Prosecution Insights
Last updated: April 19, 2026
Application No. 17/710,970

BRACHYTHERAPY TREATMENT SYSTEM AND METHOD OF OPERATING THE SYSTEM

Non-Final OA §103§112§DP
Filed
Mar 31, 2022
Examiner
DORNA, CARRIE R
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Varian Medical Systems, Inc.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
3y 5m
To Grant
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
649 granted / 900 resolved
+2.1% vs TC avg
Strong +28% interview lift
Without
With
+28.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
35 currently pending
Career history
935
Total Applications
across all art units

Statute-Specific Performance

§101
5.7%
-34.3% vs TC avg
§103
37.2%
-2.8% vs TC avg
§102
21.3%
-18.7% vs TC avg
§112
25.7%
-14.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 900 resolved cases

Office Action

§103 §112 §DP
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. Election/Restrictions Claims 1-10 are directed to a product. Upon further consideration, pursuant to the procedures set forth in MPEP § 821.04, claims 11-20, directed to the process of making or using a product, previously withdrawn from consideration as a result of a restriction requirement, claims 11-20 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 21 October 2025 is hereby withdrawn . In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler , 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. Claim Objections Claim 15 is objected to because of the following informalities: “plurality applicators” should read --plurality of applicators--. 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 1- 10 and 13-20 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 “determine a treatment time for a radioactive source for the output channel and the applicator”. As written, it is unclear how the “treatment time” is related to both the “output channel” and the “applicator”. Claim 8 recites “a treatment time” and “a radioactive source” while parent claim 1 recites “a treatment time” and “a radioactive source”. It is unclear whether applicant intends to reference the same respective treatment time and radioactive source. Claim 9 recites “the radioactive source” while parent claims 1 and 8 each recite “a radioactive source”. It is unclear whether applicant intends to reference the same respective treatment time and radioactive source. Claim 10 recites “the radioactive source” while parent claims 1, 8, and 9 each recite “a radioactive source”. It is unclear whether applicant intends to reference the same respective treatment time and radioactive source. Claims 16-20 each recite “the applicator” while parent claim 15 recites “a plurality [of] applicators”. It is unclear which of the plurality of applicators applicant intends to reference in claims 16-20. Claim 19 recites “a guide tube” and subsequently “a number of guide tubes”. It is unclear whether the “number of guide tubes” includes the previously recited “a guide tube”. Claim 19 recites “ a number of output channels” while parent claim 15 recites “a plurality of output channels”. It is unclear whether the output channels of claim 19 are intended to be the same or different than the plurality of parent claim 15. 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. Claims 1- 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0306425 (Bharat et al.) in view of U.S. Patent Application Publication No. 2006/0135843 (Heath). Regarding claim 1 , Bharat teaches a brachytherapy treatment system (abstract; Figures 1-2 , 4) comprising: an applicator (12) to deliver radiation to a tumor, the applicator having a proximate end and a distal end ([0095]; Figure 4 ); an imager (40) to take an anatomical image and a focused image (TRUS probe provides image of targeted prostate region 11, surrounding tissue structure(s), and catheters 12, construed as “anatomical image”, [0059]; initial TRUS image taken showing target region 11, [0095]) ; an afterloader (14) coupled to the imager ( [0058]; Figure 4 ) , the afterloader to drive a dummy device (16) from an output channel of the afterloader to the distal end of the applicator, command the imager to take the focused image after the dummy device has reached the distal end of the applicator, and retract the dummy device after the focused image has been taken, the dummy device having a high contrast to the imager (“dummy device” construed as tracking device 16, driven from output, construed as “output channel” of “ afterloader ” 5 to distal end of respective “applicator” 12, under TRUS imaging, thus “focused image” taken, [0095]; tracking device 16 retracted, [0064]; “high contrast” construed as readily detectable via imager, [0067]; “tracking device 16 has reached the furthest position within the respective catheter 12”, [0095]) ; and a treatment planning system coupled to the imager and the afterloader , the treatment planning system to receive the anatomical and focused images, and determine a treatment time for a radioactive source (10) for the output channel and the applicator based on the anatomical and focused images (“treatment plan is determined” based on anatomical image and image(s) of tracking device 16 at tip of catheter(s) 12 including positions and dwell times, [0002] , [0061], and [0096]). Bharat does not explicitly teach the system further includes a guide tube coupled to the proximate end of the applicator, wherein the afterloader is coupled to the guide tube and the imager. However, Heath teaches a brachytherapy treatment system (abstract ; [0025] ), comprising: an applicator (210) to deliver radiation to a tumor, the applicator having a proximate end and a distal end ; a guide tube (220) coupled to the proximate end of the applicator; and an afterloader (205) coupled to the guide tube ([0025]-[0026]; Figure 6 ). 