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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/9/2026 has been entered.
Response to Amendment
Applicant’s amendment filed 4/9/2026 is acknowledged.
Claims 21-40 remain pending in the current application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21, 22, 24, 27, 31, 32, 34, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (US 20020087079 A1) in view of Dunleavy (US 20090050812 A1) and Imran (US 20170252560 A1).
Regarding claim 21, Kaufman teaches a urinary catheter comprising an optical fiber cavity configured to receive an optical fiber ([0014] the catheters of the present invention use an array of optical detectors; [0018] FIG. 1 illustrates a simplified catheter disposed within a body lumen having radio label markers; [0022] FIG. 5 illustrates a simplified catheter having an array of optical radiation detectors)
Kaufman fails to teach a plurality of optical fibers coupled to a plurality of scintillators embedded in a wall of the urinary catheter and an inflation cavity, wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter.
However, Dunleavy teaches a plurality of optical fibers coupled to a plurality of scintillators embedded in a wall of the urinary catheter and an inflation cavity, wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity ([0021] In another aspect, this invention provides a fibre composite structure including a matrix material, a plurality of structural fibres, and at least one optical waveguide embedded therein, with a scintillator in optical contact with said waveguide and selected to emit light in response to ionising radiation, and a detector for detecting light emissions transmitted from said scintillator by said waveguide. [0022] Preferably the structure includes a plurality of scintillators and a plurality of optical waveguides embedded in said matrix).
Kaufman and Dunleavy are considered analogous because both disclose medical applications of scintillators. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to embed a combination of scintillators and optical fibers into a structure such as a catheter wall in order to incorporate radiation detection into a structure or fabric (Dunleavy [0003]).
Kaufman in view of Dunleavy fails to teach wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter.
However, Imran teaches an inflation cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter ([0029] one or more lumens including a drainage lumen 18 and inflation lumen 20 for inflating a deployable anchor 22 such as an inflatable balloon)
wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter ([0029] a third lumen 24 which carries cables or wires or other elongated electrical conductor 26 which are used to deliver energy to the distal end of the catheter; [0028] energy delivery elements capable of delivering other forms of energy are also contemplated including for example…optical fibers; see configuration in Fig. 2; given that all the structural limitations are disclosed in the prior art it is understood that the effect of maintaining the scintillators in position is achieved as well)
PNG
media_image1.png
261
266
media_image1.png
Greyscale
Kaufman and Imran are considered analogous because both disclose invasive catheters. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to make a lumen used for inflation purposes smaller in diameter than an additional lumen used for carrying optical fibers in order to provide improved urethral drainage catheters (Imran [0007]).
Regarding claim 22, Kaufman teaches a scintillator ([0049] at least one scintillator 56)
a light detector ([0049] optical detectors 52 will typically include a plurality of light detectors 54)
and a processor operable to determine a location of a radiation source ([0009] catheters which include an array of radiation detectors that convert the radiation into electrical signals within the catheter and deliver the electrical signal to a signal processor)
Regarding claim 24 Kaufman teaches a light detector ([0049] optical detectors 52 will typically include a plurality of light detectors 54).
Regarding claim 27, Kaufman fails to teach the urinary catheter comprises three scintillators and three optical fibers. Kaufman discloses the claimed invention except for specifying that the plurality of each element to be three. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make the plurality of scintillators to be three scintillators and the plurality of optical fibers to be three optical fibers, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 31, Kaufman teaches a urinary catheter comprising an afterloader operable to carry a radiation source ([0009] catheters which include an array of radiation detectors that convert the radiation into electrical signals within the catheter and deliver the electrical signal to a signal processor)
a scintillator ([0049] at least one scintillator)
and an optical fiber located in an optical fiber cavity that passes through the urinary catheter fiber ([0014] the catheters of the present invention use an array of optical detectors; [0018] FIG. 1 illustrates a simplified catheter disposed within a body lumen having radio label markers; [0022] FIG. 5 illustrates a simplified catheter having an array of optical radiation detectors)
Kaufman fails to teach a plurality of optical fibers coupled to a plurality of scintillators embedded in a wall of the urinary catheter and an inflation cavity, wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter.
