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. Specification The abstract of the disclosure is objected to because the first sentence reads “A design, quality assurance, and clinical use procedures are” but is not correct grammatically. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Objections Claim s 1, 7 -9 , 13 and 20 are objected to because of the following informalities: Claim 1 recites “ are configured and customized ” in line 8, but should read -- are configured to be customized -- in order to positively recite that the components can be customized. Claim 7 recites “their desired location” in line 2, but should read -- a desired location--. Claim 8 recites “guide catheters” in line 2, but should read -- guide the catheters-- . Claim 9 recites “ the channel configurations are positioned a specific distance ” but should read something similar to -- the channel s are configur ed to be positioned a specific distance -- or -- the channel s are configur ed to be a specific distance -- because claim 1 recites the channels are configured, so it i s not the configuration of the channel that is positioned a specific distance. Claim 13 recites “has known CAD model” in line 2 but should read -- has a known CAD model -- for grammar. Examiner further recommends -- has an associated CAD model -- to clarify “known”. Claim 20 recites “the landmarks” in lines 3-4 but should read -- the localizing landmarks -- to be consistent with previous recitations. 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 appl icant regards as his invention. Claims 1-20 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 1 recites the limitation "the channel" in line 8 . Line 3 recites “channels”, so it is unclear if the limitation “the channel” is intended to be -- the channels -- or it is referencing a single channel of the channels. Line 2-20 inherit the same deficiency. Claim 2 recites the limitation " the housing comprise s central channels " in lines 1-2. It is unclear if the limitation “central channels” is intended to be part of the channels in claim 1 or in addition to the channels in claim 1. Claim 2 should be written in a manner similar to claims 3 and 4. Claim 6 and 7 recites the limitation "the form" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 7 recites the limitation " which guides interstitial catheters " in line 2. It is unclear if the interstitial catheters are intended to be the part of the “ brachytherapy catheters ” of claim 1. Examiner suggests -- takes the form of a hybrid interstitial shape , wherein the brachytherapy catheters are interstitial catheters and the applicator guides the interstitial catheters to a desired location in t issue.-- Claim 8 recites the limitation "the tumor" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 8 recites the limitation " in the case of interstitial implants " in line 2 , which renders the claim unclear . Claim 1 does not positively recite interstitial implants. Claim 7, which claim 8 does not depend on, recites the applicator takes the form of “ a hybrid interstitial shape which guides interstitial catheters ”. Examiner suggests amending claim 8 to depend on claim 7, and removing the limitation "in the case of interstitial implants ", since it would be redundant. Claim 9 recites the limitation " in the case of intracavitary implants " in lines 2-3, which renders the claim unclear. Claim 1 does not positively recite intracavitary implants. Claim 6, which claim 9 does not depend on, recites the applicator takes the form of “ of an intracavitary shape ”. Examiner suggests amending claim 9 to depend on claim 6, and removing the limitation " in the case of intracavitary implants ", since it would be redundant. Claim 1 1 recites the limitation " the three -dimensional (3D) space " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 recites the limitation "the treatment device" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation " the patient image coordinate system " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation "the treatment device" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation " the image " in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation " the implant" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation " the position" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation "the tumor" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 3 recites the limitation " the designed or modified medical device " in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 13 recites the limitation " the exact geometry and dimensions " in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 13 recites the limitation " the exact locations" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 13 recites the limitation " the tracker(s)" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 14 recites the limitation " the tracking markers” in line 1 . There is insufficient antecedent basis for this limitation in the claim. Claim 14 recites the limitation "such as” in line 3. It is unclear if Applicant intends to positively re quire the specified tracking methods to further limit the claim or is merely providing examples. Claim 1 6 recites the limitation " the tracked applicator ” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 6 recites the limitation "the position” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 17-20 inherit the same deficiencies. Claim 17 recites the limitation " the patient” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 18 recites the limitation "the CAD model” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 18 recites the limitation "the tracking markers” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 recites the limitation " the in-room monitor ” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 19 recites the limitation " the CAD model” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 recites the limitation " the implanted medical device ” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 19 recites the limitation " the medical imaging scan ” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20 recites the limitation " the imaging/patient coordinate system ” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20 recites the limitation " the transformation ” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 20 recites the limitation " the tracking markers ” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1- 9 and 12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Krechting ( US 20180071549 A1 ) . Regarding claim 1, Krechting discloses a system for delivery of radiation therapy (abstract) comprising: an applicator, wherein