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 .
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al.( US 20100094119) hereinafter Yu et al.
Yu et al. teaches a method of treating a cancerous region in a breast of a patient. The method comprises (i) imaging the breast in a three-dimensional coordinate system, (ii) stereotactically determining the location of the cancerous region in the breast, (iii) optionally determining the volume of the entire cancerous region or portion thereof to be treated, and (iv) while maintaining the breast in a three-dimensional coordinate system that is identical to or corresponds with the three-dimensional coordinate system used in (i), noninvasively exposing the cancerous region of the breast of the patient to a cancer-treatment effective dose of radiation. [0013] The present invention further provides equipment for image-guided stereotactic radiosurgery of a cancerous region in a breast. The equipment comprises: (i) means for immobilizing the breast containing the cancerous region; (ii) a couch comprising a channel or right and left openings ( aperture), wherein the right or left breast of a patient is placed in the channel or the right or left opening, respectively, for treatment when the patient is lying prone on the couch, which optionally comprises a top layer of a self-molding medium; (iii) a stereotactic localization frame beneath the couch for placement of the breast in a coordinate system; (iv) one or two breast shields, which are removably attached to the couch, slidably mounted to the channel, or removably attached to the means for immobilizing the breast; (v) an irradiation unit comprising (i') a source holder, which comprises a wall having an interior surface, an exterior surface, and channels, which communicate with the interior surface, may or may not communicate with the exterior surface, and each of which can comprise a radiation source, (ii') a collimator holder, which is adjacent to the interior surface of the source holder and comprises collimators of different sizes in the same arrangement as the channels in the source holder such that relative rotation between the source holder and the collimator holder allows selection of radiation beams of different sizes, resulting in shots of radiation of different sizes, and (iii') a base housing (which includes an aperture), which is beneath the exterior surface of the source holder, supports the source holder and the collimator holder, and houses a motor, which rotates the collimator holder and the source holder relative to each other, and another motor, which rotates the collimator holder and the source holder together, when locked; (vi) a curved base support; (vii) three motors, which are operably connected to the couch and each of which moves the couch in a different axis of motion; and (viii) a computerized control system, which controls the movement of the couch and the irradiation unit. The equipment can, and preferably does, further comprise a treatment planning system. The operations of the irradiation unit and the couch are controlled by a computerized control system, which obtains treatment parameters from the treatment planning system, controls the movement of the couch and the irradiation unit according to the treatment plan, monitors the safety and operation of the entire unit, and provides safety interlocks and movement limits when needed.
PNG
media_image1.png
494
540
media_image1.png
Greyscale
Regarding claims 1 and 21, Yu et al. teaches a base configured for positioning a radiation source with respect to a target area, the base having an aperture defined therein; and a shield body configured for coupling with the base, wherein the source is securable proximate or adjacent the aperture;
wherein the aperture is configured to transmit radiation emitted by the source, wherein said radiation is directed toward the target area; and wherein the base and shield body are configured to absorb at least a portion of other radiation emitted by the source, which is not directed toward the target area.
Regarding claim 6, Yu et al. teaches wherein: the aperture is substantially circular, rectangular, oval, or oblong; or the aperture is at least partially defined by a geometry of the source, or with a substantially irregular geometry adapted to transmit said radiation emitted by said source directed toward a respectively geometry of the target area, or both. See figure 1.
Regarding claims 9 and 22, Yu et al. teaches wherein the base and shield body are configured to reduce a flux of radiation that is not directed to the target area by at least one order of magnitude, or at least two orders of magnitude, and:
wherein the radiation comprises x ray, gamma ray, alpha particle or beta particle radiation, or a combination thereof; or wherein the flux of radiation is reduced by at least said order or orders of magnitude at a top surface of the shield body, along a common axis of the base and shield body, and/or along an outer circumference of the base, extending about said common axis. [0024] Any suitable radiation source, such as a radioisotope, which has a half-life of appropriate length for the treatment of cancer and which can deliver a treatment-effective dose of radiation to a depth of 10 cm or more, such as .gamma.-radiation, can be used. A half-life longer than about 12 months is desirable, although a shorter half-life isotope with otherwise desirable characteristics also can be considered. A treatment-effective dose is about 20 Gy to about 60 Gy. An example of a suitable radioisotope is Cobalt 60 (.sup.60Co), which has a half-life of about 5.3 years and which can generate a treatment-effective dose of .gamma.-radiation with mean photon energy of 1.25 MeV. Alternatively, small x-ray sources, either from an x-ray tube or an x-band linear accelerator, can be used. The cancer treatment-effective dose of radiation can be delivered in one treatment session or in a number of repeated sessions.