However, Dunleavy teaches a plurality of optical fibers coupled to a plurality of scintillators embedded in a wall of the urinary catheter and an inflation cavity, wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity ([0021] In another aspect, this invention provides a fibre composite structure including a matrix material, a plurality of structural fibres, and at least one optical waveguide embedded therein, with a scintillator in optical contact with said waveguide and selected to emit light in response to ionising radiation, and a detector for detecting light emissions transmitted from said scintillator by said waveguide. [0022] Preferably the structure includes a plurality of scintillators and a plurality of optical waveguides embedded in said matrix).
Kaufman and Dunleavy are considered analogous because both disclose medical applications of scintillators. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to embed a combination of scintillators and optical fibers into a structure such as a catheter wall in order to incorporate radiation detection into a structure or fabric (Dunleavy [0003]).
Kaufman in view of Dunleavy fails to teach wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter.
However, Imran teaches an inflation cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter ([0029] one or more lumens including a drainage lumen 18 and inflation lumen 20 for inflating a deployable anchor 22 such as an inflatable balloon)
wherein the inflation cavity, in a deflated state, is smaller in diameter than the optical fiber cavity and the inflation cavity is dimensioned relative to the optical fiber cavity to maintain placement of the plurality of scintillators within the wall during inflation of a balloon of the urinary catheter ([0029] a third lumen 24 which carries cables or wires or other elongated electrical conductor 26 which are used to deliver energy to the distal end of the catheter; [0028] energy delivery elements capable of delivering other forms of energy are also contemplated including for example…optical fibers; see configuration in Fig. 2; given that all the structural limitations are disclosed in the prior art it is understood that the effect of maintaining the scintillators in position is achieved as well)
Kaufman and Imran are considered analogous because both disclose invasive catheters. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to make a lumen used for inflation purposes smaller in diameter than an additional lumen used for carrying optical fibers in order to provide improved urethral drainage catheters (Imran [0007]).
Regarding claim 32, Kaufman teaches a plurality of light detectors ([0049] optical detectors 52 will typically include a plurality of light detectors 54)
and a processor operable to determine a location of a radiation source ([0009] catheters which include an array of radiation detectors that convert the radiation into electrical signals within the catheter and deliver the electrical signal to a signal processor)
Regarding claim 34, Kaufman teaches a plurality of light detectors ([0049] optical detectors 52 will typically include a plurality of light detectors 54).
Regarding claim 37, Kaufman fails to teach the urinary catheter comprises three scintillators and three optical fibers. Kaufman discloses the claimed invention except for specifying that the plurality of each element to be three. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make the plurality of scintillators to be three scintillators and the plurality of optical fibers to be three optical fibers, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 23 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman in view of Imran as applied to claims 21 and 31 above, and further in view of Norris (US 0001662 A).
Regarding claim 23, Kaufman teaches the processor is configured to determine a location of the radiation source ([0009] catheters which include an array of radiation detectors that convert the radiation into electrical signals within the catheter and deliver the electrical signal to a signal processor)
Kaufman fails to disclose that the location is calculated through triangulation according to the electrical signals from the plurality of light detection units. However, Norris discloses the process of localization through triangulation. Given that triangulation is an established means of localization, it would be obvious to one of ordinary skill in the art before the effective filing date to use the method of triangulation using data from the plurality of light detection units in order to accurately determine the location of the radiation source.
Regarding claim 33, Kaufman teaches the processor is configured to determine a location of the radiation source ([0009] catheters which include an array of radiation detectors that convert the radiation into electrical signals within the catheter and deliver the electrical signal to a signal processor)
Kaufman fails to disclose that the location is calculated through triangulation according to the electrical signals from the plurality of light detection units. However, Norris discloses the process of localization through triangulation. Given that triangulation is an established means of localization, it would be obvious to one of ordinary skill in the art before the effective filing date to use the method of triangulation using data from the plurality of light detection units in order to accurately determine the location of the radiation source.
Claim(s) 25, 26, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman in view of Imran as applied to claims 21 and 31 above, and further in view of Isham (US 20140051968 A1).
Regarding claim 25, Kaufman fails to teach the urinary catheter comprises a fiducial marker embedded into a wall of the urinary catheter as part of a radiation sensor that comprises a scintillator.
