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 listing of references in the specification such as in pages 1-2 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Figures 3A, 3B, 4A, Fig. 4B, Fig. 4C should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed “window shielding layer” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“And werein…withing the…” in page 11 line 20 needs to be corrected. A suggested correction is -- And [[werein]] wherein…within[[g]] the…--.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Each of claims 8-10 lines 1-2 “nonreactive binding agent” needs to be corrected. A suggested correction is – the nonreactive binding agent – in light of respective antecedent in claim 1 line 3 “a nonreactive binding agent”.
Claim 11 line 1 “the treatment wafer shape” and line 2 “the upper cranium” need to be corrected. A suggested correction is – a shape of the treatment wafer [[shape]]– and –[[the]] an upper cranium-- respectively in light of respective antecedent in claim 1 line 3 “a nonreactive binding agent”.
Claim 3 line 6 “werein the treatment wafer is applied within the cutout of the window shielding layer” needs to be corrected. A suggested correction is – wherein [[werein]] the treatment wafer is applied within the cutout of the window shielding layer—.
Claim 1 “A radioactive dermatological patch, the patch designed to topically treat cutaneous skin lesions in patient tissue, the patch comprising;” needs to be corrected. A suggested correction is --A radioactive dermatological patch, the patch designed to topically treat cutaneous skin lesions in patient tissue, the patch comprising [[;]] : --.
Each of claim 14-15 “wherein an adhesive binds at least one of;” needs to be corrected. A suggested correction is -- wherein an adhesive binds at least one of [[;]] : --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in lines 5-6 recites the side in the limitation “the side of the treatment wafer to be away from the patient tissue”. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 in line 6 recites “the energy”. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 in lines 8-9 recites the side in the limitation “the side of the treatment wafer to be adjacent the patient tissue”. There is insufficient antecedent basis for this limitation in the claim.
Each of claims 6-7 in line 1 recites “the window shielding layers” (plurality). There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “the radionuclide comprises at least one of: Na-24, Ga-66, or any combination thereof”, claim 6 recites “wherein the window shielding layers of high Z shielding is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof”, claim 7 recites “wherein the window shielding layers of high Z shielding is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof”. Claim 12 recites “wherein the distal shielding layer is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof” and claim 13 recites “wherein the proximal shielding layer is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof” each of which is an open Markush group as the group uses the term “comprising”. More specifically, open Markush group is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim (see MPEP 2173.05 (h) which states inter alia that “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group “consisting of” (rather than “comprising” or “including”) the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group “comprising” or “consisting essentially of” the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim”). Examiner suggests using the term “consisting of” instead of “comprising”. For example amend to claim 6 “wherein the window shielding layers of high Z shielding is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof” to -- claim 6 recites “wherein the window shielding layers of high Z shielding consists of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof--. Similar amendments are suggested for claim 4, 7, 12, 13.
Claim 16 in line 2 recites “the electron energy. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims 2-16 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-16 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification pages 3-5, 24, 29
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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 of this title, 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.
Claims 1-3, 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sarazin et al. (Pub. No.: US 20200188691 A1, hereinafter referred to as "Sarazin") in view of Brauckman et al. (Pub. No.: US 20040192998 A1, hereinafter referred to as “Brauckman”).
