DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 November 2025 has been entered.
Status of Claims
Claim(s) 4-5, 7-8, 12, 18, 20-21 and 23 is/are currently amended. Claim(s) 1-3, 6, 9-11, 14-15 and 19 has/have been canceled. New claim(s) 24 has/have been added. Claim(s) 4-5, 7-8, 12-13, 16-18 and 20-24 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the drawings, objections to the specification, objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 20, 24 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 24 and claims dependent thereon, "three of the at least two guide holes" in the limitation "three first support wires slideably situated in three of the at least two guide holes" is indefinite. "At least two guide holes" encompasses only two guide holes, such that it is unclear to what "three of the at least two guide holes" refers in such an instance. Additionally, it is unclear if the "three of the at least two guide holes" are present in addition to the guide hole in which the first driving wire(s) are situated, or the first driving wire(s) guide hole(s) are included among the three guide holes of the limitations of claim 24. It is further unclear to which "at least two guide holes" the limitation refers, as claim 12 recites at least two guide rings have "at least two guide holes," the guide holes of either of the at least two guide rings of the distal bendable section, the guide holes of a particular one of the at least two guide rings of the distal bendable section, the guide holes of each of the at least two guide rings, etc.
Similarly, the "three of the at least three guide holes" in the limitation three intermediate driving wire slideably situated in three of the at least three guide holes" is indefinite. Claim 12, on which claim 24 depends, requires an intermediate driving wire, an intermediate support wire, and the first driving wire accommodated in three guide holes of the guide rings of the intermediate segment, such that it is unclear where three intermediate driving wires are slidably situated for embodiments having only three guide holes, as Applicant does not appear to disclose any embodiment in which multiple wires (e.g., support wires, driving wires, etc.) are arranged in the same guide hole.
Regarding claim 20 and claims dependent thereon, there is insufficient basis for "the three intermediate support wires" in the claim, as claim 24, on which claim 20 depends, recites three intermediate driving wires are slidably situated in three of the at least three guide holes.
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 22 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 22 and claims dependent thereon, all embodiments disclosed by Applicant appear to have a stiffness that increases along the proximal direction (e.g., ¶ [0062], ¶ [0085], etc.). Accordingly, Applicant fails to disclose at least one embodiment in which "at least a portion of a material of the proximal bendable segment has a stiffness that is less than a stiffness for at least a portion of a material of the distal bendable section" as required by claim 22, such that said claim is directed to and/or encompasses new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-5, 7-8, 12-13, 16-17 and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0242820 A1 (Tanaka) in view of US 2019/0298460 A1 (Al-Jadda), US 2016/0235274 A1 (Graham) and US 2018/0085219 A1 (Krivoruchko); or alternatively, over Tanaka in view of Al-Jadda, Graham, Krivoruchko and US 2002/0177841 A1 (Moloney).
Regarding claims 7-8, 12, 21 and 23, Tanaka teaches and/or suggests a medical apparatus comprising:
a bendable body (Fig. 1, 6, etc., wire-driven manipulator 1, or bendable distal portion 2 and long bendable portion 3 thereof) having a hollow chamber extending the length of the bendable body (Figs. 2-3, 8, etc.; ¶ [0024] hollow lumen 9), wherein the bendable body comprises:
a distal bendable section (Fig. 6, bendable distal portion 2b) comprising:
at least two guide rings spaced a distance from one another to create a cavity (guide members 7, e.g., 7b, spaced apart in the portion 2b);
at least two guide holes in each of the at least two guide rings (Fig. 2, fixing holes F and guide holes G);
a distal driving wire slidably situated in a first of the at least two guide holes (¶ [0024], Fig. 6, etc. flexible members 5 associated with portion 2b inserted into guide holes G of guide members 7b) and attached to a distal end of the distal bendable section (¶ [0023] one end of each member 5 associated with portion 2b is bonded with the distal end member 6, e.g., Fig. 6, distal end member 6b, via a bonding portion); and
a proximal bendable section proximal to the distal bendable section, said proximal bendable section comprising an intermediate segment (Fig. 6, bendable distal portion 2a), the intermediate segment comprising:
at least two guide rings spaced a distance from one another to create a cavity (guide members 7, e.g., 7a, spaced apart in the portion 2a);
at least three guide holes in each of the at least two guide rings (Fig. 2, fixing holes F and guide holes G; Fig. 6, guide rings of portion 2a have additional guide holes to accommodate members associate with portion 2b, e.g., as described in ¶ [0032]);
an intermediate driving wire slidably situated in a first of the at least three guide holes (¶ [0024], Fig. 6, etc. flexible members 5 associated with portion 2a inserted into guide holes G of guide members 7a) and attached to a distal end of the intermediate segment (¶ [0023] one end of each member 5 associated with portion 2a is bonded with the distal end member 6, e.g., Fig. 6, distal end member 6a, via a bonding portion),
wherein the distal driving wire is slidably situated in at least a third of the at least three guide holes (¶ [0032] flexible members 5 associated with portion 2b are slidable with respect to guide holes of the guide rings of portion 2a), and
wherein the proximal bendable section further comprises a proximal segment comprising a multi-lumen tubing, or simple multi-guide congruent tubing (multi-lumen guide tube 8 including guide lumens 10), wherein the distal driving wire and the intermediate driving wire are slidably situated in the multi-lumen tubing (e.g., ¶ [0025] flexible members 5, e.g., members 5 associated with each of portions 2a and 2b, are inserted into the guide lumens 10 which are configured to be slidable with respect to said members).
