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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 2-7, 9-17, and 22-24) in the reply filed on 02/04/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/18/2023 and 02/09/2026, have been considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. 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.
Claims 2 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (PGPub 2017/0239440), in view of Switzer (USPN 12,495,955).
[Claim 2] Yang teaches an enhanced flexibility catheter (figure 30, item 3000) comprising:
an elongate body (figure 30; paragraph [0179]) comprising:
a proximal end (figure 30, not shown),
a distal end (figure 30, near item 3006), and
a side wall (figure 30, item 3001) at least partially defining a central lumen (figure 30; paragraph [0179]), the side wall comprising:
a proximal zone (figure 30, item 3002) comprising a tubular braid (figure 30, item 3010; paragraph [0180]) and a first helical coil (figure 30, proximal portion of item 3024; paragraph [0180]) and
a distal zone (figure 30, item 3004) comprising a second helical coil (figure 30, distal portion of item 3024; paragraph [0180]).
Yang does not specifically disclose a distal section of the tubular braid is heat annealed.
However, Switzer teaches an enhanced flexibility catheter (figure 5a, item 1071) comprising an elongate body having a sidewall (figure 5a, items 500/530/540) defining a central lumen (figure 5a, item 505); wherein the sidewall comprises a heat annealed (“heat welding”) (column 28, lines 23-29) tubular braid (figure 5a, item 530; column 28, lines 8-14).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified a distal section of the tubular braid of Yang to be heat annealed, as taught by Switzer, in order to provide increased functionality and control, by allowing for a means by which flexibility might be controlled along a specific portion of the catheter (Switzer; column 4, lines 55-59).
[Claim 9] Yang and Switzer teach the limitations of claim 2, upon which claim 9 depends. In addition, Yang discloses the side wall (figure 30, item 3001) further comprises an inner liner (figure 30, item 3014) and a tie layer (figure 30, item 3012) being separated from the central lumen by the inner liner (figure 30; tie layer 3012 is radially outward from inner liner 3014), wherein the second helical coil (figure 30, distal portion of item 3024) of the distal zone (figure 30, item 3004) is adjacent the tie layer (figure 30, item 3012), and wherein the tubular braid (figure 30, item 3010) of the proximal zone (figure 30, item 3002) is adjacent the tie layer (figure 30, item 3012).
[Claim 10] Yang and Switzer teach the limitations of claim 2, upon which claim 10 depends. Yang also teaches the elongate body (figure 30; paragraph [0179]) further comprises an outer jacket (figure 30, item 3020) being formed from a plurality of axially adjacent tubular segments (figure 30, items 3022, 3026, 3028, 3030, 3032, 3034, 3036, 3038) (paragraph [0183]), and wherein a proximal tubular segment (figure 30, items 3022 and 3026) of the plurality of axially adjacent tubular segments has a durometer of at least about 60D (paragraph [0184]), and wherein a distal tubular segment (figure 30, item 3038) of the plurality of axially adjacent tubular segments has a durometer of no more than about 35D (“with gradual decrease in durometer of successive segments in a distal direction to a durometer of no more than about 35D or 25D or lower.” (paragraph [0184]).
[Claim 11] Yang and Switzer teach the limitations of claim 2, upon which claim 11 depends. Yang further discloses the elongate body (figure 30; paragraph [0179]) further comprises an axially extending filament (figure 31a, item 3042) within the side wall (figure 30, item 3001) (paragraph [0185]).
Claims 2, 3, 12, and 22, are rejected under 35 U.S.C. 103 as being unpatentable over Lilburn et al. (PGPub 2016/0000443), in view of Switzer (USPN 12,495,955).
[Claim 2] Lilburn teaches an enhanced flexibility catheter (figure 1, item 100) comprising:
an elongate body (figure 4) comprising:
a proximal end (figure 2, near item 106),
a distal end (figure 2, near item 108), and
a side wall (figure 2, items 102/116/118) at least partially defining a central lumen (paragraph [0025]), the side wall comprising:
a proximal zone (see annotated figure below) comprising a tubular braid (figure 4, item 118; paragraph [0025]) and a first helical coil (see annotated figure below; paragraph [0025]) and
a distal zone (see annotated figure below) comprising a second helical coil (see annotated figure below; paragraph [0025]).
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Lilburn does not specifically disclose a distal section of the tubular braid is heat annealed.
However, Switzer teaches an enhanced flexibility catheter (figure 5a, item 1071) comprising an elongate body having a sidewall (figure 5a, items 500/530/540) defining a central lumen (figure 5a, item 505); wherein the sidewall comprises a heat annealed (“heat welding”) (column 28, lines 23-29) tubular braid (figure 5a, item 530; column 28, lines 8-14).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified a distal section of the tubular braid of Lilburn to be heat annealed, as taught by Switzer, in order to provide increased functionality and control, by allowing for a means by which flexibility might be controlled along a specific portion of the catheter (Switzer; column 4, lines 55-59).
[Claims 3 and 22] Lilburn and Switzer teach the limitations of claim 2, upon which claims 3 and 22 depend. Lilburn further discloses a transition (see vertical dashed line in annotated figure above passing through item 114) between the distal zone (see annotated figure above) and the proximal zone (see annotated figure above), the transition comprising a distal end of the tubular braid (figure 4, item 118) within 5 mm (the examiner notes these two structures are not spaced apart) of a proximal end of the second helical coil (see annotated figure above) (figures 2-4; paragraphs [0027], [0028]).
