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
In response to the amendment filed on 5/1/2026, no claims have been cancelled, no claims have been newly added, thus claims 1-16 are pending.
Amendments to claim 7, 13-14 to remedy claim objections and USC 112(b) issues have been acknowledged and the rejections have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 20050065401 A1 Saadat et al. (hereinafter Saadat) in view of US 20200206458 Mullins et al. (hereinafter Mullins).
Regarding claim 1, Saadat discloses a flexible tubular elongate member (10, Fig. 1, paragraph 59, main body 10 has a deflectable and/or steerable shaft 20) for use with a retroflexion system (paragraph 17, 73), said flexible tubular elongate member comprising:
an exterior surface (outside surface of 10, Fig. 1) and an interior surface (as seen in Fig. 2a, shaft 20 of the main body 10 has a wall 21 with an interior surface) extending between a proximal end (12, Fig. 1) and a distal end (14, Fig. 1) of said flexible tubular elongate member (seen in Fig. 1), the interior surface defining one or more lumens (23, 24, 26, Fig. 1, 2a) through said flexible tubular elongate member between the proximal end and the distal end of said flexible tubular elongate member (Fig. 1, 2a, paragraph 60, 64);
a flexion section (20, Fig. 1) along the length of said flexible tubular elongate member between the proximal end and the distal end (seen in Fig. 1) configured to be kink-resistant and/or deformation resistant (paragraph 59, 73-74).
Saadat is silent on a filament extending between the exterior surface and the interior surface of said flexion section to reinforce said flexion section, wherein the exterior surface and the interior surface of said flexion section are corrugated as a result of the shape of said filament therebetween to facilitate flexing of said flexion section.
However, Mullins teaches a flexible catheter device (1, Fig. 1, abstract, paragraph 4) comprising a flexion section (3) having an exterior surface and an interior surface (an embodiment in Fig. 19-20 shows an exterior surface 953/1004 and an interior surface 951/1002 with a filament 952/1005 in between), a filament (6/952/1005) extending between the exterior surface and the interior surface of said flexion section to reinforce said flexion section (paragraph 90), and wherein the exterior surface and the interior surface of said flexion section are corrugated as a result of the shape of said filament therebetween to facilitate flexing of said flexion section (as seen in Fig. 1-3, 19-20, paragraph 4-5, 9, 92-98).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saadat with the teachings of Mullins in order to provide flexibility while reducing the likelihood of kinking as disclosed by Mullins (paragraph 92).
Regarding claim 2, the combination of Saadat and Mullins teaches the limitations of claim 1, and Saadat further discloses wherein at least one of the exterior surface or the interior surface of said flexion section (20) is shaped, configured and/or dimensioned to facilitate flexing thereof (as seen in Fig. 1-2, 7a-8c, paragraph 73).
Regarding claim 3, the combination of Saadat and Mullins teaches the limitations of claim 1, and Mullins teaches the filament is a wire (paragraph 85, 92, 211).
Regarding claim 4, the combination of Saadat and Mullins teaches the limitations of claim 1, and Mullins teaches wherein said filament is a wire coil between the exterior surface and the interior surface of said flexion section reinforcing said flexion section (paragraph 85, 92, 211).
Regarding claim 5, the combination of Saadat and Mullins teaches the limitations of claim 4, and Mullins teaches wherein the exterior surface and the interior surface of said flexion section are corrugated as a result of a round cross-sectional shape of said wire coil therebetween (as seen in Fig. 1, 19-20).
Regarding claim 6, the combination of Saadat and Mullins teaches the limitations of claim 1, and Mullins teaches wherein the exterior surface and the interior surface of said flexion section are corrugated as a result of a round cross-sectional shape of said filament between the exterior surface and the interior surface of said flexion section to facilitate flexion of said flexion section (as seen in Fig. 1, 19-20, paragraph 92).
Regarding claim 7, the combination of Saadat and Mullins teaches the limitations of claim 4, and Mullins teaches wherein said flexion section further comprises an outer tubular core layer (1003, Fig. 20) over said wire coil (1005) and an inner tubular core layer (1002) within said wire coil, thereby forming a multi-layer wall of said flexion section (as seen in Fig. 20).
Regarding claim 8, the combination of Saadat and Mullins teaches the limitations of claim 1, and Mullins teaches wherein one or more wall regions of said flexion section has alternating thick and thin wall thicknesses (as seen in Fig. 1-2, 19-20).
Regarding claim 9, the combination of Saadat and Mullins teaches the limitations of claim 1, and Saadat further discloses wherein the cross-sectional shape of the one or more lumens (23, 24, 26) through said flexion section (20) remains substantially the same as said flexion section is flexed (Fig. 9a-10d, paragraph 73-79).
Regarding claim 10, the combination of Saadat and Mullins teaches the limitations of claim 1, and Saadat further discloses wherein said flexion section (20) extends along a portion of a distal end (14) of said flexible tubular elongate member (as seen in Fig. 1).
