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 .
Status of the Claims
The amendment filed 05/06/2026 has been entered. Claims 1, 4-11, 13-20 and 26-28 are pending and under consideration.
Response to Arguments
Applicant's amendments to the claims have overcome each and every 112 rejections and objections previously set forth in the Non-Final Office Action
In response to the applicant’s argument with respect to 35 USC 102 and 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation as presented below.
Claim Objections
Claim 26 is objected to because of the following informalities:
Claim 26 line 2 recites “the tip portion” which should read “the tip end”
Appropriate correction is required.
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.
Claims 1, 4-7, 10, 11, 13-17, 20 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (US 20060122575 A1) in view of Davey et al (US 20010051786 A1).
Regarding claim 1, Wakabayashi substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a catheter (figure 1a, drainage tube 101) for shunting fluid, the catheter having a length (figure 1a, length of tube 101) and comprising a tip end (annotated figure 1b, tip end), a first portion (figure 1a, second portion 103), and a second portion (figure 1a, first portion 102), and a lumen (figure 1b, bore 110 extending a length of the tube 101) extending a length of at least a portion of the catheter;
wherein the first portion (figure 1a, the second portion is disposed between the tip end and the first portion 101 and they are in fluid communication through the inner bore) of the catheter is between and in fluid communication with the tip end of the catheter and the second portion of the catheter;
the first portion of the catheter is configured to have a tapered shape with a diameter expanding from a first diameter adjacent the tip end of the catheter to a second, larger diameter adjacent the second portion of the catheter;
the first portion of the catheter comprises multiple rows of holes (figures 1a-b, at least two rows of holes), and
a tip end of the lumen (figure 1b, the bore within the tip end portion have a uniform cylindrical shape) within the tip end of the catheter is configured to have a uniformly cylindrical shape.
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Wakabayashi does not teach the first portion of the catheter is configured to have a tapered shape with a diameter expanding from a first diameter adjacent the tip end of the catheter to a second, larger diameter adjacent the second portion of the catheter.
In the same field of endeavor, namely a dialysis catheter, Davey teaches a catheter conduit (figures 2a-c and 12, 102) comprising a tip end, a first portion and second portion (figure 2a, distal section 24, frusto-conical middle section 20 and proximal section 22), the first portion of the catheter is configured to have a tapered shape (figure 2a, 20 having tapered shape with a diameter expanding from 28 adjacent tip end 24 to 26 adjacent 22) with a diameter expanding from a first diameter adjacent the tip end of the catheter to a second, larger diameter adjacent the second portion of the catheter.
Davey also teaches the tip end of the lumen within the tip end have a uniformly cylindrical shape (figure 12 and [0094-0095])
Therefore, 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 Wakabayashi, to incorporate the teachings of Davey and provide the catheter as claimed for the purpose of increasing flow rate by maximizing the catheter’s internal volume to surface area ratio while maintaining acceptable catheter French size as taught by Davey ([0048-0056 and 0080]). For example, Davey teaches that the tapered configuration provide the greater ratio of lumen volume to surface area resulting more efficient geometry for maximizing flow compared to a purely cylindrical catheter ([0080]).
Regarding claim 4, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination further teaches wherein the second portion of the catheter has a constant diameter (Davey; figure 2a, 22 has constant diameter).
Regarding claim 5, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination further teaches wherein the second portion of the catheter has substantially the same diameter as the second diameter of the first portion of the catheter (Davey; figure 2a, the diameter of proximal section 22 is substantially same as the diameter at point 26).
Regarding claim 6, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination further teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at constant intervals (Wakabayashi; [0034] the distribution of side holes 111 may be at a constant interval)
Regarding claim 7, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination further teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at various intervals (Wakabayashi; [0034] the distribution of side holes 111 may be at progressively increasing interval).
Regarding claim 10, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination further teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes are configured to facilitate a relatively uniform flow rate distribution of the fluid flowing therethrough (Wakabayashi; [0034] side holes 111 inherently encompass the functional limitation As set forth in MPEP 2144, if an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness inherently teaches the functional limitation here).
Regarding claim 11, Wakabayashi teaches a system for shunting fluid, comprising:
a ventricular catheter (figure 1a and [0027], drainage tube 101, connector 105 and connecting tube), comprising:
a tip end (annotated figure 1b, tip end), a first portion (figure 1a, second portion 103), and a second portion (figure 1a, first portion 102);
a lumen (figure 1b, the bore within the tip end portion having uniform diameter) with a uniformly cylindrical tip end within the tip end of the catheter; wherein
the first portion (figure 1a, the second portion 103 is disposed between the tip end and the first portion 101 and they are in fluid communication through the inner bore) of the catheter is between and in fluid communication with the tip end of the catheter and the second portion of the catheter;
the first portion of the catheter is configured to have a tapered shape; and
the first portion of the catheter comprises multiple rows of holes;
a distal catheter ([0027] connecting tube 108); and
a valve (figure 1a and [0027] connector 105 comprising one-way valve 107 connected between the drainage tube 101 and connecting tube 108) connected between the ventricular catheter and the distal catheter.
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Wakabayashi does not teach the first portion of the catheter is configured to have a tapered shape
In the same field of endeavor, namely a dialysis catheter, Davey teaches a catheter conduit (figures 2a-c and 12, 102) comprising a tip end, a first portion and second portion (figure 2a, distal section 24, frusto-conical middle section 20 and proximal section 22), and the first portion of the catheter is configured to have a tapered shape (figure 2a, 20).
