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 06/29/026 has been entered. Claims 13-20 are pending and under consideration.
Response to Arguments
Applicants’ arguments filed 06/29/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument, page 6, the combination of Gupta, Jalgaonkar, Bosley fails to render the invention as claimed obvious. In particular, one of ordinary skill would not be motivated to combine the disclosure of Gupta and/or Jalgaonkar with the disclosure of Bosley, because Gupta and Jalgaonkar both fail to disclose deice to used with ultrasound equipment or are visible by echogenicity and/or Jalgaonkar. Rather, both disclosures are limited to device radiopaque materials Thus, the only motivation to combine the disclosure of Gupta and Jalgaonkar with the disclosure of Bosley, which is directed to echogenic medical device and methods of fabrication of use, comes from the Applicant’s own disclosure.
This is not found persuasive. Both Gupta and Jalgaonkar are directed to catheter used in medical procedures and configured to be inserted within the body, where flexibility and visualization of the catheter can facilitate navigation and positioning of the catheter at a target site. Bosley teaches incorporating discrete sound-reflective particles into a polymer matrix for catheter to provide adequate reflection for ultrasonic imaging in the medical field while maintaining desired flexibility (col 5 lines 5-20). Accordingly, a person of ordinary skill in the art seeking to improve visualization of the catheter while maintaining desired flexibility for medical procedures of Gupta or Jalgaonkar would have been motivated to look for Bosley, with a reasonable expectation of success. The motivation to combine arises from the teachings of the prior art rather than form applicant’s disclosure.
Applicant further argues, pages 6-7, that even if the references are combined, the combined disclosures would fail to render the invention as claimed obvious, because the deficiencies of Gupta are not remedied by Jalgaonkar or Bosley because Jalgaonkar is directed to a may include an inner liner, at least one support structure over the inner liner, and an outer jacket over the at least one support structure, and Bosley is directed to echogenic medical devices and methods of fabrication and of use. Bosley and Jalgaonkar are silent regarding providing a device having three concentric layer made of a thermoplastic material, 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 in the plural space and wherein the particulate additive has a diameter from about 2 microns to about 14 microns
This is not found persuasive. The rejection does not rely on any one reference alone to teach all the claimed limitations. Rather, Gupta is relied upon for teaching the drainage catheter and the three concentric thermoplastic layer, Jalgaonkar is relied upon for teaching the tapered distal tip, and Bosley is relied upon for teaching the use of particulate material incorporated into a polymeric material to provide sound reflection for medical imaging, and the combination is made As set forth in MPEP 2145, One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
In response to applicant's argument that Gupta fails to disclose a device visible by echogenicity and/or echopacity in the pleural cavity, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, Gupta teaches a drainage catheter including three concentric layers as claimed and intended to be inserted within the body cavity. Bosley teaches the particulate additive as claimed. Accordingly, the proposed combination is capable of providing the claimed echogenicity visibility of the catheter within the pleural cavity.
The applicant additionally argues that the declaration filed August 5, 2025 establishes unexpected results associated with the claimed particle size range of 2 to about 14 microns. This is not found persuasive. Applicants’ evidence does not establish that the claimed range provides an unexpected result relative to the prior art. In particular, the declaration does not provide comparative evidence demonstrating that the claimed range provides an unexpected advantage over particle sizes outside of the claimed range or over the particle size expressly disclosed by Bosley. Furthermore, Bosley expressly teaches discrete sound-reflective particles have a diameter of 5 microns, which falls within the claimed range. Thus, the evidence does not establish that the claimed range produces a result that would have been unexpected in view of prior art.
Accordingly, Applicant’s argument is not persuasive, and the rejection is maintained.
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) for a pleural cavity, 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 in the pleural cavity 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 in the pleural cavity 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, the discrete sound reflective particles is visible by echogenicity and/or echopacity in the body cavity including the plural cavity.).
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).
Examiner’s note the rejection has been revised for the amended claim language, i.e, a pleural cavity, but the current rejection is based on the same prior art and the same rationale as set forth in the previous office action.
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 the 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 the 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 illustrates 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 in the pleural cavity).
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 the 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 includes 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 of thermoplastic material (Gupta; [0046] the tubular body of the catheter including the distal portion comprises the three thermoplastic 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
THIS ACTION IS MADE FINAL. 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.
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
