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 September 24, 2025. As directed by the amendment: no claims have been amended, no claims have been cancelled, and claims 13-14 have been added. Thus, claims 1-14 are presently pending in this application.
Response to Arguments
Applicant's arguments filed September 24, 2025 have been fully considered but they are not persuasive.
On pages 8-9 of the Remarks, to the best of Examiner’s understanding, Applicant is arguing that Martin does not teach, suggest or motivate one of ordinary skill in the art to modify the embodiment of Martin Figs. 10A-B in light of the embodiment of Martin Figs. 3I-J because the embodiment of Martin Figs. 3I-J does not also teach the first and second material sections having the same structural property. In response, Examiner notes that claim 1 is an obviousness rejection rather than an anticipatory rejection, and the issue is whether one of ordinary skill in the art would have found it obvious to modify Martin Figs. 10A-B with a strand of differing height in view of Martin Figs. 3I-J. P0092 of Martin teaches that strands can be different materials, shapes, sizes, and mixed together. P0094 of Martin teaches the polymer strands in each of the material sections can comprise polymers of varying compositions, and that clearly, any number of variations are within the scope of the disclosure. Therefore, Martin does not teach that use of a varying height strand is limited to only the illustrated embodiment of Figs. 3I-J. P0101 of Martin teaches that modification of the tube with a strand of greater height will cause the resulting material section to slightly protrude from the surface of the tube, and the motivation to modify the embodiment of Figs. 10A-B of Martin with a strand of greater height is set forth 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 13 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 13 line 2 recites “…distinguishable from each other by color…”. It is not clear if this is in reference to the color of the medical tubing or of the first and second material sections. For purposes of examination, this is interpreted as “…distinguishable from each other by color of the medical tubing…”.
Claim 14 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 14 line 2 recites “…surface texture…”. It is not clear if this is in reference to the surface texture of the medical tubing or of the first and second material sections. For purposes of examination, this is interpreted as “…surface texture of the medical tubing…”.
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.
Claims 1 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scott et al. (Scott) US 2018/0243046 A1.
Regarding claim 1, Scott discloses a medical tubing (delivery system 200, P0031 and shown in Fig. 6A) comprising: a tubular body (catheter 110, P0031) having an axial length (axial length is the length of the catheter from proximal end to distal end) and comprising a first region (first region, see annotated Fig. 6A below) and a second region (second region, see annotated Fig. 6A below) axially spaced from the first region (see annotated Fig. 6A below), where a first structural property of the first region (first structural property of the first region is its relative location on the catheter proximal of second region) differs from a second structural property of the second region (second structural property of the second region is its relative location on the catheter distal of first region); a first material section (first material section, see annotated Fig. 6A below) and a second material section (second material section, see annotated Fig. 6A below) extending in the second region (see annotated Fig. 6A below), and where a first structural property of the first material section (first structural property of the first material section is that it is positioned distal to the first region) is the same as a second structural property of the second material section (second structural property of the second material section is that it is also positioned distal to the first region), wherein the first material section and the second material section are visually distinguishable from each other by an operator from an exterior of the medical tubing (first material section and second material section have different colors, wherein distal portion 114 seen below may include a colored region that is different than the color of the remaining portion of the catheter, P0031).
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Regarding claim 12, Scott discloses the medical tubing of claim 1, wherein the tubular body comprises a proximal region (proximal end not shown in Fig. 6A, P0031) located proximally to both the first region and the second region, the proximal region comprising a single material (the proximal end comprises a single material inherently).
Regarding claim 13, Scott discloses the medical tubing of claim 1, wherein the first material section and the second material section are visually distinguishable from each other by color (first material section and second material section have different colors, wherein distal portion 114 seen above may include a colored region that is different than the color of the remaining portion of the catheter, P0031).
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 1-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Martin US 20200391009 A1.
Regarding claim 1, Martin discloses a medical tubing (catheter 100, P0080 and shown in Fig. 2A) comprising: a tubular body (outer layer 103, P0080) having an axial length (axial length along axis 105, P0081).
Martin teaches customization of outer layer 103 for catheters, P0080. P0092 describes the process for constructing outer layer 103 from polymer strands.
The embodiment of Fig. 2A does not teach the tubular body comprising a first region and a second region axially spaced from the first region, where a first structural property of the first region differs from a second structural property of the second region; a first material section and a second material section extending in the second region, and where a first structural property of the first material section is the same as a second structural property of the second material section.
However, Martin teaches a variation of polymer strands illustrated in Figs. 10A-B and described in P0109-0113, for constructing a tubular body from polymer strands P0026, the tubular body comprising a first region (region 172, P0109) and a second region (region 170, P0109) axially spaced from the first region, where a first structural property of the first region (relative stiffness less in comparison to region 170, resulting from the combination of one strand of polymer 206 and four strands of polymer 204, P0113, and see applicant’s P0006) differs from a second structural property of the second region (relative stiffness greater in comparison to region 172, resulting from all five strands in region 170 being polymer 204, P0113); a first material section (first material section, see annotated Fig. 10B below, which is a strand of polymer 204 in region 170) and a second material section (second material section, see annotated Fig. 10B below, which is a different strand of polymer 204 in region 170) extending in the second region, and where a first structural property of the first material section (stiffness) is the same as a second structural property of the second material section (stiffness, polymer strands 204 have the same stiffness because they are the same polymer material, and see P0113).
