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 .
Information Disclosure Statement
The information disclosure statement(s) filed 06/13/2024 AND 05/25/2026 has/have been considered by the Examiner.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. 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. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schultheis (US 20210307828 A1 – hereinafter Schultheis).
Re. claim 1, Schultheis teaches a balloon catheter system with repair function (abstract – “A catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve includes an energy source, a balloon…”; see figure 1),
PNG
media_image1.png
478
750
media_image1.png
Greyscale
comprising:
a tube body, having a distal end and a proximal end opposite to the distal end (figure 1, catheter shaft 110),
and the tube body at least forming a fluid channel (figure 1, inflation conduit 140; paragraph 0058 – “The catheter system 100 can also include the fluid pump 138 that is configured to inflate the balloon 104 with the balloon fluid 132, i.e. via the inflation conduit 140, as needed”) and an optical fiber channel (figure 1, the optical fiber 122A within catheter shaft 110);
a balloon body, located at an outer periphery of the distal end of the tube body and communicating with the fluid channel (figure 1, balloon 104; paragraph 0058 – “The catheter system 100 can also include the fluid pump 138 that is configured to inflate the balloon 104 with the balloon fluid 132, i.e. via the inflation conduit 140, as needed”);
an optical fiber (figure 1, light guide 122A; paragraph 0037 – “In some embodiments, each light guide 122A can be an optical fiber and the light source 124 can be a laser”), arranged in the optical fiber channel (figure 1 shows the light guide 122A within the catheter shaft 110) and having a light emitting section extending to a position of the balloon body (figure 1 shows the light guide 122A proximate to the balloon 104 within the catheter shaft 110), and
a laser generator (figure 1, light source 124), connected to a proximal end of the optical fiber and emitting a laser (paragraph 0037 – “In some embodiments, each light guide 122A can be an optical fiber and the light source 124 can be a laser”) having a repair function with a wavelength ranging from 400 to 750 nm (paragraph 0068 – “In some embodiments, the light sources 124 suitable for use in the catheter systems 100 herein can include those capable of producing light at wavelengths of from at least 750 nm to 2000 nm. In other embodiments, the light sources 124 can include those capable of producing light at wavelengths of from at least 700 nm to 3000 nm. In still other embodiments, the light sources 124 can include those capable of producing light at wavelengths of from at least 100 nm to ten micrometers (μm)”).
Re. claim 20, Schultheis further teaches wherein an outer surface of the balloon body is coated with at least one selected from an anti-proliferative drug, a drug that induce collagen or elastin cross-linking, and an anti-vasospasm drug; OR, the balloon body is provided with an implantable vascular stent on the outer surface thereof (paragraph 0044 – “In some embodiments, the balloons 104 herein can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like”).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis (US 20210307828 A1 – hereinafter Schultheis) in view of Prescott (US 5989245 A – hereinafter Prescott).
Re. claim 2, Schultheis teaches the claimed invention of claim 1 except wherein a power of the laser emitted by the laser generator ranges from 10 to 30 mW.
Prescott teaches a similar laser catheter system (abstract – “The device supplies the patient with a preprogrammed laser therapy regimen…Alternatively, the device may be adapted to be implanted into a skin surface of the patient, or provided in a catheter that is inserted in the vasculature system of the patient”), and further teaches a power of the laser emitted by the laser generator ranges from 10 to 30 mW (column 5, lines 56-61: “The lasers 20 are preferably vertical-cavity surface-emitting lasers ("VCSELs") having a nominal power output of 2.6 mW and a wavelength on the order of 400-1300 nanometers, with the preferred wavelength being approximately 780 nanometers. The preferred power output of the lasers is at least 5-10 mW per VCSEL chip”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the laser system of Schultheis, specifically the laser power, to incorporate the laser power ranging from 10 to 30 mW as taught by Prescott, since such modification would predictably result in providing effective in the treatment of these various medical conditions (Prescott column 1, lines 57-62).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis (US 20210307828 A1 – hereinafter Schultheis) in view of Overholt (US 6146409 A – hereinafter Overholt).
Re. claim 4, Schultheis further teaches wherein the balloon body comprises an isodiametric section and two tapered sections respectively located at both ends of the isodiametric section (figure 1 shows the isodiametric balloon 104 with tapered ends),
PNG
media_image2.png
201
332
media_image2.png
Greyscale
But does not expressly teach a surface of each tapered section at a distal end of the balloon body is covered with a black coating.
Overholt teaches a balloon catheter system (column 1, lines 13-16: “The present invention provides improved methods for providing light to a biological column that involve irradiating an extended irradiation segment, such as by using a balloon catheter with extended irradiation window, to reduce the formations of strictures”), comprising a fiber optic cable (column 7, lines 64-67: “The apparatus of the present invention may further comprise a fiber optic cable, a fiber optic bundle or liquid light guide, for convenience, hereinafter referred collectively as a fiber optic cable”),
and further includes a balloon isodiametric section and two tapered sections respectively located at both ends of the isodiametric section (figures 1A-1B), comprising coated ends, wherein a surface of each tapered section at a distal end of the balloon body is covered with a black coating (column 5, lines 31-34: “Cylindrical shaped balloon catheters typically contain an irradiation window in the balloon catheter that is defined by an absorptive black or reflective/scattering covering on the ends of the balloon, FIG. 1”).
