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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-13 in the reply filed on September 8, 2025 is acknowledged.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes the phrase “The disclosure includes,” which is a phrase that can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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, 2, and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNiven et al. (10,661,052). McNiven et al. disclose, at least in figures 2 and 18 and col. 5, line 62 to col. 6, line 21; col. 7, lines 13-17; col. 21, lines 14-27; and col. 22, line 11 to col. 23, line 8; a catheter (912), comprising: a proximal end; a distal end located opposite the proximal end; a working lumen extending between the proximal end and the distal end; an outer surface (at 986) extending between the proximal end and the distal end, the outer surface defining an outer diameter; an inner surface (at 984) extending between the proximal end and the distal end, the inner surface defining an inner diameter, wherein the inner surface is located opposite the outer surface; a first hydrophilic coating (according to col. 22, lines 25-27) located on the outer surface and configured to reduce surface friction and increase lubricity of the outer surface, the first hydrophilic coating comprising a substantially smooth surface; and a second hydrophilic coating (according to col. 22, lines 37-38) located on the inner surface and configured to reduce surface friction and increase lubricity of the inner surface, the second hydrophilic coating comprising a textured surface (i.e., the texture of the hydrophilic material); wherein the working lumen is configured to receive a secondary device (e.g., 102, according to col. 5, line 63 to col. 6, line 2) comprising at least one of a guidewire, a microcatheter, an intermediate catheter, and a stent retriever; wherein the first hydrophilic coating extends between the proximal end and the distal end of the catheter; wherein the first hydrophilic coating extends along a surface extending between the proximal end and the distal end; wherein the second hydrophilic coating extends between the proximal end and the distal end; and wherein the second hydrophilic coating extends along a surface extending between the proximal end and the distal end.
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.
Claims 3-7, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over McNiven et al. (10,661,052) in view of Preissman et al. (5,728,063). McNiven et al. disclose the invention substantially as claimed, wherein the catheter includes a device wall (988) including a material coupled to a catheter reinforcement structure, wherein the material is configured to provide at least one of flexibility and structural support to the catheter, wherein the catheter reinforcement structure comprises a coil reinforcement structure (e.g., 924); and wherein the device wall is located between the first hydrophilic coating and the second hydrophilic coating.
However, McNiven et al. do not explicitly disclose that the device wall includes at least one polymer. Preissman et al. teach, at least in figure 3 and col. 7, line 54 to col. 8, line 20; a catheter including a device wall composed of one polymer (e.g., PEBAX). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Preissman et al., to modify the material of the device wall of McNiven et al., so that it comprises at least one polymer. Such a modification would render the device wall to be strong, flexible, and biocompatible and would allow a reinforcement structure to be encapsulated in the device wall.
McNiven et al. also do not explicitly disclose, for the catheter of fig. 18, that the reinforcement structure is a braid and coil reinforcement structure, wherein the braid and coil reinforcement structure comprises a coil defining a pitch smaller than 0.03 inches. Nevertheless, McNiven et al. teach, in fig. 7-1 and col. 11, lines 35-39; a catheter embodiment including a braid and coil reinforcement structure (e.g., 322 or 324). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reinforcement structure of the catheter of fig. 18, so that it is a braid and coil reinforcement structure. Such a modification would render the catheter to be strong and flexible and able to withstand forces from an expandable intravascular device. Regarding the coil pitch, it would have been a matter of obvious design choice to dimension the coil, so that it has a pitch as desired, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose.
McNiven et al. also do not explicitly disclose that the catheter has an outer diameter that is about 0.111 inches or about 0.098 inches, and an inner diameter that is about 0.100 inches or about 0.088 inches. Preissman et al. also teach, in col. 5, line 67 to col. 6, line 11; a catheter that may have an outer diameter in the range of about 0.33 mm to about 4 mm (about .013 inches to about 0.157 inches) and an inner diameter in the range of about 0.1 mm to about 3.6 mm (about .004 inches to about .142 inches). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Preissman et al., to dimension the outer diameter and the inner diameter of the catheter as claimed. Such modifications would allow the catheter to be sized for its intended use within vascular and other narrow passageways in a patient’s body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Samson et al. (5,782,811) teach a catheter.
Any inquiry concerning this communication should be directed to Julian W. Woo at telephone number (571)272-4707. Normal office hours are: M-Th, 8-5:30 ET, 1st Fri. of biweek OFF; 2nd Fri., 8-4:30 ET.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771