Regarding claim 12, Yu et al. teaches comprising one or more engagement features or engagement elements disposed or defined in or on the shield body, wherein the engagement features or engagement elements are configured for releasably coupling the shield body with the base. {0013] One or two breast shields, which are removably attached to the couch, slidably mounted to the channel, or removably attached to the means for immobilizing the breast;
Regarding claim 15, Yu et al. teaches an attachment system coupled to the base, wherein the attachment system is configured for releasably securing the device to one or more anatomical features adjacent the target area. [0013] A couch comprising a channel or right and left openings ( aperture), wherein the right or left breast of a patient is placed in the channel or the right or left opening, respectively, for treatment when the patient is lying prone on the couch, which optionally comprises a top layer of a self-molding medium; (iii) a stereotactic localization frame beneath the couch for placement of the breast in a coordinate system; (iv) one or two breast shields, which are removably attached to the couch, slidably mounted to the channel, or removably attached to the means for immobilizing the breast and a base housing (which includes an aperture), which is beneath the exterior surface of the source holder, supports the source holder and the collimator holder, and houses a motor, which rotates the collimator holder and the source holder relative to each other, and another motor, which rotates the collimator holder and the source holder together, when locked; (vi) a curved base support; (vii) three motors, which are operably connected to the couch and a means to immobilize the breast, such as a breast cup (as described below), and a stereotactic localization frame around the cup to establish a coordinate system with respect to the cup.
Regarding claim 23, Yu et al. teaches providing a collimator in the base, wherein the source is disposed adjacent the collimator, wherein the collimator defines the aperture, and wherein the aperture defines a geometry of the target area; or visually aligning the aperture defined by the collimator or base to the target area before the source is inserted. Note fig. 1, [0028] A collimator holder containing different sizes of collimator holes is used to select the size of the beam of radiation (see FIG. 4a). The collimator holder is also preferably bowl-shaped but smaller in size (e.g., with an internal diameter that will accommodate a breast with a breast cup, such as about 30 cm or so) such that it can fit concentrically inside of the source holder with a separation of less than about 1 mm (see FIG. 1).
Regarding claim 25, Yu et al. teaches wherein the source is attached to the shield and disposed adjacent the base, or further comprising one or more of removing the device from the subject, decoupling the shield body from the base, and removing the source from the base. [0013], A couch comprising a channel or right and left openings ( aperture), wherein the right or left breast of a patient is placed in the channel or the right or left opening, respectively, for treatment when the patient is lying prone on the couch, which optionally comprises a top layer of a self-molding medium; (iii) a stereotactic localization frame beneath the couch for placement of the breast in a coordinate system; (iv) one or two breast shields, which are removably attached to the couch, slidably mounted to the channel, or removably attached to the means for immobilizing the breast, a base housing (which includes an aperture), which is beneath the exterior surface of the source holder, supports the source holder and the collimator holder, and houses a motor, which rotates the collimator holder and the source holder relative to each other, and another motor, which rotates the collimator holder and the source holder together, when locked; (vi) a curved base support; (vii) three motors, which are operably connected to the couch.
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.
Claim(s) 1,6, 9-12, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cipriani et al.(9486642) hereinafter Cipriani et al. and further in view of Sarazin et al.( US 20200188691) hereinafter Sarazin et al.
