi-layer coil member 40a & 40b, see Fig. 6; wherein the multi-layer coil member 40a & 40b comprises first and second coil layers 40 a & 40b wound in opposing directions, Figs. 3 & 6;
a tip member 12 comprised of a metallic composition (#30, tungsten power is mixed into the tip 12, para [0053]) disposed at the distal end of the shaft body 10, the tip member 12 comprises a non-tapered proximal portion (region 44 in Fig. 8) and a tapered distal portion (region 46 in Fig. 8); wherein the outer polymer cover 28 terminates proximal to the tip member (Fig. 8);
wherein the distal end of the liner 32 and the multi-layer coil member 51 (e.g., the coil member 51 is a part of the multi-layer coil member 40a-40b & 51) extend beyond the distal end of the shaft body 10 and into a proximal end 50 of the tip member 12;
wherein a polymer layer 46/12 (made of polyurethan, para [0053]) separate from the outer polymer cover 28 (made of polyamide, para [0051]) surrounds the multi-layer coil member (e.g., coil 51) within the tip member
Shimogami does not disclose that:
a) the elongate shaft having a first set of helical threads; wherein the first set of helical threads positioned around a distal end portion of the shaft body and extends radially outward, the first set of helical threads having a first thread pitch, the tip member having a second set of helical threads; the tapered distal portion includes some or all of the second set of helical threads;
b) the tip member comprises a void space between the inner surface of the polymer layer and the multi-layer coil member.
c) wherein the first set of helical threads positioned around a distal end portion of the shaft body and extends radially outward, the first set of helical threads having a first thread pitch, wherein the second set of helical threads is separate from the first set of helical threads, and extends radially outward from the outer surface of the tip member, the second set of one or more helical threads having a second thread pitch that is different from the first thread pitch; the first set of helical threads and the second set of helical threads each has a shape and radial height sufficient to provide a longitudinal pull on a blood vessel or a stenosis located therein when rotated within the blood vessel;
d) wherein the first set of helical threads is formed from a synthetic fiber having a fully-round cross-sectional shape having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover.
Modification part a & c) above:
Whitman discloses a trocar/catheter, in Figs. 3A-4C comprising: an elongate shaft body 202/302 having a first set of helical threads 210/310 positioned around a distal portion of the shaft body and extends radially outward form the body of the trocar/catheter, the first set of helical threads having a first thread pitch; a tip member 204/304 & 306 having a second set of helical threads 208/314; wherein the tip member comprising a tapered distal portion 204/306; the tapered distal portion including some or all of the second set of helical threads 208/314; wherein the second set of helical threads is separate from the first set of helical threads, and extends radially outward from the outer surface of the tip member, the second set of one or more helical threads having a second thread pitch that is different from the first thread pitch. Whitman further discloses that the first the first set of helical threads and the second set of helical threads each has a shape, i.e., coil shaped and radial height sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel.
Note: with regarding the limitation, i.e., … to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel, is a functional limitation and only requires to performing a function. In this case, the claimed invention does not require any parameters of the height of the first and second helical threads. Therefore, if the helical threads/coils are provided an outer surface of the shaft body with any radial height level, then the helical threads/coils sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel. Similarly, the first the first set of helical threads and the second set of helical threads in Whitman that each has a shape, i.e., coil shaped and radial height and therefore, the first and second helical threads sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Shimogami with providing a first set and second set of helical threads; wherein a first thread pitch of the first set of the helical threads is different from a second thread pitch of the second set of the helical threads, a tapered distal portion provided in the tip member, as taught by Whitman, in order to have sufficient torque transmission capability from the catheter device and to support rotational advancement without drag and avoid bunching or damage a body lumen of a patient.
Note: Examiner relies on the teaching of Whitman that the first and second set of helical threads are having different pitches and being provided on the outer surface of elongate shaft body and the tip member of the catheter. Examiner does not use the teaching of electro-mechanical driver device in the trocar in Whitman to apply in Shimogami’s device.
Having said above, the first and second helical threads in Whitman sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel. Therefore, Shimogami in view of Whitman discloses that the first and second helical threads (as modified by Whitman) sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel.
Modification part b) above: the tip member comprises a void space between the inner surface of the polymer layer and the multi-layer coil member.
