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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/6/2026 has been entered.
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) 1-2, 4-12, 14- 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewitt et al. (US Patent 7507229 hereinafter “Hewitt”) in view of Tal (WO 2019087191).
Regarding Claim 1, Hewitt teaches (Figs 2 and 6-9) an embolization microcatheter for embolization of peripheral arteries comprising:
an elongated tubular member comprising a distal end (Annotated Fig 9) extending from a proximal marker (51) to a distal end opening (Annotated Fig 9), the distal end having an outer diameter of about 0.7 mm or less (Col 7 lines 57-59 teaches "the final outside diameter of the finished catheter was 1.7 F (0.57 mm--0.023'') at the distal end"),
wherein the elongated tubular member comprises a multiplicity of sections (Figs 6-8) between a proximal end (40) and the proximal end marker (51), each having a length of 5 mm -120 mm (See Fig 8; and table in Col 5), wherein a wall of each of the multiplicity of sections comprises a braid (Fig 4 and 6, braid 20), a polymer (30) formed around the braid (20) and an inner liner (10) coating an inner surface thereof;
wherein the polymer hardness decreases in each inner section towards the distal end (See Col 5 table teaching sections with different durometers; also see Col 5 lines 12-14 teaching “These sections vary in durometer of their polymers, wherein the proximal durometers are higher than the more distal durometers”) and
a distal tip (Annotated Fig 9) extending between a proximal end of a distal radiopaque marker (50) of the elongated tubular member and a distal end opening of the elongated tubular member;
wherein the wall of the distal tip is devoid of braid (see Figs 1-2, 4 and 9 the braid does not extend to the distal tip, only until distal band 50).
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Annotated Fig 9 (Hewitt)
Hewitt does not specify wherein a thickness of the wall is less than 100 microns, and the distal tip has a length of 0.5mm - 3mm.
Tal teaches an embolization microcatheter wherein a wall has a thickness of 0.08 mm – 0.1mm (See Pg. 25 lines 6-7; 0.8 mm -0.1 mm is approximately 80-100 microns), and a distal tip (section from marker 762 to the distal end opening 780) having a length of 1 mm (see Pg. 25 lines 4-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wall thickness and length of the distal tip of Hewitt such that a thickness of the wall is less than 100 microns, and the distal tip has a length of 0.5mm - 3mm as taught by Tal. One of ordinary skill in the art would have been motivated to do so in order to improve flexural rigidity of the device (See Tal Pg. 14 lines 23-26).
Hewitt does not specify a filter formed in an at least one section of the multiplicity of sections, the filter comprising of a multiplicity of side openings and a plurality of sub-side openings, the multiplicity of side openings extending through the polymer formed around the braid and the inner liner, the plurality of sub-side openings extending only through the polymer formed around the braid, the multiplicity of side openings distributed in at least 5 circumferential rings spaced apart from each other by 100 microns -200 microns.
Tal teaches (Fig 1) a filter (120) formed in the wall of the elongate tubular member, the filter comprising a plurality of side openings (122) , the plurality of side openings distributed in at least 5 circumferential rings (see Pg. 17 lines 6-10 "According to some embodiments, the fluid-barrier forming section 120 may include 5-8 spaced apart circumferential sections, each section including 5-8 axial slits (e.g. 6 slits in each circumferential section)") spaced apart from each other by 200 microns (Pg. 17 lines 8-9 and 17 teach spaced apart by 0.2 mm). Tal also teaches in Fig 4 how the slits are formed over the braid/coil, forming sub-side openings (See annotated Fig 4, the sub-side openings are similar to the sub-side opening 225a shown in instant application fig 2d and explained in instant application [0086]).
