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 (IDS) filed 10/22/2024 has been considered y the Examiner.
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.
(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.
Claims 1-3 and 6-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scharf et al (US 20160151639 A1).
Regarding claim 1, Scharf teaches an apparatus (100), comprising:
a flexible elongate member (110) configured to be positioned within a body lumen of a patient (see [0138]; constructed and arranged to be inserted into a mammalian body such as through an incision in the skin or through a natural body orifice); and
at least one optical fiber (151) positioned within the flexible elongate member (see Fig. 1, [0140-0141]; optical element comprising optical fiber 151 and light delivery element 155), the at least one optical fiber comprising a proximal portion and a distal portion (see Fig. 1, optical fiber 151a having a proximal and distal end, and/or [0145]; optical fibers 151b extending to a distal portion of the shaft 110), wherein:
the proximal portion of the at least one optical fiber is configured to receive light from a light source (see [0147]; proximal end of each fiber 151a is attached to a light source 150a),
wherein the light comprises a wavelength between 650 nm and 750 nm (see [0150]; light source 150 can be constructed and arranged to provide one or more wavelengths of light between 400nm and 750nm); and
the distal portion of the at least one optical fiber is configured to emit the light from the light source radially outward along a length of the optical fiber and into tissue of the body lumen of the patient (see Fig. 1, [0142-0143]; light delivery elements 155 positioned within an axial segment of shaft 110 to deliver light radially out from shaft 110, one or more light delivery elements 155b can be positioned within balloon 125 such as to transmit light radially out from balloon 125; at portion D1, light from light delivery elements 155a emanates out radially).
Regarding claim 2, Scharf teaches the apparatus of claim 1, wherein the optical fiber comprises:
a core (optical fiber 151a); and a cladding (cladding 152a).
Regarding claim 3, Scharf teaches the apparatus of claim 2, wherein a section of the cladding in the distal portion is configured to cause the light to emit radially outward along the length of the optical fiber (see [0142]; when reaching the uncladded portion D1 defined by light delivery element 155a, the conducted light emanates radially out from the associated light delivery element 155a).
Regarding claim 6, Scharf teaches the apparatus of claim 3, wherein the section of the cladding has a first thickness (see [0143]; uncladded portion D1 has a thickness of zero),
the first thickness less than a second thickness of the cladding in the proximal portion (see [0143]; optical fibers 151a include an axial portion covered by an opaque cladding 152a).
Regarding claim 7, Scharf teaches the apparatus of claim 2, wherein a section of core in the distal portion is configured to cause the light to emit radially outward along the length of the optical fiber (see Fig. 1, [0142-0143]; light delivery elements 155 positioned within an axial segment of shaft 110 to deliver light radially out from shaft 110, one or more light delivery elements 155b can be positioned within balloon 125 such as to transmit light radially out from balloon 125; at portion D1, light from light delivery elements 155a emanates out radially).
Regarding claim 8, Scharf teaches the apparatus of claim 7, wherein the section of the core includes one or more scattering elements (see [0041]; the light delivery element can comprise a first optical component connected to a first optical fiber, the first optical component can comprise light scattering material).
Regarding claim 9, Scharf teaches the apparatus of claim 8, wherein the one or more scattering elements include at least one of an air bubble, a nanosphere, or a microsphere (see [0173]; light scattering material comprises a material selected from the group consisting of alumina particles, silica particles, titania particles, and combinations thereof).
Regarding claim 10, Scharf teaches the apparatus of claim 1, wherein the at least one optical fiber includes a plurality of optical fibers (see [0143]; device 100 can include one or more optical fibers 151a, [0145]; device 100 can include one or more optical fibers 151b).
Regarding claim 11, Scharf teaches the apparatus of claim 1, further comprising: the light source (see Fig. 1, [0147]; light source 150a).
Regarding claim 12, Scharf teaches the apparatus of claim 11, wherein the wavelength of the light is configured to trigger release of nitric oxide from the tissue (see [0140]; light delivery elements can be configured to cause a physiological effect including increase in local nitric oxide, enhance nitric oxide release from the vascular endothelium, [0201]; deliver light energy such as between 250nm and 730nm to affect nitric oxide).
Regarding claim 13, Scharf teaches the apparatus of claim 1, further comprising: a thermal monitoring device (119) positioned within the flexible elongate member (see [0152]; temperature sensor 119 can be positioned in or proximate balloon 125 or on/in shaft 110).
Regarding claim 14, Scharf teaches the apparatus of claim 13, further comprising:
a controller (see [0152]; measurement assembly 200 can include a microprocessor) in communication with the thermal monitoring device (119) and the light source (150),
wherein the controller is configured to control one or more attributes of the light source based on feedback received from the thermal monitoring device (see [0152]; temperature sensor 119 can be operably attached to sensor measurement assembly 200 and the temperature determined by assembly 200 can be used to regulate the light delivered by light source 150 in a closed loop fashion).
