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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/04/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/04/2025 was filed after the mailing date of the final office action on 09/04/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The amendment filed 12/24/2025 has been entered. Claims 13-20 are pending and under consideration.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 line 2 recites “the f distal tip” which should read “the tapered distal tip”
Claim 19 line 3 “three concentric layer of material” which should read “three concentric layer of the thermoplastic material”
Appropriate correction is required.
Response to Arguments
With regard applicant’s argument with respect 35 USC 103 rejections have been considered and are persuasive, but are moot in light of new rejection/interpretation.
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 13, 16, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al (US 20190126016 A1) in view of Jalgaonkar et al (US 20190366036 A1) and Bosley et al (US 5201314 A)
Regarding claim 13, Gupta 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 drainage catheter (figure 1, drainage catheter 10), comprising:
a tubular body (figure 1, abstract and figure 1, tubular member of the catheter 10) extending along a longitudinal axis (figure 1, a longitudinal axis of the tubular member), the tubular body comprising:
three concentric layers of thermoplastic material extending longitudinally, the three concentric layers comprising an exterior layer, a middle layer, and an interior layer (figures 4-5, [0010] and [0062]-[0063], polymeric outer sheath 50, braided reinforcement 42, and inner polymeric member 30 comprising any suitable polymers including polyurethane. Polyurethane is thermoplastic as disclosed in applicant’s specification [0073]);
a lumen (figure 5, lumen 36) extending longitudinally throughout the tubular body;
a tapered distal tip (figures 1 and 2, tip at distal region 14); and
a plurality of holes (figure 1, drainage holes 22 proximal to the distal tip) proximal to the tapered distal tip and spaced apart longitudinally;
wherein the exterior layer, the middle layer, or the interior layer is a layer comprising a particulate additive incorporated into or distributed uniformly within the material of the layer configured to be visible by echogenicity and/or echopacity and wherein the particulate additive has a diameter from about 2 microns to about 14 microns.
Gupta does not teach the drainage catheter comprising a tapered distal tip.
In the same field of endeavor, namely a flexible tip catheter, Jalgaonkar teaches the drainage catheter comprising a tapered distal tip (figure 2, tapered tip jacket 46).
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 Gupta to incorporate the teachings of Jalgaonkar and provide the tapered distal tip for the purpose of aiding navigation of the catheter as taught by Jalgaonkar ([0003]).
The combination does not teach wherein the exterior layer, the middle layer, or the interior layer is a layer comprising a particulate additive incorporated into or distributed uniformly within the material of the layer configured to be visible by echogenicity and/or echopacity and wherein the particulate additive has a diameter from about 2 microns to about 14 microns.
In the same field of endeavor, namely an echogenic devices, Bosley teaches wherein the exterior layer, the middle layer, or the interior layer is a layer comprising a particulate additive incorporated into or distributed uniformly within the material of the layer configured to be visible by echogenicity and/or echopacity and wherein the particulate additive has a diameter from about 2 microns to about 14 microns (figures 1-2 col 7 lines 1-65 and , body member 123 is a part of echogenic device and comprising matrix material 125 made of plastic, for example polyurethane, with discrete sound reflective particles 127 having an outer diameter of about 5 microns).
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 Gupta, as modified by Jalgaonkar, to incorporate the teachings of Bosley and provides the three concentric layers as claimed for the purpose of maintaining desired flexibility while providing adequate reflection for medical image as taught by Bosley (col 5 lines 5-20).
Regarding Claim 16, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 13.
The combination does not teach wherein the layer configured to be visible by echogenicity and/or echopacity provides a visual confirmation to an operator of a depth of the drainage catheter in a pleural cavity of a patient past the plurality of holes
In the same field of endeavor, namely an echogenic deices, Bosley teaches wherein the layer configured to be visible by echogenicity and/or echopacity provides a visual confirmation to an operator of a depth of the drainage catheter in a pleural cavity of a patient past the plurality of holes (figure 2 col 7 lines 30-45, catheter wall 231 comprises sound reflective particle 227 and the particle visible by echogenicity. Additionally, figure 12 illustrate the sound-reflective particles embedded within spherical indentations (figure 12, 1202), and such configuration allows the operator to visually confirm the depth of the drainage catheter through ultrasound imaging device).
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 Gupta, as modified by Jalgaonkar and Bosley, to incorporate the teachings of Bosley and provides wherein the layer configured to be visible by echogenicity and/or echopacity provides a visual confirmation to an operator of a depth of the drainage catheter in a pleural cavity of a patient past the plurality of holes, as one of skill in the art motivated to do so, for the purpose of allowing the operator to visually confirm the depth of the catheter insertion.
Regarding claim 17, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 13.
The combination further teaches wherein the tubular body comprises a distal portion (Gupta; distal region 14) comprising the tapered distal tip (claim 1; tapered distal tip as set forth in claim 13) and the plurality of holes (figure 1 and [0046] plurality of drainage holes 22 ); and
wherein the distal portion has a degree of curvature of greater than 0 degrees (Gupta; figure 1 and [0045] the distal end portion 14 include a curved portion 18 defining a degree of curvature greater than 0 degrees).
Regarding claim 19, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 13.
The combination further teaches wherein the tubular body comprises a distal portion (Gupta; figure 1 and [0046], distal region 14 comprising the tapered distal tip as set forth in claim 13 and plurality of holes 22) comprising the tapered distal tip and the plurality of holes; and
wherein the distal portion comprises the three concentric layers of material (Gupta; [0046] the tubular body of the catheter including the distal portion comprises the three concentric layer as set forth in claim 13).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al (US 20190126016 A1) in view of Jalgaonkar et al (US 20190366036 A1) and Bosley et al (US 5201314 A), and in further view of Osborne (US 20050004554 A1).
