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 .
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.
Claims 1-20 are 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 1 recites the limitation "the axial component" in line three of claim 1. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution examiner is interpreting the limitation as “the at least one axial component”.
Claims 2-20 are rejected by virtue of depending on claim 1.
Claim 5 recites the limitation "the axial member" in line one of claim 5. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution examiner is interpreting the limitation as “the at least one axial component”.
Regarding claim 8, the phrase "a plurality of said axial components" renders the claim indefinite because it is unclear. It is unclear whether the phrase includes new/different axial components or the previously introduced “at least one axial component” in claim 1.
Regarding claim 9, the phrase "a plurality of said axial components" renders the claim indefinite because it is unclear. It is unclear whether the phrase includes new/different axial components or the previously introduced “at least one axial component” in claim 1.
Regarding claim 13, the phrase "between two axial components" renders the claim indefinite because it is unclear. It is unclear whether the phrase includes new/different axial components or the previously introduced “at least one axial component” in claim 1.
Claim 14 recites the limitation "the at least one axial member" in line one of claim 14. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution examiner is interpreting the limitation as “the at least one axial component.
Claim 15 recites the limitation "the axial component" in line one of claim 15. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution examiner is interpreting the limitation as “the at least one axial component”.
Claim 19 recites the limitation "the braided wires" in line two of claim 19. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 12, 14-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN105105894. (Examiner notes: CN105105894 is cited in the IDS. Translation Attached as NPL).
Regarding claim 1, CN105105894 discloses
A catheter reinforcement layer (Figs. 4-6), comprising a braided component (1a and 1b) and at least one axial component (2), wherein the braided component (1a and b) is a mesh tube (Figs. 4-6) formed by braiding wires in a crosswise manner (Figs. 4-6), and the axial component (2) extends along (Figs. 4-6) the braided component (1a and 1b) from a proximal end (Figs. 4-6) to a distal end (Figs. 4-6), and has at least one intersection (Figs. 4-6) with the braided component (1a and 1b). (Figs. 4-6, Lines 102-236).
Regarding claim 2, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein a material of the axial component is metal and/or polymer filament (Lines 233-263).
Regarding claim 3, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the axial component (2) has a filamentous structure shaped as any one or a combination of a straight line (Figs. 1-6), wave line or spiral line. (Figs. 1-6, Lines 60-61).
Regarding claim 4, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the axial component is arranged parallel to an axial direction of the braided component; or
the axial component (2) is arranged at an angle of 0-450 (Lines 270-271) with an axial direction (Figs. 1-6) of the braided component (1a and 1b); or
at least a part of the axial component is arranged at an angle of 0-450 with an axial direction of the braided component, and other parts of the axial component are parallel to the axial direction of the braided component. (Figs. 1-6 and Lines 270-271).
Regarding claim 5, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the axial member (2) has 1-45,000 said intersections (Figs. 1-6) with the braided component (1a and 1b). (Figs. 1-6).
Regarding claim 6, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the braided wires (Lines 85-92 and 257-261) of the braided component (1a and 1b) are braided in the crosswise manner to form a mesh (Figs. 4-6, Lines 368-370), and mesh intersections are formed at positions where the wires intersect, wherein,
all the at least one intersection of the axial component coincides with the mesh intersections; or
a part of the at least one intersection (Figs. 4-6) of the axial component (2) coincides with the mesh intersections (Figs. 4-6, Lines 368-370); or
none of the at least one intersection of the axial component coincides with the mesh intersections. (Figs. 4-6, Lines 85-92, 257-261 and 368-370).
Regarding claim 7, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the axial component (2), from the proximal end (Figs. 4-6) to the distal end (Figs. 4-6), is shaped as a straight line (Figs. 4-6) or spiral line attached to an inner surface or an outer surface of the braided component; or
the axial component, from the proximal end to the distal end, is shaped as a wave line attached between an inner surface and an outer surface of the braided component in a staggered manner; or
the axial component, from the proximal end to the distal end, is arranged in the mesh of the braided component, and the axial component and the braided component are in a same plane. (Figs. 4-6).
