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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 February 2026 has been entered.
Claims 21-40 are currently under consideration. The Office acknowledges the amendments to claims 21, 23, 26, 27, and 33-35.
Specification
The disclosure is objected to because of the following informalities: as has been indicated in the previous two Office actions, Applicant is requested to amend the first paragraph of the specification to indicate that parent application 17/832,780 is now U.S. Patent No. 12,064,642.
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 23, 26, 34, and 35 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 23 recites the limitation "the patient" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this is intended to refer to the subject recited in the last line of claim 21 or to a separate person.
Claim 26 recites the limitation "the treatment region" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the light" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the treatment region" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
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.
Claims 21-25, 29-34, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Senden et al. (U.S. Pub. No. 2019/0046814 A1; hereinafter known as “Senden”), in view of Keppel et al. (U.S. Pub. No. 2010/0288934 A1; hereinafter known as “Keppel”).
Regarding claim 21, Senden discloses a system 1 (Abstract; Fig. 1), the system comprising: a non-transitory memory and one or more processors forming a treatment controller 37 ([0028]-[0029]; [0059]-[0060]; [0078]-[0079]) operable to generate an adaptive treatment plan according to differences between a predetermined dosage of radiation in a location and a current dosage of radiation in the location ([0065]; [0071]; difference between planned dose and delivered dose from current position); and a visual display 41 configured to overlay the adaptive treatment plan on a real-time image of the location ([0052]; [0065]). Senden fails to disclose that the treatment controller is configured to automatically adjust the adaptive treatment plan in response to the current dosage of radiation and to control delivery of radiation to a subject according to the adaptive treatment plan. Keppel discloses a similar system (Abstract; Figs. 1-2) that automatically adjusts an adaptive treatment plan in response to a current dosage of radiation and to control delivery of radiation to a subject according to the adaptive treatment plan in order to more accurately deliver a desired dosage level and distribution ([0007]-[0008]; [0016]; [0020]; [0072]; [0080]; [0085]; [0088]). 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 invention of Senden so that the treatment controller can automatically adjust the adaptive treatment plan in response to the current dosage of radiation and control delivery of radiation to a subject according to the adaptive treatment plan, as taught by Keppel, in order to more accurately deliver a desired dosage level and distribution.
Regarding claim 22, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Keppel further discloses that the current dosage of radiation is generated according to IVD data in order to detect the current dosage in vivo ([0016]; [0020]; [0055]-[0056]; [0062]-[0065]; [0085]; [0088]). 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 combination of Senden and Keppel by generating the current dosage of radiation according to IVD data, as taught by Keppel, in order to detect the current dosage in vivo.
Regarding claim 23, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Keppel further discloses that the IVD data is generated according to light received, from a plurality of scintillators 205 in a presence of a radiation source 115, by a plurality of light detection units positioned external to the patient and optically coupled to the plurality of scintillators via one or more probes 125/215 ([0047]; [0049]; [0055]-[0058]; [0100]-[0101]).
Regarding claim 24, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Senden further discloses that the predetermined dosage of radiation is a desired dosage of radiation that is determined prior to radiotherapy ([0065]; [0071]; planned dose).
Regarding claim 25, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Keppel further discloses an IVD detector that is configured to generate a location of a radiation source according to electrical signals from a plurality of light detection units positioned to detect radiation from a brachytherapy source 115 in order to assure the location of the source ([0065]; [0069]-[0070]) and in order to adjust the treatment plan based upon the detected level of radiation ([0016]; [0020]; [0055]-[0056]; [0062]-[0065]; [0085]; [0088]). 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 combination of Senden and Keppel with such an IVD detector, as taught by Keppel, in order to assure the location of the source and to adjust the treatment plan based upon the detected level of radiation.
Regarding claim 29, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and further discloses that the system comprises an afterloader (Senden: [0043]; Keppel: [0046]), and the afterloader is configured, according to the treatment controller, to control a time period that a radiation source is located at a targeted position in real-time (Keppel: [0070], [0072], [0080]).
Regarding claim 30, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Keppel further discloses that the time period is dynamically adjusted according to changes in the current dosage of radiation ([0070], [0072], [0080]).
Regarding claim 31, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Senden further discloses that the targeted position is adaptive ([0043]; e.g., different dwell positions).
Regarding claim 32, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Senden further discloses that the current dosage of radiation in the location is communicated wirelessly via the treatment controller to the visual display ([0078]-[0079]).