As per independent Claim 1, Sarazin discloses a radioactive dermatological patch, the patch designed to topically treat cutaneous skin lesions in patient tissue (Sarazin in at least abstract, fig. 34-38, [0003], [0012], [0059-0061], [0063-0065], [0071], [0073-0078], [0081], [0084], [0091], [0099-0105], [0107-0110], [0112-0119], [0167] for example discloses relevant subject-matter. More particularly, Sarazin in at least fig. 38, abstract, [0002], [0012], [0059], [0064] for example discloses radioactive dermatological patch, the patch designed to topically treat cutaneous skin lesions in patient tissue. See at least Sarazin [0012] “a skin patch for treatment of various skin conditions in a subject, for example skin cancer. The skin patch includes a substrate, and a layer of an isotope deposited on the substrate. The isotope layer is substantially uniform and has a thickness that varies less than about 20%. The skin patch may further include an encapsulation layer, one or more additional isotope layers, a modulating layer, and/or a radioprotective layer”; [0064] “skin condition for treatment with the disclosed skin patches and methods may include … lesions…lesion is a basal cell carcinoma or squamous cell carcinoma”), the patch comprising;
a layer of a radionuclide with a nonreactive binding agent to form a treatment wafer, the treatment wafer placed within the radioactive dermatological patch (Sarazin in at least fig. 38, [0061], [0112], [0114] for example discloses a layer of a radionuclide/isotope layer 108 with a nonreactive binding agent to form a treatment wafer/substrate layer 106, the treatment wafer placed within the radioactive dermatological patch. See at least Sarazin [0061] “skin patch of the present disclosure may be a thin film or foil physically deposited onto a flexible substrate (e.g., a polymeric or plastic sheet). The thin film or foil may include an element having a radioactive isotope … skin patch comprises an isotope layer … deposited on a KAPTON sheet.”; [0112] “skin patch having an isotope layer … patch 100 comprises a handle 102, backing layer 104, substrate layer 106, isotope layer 108 (here activated), and encapsulation layer 110”; [0114] “isotope layer 108 may be deposited on, adhered to, coupled to, and/or formed on the substrate layer 106… isotope layer 108 is deposited on a lower surface of the substrate layer 106 (e.g., closer to the patient's skin 112 than the substrate layer 106)…all three layers may be the same thickness, similar thicknesses, or different thicknesses…encapsulation layer 110 may be coupled to the patient's skin 112, e.g., by an adhesive layer adjacent the encapsulation layer and/or an adhesive layer positioned between the patch 100 and the skin 112.”);
a distal shielding layer placed adjacent the side of the treatment wafer to be away from the patient tissue, the distal shielding layer attenuating the energy of the radionuclide from an environment external to the patient (Sarazin in at least fig. 38, [0112] for example discloses a distal shielding layer/backing 104 placed adjacent the side of the treatment wafer to be away from the patient tissue, the distal shielding layer attenuating the energy of the radionuclide from an environment external to the patient. See at least Sarazin [0112] “skin patch having an isotope layer … patch 100 comprises a handle 102, backing layer 104, substrate layer 106, isotope layer 108 (here activated), and encapsulation layer 110…thickness of the backing layer 104 may be selected to prevent radiation from passing through the upper surface of the backing layer, for example, exposing a medical practitioner and/or the patient to radiation from the isotope layer 108.”;); and
a proximal patient shielding layer placed adjacent the side of the treatment wafer to be adjacent the patient tissue (Sarazin in at least fig. 38, [0118-0119] for example discloses a proximal patient shielding layer/radioprotective layer 116 placed adjacent the side of the treatment wafer to be adjacent the patient tissue. See at least Sarazin [0118] “skin patch 100, wherein the patch 100 further includes a radioprotective layer 116 positioned between the encapsulation layer 110 and the patient's skin 112… …radioprotective layer 116 may be a part of the disclosed patch 100 and may couple the patch 100 to the patient's skin 112”; [0119] “radioprotective layer 116 may help to protect the patient's skin 112 around the skin lesion from radioactivity… radioprotective layer 116 may be custom sized and shaped to match the size and shape of the patient's skin lesion…radioprotective layer 116 may be positioned on the patient's skin 112 …to align the gap or hole 118 with the skin lesion.”).
Sarazin does not explicitly disclose the distal shielding layer and proximal patient shielding layers are made of high Z material i.e. high Z material shielding layers.
However, in an analogous radioactive patch field of endeavor, Brauckman discloses a radioactive patch (Brauckman in at least fig. 1, [0029-0031], [0056-0058], [0073] for example discloses relevant subject-matter. More specifically, Brauckman in at least fig. 1, [0029], [0031], [0056-0058], [0073] for example discloses radioactive patch. See at least Brauckman [0029] “a radiation delivery device … comprises at least a radiation compatible substrate and a radiation source…combination can be incorporated into a structure, which will serve as the radiation delivery device”; [0056] “films provided with a radioactive material can serve as radiation delivery devices … in the form of a patch... adhesive can be applied to one surface of the device to adhere it in place” ) including,
shielding layers that are high Z shielding layers (Brauckman in at least [0073] for example discloses the patch form devices that include a high Z shielding layers comprising at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass. See at least Brauckman [0073] “device may be selectively shielded at predetermined locations to provide for non-uniform, i.e., directional, radiation distribution. Such selective shielding can be accomplished by the incorporation of a shielding component into the delivery device at one or more predetermined locations or by fabricating all or a portion of the substrate from a shielding material. Shielding components can include radiation absorbing materials such as tin, silver, platinum, gold, tungsten, stainless steel, lead, brass, copper, or alloys thereof. More preferably, biocompatible shielding components are employed. …flexible or deformable radiation delivery devices described herein can be directly adhered or attached to a shielding substrate in any suitable manner in order to provide a directional device.”).
