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 § 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.
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, 3-5, 8-9, 15, 21, 25, 29, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US Pub No. 20170072163 A1, herein, Lim).
Regarding claim 1, a catheter (100 – Fig.1A) comprising:
a catheter body (106 – Fig.1A), the catheter body comprising
a proximal end portion (106a – Fig.1A);
a distal end portion (106b – Fig.1A);
an inner liner (114 – Fig.2); and
a braided structure (Fig.2), the braided structure comprising
an inner braid layer (160 – Fig.2), the inner braid layer comprising
a first set of inner wires; and
a second set of inner wires (“The inner… braids are formed of a plurality of interwoven wires” – Para [0035]);
an outer braid layer (162 – Fig.2), the outer braid layer comprising
a first set of outer wires; and
a second set of outer wires (“The… outer braids are formed of a plurality of interwoven wires” – Para [0035]);
wherein the braided structure is disposed over the inner liner (Fig.2);
However, Lim fails to explicitly disclose wherein the first set of inner wires are larger than the second set of inner wires; and wherein the first set of outer wires are larger than the second set of outer wires.
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 sizes/proportions of the inner and outer wires since it has been held that mere changes in sizes/proportion are obvious, MPEP 2144.04 IV A. The device of Lim would not operate differently with the claimed sizes/proportions of the inner and outer wires considering Lim discloses that the inner braid and/or the outer braid can be formed of braided filaments having the same or varying diameters (individually and/or relative to the other braid (Para [0034]). Further, applicant places no criticality on the sizes/proportions claimed, indicating simply “The first set
of inner wires can be larger than the second set of inner wires and the first set of outer wires can be larger than the second set of outer wires” (Abstract).
Regarding claim 3, Lim discloses the catheter as recited above, wherein the outer braid layer extends farther toward the distal end portion than the inner braid layer (Fig.1B, Para [0031]).
Regarding claim 4, Lim discloses the catheter as recited above, the outer braid layer extends farther toward the distal end portion than the inner braid layer but Lim fails to explicitly disclose wherein the outer braid layer extends farther toward the distal end portion than the inner braid layer by 5 to 8 millimeters.
However, Lim discloses the length of the inner braid can vary depending upon, for example, the length of the shaft and the desired characteristics and functions of the catheter (Para [0030]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the inner braid layer disclosed by Lim wherein the outer braid layer extends farther toward the distal end portion than the inner braid layer by 5 to 8 millimeters since Lim discloses that the length of the inner braid can vary depending on the desired characteristics and functions of the catheter (Lim, Para [0030]). Further, applicant places no criticality on the sizes claimed, indicating simply “the outer braid layer extends farther toward a distal end portion than an inner braid layer by 5 to 8 millimeters” (Para [0060]).
Regarding claim 5, Lim discloses the catheter as recited above, the catheter body comprising a jacket layer (116 – Fig.1B), wherein the jacket layer is disposed over and penetrates into the braided structure (Fig.2, “inner braid embedded in the outer polymer structure” – Para [0019]).
Regarding claim 8, Lim discloses the catheter as recited above, the jacket layer comprising:
a proximal jacket portion (120 – Fig.1A);
a distal jacket portion (140 – Fig.1A); and
a tip portion (150 – Para 1A), wherein the tip portion is formed of a polymer (“outer polymer structure” – Para [0019]) having a different Shore hardness than a polymer forming the distal jacket portion (“stiffnesses of the portions decrease sequentially in a proximal to distal direction” – Para [0026]).
Regarding claim 9, Lim discloses the catheter as recited above, the catheter body comprising a lubricious outer coating, wherein the lubricious outer coating is disposed over an outside of the catheter body (“the outer polymer structure is or at least includes a lubricious polymer” – Para [0022]).
Regarding claim 15, Lim discloses the catheter as recited above, but Lim fails to explicitly disclose wherein the inner braid layer has a braid angle that is less than the outer braid layer.
However, Lim discloses the inner braid and/or the outer braid can individually have a generally constant braid angle along its respective length or have a varying braid angle along its respective length to provide different zones of stiffness and/or flexibility (Para [0034]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the inner braid layers braid angle disclosed by Lim wherein the inner braid layer has a braid angle that is less than the outer braid layer since Lim discloses that the inner and outer braid can have different braid angles to provide different zones of stiffness and/or flexibility (Lim, Para [0034]). Further, applicant places no criticality on the size claimed, indicating simply, “the inner braid layer can have a braid angle that is less than an outer braid layer” (Para [0063]).