Therefore, 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 Wakabayashi, to incorporate the teachings of Davey and provide the catheter as claimed for the purpose of increasing flow rate by maximizing the catheter’s internal volume to surface area ratio while maintaining acceptable catheter French size as taught by Davey ([0048-0056 and 0080]). For example, Davey teaches that the tapered configuration provide the greater ratio of lumen volume to surface area resulting more efficient geometry for maximizing flow compared to a purely cylindrical catheter ([0080]).
Regarding claim 13, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches wherein the first portion of the catheter has a first diameter (Davey; point 28) close to the tip end of the catheter and a second diameter (Davey; figure 2a, point 26) close to the second portion of the catheter, the first diameter being smaller than the second diameter (Davey; diameter of 28 is smaller than 26).
Regarding claim 14, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches wherein the second portion of the catheter has a constant diameter (Davey; figure 2a, cylindrical proximal section 22 has a constant diameter).
Regarding claim 15, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches wherein the second portion of the catheter has a second diameter (Davey; figure 2a, diameter of the cylindrical proximal section 22)
Regarding claim 16, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at constant intervals. (Wakabayashi; [0034] the distribution of side holes 111 may be at a constant interval)
Regarding claim 17, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at various intervals (Wakabayashi; [0034] the distribution of side holes 111 may be at progressively increasing interval).
Regarding claim 20, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes are configured to facilitate a relatively uniform flow rate distribution of the fluid flowing therethrough (Wakabayashi; [0034] side holes 111 configured to facilitate uniform flow rate distribution of the fluid flowing therethrough. As set forth in MPEP 2144, if an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness inherently teaches the functional limitation here)
Regarding claim 26, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination further teaches the ventricular catheter further comprising a lumen (Wakabayashi; figure 1b, bore 110 extending from the tip end through 103 and 102) extending from the tip portion through the first portion and the second portion, wherein the ventricular catheter is configured to maintain a constant low velocity inside the lumen when implanted in a human (The combination teaches all the structure as claimed, which inherently encompasses the functional limitation here. As set forth in MPEP 2144, if an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness inherently teaches the functional limitation here. In the instant case, The combination teaches all the structure as claimed in claims 11 and 21 i.e., a tip end, a first portion, a second portion and a lumen as claimed, the combination is fully capable of performing claimed function)
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (US 20060122575 A1) in view of Davey et al (US 20010051786 A1), and in further view of Eldor (US 5800407 A).
Regarding claim 8, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination does not expressly teach wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having the same diameter.
In the same field of endeavor, namely a multiple hole catheter, Eldor teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having the same diameter (col 3 lines 55-60 “each of the lateral holes 22 and 32 may be preferably formed of equal size”).
Therefore, 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 Wakabayashi, as modified by Davey, to incorporate the teachings of Eldor and provide the multiple holes as claimed for the purpose of achieving constant equal flow through the multiple rows of holes (col 3 lines 35-65).
Regarding claim 18, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination does not expressly teach wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having the same diameter.
In the same field of endeavor, namely a multiple hole catheter, Eldor teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having the same diameter (col 3 lines 55-60 “each of the lateral holes 22 and 32 may be preferably formed of equal size”).
Therefore, 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 Wakabayashi, as modified by Davey, to incorporate the teachings of Eldor and provide the multiple holes as claimed for the purpose of achieving constant equal flow through the multiple rows of holes (col 3 lines 35-65).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (US 20060122575 A1) in view of Davey et al (US 20010051786 A1), and in further view of Hurt (US 20030216710 A1).
Regarding claim 9, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination does not expressly teach wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having different diameters.
In the same field of endeavor, namely a catheter, Hurt teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having different diameters (figures and [0032] inlet holes 9-13 having progressively decreased in cross-sectional area).
Therefore, 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 Wakabayashi, as modified by Davey, to incorporate the teachings of Hurt and provide the multiple holes as claimed for the purpose of providing uniform inflow into all inlet holes while preventing catheter blockage as taught by Hurt (abstract).
Regarding claim 19, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination does not expressly teach wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having different diameters.
In the same field of endeavor, namely a catheter, Hurt teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes having different diameters (figures and [0032] inlet holes 9-13 having progressively decreased in cross-sectional area).
Therefore, 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 Wakabayashi, as modified by Davey, to incorporate the teachings of Hurt and provide the multiple holes as claimed for the purpose of providing uniform inflow into all inlet holes while preventing catheter blockage as taught by Hurt (abstract).
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi (US 20060122575 A1) in view of Davey et al (US 20010051786 A1), and in further view of Siewiorek et al (US 20190269886 A1).
Regarding claim 27, Wakabayashi, as modified by Davey, teaches the catheter of claim 1.
The combination does not expressly teach wherein the slope of the first portion of the catheter is 30 °.
In the same field of endeavor, namely a medical device such as catheters, Siewiorek teaches wherein the slope of the first portion of the catheter is 30 ° ([0058] angle of the beveled portion is about 30 degrees).
Therefore, 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 Wakabayashi, to incorporate the teachings of Davey to incorporate the teachings of Siewiorek and provide the first portion as claimed for the purpose of providing comfort during insertion and during use as taught by Siewiorek ([0058]), while maintaining optimal flow rate.
Regarding claim 28, Wakabayashi, as modified by Davey, teaches the catheter of claim 11.
The combination does not expressly teach wherein the slope of the first portion of the catheter is 30 °.
In the same field of endeavor, namely a medical device such as catheters, Siewiorek teaches wherein the slope of the first portion of the catheter is 30 ° ([0058] angle of the beveled portion is about 30 degrees).
Therefore, 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 Wakabayashi, to incorporate the teachings of Davey to incorporate the teachings of Siewiorek and provide the first portion as claimed for the purpose of providing comfort during insertion and during use as taught by Siewiorek ([0058]) , while maintaining optimal flow rate.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781
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