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 shielding layers of the radioactive dermatological patch as taught by Sarazin, such that the shielding layers are a high Z shielding layers, as taught by Brauckman. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage that Sarazin discloses that the radioprotective layers may be formed of a metal capable of absorbing and/or blocking radiation from the skin patch (Sarazin, Paras. [0109-0110]; Fig. 38), while Brauckman discloses such metals/materials as radiation absorbing materials useful for forming directional radiation distribution devices (Brauckman, [0073]).
As per dependent Claim 2, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein an additional window shielding layer of high Z shielding is placed between the treatment wafer and the proximal patient shielding layer (Sarazin in at least fig. 37-38, [0102], [0104], [0109] for example discloses an additional window shielding layer/modulating layer of shielding is placed between the treatment wafer and the proximal patient shielding layer while Brauckman in at least [0073] for example discloses high Z shielding layers. See at least Sarazin [0102] “radiation dose pattern of a skin patch may be modified by adding one or more layers of an absorbing or modulating material over the deposited isotope layer and/or encapsulation layer… the modulatig layer material would help to absorb all or a portion of the radiation… creating a pattern of radioactivity that is tailored for the depth and/or density of the target cells in the lesion. The disclosed modified skin patches may deposit the highest energy and dose to the deepest, densest, and/or most diseased areas of the lesion, while limiting the deposited dose at areas with less extensive disease penetration”; [0104] “modulating layer material …modulating material may block all or some of the radioactivity from the skin patch”; [0109] “patch may comprise a modulating layer and a radioprotective layer”), the window layer of high Z shielding comprising a cutout opening within the window shielding layer in the shape of the cancerous tissue to be treated by the radionuclide (Sarazin in at least fig. 37, [0102], [0117], [0119] for example discloses window layer of shielding comprising a cutout opening/gap or hole 118 within the window shielding layer in the shape of the cancerous tissue to be treated by the radionuclide while Brauckman in at least [0073] for example discloses high Z shielding layers. See at least Sarazin [0117] “modulation layer 114 is not continuous. Rather, at or near a center of the modulating layer 114, below a portion of the isotope layer 108, there is no modulating layer 114. A non-continuous modulating layer 114 … the modulating layer 114 may be selectively omitted at different positions along the base of the patch 100 depending on the desired amount of radioactive energy at the different positions”; [0119] “radioprotective layer 116 may help to protect the patient's skin 112 around the skin lesion from radioactivity… radioprotective layer 116 may be custom sized and shaped to match the size and shape of the patient's skin lesion…radioprotective layer 116 may be positioned on the patient's skin 112 …to align the gap or hole 118 with the skin lesion.”) and the window layer comprising a substantially solid layer of high Z shielding above the remaining healthy patient tissue (Sarazin in at least fig. 37-38, [0117], [0119] for example discloses window layer comprising a substantially solid layer of shielding above the remaining healthy patient tissue while Brauckman in at least [0073] for example discloses high Z shielding layers. See at least Sarazin [0117] “a modulating layer 114…is not continuous… non-continuous modulating layer 114 may aid in controlling the amount of radioactive energy delivered at different portions of the patient's skin lesion… the modulating layer 114 may be selectively omitted at different positions along the base of the patch 100 depending on the desired amount of radioactive energy at the different positions”; [0119] “radioprotective layer 116 may help to protect the patient's skin 112 around the skin lesion from radioactivity… radioprotective layer 116 may be custom sized and shaped to match the size and shape of the patient's skin lesion…radioprotective layer 116 may be positioned on the patient's skin 112 …to align the gap or hole 118 with the skin lesion.”).