Cipriani et al. teaches a method of treating a cancerous or non-cancerous skin lesion of a subject, e.g. a human patient, by epidermal radioisotope therapy, a specialized type of brachytherapy. The method can include defining and marking an area of skin to be treated; covering the area with a protective layer, e.g. a protective film or foil; applying a tailor-made radioactive source by applying a layer of a radioactive source material on the protective layer, such that the area is covered by the material while any area not to be treated is spared; and removing the radioactive source after a predetermined time period of irradiation.
Regarding claim 1, Cipriani et al. teaches a system (abstract; system comprising marked area 2, protective layer 3, and radioactive source layer 4, Fig. 1) comprising: a base configured for positioning a radiation source with respect to a target area (marked area 2 is used as a foundation or reference point for positioning radioactive source layer 4 with respect to skin 1, Fig. 1); and a shield body configured for coupling with the base (protective layer 3 is positioned on marked area 2, Fig. 1); wherein said radiation is directed toward the target area ("radioactive source material is applied to the area of skin to be treated", Col. 7 Lns. 6-7); and wherein the shield body is configured to absorb at least a portion of other radiation emitted by the source, which is not directed toward the target area (protective layer 3 is capable of absorbing at least a portion of other radiation emitted by radioactive source layer 4, which is not directed toward the skin 1, Col. 8 Lns. 4-9).
Cipriani et al. fails to explicitly disclose the base having an aperture defined therein; wherein the source is securable proximate or adjacent the aperture; wherein the aperture is configured to transmit radiation emitted by the source; and wherein the base is configured to absorb at least a portion of other radiation emitted by the source, which is not directed toward the target area.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) comprising a base having an aperture defined therein (radioprotective layer 116 serves as a base for skin patch 100 and defines a hole 118 through the radioprotective layer, Fig. 38); wherein the source is securable proximate or adjacent the aperture (radioactive isotope 108 is securable adjacent hole 118, Para. [0065]. Fig. 38); wherein the aperture is configured to transmit radiation emitted by the source (hole 118 is capable of allowing radiation to be transmitted by radioactive isotope 108 to the patient's skin 112. Para. [0119], Fig. 38); and wherein the base is configured to absorb at least a portion of other radiation emitted by the source, which is not directed toward the target area (radioprotective layer 116 is capable of absorbing at least a portion of other radiation emitted by radioactive isotope 108, which is not directed toward the patient's skin 112, Paras. [0109] and [0119], Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include the base having an aperture defined therein, wherein the source is securable proximate or adjacent the aperture and wherein the aperture is configured to transmit radiation emitted by the source; and wherein the base is configured to absorb at least a portion of other radiation emitted by the source, which is not directed toward the target area as taught by Sarazin et al. to allow for more precise positioning and focusing the radiation beam to the specific target area.
Regarding claim 6, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach wherein: the aperture is substantially circular, rectangular, oval, or oblong; or the aperture is at least partially defined by a geometry of the source, or with a substantially irregular geometry adapted to transmit said radiation emitted by said source directed toward a respectively geometry of the target area, or both.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) comprising wherein: the aperture is substantially rectangular (hole 118 is substantially rectangular, Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani to include wherein the aperture is substantially rectangular as taught by Sarazin et al. to help shape the radiation field with defined boundaries, ensuring accurate treatment.
Regarding claim 9, Cipriani et al. teaches the claimed invention as set forth above including Cipriani further discloses wherein the shield body is configured to reduce a flux of radiation that is not directed to the target area by at least one order of magnitude (protective layer 3 is capable of reducing a flux of radiation that is not directed to skin 1 by at least one order of magnitude, Col. 7 Lns. 63-67), or at least two orders of magnitude, and: wherein the radiation comprises X ray, gamma ray, alpha particle or beta particle radiation (the radiation comprises beta radiation isotopes, Col. 10 Lns. 28-30), or a combination thereof; or wherein the flux of radiation is reduced by at least said order or orders of magnitude at a top surface of the shield body, along a common axis of the base and shield body, and/or along an outer circumference of the base, extending about said common axis.