Tanaka does not teach the distal bendable section comprises a distal support wire slidably situated in a second of the at least two guide holes of the guide rings of the distal bendable section and attached to a distal end of the distal bendable section, wherein the distal support wire runs into and is slidably situated in the multi-lumen tubing, or the intermediate segment further comprises an intermediate support wire slidably situated in a second of the at least three guide holes of the guide rings of the intermediate segment and attached to a distal end of the intermediate segment, wherein the intermediate support wire runs into and is slidably situated in the multi-lumen tubing.
Al-Jadda discloses a comparable apparatus comprising a distal bendable section (114) and a proximal bendable segment including an intermediate segment (116) and a proximal segment (118 and/or 120), wherein each of the distal bendable section, intermediate segment and proximal segment have a different stiffness and wherein stiffness increases from the distal bendable section to the proximal segment (i.e., the proximal bendable segment has a stiffness that is more than the stiffness of the distal bendable section) (e.g., Fig. 16; ¶ [0138]; etc.). Al-Jadda discloses this stiffness profile facilitates steering or navigation, while facilitating pushability of the apparatus through a patient lumen while preventing/reducing the likelihood of buckling (¶ [0113]; ¶ [0135]; etc.).
Graham teaches/suggests a comparable apparatus (e.g., Figs. 17-23) including a bendable section comprising two guide rings (non-wave elements 1606 of framework 1600, 2000); guide holes in each of the guide rings (holes 1618, additional holes 1620); a first driving wire slidably situated in at least one of the guide holes (wire 2008; ¶ [0124]); and a first support wire situated in another of the guide holes (¶ [0146] non-wave elements may accommodate stiffeners). Similar to Tanaka, Graham further discloses components situated within guide holes may be attached to a distal end of the bendable section (e.g., Tanaka, ¶ [0023] members 5 are bonded with distal end member 6; Graham, ¶ [0119] devices fed through channels are bonded to distal anchor plate 2002; etc.).
Krivoruchko discloses an apparatus comprising at least one first support wire attached to a distal end of a distal section of the apparatus, and at least one intermediate support wire attached to a distal end of an intermediate section, wherein the support wires run into a proximal portion of the apparatus (e.g., ¶ [0029] stiffening wires 132 may extend from a proximal end of the proximal portion 122, and the number of stiffening wires 132 may be reduced moving distally along outer shaft 110 such that outer shaft 110 becomes more flexible towards the distal end thereof).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical apparatus of Tanaka with at least the distal bendable section comprising a distal support wire situated in a second of the at least two guide holes of the distal bendable section and attached to a distal end of the distal bendable section, and at least the intermediate segment comprising an intermediate support wire situated in a second of the at least three guide holes of the intermediate segment and attached to a distal end of the intermediate segment, wherein the distal and intermediate support wires run into the proximal segment/multi-lumen tubing, as taught and/or suggested by Graham and Krivoruchko, such that each of the distal bendable segment, the intermediate segment an the proximal segment have different and respectively greater stiffnesses, as taught/suggested by Al-Jadda, in order to provide the apparatus with a stiffness profile that facilitates steering/navigation and pushability of the apparatus through a patient lumen (Graham, ¶ [0159]; Krivoruchko, ¶ [0029]; Al-Jadda, ¶ [0113], ¶ [0135]; etc.).
