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 03/21/2025 has been entered. Claims 1, 2, 4-20 and 26 are pending and under consideration.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “the tip end is configured to have a cylindrical shape” “uniformly cylindrical tip end”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-20 and 26 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 is amended and recites "a uniformly cylindrical tip end" which implies a structure with a constant radius along its longitudinal axis. However, the specification as originally filed silent on such uniformity, i.e., the distal tip illustrated in the specification [0043], [0046] the drawings, figures 3a-c, discloses that the distal portion of the tip end (306) tapered inward
Claims 11-20 and 26 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 11 recites “a uniformly cylindrical tip end” which renders the claim indefinite. For instance, it is not clear if the claim refers to the tip end having cylindrical structure with a constant radius along its longitudinal axis or the tip end illustrated in figures 3a-c, i.e., distal tip end including tapered end. In an effort to compact prosecution the limitans is being interpreted as “cylindrical tip end”
Claims 12-20 and 26 are rejected for at least being dependent of claim 11.
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.
Claims 1, 2, 4, 5 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thungana et al (US 20150165160 A1)
Regarding claim 1, Thungana teaches a catheter (figure 1 [0002], device 10) for shunting fluid, comprising a tip end (figure 1, distal tip 52), a first portion (figure 1, figure 1, tapered portion 12), and a second portion (figure 1, un-tapered portion 12); wherein
the first portion is between and in fluid communication with the tip end and the second portion ([0017] and claim 1, lumen defined within the body 10 place the tapered and untampered portion in fluid communication );
the tip end is configured to have a cylindrical shape (figure 1 and [0009] the tapered portion including the distal tip has generally cylindrical elongated shape);
the first portion is configured to have a tapered shape (figure 1, portion 14 having a tapered shape) with a diameter expanding from a first diameter adjacent (figure 1, diameter of tapered portion 14 adjacent the distal tip 52) the tip end to a second, larger diameter (figure 1, proximal end 15 adjacent to un-taped portion 12) adjacent the second portion; and
the first portion comprises multiple rows of holes (figure 1, plurality of holes 28i).
Regarding claim 2, Thungana teaches the catheter of claim 1.
Thungana further teaches wherein the tip end is a closed end (figures 1 and 2, the distal tip is closed end)
Regarding claim 4, Thungana teaches the catheter of claim 1.
Thungana further teaches wherein the second portion has a constant diameter (figure 1, namely un-tampered portion has a constant diameter)
Regarding claim 5, Thungana teaches the catheter of claim 1.
Thungana further teaches wherein the second portion has substantially the same diameter as the second diameter of the first portion (figure 1, the un-tapered portion 12 joined to tapered portion 14 at proximal end 14 thereby having same diameter).
Regarding claim 10, Thungana teaches the catheter of claim 1.
Thungana 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 (Thungana 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, Thungana teaches all the structure as claimed in claims 1 and 10, i.e., a tip end, a first portion and a second portion as claimed, Thungana fully capable of performing claimed function).
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 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Wakabayashi (US 20060122575 A1).
Regarding claim 6, Thungana teaches the catheter of claim 1.
Thungana does not expressly teach wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at constant intervals.
In the same field of endeavor, namely a system and efficient drainage of body cavity, Wakabayashi teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at constant intervals ([0034] “The distribution of side holes 111 along the tube 101 may be at a constant interval”).
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 Thungana to incorporate the teachings of Wakabayashi and provide the multiple rows of holes as claimed for the purpose of increasing drainage efficiency without compromising the mechanical strength of the catheter as taught by Wakabayashi ([0009] [0034]).
Regarding claim 7, Thungana teaches the catheter of claim 1.
Thungana does not expressly teach wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at various intervals.
In the same field of endeavor, namely a system and efficient drainage of body cavity, Wakabayashi teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at various intervals ([0034] “The distribution of side holes 111 along the tube 101 may be at a constant interval or progressively increasing interval’).
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 Thungana to incorporate the teachings of Wakabayashi and provide the multiple rows of holes as claimed for the purpose of increasing drainage efficiency without compromising the mechanical strength of the catheter as taught by Wakabayashi ([0009] [0034]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Eldor (US 5800407 A).
Regarding claim 8, Thungana teaches the catheter of claim 1.
Thungana 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 Thungana 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).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Hurt (US 20030216710 A1).
Regarding claim 9, Thungana teaches the catheter of claim 1.
Thungana 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 Thungana 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 11-15, 20 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Yang (US 20040236309 A1).