Shimogami in view of Whitman does not disclose that the tip member comprises a void space between an inner surface of the polymer layer and the multi-layer coil member.
Plassman discloses a catheter 100 comprising: an elongate shaft body 102; a polymer layer 104/114 comprises a void space between an inner surface 114 of the polymer layer 104 and a coil member 120/122 to enhance the flexibility and torsional properties of the shaft body, see Fig. 1-2, also see Figs. 5-6 for similar feature, e.g., the void space is located in between the inner surface and the coil member.
Given the teaching of Plassman, a person having ordinary skill in the art would have easily recognized that modifying the device of Shimogami in view of Whitman to obtain a space between the coil members (or a void spaced between an inner surface of the polymer layer and the coil members), as taught by Plassman, would provide the benefits of enhancing the flexibility and torsional properties of the shaft body.
Modification part d) above: wherein the first set of helical threads is formed from a synthetic fiber having a fully-round cross-sectional shape having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover.
Shimogami in view of Whitman and Plassman does not disclose that limitations: wherein the first set of helical threads (located outside of the shaft body) is formed from a synthetic fiber having a fully-round cross-sectional shape having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover and wherein the first set of helical threads is inlaid in the outer polymer cover after being thermally bonded to the outer polymer cover.
Note: the product-by-process limitation “… after being thermally bonded” (to the outer polymer cover) has not been given weight in determining the patentability of the device claim. See MEPE §2113. However, the prior art Kelly teaches a method of thermally bonded in between the helical threads to the polymer cover, as below.
Kelly discloses that a method of manufacture of engaging a helical structure 36, in Figs. 2-6, formed of a synthetic fiber, col. 5, lines 43-47, comprises a step of engaging the helical threads 36 over and inlaid (partially inlaid at portion 43 to portion 36, as shown in Fig. 4) in an outer polymer cover 31 after being thermally bonded (via thermal source, i.e., heater, in Figs. 2-3) to the polymer cover 31, see Fig. 4.; wherein a fully-round cross-sectional shape of the helical threads having a diameter in a range of 0.0005”-0.012” (0.0127-0.3048 mm), or preferably ranging from 0.001”-0.004” (0.0254-0.1016 mm), which is in the required range of 0.05-0.2mm in the claimed invention, col. 5, lines 56-67.
Note: Examiner relies on the teaching of Kelly that the helical structure being thermally bonded and inlaid partially in the polymer cover 31.
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It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of McFerran in view of Whitman, Parkerichandran, and Plassman by providing a helical thread diameter of 0.0005”–0.012” (0.0127–0.3048 mm), or preferably 0.001”–0.004” (0.0254–0.1016 mm). This overlaps with the required range of 0.05–0.2 mm in the claimed invention. Furthermore, as taught by Kelly (col. 5, lines 56–67), it would have been obvious to bond (thermally bond) and inlay the helical threads completely or partially within the outer polymer cover. This modification minimizes the profile or overall outside diameter of the catheter to meet the dimensional limitations of the human body lumen, while also ensuring a secure bond between the helical threads and the outer cover.
In addition, with regarding to the limitation that: the a fully-round cross-sectional shape of the first set of helical threads having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover, Applicant states in lines 22-26 of page 7 in the original specification of the current application or in para [0032] of the PGPub 2021/0015517 of the current application that: the one or more helical threads 420 include a polymer member wound around the polymer cover 440. The polymer member can be a strip of a synthetic fiber, such as nylon or polyester, having a fully-round cross-sectional shape of about 0.05 mm-0.2 mm in diameter prior to being bonded to the polymer cover 440. The polymer member can have a melting temperature higher than a melting temperature of the polymer cover 440 so that the helical threads 420 can be thermally bonded to, and inlaid in, the polymer cover 440.
The applicant does not state any reasons or benefits for selecting a helical thread diameter of 0.05–0.2 mm. Therefore, selecting a reasonable diameter prior to bonding the thread to the polymer cover would have been a routine design choice. The applicant has not disclosed how this specific range solves a stated problem or serves a particular purpose. Furthermore, as demonstrated by Kelly or other prior art references, the invention appears to perform equally well with any reasonable thread diameter.
