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
This office action is responsive to the amendment filed on July 6, 2026. As directed by the amendment: claims 8, 10, 13, 19 and 29 have been amended, claims 1-7, 9, 17 and 26-28 have been cancelled, and no claims have been added. Thus, claims 8, 10-16, 18-25 and 29-31 are presently pending in this application. Applicant’s amendments are not sufficient to overcome the §112(b) rejection of the previous action, see below.
Response to Arguments
Applicant’s arguments, see Remarks, filed July 6, 2026, with respect to the rejections of newly amended independent claims 8, 13 and 29 under 35 U.S.C. §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Chouinard US 2004/0176740 A1.
On pages 9-11 of the Remarks, Applicant argues support for amended claim 10 in response to the §112(b) rejection of the previous action. Applicant notes on page 10 of the Remarks that the braid profile refers to a repeating pattern of filaments (“filar arrays”) wound in a helical braid forming a tubular mesh. In response, Examiner notes that the braid profile is determined by the pitch of a filar (angle from the longitudinal axis), see Applicant’s P0147.
Examiner notes that US 2019/0126016 to Gupta et al. teaches a braid profile in P0031 and shown in Fig. 6 comprising two counter wound filaments 66 and 68. This indicates that “braid profile” comprises more than one filar in other references, which differs from Applicant’s P0147.
On pages 12-14, Applicant argues newly amended independent claims 8, 13 and 29. In response, Examiner points to the rejections below.
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 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.
Claim 10 is 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. Claim 10 lines 2-4 recite “…the second braid profile is rotationally offset form the first braid profile to rotationally offset the first filar array and the second filar array from the third filar array and the fourth filar array…”. It is not clear how a braid profile rotationally offsets a filar array. Lines 5-6 of claim 10 recite the braid profile at an angle relative to the longitudinal axis. It is not clear how an angle of 90 degrees would allow for a braid to form profile since there is no pitch. No art has been applied to claim 10 for the reasons noted above.
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:
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.
Claims 8, 12-16, 18-25 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Chouinard US 2004/0176740 A1.
Regarding claim 8, Chouinard discloses a catheter assembly (intraluminal delivery system 1, P0025), comprising: a catheter body (sheath 2, shown in Figs. 3-6, wherein the braid of Fig. 5a overlays the braid of Fig. 5b as described in P0043, wherein the braid of Fig. 5a has a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer that provides a sheath with greater longitudinal compressive stiffness) extending from a catheter proximal portion to a catheter distal portion (catheter proximal portion toward the hub end, and catheter distal portion toward the tip end); a first braided metal layer (braid layer 9 of Fig. 5b, metal P0046) within the catheter body, wherein: the first braided metal layer includes at least a first filar array (strands 14 P0042 wound clock-wise as shown in Fig. 5b) and a second filar array (strands 14 P0042 wound counter clock-wise as shown in Fig. 5b), and the first filar array is interlaced with the second filar array (Fig. 5b, and braid configuration of P0039), the first filar array and the second filar array including one or more filars having a first thickness (Fig. 5a); and the first braided metal layer has a first braid profile, and the first braid profile is a tubular shape (Fig. 6); a second braided metal layer (braid layer 8 of Fig. 5a, metal P0046) coupled along an exterior of the first braided metal layer (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer), wherein: the second braided metal layer includes at least a third filar array (strands 13 P0042 wound clock-wise as shown in Fig. 5a) and a fourth filar array (strands 13 P0042 wound counter clock-wise as shown in Fig. 5a), and the third filar array is interlaced with the fourth filar array (Fig. 5a, and braid configuration of P0039); and the second braided metal layer has a second braid profile, and the second braid profile is a second tubular shape (Fig. 6); and wherein the first braided metal layer and the second braided metal layer are configured to expand to an expanded configuration with application of an axial force along a catheter longitudinal axis (radially expanded configuration results from longitudinal compression of the sheath), and in the expanded configuration: the first braided metal layer is configured to expand at a first rate (due to braid angle 12), the first braided metal layer being within the second braided metal layer (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer); and the second braided metal layer is configured to expand at a second rate less than the first rate of expansion (due to braid angle 11 being greater than braid angle 12), and the second braided metal layer is configured to constrain and brace the first braided metal layer (the dissimilarity of the angles of the braid layers create resistance to relative movement radially, P0043).
Chouinard does not explicitly teach one or more of the third filar array or the fourth filar array including one or more filars having a second thickness greater than the first thickness, wherein the second braided metal layer having the one or more filars with the second thickness is configured to constrain and brace the first braided metal layer.