As per dependent Claim 3, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein an additional window shielding layer of high Z shielding is placed between the distal shielding layer and the proximal patient shielding layer (Sarazin in at least fig. 37-38, [0102], [0104], [0109] for example discloses an additional window shielding layer/modulating layer of shielding is placed between the distal shielding layer 104 and the proximal patient shielding layer 116 while Brauckman in at least [0073] for example discloses high Z shielding layers. Sarazin [0102] “radiation dose pattern of a skin patch may be modified by adding one or more layers of an absorbing or modulating material over the deposited isotope layer and/or encapsulation layer… the modulatig layer material would help to absorb all or a portion of the radiation… creating a pattern of radioactivity that is tailored for the depth and/or density of the target cells in the lesion. The disclosed modified skin patches may deposit the highest energy and dose to the deepest, densest, and/or most diseased areas of the lesion, while limiting the deposited dose at areas with less extensive disease penetration”; [0104] “modulating layer material …modulating material may block all or some of the radioactivity from the skin patch”; [0109] “patch may comprise a modulating layer and a radioprotective layer”), the window shielding layer comprising a cutout opening within the window shielding layer in the shape of the cancerous tissue to be treated by the radionuclide (Sarazin in at least fig. 37, [0102], [0117], [0119] for example discloses window shielding layer comprising a cutout opening within the window shielding layer in the shape of the cancerous tissue to be treated by the radionuclide) and the window shielding layer comprising a substantially solid layer of high Z shielding above the remaining healthy patient tissue (Sarazin in at least fig. 37-38, [0117], [0119] for example discloses window layer comprising a substantially solid layer of shielding above the remaining healthy patient tissue while Brauckman in at least [0073] for example discloses high Z shielding layers. See at least Sarazin [0117] “a modulating layer 114…is not continuous… non-continuous modulating layer 114 may aid in controlling the amount of radioactive energy delivered at different portions of the patient's skin lesion… the modulating layer 114 may be selectively omitted at different positions along the base of the patch 100 depending on the desired amount of radioactive energy at the different positions”; [0119] “radioprotective layer 116 may help to protect the patient's skin 112 around the skin lesion from radioactivity… radioprotective layer 116 may be custom sized and shaped to match the size and shape of the patient's skin lesion…radioprotective layer 116 may be positioned on the patient's skin 112 …to align the gap or hole 118 with the skin lesion.”); and werein the treatment wafer is applied within the cutout of the window shielding layer (Sarazin in fig. 37-38, [0103] for example discloses the treatment wafer is applied within the cutout of the window shielding layer. See at least Sarazin [0103] “modulating material may block all or some of the radioactivity from the skin patch… use of silicone-based modulating layers may provide for a softer and more comfortable skin patch that may conform to the contours of the surface of the lesion”).
As per dependent Claim 6, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the window shielding layers of high Z shielding is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof (Brauckman in at least [0073] for example discloses the patch comprises, a high Z shielding layer comprising at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass which reads on the subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Brauckman [0073] “device may be selectively shielded at predetermined locations to provide for non-uniform, i.e., directional, radiation distribution. Such selective shielding can be accomplished by the incorporation of a shielding component into the delivery device at one or more predetermined locations or by fabricating all or a portion of the substrate from a shielding material. Shielding components can include radiation absorbing materials such as tin, silver, platinum, gold, tungsten, stainless steel, lead, brass, copper, or alloys thereof. More preferably, biocompatible shielding components are employed. …flexible or deformable radiation delivery devices described herein can be directly adhered or attached to a shielding substrate in any suitable manner in order to provide a directional device.”).
As per dependent Claim 7, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the window shielding layers of high Z shielding is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof (Brauckman in at least [0073] for example discloses the patch comprises, a high Z shielding layer comprising at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass which reads on the subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Brauckman [0073] “device may be selectively shielded at predetermined locations to provide for non-uniform, i.e., directional, radiation distribution. Such selective shielding can be accomplished by the incorporation of a shielding component into the delivery device at one or more predetermined locations or by fabricating all or a portion of the substrate from a shielding material. Shielding components can include radiation absorbing materials such as tin, silver, platinum, gold, tungsten, stainless steel, lead, brass, copper, or alloys thereof. More preferably, biocompatible shielding components are employed. …flexible or deformable radiation delivery devices described herein can be directly adhered or attached to a shielding substrate in any suitable manner in order to provide a directional device.”).
As per dependent Claim 8, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the radionuclide and nonreactive binding agent are formed in a substantially circular treatment wafer within a mold (Sarazin in at least fig. 14, [0073-0074], [0099], [0132] for example discloses the radionuclide and nonreactive binding agent are formed in a substantially circular treatment wafer within a mold. See at least [0073] “skin patch … has a geometry that follows that of the malignancy… shaped to match the contour of the lesion or tumor. The skin patch may be cut to the desired shape after it is produced or a mold or shadow mask may be used to shape the skin patch as a stable isotope is deposited on a substrate to form the skin patch”; [0074] “masks or molds may be used during deposition of the isotope so that areas of the patch may have two or more layers of the isotope.”; [0099] “sizing process shapes and sizes the skin patch of the present disclosure to a shape and size that matches the shape and size of the lesion…patch may be shaped using a mold during the deposition process… patch may be cut to the desired size and shape after the deposition process”).
