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 § 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) 1-4, 8-9, 11-12, 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaneko et al. (US 2003/0165647).
Regarding claim 1, Kaneko discloses
A catheter assembly (fig. 4 and pars. 0055-0068), comprising:
a catheter adapter (13), comprising a distal end (14) and a proximal end (15); and
a catheter (7 in fig. 4 or 1 in figs. 1-3. Examiner notes: see par. 0044-0045 for 1 being a medical tubing and see par. 0055 for 7 being an introducer sheath in which the medical tubing of the invention is used as the sheath portion) extending from the distal end (14) of the catheter adapter (13), wherein the catheter (7) comprises a shaft (8) and a lumen (lumen of 8, see par. 0055 for 8 being elongated hollow tubular body) extending through the shaft (see par. 0055), wherein the shaft (8) comprises a wall, a stripe or an annular layer within the wall, and a plurality of reinforcement fibers within the stripe or the annular layer (Examiner notes: see figs.1-3 and pars. 0048-0052 for the layers of the shaft. See fig. 3 for layers 2, 4 and 5 forming the wall of the shaft, layer 2 being an annular layer within the wall, and the filler including whiskers and chopped fibers in layer 2 being a plurality of reinforcement fibers within the annular layer), wherein each of the plurality of reinforcement fibers (whiskers and chopped fibers in layer 2, pars. 0051-0052) have a greater tensile strength than the wall (Examiner notes: see pars. 0048-0052 for layers 4/5 being a filler-free resin layer while the fibers being potassium titanium), wherein each of the plurality of reinforcement fibers have a greater tensile strength than the stripe or the annular layer (Examiner notes: see pars. 0051-0052 for layer 2 being a resin layer while the fibers being potassium titanium).
Regarding claim 2, Kaneko discloses
The catheter assembly of claim 1, wherein the wall (4 and 5 in fig. 3) comprises an inner surface forming the lumen (see fig. 3 for layer 4) and an outer surface forming an exterior of the catheter (see fig. 3 for layer 5).
Regarding claim 3, Kaneko discloses
The catheter assembly of claim 2, wherein the shaft (8) comprises the stripe (see figs. 2A and 2B for the orientation of the filler, making the shaft comprising a stripe layer), wherein the stripe is proximate the inner surface and extends partially through the wall (see fig. 3 for layer 2 being proximate to layer 4 and extending partially through the wall of 1).
Regarding claim 4, Kaneko discloses
The catheter assembly of claim 2, wherein the shaft (8) comprises the stripe (see figs. 2A and 2B for the orientation of the filler, making the shaft comprising a stripe layer), wherein the stripe is proximate the outer surface and extends partially through the wall (see fig. 3 for layer 2 being proximate to layer 5 and extending partially through the wall of 1).
Regarding claim 8, Kaneko discloses
The catheter assembly of claim 1, wherein the plurality of reinforcement fibers comprises nylon, aromatic polyamide fiber, or carbon fiber (see par. 002 for carbon fibers).
Regarding claim 9, Kaneko discloses
The catheter assembly of claim 1, wherein the shaft (8) comprises the stripe (see figs. 2A and 2B for the orientation of the filler, making the shaft comprising a stripe layer), wherein the stripe is conductive (see par. 002 for carbon fibers. Examiner notes: carbon fibers are conductive).
Regarding claim 11, Kaneko discloses
The catheter assembly of claim 1, wherein a distance of each of the plurality of reinforcement fibers from a longitudinal axis of the catheter is different, wherein a distal end of a particular one of the plurality of reinforcement fibers overlaps with a proximal end of another particular one of the plurality of reinforcement fibers (Examiner notes: see par. 0052 for the fibers being whiskers and chopped fibers, see figs. 10A-10B for different orientation of the reinforcement fibers within the reinforced layer).
Regarding claim 12, Kaneko discloses
The catheter assembly of claim 1, wherein the plurality of reinforcement fibers are oriented generally parallel to a longitudinal axis of the catheter (Examiner notes: see figs. 2A and 2B for the orientation of the filler, and see figs. 10A-10B for different orientation of the reinforcement fibers within the reinforced layer).
Regarding claim 14, Kaneko discloses
The catheter assembly of claim 1, wherein the shaft (8) comprises the annular layer (2) within the wall (4 and 5, see fig. 3), wherein the wall sandwiches the annular layer (see fig. 3).