Regarding claim 11, Saadat discloses a system for retroflexing a flexible elongate member (first arm 30, Fig. 1, paragraph 61) of a medical device (2, Fig. 1) (paragraph 17, 73), said system comprising:
an elongated actuation component (96, Fig. 12a-13b, 17c-b, 21a-d, 27a-28b) extending along said flexible elongate member and having a proximal end and a distal end (paragraph 84-96);
a distal mount (66, Fig. 15) configured to be mounted with respect to the distal end of the flexible elongate member (seen in Fig. 15);
a pivot mount (16, Fig. 3a-d) configured to be mounted with respect to the flexible elongate member proximal to the distal mount (seen in Fig. 3b-d); and
an auxiliary flexible tubular elongate member (second arm 30, Fig. 1) configured to extend along the flexible elongate member (seen in Fig. 2, 3b-6, 15) and having a proximal end (32, Fig. 1) and a distal end (34, Fig. 1) (paragraph 61);
wherein:
the distal end of said auxiliary flexible tubular elongate member is operatively associated with said distal mount (66) (seen in Fig. 15);
the distal end of said actuation component (96) is operatively associated with said distal mount to cause flexion of the distal end of the flexible elongate member when said actuation component is pulled proximally (paragraph 84-96);
an actuation region of said actuation component pivots with respect to said pivot mount when said actuation component is pulled proximally to cause the flexible elongate member to retroflex (paragraph 84-96, seen in Fig. 17, 17a-c, actuation region of actuation component (96) is within the linkages (62) of the arm (30) and pivots with respect the pivot mount (16, Fig. 3a-d) when actuation component is pulled proximally);
said auxiliary flexible tubular elongate member comprises a flexion section (section of linkages 62 of distal end 34, Fig. 11-15), operatively associated with said distal mount to flex when said actuation component is pulled proximally (paragraph 84-96);
said flexion section is configured to be kink-resistant and/or deformation resistant when flexed (paragraph 74); and
one or more lumens (38, 114, Fig. 1, 2a, 14, 16b) are defined through said flexion section and have a cross-sectional shape unaffected and unchanged by flexing of said flexion section (seen in Fig. 16b, 17c).
Saadat is silent on wherein said flexion section includes a filament between an exterior surface and an interior surface thereof reinforcing said flexion section, and wherein the exterior surface and the interior surface of said flexion section are corrugated as a result of the shape of said filament therebetween.
However, Mullins teaches a flexible catheter device (1, Fig. 1, abstract, paragraph 4) comprising a flexion section (3) having an exterior surface and an interior surface (an embodiment in Fig. 19-20 shows an exterior surface 953/1004 and an interior surface 951/1002 with a filament 952/1005 in between), a filament (6/952/1005) extending between the exterior surface and the interior surface of said flexion section to reinforce said flexion section (paragraph 90), and wherein the exterior surface and the interior surface of said flexion section are corrugated as a result of the shape of said filament therebetween to facilitate flexing of said flexion section (as seen in Fig. 1-3, 19-20, paragraph 4-5, 9, 92-98).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saadat with the teachings of Mullins in order to provide flexibility while reducing the likelihood of kinking as disclosed by Mullins (paragraph 92).
Regarding claim 12, the combination of Saadat and Mullins teaches the limitations of claim 11, and Saadat further discloses further comprising a flexible tubular elongate member (10, Fig. 1, paragraph 59) having a proximal end (12, Fig. 1) and a distal end (14, Fig. 1) with a lumen (23, 24, 26, Fig. 1, 2a) extending therebetween (paragraph 60, 64):
wherein:
said actuation component (96) extends through the flexible tubular elongate member lumen (Fig. 1-6, 15, actuation component (96) extends through arms (30) and arms (30) extend through lumen 26, therefore the actuation component (96) extends through the flexible tubular elongate member lumen (26));
said flexible tubular elongate member is configured to be mounted with respect to the flexible elongate member with the distal end (14) of the flexible tubular elongate member proximal to the distal end (34) of the flexible elongate member (30) (seen in Fig. 2-6);
the distal end of said flexible tubular elongate member forms said pivot mount (16) for said actuation component (seen in Fig. 3c-d, arms (30) pivot at pivot mount (16), actuation component (96) within arms (30) therefore pivot at the pivot mount (16)); and
said auxiliary flexible tubular elongate member (30) extends along said flexible tubular elongate member (10) with said flexion section (section of linkages 62 of distal end 34) extending distally beyond the distal end (14) of said flexible tubular elongate member to be operatively associated with said distal mount (66) (seen in Fig. 2, 3b-6, 15, 20).
Regarding claim 13, the combination of Saadat and Mullins teaches the limitations of claim 12, and Saadat further discloses wherein said flexion section (section of linkages 62 of distal end 34) of said auxiliary flexible tubular elongate member (30) does not extend to the proximal end (12) of said flexible tubular elongate member (10) (seen in Fig. 1-2, 11).
Regarding claim 14, the combination of Saadat and Mullins teaches the limitations of claim 12, and Saadat further discloses wherein said auxiliary flexible tubular elongate member (30) extends through a lumen (26) defined through said flexible tubular elongate member (10) (paragraph 60-61, Fig. 1).
Regarding claim 15, the combination of Saadat and Mullins teaches the limitations of claim 11, and further discloses wherein:
said flexion section has an exterior surface (outside surface of section of linkages 62 of distal end 34) and an interior surface (inside surface of section of linkages 62 of distal end 34), the interior surface defining the lumen through said flexion section (seen in Fig. 1, 2a, 14, 16b);
and at least one of the exterior surface or the interior surface of said flexion section is shaped, configured, and/or dimensioned to facilitate flexing of said flexion section (Fig. 1-6, 11-20, paragraph 84-93).
Regarding claim 16, the combination of Saadat and Mullins teaches the limitations of claim 11, and Mullins teaches wherein said flexion section is reinforced with a wire coil (paragraph 85, 92, 211).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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