the applicator comprises a housing ( Figure 4), wherein the housing defines channels ( Paragraph [0020] , Figure 3 ) configured to guide brachytherapy catheters ( Paragraph [0035]) and wherein the housing is configured to receive a source of radiation ( Paragraph [0035]) , and wherein the housing defines identification chambers ( Paragraph [ 0035 ]) ; shielding configured to protect a recipient from radiation generated by the source of radiation ( Paragraph [ 003 6 ]) ; wherein the applicator, the channel, and the shielding are configured and customized to provide the radiation therapy in accordance with an imaging ( Paragraph [ 003 3 ]) and radiation treatment plan ([003 3 ]) and wherein the channels and shielding are placed in a customized configuration based on the radiation treatment plan ( Paragraph [ 003 3 ]) ; a real-time tracking system comprising: a tracking device ( Paragraph [0035]); imaging markers disposed in the applicator to localize the applicator for image-based treatment planning and for image-guided treatment delivery ( Paragraph [0035]) ; and, localizing landmarks ( Paragraphs [006 7 ] - [006 8 ] ). Regarding claims 2-4, Krechting discloses the channels comprise a central channel and a number of peripheral channels (Figure 3) . Regarding claim 5, Krechting discloses the channels and catheters are secured in place relative to the applicator using a catheter locking mechanism (Paragraph [003 8 ] ) . Regarding claims 6 and 7, Krechting discloses the applicator takes the form of an intracavitary shape or a hybrid interstitial shape (Paragraph [00 20 ] ). Regarding claim 8, Krechting discloses the channel configurations are optimized to guide catheters into the tumor and away from healthy tissues using patient-specific imaging of anatomy and tumor topology (Paragraph [0044]) . Regarding claim 9, Krechting discloses the channel configurations are positioned a specific distance into the applicator housing to avoid hotspots in mucosal surfaces in the case of intracavitary implants (Paragraphs [0002], [00 32 ] ) . Regarding claim 12, Krechting discloses the applicator is tracked in the patient image coordinate system to track the treatment device in the image enabling on the fly adjustment of the implant with real-time feedback of the position relative to the tumor and organs at risk (Paragraph [0033]) . 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . 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. Claim(s) 10 -11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Krechting ( US 20180071549 A1 ) in view of Gelman ( US 20190056693 A1 ) . Regarding claims 10-11 and 13-20, Krechting discloses a system for delivery of radiation therapy (abstract) and further teaches using three-dimensional ultrasound to position the radiation delivery apparatus (Paragraph [0047]) for treatment . Kretching does not disclose an external positioning system using a plurality of tracking mediums to locate the radiation delivery system with respect to the patient and the procedure room. Gelman discloses a system for displaying a holographic image of an object behind a real object surface (Abstract) that can be used for brachytherapy (Paragraph [0390]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Krechting , with the system of Gelman to include real-time tracking system with respect to the patient and the procedure room (Paragraph [0559]) as taught by Gelman , since such a modification would provide the predictable results of increase accuracy of object registration (Paragraph [0331]). In the following paragraphs, the Examiner will provide references for claims 10-11 and 13-20 as to where the system of Krechting , as modified by Gelman, would be obvious over the claim limitations. Regarding claim 10, Gelman discloses the system utilizes an optical tracking system to track the location of inserted objects like needles (Paragraph [0280]). Regarding claim 11, Gelman discloses the applicator is tracked in the three-dimensional (3D) space of a procedure room coordinate system to track the treatment device in the room and within a 3D imaging space (Paragraph [0559]) . Regarding claim 13, Gelman discloses the designed or modified medical device used has a known CAD model which contains the exact geometry and dimensions of the applicator in addition to the exact locations of the tracker(s) and localization landmarks (Paragraph s [0567]-[0569]) . Regarding claim 14, Gelman discloses the tracking markers are detectable using one or a combination of tracking methods such as optical (Paragraph [0280]) or MRI active tracking (Paragraph [0280]). Regarding claim 15, Gelman disclose s the localizing landmarks are visible on medical imaging comprising one of more of an MRI, CT, Ultrasound, SPECT or PET scan (Paragraph [0365]-[0483] ) . Regarding claim 16, Gelman discloses an intra-procedural room monitor and a computer for visualization of the tracked applicator and information on the position of the applicator (Paragraphs [0010] and [0103]) . Regarding claim 17, Gelman discloses the computer receives tracking information from the tracking system and new or existing medical image scans of the patient (Paragraph [0142]). Regarding claim 18, Gelman discloses the computer is programmed to solve a mapping transformation between the CAD model and the tracking markers and localizing landmarks (Paragraph [0473]) . Regarding claim 19, Gelman discloses the in-room monitor displays an overlay of the CAD model of the implanted medical device onto the medical imaging scan in real-time at regular intervals ( (Paragraphs [0142], [0559], [0567]-[0569]). Regarding claim 20, Gelman discloses the computer is programmed to determine location and orientation of the applicator in the imaging/patient coordinate system by mathematically solving the transformation, which maps the tracking markers to the landmarks (Paragraphs [0139], [0473]) . Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Park ( US 20180318603 A1 ), Fram ( US 9821174 B1 ), Pouliot ( US 20160271379 A1 ), and Krechting ( US 20150265849 A1 ) disclose custom brachytherapy devices based on the anatomy of the patient. Maraghoosh ( US 20160143615 A1 ) and Dehgahn ( US 20180333217 A1 ) disclose real-time 3D imaging during brachytherapy treatment. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Marc D Honrath whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6219 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 7:30-5:00 . 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 Charles A Marmor II can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /CHARLES A MARMOR II/ Supervisory Patent Examiner Art Unit 3791 /M.D.H./ Examiner, Art Unit 3791