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Annotated Fig 4 (Tal)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular member of Hewitt such that it a filter formed in an at least one section of the multiplicity of sections, the filter comprising of a multiplicity of side openings and a plurality of sub-side openings, the multiplicity of side openings extending through the polymer formed around the braid and the inner liner, the plurality of sub-side openings extending only through the polymer formed around the braid, the multiplicity of side openings distributed in at least 5 circumferential rings spaced apart from each other by 100 microns -200 microns as taught by Tal. One of ordinary skill in the art would have been motivated to do so in order to allow lateral outflow of a suspension fluid while blocking passage of beads/particles (i.e. embolization particles) flowing therein (Tal. Pg. 11 last paragraph).
Regarding Claim 2, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein an inner lumen of the distal end is in a range of 0.3 mm - 0.7 mm (Hewitt Col 3 lines 28-30 teaches inner lumen dimeter of 0.008 inches to - 0.03 inches, which is equivalent to 0.20 mm - 0.76mm).
Regarding Claim 4, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein an inner lumen of the distal tip is below 0.5 mm (Hewitt Col 3 lines 28-30 teaches inner lumen dimeter of 0.008 inches to -0.03 inches, which is equivalent to 0.20 mm - 0.76mm).
Regarding Claim 5, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the thickness of the is less than 90 microns (See Tal Pg. 25 lines 6-7 teaching thickness 0.08 mm - 0.1mm which equivalent to 80-100 microns).
Regarding Claim 6, the combination of Hewitt and Tal teaches all elements of claim 1 as described above. Hewitt teaches (Col 4 lines 6-7) the braid material 20 may be formed of a metallic thread, such as Nitinol, stainless steel, or other metal. Hewitt does not specify wherein the braid is made of tungsten wires.
Tal teaches (Pg. 19 first paragraph) a braided coil that could be made from tungsten or Nitinol wires.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the braid of Hewitt such that it is made of tungsten wires as taught by Tal. It has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose of stronger support in the catheter and prevent kinking (see MPEP 2144.07).
Regarding Claim 7, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the braid is made of wires having a diameter of 15-20 microns (Hewitt Col 4 lines 31-34 teaches an example of a wire diameter including 0.0007 inches, which is 17.78 microns).
Regarding Claim 8, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the braid has a picks per inch (PPI) of 150-220 (See Hewitt Col 4 lines 18 - 19 teaching "the distal end pic rate is preferably greater than 80 ppi.").
Regarding Claim 9, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the multiplicity of sections comprises at least 5 sections (See Hewitt Fig 8, there are at least five sections; also see Hewitt Col 5 lines 10-12 teaching "the outer jacket 30 includes at least two and preferably 5-10 segments").
Regarding Claim 10, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 9, wherein the multiplicity of sections comprises at least 9 sections (see Hewitt Col 5 lines 10-12 teaching "the outer jacket 30 includes at least two and preferably 5-10 segments").
Regarding Claim 11, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the distal most section of the multiplicity of sections has a length of 5-15 mm (See Hewitt Fig 8, distal section “A” is 3.5 cm. it is interpreted that distal section A could be split into three equal sized segments/sections, this would result in the distal most section having a length of 11.67 mm).
Regarding Claim 12, the combination of Hewitt and Tal teaches all elements of claim 1 as described above. Hewitt does not specify the embolization microcatheter wherein the distal radiopaque marker comprises a metal marker band.
Tal teaches (Pg. 15 lines 6-7) a distal marker (114) that is metallic.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal marker of Hewitt such that it is a metallic marker as taught by Tal. One of ordinary skill in the art would have been motivated to do so in order to allow the catheter to withstand forces of at least 5N and serve distinct indications of the proximal and distal ends with the difference in radio-opaqueness (See Tal Pg. 15 lines 12-16). Furthermore, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose of providing indications of the section of the catheter that is marked (see MPEP 2144.07).
Regarding Claim 14, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the plurality of openings (Tal 122) is in the form of axial slits (See Tal Pg. 15 lines 18-19 "Fluid-barrier forming section 120 includes a plurality of axial slits 122").