Cipriani et al. fails to explicitly disclose wherein the base is configured to reduce a flux of radiation that is not directed to the target area by at least one order of magnitude, or at least two orders of magnitude.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) wherein the base is configured to reduce a flux of radiation that is not directed to the target area by at least one order of magnitude (radioprotective layer 116 is capable of reducing a flux of radiation that is not directed to the patient's skin 112 by at least one order of magnitude, Paras. [0109] and [0119], Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include wherein the base is configured to reduce a flux of radiation that is not directed to the target area by at least one order of magnitude as taught by Sarazin et al. to help minimize unnecessary exposure to surrounding tissues.
Regarding claim 10, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach wherein the base and aperture define a common transverse axis and further comprising one or more of: an upper shield disposed on or adjacent an upper surface of the source, opposite the aperture along the axis; an edge shield disposed about or along a perimeter of the source,
extending transverse to the axis; an auxiliary shield disposed on or at least partially embedded in the shield body, spaced from the source along the axis.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) wherein the base and aperture define a common transverse axis (radioprotective layer 116 and hole 118 define a common transverse axis, Fig. 38) and further comprising: an upper shield disposed on an upper surface of the source (substrate 106 is disposed on an upper surface of radioactive isotope 108, Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include wherein the base and aperture define a common transverse axis and further comprising: an upper shield disposed on an upper surface of the source as taught by Sarazin et al. to allow for precise focusing as well as minimize radiation to surrounding healthy tissues.
Regarding claim 11, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach wherein one or more of the upper shield, the edge shield and the auxiliary shield is formed of or comprises a material having a higher average density or greater average atomic number (Z) than that of the base, and wherein the material is selected for preferentially absorbing a penetrating component of the radiation emitted by the source, as compared to absorption of the penetrating component by the base, wherein the penetrating component comprising beta particles, X rays, gamma rays, or a combination thereof.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) wherein the upper shield is formed of a material (substrate 106 is formed of polyimide, Para. [0061]) and the base (radioprotective layer 116 is formed of aluminum, hydrocarbon based polymeric material, or a silicone polymer based material. Para. [0109]), and wherein the material is selected for preferentially absorbing a penetrating component of the radiation emitted by the source, wherein the penetrating component comprising beta particles (polyimide is capable of absorbing beta particles emitted by radioactive isotope 108, Paras. [0065] and [0081], Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include wherein the upper shield is formed of a material and the base, and wherein the material is selected for preferentially absorbing a penetrating component of the radiation emitted by the source, wherein the penetrating component comprising beta particles as taught by Sarazin et al. to reduce unnecessary radiation to surrounding healthy tissues.
Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to make the material of the protective layer in Cipriani et al. a plurality of layers formed of a material having a higher average density than that of another protective layer, and wherein the material is selected for preferentially absorbing a penetrating component of the radiation emitted, as compared to absorption of the penetrating component, since selection of a known material on the basis of its suitability for an intended use and mere duplication of essential working parts of device only involve routine skill in the art to provide better protection and minimize radiation exposure.
Regarding claim 12, Cipriani et al. teaches the claimed invention as set forth above including the
system (system comprising marked area 2, protective layer 3, and radioactive source layer 4, Fig. 1) further comprising one or more engagement features or engagement elements disposed or defined in or on the shield body, wherein the engagement features or engagement elements are configured for releasably coupling the shield body with the base (protective layer 3 comprises an adhesive layer for releasably coupling protective layer 3 with the marked area 2, Col. 7 Los. 63-65, Fig. 1).
Regarding claim 15, Cipriani et al. teaches the claimed invention as set forth above including the system (system comprising marked area 2, protective layer 3, and radioactive source layer 4, Fig. 1) further comprising an attachment system coupled to the base (protective layer 3 comprises an adhesive layer for coupling to marked area 2, Col. 7 Lns. 63-65, Fig. 1), wherein the attachment system is configured for releasably securing the system to one or more anatomical features adjacent the target area (the adhesive layer within protective layer 3 is capable of securing protective layer 3 and radioactive source layer 4 to skin 1 of a face, nose, an ear, an eyelid, a lip, penis, or vulva, Col. 7 Lns. 48-50, Fig. 1).