Regarding claim 8, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein a plurality of said axial components (2, Lines 289-291)is comprised; wherein
the plurality of axial components (2, Lines 289-291) are arranged symmetrically (Lines 289-291) or asymmetrically along a circumference (Lines 289-291) of the braided component (1a and 1b); and/or
the plurality of axial components are sequentially arranged at intervals along an axial direction of the braided component.
Regarding claim 12, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein a number of the axial components (2) ranges from 1 (Figs. 1-6) to 16,000. (Figs. 1-6, Lines 197-227 and 289-291).
Regarding claim 14, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein a material of at least one of the at least one axial member (2) is a radioautographic material (platinum rhodium alloy, Line 253). Examiner notes platinum rhodium alloy is a radioautographic material.
Regarding claim 15, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the axial component (2) is a monofilament (Lines 79-83 and 265-273) or a twisted filament composed of a plurality of monofilaments (Lines 243-246). (Lines 79-83, 243-246 and 265-273).
Regarding claim 16, CN105105894 discloses
The catheter reinforcement layer according to claim 15, wherein a diameter of the monofilament is in a range of 0.0005-0.003 inches (Lines 243-246), and a number of the monofilaments contained in the twisted filament is in a range of 1-20 (Lines 243-246). (Lines 79-83, 243-246 and 265-273).
Regarding claim 17, CN105105894 discloses
The catheter reinforcement layer according to claim 1, wherein the axial component (2) is connected to the braided component by means of gluing, polymerization, welding or heating (Lines 85-92), or is integrally formed with the braided component by means of braiding.
Regarding claim 18, CN105105894 discloses
A catheter (Figs. 4-6), comprising an inner layer (A), a reinforcement layer (B) and an outer layer (C) that are sequentially arranged from inside to outside (Figs. 4-6) and are all in a shape of a tube (Figs. 4-6), and wherein the reinforcement layer (B) comprises the catheter reinforcement layer according to claim 1. (Figs. 4-6, Lines 102-236).
Regarding claim 19, CN105105894 discloses
The catheter according to claim 18, comprising a plurality of catheter segments (Line 367) connected in series (Line 367), the axial component (2) being arranged at a predetermined position (Figs. 4-6, Lines 369-371); wherein
the predetermined position (Figs. 4-6, Lines 369-371) is between a circumferential surface (Figs. 4-6, Lines 369-371) of the braided component (1a and 1b)
or a clearance of the braided wires where joint seams of adjacent catheter segments are located; or the predetermined position is between a circumferential surface of the braided component or a clearance of the braided wires where a modulus value of a catheter segment is lower than a modulus value of an adjacent catheter segment at one or both sides; or the predetermined position is at a part of the inner or outer layer of the catheter with a smaller thickness, or between a circumferential surface of the braided component or a clearance of the braided wires where a flexibility of a catheter segment is higher; or the predetermined position is between a circumferential surface of the braided component or a clearance of the braided wires where a diameter of the catheter segment is smaller than a diameter of an adjacent catheter segment at one or both sides (Examiner notes: claim 19 uses the words “or”, which makes the limitations after the words “or” not positively recited in claim 19). (Figs. 4-6, Lines 366-371).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN105105894.
Regarding claim 20, CN105105894 discloses the catheter according to claim 18, wherein the inner layer is a polymer material layer (layer A, Figs. 4-6. See Lines 72-73 and Lines 302-307 for inner layer being a polymer material layer)
CN105105894 is silent about the inner layer having a thickness of 0.0001-0.002 inches.
There is no evidence of record that establishes that changing the thickness of the inner layer would result in a difference in function of CN105105894 catheter. Further, a person having ordinary skill in the art, being faced with modifying the inner layer of CN105105894, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the inner layer of CN105105894 to have a thickness of 0.0001-0.002 inches as an obvious matter of design choice within the skill of the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DUNG T ULSH/Examiner, Art Unit 3783