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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 outer layer of Fig. 2A with the polymer strands of Fig. 10A for the purpose providing a gradual variation over a transition region, P0109, from one material to another material that have different mechanical properties.
The embodiment of Figs. 10A-B does not teach wherein the first material section and the second material section are visually distinguishable from each other by an operator from an exterior of the medical tubing.
However, Martin teaches variations of strands being joined together where the strands are not uniform, see Figs. 3I and 3J, and thus are both visually and mechanically distinguishable from each other by an operator from an exterior of the medical tubing due to variations in the shapes, sizes, widths, heights, etc. within a polymer layer, P0101.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the height of one polymer strand 204 of the first or second material section for the purpose of causing the that material section to slightly protrude from a surface of the tube relative to the other material section, P0101, providing a textured surface for improved surgeon manipulation, that is both mechanically and visually distinguishable by an operator from an exterior of the medical tubing due to the protrusion.
Regarding claim 2, Martin teaches the medical tubing of claim 1, wherein the first material section and the second material section extend spirally along the axial length of the second region (method of forming a polymer tube includes wrapping a plurality of polymer strands in a spiral configuration, P0026 and P0112 and Fig. 10B).
Regarding claim 3, Martin teaches the medical tubing of claim 1, further comprising a plurality of material sections in the first region (five-strand construction, P0109 and see Fig. 10A).
Regarding claim 4, Martin teaches the medical tubing of claim 1, wherein the first material section and the second material section are mechanically distinguishable from each other (mechanically distinguishable via the protrusion on one of the first and second material sections).
Regarding claim 5, Martin teaches the medical tubing of claim 1, further comprising an inner liner (inner liner 14, P0082) that is interior to the tubular body (Fig. 2A).
Regarding claim 6, Martin teaches the medical tubing of claim 5, further comprising a reinforcement structure (braid or coil 20, P0082) exterior to the inner liner (Fig. 2A).
Regarding claim 7, Martin teaches the medical tubing of claim 6, wherein the reinforcement structure is embedded within the wall (reinforcement structure within outer layer, P0039).
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 of Martin by embedding the braid or coil within the outer layer as taught by Martin for the purpose of linking elements that transfer torque, P0082.
Regarding claim 8, Martin teaches the medical tubing of claim 1, wherein the first material section extends in in a right-hand wind direction in the first region (right-hand wind, P0037).
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 of Martin with a right-hand wind direction in the first region for the purpose of pre-disposing the catheter to bend or navigate in a particular rotational direction within the anatomy, P0086.
Regarding claim 9, Martin teaches the medical tubing of claim 1, wherein the first material section extends in in a left-hand wind direction in the first region (left-hand wind, P0037).
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 of Martin with a left-hand wind in the first region for the purpose of pre-disposing the catheter to bend or navigate in a particular rotational direction within the anatomy, P0086.
Regarding claim 10, Martin teaches the medical tubing of claim 1, further comprising a soft distal tip section (distal portion of layer 103 is the softest/least stiff region, P0085).
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 of Martin to comprise a soft distal tip section as taught by Martin for the purpose of bending more easily and gently around the more delicate and tortuous distal curves, P0008.
Regarding claim 11, Martin teaches the medical tubing of claim 10, wherein the soft distal tip section comprises a single material (entirely formed from a single material, claim 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 soft distal section to comprise a single material for the purpose of maximizing softness since the balance described in P0008 between stiffness and softness as it relates to the problem of torque transmission versus navigating tortuous anatomy does not apply at the distal tip section since there is nothing more distal for which torque would need to be transmitted.
Regarding claim 12, Martin teaches the medical tubing of claim 1, wherein the tubular body comprises a proximal region (proximal region, P0033) located proximally to both the first region and the second region, the proximal region comprising a single material (entirely formed from a single material, P0033).
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 of Martin to comprise a proximal region located proximally to both the first and second region comprising a single material as taught by Martin for the purpose of maximizing stiffness since the balance described in P0008 between stiffness and softness as is relates to torque transmission versus navigating tortuous anatomy does not apply at the proximal region since the proximal region extends from the patients anatomy during use, not entering the anatomy during use but instead being manipulated by a surgeon.
Regarding claim 14, Martin teaches the medical tubing of claim 1, wherein the first material section and the second material section are visually distinguishable from each other by surface texture (the surface texture of the medical tubing is not smooth due to the difference in height of the first and second material sections of the modified tubing of claim 1, such that they are fully capable of being visually distinguished from each other).
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