Regarding claim 16, Cipriani et al. teaches the claimed invention as set forth above including wherein the attachment system comprises one or more of a flexible fabric, a flexible band, a flexible tape, a woven or non-woven fabric, magnetic coupling elements, mechanical fasteners, a VELCRO-type hook and loop fastening system, an adhesive material (protective layer 3 comprises an adhesive layer for coupling to marked area 2, Col. 7 Lns. 63-65, Fig. 1), or a removable adhesive material.
Regarding claim 17, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach the system further comprising a contour defined along a bottom surface of the base, collimator, and/or adapter adjacent the aperture, wherein the contour is adapted for coupling the base, collimator, and/or adapter to or along one or more anatomical features defined adjacent the target area.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) comprising a contour defined along a bottom surface of the base adjacent the aperture, wherein the contour is adapted for coupling the base to one or more anatomical features defined adjacent the target area (an adhesive is defined along a bottom surface of radioprotective layer 116 adjacent hole 118 for coupling radioprotective layer 116 to patient's skin 112 of a nose, lip, or eyelids, Paras. [0004] and [0018], Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include a contour defined along a bottom surface of the base adjacent the aperture, wherein the contour is adapted for coupling the base to one or more anatomical features defined adjacent the target area as taught by Sarazin et al. to provide a secure connection to the target area, which improves the treatment procedure.
Regarding claim 18, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach wherein the contour is substantially planar or comprises a substantially spherical or substantially cylindrical section, or wherein the contour defines one or more portions of a conic section.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch100, Fig. 38) wherein the contour is substantially planar (the adhesive is substantially planar, Para. [0018],Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include wherein the contour is substantially planar as taught by Sarazin et al. to provide a more secure and stable attachment, maintaining proper positioning.
Regarding claim 19, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach wherein the contour is adapted to one or more anatomical features selected from a nose, lip, eye, brow or other facial feature, an ear, head or neck feature, a chest, torso or pelvic feature, a limb, hand or foot feature, a finger, toe or other digital feature, or a combination thereof.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) wherein the contour is adapted to one or more anatomical features selected from a nose (anadhesive is defined along a bottom surface of radioprotective layer 116 adjacent hole 118 for coupling radioprotective layer 116 to patient's skin 112 of a nose, Paras. [0004] and [0018], Fig. 38).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include wherein the contour is adapted to one or more anatomical features selected from a nose as taught by Sarazin et al. to provide a targeted treatment directly to the affected area.
Regarding claim 20, Cipriani et al. teaches the claimed invention as set forth above but does not specifically teach wherein an outer footprint, thickness or geometry of one or more of the base, collimator, shield, adapter and source varies according to an anatomical geometry.
However, Sarazin et al. is in the field of irradiation skin patches (abstract) and teaches a system (skin patch 100, Fig. 38) comprising a geometry of the base (radioprotective layer 116 has a specific geometry, Fig.38) and an anatomical geometry (each of nose, lip, and eyelids have specific geometries, Para. [0004]).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. to include a geometry of the base and an anatomical geometry as taught by Sarazin et al. to provide proper connection and allow for targeted treatment.
Furthermore, It would have been obvious to one of ordinary skill in the art at the time of the invention to make the geometry of the base and system of Cipriani et al. to vary according to the geometry of a nose, lip, or eyelids, since a change in shape of an element involves only routine skill in the art. The motivation would be to improve securement and allow for targeted treatment directly to the affected area.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cipriani et al.(9486642) hereinafter Cipriani et al. and further in view of Sarazin et al.( US 20200188691) hereinafter Sarazin et al. and further in view of Kleinwaechter et al.( US 8724775) hereinafter Kleinwaechter et al.
Regarding claim 13, Cipriani et al. as modified by Sarazin et al. teaches the claimed invention as set forth above including Cipriani et al. teaches wherein the engagement features or engagement elements are configured for releasably coupling the shield body with the base (protective layer 3 comprises an adhesive layer for releasably coupling protective layer 3 with the marked area 2, Col. 7 Lns. 63-65, Fig. 1).