Regarding claim 11, Thungana 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 system (figure 1 [0002] device 10) for shunting fluid, comprising:
a ventricular catheter (figure 1, device 10), comprising:
a cylindrical tip end (figure 1 [0009], distal tip 52), a first portion (figure 1, tapered portion 12), and a second portion (figure 1, un-tapered portion 12); wherein
the first portion is between and in fluid communication with the tip end and the second portion ([0017] and claim 1, lumen defined within the body 10 place the tip end, the second portion and the portion in fluid communication );
the first portion is configured to have a tapered shape (figure 1, portion 14 having a tapered shape); and
the first portion comprises multiple rows of holes (figure 1, plurality of holes 28i);
a distal catheter; and
a valve connected between the ventricular catheter and the distal catheter.
Thungana does not teach the system comprising a distal catheter; and
a valve connected between the ventricular catheter and the distal catheter.
In the same field of endeavor, namely a ventricular catheter, Yang teaches the system (figure 1, shunt system 10) comprising a distal catheter (figure 1, tube 16); and
a valve (figure 1 [0012], valve mechanism 13) connected between the ventricular catheter and the distal catheter.
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 Thungana to incorporate the teachings of Yang and provide the system as claimed for the purpose of regulate the drainage passage and shunt fluid to another part of the body of the patient as taught by Yang ([0012]).
Regarding claim 12, Thungana, as modified by Yang, teaches the catheter of claim 11.
The combination further teaches wherein the tip end is a closed end (Thungana; figures 1 and 2, the distal tip 52 is closed end)
Regarding claim 13, Thungana, as modified by Yang, teaches the catheter of claim 11.
The combination further teaches wherein the first portion has a first diameter (Thungana; figure 1, diameter near annual 24 close to tip end 52 ) close to the tip end and a second diameter (Thungana; figure 1; diameter of proximal end 15 close to un-tapered portion 12 has greater diameter than the first diameter) close to the second portion, the first diameter being smaller than the second diameter.
Regarding claim 14, Thungana, as modified by Yang, teaches the catheter of claim 11.
The combination further teaches wherein the second portion has a constant diameter (Thungana; figure 1 and claim 1 “an elongated cylindrical un-tapered portion” indicates the un-tapered portion having a constant diameter).
Regarding claim 15, Thungana, as modified by Yang, teaches the catheter of claim 11.
The combination further teaches wherein the second portion has a second diameter (Thungana; figure 1, diameter of un-tapered portion 12).
Regarding claim 20, Thungana, as modified by Yang, 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 (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 20 i.e., a tip end, a first portion and a second portion as claimed, the combination is fully capable of performing claimed function).
Regarding claim 26, Thungana, as modified by Yang, teaches the catheter of claim 11.
The combination further teaches the ventricular catheter further comprising a lumen extending from the tip portion through the first portion and the second portion (Thungana; [0017] and claim 1, lumen defined within the body 10 extending from the tip portion to the un-tapered 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 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Yang (US 20040236309 A1), and in further view of Wakabayashi (US 20060122575 A1).
Regarding claim 16, Thungana, as modified by Yang, 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 being placed at constant intervals.
In the same field of endeavor, namely a system and efficient drainage of body cavity, Wakabayashi teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at constant intervals ([0034] “The distribution of side holes 111 along the tube 101 may be at a constant interval”).
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 Thungana, as modified by Yang, to incorporate the teachings of Wakabayashi and provide the multiple rows of holes as claimed for the purpose of increasing drainage efficiency without compromising the mechanical strength of the catheter as taught by Wakabayashi ([0009] [0034]).
Regarding claim 17, Thungana, as modified by Yang, 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 being placed at various intervals.
In the same field of endeavor, namely a system and efficient drainage of body cavity, Wakabayashi teaches wherein an individual row of the multiple rows of holes comprises multiple holes, the multiple holes being placed at various intervals ([0034] “The distribution of side holes 111 along the tube 101 may be at a constant interval or progressively increasing interval’).
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 Thungana, as modified by Yang, to incorporate the teachings of Wakabayashi and provide the multiple rows of holes as claimed for the purpose of increasing drainage efficiency without compromising the mechanical strength of the catheter as taught by Wakabayashi ([0009] [0034]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Yang (US 20040236309 A1), and in further view of Eldor (US 5800407 A).
Regarding claim 18, Thungana, as modified by Yang, 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 Thungana, as modified by Yang, 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).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Thungana et al (US 20150165160 A1) in view of Yang (US 20040236309 A1), and in further view of Hurt (US 20030216710 A1).
Regarding claim 19, Thungana, as modified by Yang, 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 Thungana, as modified by Yang, 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 the catheter blockage as taught by Hurt (abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mckinnon et al (US 9789282 B2).
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.
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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