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 and Request for Continued Examination (RCE) filed on 01/05/26 have 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 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.
Claims 1-4, 6-12, 16-20 & 22 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.
The limitation “a tip member comprised of a metallic composition disposed at the distal end of the shaft body, .... wherein a polymer layer surrounds the muti-layer coil member within the tip member, and where the tip member further comprises a void space between an inner surface of the polymer layer and the multi-layer coil member” in claim 1 is failing to comply with the written description requirement. Nowhere in the original specification has described a combination of the limitations above in the same catheter device. For example: metallic tip members 108, 208, 508, 608 in Figs. 1-2 & 5-6 do not include a polymer layer, see para [0034] in the PG-Pub 2021/0015517 of the current application. Meanwhile, the polymer tip members 308, 708 in Figs. 3 & 7 do not include a metallic layer. It is noted that the Figs. 1-2 & 5-6 are different embodiment with the Figs. 3 & 7-11. The Fig. 11 illustrates a cross-section of catheter’s polymer tip member in Fig. 3; wherein the polymer tip member is not formed a metallic composition, as recited in the claim 1. In addition, the para [0033] of the PG-Pub’517 states that: Hard, metallic tip members or soft, polymer tip member... Figs. 1-2 & 5-6 illustrate optional metallic tip members 108, 208, 508 & 608, and Figs. 3 and 7 illustrate an optional polymer tip member 308, 708. Having said the above, there is no combination of the metallic tip member and polymer tip member in the same catheter device.
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 1-4, 6-12, 16-20 & 22 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.
The limitation “wherein the outer polymer cover terminates proximal to the tip member... wherein a polymer layer surrounds the multi-player coil member within the tip member, where the tip member further comprises a void space between an inner surface of the polymer layer and the multi-layer coil member” in claim 1 is vague.
First, the outer polymer cover terminates proximal/near to the tip member. In other words, the tip member is not covered by a polymer layer (i.e. outer polymer cover). Then the claim further requires that the tip member further comprises a void space between an inner surface of the polymer layer and the multi-layer coil member. In other words, the tip member must be covered by the polymer layer. Therefore, it is unclear to Examiner that does the tip member include the polymer layer or only metallic layer formed at the tip member.
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, 6-14, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ravichandran et al. (US 2013/0018318) in view of Whitman et al. (US 9,055,971), Miyata et al. (US 8,814,890), Adams et al. (US 2009/0156999), DeMello et al. (US 5,429,597) & Kelly (US 5,879,342).
Regarding claim 1, Ravichandran discloses a catheter comprising:
an elongate shaft body 11 extending from a proximal end 15 to a distal end 28 (Note: at a vertical line in between elements 28 & 30, in Fig. 1; however, for convenience, the element 28 is called as a distal end) and defining an inner lumen 13, the shaft body 11 including a liner 20, a braid member 22, a coil member 14 surrounding at least a portion of the liner 20, and the braid member 22, see Fig. 3A, and an outer polymer cover 18 surrounding the coil 14; and
Note: The Fig. 3A shows another example medical device with a braided filament securement; wherein the coil member 14 surrounds the liner 20; the braid member 16. Thus, a person skilled in the art would recognize that the catheter in Fig. 1 can be modified to obtain the coil member 14 surrounding the liner and the braid member, as suggested in Fig. 3A, as considered as rearrangement parts.
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a tip member 31 comprised of a metallic composition (elements 14, 21-22 or 45 are formed of metallic materials, paras [0032-0033, 0040, 0044]) disposed at the distal end 28 of the shaft body 11; wherein the outer polymer cover 18 terminates proximal to the tip member 31, see marked up Fig. 1 above;
wherein a distal end 207 of the liner 20 (see Figs. 3A & 9-10) and the coil member 14 extend beyond the distal end 28 of the shaft body 11 and into a proximal end of the tip member 31, see Fig. 3A;
Note: The Fig. 10 shows that the coil member 14 and the braid member 16 extend from the shaft body 11 to adjacent to the distal end 207 of the liner 20 (or distal end 17 of the tip member, see Figs. 1, 3A & 11). In other words, the coil member 14 & the braid member 16 extend beyond the distal end of the shaft body and into the proximal end of the tip member.