As per dependent Claim 9, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the radionuclide and nonreactive binding agent are formed in a substantially elliptical treatment wafer within a mold (Sarazin in at least [0073-0074], [0099], [0132] for example discloses the radionuclide and nonreactive binding agent are formed in a substantially elliptical/round treatment wafer within a mold while Brauckman in fig. 2 discloses substantially elliptical radiation delivery treatment device, and thus, combination of applied art as a whole discloses subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Sarazin [0073] “skin patch … has a geometry that follows that of the malignancy… shaped to match the contour of the lesion or tumor. The skin patch may be cut to the desired shape after it is produced or a mold or shadow mask may be used to shape the skin patch as a stable isotope is deposited on a substrate to form the skin patch”; [0074] “masks or molds may be used during deposition of the isotope so that areas of the patch may have two or more layers of the isotope.”; [0099] “sizing process shapes and sizes the skin patch of the present disclosure to a shape and size that matches the shape and size of the lesion…patch may be shaped using a mold during the deposition process… patch may be cut to the desired size and shape after the deposition process”).
As per dependent Claim 10, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the radionuclide and nonreactive binding agent are formed in a custom shape corresponding to the shape of the cutaneous skin lesions in the patient tissue (Sarazin in at least [0073], [0099] for example discloses the radionuclide and nonreactive binding agent are formed in a custom shape corresponding to the shape of the cutaneous skin lesions in the patient tissue . See at least Sarazin [0073] “skin patch … has a geometry that follows that of the malignancy… shaped to match the contour of the lesion or tumor. The skin patch may be cut to the desired shape after it is produced or a mold or shadow mask may be used to shape the skin patch as a stable isotope is deposited on a substrate to form the skin patch”; [0099] “sizing process shapes and sizes the skin patch of the present disclosure to a shape and size that matches the shape and size of the lesion”).
As per dependent Claim 11, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the treatment wafer shape corresponds to a portion of the upper cranium of the patient (Sarazin in at least [0073], [0099] for example discloses the treatment wafer shape corresponds to a portion of the upper cranium of the patient as the patch as a whole may be shaped to match the contour of a lesion or tumor. Such a shape is capable of corresponding to a portion of an upper cranium of a patient as [0004] notes eyelids among areas to be treated for skin cancer lesions. See at least Sarazin [0073] “skin patch … has a geometry that follows that of the malignancy… shaped to match the contour of the lesion or tumor. The skin patch may be cut to the desired shape after it is produced or a mold or shadow mask may be used to shape the skin patch as a stable isotope is deposited on a substrate to form the skin patch”; [0099] “sizing process shapes and sizes the skin patch of the present disclosure to a shape and size that matches the shape and size of the lesion”).
As per dependent Claim 12, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the distal shielding layer is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof (Brauckman in at least [0073] for example discloses the patch comprises, a high Z shielding layer comprising at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass which reads on the subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Brauckman [0073] “device may be selectively shielded at predetermined locations to provide for non-uniform, i.e., directional, radiation distribution. Such selective shielding can be accomplished by the incorporation of a shielding component into the delivery device at one or more predetermined locations or by fabricating all or a portion of the substrate from a shielding material. Shielding components can include radiation absorbing materials such as tin, silver, platinum, gold, tungsten, stainless steel, lead, brass, copper, or alloys thereof. More preferably, biocompatible shielding components are employed. …flexible or deformable radiation delivery devices described herein can be directly adhered or attached to a shielding substrate in any suitable manner in order to provide a directional device.”).
As per dependent Claim 13, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the proximal shielding layer is comprised of at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass, or any combination thereof (Brauckman in at least [0073] for example discloses the patch comprises, a high Z shielding layer comprising at least one of: lead, tungsten, iron, silver, gold, platinum, copper, brass which reads on the subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least Brauckman [0073] “device may be selectively shielded at predetermined locations to provide for non-uniform, i.e., directional, radiation distribution. Such selective shielding can be accomplished by the incorporation of a shielding component into the delivery device at one or more predetermined locations or by fabricating all or a portion of the substrate from a shielding material. Shielding components can include radiation absorbing materials such as tin, silver, platinum, gold, tungsten, stainless steel, lead, brass, copper, or alloys thereof. More preferably, biocompatible shielding components are employed. …flexible or deformable radiation delivery devices described herein can be directly adhered or attached to a shielding substrate in any suitable manner in order to provide a directional device.”).
