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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Specification 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 Claim 9 is objected to because of the following informalities: “Yttrium 90” should read --Yttrium-90--. Appropriate correction is required. Claim Rejections - 35 USC § 112 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 10, 11, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 10 recites “a radionuclide brachytherapy source” while parent claim 1 recites “[a] radionuclide brachytherapy source”. It is unclear whether applicant intends to reference the same radionuclide brachytherapy source in claim 10. Claim 11 recites “the dose flattening filter” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 11 recites “an active area” while parent claim 1 recites “an active area”. It is unclear whether applicant intends to reference the same active area in claim 11. Claim 20 recites the limitation “the target” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1- 5, 7, 10-13 , 16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/178746 (Vose et al.). Regarding claim 1 , Vose teaches a radionuclide brachytherapy source (RBS) (100) (abstract ; [00024] ) comprising a beta radioisotope component (318) encased in a capsule ( 2 00) wherein at least a portion of a bottom surface (302) of the RBS is an active area ([00024]; Figure 3 ; “capsule” construed as instrument 200 encasing “RBS” 100 as depicted in Figures 6-7 , [00018] ) , the active area being where beta radiation is emitted from, wherein an area within 3-4 mm from the center of the active area of the bottom surface of the RBS emits a dose that is at least 80% of the dose emitted at the center of the active area ( The diameter of the radioactive source 100 is 4.05 mm in diameter and emits a “flat beam profile, achieving a more constant absorbed dose rate throughout a target volume of tissue” , wherein the target volume is 3.0 mm in diameter, [00022], [00025]. Since the source diameter is 4.05 mm and the target volume is 3.0 mm in diameter, with a “flat dose profile” at the target volume, then the dose emitted within 3-4 mm of the center of the active area of the bottom surface of the source is at least 80% of the dose emitted at the center. See also Figure 4 .). Regarding claim 2 , Vose teaches the RBS (100) is cylindrical ([00024]). Regarding claim 3 , Vose teaches the beta radioisotope component (318) is in a disc configuration ([00024]; Figures 1A and 3 ). Regarding claim 4 , Vose teaches the beta radioisotope component (318) is in an annulus configuration ([00024]; Figures 1A and 3 ). Regarding claim 5 , Vose teaches the RBS (100) has a diameter from 4 to 15 mm (4.05 mm, [00025]). Regarding claim 7 , Vose teaches the beta radioisotope (318) comprises Strontium-90 (Sr-90) ([00024]). Regarding claim 10 , Vose teaches a radiation attenuation mask (300) for housing a radionuclide brachytherapy source (RBS) (318) , the radiation attenuation mask (300) comprises a side wall (308) , an open top end for accepting the RBS, and a bottom end (302) sealed with the side wall along an entire bottom circumference of the side wall, forming an inner cavity ([00024]; Figure 3 ). Regarding claim 11 , Vose teaches the radiation attenuation mask (300) further comprises an attenuation component (304) disposed in the inner cavity on the bottom surface, the dose flattening filter prevents a portion of beta radiation emitted from an active area of the RBS from passing through the bottom surface, thereby controlling an amount of beta radiation emitted from the bottom surface of the radiation attenuation mask ([00025]; Figures 3 and 4 ) . Regarding claim 12 , Vose teaches the radiation attenuation mask (300) is cylindrical ([00024]; Figure 3 ). Regarding claim 13 , Vose teaches the attenuation component (304) is annulus shaped (since channel 306 formed by plateau 304 is toroidal, then the “attenuation component” 304 is annulus shaped, [00024]; Figure 3 ). Regarding claim 16 , Vose teaches a dose profile wherein all points of a treatment volume within a 4 mm radius has a dose that is at least 80% of the dose at the center, the points of the treatment volume being at a depth relative to the RBS system (see discussion for claim 1). Regarding claim 19 , Vose teaches the dose profile is therapeutic (“therapeutic volume” treated at dose profile, [00025]). Regarding claim 20 , Vose teaches the target is a target in an eye ([00025]). Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim s 6 , 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/178746 (Vose et al.) in view of U.S. Patent Application Publication No. 2015/0105601 (Finger et al.). Regarding claim s 6 and 15 , Vose teaches all the limitations of claim 6. Vose teaches the active area is 4.05 mm (“source 100 of a diameter of 4.05 mm”, [00024]). Vose recognizes “different structural parameters will result in different radiation distributions, as may be required by the specific application” ([00024]), but does not teach the active area is from 6 to 12 mm in diameter and consequently does not teach the bottom surface of the radiation attenuation mask is from 7 to 14 mm in diameter . However, Finger teaches an RBS (abstract ) , comprising a beta radioisotope component (4b) having an active area for emitting beta radiation ( beta, [0028] ; [0038]; [0051] ) , wherein the active area is 2.0 to 22.0 mm in diameter ([0051]; Figures 2 and 3c ). 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 diameter of the active area and bottom surface of the radiation attenuation mask of Vose to be between 2.0 to 22.0 mm, such as an active area diameter of 6 to 12 mm and a mask bottom surface o 7 to 14 mm , as taught by Finger, in order to meet the treatment needs of the individual patient, wherein the optimum diameter is discoverable through routine experimentation (Finger: [0051]). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) . See MPEP 2144.05(II)(A). Regarding claim 8 , Vose teaches all the limitations of claim 1. Vose does not teach the beta radioisotope is Yttrium-90 (Y-90). However, Finger teaches an RBS (abstract), comprising a beta radioisotope component (4b) including Yttrium-90 (Y-90) (beta, [0028]; [0038]; [0051] ; Y-90, [0092] and claim 5 ) . 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 beta radioisotope of Vose to include Yttrium-90 as taught by Finger, as Finger teaches Yttrium-90 is one of many therapeutically effective beta emitting radioisotopes for ocular brachytherapy ([0028]; [0092]; claim 5). Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/178746 (Vose et al.) in view of WO 2005/079294 (Hillstead et al. ; also identified as AU 2005/214040 to Bermann ). Regarding claim 9 , Vose teaches all the limitations of claim 1. Vose does not teach the beta radioisotope comprises Strontium-90 in secular equilibrium with Yttrium-90. However, Hillstead teaches an RBS (abstract), comprising a beta radioisotope comprising Strontium-90 in secular equilibrium with Yttrium-90 ([00029]-[00030]) . 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 beta radioisotope of Vose to include Strontium-90 in secular equilibrium with Yttrium-90 as taught by Hillstead in order to provide an therapeutically effective beta emitting material for ocular brachytherapy, depending on the needs of the patient ([00029]-[00030]). Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/178746 (Vose et al.) in view of WO 2015/105539 (Marsteller et al.). Regarding claim 14 , Vose teaches all the limitations of claim 1. Vose does not teach the attenuation component is dome-shaped. However, Marsteller teaches an RBS (abstract; [0001]), comprising a beta radioisotope component (401), a radiation attenuation mask having an attenuation component (410) in an inner cavity of the mask on the bottom surface, wherein the attenuation component is dome-shaped (dome, [0023]; [0061]; Figures 4 and 7B ). 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 attenuation component of Vose to have a dome shape as taught by Marsteller as the attenuation component shape may be varied to meet the dose profile required to treat the individual patient ([0023]). Claim s 17 and 18 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/178746 (Vose et al.) . Regarding claim 17 , Vose teaches all the limitations of claim 17. Vose teaches the depth is from 1.438 mm to 2.196 mm (flat dose profile at treatment volume depth, [00025]). Vose recognizes the radiation distribution may be varied “as may be required by the specific application” ([00025]), but does not expressly state the depth is 0.2 to 1 mm. 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 depth of Vose to be 0.2 to 1 mm in order to meet the treatment needs of the individual patient, wherein the optimal depth of the flat dose profile is discoverable through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A). Regarding claim 18 , Vose teaches all the limitations of claim 16. Vose teaches the depth is from 1.438 mm to 2.196 mm ( flat dose profile at treatment volume depth, [00025]). 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 depth to range from 1 to 1.5 mm in light of the teachings of Vose, as “[i] n the case where the claimed ranges ‘ overlap or lie inside ranges disclosed by the prior art ’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) ”. See MPEP 2144.05(I). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Carrie R Dorna whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7483 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 8am-5pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Alexander Valvis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-4233 . 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. /CARRIE R DORNA/ Primary Examiner, Art Unit 3791