Regarding claim 4, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter. Shimogami discloses that the multi-layer coil member includes multiple elongate strands having a fully-round transverse profile, see Figs. 3, 6-8.
Regarding claims 6-7, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter. Shimogami discloses that the braid member includes a plurality of inter-braided, metallic elongate strands along its length that form multiple strand crossings, wherein the elongated strands are axially spaced apart, see Fig. 4.
Regarding claim 8, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter. Shimogami discloses that the braid member includes a plurality of elongate strands would helically in opposite directions, see Fig. 4.
Regarding claim 9, Shimogami in view of Whitman, Plassman & Kellydiscloses all claimed subject matter. Shimogami discloses that a distal end of the braid member 30/30a extends beyond the distal end of the shaft body, see Fig. 8
Regarding claim 10, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter. Shimogami discloses that the braid member includes a plurality of elongate strands having a rectangular transverse profile, Fig. 4.
Regarding claim 11, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention except for the rectangular transverse profile includes a thickness directed radially, the thickness being in the range of 0.010 mm to 0.015 mm, inclusive. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the values of thickness of the braid member in the claim 11, since it has been held that discovering these values of a result effective variable involves only routine skill in the art. For example: small thickness of the braid member for reducing cost, reducing the occupy in the catheter wall but enhancing more flexibility in the catheter tube.
Regarding claim 12, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention. Shimogami discloses that a proximal portion of the shaft body is configured to be less flexible than a distal portion of the shaft body (e.g., the proximal section 22, the middle section 20, and the distal section 18 of the catheter body 11 have flexibility which increases in a step-like manner in that order, para [0050]).
Regarding claim 16, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention. Shimogami discloses that the tip member 12 has increased flexibility relative to the shaft body 11, para [0058].
Regarding claim 17, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention. It appears in Fig. 2 in Shimogami shows that the inner lumen 16 has a constant diameter that extends from the proximal end of the shaft body to the distal end of the shaft body. In addition, a person skilled in the art would recognize that providing a constant diameter to obtain constant flow rate of the fluid when entering the lumen of the shaft body.
Regarding claim 18, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention. Shimogami discloses that wherein the tip member 12 includes a lumen that is coaxial with the inner lumen 16, see Fig. 2.
Regarding claim 19, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention. Shimogami discloses that wherein the inner lumen 16 and the lumen are configured to receive a guidewire, para [0017]
Regarding claim 20, Shimogami in view of Whitman, Plassman & Kelly discloses all claimed subject matter as required in the claimed invention. Shimogami discloses that the proximal end 15 of the shaft body 11 is configured to connect to hub. It appears to Examiner that the hub is a luer hub, see Fig. 1. In addition, it is well-known in the art to provide a luer hub to secure connection, prevent leaks and ensure device compatibility.
Regarding claim 22, this claim uses the same analysis as noted above with regard to the limitation in claim 1 (e.g., the first set of helical threads has a diameter of about 0.05 millimeters to about 0.2 millimeters prior to being bonded to the outer surface).
Claims 1-4, 9, 12, 16-20 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over McFerran et al. (US 7,621,904) in view of Whitman et al. (US 9,055,971), Parker et al. (US 6,939,337), Plassman et al. (US 2015/0258306) & Kelly (US 5,879,342).
Regarding claim 1, McFerran discloses a catheter comprising:
an elongate shaft body 12 extending from a proximal end 34 to a distal end 24 and defining an inner lumen 20; the shaft body 10 including a liner 36, a multi-layer coil member 64 surrounding at least a portion of the liner 36, and an outer polymer cover 38/42 surrounds the multi-layer coil member 64;
tip member 18 comprised of a metallic composition (e.g., coil 68) disposed at the distal end 46 of the shaft body 12; the tip member comprises a non-tapered proximal portion 66 and a tapered distal portion 60, wherein the outer polymer cover 38/42 terminates proximal to the tip member;
wherein a distal end of the liner 36 and the multi-layer coil member 64/68 extend beyond the distal end of the shaft body and into a proximal end 46 of the tip member 18; wherein a polymer layer 40/48 separate from the outer polymer cover 38/42 surrounds the multi-layer coil member 68 within the tip member
McFerran does not disclose that:
a) the elongate shaft having a first set of helical threads; the tip member having a second set of helical threads; wherein the first set of helical threads positioned around a distal end portion of the shaft body and extends radially outward, the first set of helical threads having a first thread pitch, wherein the second set of helical threads is separate from the first set of helical threads, and extends radially outward from the outer surface of the tip member, the second set of one or more helical threads having a second thread pitch that is different from the first thread pitch; the first set of helical threads and the second set of helical threads each has a shape and radial height sufficient to provide a longitudinal pull on a blood vessel or a stenosis located therein when rotated within the blood vessel;
b) a braid member being covered by the multi-coil member
c) the multi-layer coil member comprises first and second coil layers wound in opposing directions
d) the tip member comprises a void space between an inner surface of the polymer layer and the multi-layer coil member
e) wherein the first set of helical threads is formed from a synthetic fiber having a fully-round cross-sectional shape having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover.