As per dependent Claim 14, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein an adhesive binds at least one of; the proximal shielding layer to the window shielding layer, the distal shielding layer to the window shielding layer, the proximal shielding layer to the treatment wafer, the distal shielding layer to the treatment wafer, the proximal shielding layer to the distal shielding layer (Sarazin in at least [0113] for example discloses an adhesive binds at least one of; the proximal shielding layer to the window shielding layer, the distal shielding layer to the window shielding layer, the proximal shielding layer to the treatment wafer, the distal shielding layer to the treatment wafer, the proximal shielding layer to the distal shielding layer. See at least [0113] “backing layer 104 may be coupled to the substrate layer 106, for example by an adhesive…or the like… substrate may have an adhesive backing, for example the substrate may be a tape to aid in adhering to the backing layer and/or the isotope layer.”).
As per dependent Claim 15, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch, wherein an adhesive binds at least one of; the proximal shielding layer to the window shielding layer, the distal shielding layer to the window shielding layer, the proximal shielding layer to the distal shielding layer (Sarazin in at least fig. 37-38, [0113], [0116], [0118] for example discloses an adhesive binds at least one of; the proximal shielding layer to the window shielding layer, the distal shielding layer to the window shielding layer, the proximal shielding layer to the distal shielding layer. See at least [0113] “backing layer 104 may be coupled to the substrate layer 106, for example by an adhesive…or the like… substrate may have an adhesive backing, for example the substrate may be a tape to aid in adhering to the backing layer and/or the isotope layer.”; [0116] “modulating layer 114 is coupled to the encapsulation layer 110, e.g., by an adhesive… modulating layer 114 is coupled to the patient's skin 112, e.g. by an adhesive.”; [0118] “radioprotective layer 116 may be a separate structure, that may be coupled to the encapsulation layer 110, e.g., by an adhesive… radioprotective layer 116 may be coupled to the patient's skin 112, e.g., by adhesive.”).
As per dependent Claim 16, the combination of Sarazin and Brauckman as a whole further discloses radioactive dermatological patch wherein the proximal shielding layer substantially attenuates the electron energy emitted from the radionuclide (Sarazin in at least [0109], [0119] for example discloses the proximal shielding layer 116 substantially attenuates the electron energy emitted from the radionuclide in isotope layer 108. See at least Sarazin [0109] “radioprotective layer may be positioned between the isotope layer and the patient's skin to protect the patient's skin that is not to be treated from exposure. … patch may comprise a modulating layer and a radioprotective layer… radioprotective layer may be manufactured of a material that absorbs most or all of the radiation from the activated patch, but is able to be shaped by the practitioner to conform to the shape and size of the lesion or skin to be treated”; [0119] “radioprotective layer 116 may help to protect the patient's skin 112 around the skin lesion from radioactivity… radioprotective layer 116 may be custom sized and shaped to match the size and shape of the patient's skin lesion…radioprotective layer 116 may be positioned on the patient's skin 112 …to align the gap or hole 118 with the skin lesion.”).
Claim 4 are rejected under 35 U.S.C. 103 as being unpatentable over Sarazin in view of Brauckman and further in view of Wang et al. (Pub: English Translation of CN 106730307 A, hereinafter referred to as “Wang-NPL”).
As per dependent Claim 4, the combination of Sarazin and Brauckman as a whole discloses radioactive dermatological patch of claim 1 (see claim 1)
The combination of Sarazin and Brauckman as a whole does not explicitly disclose the radionuclide comprises at least one of: Na-24, Ga-66, or any combination thereof.