Regarding claim 14, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 13.
The combination does not teach wherein the layer configured to be visible by echogenicity and/or echopacity comprises from 70 weight % to 90 weight % of tungsten uniformly distributed in the layer.
In the same field of endeavor, namely a catheter assembly, Osborne teaches a drainage catheter comprises a tubular body comprises from 20 weight % to 80 weight % of tungsten ([0037] “the catheter material is loaded with between 20 and 80 weight percent of a radiopaque material, such as tungsten, bismuth, and the like”) uniformly distributed in the tubular body or the layer.
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 Gupta, as modified by Jalgaonkar and Bosley, to incorporate the teachings of Osborne and provide the tubular body comprises from 20 weight % to 80 weight % of tungsten for the purpose of provide optimized radiopaque characteristics to the catheter, as taught by Osborne ([0037])
The combination does not explicitly teach the composition of tungsten within the tubular body ranges from 70 weight % to 90 weight %,
though Osborne teaches the amount of tungsten between 20 and 80 weight percent of the catheter material ([0037]).
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 Gupta, as modified by Jalgaonkar, Bosley and Osborne, and provide the composition as claimed as it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05(I)). In the instant case, ordinary skill in the art motivated to do so, for the purpose of optimizing echogenicity.
Regarding claim 15, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 13.
The combination does not teach wherein the layer configured to be visible by echogenicity and/or echopacity comprises from 40 weight % to 60 weight % of bismuth uniformly distributed in the layer.
In the same field of endeavor, namely a catheter assembly, Osborne teaches a drainage catheter comprises a tubular body comprises from 20 weight % to 80 weight % of bismuth ([0037] “the catheter material is loaded with between 20 and 80 weight percent of a radiopaque material, such as tungsten, bismuth, and the like”) uniformly distributed in the layer.
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 Gupta, as modified by Jalgaonkar and Bosley, to incorporate the teachings of Osborne and provide the tubular body comprises from 20 weight % to 80 weight % of bismuth for the purpose of provide optimized radiopaque characteristics to the catheter, as taught by Osborne ([0037])
The combination does not explicitly teach the composition of bismuth within the tubular body ranges from 40 weight % to 60 weight %;
though Osborne teaches the amount of bismuth between 20 and 80 weight percent of the catheter material ([0037]).
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 Gupta, as modified by Jalgaonkar, Bosley and Osborne, and provide the composition as claimed as it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05(I)). In the instant case, ordinary skill in the art motivated to do so, for the purpose of optimizing echogenicity.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al (US 20190126016 A1) in view of Jalgaonkar et al (US 20190366036 A1) and Bosley et al (US 5201314 A), and in further view of Terwilliger (US 5766135 A).
Regarding Claim 18, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 17.
The combination does teach wherein the distal portion comprises an elliptically-shaped hole proximal to the plurality of holes
In the same field of endeavor, namely an echogenic needle, Terwilliger teaches a hole at the distal tip is elliptically-shaped (col 3 lines 1-10, specifically “the stylet or cannula has a hole machined through the distal tip of the diameter of the stylet or cannula, perpendicular to the axis of the stylet or needle. This hole is positioned slightly above the centerline of the stylet or cannula, so the hole breaks out on the diameter as oval openings”)
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 Gupta, as modified by Jalgaonkar and Bosley, to incorporate the teachings of Terwilliger and provide an elliptically-shaped hole proximal to the plurality of holes for the purpose of enhancing indication of the hole in the ultrasound image, as taught by Terwilliger (col 3 lines 1-10, col 4 lines 2-9)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al (US 20190126016 A1) in view of Jalgaonkar et al (US 20190366036 A1) and Bosley et al (US 5201314 A), and in further view of Klein (US 20190298648 A1)
Regarding Claim 20, Gupta, as modified by Jalgaonkar and Bosley, teaches the drainage catheter of claim 13.
The combination further teaches wherein the tubular body comprises a distal portion (Gupta; figure 1 and [0046] distal region 14 comprising the tapered distal tip a set forth in claim 13 and plurality of holes 22 ) comprising the tapered distal tip and the plurality of holes;
wherein the distal portion has a degree of curvature of about 0 degrees (Gupta; figure 1 and [0045] the distal end portion 14 include a curved portion 18 defining a degree of curvature greater than 0 degrees);
The combination does not teach wherein the plurality of holes is spaced apart circumferentially about a circumference of the tubular body.
In the same field of endeavor, namely an infiltration cannula, Klein teaches the plurality of holes are spaced apart circumferentially about a circumference of the distal portion ([0076] “the apertures 18 are disposed along the distal end 16 of the cannula 10 in a spiral or helical pattern and are distributed over the distal 33% to 100% of the tubular needle 12 of the cannula 10” apertures disposed in helical pattern would be spaced apart in both longitudinal and circumferential direction);
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 Gupta, as modified by Jalgaonkar and Bosley, to incorporate the teachings of Klein and provides the plurality of holes are spaced apart circumferentially about a circumference of the distal portion for the purpose of providing adequate flow rates through the holes while maintaining structural integrity as taught by Klein ([0076])
Conclusion
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.
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.
/SETH HAN/Examiner, Art Unit 3781