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 February 4, 2026. As directed by the amendment: claims 1 and 33 have been amended, claims 5 and 11-26 have been cancelled, and claim 34 has been added. Thus, claims 1-4, 6-10 and 27-34 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 4, 2026, with respect to the rejections of newly amended independent claims 1 and 33 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Ju et al. (Ju) US 6,217,566 B1.
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 1-2, 6-8, 10 and 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Zayed et al. (Zayed) US 2025/0090801 A1 in view of Ju et al. (Ju) US 6,217,566 B1.
Regarding claim 1, Zayed discloses a rigidizing device (catheter 100, P0028 and shown in Figs. 1-3) comprising: an elongate flexible tube (inner layer 102, P0028), wherein the elongate flexible tube comprises a first reinforcement element and second reinforcement element (first and second reinforcement elements of braid elements 104, see annotated Fig. 1 below), and wherein the second reinforcement element is counterwound relative to the first reinforcement element (braid, and see Fig. 1); a stiffening layer (middle layer 106, P0028) radially offset of the elongate flexible tube (Fig. 1); a containment layer (outer layer 108, P0028) radially offset from the elongate flexible tube (Fig. 1) so that the stiffening layer is in a region between the elongate flexible tube and the containment layer (Fig. 1); and a vacuum (vacuum, P0028) in fluid communication with the region between the elongate flexible tube and the containment layer (middle layer 106 may form a lumen 107, P0029 and shown in Figs. 3A-B) and configured to attach to a source of vacuum (the lumen 107 of the middle layer 106 may be fluidly connected to a vacuum source, P0029); wherein the rigidizing device is configured to have a rigid configuration when vacuum is applied through the inlet and a flexible configuration when vacuum is not applied through the inlet (P0029).
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Catheter 100 of Figs. 1-3 does not explicitly teach a vacuum inlet.
However, Zayed teaches another catheter embodiment 200 and shown in Fig. 7A having a vacuum inlet, see annotated Fig. 7A below, which is configured to attach to an actuation syringe 242 for communication with the lumen 207 of the middle layer, P0047.
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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 embodiment of Figs. 1-3 with a vacuum inlet for the purpose of fluidly coupling a vacuum source such as a syringe for moving fluid into and out of the lumen.
Zayed does not teach wherein the first and second reinforcement elements are embedded within an elastomeric matrix.
However, Ju teaches a catheter wherein the first and second reinforcement elements (braid 140 of Fig. 4A, c 10 ln 2-3) are embedded (embedded, c 1 ln 12) within an elastomeric matrix (polyurethane, c 8 ln 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the rigidizing device of Zayad by embedding the first and second reinforcement elements of Zayad within the inner layer 102 of Zayad, wherein the inner layer 102 is an elastomeric matrix (the material of inner layer is the matrix from which the inner layer 102 of Zayad takes form, wherein Zayad teaches inner layer 102 can be formed of elastic polymers including polyether block amide and PU P0031, wherein PU is known to one of ordinary skill in the art as an acronym for polyurethane) for the purpose of maximizing the size of the inner lumen with a thin wall as taught by Ju c 1 ln 8-10.
Regarding claim 2, Zayed in view of Ju teaches the rigidizing device of claim 1.
Zayed does not does not teach wherein the stiffening layer is a braid layer in the embodiment of Figs. 1-3.
However, Zayed teaches another embodiment 200 shown in Figs. 6A-C, wherein the stiffening layer is a braid layer (wrapping 240 interwoven with strings, P0048).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Figs. 1-3 of Zayed with wrapping 240 as taught by Zayed for the purpose of keeping the strings in a in a linear parallel pattern, Zayed P0048.
Regarding claim 6, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the first reinforcement element is wound in a positive direction and the second reinforcement angle is wound a negative direction (braid 104, wherein the reinforcement elements are wound in opposite directions to form a braid).
Zayed does not explicitly teach wherein the first reinforcement is wound at an angle and the second reinforcement angle is wound at the same angle.
However, Zayed teaches a braid 104 to support the inner layer 102 against buckling and arranged in a crossing pattern to aid in the support of the inner layer 102. Thus, the crossing pattern is a result effective variable that achieves a recognized result of preventing buckling. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the crossing pattern of Zayed as claimed as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, Zayed in view of Ju teaches the rigidizing device of claim 1.
Zayed does not teach wherein the first reinforcement element or the second reinforcement element is wound at an angle of greater than 60 degrees and less than 90 degrees relative to a longitudinal axis of the rigidizing device.
However, Zayed teaches a braid 104 to support the inner layer 102 against buckling and arranged in a crossing pattern to aid in the support of the inner layer 102. Thus, the crossing pattern is a result effective variable that achieves a recognized result of preventing buckling. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the crossing pattern of Zayed as claimed as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the first reinforcement element is positioned radially outwards of the second reinforcement element (braid 104, wherein portion of the first reinforcement element will be positioned radially outwards of the second reinforcement element at times because the two elements form a braid).
Regarding claim 10, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the first and second reinforcement elements are woven together (braid 104, P0031).
Regarding claim 27, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the stiffening layer comprises a plurality of longitudinal strands (strings 106, P0028 and shown in Fig. 1).
Regarding claim 28, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the stiffening layer comprises a plurality of longitudinal strands (strings 106, P0028 and shown in Fig. 1).
Zayed does not teach the stiffening layer comprising a braid layer in the embodiment of Figs. 1-3.
However, Zayed teaches another embodiment 200 shown in Figs. 6A-C, wherein the stiffening layer comprises a braid layer (wrapping 240 interwoven with strings, P0048 and shown in Figs. 6A-C).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Figs. 1-3 of Zayed with wrapping 240 as taught by Zayed for the purpose of keeping the strings in a in a linear parallel pattern, Zayed P0048.
Regarding claim 29, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the first reinforcement element comprises a flat wire (nitinol, P0031 and see Fig. 1 showing a flat wire 104).
Regarding claim 30, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the first reinforcement element is a different shape than the second reinforcement element (first and second reinforcement elements are counterwound, and therefore individually form clockwise and counter-clockwise rotating helixes, see Fig. 1).
Regarding claim 31, Zayed in view of Ju teaches the rigidizing device of claim 1, wherein the containment layer comprises a bladder layer (outer layer 108 may be a compliant layer that collapses down to compress the inner layer 102 and strings 105 when vacuum/suction is applied to the middle layer, P0033).
Regarding claims 32 and 33, Zayed discloses a rigidizing device (catheter 100, P0028 and shown in Figs. 1-3) comprising: an elongate flexible tube (inner layer 102, P0028), wherein the elongate flexible tube comprises a first reinforcement element (first reinforcement element of braid elements 104, see annotated Fig. 1 below) comprising a first length (first length shown in Fig. 1 below, and not a limitation of claim 32) and second reinforcement element (second reinforcement element of braid elements 104, see annotated Fig. 1 below) comprising a second length (second length shown in Fig. 1 below, and not a limitation of claim 32), and wherein the second reinforcement element is counterwound relative to the first reinforcement element (braid, and see Fig. 1); a stiffening layer (middle layer 106, P0028) radially offset of the elongate flexible tube (Fig. 1); a containment layer (coating 110, P0028, which is the outermost layer and thus contains the radially inward layers) radially offset from the elongate flexible tube so that the stiffening layer is in a region between the elongate flexible tube and the containment layer (Fig. 1); a bladder layer (outer layer 108, P0028, wherein outer layer 108 may be a compliant layer that collapses down to compress the inner layer 102 and strings 105 when vacuum/suction is applied to the middle layer, P0033) between the containment layer and the elongate flexible tube (Fig. 1); and a vacuum (vacuum, P0028) in fluid communication with the region between the elongate flexible tube and the containment layer (middle layer 106 may form a lumen 107, P0029 and shown in Figs. 3A-B) and configured to attach to a source of vacuum (the lumen 107 of the middle layer 106 may be fluidly connected to a vacuum source, P0029); wherein the rigidizing device is configured to have a rigid configuration when vacuum is applied through the inlet to drive the bladder layer against the stiffening layer, and a flexible configuration when vacuum is not applied through the inlet (P0029).
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Catheter 100 of Figs. 1-3 does not explicitly teach a vacuum inlet.
However, Zayed teaches another catheter embodiment 200 and shown in Fig. 7A having a vacuum inlet, see annotated Fig. 7A below, which is configured to attach to an actuation syringe 242 for communication with the lumen 207 of the middle layer, P0047.
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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 embodiment of Figs. 1-3 with a vacuum inlet for the purpose of fluidly coupling a vacuum source such as a syringe for moving fluid into and out of the lumen.
Zayed does not teach wherein the first and second reinforcement elements are embedded within an elastomeric matrix.
However, Ju teaches a catheter wherein the first and second reinforcement elements (braid 140 of Fig. 4A, c 10 ln 2-3) are embedded (embedded, c 1 ln 12) within an elastomeric matrix (polyurethane, c 8 ln 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the rigidizing device of Zayad by embedding the first and second reinforcement elements of braid elements 104 of Zayad within the inner layer 102 of Zayad which is an elastomeric matrix (elastomeric is a portmanteau for elastic polymer which includes polyurethane, and the inner layer 102 materials of Zayed are the matrix from which the inner layer 102 of Zayad takes form, wherein Zayad teaches inner layer 102 can be formed of elastic polymers including polyether block amide and PU P0031, wherein PU is known to one of ordinary skill in the art as an acronym for polyurethane) for the purpose of maximizing the size of the inner lumen with a thin wall as taught by Ju c 1 ln 8-10.