However, Isham teaches the urinary catheter comprises a fiducial marker embedded into a wall of the urinary catheter as part of a radiation sensor that comprises a scintillator ([0081] FIG. 4 also shows a plurality of fiducial markers 72 located on or below the surface of the balloon 14).
Kaufman as modified and Isham are considered to be analogous to the claimed invention because both are in the same field of detecting radiation in a medical application. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed a plurality of fiducial markers in the walls of the catheter in order to provide a means of localization.
Regarding claim 26, Kaufman fails to teach wherein the fiducial marker is located via an MRI machine after the urinary catheter is placed in a patient and prior to radiation therapy.
However, Isham teaches wherein the fiducial marker is located via an MRI machine after the urinary catheter is placed in a patient and prior to radiation therapy ([0081] The fiducial markers 72 may be made of a tungsten material or any of the known radiopaque or reflective materials, depending on the imaging means used; [0020] The disclosure provides an endorectal balloon that immobilizes the prostate for e.g., external beam radiation therapy)
Kaufman as modified and Isham are considered to be analogous to the claimed invention because both are in the same field of detecting radiation in a medical application. Given that MRI is a known technique in the art that detects radio-opaque materials and that the disclosure in Isham prepares the patient for radiation therapy it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to detect the markers with MRI prior to radiation therapy so that that the radiation dose and movement can both be monitored during treatment (Isham [0019]).
Regarding claim 35, Kaufman fails to teach the urinary catheter comprises a fiducial marker embedded into a wall of the urinary catheter as part of a radiation sensor that comprises a scintillator.
However, Isham teaches the urinary catheter comprises a fiducial marker embedded into a wall of the urinary catheter as part of a radiation sensor that comprises a scintillator ([0081] FIG. 4 also shows a plurality of fiducial markers 72 located on or below the surface of the balloon 14).
Kaufman as modified and Isham are considered to be analogous to the claimed invention because both are in the same field of detecting radiation in a medical application. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embed a plurality of fiducial markers in the walls of the catheter in order to provide a means of localization.
Regarding claim 36, Kaufman fails to teach wherein the fiducial marker is located via an MRI machine after the urinary catheter is placed in a patient and prior to radiation therapy.
However, Isham teaches wherein the fiducial marker is located via an MRI machine after the urinary catheter is placed in a patient and prior to radiation therapy ([0081] The fiducial markers 72 may be made of a tungsten material or any of the known radiopaque or reflective materials, depending on the imaging means used; [0020] The disclosure provides an endorectal balloon that immobilizes the prostate for e.g., external beam radiation therapy)
Kaufman as modified and Isham are considered to be analogous to the claimed invention because both are in the same field of detecting radiation in a medical application. Given that MRI is a known technique in the art that detects radio-opaque materials and that the disclosure in Isham prepares the patient for radiation therapy it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to detect the markers with MRI prior to radiation therapy so that that the radiation dose and movement can both be monitored during treatment (Isham [0019]).
Claims 28, 29, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman and Imran as applied to claim 1 above, and further in view of D’Andrea (US 20160310759 A1).
Regarding claim 28, Kaufman discloses the invention substantially as claimed for the urinary catheter of claim 1, but fails to teach wherein the urinary catheter comprises a balloon for maintaining one end of the urinary catheter in a patient's bladder. However, D’Andrea teaches a brachytherapy catheter and mobile balloon device system is provided [0010].
Kaufman as modified by Daghighian and D’Andrea are considered to be analogous art because both are in the same field of catheters used in brachytherapy applications. While the application in D’Andrea slightly differs from that in Kaufman, the balloon taught by D’Andrea is capable of performing the function of the claimed invention. Therefore, it would have been obvious to one of ordinary skill in the art to attach a balloon device system to a catheter to maintain one end of the urinary catheter in the patient’s bladder.
Regarding claim 29, Kaufman fails to teach wherein the urinary catheter comprises a balloon for expanding the urinary catheter at a tumor location. However, D’Andrea teaches a brachytherapy catheter and mobile balloon device system is provided [0010].