However, in an analogous radiotherapy bandages field of endeavor, Wang-NPL discloses radioactive patch (Wang-NPL in at least abstract, [0002], [0008], [0026], [0050], [0054], [0061-0062], [0132-0133] for example discloses relevant subject-matter. More specifically, Wang-NPL in at least abstract discloses conformal radiotherapy patch. See at least Wang-NPL [0008] “radionuclide patch therapy that allows for precise dosage control and is relatively simple to administer”) wherein the radionuclide comprises at least one of: Na-24, Ga-66, or any combination thereof (Wang-NPL in at least [0050], [0048] for example discloses the radionuclide comprises at least one of: Na-24, Ga-66, or any combination thereof. See at least Wang-NPL [0050] “Radionuclides may be selected based on the patient's disease type, including Na-24… Ho-166 …Au-198).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify radionuclide used in the radioactive dermatological patch of Sarazin, as modified with Brauckman, with the radionuclide comprises at least one of: Na-24, Ga-66, or any combination thereof Wang-NPL. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage that such a radionuclide use is consistent with providing a radionuclide application therapy method that is accurate in dosage control and relatively simple in therapy, has a short half-life, and can achieve continuous radiotherapy. Furthermore, Wang-NPL notes the use of Na-24 as an alternative to holmium-166 (Wang-NPL, [0008], [0026], [0050]), and Sarazin notes that other isotopes may be used (Sarazin, [0063]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sarazin in view of Brauckman and further in view of Fischell et al. (Pub. No.: US 6350226 B1, hereinafter referred to as “Fischell”).
As per dependent Claim 5, the combination of Sarazin and Brauckman as a whole does not explicitly discloses radioactive dermatological patch of claim 1 (see claim 1 analysis)
The combination of Sarazin and Brauckman as a whole does not explicitly discloses the nonreactive binding agent is comprised of a silicone rubber.
However, in an analogous radioactive bandages field of endeavor, Fischell discloses radioactive bandage (Fischell in at least abstract, col. 3 lines 10-23 for example discloses relevant subject-matter. More specifically, Fischell in at least abstract, col. 3 lines 10-15 discloses radioactive bandage. See at least abstract “radioactive bandage would typically be an elongated flexible structure which can be applied along a wound or surgical incision…radioactive bandage would include a shield structure which surrounds the thin, elongated radioactive portion thus disallowing stray radiation outward from the patient's skin”; col. 3 lines 10-15 “radioactive bandage 10 consists of an elongated, substantially one-dimensional, radioactive source 9 which contains the radioisotope which is the source of radiation that is used to provide a dose of ionizing radiation to at least the upper portions of the incision 1.”) wherein the nonreactive binding agent is comprised of a silicone rubber (Fischell in at least Col. 3 lines 10-23 for example discloses the nonreactive binding agent is comprised of a silicone rubber. Fischell col. 3 lines 10-23 “radioactive bandage 10 consists of an elongated, substantially one-dimensional, radioactive source 9 which contains the radioisotope which is the source of radiation that is used to provide a dose of ionizing radiation to at least the upper portions of the incision 1…radioisotope source 9 might typically be an elastomer into which a radioisotope has been placed. A typical elastomer could be silicone rubber… or any other similar material which could be made into an elongated source into which a radioisotope could be placed”).
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 nonreactive binding agent used in the radioactive dermatological patch of Sarazin, as modified with Brauckman, such that the nonreactive binding agent is comprised of a silicone rubber as disclosed in Fischell. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of such a configuration provides an elongated source into which a radioisotope can be placed (Fischell, col. 3 lines 18-23), and is consistent with the aims of Sarazin to provide a flexible polymeric substrate onto which the radioactive isotope can be deposited (Sarazin [0061] and [0063]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20080031811 A1 to Ryu et al. for disclosing a radioactive film for local radioactive treatment similar to that disclosed.
Prior art US 9486642 B2 to Cipriani et al. for disclosing a brachytherapy method of treating a tumor skin lesion, preferably a basal cell carcinoma or a squamous cell carcinoma, comprising the step of applying to an area of skin to be treated a tailor-made radioactive source comprising a matrix-forming component, preferably an acrylic resin, and a radioactive isotope, preferably a beta emitter isotope, on a film or foil covering said area in order to protect the skin from radioactive contamination similar to that claimed and disclosed.
Prior art US 20150105602 A1 to Finger et al. for disclosing polymeric radiation-source with customized geometries to maximize receipt of radiation into treatment areas that is formed from either radioisotopes molecularly bonded to a polymer or radioisotopes encased within a polymer similar to that disclosed.
Prior art US 20170215824 A1 to Brachman et al. for disclosing configurations of shielding materials including high-Z material or alloys within shielding layers, such as for use in shielding radiation from implanted radioactive carriers similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791