Regarding claim 15, Kaneko discloses
A catheter assembly (fig. 4 and pars. 0055-0068), comprising:
a catheter adapter (13), comprising a distal end (14) and a proximal end (15); and
a catheter (7 in fig. 4 or 1 in figs. 1-3. Examiner notes: see par. 0044-0045 for 1 being a medical tubing and see par. 0055 for 7 being an introducer sheath in which the medical tubing of the invention is used as the sheath portion) extending from the distal end (14) of the catheter adapter (13), wherein the catheter (7) comprises a shaft (8) and a lumen (lumen of 8, see par. 0055 for 8 being elongated hollow tubular body) extending through the shaft (see par. 0055), wherein the shaft (8) comprises a wall and a plurality of reinforcement fibers within the wall (Examiner notes: see figs.1-3 and pars. 0048-0052 for the layers of the shaft. See fig. 3 for layers 2, 4 and 5 forming the wall of the shaft, layer 2 within the wall, and the filler including whiskers and chopped fibers in layer 2 being a plurality of reinforcement fibers), wherein each of the plurality of reinforcement fibers (whiskers and chopped fibers in layer 2, pars. 0051-0052) have a greater tensile strength than the wall (Examiner notes: see pars. 0048-0052 for layers 4/5 being a filler-free resin layer while the fibers being potassium titanium).
Regarding claim 16, see the rejection of claim 8.
Regarding claim 17, see the rejection of claim 9.
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) 5-7, 13, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al. (US 2003/0165647) in view of Voznyakovski et al. (US 2008/0086096).
Regarding claim 5, Kaneko discloses the catheter assembly of claim 2, as set forth above, except for wherein the shaft comprises the stripe, wherein the stripe extends through the wall from the inner surface to the outer surface.
However, Voznyakovski teaches different embodiments of a catheter assembly (100 in fig. 1, 200 in fig. 2, 300 in fig. 3, 400 in fig. 4, 500 in fig. 5) wherein one of the embodiments teaches the shaft (400, fig. 4) comprising a stripe (414/418) wherein the stripe extends through the wall from the inner surface to the outer surface (see fig. 4).
Kaneko discloses different embodiments of a catheter assembly comprising a filler layer to improve its maneuverability, push-ability, ability to transmit torque, trackability and kink resistance. And, Voznyakovski teaches different embodiments of a catheter assembly comprising a reinforced layer. 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 filler layer of Kaneko extending through the wall from the inner surface to the outer surface, as taught by Voznyakovski, for the purpose of increasing mechanical strength of the catheter (par. 0031 of Voznyakovski).
Regarding claim 6, Kaneko discloses the catheter assembly of claim 1, as set forth above, except for wherein the shaft comprises a plurality of stripes spaced around a circumference of the shaft, wherein the plurality of stripes comprises the stripe, wherein the wall completely surrounds each of the plurality of stripes.
However, Voznyakovski teaches different embodiments of a catheter assembly (100 in fig. 1, 200 in fig. 2, 300 in fig. 3, 400 in fig. 4, 500 in fig. 5) wherein one of the embodiments teaches the shaft (400, fig. 4) comprising a plurality of stripes (414/418) spaced around a circumference of the shaft (see fig. 4), wherein the plurality of stripes (414/418) comprises the stripe, wherein the wall completely surrounds each of the plurality of stripes (as shown in fig. 4, 414 and 418 are surrounded by the outer surface of catheter 400 and the inner surface of catheter 400).
Kaneko discloses different embodiments of a catheter assembly comprising a filler layer to improve its maneuverability, push-ability, ability to transmit torque, trackability and kink resistance. And, Voznyakovski teaches different embodiments of a catheter assembly comprising a reinforced layer. 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 filler layer of Kaneko to have a plurality of stripes, as taught by Voznyakovski, for the purpose of increasing mechanical strength of the catheter (par. 0031 of Voznyakovski).
Regarding claim 7, Kaneko discloses the catheter assembly of claim 1, as set forth above, except for wherein the catheter comprises another lumen extending through the shaft, wherein the shaft comprises the stripe and another stripe, wherein the stripe and the other stripe are opposite each other between the lumen and the other lumen and completely surrounded by the wall.
