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 .
REJECTIONS WITHDRAWN
There are no rejections withdrawn.
REJECTIONS REPEATED
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 and 4-8 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Millet (US 6,146,814, cited by applicant).
Millet discloses a medical tubing comprising: a tubular body having an axis extending lengthwise, the tubular body having a wall formed from a plurality of material sections that extend spirally along the axis, where each of the plurality of material sections includes a width; and wherein the plurality of material sections includes a transition material section extending in a continuous spiral over both a first region and a second region, wherein a first width of the transition material section is consistent at the first region and where the transition material section decreases at a stepdown region to a second width, which is consistent at the second region (column 2, lines 10-67, column 3, lines 1-6 and Figs. 2-3).
Millet discloses further comprising an inner liner that is interior to the tubular
body, further comprising a reinforcement structure exterior to the
inner liner, wherein the reinforcement structure is embedded within
the wall, wherein the plurality of material sections extends in in a
right-hand wind direction in the first region, wherein the plurality of material sections extends in in a left-hand wind direction in the first region (column 1, lines 46-67, column 2, lines 10-67, column 3, lines 1-6 and Figs. 2-3).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet (US 6,146,814, cited by applicant).
Millet discloses variable width stripes with wide regions and narrow regions at different points along the length of the catheter (column 2, lines 15-20) in order to provide improved bending and non-kinking properties (column 1, lines 13-29).
Milet does not disclose where a length of the stepdown region is less than the
first width. However, a change in size/shape is obvious and well within the level of one of ordinary skill in the art (MPEP 2144.04 (IV)). It would have been obvious to one of ordinary skill in the art to have provided where a length of the stepdown region is less than the first width in order to provide improved bending and non-kinking properties since changes in shape/size are obvious and Milet discloses variable width stripes with wide regions and narrow regions at different points along the length of the catheter (column 2, lines 15-20) in order to provide improved bending and non-kinking properties (column 1, lines 13-29).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet (US 6,146,814, cited by applicant) in view of JP2007-260403 (English machine translation provided herein).
Millet does not disclose wherein the first region the transition material section comprises a first material and in the second region, the transition material section comprises a second material.
JP2007-260403 discloses wherein the first region the transition material section comprises a first material and in the second region, the transition material section comprises a second material (paragraphs [0018-0022]) in order to provide improved bending properties (paragraphs [0009-0011]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the first region the transition material section comprises a first material and in the second region, the transition material section comprises a second material in Millet in order to provide improved bending properties as taught or suggested by JP2007-260403.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet (US 6,146,814, cited by applicant) in view of Martin (US 2020/0391009).
Millet does not disclose wherein at least one of the plurality of material sections comprises a non-fusable material, further comprising a soft distal tip section, wherein the soft distal tip section comprises a single material, wherein the tubular body comprises a proximal region located proximally to both the first region and the second region, the proximal region comprising a single material.
Martin discloses wherein at least one of the plurality of material sections comprises a non-fusable material, further comprising a soft distal tip section, wherein the soft distal tip section comprises a single material, wherein the tubular body comprises a proximal region located proximally to both the first region and the second region, the proximal region comprising a single material (paragraphs [0016-0018], [0038], [0085-0088]) for the purpose of providing customized properties such as flexibility, stiffness, durometer, strength and torque control (paragraph [0012]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided at least one of the plurality of material sections comprises a non-fusable material, further comprising a soft distal tip section, wherein the soft distal tip section comprises a single material, wherein the tubular body comprises a proximal region located proximally to both the first region and the second region, the proximal region comprising a single material in Millet in order to provide customized properties such as flexibility, stiffness, durometer, strength and torque control as taught or suggested by Martin.
NEW REJECTIONS
Claim(s) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millet (US 6,146,814, cited by applicant) in view of Martin (US 2020/0391009, cited by applicant).
Millet does not disclose wherein the wall in the first region is entirely
formed from a plurality of polymeric material sections, wherein the transition material section comprises a first polymer in the first region, wherein the transition material section comprises the first polymer in the second region, wherein the transition material section comprises a second polymer in the second region, wherein the transition material section comprises a second polymer in the second region, wherein the plurality of material sections comprises a plurality of adjacent polymeric material sections adjacent to the transition material section, wherein a hardness of the transition material
section is greater than a hardness of plurality of adjacent polymeric material sections, wherein a hardness of the transition material section is less than a hardness of plurality of adjacent polymeric material sections.