However, Chouinard teaches in P0039 “The configuration and number of braided layers 6 can be changed to adjust the torsional stiffness and longitudinal stiffness. This is achieved by changing…the braid wire diameter....”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second thickness greater than the first thickness for the purpose of adjusting the torsional stiffness and longitudinal stiffness, Chouinard P0039, wherein the modified catheter of Chouinard is expected to perform as claimed wherein the second braided metal layer having the one or more filars with the second thickness is configured to constrain and brace the first braided metal layer, because Chouinard teaches the claimed structure.
Regarding claim 12, Chouinard teaches the catheter assembly of claim 8, wherein the second braided metal layer constrains and braces the first braided metal layer and minimizes kinking of the catheter body (greater longitudinal compressive stiffness from the dissimilarity of the angles of the braid layers create resistance to relative movement radially, P0043).
Regarding claim 13, Chouinard discloses a catheter assembly (intraluminal delivery system 1, P0025), comprising: a catheter body (sheath 2, shown in Figs. 3-6, wherein the braid of Fig. 5a overlays the braid of Fig. 5b as described in P0043, wherein the braid of Fig. 5a has a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer that provides a sheath with greater longitudinal compressive stiffness) extending from a catheter proximal portion to a catheter distal portion (catheter proximal portion toward the hub end, and catheter distal portion opposite the proximal portion) having a distal tip (distal tip 5, P0026); a first braided metal layer (braid layer 9 of Fig. 5b, metal P0046) within the catheter body, wherein: the first braided metal layer includes a first braided profile and the first braided profile is a tubular shape (Fig. 6); and the first braided metal layer includes at least a first filar array (strands 14 P0042 wound clock-wise as shown in Fig. 5b) and a second filar array (strands 14 P0042 wound counter clock-wise as shown in Fig. 5b), and the first filar array is interwoven with the second filar array (Fig. 5b, and braid configuration of P0039), the first filar array and the second filar array including one or more filars having a first thickness (Fig. 5a); a second braided metal layer (braid layer 8 of Fig. 5a, metal P0046) coupled along an exterior of the first braided metal layer (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer), wherein: the second braided metal layer includes a second braided profile and the second braided profile is a second tubular shape (Fig. 6), wherein the first braided metal layer is within the second braided metal layer; and the second braided metal layer includes at least a third filar array (strands 13 P0042 wound clock-wise as shown in Fig. 5a) and a fourth filar array (strands 13 P0042 wound counter clock-wise as shown in Fig. 5a), and the third filar array is interwoven with the fourth filar array (Fig. 5a, and braid configuration of P0039); and wherein the first braided metal layer and the second braided metal layer are configured to expand to an expanded configuration with application of an axial force along a catheter longitudinal axis (radially expanded configuration results from longitudinal compression of the sheath), and in the expanded configuration: the first braided metal layer is configured to expand at a first rate (due to braid angle 12), the first braided metal layer being within the second braided metal layer; and the second braided metal layer is configured to expand at a second rate less than the first rate of expansion (due to braid angle 11 being greater than braid angle 12), and the second braided metal layer is configured to constrain and brace the first braided metal layer (the dissimilarity of the angles of the braid layers create resistance to relative movement radially, P0043).
Chouinard does not explicitly teach one or more of the third filar array or the fourth filar array including one or more filars having a second thickness greater than the first thickness, wherein the second braided metal layer having the one or more filars with the second thickness is configured to constrain and brace the first braided metal layer.
However, Chouinard teaches in P0039 “The configuration and number of braided layers 6 can be changed to adjust the torsional stiffness and longitudinal stiffness. This is achieved by changing…the braid wire diameter....”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second thickness greater than the first thickness for the purpose of adjusting the torsional stiffness and longitudinal stiffness, Chouinard P0039, wherein the modified catheter of Chouinard is expected to perform as claimed wherein the second braided metal layer having the one or more filars with the second thickness is configured to constrain and brace the first braided metal layer, because Chouinard teaches the claimed structure.
Regarding claim 14, Chouinard teaches the catheter assembly of claim 13, wherein the first filar array includes a first filar and a second filar, and the first filar is spaced apart from the second filar by a first interstitial space (see annotated Figs. 5a-b below).
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Regarding claim 15, Chouinard teaches the catheter assembly of claim 14, wherein the second filar array includes a third filar and a fourth filar, and the third filar is spaced apart from the fourth filar by a second interstitial space (see annotated Figs. 5a-b above).