Cipriani et al. as modified by Sarazin et al. fails to explicitly disclose wherein the engagement features or engagement elements comprise: one or more magnets, flexures, tabs, prongs, or resiliently biased structures; or one or more threaded couplings, magnetic coupling elements, or friction or snap fittings; or any combination thereof.
However, Kleinwaechter is in the field of radiation therapy systems (abstract) and teaches a system (radiation therapy device 10 and fastening means 30, Figs. I and 4) wherein the engagement elements comprise tabs ("fastening means 30 is designed as a fastening ring, by means of which the applicator means 20 can be attached and fixed onto the surface to be treated Fastening ring 30, in turn, can be attached and fixed onto the surface to be treated, for example, the skin. fastening ring 30 has at least one fastening tab projecting outwardly from its outer side 32. Two such fastening tabs 33, 34 are shown in FIG. 4", Col. 6 Ln. 40-54).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Cipriani et al. as modified by Sarazin et al. to include wherein the engagement elements comprise tabs as taught by Kleinwaechter et al. to provide a more secure and stable connection.
Claim(s) 21,22,24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarazin et al.( US 20200188691) hereinafter Sarazin et al. in view of Fischell et al.( US 6350226) hereinafter Fischell et al.
Regarding claim 21, Sarazin et al. teaches a method (abstract) comprising: positioning a device with respect to a target area on a subject (patch 100 is positioned on a patient's skin 112, Fig. 38), the device having a base with an aperture defined therein (patch 100 comprises radioprotective layer 116 with hole 118 defined therein, Fig. 38); disposing the device adjacent one or more anatomical features of the subject (when patch 100 is disposed on patient's skin 112, it is implied that patch 100 would be disposed adjacent an anatomical feature of the subject such as a nose, lips, or eyelids, Para. [0004], Fig. 38); a source (radioactive isotope 108, Fig. 38), wherein radiation emitted by the source is directed toward the target area through the aperture (radiation emitted by radioactive isotope 108 is directed toward patient's skin 112 through hole 118, Para. [0119], Fig. 38); wherein the source is disposed in or adjacent the base (radioactive isotope 108 is disposed adjacent radioprotective layer 116, Fig. 38), or secured or adhered within the base, and at least a portion of radiation emitted by the source that is not directed to the target area is absorbed by the base (a portion of radiation emitted by radioactive isotope 108 that is not directed to the patient's skin 112 is absorbed by radioprotective layer 116, Para. [0109], Fig. 38).
Sarazin et al. fails to explicitly disclose inserting a source into the base; coupling a shield body to the base; and at least a portion of radiation emitted by the source that is not directed to the target area is absorbed by the shield body.
However, Fischell et al. is in the field of wound dressings which apply ionizing radiation (abstract) and teaches a device (radioactive bandage 10, Fig. 5) comprising inserting a source into the base ("radioisotope source 9 might typically be an elastomer into which a radioisotope has been placed. A typical elastomer could be silicone rubber, polyurethane, polyethylene or any other similar material which could be made into an elongated source into which a radioisotope could be placed", Col. 3 Lns. 19-23); coupling a shield body to the base; and at least a portion of radiation emitted by the source that is not directed to the target area is absorbed by the shield body ("shield 12 might typically be formed from a high density metal such as hingsten impregnated into any one of several elastomers. The purpose of the shield 12 would he to absorb any photon emission caused by bremsstrahlung which resulted from a beta particle hitting the nucleus of some atom", Col. 3 Lns. 36-41, Fig. 6).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method
of Sarazin et al. to include inserting a source into the base; coupling a shield body to the base; and at least a portion of radiation emitted by the source that is not directed to the target area is absorbed by the shield body as taught by Fischell et al. to help minimize unnecessary exposure to surrounding tissues.
Regarding claim 22, Sarazin et al. teaches activating the source in a radiation environment. wherein the radiation emitted by the source comprises X rays, gamma rays, alpha particles, beta particles (radioactive isotope 108 is activated and emits beta particles, Paras. [0065] and [0118]-[0119], Fig. 38), or a combination thereof.