Regarding claim 33, Senden discloses a method (Abstract; Fig. 1) comprising: generating an adaptive treatment plan, via a treatment controller 37 ([0059]-[0060]), according to differences between a predetermined dosage of radiation in a location and a current dosage of radiation in the location ([0065]; [0071]; difference between planned dose and delivered dose from current position); and displaying the adaptive treatment plan on a real-time image of the location ([0052]; [0065]). Senden fails to disclose automatically modifying the adaptive treatment plan in response to the current dosage of radiation and controlling delivery of radiation to a subject according to the adaptive treatment plan. Keppel discloses a similar method (Abstract; Figs. 1-2) that automatically modifies an adaptive treatment plan in response to a current dosage of radiation and controls delivery of radiation to a subject according to the adaptive treatment plan in order to more accurately deliver a desired dosage level and distribution ([0007]-[0008]; [0016]; [0020]; [0072]; [0080]; [0085]; [0088]). 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 invention of Senden by automatically modifying the adaptive treatment plan in response to the current dosage of radiation and controlling delivery of radiation to a subject according to the adaptive treatment plan, as taught by Keppel, in order to more accurately deliver a desired dosage level and distribution.
Regarding claim 34, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Keppel further discloses receiving in-vivo dosimetry (IVD) data generated by an IVD detector according to the light received from a plurality of scintillators in a presence of a radiation source in order to detect the current dosage in vivo ([0016]; [0020]; [0055]-[0056]; [0062]-[0065]; [0085]; [0088]). 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 combination of Senden and Keppel by receiving IVD data generated by an IVD detector according to the light received from a plurality of scintillators in a presence of a radiation source, as taught by Keppel, in order to detect the current dosage in vivo.
Regarding claim 38, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Senden further discloses controlling, via an afterloader ([0043]), a time period that a radiation source is located at a targeted position ([0044]).
Regarding claim 39, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Senden further discloses that one or both of the time period and the targeted position are adaptive ([0043]; e.g., different dwell positions).
Regarding claim 40, the combination of Senden and Keppel discloses the invention as claimed, see rejection supra, and Senden further discloses wirelessly communicating the current dosage of radiation in the location to the visual display ([0078]-[0079]).
Claims 28 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Senden and Keppel as applied to claims 21 and 33 above, and further in view of Uhlemann (U.S. Pub. No. 2016/0213949 A1; hereinafter known as “Uhlemann”). The combination of Senden and Keppel discloses the invention as claimed, see rejection supra, but fails to disclose a surgical robot that is configured to control a placement of one or more interstitial catheters according to a treatment controller adjustment signal according to the adaptive treatment plan (or a method of such), though Senden does teach placement of such interstitial catheters 12 and Keppel teaches a surgical robot that is controlled according to the adaptive treatment plan. Uhlemann discloses a similar system and method (Abstract) comprising a surgical robot that controls placement of one or more interstitial catheters according to a treatment controller adjustment signal in order to automatically control catheter insertion and provide greater accuracy ([0037]; [0106]). 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 combination of Senden and Keppel with such a surgical robot to control catheter placement, as taught by Uhlemann, in order to automatically control catheter insertion and provide greater accuracy.
Allowable Subject Matter
Claims 27 and 36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 26 and 35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 26 and 35, as detailed previously, none of the prior art of record teaches or reasonably suggests such an IVD detector (or method of using) that generates a location of a radiation source by triangulation according to electrical signals from a plurality of light detection units distributed around a treatment region. Regarding claims 27 and 36, as detailed previously, none of the prior art of record teaches or reasonably suggests generating a velocity of a radiation source according to electrical signals from a plurality of light detection units and automatically updating the adaptive treatment plan in response to the velocity.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim 23 under 35 U.S.C. 112(a) have been fully considered and are persuasive in light of the amendments. The rejection has been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are partially persuasive in light of the amendments. Several rejections have been withdrawn; however, as detailed supra, some persist.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 101 have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn.
Applicant's arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends that the combination of Senden and Keppel fails to teach the limitations now recited by the independent claims. However, as detailed supra, the proposed combination does indeed teach controlling delivery of radiation according to the adaptive treatment plan. To the extent that Applicant argues that the proposed combination fails to teach triangulating a radiation source location based on signals from a plurality of light detection units or automatically modifying radiation delivery in response to detected source velocity, the examiner agrees; see Allowable Subject Matter supra.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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