Regarding claim 16, Chouinard teaches the catheter assembly of claim 15, wherein: the first filar and the second filar have a first orientation (clock-wise); the third filar and the fourth filar have a second orientation (counter clock-wise); and the first orientation is different than the second orientation.
Regarding claim 18, Chouinard teaches the catheter assembly of claim 15, wherein at least a first portion of the first interstitial space is coincident with at least a second portion of the second interstitial space in correspondence with the first filar array interwoven with the second filar array (see annotated Figs. 5a-b above).
Regarding claim 19, Chouinard teaches the catheter assembly of claim 18, wherein: the third filar array includes a fifth filar and a sixth filar, and the fifth filar is spaced apart from the sixth filar by a third interstitial space; the fourth filar array includes a seventh filar and an eighth filar, and the seventh filar is spaced apart from the eighth filar by a fourth interstitial space; and at least a third portion of the third interstitial space is coincident with at least a fourth portion of the fourth interstitial space in correspondence with the third filar array interwoven with the fourth filar array (see annotated Figs. 5a-b above).
Regarding claim 20, Chouinard teaches the catheter assembly of claim 19, wherein: the first filar and the second filar have a first orientation (clock-wise); the third filar and the fourth filar have a second orientation (counter clock-wise); the first orientation is different than the second orientation; the fifth filar and the sixth filar have a third orientation (clock-wise); the seventh filar and the eighth filar have a fourth orientation (counter clock-wise); and the third orientation is different than the fourth orientation.
Regarding claim 21, Chouinard teaches the catheter assembly of claim 20, wherein one or more of the first orientation or the second orientation are different than one or more of the third orientation or the fourth orientation (see claim 21 above).
Regarding claim 22, Chouinard teaches the catheter assembly of claim 19, wherein the first filar and the second filar of the first filar array and the third filar and the fourth filar of the second filar array are located radially inwards of the fifth filar and the sixth filar of the third filar array and the seventh filar and the eighth filar of the fourth filar array (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer).
Regarding claim 23, Chouinard teaches the catheter assembly of claim 22, wherein the fifth filar and the sixth filar of the third filar array and the seventh filar and the eighth filar of the fourth filar array extend along exteriors of the first filar and the second filar of the first filar array and of the third filar and the fourth filar of the second filar array (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer).
Regarding claim 24, Chouinard teaches the catheter assembly of claim 23, wherein the first filar and the second filar of the first filar array and the third filar and the fourth filar of the second filar array are not interwoven with the fifth filar and the sixth filar of the third filar array and the seventh filar and the eighth filar of the fourth filar array (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer).
Regarding claim 25, Chouinard teaches the catheter assembly of claim 23, wherein the first braided metal layer is not interwoven with the second braided metal layer (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer).
Regarding claim 29, Chouinard discloses a catheter assembly (intraluminal delivery system 1, P0025), comprising: a catheter body (sheath 2, shown in Figs. 3-6, wherein the braid of Fig. 5a overlays the braid of Fig. 5b as described in P0043, wherein the braid of Fig. 5a has a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer that provides a sheath with greater longitudinal compressive stiffness) extending from a catheter proximal portion to a catheter distal portion (catheter proximal portion toward the hub end, and catheter distal portion toward the tip end); a first braided metal layer (braid layer 9 of Fig. 5b, metal P0046) within the catheter body, wherein: the first braided metal layer includes at least a first filar array (strands 14 P0042 wound clock-wise as shown in Fig. 5b) and a second filar array (strands 14 P0042 wound counter clock-wise as shown in Fig. 5b), the first filar array and the second filar array including one or more filars having a first thickness (Fig. 5a), and the first filar array is interlaced with the second filar array (Fig. 5b, and braid configuration of P0039); and the first braided metal layer has a first braid profile, and the first braid profile is a tubular shape (Fig. 6); a second braided metal layer (braid layer 8 of Fig. 5a, metal P0046) coupled along an exterior of the first braided metal layer (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer), wherein: the second braided metal layer includes at least a third filar array (strands 13 P0042 wound clock-wise as shown in Fig. 5a) and a fourth filar array (strands 13 P0042 wound counter clock-wise as shown in Fig. 5a), and the third filar array is interlaced with the fourth filar array (Fig. 5a, and braid configuration of P0039); and the second braided metal layer has a second braid profile, and the second braid profile is a second tubular shape (Fig. 6) with the first braided metal layer within the second tubular shape (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer, and P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer); and wherein: the first braided metal layer and the second braided metal layer are configured to expand to an expanded configuration with an application of axial force along a catheter longitudinal axis (radially expanded configuration results from longitudinal compression of the sheath), and in the expanded configuration: the first braided metal layer is configured to expand at a first rate (due to braid angle 12); and the second braided metal layer is configured to expand at a second rate less than the first rate of expansion (due to braid angle 11 being greater than braid angle 12), and the expansion at the second rate is configured to constrain and brace the first braided metal layer (the dissimilarity of the angles of the braid layers create resistance to relative movement radially, P0043); (see annotated Figs. 5a-c below for the following limitations) the first filar array includes a first filar and a second filar, and the first filar is spaced apart from the second filar by a first interstitial space; the second filar array includes a third filar and a fourth filar, and the third filar is spaced apart from the fourth filar by a second interstitial space; the third filar array includes a fifth filar and a sixth filar, and the fifth filar is spaced apart from the sixth filar by a third interstitial space; the fourth filar array includes a seventh filar and an eighth filar, and the seventh filar is spaced apart from the eighth filar by a fourth interstitial space; at least a first portion of the first interstitial space is coincident with at least a second portion of the second interstitial space in correspondence with the first filar array interlaced with the second filar array; and at least a third portion of the third interstitial space is coincident with at least a fourth portion of the fourth interstitial space in correspondence with the third filar array interlaced with the fourth filar array.