Modification part a & c) above:
Whitman discloses a trocar/catheter, in Figs. 3A-4C comprising: an elongate shaft body 202/302 having a first set of helical threads 210/310 positioned around a distal portion of the shaft body and extends radially outward form the body of the trocar/catheter, the first set of helical threads having a first thread pitch; a tip member 204/304 & 306 having a second set of helical threads 208/314; wherein the tip member comprising a tapered distal portion 204/306; the tapered distal portion including some or all of the second set of helical threads 208/314; wherein the second set of helical threads is separate from the first set of helical threads, and extends radially outward from the outer surface of the tip member, the second set of one or more helical threads having a second thread pitch that is different from the first thread pitch. Whitman further discloses that the first the first set of helical threads and the second set of helical threads each has a shape, i.e., coil shaped and radial height sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel.
Note: with regarding the limitation, i.e., … to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel, is a functional limitation and only requires to performing a function. In this case, the claimed invention does not require any parameters of the height of the first and second helical threads. Therefore, if the helical threads/coils are provided an outer surface of the shaft body with any radial height level, then the helical threads/coils sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel. Similarly, the first the first set of helical threads and the second set of helical threads in Whitman that each has a shape, i.e., coil shaped and radial height and therefore, the first and second helical threads sufficient to provide a longitudinal pull on a blood vessel of a stenosis located therein when rotated within the blood vessel.
It would have been obvious to a person having ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the McFerran device to include a first set of helical threads on the shaft body and a second set of helical threads at the tapered distal portion. As taught by Whitman, the first thread pitch is different from the second thread pitch. This modification provides sufficient torque transmission for the catheter device, supports rotational advancement without drag, and prevents bunching or damaging the patient's body lumen.
Note: Examiner relies on the teaching of Whitman that the first and second set of helical threads are having different pitches and being provided on the outer surface of elongate shaft body and the tip member of the catheter. Examiner does not use the teaching of electro-mechanical driver device in the trocar in Whitman to apply in McFerran’s device.
As discussed above, the first and second helical threads in Whitman are sufficient to provide a longitudinal pull on a blood vessel at a stenosis located therein when rotated within the blood vessel. Therefore, McFerran in view of Whitman discloses that the first and second helical threads (as modified by Whitman) are sufficient to provide a longitudinal pull on a blood vessel at a stenosis located therein when rotated within the blood vessel.
Modification part b) above: the coil member is surrounding the braid member
Parker discloses a catheter comprising: an elongate shaft body 11 extending from a proximal end to a distal end and defining an inner lumen; the shaft body 11 having a braid member 14; a multi-layer coil member 22 surrounding the braid member 14; wherein the multi-layer coil member comprises first and second coil layers wound in opposing directions, see Fig. 2.
Note: in prior art Parker, the coil is designated as element 14, and the braid is designated as element 16. Both elements 14 and 16 are formed of medical-grade metal (col. 6, lines 11–18). Element 16 has a circular cross-section, whereas element 14 is formed of a flat wire cross-section. A person skilled in the art would recognize that elements 14 and 16 are interchangeable. In this case, element 14 is shown as a flat wire and is equivalent to the claimed “braid member”, while element 16 [or 22] is shown as a coil (or multi-layer coil) and is equivalent to the claimed “coil member” or “multi-layer coil member”.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of McFerran in view of Whitman by providing a braid member covered by a multi-layer coil member, wherein the multi-layer coil member comprises first and second coil layers wound in opposing directions, as taught by Parker, in order to impart stiffness, pushability, and torqueability to the shaft body and to resist kinking during use.