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 system of Bharat to include a guide tube coupled to the proximate end of the applicator and the afterloader as taught by Heath in order to facilitate the delivery of a source or dummy device driven from the afterloader to the applicator. Note: The limitations “to deliver radiation to a tumor” is intended use. Since Bharat teaches delivery of HDR brachytherapy to treat cancer, the system is capable of performing the claimed intended use ([0099]). Regarding claim 2 , Bharat in view of Heath teaches all the limitations of claim 1. Bharat teaches the anatomical image includes an image of the tumor and images of any organs at risk (anatomical image of treatment region and surrounding tissue structures, [0059] and [0095] -[0096] ; cancer, [0099]). Regarding claim 3 , Bharat in view of Heath teaches all the limitations of claim 2 . Bharat teaches the anatomical image data from the anatomical image includes image data of the applicator (catheters introduced to target region 11 under ultrasound guidance, [0059] and [0095]). Regarding claim 4 , Bharat in view of Heath teaches all the limitations of claim 2 . Bharat teaches the treatment planning system determines a position of the tumor and positions of any organs at risk from the anatomical image (target region imaged: [0059]; [0095]-[0096]; cancer, [0099]). Regarding claims 5 and 6 , Bharat in view of Heath teaches all the limitations of claim s 4 and 5 . Bharat teaches the treatment planning system determines an exact location of the distal end of the applicator (12) from one or both the anatomical and focused images (“tracking device 16 has reached the furthest position within the respective catheter 12” under TRUS imaging, [0095]); wherein the focused image includes the distal end of the applicator (12) (catheters 12 placed under TRUS imaging, thus “distal end of applicator” in focused image, [0095]); and the focused image includes the proximate end of the applicator is missing from the focused image (proximate end of catheter 12 is not in imaging region of TRUS system, see Figure 4 ). Regarding claim 7 , Bharat in view of Heath teaches all the limitations of claim 5 . Bharat teaches the anatomical and focused images have a same frame of reference ([0095]-[0096]). Regarding claim 8 , Bharat in view of Heath teaches all the limitations of claim 5 . Bharat teaches the treatment planning system determines a treatment time for a radioactive source (10) based on the exact location of the distal end of the applicator (12) with respect to the position of the tumor and the positions of any organs at risk (“determined treatment plan” for target region 11, [0096]-[0097]; treatment times, [0002], [0061]). Regarding claim 9 , Bharat in view of Heath teaches all the limitations of claim 8. Bharat teaches the afterloader (14) drives the radioactive source (10) from the output channel of the afterloader to the distal end of the applicator (12) ([0055]; [0061]). Regarding claim 10 , Bharat in view of Heath teaches all the limitations of claim 9. Bharat teaches the afterloader starts the treatment time after the radioactive source (10) has reached the distal end of the applicator (12); and the afterloader (14) retracts the radioactive source after the treatment time has expired (“dwell times” at treatment location, [0002], [0055], [0061]). Claims 11- 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0306425 (Bharat et al.) in view of U.S. Patent Application Publication No. 2018/0085597 ( Isham et al.). Regarding claim 11 , Bharat teaches a method of operating a brachytherapy treatment system ([0094]) , the method comprising: taking an anatomical image with an imager (40) of a patient to determine shapes and locations of a target region (11) (TRUS probe 40 provides image of targeted prostate region 11, surrounding tissue structure(s), and catheters 12, construed as “anatomical image”, [0059]; initial TRUS image taken showing target region 11, [0095]); driving a dummy device (16) from an output channel of an afterloader (14) to a distal end of an applicator (12) , the dummy device having a high contrast to the imager (“dummy device” construed as tracking device 16, driven from output, construed as “output channel” of “ afterloader ” 5 to distal end of respective “applicator” 12, [0095]; tracking device 16 retracted, [0064]; “high contrast” construed