Regarding claim 21, Lim discloses the catheter as recited above, wherein the first set of inner wires and the second set of inner wires are at least partially flat wires (“rectangular cross-sectional shape” – Para [0035]).
Regarding claim 25, Lim discloses the catheter as recited above, wherein the first set of outer wires and the second set of outer wires are at least partially flat wires (“rectangular cross-sectional shape” – Para [0035]).
Regarding claim 29, Lim discloses the catheter as recited above, further comprising a flexible strain relief device (104 – Fig.1A), wherein the flexible strain relief device is disposed over the proximal end portion of the catheter body (“configured to provide strain relief at the proximal portion” – Para [0014]).
Regarding claim 31, Lim discloses the catheter as recited above, but Lim does not explicitly disclose the catheter comprising a distal end portion defining a tapered tip.
However, Lim discloses, in a different embodiment of the catheter, a catheter (Fig.3) comprising a distal end portion defining a tapered tip (300 – Fig.3).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the distal end portion of the catheter disclosed by Lim where it defines a tapered tip as taught Lim, in a different embodiment, since a catheter comprising a tapered tip makes patient insertion more comfortable and reduces the possibility of trauma or pain.
Regarding claim 33, Lim discloses the catheter as recited above, the first set of inner wires having dimensions of 0.0010 to 0.0020 inches in thickness by 0.0025 to 0.0035 inches in width, the second set of inner wires having dimensions of 0.0002 to 0.0008 inches in thickness by 0.0025 to 0.0035 inches in width, the first set of outer wires having dimensions of 0.0010 to 0.0020 inches in thickness by 0.0025 to 0.0035 inches in width, the second set of outer wires having dimensions of 0.0002 to 0.0008 inches in thickness by 0.0025 to 0.0035 inches in width (“0.0005 inches by 0.0025 inches to about 0.001 inches by 0.005 inches” – Para [0035]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Kugler et al. (US Pub No. 20160101261 A1, herein, Kugler).
Regarding claim 2, Lim discloses the catheter as recited above, but Lim does not explicitly disclose wherein the first set of inner wires wrap around the inner liner in a direction that is opposite to a direction that the first set of outer wires wrap around the inner liner.
Kugler teaches a catheter wherein a first set of inner wires (636 – Fig.6) wrap around an inner liner in a direction that is opposite to a direction that a first set of outer wires (638 – Fig.6) wrap around the inner liner (Fig.6).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the inner and outer wires as disclosed by Lim to have the first set of inner wires wrap around the inner liner in a direction that is opposite to a direction that the first set of outer wires wrap around the inner liner as taught by Kugler since the wires can provide the catheter with bi-directional torqueability, pushability capabilities, and inhibit kinking (Para [0038]).
Claim 7 and 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Ganske et al. (US Pub No. 20170252535 A1, herein, Ganske).
Regarding claim 7, Lim discloses the catheter as recited above, but Lim does not explicitly disclose the jacket layer comprising reflowed Pebax.
Ganske teaches a catheter with a jacket layer comprising reflowed Pebax (“reflowed outer layer”, “Pebax” – Para [0053]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the jacket layer disclosed by Lim to comprise reflowed Pebax as taught by Ganske since Ganske teaches that Pebax is a polymer that could be used for the jacket layer of the catheter since Pebax is heat shrinkable to be able to snugly couple form the outer layer onto the braid assembly (Ganske, Para [0053]).
Regarding claim 10, Lim discloses the catheter as recited above with a lubricious outer coating (“the outer polymer structure is or at least includes a lubricious polymer” – Para [0022]).
However, Lim does not explicitly disclose lubricious outer coating comprising a hydrophilic polymer.
Ganske teaches a catheter with a lubricious outer coating (610 – Fig.6) comprising a hydrophilic polymer (“the outer layer is coated with a hydrophilic polymer” – Para [0053]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the lubricious outer coating disclosed by Lim to comprise hydrophilic polymer as taught by Ganske to reduce friction and create a slippery surface making the catheter easier and less painful to insert and remove from the patient, improving their comfort and safety.
Claims 16, 18-19, 23, and 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of McNiven (US Pub No. 20180126119 A1).
Regarding claim 16, Lim discloses the catheter as recited above, wherein the inner and the outer braid layers may have varying braid angle along its respective length to provide different zones of stiffness and/or flexibility (Para [0034).