Kaufman as modified and D’Andrea are considered to be analogous art because both are in the same field of catheters used in brachytherapy applications. While the application in D’Andrea slightly differs from that in Kaufman, the balloon taught by D’Andrea is capable of performing the function of the claimed invention. Therefore, it would have been obvious to one of ordinary skill in the art to attach a balloon device system to a catheter expand near the tumor location.
Regarding claim 38, Kaufman discloses the invention substantially as claimed for the urinary catheter of claim 1, but fails to teach wherein the urinary catheter comprises a balloon for maintaining one end of the urinary catheter in a patient's bladder. However, D’Andrea teaches a brachytherapy catheter and mobile balloon device system is provided [0010].
Kaufman as modified by Daghighian and D’Andrea are considered to be analogous art because both are in the same field of catheters used in brachytherapy applications. While the application in D’Andrea slightly differs from that in Kaufman, the balloon taught by D’Andrea is capable of performing the function of the claimed invention. Therefore, it would have been obvious to one of ordinary skill in the art to attach a balloon device system to a catheter to maintain one end of the urinary catheter in the patient’s bladder.
Regarding claim 39, Kaufman fails to teach wherein the urinary catheter comprises a balloon for expanding the urinary catheter at a tumor location. However, D’Andrea teaches a brachytherapy catheter and mobile balloon device system is provided [0010].
Kaufman as modified and D’Andrea are considered to be analogous art because both are in the same field of catheters used in brachytherapy applications. While the application in D’Andrea slightly differs from that in Kaufman, the balloon taught by D’Andrea is capable of performing the function of the claimed invention. Therefore, it would have been obvious to one of ordinary skill in the art to attach a balloon device system to a catheter expand near the tumor location.
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman as modified by Daghighian and D’Andrea as applied to claims 29 and 39 above, and further in view of Isham.
Regarding claim 30, Kaufman fails to teach wherein the plurality of scintillators and the plurality of optical fibers are spread out when the balloon is expanded. However, by inspecting Figures 3-5 of the Isham disclosure, it is clear that the balloon Isham teaches would be capable of performing the application of the claimed invention, see the figure below which shows item 72 spreading out as the balloon expands and contracts. Though reference number 72 in the figures refers to a fiducial marker, this item could be interchangeable with scintillators and optical fibers. Therefore, it would be obvious to one of ordinary skill in the art to have the components of the invention spread out when the balloon expands.
PNG
media_image2.png
553
742
media_image2.png
Greyscale
Regarding claim 40, Kaufman fails to teach wherein the plurality of scintillators and the plurality of optical fibers are spread out when the balloon is expanded. However, by inspecting Figures 3-5 of the Isham disclosure, it is clear that the balloon Isham teaches would be capable of performing the application of the claimed invention, see the figure below which shows item 72 spreading out as the balloon expands and contracts. Though reference number 72 in the figures refers to a fiducial marker, this item could be interchangeable with scintillators and optical fibers. Therefore, it would be obvious to one of ordinary skill in the art to have the components of the invention spread out when the balloon expands.
Response to Arguments
Applicant’s arguments, see pages 7 and 8, filed 4/9/2026, with respect to the rejection(s) of the independent claims under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly uncovered Dunleavy reference.
Applicant has amended the independent claim to specify that the scintillators are to be embedded in the walls of the catheter, a feature not present in the previous prior art combination. However, an updated search has uncovered the newly cited Dunleavy reference which specifically specifies that scintillators are coupled to optical fibers and are entirely embedded into a matrix, which in the instant case is considered to be a catheter wall. Applicant has also amended the claim to include a functional limitation that specifies that the configuration of the different lumens maintains the scintillators in place. Seeing as the entire structure of the claim is disclosed by the cited prior art combination, it is understood that the effect disclosed in the newly cited functional limitation will be achieved and thus every limitation of the independent claims is obviated to one of ordinary skill in the art from the cited prior art combination. For at least the aforementioned reasons, the claims remain rejected under 35 USC 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ciamacco (US 5772642 A) teaches a catheter with separate tool and guidewire lumens [abst].
PNG
media_image3.png
335
420
media_image3.png
Greyscale
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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, Anne Kozak can be reached at (571) 270-0552. 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.
/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
Prosecution Insights