Tanaka as modified does not expressly disclose each of the distal support wire and the intermediate support wire has an unfixed proximal end, such that said distal support wire is slidably situated in the second guide hole of the distal bendable section guide rings, or the intermediate support wire is slidably situated in the second guide hole of the intermediate section guide rings, wherein the distal support wire and the intermediate support wire are slidably situated in the multi-lumen tubing. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the apparatus of Tanaka with the distal support wire having an unfixed proximal end, such that said distal support wire is slidably situated in the guide hole of the distal bendable section guide rings, in the guide hole of the intermediate section guide rings and in the multi-lumen tubing, and the intermediate support wire having an unfixed proximal end, such that said intermediate support wire is slidably situated in the guide hole of the intermediate section guide rings and in the multi-lumen tubing because Applicant has not disclosed that said configuration provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, to the contrary, Applicant appears to disclose the claimed arrangement is "counter-productive," disclosing only a disadvantage(s) to said arrangement (e.g., ¶ [0078]). Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the distal and intermediate support wires situated as implicitly taught and/or suggested by Tanaka as modified because either arrangement facilitates providing the above-noted stiffness profile.
Alternatively/Additionally, Moloney teaches/suggests an apparatus comprising a support wire (stiffening wire), wherein the support wire is attached at its distal end, extends through an intermediate section and into a proximal section of the apparatus, and has an unfixed proximal end (Abstract; ¶ [0022]; ¶ [0066]; ¶ [0069]; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical apparatus of Tanaka with the distal and intermediate support wires each having an unfixed proximal end situated in the proximal segment/multi-lumen tubing as taught and/or suggested by Moloney, such that the distal support wire is slidably situated in the guide hole of the guide rings of the distal bendable section, and in the guide hole of the guide rings of the intermediate section, and the intermediate support wire is slidably situated in the guide hole of the guide rings of the intermediate section, in order to facilitate/further facilitate advancement of the apparatus through the anatomy (Moloney, ¶ [0007]).
Regarding claims 13 and 4-5, Tanaka as modified teaches/suggests the apparatus further comprises a pliable wall extending the length of the bendable body (e.g., ¶ [0045] skin 16, 17, 18, 19), wherein an inside diameter of the at least two guide rings are affixed to at least a portion of the wall (e.g., ¶ [0042] distal inner skin 17 is fixed at one or more positions on the distal end member 6 and the guide members 7), and wherein the wall further comprises a resilient outer lining for encapsulating the at least two rings (e.g., Fig. 13A, distal outer skin 16).
Regarding claims 16-17, Tanaka as modified teaches/suggests the apparatus comprises a first actuator attached to a proximal end of the distal driving wire, and configured to actuate the distal driving wire, and a second actuator attached to a proximal end of the intermediate driving wire, and configured to actuate the intermediate driving wire (¶ [0026]; Figs. 2, 4, etc.; base 4 includes drive units 11 to which the members 5 are connected, where the drive units 11 are controlled by a control unit to drive each member in a push-pull way).
Regarding claims 20 and 24, Tanaka as modified teaches/suggests the limitations of claim 12, as discussed above, and further discloses three intermediate driving wires are slidably situated in three guide holes of the guide rings of the intermediate segment, wherein the three intermediate driving wires are symmetrically arranged in the at least two guide rings of the intermediate segment (Fig. 6; ¶ [0031]; etc.). Tanaka as modified does not expressly disclose three distal/first support wires are slidably situated in three guide holes of each of the guide rings of the distal bendable section, wherein the three distal/first support wires are symmetrically arranged in the guide rings of the distal bending section. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the apparatus of Tanaka to comprise three distal/first support wires in three guide holes of each of the guide rings of the distal bendable section and arranged symmetrically in said guide rings because Applicant discloses neither the number of support wires, nor the symmetry of their arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the distal bendable section having at least one distal/first support wire because either arrangement facilitates providing the distal bendable portion with an appropriate/desired level of stiffness.