PNG
media_image3.png
454
616
media_image3.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter of Schultheis, to incorporate the black coating on the tapered ends of the balloon as taught by Overholt, since such modification would predictably result in providing an irradiation window for preventing harmful laser light scattering (Overton column 5, lines 31-34).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis (US 20210307828 A1 – hereinafter Schultheis) in view of Sinofsky (US 4878492 A – hereinafter Sinofsky) and Glover (US 20200022587 A1 – hereinafter Glover).
Re. claim 18, Schultheis further teaches wherein the tube body comprises:
an inner tube (guidewire lumen 118)
and an outer tube mounted around the inner tube (catheter shaft 110),
a distal end of the balloon body is in sealed connection with an outer wall of the inner tube (figure 1, tapered distal end of the balloon 104 is sealed to the guidewire lumen 118),
PNG
media_image4.png
365
528
media_image4.png
Greyscale
and a proximal end of the balloon body in sealed connection with the outer tube (figure 1, tapered proximal end of the balloon 104 is sealed to the catheter shaft 110),
PNG
media_image5.png
365
528
media_image5.png
Greyscale
And the balloon catheter system comprises a plurality of the optical fibers (paragraph 0037 – “In some embodiments, each light guide 122A can be an optical fiber…”; paragraph 0058 – “The source manifold 136 can include one or more proximal end openings that can receive the plurality of light guides 122A of the light guide bundle 122…”).
Schultheis does not expressly teach a radial gap between the inner tube and the outer tube forms the optical fiber channel, and each optical fiber is arranged in parallel with the inner tube or by wrapping around the inner tube.
Sinofsky teaches a similar balloon catheter system comprising a laser (abstract – “A laser balloon catheter intended primarily for coronary angioplasty includes a flexible tube having an inflatable balloon secured to its distal end, a central shaft within the balloon for carrying a guide wire, an optical fiber for carrying laser radiation through the flexible tube into the balloon…”), and further includes an outer tube (figure 2, flexible tube 10), an inner tube (figure 2, central shaft 26), and a radial gap between the inner tube and the outer tube which forms the optical fiber channel, and each optical fiber is arranged in parallel with the inner tube or by wrapping around the inner tube (figure 2, optical fiber tip assembly 24 which wraps around the inner central shaft 26 and below the outer flexible tube 10).
PNG
media_image6.png
214
606
media_image6.png
Greyscale
And further teaches this arrangement with a plurality of optical fibers uniformly distributed around an axis of the tube body (see figure 12 with optical fibers 90, 92 and 94 between a radial gap between an outer and inner tube).
PNG
media_image7.png
96
144
media_image7.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ballon catheter of Schultheis, to try incorporating the outer-inner tube and helical optical fiber(s) configuration as taught by Sinofsky as stated above, since such modification would predictably result in, for example, preventing “shadowing” by the inner tube (Sinofsky column 6, lines 47-53).
The newly combined invention teaches the optical fibers as stated above, but do not expressly teach a diameter of each optical fiber ranges from 0.125 to 0.25 mm.
Glover teaches a similar balloon catheter system (abstract – “A system comprising a multi-sensor catheter for monitoring of a cardiac hemodynamic condition, e.g. heart failure, is disclosed. The multi-sensor catheter comprises multi-lumen catheter tubing comprising first and second optical pressure sensors, and their respective optical fibers and connectors. For right heart and pulmonary artery catheterization, a flow-directed multi-sensor catheter comprises a guidewire lumen, an inflatable balloon tip...”), and further teaches a plurality of optical fibers (figures 7-8, optical fibers 2011) which has diameters of 0.155 mm (paragraph 0098 – “Also, by way of example, FIG. 7 shows typical dimensions for catheter tubing comprising seven lumens and having an outside diameter of 6 French (0.079 inch/2.00 mm), and for optical fibers 2011 having a diameter of 0.155 mm”).
PNG
media_image8.png
320
480
media_image8.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter of newly combined invention, specifically the optical fibers, to incorporate the optical fiber diameter of 0.155 mm as taught by Glover, since such modification would predictably result in the ease of traversal for the optical fibers though the balloon catheter.
Allowable Subject Matter
Claims 3, 5-17 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, alone or in combination, fails to anticipate and/or render obvious to the claimed subject matter of claims 3, 5, 8 and 19 in their entireties. Dependent claims 6-7 and 9-17 are only further objected to for their dependencies to claims 5 and 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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, DAVID HAMAOUI can be reached at 571-270-5625. 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.
/ANH-KHOA N DINH/Examiner, Art Unit 3796