as readily detectable via imager, [0067]; “tracking device 16 has reached the furthest position within the respective catheter 12”, [0095]) ; taking a focused image with the imager of the dummy device at the distal end of the applicator (“dummy device” construed as tracking device 16, driven from output, construed as “output channel” of “ afterloader ” 5 to distal end of respective “applicator” 12, under TRUS imaging, thus “focused image” taken, [0095]) ; retracting the dummy device into the afterloader after the focused image has been taken (tracking device 16 retracted, [0064]) ; determining an exact location of the applicator based on one or both the anatomical image and the focused image ([0095]) ; determining a treatment time for a radioactive source (10) for the applicator based on the location of target region and the exact location of the applicator (“determined treatment plan” for target region 11, [0096]-[0097]; treatment times, [0002], [0055], [0061]) . Bharat teaches HDR brachytherapy treats cancer ([0099]), but does not expressly teach the anatomical image includes a tumor and any organs of risk. However, Isham teaches a method of operating a brachytherapy treatment system (abstract) comprising: taking an anatomical image with an imager of a patient to determine shapes and locations of a tumor and any organs at risk ([0049]). 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 method of Bharat such that the anatomical image includes determining shapes and locations of a tumor and any organs at risk as taught by Isham , “[ i ]n order to accurately plan the brachytherapy procedure” and “understand the characteristics of the tumor” ([0049]). Consequently, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Bharat as modified such that the treatment time for the radioactive source for the applicator based additionally on the location of the tumor and any organs at ris k based on the teaching of Isham in order to ensure the treatment is accurate and reduces risk to surrounding healthy and/or non-targeted tissue. Regarding claim 12 , Bharat in view of Isham teaches all the limitations of claim 11. Bharat teaches anatomical image data from the anatomical image includes image data of the applicator (12) (catheters introduced to target region 11 under ultrasound guidance, [0059] and [0095]). Regarding claim 13 , Bharat in view of Isham teaches all the limitations of claim 12. Bharat teaches driving the radioactive source (10) from the output channel of the afterloader (14) to the distal end of the applicator (12) ([0055]; [0061]). Regarding claim 14 , Bharat in view of Isham teaches all the limitations of claim 13. Bharat teaches starting the treatment time after the radioactive source (10) has been placed at the distal end of the applicator (12); and retracting the radioactive source after the treatment time has expired (“dwell times” at treatment location, [0002], [0055], [0061]). Regarding claim 15 , Bharat teaches a method of operating a brachytherapy treatment system ([0094]) , the method comprising: taking an anatomical image of a patient to determine shapes and locations of a target region (11) (TRUS probe 40 provides image of targeted prostate region 11, surrounding tissue structure(s), and catheters 12, construed as “anatomical image”, [0059]; initial TRUS image taken showing target region 11, [0095]) ; sequentially driving a dummy device (16) from a plurality of output channels of an afterloader (14) to distal ends of a plurality applicators (12) , the dummy device having a high contrast to an imager (40) (“dummy device” construed as tracking device 16, driven from output, construed as “output channel” of “ afterloader ” 5 to distal end of eacg respective “applicator” 12, [0095]; tracking device 16 retracted, [0064]; “high contrast” construed as readily detectable via imager, [0067]; “tracking device 16 has reached the furthest position within the respective catheter 12”, [0095]; “several catheters 12 are present”, [0087]; steps “performed for each catheter 12”, [0095]) ; taking a plurality of focused images with the imager of the dummy device such that a focused image is taken of the dummy device at the distal end of each applicator (“dummy device” construed as tracking device 16, driven from output, construed as “output channel” of “ afterloader ” 5 to distal end of respective “applicator” 12, under TRUS imaging, thus “focused image” taken, [0095]; “several catheters 12 are present”, [0087]; steps “performed for each catheter 12”, [0095]) ; retracting the dummy device into the afterloader after each focused image has been taken (tracking device 16 retracted, [0064]) ; determining exact locations of the applicators based on one or both of the anatomical image and the focused images ([0095]) ; determining a treatment time for a radioactive source (10) for the applicator associated with each output channel based on the location of the target region (11) and the exact locations of the distal ends of the applicators (“determined treatment plan” for target region 11, [0096]-[0097]; treatment times, [0002], [0055], [0061]) . Bharat teaches HDR brachytherapy treats cancer ([0099]), but does not expressly teach the anatomical image includes a tumor and any organs of risk. However, Isham teaches a method of operating a brachytherapy treatment system (abstract) comprising: taking an anatomical image with an imager of a patient to determine shapes and locations of a tumor and any organs at risk ([0049]). 