Alternatively/Additionally, Krivoruchko discloses adding support wires increases stiffness or pushability, disclosing any number of support wires may be arranged symmetrically around the circumference of the apparatus (e.g., ¶ [0029]). Since Krivoruchko discloses the number of support wires provides a quality which can be optimized (e.g., degree of stiffness provided to the apparatus, or a section(s) thereof), it would have been obvious to modify the medical apparatus of Tanaka to comprise three distal/first support wires in three guide holes of each of the guide rings of the distal bendable section because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical apparatus of Tanaka with the three distal/first support wires being arranged symmetrically in the at least two guide rings of the distal bending section as taught/suggested by Krivoruchko in order to facilitate stiffening the bendable body equally around its circumference and/or as a simple substitution of one suitable support wire(s) arrangement increasing pushability of the apparatus, or bendable body thereof, for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 22, Tanaka as modified teaches/suggests the limitations of claim 21, as discussed above, but does not expressly disclose at least a portion of a material of the proximal bendable segment has a stiffness that is less than a stiffness for at least a portion of a material of the distal bendable section. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the apparatus of Tanaka with at least a portion of a material of the proximal bendable segment having a stiffness that is less than a stiffness for at least a portion of a material of the distal bendable section because Applicant has not disclosed that said configuration provides an advantage, is used for a particular purpose, or solves a stated problem. Indeed, as noted above with respect to rejections under 35 U.S.C. 112(a), it is not readily apparent that the above-noted features are even supported by the application as filed. Accordingly, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the materials disclosed by Tanaka and using an appropriate/desired number of support/stiffening wires, as taught/suggested by Krivoruchko, because either arrangement facilitates providing the bendable body with an overall stiffness that increases from the distal end to the proximal end thereof.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Al-Jadda, Graham and Krivoruchko (or Tanaka in view of Al-Jadda, Graham, Krivoruchko and Moloney) as applied to claim(s) 12 above, and further in view of US 2015/0119638 A1 (Yu).
Regarding claim 18, Tanaka as modified teaches and/or suggests the limitations of claim 12, as discussed above, but does not expressly teach the distal/first driving wire and/or at a guide hole that is not occupied by at least one first driving wire, at least one intermediate driving wire or at least one first support wire comprise a radio opaque material.
Yu discloses a medical apparatus comprising a bendable body comprising a plurality of radio-opaque markers thereon, including a control ring and pull wires (¶ [0211]).
It would have been obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to modify the medical apparatus of Tanaka with at least the distal/first driving wire comprising a radio opaque material as taught/suggested by Yu in order to facilitate tracking the medical apparatus within the patient's anatomy to enhance navigational capabilities (Yu, ¶ [0196]).
Response to Arguments
To the extent Applicant's arguments are pertinent to the rejections of record above, said arguments have been fully considered but they are not persuasive.
With respect to rejections under 35 U.S.C. 112(a), Applicant contends the application as filed provides sufficient support for the limitations of claim 21, citing paragraph [0068] of the specification as filed and concluding, "Therefore, the use of the support wires having a stiffness that change the overall stiffness in claim 22 has sufficient written description" (Remarks, pg. 8).
The examiner has made no indication that "the user of the support wires having a stiffness that change the overall stiffness" lacks support. However, neither the paragraph/embodiment cited by Applicant, nor the remainder of the application as filed discloses "at least a portion of a material of the proximal bendable segment has a stiffness that is less than a stiffness for at least a portion of a material of the distal bendable section" as required by claim 22.
With respect to the prior art rejections, Applicant contends Tanaka does disclose at least the first support wire limitations (Remarks, pg. 9); contends Graham does not disclose or suggest "the conduit tube or other object would have an unfixed proximal end slideably situated in the intermediate segment," does not disclose or suggest both a distal and intermediate support wire are provided on the device, and does not disclose the support wire run into multi-lumen tubing and are slidably situated therein (Remarks, pg. 10); and contends Krivoruchko "does not teach or suggest the claimed structure of the apparatus with the first (and intermediate) support wires of claim 12 that extend through three (or two) unique sections including a skeleton structure (e.g., the section having two guide rings spaced a distance from one another to create a cavity) and a multi-lumen tubing" (Remarks, pg. 11).
The examiner notes one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The primary reference to Tanaka discloses wires, particularly driving wires, are provided in guide holes of guide rings in each of distal bendable section and an intermediate segment. Al-Jadda discloses a stiffness profile that facilitates at least steering/navigation and pushability of a comparable apparatus through a patient lumen (¶ [0113]; ¶ [0135]; etc.). Graham discloses an apparatus that, like the apparatus of Tanaka, includes guide rings having a plurality of guide holes (e.g., Figs. 17, 19, etc.), wherein at least one of guide hole accommodates a driving wire (e.g., wire 2008 in hole 1618; ¶ [0124]) and a number (e.g., 2-15) of additional guide holes (perimeter holes 1620) are included on the guide rings to accommodate additional components, such as stiffeners (¶ [0111]; ¶ [0146]; etc.). Additionally similar to Tanaka, Graham discloses components situated within guide holes may be attached to a distal end of a bendable section (¶ [0119]). Krivoruchko discloses an apparatus comprising a plurality of support wires (stiffening wires) extending from a proximal section of the apparatus, wherein the number of support/stiffening wires may be reduced moving distally along body of the apparatus such that the body becomes more flexible towards its distal end. Accordingly, Krivoruchko discloses/suggests the beneficial stiffness profile disclosed by Al-Jadda may be achieved by including support wires that extend from the proximal segment towards the distal end of the apparatus, such that the number of the support/stiffening wires in the proximal segment is greater than the number of the support/stiffening wires in the intermediate segment, and the number of the support/stiffening wires in the intermediate segment is greater than the number of support/stiffening wires in the distal bendable section. Graham discloses such support wires may be accommodated in additional guide holes provided on the guide rings of Tanaka, such that it would have been obvious to modify Tanaka to include an adequate number of additional guide holes in the guide rings of each section, and having support wires accommodated therein for at least the reasons noted above.