However, Lim does not explicitly disclose wherein the inner braid layer has a braid angle from 25 to 45 and the outer braid layer has a braid angle from 45 to 65 degrees.
McNiven teaches a catheter wherein the inner braid layer has a braid angle from 16.5 to 75 (“the inner layer angle may be between 16.5° and 75°degrees” – Para [0070]) and the outer braid layer has a braid angle from 45 degrees (“outer layer angle may be 45°” – Para [0070]).
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 inner and outer braid angles disclosed by Lim to have specific and/or differing braid angles as taught by McNiven since the braid layers having varying braid angles along its respective length, provides different zones of stiffness and/or flexibility to the catheter (Lim , Para [0034]). Further, applicant places no criticality on the range claimed, indicating simply that, “the inner braid layer has a braid angle from 25 to 45 degrees and an outer braid layer has a braid angle from 45 to 65 degrees” (Para [0063]).
Regarding claim 18, Lim discloses the catheter as recited above wherein the inner and the outer braid layers may have varying braid angle along its respective length to provide different zones of stiffness and/or flexibility (Para [0034).
However, Lim does not explicitly disclose wherein the inner braid layer has a braid angle that is greater than the outer braid layer.
McNiven teaches wherein the inner braid layer has a braid angle that is greater than the outer braid layer (“the outer layer angle may be less than the inner layer angle” – Para [0070]).
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 inner braid angles disclosed by Lim to be greater than the outer braid layer as taught by McNiven since the braid layers having varying braid angles along its respective length, provides different zones of stiffness and/or flexibility to the catheter (Lim , Para [0034]).
Regarding claim 19, Lim discloses the catheter as recited above wherein the inner and the outer braid layers may have varying braid angle along its respective length to provide different zones of stiffness and/or flexibility (Para [0034).
However, Lim does not explicitly disclose wherein the inner braid layer has a braid angle from 45 to 65 degrees and the outer braid layer has a braid angle from 25 to 45 degrees.
McNiven teaches a catheter wherein the inner braid layer has a braid angle from 16.5 and 75 degrees (“the inner layer angle may be between 16.5° and 75°degrees” – Para [0070]) and the outer braid layer has a braid angle from 45 degrees (“outer layer angle may be 45°” – Para [0070]).
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 inner and outer braid angles disclosed by Lim to have specific and/or differing braid angles as taught by McNiven since the braid layers having varying braid angles along its respective length, provides different zones of stiffness and/or flexibility to the catheter (Lim , Para [0034]). Further, applicant places no criticality on the range claimed, indicating simply that, “the inner braid layer has a braid angle from 45 to 65 degrees and an outer braid layer has a braid angle from 25 to 45 degrees” (Para [0064]).
Regarding claim 23, Lim discloses the catheter as recited above the inner braid is formed of a plurality of interwoven wires (Para [0035), but Lim does not explicitly disclose wherein the first set of inner wires and the second set of inner wires each comprise from 6 to 10 wires.
McNiven teaches a catheter wherein the inner braid comprises between 16 and 72 wires (“include between 16 and 72 threads of stainless steel” – Para [0063]). The first and second set of inner wires together form a single braid structure, the total number of wires in the range (i.e., 12 to 20 wires) would be within the range taught by McNiven.
Therefore, 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 inner braid as disclosed by Lim to have a specific number of wires such as taught by McNiven since the number of wires in the braid depends on the desired characteristics and functions of the catheter. Further, applicant places no criticality on the range claimed, indicating simply that, “the first set of inner wires and a second set of inner wires each comprise from 6 to 10 wires” (Para [0075]).
Regarding claim 27, Lim discloses the catheter as recited above the outer braid is formed of a plurality of interwoven wires (Para [0035), but Lim does not explicitly disclose wherein the first set of outer wires and the second set of outer wires each comprise from 6 to 10 wires.
McNiven teaches a catheter wherein the inner braid comprises between 16 and 72 wires (“include between 16 and 72 threads of stainless steel” – Para [0063]). The first and second set of outer wires together form a single braid structure, the total number of wires in the range (i.e., 12 to 20 wires) would be within the range taught by McNiven.
Therefore, 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 inner braid as disclosed by Lim to have a specific number of wires such as taught by McNiven since the number of wires in the braid depends on the desired characteristics and functions of the catheter. Further, applicant places no criticality on the range claimed, indicating simply that, “the first set of outer wires and a second set of outer wires each comprise from 6 to 10 wires” (Para [0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/ /BHISMA MEHTA/Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783
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