Regarding Claim 15, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 14, wherein the axial slits (122) have a length of about 100-150 microns (Tal Pg. 19 third paragraph teaches "According to some embodiments, each of the axial slits may have a length within the range of 50-400 microns") and a height of about 20-40 microns (See Tal Pg. 20 teaches second paragraph "According to some embodiments, the width of each of the plurality of axial slits at the inner surface of the microcatheter may be in the range of 10-80 microns, in the range of 10-25 microns, in the range of 15-20 microns, in the range of 20-70 microns, in the range of 30-60 microns, in the range of 40-60 microns or any other suitable range within the range of 10-80 microns.).
Regarding Claim 16, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein a distal most of the circumferential rings of the distal most filter section is positioned about 2-6 mm proximally to the distal end opening (See Tal Pg. 27 line 25-26 teaching "The distal most of circumferential sections 724 is located approximately 3.5 mm proximal to distal end opening 780 (L2)", and Pg. 32 lines 19-20 teaching "The distal most circumferential section is located approximately 2.9 mm proximal to distal end opening 980 (L2).") .
Regarding Claim 17, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein the plurality of side opening is distributed in at least 8 circumferential rings (See Tal Pg. 17 lines 6-10 "According to some embodiments, the fluid-barrier forming section 120 may include 5-8 spaced apart circumferential sections, each section including 5-8 axial slits (e.g. 6 slits in each circumferential section)").
Regarding Claim 18, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein each of the circumferential rings comprises 4-8 axial slits (See Tal Pg. 17 lines 6-10 "According to some embodiments, the fluid-barrier forming section 120 may include 5-8 spaced apart circumferential sections, each section including 5-8 axial slits (e.g. 6 slits in each circumferential section)").
Regarding Claim 19, the combination of Hewitt and Tal teaches the embolization microcatheter according to claim 1, wherein a proximal most circumferential ring of the at least 5 circumferential rings comprise fewer side openings than rings distal thereto (See Tal Pg. 26 second paragraph teaching “According to some embodiments, the number of axial slits in the row may be different. As a non-limiting example, some (e.g. 4) rows may include 6 axial slits, while others (e.g. 1) may include 3 axial slits.” This is interpreted as reading on the instant claim as the distal four rows ( “circumferential rings”) would include 6 slits each, while the proximal most one row ( “circumferential ring”) would include only 3 slits, resulting in the proximal ring having fewer side openings than the rings distal).
Regarding Claim 21, the combination of Hewitt, Tal teaches the embolization microcatheter according to claim 19, wherein the side openings, of the proximal most circumferential section, is circumferentially shifted relative to the side openings in its neighboring circumferential section (See Tal Pg. 27 lines 1-2, which state the slits may be staggered, zigzagged or any uneven distribution; this is interpreted as resulting in a circumferentially shifted set of side openings).
Response to Arguments
Applicant's arguments filed 3/6/2026 have been fully considered but they are not persuasive.
As to the remarks on Pg. 5 lines 9-end of page, the applicant argues that Hewitt and Tal do not teach “a filter formed in an at least one section of the multiplicity of sections, the filter comprising of a multiplicity of side openings and a plurality of sub-side openings, the multiplicity of side openings extending through the polymer formed around the braid and the inner liner, the plurality of sub-side openings extending only through the polymer formed around the braid, the multiplicity of side openings distributed in at least 5 circumferential rings spaced apart from each other by 100 microns -200 microns”. Tal teaches in Fig 1 a filter that goes through the polymer layer with side openings 122. Furthermore, Tal shows in Fig 4 how the side openings could form sub-side openings between the sides of openings (422) and the coil/braid (426), similar to the instant application Fig 2d and instant application [0086]. For these reasons the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Day (US Patent Pub. 20130138077) teaches a difference in density between the slits on a proximal side compared to the distal side of a catheter.
Tal (US 20190217052) teaches a filter formed on a side wall comprising a plurality of slits.
Jin (EP 2450077) teaches a microcatheter with multiple sections.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783