Modification part d) above: the tip member comprises a void space between an inner surface of the polymer layer and the multi-layer coil member
Plassman discloses a catheter 100 comprising: an elongate shaft body 102; a polymer layer 104/114 comprises a void space between an inner surface 114 of the polymer layer 104 and a coil member 120/122 to enhance the flexibility and torsional properties of the shaft body, see Fig. 1-2, also see Figs. 5-6 for similar feature, e.g., the void space is located in between the inner surface and the coil member.
Given the teaching of Plassman, a person having ordinary skill in the art would have easily recognized that modifying the device of McFerran in view of Whitman & Parker to obtain a space between the coil members (or a void spaced between an inner surface of the polymer layer and the coil members), as taught by Plassman, would provide the benefits of enhancing the flexibility and torsional properties of the shaft body.
Modification part e) above: wherein the first set of helical threads is formed from a synthetic fiber having a fully-round cross-sectional shape having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover.
McFerran in view of Whitman, Parker & Plassman does not disclose that limitations: wherein the first set of helical threads (located outside of the shaft body) is formed from a synthetic fiber having a fully-round cross-sectional shape having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover and wherein the first set of helical threads is inlaid in the outer polymer cover after being thermally bonded to the outer polymer cover.
Note: the product-by-process limitation “… after being thermally bonded” (to the outer polymer cover) has not been given weight in determining the patentability of the device claim. See MEPE §2113. However, the prior art Kelly teaches a method of thermally bonded in between the helical threads to the polymer cover, as below.
Kelly discloses that a method of manufacture of engaging a helical structure 36, in Figs. 2-6, formed of a synthetic fiber, col. 5, lines 43-47, comprises a step of engaging the helical threads 36 over and inlaid (partially inlaid at portion 43 to portion 36, as shown in Fig. 4) in an outer polymer cover 31 after being thermally bonded (via thermal source, i.e., heater, in Figs. 2-3) to the polymer cover 31, see Fig. 4.; wherein a fully-round cross-sectional shape of the helical threads having a diameter in a range of 0.0005”-0.012” (0.0127-0.3048 mm), or preferably ranging from 0.001”-0.004” (0.0254-0.1016 mm), which is in the required range of 0.05-0.2mm in the claimed invention, col. 5, lines 56-67.
Note: Examiner relies on the teaching of Kelly that the helical structure being thermally bonded and inlaid partially in the polymer cover 31.
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It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of McFerran in view of Whitman, Parker, and Plassman by providing a helical thread diameter of 0.0005”–0.012” (0.0127–0.3048 mm), or preferably 0.001”–0.004” (0.0254–0.1016 mm). This overlaps with the required range of 0.05–0.2 mm in the claimed invention. Furthermore, as taught by Kelly (col. 5, lines 56–67), it would have been obvious to bond (thermally bond) and inlay the helical threads completely or partially within the outer polymer cover. This modification minimizes the profile or overall outside diameter of the catheter to meet the dimensional limitations of the human body lumen, while also ensuring a secure bond between the helical threads and the outer cover.
In addition, with regarding to the limitation that: the a fully-round cross-sectional shape of the first set of helical threads having a diameter in a range of 0.05 to 0.2 millimeters prior to being bonded to the outer polymer cover, Applicant states in lines 22-26 of page 7 in the original specification of the current application or in para [0032] of the PGPub 2021/0015517 of the current application that: the one or more helical threads 420 include a polymer member wound around the polymer cover 440. The polymer member can be a strip of a synthetic fiber, such as nylon or polyester, having a fully-round cross-sectional shape of about 0.05 mm-0.2 mm in diameter prior to being bonded to the polymer cover 440. The polymer member can have a melting temperature higher than a melting temperature of the polymer cover 440 so that the helical threads 420 can be thermally bonded to, and inlaid in, the polymer cover 440.
The applicant does not state any reasons or benefits for selecting a helical thread diameter of 0.05–0.2 mm. Therefore, selecting a reasonable diameter prior to bonding the thread to the polymer cover would have been a routine design choice. The applicant has not disclosed how this specific range solves a stated problem or serves a particular purpose. Furthermore, as demonstrated by Kelly or other prior art references, the invention appears to perform equally well with any reasonable thread diameter.
Regarding claim 2, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that the multi-layer coil member 64/68 includes one or more helicall wound elongate strands composed of a same material composition at each of the proximal end of the shaft body, the distal end of the shaft body, and the proximal end of the tip member.
Regarding claim 3, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that the multi-layer coil member 64/68 includes one or more helically wound elongate strands having a cross-sectional size that is the same at each of the proximal end of the shaft body, the distal end of the shaft body, and the proximal end of the tip member.
Regarding claim 4, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. It appears to the Examiner, as is well known in the art, that the multi-layer coil member 64 includes multiple elongate strands with a fully round transverse profile to provide strength and prevent kinking. In addition, Parker discloses that the multi-layer coil member 22 includes multiple elongate strands having a fully-round transverse profile.
Regarding claim 9, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. Parker discloses that a distal end of the braid member 14 extends beyond the distal end (a vertical line in between elements #28 & #30 in Fig. 1) of the shaft body
Regarding claim 12, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that a proximal portion of the shaft body is configured to be less flexible than a distal portion of the shaft body.
Regarding claim 16, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that the tip member has increased flexibility relative to the shaft body.
Regarding claim 17, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that the inner limen 20 has a contains diameter that extends from the proximal end of the shaft body to the distal end of the shaft body.
Regarding claim 18, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that wherein the tip member 18 includes a lumen that is coaxial with the inner lumen 20, see Fig. 2.
Regarding claim 19, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that wherein the inner lumen 20 and the lumen are configured to receive a guidewire 26, see Fig. 1
Regarding claim 20, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. McFerran discloses that the proximal end 34 of the shaft body 12 is configured to connect to hub 28. It appears to Examiner that the hub is a luer hub, see Fig. 1. In addition, it is well-known in the art to provide a luer hub to secure connection, prevent leaks and ensure device compatibility.
Regarding claim 22, this claim uses the same analysis as noted above with regard to the limitation in claim 1 (e.g., the first set of helical threads has a diameter of about 0.05 millimeters to about 0.2 millimeters prior to being bonded to the outer surface).
Claims 6-8 & 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over McFerran et al. (US 7,621,904) in view of Whitman et al. (US 9,055,971), Parker et al. (US 6,939,337), Plassman et al. (US 2015/0258306) & Kelly (US 5,879,342) and further in view of Shimogami et al. (US 2010/0094258).
Regarding claims 6-8 & 10, McFerran in view of Whitman, Parker, Plassman & Kelly discloses all claimed subject matter. Parker discloses that the braid member14 as a single metal strand. Meanwhile, the claimed invention requires that the braid member includes a plurality of inter-braided, elongate strands along its length that form multiple strand crossings.
Shimogami discloses a catheter comprising: a catheter body shaft, a braid member 30 includes a plurality of inter-braided, metallic elongate strands 38 along its length that form multiple strands crossings; wherein the elongate strands are axially spaced apart, see Fig. 4; wherein the braid member includes a plurality of elongate strands would helically in opposite directions; wherein the braid member includes plurality of elongate strands 38 having a rectangular transverse profile.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of McFerran in view of Whitman, Parker, Plassman & Kelly by providing a plurality of inter-braided, metallic elongate strands formed as a braid member, as taught by Shimogami, in order to enhance tensile strength, increase flexibility and resist kinking during use.
Regarding claim 11, McFerran in view of Whitman, Parker, Plassman & Kelly and further in view of Shimogami discloses all claimed subject matter as required in the claimed invention except for the rectangular transverse profile includes a thickness directed radially, the thickness being in the range of 0.010 mm to 0.015 mm, inclusive. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the values of thickness of the braid member in the claim 11, since it has been held that discovering these values of a result effective variable involves only routine skill in the art. For example: small thickness of the braid member for reducing cost, reducing the occupy in the catheter wall but enhancing more flexibility in the catheter tube.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-12, 16-20 & 22 have been considered but are moot because the new ground of rejection does not rely in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
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