As best as understood, wherein a polymer layer 30 (Fig. 1, or layer 30 in similar Fig. 2) surrounds the coil member 14 within the tip member 31.
Ravichandran does not disclose that:
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 coil member is in formed as multi-layer coil member;
the tip member having a second set of helical threads; the tip member comprising a tapered distal portion; the tapered distal portion including some or all of the second set of helical threads;
the polymer layer comprises a void space between an inner surface of the polymer layer and the multi-layer coil member
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,
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.
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 Ravichandran 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 Ravichandran’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, Ravichandran 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.
Ravichandran in view of Whitman does not disclose that the tip member comprising: a non-tapered proximal portion and a tapered distal portion.
Miyata discloses a catheter 1 comprising: an elongate shaft body 2; a tip member 3 comprising: a non-tapered proximal portion and a tapered distal portion 31, see Figs. 1, 8 & 11. Miyata further discloses in Figs. 19 -22 that a whole unit of a tip member including helical threads. In other words, a distal portion 7 of the tip member including some of helical threads 75. A person skilled in the art would recognize that the tapered distal portion of the tip member 3 (in Fig. 1 & 8) can be obtained some or all of helical threads 75.
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 tip member in the device of Ravichandran in view of Whitman with including a non-tapered proximal portion and a tapered distal portion in the tip member, as taught by Miyata, in order to enhance of penetration or dilatation against an occlusive area and a stenotic area in a blood vessel.
Ravichandran in view of Whitman and Miyata does not disclose that: a coil member is in formed as multi-layer coil member; the polymer layer comprises a void space between an inner surface of the polymer layer and the multi-layer coil member;
DeMello discloses a catheter comprising: an elongate shaft body including a multi-layer coil members 23 & 24; wherein the multi-layer coil member comprising first and second coil layers 23 & 24 are being wounded in opposing direction for acting to lock the coils against one another and providing a high level of torque transmission during rotation of cross-wound multifilar (CWMF), col. 6, lines 3-18.
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 coil member in the device of Ravichandran in view of Whitman and Miyata with providing first and second coil layers being wounded in opposing direction, as taught by DeMello, for the benefits of acting to lock the coils against one another and providing a high level of torque transmission during rotation of cross-wound multifilar (CWMF).
Ravichandran in view of Whitman, Miyata & DeMello does not disclose that: the polymer layer comprises a void space between an inner surface of the polymer layer and the multi-layer coil member.
Adams discloses a catheter comprising: an elongate shaft body; a polymer layer 1034 comprises a void space 1008 between an inner surface of the polymer layer 1034 and a coil member 1004 to enhance the flexibility and torsional properties of the shaft body.
Giving such a teaching by Adams, a person having ordinary skill in the art would have easily recognizes that modifying the device of Ravichandran in view of Whitman, Miyata & DeMello with obtaining a space/void in between coil member (or a void being spaced in between an inner surface of the polymer layer and coil member or multiple coil member), as taught by Adams, would provide the benefits of enhancing the flexibility and torsional properties of the shaft body
Ravichandran in view of Whitman, Miyata, DeMello & Adams 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 filling date of the claimed invention to modify the device of Ravichandran in view of Whitman, Miyata, DeMello & Adams with providing a diameter of the helical thread in 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 and the helical threads being bonded (thermally bonded) and in-laid in or partially in the outer polymer cover, as taught by Kelly, in order to minimize the profile or overall outside diameter of the total diameter of the catheter size to match dimensional limitations of the human body lumen and also to provide a secure of bonding in between the helical threads and the outer cover of the catheter, col. 5, lines 56-67.
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.
Applicant does not state any reasons nor benefit of using 0.05-0.2 in diameter of the helical thread, therefore, it would have been an obvious matter of design choice to obtain any reasonable size of diameter of the helical threads for bonding to the polymer cover, since applicant has not disclosed that the diameter of 0.05-0.2 mm of the helical threads solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with any reasonable size of the diameter of the helical threads as discussed in the prior art Kelly or other prior arts.