Applicant further contends "Further, even if a person of ordinary skill in the art tried to combine Krivoruchko with Tanaka, there is nothing in either reference (or in Graham and/or Moloney) to combine the various elements and relationships between the elements to form the apparatus as claimed There is no teaching to modify the skeletal structure of Tanaka by adding the wires of Krivoruchko. In Krivoruchko, the support wires are located within wire members woven together to form braided shafts. There is nothing to suggest taking these wire members out of the braided shaft and guiding them through guide holes and cavity between the at least two guide rings to obtain the claimed elements in contrast to, for example, adding the Krivoruchko braided shaft around the skeletal structure of Tanaka" (Remarks, pgs. 11-12).
The examiner respectfully disagrees. Even the stiffening wires of Krivoruchko are not limited to being provided in the braided shaft. Rather, Krivoruchko expressly discloses the stiffening wires may extend to other portions of the outer shaft, such as extending from "a proximal end of the proximal portion 122," where no braided shaft is present (see, e.g., Krivoruchko, Fig. 1). The apparatus of Tanaka already has guide rings with guide holes. Graham discloses/suggests additional guide holes may be provided in said guide rings in which support/stiffening wires may be provided (e.g., in the arrangement disclosed/suggested by Krivoruchko) in order to provide a desirable stiffness profile (e.g., as disclosed by Al-Jadda).
Applicant contends the proximal ends of the support wires being unfixed and slidable within the guide rings and/or multi-lumen tubing is not a mere design choice. Applicant cites paragraphs [0011], [0040]-[0042], [0057] and [0071] in support of this contention (Remarks, pgs. 12-13).
The examiner respectfully disagrees. None of the cited paragraphs appear to discuss the particular feature that is identified as a mere design choice in the rejection. Specifically, none of these paragraphs disclose any advantage of, particular purpose for, or problem solved by the proximal ends of the support wires being unfixed and slidable within the guide rings and/or multi-lumen tubing. Rather, as noted in the rejection of record above, the only mention of this particular arrangement in the application as filed instead describes the claimed arrangement as "counter-productive," disclosing only a disadvantage(s) to said arrangement (e.g., ¶ [0078]).
With respect to Moloney, Applicant appears to contend that the apparatus disclosed by Moloney having a support wire with an unfixed proximal end is an intermediate at some point in the apparatus fabrication, while the final product has the stiffening wire fixed within the guidewire lumen. Applicant cites paragraphs [0065]-[0067] of Moloney in support of said interpretation. (Remarks, pg. 14-15).
The examiner respectfully disagrees. In discussing the disclosed invention, e.g., in the Abstract, Moloney clearly discloses the proximal end of the stiffening wire is "free floating within the proximal section of the catheter." The paragraphs cited by Applicant do not indicate that the proximal end of the stiffening wire is part of the formed laminate, only that a portion of the stiffening wire located at the exchange joint is part of the formed laminate. Moloney explicitly discloses the stiffening wire, particularly the proximal end thereof, extends proximal to the exchange joint and into the proximal portion of the catheter (Figs. 18-19; ¶ [0068]). There is no indication in Moloney that the proximal end of the stiffening wire is treated in any way during the heat lamination process such that said end is ultimately fixed in placed as Applicant contends.
Lastly, Applicant contends there is no motivation to combine the cited reference because "all catheters are not interchangeable" (Remarks, pg. 15-16).
The examiner has made no contention that all catheters are interchangeable. Al-Jadda discloses it is beneficial for the apparatus disclosed by Tanaka (e.g., usable as endoscope, ¶ [0001]) to have a particular bending profile for steering/navigation and pushability. The features of the catheters disclosed by Krivoruchko and Moloney relied on to modify the apparatus of Tanaka similarly relate to pushability of the apparatus, such that a person of ordinary skill in the art would have been sufficiently motivated to look to and combine the references as suggested.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791