[Claim 12] Lilburn and Switzer teach the limitations of claim 2, upon which claim 12 depends. Lilburn also discloses a tubular support (figure 4, item 120) comprising:
a proximal end (figure 4) surrounding a distal portion of the tubular braid (figure 4, item 118) (figure 4), and
a distal end (figure 4) surrounding a proximal portion of the second helical coil (see annotated figure above) (figure 4).
Claims 14, 15, and 24, are rejected under 35 U.S.C. 103 as being unpatentable over Gore et al. (USPN 5,662,622), in view of Sutermeister et al. (PGPub 2015/0174363).
[Claims 14 and 24] Gore teaches an enhanced flexibility catheter (figure 1, item 10) comprising:
an elongate body (figure 1) comprising:
a proximal end (figure 1, item 18),
a distal end (figure 1, item 16), and
a side wall (figure 1, item 14) at least partially defining a central lumen (figure 1), the side wall (figure 1, item 14) comprising:
a proximal tubular braid (figure 1, item 34) comprising a distal end adjacent a proximal end of a helical coil (figure 1, item 38) to form a junction (figure 1; column 5, lines 11-15), and
an outer jacket (figure 1, item 22).
Gore does not specifically disclose a tubular metal support, wherein the outer jacket surrounds the tubular metal support.
However, Sutermeister teaches a flexible catheter (figure 1, item 100) comprising a tubular metal support (figure 3a, item 140; paragraphs [0050], [0051]) which spans a junction (figure 3a) between a coil (figure 3a, item 116) and a braid (figure 3a, item 108); wherein an outer jacket (figure 3a, item 110) surrounds the tubular metal support (figure 3a, item 140).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Gore, to have utilized the tubular metal support arrangement within the outer jacket, as taught by Sutermeister, in order to provide increased functionality and control, by allowing for a means of increased stabilization, while maintaining a smooth outer catheter surface.
[Claim 15] Gore and Sutermeister teach the limitations of claim 14, upon which claim 15 depends. Gore does not specifically disclose an axial filament extending distally from beneath a tubular metal support.
However, Sutermeister, while teaching the tubular metal support (figure 3a, item 140), further discloses an axial filament (figure 2, item 114) extending distally beneath (paragraph [0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Gore and Sutermeister, to have utilized the axial filament arrangement, as taught by Sutermeister, in order to provide increased functionality and control, by allowing for a means to control steering of the catheter, as well as additional structural support (Sutermeister; paragraph [0038]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gore et al. (USPN 5,662,622), in view of Sutermeister et al. (PGPub 2015/0174363), in further view of Yang et al. (PGPub 2017/0239440).
[Claim 16] Gore and Sutermeister teach the limitations of claim 14, upon which claim 16 depends. Although disclosing the side wall (figure 1, item 14) comprises an inner liner (figure 1, item 20), Gore does not specifically disclose a tie layer being separated from the central lumen by the inner liner, wherein the helical coil surrounds the tie layer, and wherein the proximal tubular braid surrounds the tie layer.
However, Yang teaches an enhanced flexibility catheter (figure 30, item 3000) comprising an elongate body having a side wall (figure 30, item 3001) at least partially defining a central lumen (figure 30; paragraph [0179]), the side wall comprising a tubular braid (figure 30, item 3010; paragraph [0180]) and a helical coil (figure 30, item 3024; paragraph [0180]), wherein an inner liner (figure 30, item 3014) and a tie layer (figure 30, item 3012) are separated from the central lumen by the inner liner (figure 30; tie layer 3012 is radially outward from inner liner 3014), wherein the helical coil (figure 30, item 3024) surrounds the tie layer (figure 30, item 3012), and wherein the tubular braid (figure 30, item 3010) surrounds the tie layer (figure 30, item 3012).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Gore and Sutermeister, to have utilized the claimed tie layer configuration, as taught by Yang, in order to provide increased functionality, control, and safety, by allowing for a means by which the catheter might be further stabilized, as well as providing for additional containment for the contents of the central lumen.
[Claim 17] Gore and Sutermeister teach the limitations of claim 14, upon which claim 17 depends. Gore does not specifically disclose the outer jacket is formed from a plurality of axially adjacent tubular segments extending coaxially about the helical coil, wherein a proximal tubular segment of the plurality of axially adjacent tubular segments has a durometer of at least about 60D, and wherein a distal tubular segment of the plurality of axially adjacent tubular segments has a durometer of no more than about 35D.
However, Yang teaches an enhanced flexibility catheter (figure 30, item 3000) comprising an elongate body having a side wall (figure 30, item 3001) at least partially defining a central lumen (figure 30; paragraph [0179]), the side wall comprising a tubular braid (figure 30, item 3010; paragraph [0180]) and a helical coil (figure 30, item 3024; paragraph [0180]), wherein the elongate body (figure 30; paragraph [0179]) further comprises an outer jacket (figure 30, item 3020) being formed from a plurality of axially adjacent tubular segments (figure 30, items 3022, 3026, 3028, 3030, 3032, 3034, 3036, 3038) (paragraph [0183]), and wherein a proximal tubular segment (figure 30, items 3022 and 3026) of the plurality of axially adjacent tubular segments has a durometer of at least about 60D (paragraph [0184]), and wherein a distal tubular segment (figure 30, item 3038) of the plurality of axially adjacent tubular segments has a durometer of no more than about 35D (“with gradual decrease in durometer of successive segments in a distal direction to a durometer of no more than about 35D or 25D or lower.” (paragraph [0184]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Gore and Sutermeister, to have utilized the claimed outer jacket configuration, as taught by Yang, in order to provide increased functionality and versatility, by allowing for a smooth continuous outer tubular body to facilitate easier catheter insertion (Yang; paragraph [0183]).
Allowable Subject Matter
Claims 4-7, 13, and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 03/04/2026