Regarding claim 2, Ravichandran in view of Whitman, Miyata, DeMello & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses that wherein the coil member 14 includes one or more helically 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, see cross-section element 14 in Figs. 2, 9-10.
Regarding claim 3, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses that wherein the coil member 14 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, see Fig. 3A-3B & 10.
Regarding claim 4, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. As seen in Fig. 2 in DeMello, the multi-layer coil member includes multiple elongate strands having a fully-round transverse profile.
Regarding claims 6-7, Ravichandran in view of Whitman, Miyata, DeMello & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses that wherein the braid member 16 includes a plurality of inter-braided, metallic elongate strands along its length that form multiple strand crossings, see Figs. 3B-10; as best as understood, wherein the elongate strands 16/22 are axially spaced apart to define multiple pics (e.g., the strands 22 being formed in multiple diagonal shapes).
Regarding claim 8, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran discloses that the braid member 16/22 includes a plurality of elongate strands would helically in opposite directions, see Figs. 3B & 6-10.
Regarding claim 9, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses that wherein a distal end of the braid member 14 extends beyond the distal end 24 of the shaft body 11, Fig. 3A. Note: the distal end 211 of the braid member 14 is located adjacent to the distal end 17 of the tip member 31, see Figs. 1 & 3A. In other words, the distal end of the braid member extends beyond the distal end of the shaft body.
Regarding claim 10, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses that the braid member 16 comprises a plurality of intersecting filaments 22 of flat or other conventional wire cross-section, para [0033]. Therefore, it is well-known in the art that the elongate strands 22 having a rectangular transverse profile.
Regarding claim 11, Ravichandran in view of Whitman, Miyata, DeMello, Adams & 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, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses in para [0037] that: making the distal segment 30 of the outer layer 18 from a softer material than from which the proximal segment 28. In other words, a proximal portion of the shaft body is configured to be less flexible than a distal portion of the shaft body.
Regarding claim 16, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran further discloses in para [0037] that: making the distal segment 30 of the outer layer 18 from a softer material than from which the proximal segment 28. In other words, the tip member has increased flexibility relative to the shaft body.
Regarding claim 17, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. It appears in Fig. 1 in Ravichandran shows that the inner lumen 13 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, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran discloses that wherein the tip member 30 includes a lumen that is coaxial with the inner lumen, see Fig. 1.
Regarding claim 19, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran discloses that wherein the inner lumen and the lumen are configured to receive a guidewire, paras [0004, 0037].
Regarding claim 20, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention. Ravichandran discloses that the proximal end 15 of the shaft body 11 is configured to connect to a luer hub, see Fig. 1.
Alternatively, claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ravichandran et al. (US 2013/0018318) in view of Whitman et al. (US 9,055,971), Miyata et al. (US 8,814,890), DeMello et al. (US 5,429,597), Adams et al. (US 2009/0156999) & Kelly (US 5,879,342) and further in view of Pedersen et al. (US 6,171,297).
Regarding claim 11, Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly discloses all claimed subject matter as required in the claimed invention except for the rectangular transverse profile of the strands of the braid member includes a thickness directed radially, the thickness being in the range of 0.010 mm to 0.015 mm, inclusive.
Pedersen discloses that the elongated elements 14a, 14b can be a wire, filament or ribbon, col. 4, lines 47-48. In other words, the elongated element 14a is equivalent to a claimed braid member, and the elongated element 14b is equivalent to a claimed coil member. Pedersen further states that the elements 14a, 14b have an average diameter between about 0.001’-0.005’ = 0.0254-0.127 mm). Therefore, the braid member 14a having a rectangular transverse profile (e.g., in filament or ribbon shaped, col. 4, lines 47-48) includes a thickness/diameter being in the range of 0.001’-0.005’ = 0.0254-0.127 mm (within the ranges of 0.010-0.015mm, as required in claim 11).
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 Ravichandran in view of Whitman, Miyata, DeMello, Adams & Kelly with providing a thickness of the braid member in the ranges of 0.010-0.015 mm, as taught by Pedersen, in order to create more strength, flexibility and prevent kinking of the catheter tube during procedure.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights