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 .
Detailed Action
This is in response to the amendment filed 01/08/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6, 8, 10, 11, 13, 15, 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 5,176,600 (Truckai)
Regarding claims 1, 6, 8, 48 Truckai discloses as shown in Figure 4, a dilator for an endovascular treatment of a lesion within a patient, comprising: a dilator shaft comprising a distal dilator shaft end and a proximal dilator shaft end and the dilator shaft extends along a longitudinal axis (L), the dilator shaft comprising at least one braided section comprising an arrangement of braid threads woven to form a braid, a first group of the braid threads (strands 30, 28, see col. 4, lines 56-69) and a second group of the braid threads (strands 18c, 20c, see col. 4, lines 56-69) being woven with one another and being arranged to cross one another at an angle (α, β, γ) therebetween, wherein the angle varies between the distal dilator shaft end and the proximal dilator shaft end (see col. 3, lines 8-19), and wherein the dilator shaft further comprises at least one longitudinal wire (filaments 32, see col. 4, lines 56-69) extending longitudinally along the dilator shaft, wherein the at least one longitudinal wire is interlaced with said first group of the braid threads and said second group of the braid threads, wherein said braid threads are formed by wires or stripes and/or, wherein said braid threads and/or the at least one longitudinal wire are made of a metal, a metal alloy or a polymer, wherein the at least one longitudinal wire runs from the distal dilator shaft end to the proximal dilator shaft end, wherein the dilator shaft comprises a polymer matrix material embedding said braid. See col. 2, lines 16-21 and col. 3, lines 8-17.
Regarding claims 10, 11, 13 Truckai discloses wherein the dilator shaft comprises an inner dilator lumen longitudinally extending along the dilator shaft, wherein said inner dilator lumen is arranged radially within said braid, wherein the dilator shaft has at least one non-braided section comprising no braid threads. see col. 4, lines 56-69 and Figure 4.
Claim(s) 43, 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2016/0220741 (Garrison et al.)
Regarding claims 43, 44 Garrision discloses as shown in Figure 1, a multi-functional catheter system comprising a support catheter (support catheter 320, see paragraph [0044]) and at least one support catheter lumen, wherein the support catheter is capable of accommodating simultaneously or consecutively at least two inner members in the at least one support catheter lumen and wherein one of the at least two inner members is a dilator according to claim 1, wherein another of the at least two inner members is a guidewire or a balloon catheter.
To be clear claim 43 recites a support catheter capable of accommodating an inner member, and not the inner members themselves.
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.
Claim(s) 2, 17, s/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,176,600 (Truckai) in view of U.S. Patent Publication Number 2015/0374483 Janardhan et al.)
Regarding claims 2, Truckai discloses wherein at the distal dilator shaft end the first group of the braid threads and the second group of the braid threads are arranged to cross one another at a first angle (α) therebetween, and at the proximal dilator shaft end the first group of the braid threads and the second group of the braid threads are arranged to cross one another at a second angle (β) therebetween, wherein the dilator shaft comprises a polymer matrix material embedding said braid. See col. 2, lines 16-21 and col. 3, lines 8-17.
Truckai fails to disclose wherein the first angle (α) at the distal dilator shaft end is larger than the second angle (β) at the proximal dilator shaft end.
Janardhan et al., from a related field of endeavor teaches a similar braid as shown in Figure 6B used for the same purpose of being inserted into a lumen in the body, where a first angle (α) at the distal dilator shaft end is larger than the second angle (β) at the proximal dilator shaft end. See paragraph [0633].
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 device disclosed by Truckai such that the first angle (α) at the distal dilator shaft end is larger than the second angle (β) at the proximal dilator shaft end for the purpose of configuring the section of the braid at the distal end of the shaft to have a higher radial strength.
Regarding claim 17 Truckai discloses the dilator shaft comprises at least a first section comprising a first axial length (L1) and a second section comprising a second axial length (L2), wherein the second section adjoins the first section when viewed along the longitudinal axis (L). see col. 4, lines 56-69 and Figure 4.
Truckai is silent regarding wherein in said first section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said first angle (α) therebetween, and in said second section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said second angle (β) therebetween.
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 device disclosed by Truckai such that wherein in said first section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said first angle (α) therebetween, and in said second section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said second angle (β) therebetween because it would only require a rearrangement of parts without changing how the device operates (braid would still provide structural support, expand, contract in the same manner). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Claim(s) 3-5, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,176,600 (Truckai)
Regarding claims 3, 4, Truckai discloses the dilator shaft comprises at least a first section comprising a first axial length (L1) and a second section comprising a second axial length (L2), wherein the second section adjoins the first section when viewed along the longitudinal axis (L). see col. 4, lines 56-69 and Figure 4.
Truckai is silent regarding wherein in said first section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said first angle (α) therebetween, and in said second section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said second angle (β) therebetween.
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 device disclosed by Truckai such that wherein in said first section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said first angle (α) therebetween, and in said second section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at said second angle (β) therebetween because it would only require a rearrangement of parts without changing how the device operates (braid would still provide structural support, expand, contract in the same manner). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claim 5, Trukai disclose comprises a third section comprising a third axial length (L3), wherein in said third section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at a third angle (γ) therebetween, the third angle (γ) being different than said first angle (α) and said second angle (β). see col. 4, lines 56-69 and Figure 4.
Claim(s) 15, 49, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,176,600 (Truckai) in view of U.S. Patent Number 6,749,600 (Levy)
Regarding claim 15, 49 Truckai discloses as shown in Figure 4 a dilator for an endovascular treatment of a lesion within a patient, comprising: a dilator shaft having a distal dilator shaft end and a proximal dilator shaft end and the dilator shaft extends along a longitudinal axis (L), the dilator shaft comprising at least one braided section comprising an arrangement of braid threads woven to form a braid, a first group of the braid threads (strands 30, 28, see col. 4, lines 56-69) and a second group of the braid threads (strands 18c, 20c, see col. 4, lines 56-69) being woven with one another and being arranged to cross one another at an angle (α, β, γ) therebetween, wherein the angle varies between the distal dilator shaft end and the proximal dilator shaft end, wherein the dilator shaft comprises a polymer matrix material embedding said braid, wherein the dilator shaft comprises at least one longitudinal wire (filaments 32, see col. 4, lines 56-69) extending longitudinally along the dilator shaft. See col. 2, lines 22-32.
Tuckai fails to disclose at least one non-braided section comprising no braid threads, the at least one non-braided section being longitudinally adjoined to the at least one braided section.
Levy, from the same field of endeavor teaches a similar dilator with at least one non-braided section comprising no braid threads, the at least one non-braided section being longitudinally adjoined to the at least one braided section for the purpose of configuring sections of the dilators to have increased flexibility. See col. 3, lines 23-44.
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 dilator disclosed by Tuckai to include the non-braided section in order to configure a section of the dilator to have increased flexibility.
Claim(s) 16, 19, 25, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,176,600 (Truckai) in view of U.S. Patent Number 6,749,600 (Levy) as applied to claim 15 above, and further in view of U.S. Patent Publication Number 2015/0374483 Janardhan et al.)
Regarding claims 16, 25 Truckai discloses wherein at the distal dilator shaft end the first group of the braid threads and the second group of the braid threads are arranged to cross one another at a first angle (α) therebetween, and at the proximal dilator shaft end the first group of the braid threads and the second group of the braid threads are arranged to cross one another at a second angle (β) therebetween, wherein the dilator shaft comprises a polymer matrix material embedding said braid. See col. 2, lines 16-21 and col. 3, lines 8-17.
Truckai fails to disclose wherein the first angle (α) at the distal dilator shaft end is larger than the second angle (β) at the proximal dilator shaft end.
Janardhan et al., from a related field of endeavor teaches a similar braid as shown in Figure 6B used for the same purpose of being inserted into a lumen in the body, where a first angle (α) at the distal dilator shaft end is larger than the second angle (β) at the proximal dilator shaft end. See paragraph [0633].
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 device disclosed by Truckai such that the first angle (α) at the distal dilator shaft end is larger than the second angle (β) at the proximal dilator shaft end for the purpose of configuring the section of the braid at the distal end of the shaft to have a higher radial strength.
Regarding claim 19, Trukai disclose comprises a third section comprising a third axial length (L3), wherein in said third section said first group of the braid threads and said second group of the braid threads are arranged to cross one another at a third angle (γ) therebetween, the third angle (γ) being different than said first angle (α) and said second angle (β). see col. 4, lines 56-69 and Figure 4.
Regarding claim 27, Trukai disclose wherein the dilator shaft comprises an inner dilator lumen longitudinally extending along the dilator shaft. See col. 2, lines 16-21 and col. 3, lines 8-17 and Figure 4.
Response to Arguments
The applicant’s arguments filed 01/08/2026 have been considered but are not persuasive. The applicant argues Truckai fails to disclose the at least one longitudinal a wire is interlaced with the first group of braided threads and the second group of braided threads. In response, the Office respectfully disagrees.
The plain meaning of the term interlaced is varied by alternation (according to webster’s dictionary) and is no inconsistent with the specification.
In this case, filament 32 is varied by alternation with strands 18c, 20c in the positions. Figure 5 clearly shows filament 3 between strands 18c, 20c:
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The applicant’s argument that the filaments are pressed by the strands and not interlaced is not persuasive as it ignores the plain meaning of the term “interlaced” Being pressed by the strands as described by Truckai does not exclude them being interlaced.
Moreover, one longitudinal a wire is interlaced with the first group of braided threads and the second group of braided threads is known in the art. See Figure 3 of U.S. Patent Publication Number 2013/0289697 and paragraph [0041].
Furthermore, strands 18c, 20c are disclosed as wound completely around the inner lining. It follows that each strands 18c, 20c would press against each filament 32 at different axial positions of filament 32. The radial positions of strand 18c, 20c are not singular as the applicant argues.
The applicant’s argument with respect to the rejection of claim 15 have been considered but are moot in view of the new grounds of rejection.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
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