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Chouinard does not explicitly teach one or more of the third filar array or the fourth filar array including one or more filars having a second thickness greater than the first thickness, wherein the expansion at the second rate having the one or more filars with the second thickness is configured to constrain and brace the first braided layer.
However, Chouinard teaches in P0039 “The configuration and number of braided layers 6 can be changed to adjust the torsional stiffness and longitudinal stiffness. This is achieved by changing…the braid wire diameter....”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second thickness greater than the first thickness for the purpose of adjusting the torsional stiffness and longitudinal stiffness, Chouinard P0039, wherein the modified catheter of Chouinard is expected to perform as claimed wherein the expansion at the second rate having the one or more filars with the second thickness is configured to constrain and brace the first braided layer, because Chouinard teaches the claimed structure.
Regarding claim 30, Chouinard teaches the catheter assembly of claim 29, wherein: the first filar and the second filar have a first orientation (clock-wise); the third filar and the fourth filar have a second orientation; (counter clock-wise) the first orientation is different than the second orientation; the fifth filar and the sixth filar have a third orientation (clock-wise); the seventh filar and the eighth filar have a fourth orientation (counter clock-wise); and the third orientation is different than the fourth orientation.
Regarding claim 31, Chouinard teaches the catheter assembly of claim 29, wherein: the interlaced filars of the third filar array and the fourth filar array extend along an exterior of the interlaced filars of the first filar array and the second filar array (sheath 2 of P0043 and shown in Figs. 5a-b, having a smaller braid angle 12 layer circumferentially covered by a larger braid angle 11 layer); and the interlaced filars of the first filar array and the second filar array are not interlaced with the interlaced filars of the third filar array and the fourth filar array (P0045-0046 describe the method of making, wherein the second braid layer is slid over the first braid layer).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chouinard in view of Stigall et al. (Stigall) US 2014/0058257 A1.
Regarding claim 11, Chouinard teaches the catheter assembly of claim 8.
Chouinard does not teach the catheter assembly further comprising: a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward a distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic, and the distal tip includes the second section of the coil; and the second imaging characteristic differs from the first imaging characteristic, and the first imaging characteristic and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to a remainder of the catheter body.
However, Stigall teaches a catheter body (body 510, P0055) comprising: a coil (coil 120, P0056) proximate to the catheter distal portion (distal shaft portion 545 includes the marker coil 120, P0056), the coil having a first section (loosely wound section 160, P0063) and a second section (tightly wound section 155, P0063), wherein: the first section of the coil extends toward a distal tip (see annotated Fig. 14 below), and the first section has a first imaging characteristic (less radiopacity, P0038); the second section is swaged (Fig. 10 showing the coil swaged) and extends from the first section to the distal tip (see annotated Fig. 14 below), and the second section of the coil has a second imaging characteristic (greater radiopacity, P0038), and the distal tip includes the second section of the coil (see annotated Fig. 14 below); and the second imaging characteristic differs from the first imaging characteristic (coil 120 forms blocks of greater radiopacity or radiodensity than the loosely wound sections 160, see P0039-0040), and the first imaging characteristic and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to a remainder of the catheter body (P0038 and Fig. 14).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter assembly of Chouinard with the coil of Stigall for the purpose of visualizing the progress of the catheter assembly towards the target location within a patient’s body, as taught by Stigall P0003.
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 JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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