Regarding claim 24, Sarazin et al. teaches providing a contour on the bottom surface of the base, collimator, and/or adapter, adjacent the aperture, wherein the contour is adapted to secure the device to the one or more anatomical features of the subject (an adhesive is defined along a bottom surface of radioprotective layer 116 adjacent hole 118 for coupling patch 100 to patient's skin 112 of a nose, lip, or cyclids, Paras. [0004] and [0018], Fig. 38).
Regarding claim 25, Sarazin et al. teaches fails to explicitly disclose wherein the source is attached to the shield and disposed adjacent the base, or further comprising one or more of removing the device from the subject, decoupling the shield body from the base, and removing the source from the base.
However, Fischell et al. is in the field of wound dressings which apply ionizing radiation (abstract) and teaches a device (radioactive bandage 10, Fig. 5) wherein the source is attached to the shield and disposed adjacent the base ("radioisotope source 9 might typically be an elastomer into which a radioisotope has been placed. A typical elastomer could be silicone rubber, polyurethane, polyethylene or any other similar material which could be made into an elongated source into which a radioisotope could be placed", Col. 3 Lns. 19-23. "shield 12 might typically be formed from a high density metal such as tungsten impregnated into any one of several elastomers", Col. 3 Lns. 36-38, Fig. 6).
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Sarazin et al. to include wherein the source is attached to the shield and disposed adjacent the base as taught by Fischell et al. to provide better stability and control, helping to direct the radiation precisely to the targeted area.
Allowable Subject Matter
Claims 2-5,7,8, and 14 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 an examiner’s statement of reasons for allowance:
Regarding claim 2, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 1, wherein the base comprises an adapter or interface portion having the aperture defined therein and a shield guide portion coupled to or defined on the adapter or interface portion, opposite the aperture, wherein the adapter or interface portion is configured for positioning the source with respect to the target area and the shield guide portion is configured for coupling the shield body with the base.
Claims 3-5, 7, and 8 depend from claim 2, and therefore meet the criteria set out in PCT Article 33(2)-(3) for at least the same reasons as claim 2.
Regarding claim 14, the prior art of record, individually or in combination, does not teach or fairly suggest the system of claim 12, wherein the engagement features or engagement elements are configured to generate an audio, visual, and/or haptic signal responsive to releasably coupling the shield body with the base, wherein the signal is indicative of securing the source within the base.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
BEHRMANN et al.( WO 2005049139) teaches a radioactive radiation source of the invention is suitable for brachytherapy and especially for ocular or ophthalmic brachytherapy such as in the treatment of macula degeneration, preferably age related macula degeneration (AMD). The radiation source of the invention comprises a radiation source for brachytherapy having an elongated radiation emitting element (1) within an elongated means for containment (2) preferably arranged such that the longitudinal axis of the radiation emitting element and the longitudinal axis of said means for containment are aligned. Said means for containment comprises a shielding section (3) and a radiation transition section (4). Said shielding section (3) covers said radiation emitting element at least partially to substantially attenuate any radiation emitted in the direction of said shielding section. Preferably the shielding section covers the element to about 30-90 %, preferably 40-70 % and more preferably 50-60 %.
Baker et al.( US 20200261740) teaches loading apparatus is usable to embed radioactive seeds into carriers, while limiting exposure of the user to radioactive energy from the radioactive seeds. The loading apparatus facilitates accurate positioning of radioactive seeds within a carrier. The illustrated loaders comprise two components, a base and a lid, although in other embodiments the loaders may be separated into additional components.
SIOSHANSI et al.( EP 1853346) teaches system for and method of applying non-invasive brachytherapy to a targeted volume within a protruding organ of a patient, employs an applicator constructed so as to be positioned relative to the organ so that an enhanced dose of divergent radiation is deliverable from at least two locations at or very near the periphery of the organ transcutaneously to the targeted volume of the protruding organ from at least two directions so that a higher dose is delivered to the targeted volume than to tissue surrounding the targeted volume. The treatment planning, and image guidance techniques are also described.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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, Charles Marmor can be reached at (571)272-4730. 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.
/BRIAN L CASLER/Primary Examiner, Art Unit 3791
Prosecution Insights