Regarding claim 15, Scharf teaches a method, comprising:
introducing a flexible elongate member (110) into a body lumen of a patient (see [0138]; constructed and arranged to be inserted into a mammalian body such as through an incision in the skin or through a natural body orifice),
wherein the flexible elongate member includes at least one optical fiber (see Fig. 1, [0140-0141]; optical element comprising optical fiber 151 and light delivery element 155);
positioning a distal portion of the at least one optical fiber proximate to a region of interest (see [0143]; during use, light deliver element 155a can be positioned in an area of the patient to be treated, [0163]; shaft 110 can be configured to be inserted through a subcutaneous tissue tunnel of other body location, distal end 112 can be configured to insertion into a body location such as a blood vessel, ventricle of the brain, etc.); and
directing light from a light source radially outward along a length of the distal portion of the optical fiber and into tissue in the region of interest (see Fig. 1, [0142-0143]; light delivery elements 155 positioned within an axial segment of shaft 110 to deliver light radially out from shaft 110, one or more light delivery elements 155b can be positioned within balloon 125 such as to transmit light radially out from balloon 125; at portion D1, light from light delivery elements 155a emanates out radially),
wherein the light comprises a wavelength between 650 nm and 750 nm (see [0150]; light source 150 can be constructed and arranged to provide one or more wavelengths of light between 400nm and 750nm).
Regarding claim 16, Scharf teaches the method of claim 15, wherein the wavelength of the light triggers release of nitric oxide from the tissue (see [0140]; light delivery elements can be configured to cause a physiological effect including increase in local nitric oxide, enhance nitric oxide release from the vascular endothelium, [0201]; deliver light energy such as between 250nm and 730nm to affect nitric oxide).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Scharf et al (US 20160151639 A1) in view of Swift et al (US 20150057648 A1).
Regarding claim 3, Scharf teaches the apparatus of claim 2 wherein a section of the cladding in the distal portion is configured to cause the light to emit radially outward along the length of the optical fiber (see Scharf [0142]; when reaching the uncladded portion D1 defined by light delivery element 155a, the conducted light emanates radially out from the associated light delivery element 155a). It can be appreciated that a section of the cladding in the distal portion is configured to cause the light to emit radially by removing the cladding in a particular section. While Examiner maintains that the device disclosed by Scharf teaches the structural limitations claimed in the present application, Examiner offers the following alternative rejection of claim 3 under 35 USC 103.
Swift teaches a flexible elongate member configured to be positioned within a body lumen of a patient comprising at least one optical fiber positioned within a body lumen of a patient (Swift [0021]), the optical fiber (3) comprising a core (5) and a cladding (10), wherein a section of the cladding in the distal portion is configured to cause the light to emit radially outward along the length of the optical fiber (see Swift Fig. 2A, [0057]; distal section 12 of the optical fiber comprises fiber core 5 surrounded by cladding layer 10 forming radial energy emitting section 4 comprising the core 5 with etches, a cladding layer 10, and slits 15 of removed cladding).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus as taught by Scharf with the cladding comprising slits surrounding the optical fiber core as taught by Swift. One of ordinary skill in the art would have been motivated to make this modification in order to achieve the desired energy densities along the treatment zone by altering and customizing the size, placement, and number of slits in the cladding (Swift [0063]).
Claims 4 and 5 are product-by-process claims wherein the determination of patentability if based on the product itself and does not depend on its method of production.
As stated in MPEP 2113: Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The claimed product and the end product of the prior art are equivalent as they both teach an optical fiber comprising a core and a cladding wherein a section of the cladding has been removed to cause light to emit radially outward along the length of the optical fiber, the removal of at least one section of the cladding using acid or laser etching does not patentably distinguish over the prior art.
Regarding claims 4 and 5, Scharf in view of Swift, teaches the apparatus of claim 3 wherein a section of the cladding in the distal portion is configured to cause the light to emit radially outward along the length of the optical fiber (see Swift Fig. 2A, [0057]; distal section 12 of the optical fiber comprises fiber core 5 surrounded by cladding layer 10 forming radial energy emitting section 4 comprising the core 5 with etches, a cladding layer 10, and slits 15 of removed cladding), wherein the wherein the section of the cladding is partially removed to form slits in the cladding using known methods in the art (Swift [0062]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus as taught by Scharf with the cladding comprising slits surrounding the optical fiber core as taught by Swift. One of ordinary skill in the art would have been motivated to make this modification in order to achieve the desired energy densities along the treatment zone by altering and customizing the size, placement, and number of slits in the cladding (Swift [0063]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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