Regarding claim 34, Zayed discloses a rigidizing device (catheter 100, P0028 and shown in Figs. 1-3) comprising: an elongate flexible tube (inner layer 102, P0028), wherein the elongate flexible tube comprises a first reinforcement element (first reinforcement element of braid elements 104, see annotated Fig. 1 below) comprising a first length (first length shown in Fig. 1 below) of metal (nitinol, P0031) and second reinforcement element (second reinforcement element of braid elements 104, see annotated Fig. 1 below) comprising a second length (second length shown in Fig. 1 below) of metal (nitinol, P0031), and wherein the second reinforcement element is counterwound relative to the first reinforcement element (braid, and see Fig. 1); a stiffening layer (middle layer 106, P0028) radially offset of the elongate flexible tube; a containment layer (outer layer 108, P0028) radially offset from the elongate flexible tube so that the stiffening layer is in a region between the elongate flexible tube and the containment layer (Fig. 1); and a vacuum (vacuum, P0028) in fluid communication with the region between the elongate flexible tube and the containment layer (middle layer 106 may form a lumen 107, P0029 and shown in Figs. 3A-B) and configured to attach to a source of vacuum (the lumen 107 of the middle layer 106 may be fluidly connected to a vacuum source, P0029); wherein the rigidizing device is configured to have a rigid configuration when vacuum or pressure is applied and a flexible configuration when vacuum or pressure is not applied (P0029).
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Catheter 100 of Figs. 1-3 does not explicitly teach a vacuum inlet.
However, Zayed teaches another catheter embodiment 200 and shown in Fig. 7A having a vacuum inlet, see annotated Fig. 7A below, which is configured to attach to an actuation syringe 242 for communication with the lumen 207 of the middle layer, P0047.
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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 embodiment of Figs. 1-3 with a vacuum inlet for the purpose of fluidly coupling a vacuum source such as a syringe for moving fluid into and out of the lumen.
Zayed does not teach wherein the first and second reinforcement elements are embedded within an elastomeric matrix.
However, Ju teaches a catheter wherein the first and second reinforcement elements (braid 140 of Fig. 4A, c 10 ln 2-3) are embedded (embedded, c 1 ln 12) within an elastomeric matrix (polyurethane, c 8 ln 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the rigidizing device of Zayad by embedding the first and second reinforcement elements of braid elements 104 of Zayad within the inner layer 102 of Zayad which is an elastomeric matrix (elastomeric is a portmanteau for elastic polymer which includes polyurethane, and the inner layer 102 materials of Zayed are the matrix from which the inner layer 102 of Zayad takes form, wherein Zayad teaches inner layer 102 can be formed of elastic polymers including polyether block amide and PU P0031, wherein PU is known to one of ordinary skill in the art as an acronym for polyurethane) for the purpose of maximizing the size of the inner lumen with a thin wall as taught by Ju c 1 ln 8-10.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 6-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,744,443 in view of Ju et al. (Ju) US 6,217,566 B1.
With regard to claim 1 of the application, claim 1 of the patent discloses a rigidizing device (c 21, ln 51) comprising: an elongate flexible tube (c 21, ln 51), wherein the elongate flexible tube comprises a first reinforcement element and second reinforcement element (c 21, ln 52-54), and wherein the second reinforcement element is counterwound relative to the first reinforcement element (c 21, ln 54-56); a stiffening layer (c 21, ln 59) radially offset of the elongate flexible tube; a containment layer (outer layer, c 21, ln 61) radially offset from the elongate flexible tube so that the stiffening layer is in a region between the elongate flexible tube and the containment layer; and a vacuum or pressure inlet (c 21, ln 63) in fluid communication with the region between the elongate flexible tube and the containment layer and configured to attach to a source of vacuum or pressure (c 21, ln 65); wherein the rigidizing device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet (c 21, ln 66 to c 22 ln 3).
Zayed does not teach wherein the first and second reinforcement elements are embedded within an elastomeric matrix.
However, Ju teaches a catheter wherein the first and second reinforcement elements (braid 140 of Fig. 4A, c 10 ln 2-3) are embedded (embedded, c 1 ln 12) within an elastomeric matrix (polyurethane, c 8 ln 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the rigidizing device of Zayad by embedding the first and second reinforcement elements of braid elements 104 of Zayad within the inner layer 102 of Zayad which is an elastomeric matrix (elastomeric is a portmanteau for elastic polymer which includes polyurethane, and the inner layer 102 materials of Zayed are the matrix from which the inner layer 102 of Zayad takes form, wherein Zayad teaches inner layer 102 can be formed of elastic polymers including polyether block amide and PU P0031, wherein PU is an acronym for polyurethane) for the purpose of maximizing the size of the inner lumen with a thin wall as taught by Ju c 1 ln 8-10.
Claims 2-4 and 6-10 are rejected in view of the claims from 11,744,443 noted in the chart below in view of Ju.
Application
11,744,443
citation
1
1
2
4
3
1
C 21 ln 57-58
4
2
6
5
-
7
6
8
8
9
8
10
7
27
28
-
29
-
30
-
31
-
32
-
33
-
34
-
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