However, Voznyakovski teaches different embodiments of a catheter assembly (100 in fig. 1, 200 in fig. 2, 300 in fig. 3, 400 in fig. 4, 500 in fig. 5) wherein some of the embodiments teaches the catheter comprising dual lumens (see figs. 1-3) extending through the shaft (pars. 0031 and 0033).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Kaneko’s catheter by adding another lumen, as taught by Voznyakovski, for the purpose of allowing fluid to circulating to and from the system (par. 0031 of Voznyakovski).
One of Voznyakovski embodiments teaches the shaft (400, fig. 4) comprising a plurality of stripes (414 and 418) positioned opposite of each other (see fig. 4) and completely surrounded by the wall (as shown in fig. 4, 414 and 418 are surrounded by the outer surface of catheter 400 and the inner surface of catheter 400).
Kaneko discloses different embodiments of a catheter assembly comprising a filler layer to improve its maneuverability, push-ability, ability to transmit torque, trackability and kink resistance. And, Voznyakovski teaches different embodiments of a catheter assembly comprising a reinforced layer. 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 filler layer of Kaneko to have a plurality of stripes, as taught by Voznyakovski, for the purpose of increasing mechanical strength of the catheter (par. 0031 of Voznyakovski).
Regarding claim 13, Kaneko discloses the catheter assembly of claim 1, as set forth above, except for wherein the shaft comprises the annular layer within the wall, wherein the annular layer comprises an inner surface forming the lumen and an outer surface proximate the wall.
However, Voznyakovski teaches different embodiments of a catheter assembly (100 in fig. 1, 200 in fig. 2, 300 in fig. 3, 400 in fig. 4, 500 in fig. 5) wherein one of the embodiments teaches the shaft comprises the annular layer within the wall, wherein the annular layer comprises an inner surface forming the lumen and an outer surface proximate the wall (see par. 0035 for any or all of the layers being reinforced with nano particles).
Kaneko discloses different embodiments of a catheter assembly comprising a filler layer to improve its maneuverability, push-ability, ability to transmit torque, trackability and kink resistance. And, Voznyakovski teaches different embodiments of a catheter assembly comprising a reinforced layer. 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 filler layer of Kaneko to have its inner surface forming the lumen and its outer surface proximate the wall, as taught by Voznyakovski, for the purpose of increasing mechanical strength of the catheter (par. 0031 of Voznyakovski).
Regarding claim 19, Kaneko discloses the catheter assembly of claim 13, as set forth above, except for wherein each of the plurality of reinforcement fibers is encapsulated by the wall.
However, Voznyakovski teaches different embodiments of a catheter assembly (100 in fig. 1, 200 in fig. 2, 300 in fig. 3, 400 in fig. 4, 500 in fig. 5) wherein one of the embodiments teaches the shaft (100 in fig. 1 or 200 in fig. 2) comprising a plurality of reinforcement particles (104/204) wherein each of the plurality of reinforcement particles is encapsulated by the wall (see fig. 1 or see fig. 2).
Kaneko discloses different embodiments of a catheter assembly comprising a filler layer to improve its maneuverability, push-ability, ability to transmit torque, trackability and kink resistance. And, Voznyakovski teaches different embodiments of a catheter assembly comprising a reinforced layer. 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 plurality of reinforcement fibers of Kaneko such that each of the fibers is encapsulated by the wall, as taught by Voznyakovski, for the purpose of increasing mechanical strength of the catheter (par. 0031 of Voznyakovski).
Claim(s) 10, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al. (US 2003/0165647).
Regarding claim 10, Kaneko discloses the catheter assembly of claim 1, as set forth above, except for wherein a length of each of the plurality of reinforcement fibers is between 10 microns and 1,000 microns.
There is no evidence of record that establishes that changing the length of each of the reinforcement fibers would result in a difference in function of Kaneko catheter. Further, a person having ordinary skill in the art, being faced with modifying the layer of the catheter would have a reasonable expectation of success in making such as modification and it appears the catheter would function as intended being given the claimed length. 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 length of each of the plurality of reinforcement fibers between 10 microns and 1000 microns as an obvious matter of design choice within the skill of the art.
Regarding claim 18, see the rejection of claim 10.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DUNG T ULSH/Examiner, Art Unit 3783
Prosecution Insights