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 method of Bharat such that the anatomical image includes determining shapes and locations of a tumor and any organs at risk as taught by Isham , “[ i ]n order to accurately plan the brachytherapy procedure” and “understand the characteristics of the tumor” ([0049]). Consequently, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Bharat as modified such that the treatment time for the radioactive source for the applicator based additionally on the location of the tumor and any organs at risk based on the teaching of Isham in order to ensure the treatment is accurate and reduces risk to surrounding healthy and/or non-targeted tissue. Regarding claim 16 , Bharat in view of Isham teaches all the limitations of claim 15. Bharat teaches anatomical image data from the anatomical image includes image data of the applicator (12) (catheters introduced to target region 11 under ultrasound guidance, [0059] and [0095]). Regarding claim 17 , Bharat in view of Isham teaches all the limitations of claim 16. Bharat teaches driving the radioactive source (10) from the output channel of the afterloader (14) to the distal end of the applicator (12) ([0055]; [0061]). Regarding claim 18 , Bharat in view of Isham teaches all the limitations of claim 17. Bharat teaches starting the treatment time after the radioactive source (10) has been placed at the distal end of the applicator (12); and retracting the radioactive source after the treatment time has expired (“dwell times” at treatment location, [0002], [0055], [0061]). Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0306425 (Bharat et al.) in view of U.S. Patent Application Publication No. 2018/0085597 ( Isham et al.) as applied to claim 18 above, and further in view of U.S. Patent Application Publication No. 2006/0135843 (Heath) . Regarding claim s 19 and 20 , Bharat in view of Isham teaches all the limitations of claim 18. Bharat as modified does not explicitly teach coupling the applicator to a guide tube; and randomly coupling a number of guide tubes to a number of output channels of the afterloader so that each guide tube is coupled to an output channel. However, Heath teaches a method of operating a brachytherapy treatment system (abstract; [0025]), comprising: providing an applicator (210) to deliver radiation to a tumor; coupling the applicator to a guide tube (220); and coupling a number of guide tubes to a number of output channels of an afterloader (205) so that each guide tube is coupled to an output channel ([0003]; [0025]-[002 7 ] ; [0029]; [0037] ; Figure 6 ). Heath teaches the afterloader (205) determines whether a channel identified by a channel number is coupled to an applicator (210) ( each tag has a unique RFID number, [0027]; each guide tube connection confirmed via tag, [0029] ; [0037] ) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Bharat, as modified, to include a guide tube coupled to the applicator, and coupling a number of guide tubes to a number of output channels of an afterloader so that each guide tube is coupled to an output channel , wherein the afterloader determines whether a channel identified by a channel number is coupled to an applicator as taught by Heath in order to facilitate the delivery of a source or dummy device driven from the afterloader to the applicator in accordance with a planned treatment . Absent a special definition, “randomly” is interpreted as unplanned, thus “randomly” in context of the claim is construed as attaching the guide tubes to their prescribed output channels of the afterloader in a sequential order that is not pre-planned. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Bharat, as modified, to randomly couple the guide tubes to their respective corresponding output channels in order to achieve assembly for treatment as each respective guide tube, afterloader channel, and applicator is marked with a unique identifier to ensure the correct components are coupled ( Heath: [00 27]; [0029]; [0037]) , thus the order in which each radiation source pathway is coupled is not necessarily crucial. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2015/0327949 (Van de Wardt et al.) teaches a system and method for image tracking of brachytherapy applicators in treatment planning (abstract; [0018]; [0043]) 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
Read full office action

Prosecution Timeline

Mar 31, 2022
Application Filed
Mar 27, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+28.4%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 900 resolved cases by this examiner. Grant probability derived from career allow rate.

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