Martin teaches or suggests wherein the wall in the first region is entirely
formed from a plurality of polymeric material sections, wherein the transition material section comprises a first polymer in the first region, wherein the transition material section comprises the first polymer in the second region, wherein the transition material section comprises a second polymer in the second region, wherein the transition material section comprises a second polymer in the second region, wherein the plurality of material sections comprises a plurality of adjacent polymeric material sections adjacent to the transition material section, wherein a hardness of the transition material
section is greater than a hardness of plurality of adjacent polymeric material sections, wherein a hardness of the transition material section is less than a hardness of plurality of adjacent polymeric material sections (paragraphs [0004], [0006], [0012], [0015-0018], [0085-0088] and the figures) in a catheter for the purpose of providing improved stiffness, resistance to twisting or torsion, flexibility and column strength etc. (paragraph [0006]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the wall in the first region is entirely formed from a plurality of polymeric material sections, wherein the transition material section comprises a first polymer in the first region, wherein the transition material section comprises the first polymer in the second region, wherein the transition material section comprises a second polymer in the second region, wherein the transition material section comprises a second polymer in the second region, wherein the plurality of material sections comprises a plurality of adjacent polymeric material sections adjacent to the transition material section, wherein a hardness of the transition material section is greater than a hardness of plurality of adjacent polymeric material sections, wherein a hardness of the transition material section is less than a hardness of plurality of adjacent polymeric material sections in Millet in order to provide improved stiffness, resistance to twisting or torsion, flexibility and column strength etc. as taught or suggested by Martin.
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments of 8/5/26 have been carefully considered but are deemed unpersuasive.
Applicant argues, “Millet teaches a polymeric tubular section 10 that is initially covered with a layer of an etchable metal (Millet C1, L45-55) Once the metal is formed over the tube, the metal covered tubular section is patterned with a photoresist, which is exposed to light to form a pattern in the photoresist, such that the unexposed photoresist is etched away causing removal of the metal in the unexposed areas. (Millet C1 L55 to C2 L10). Such a process leaves metal stripes 22 that are separated by gaps 24 (Millet C2 L11-20). These gap-spaced stripes of metal are not a wall. Instead, the gaps must be filled with a polymer that covers the gap-spaced metal stripes to form a smooth surface (Millet C2 L42-50). Again, the metal stripes do not form the wall, they are located within the polymeric layer that is placed over the gap-spaced stripes. This configuration is clearly shown in FIG. 3 of Millet.
Millet confirms that FIG. 2 is not the finished catheter, by stating that FIG. 2 shows an unfinished portion of the catheter "after completion of some manufacturing steps." (Millet C1, L34-36) FIG. 3, "is a cross-sectional view of the catheter shown in FIG. 2 at a later stage of the process." (Millet C1 L37-38).
Again, the Office action is factually incorrect when asserting that Millet discloses a medical tubing comprising a tubular body having a wall formed from a plurality of material sections that extend spirally along the axis. The metal stripes 22 or 28 are located within the wall 26 or 30, where the wall covers the stripes.”
However, Millet discloses that the constitutes both the metal stripes and the polymer (column 2, line 1 through column 3, line 6) and applicant’s claims do not exclude a wall made from the metal stripes and a polymer.
Applicant argues, “Regardless of the above, claim 1 also requires that the plurality of material sections includes a transition material section extending in a continuous spiral over both a first region and a second region, wherein a first width of the transition material section is consistent at the first region and where the transition material section decreases at a stepdown region to a second width, which is consistent at the second region. FIG. 17B from Applicant's specification provides a non-limiting example of such a requirement.
FIG. 17B shows a material section 380 that has a first constant width 385, which
decreases at a stepdown region 387 to a second constant width 386.
The Office action argues that Millet teaches "a first width of the transition material
section is consistent at the first region and where the transition material section decreases at a stepdown region to a second width, which is consistent at the second region (column 2, lines 10-67, column 3, lines 1-6 and Figs. 2-3)." Again, this assertion is factually incorrect. There is absolutely no teaching, suggestion, or hint in Millet that meets the above stated requirement of claim 1 of having a material that steps down in width but has constant widths before and after the stepdown.
In column 2, lines 15-19, merely teaches that the Millet catheter can form variable-width stripes, with wide regions 19 and narrow regions 21 at different points along the length of the catheter. Applicant is unable to find any discussion in Millet of a first width of the transition material section that is consistent at the first region, a stepdown region, and a second width, which is consistent at the second region. In fact, Millet actually states that the catheter can have "variable width stripes", which explicitly states that the width is variable and not constant. Applicant requests a citation for where Millet teaches the above-stated requirement of claim 1.”
However, Millet specifically discloses, “This action is coordinated with the rotation and translation of the catheter, so as to form variable-width stripes, with wide regions 19 and narrow regions 21 at different points along the length of the catheter” (column 2, lines 15-20 and Fig. 2). In order to have wider and narrower regions, there must be stepdown regions and consistent regions even if such regions are very small or very large.
Applicant argues, “Additionally, the conductive stripes in Millet's device are intended to be electrical conductors (Millet Abstract). It is universally understood that narrowing an electrical conductor increases resistance in the conductor. Accordingly, since the conductive stripes in Millet are used to conduct electricity any suggestion to provide a stepdown region, as required by claim 1, is contrary to basic electrical design principles.”
However, conductive stripes are but one embodiment disclosed. Millet specifically discloses, “Alternatively or additionally, metallic elements may be provided to reinforce the physical structure of the polymeric body. The size, shape and distribution of metallic elements can substantially affect properties of the catheter such as the ease with which the tube can be bent and resistance of the tube to kinking and collapse during use” (column 1, lines 22-30). In other words, metallic stripes may be added that aren’t conductive at all.
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 MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
September 22, 2026
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