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 .
Claim Objections
Claims 1, 12, and 18 are objected to because of the following informalities: "retract the at least radiation source" should read --retract the at least one radiation source--. 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 1-18 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 as amended recites “adapt the brachytherapy treatment plan…, control repositioning of the at least one radiation source…, redefine the brachytherapy treatment plan…, retract the at least [one] radiation source…, or any combination thereof”. As written, it is unclear whether applicant intends to require each or at least one of the adapt, control, redefine, and retract steps given the phrase “or any combination thereof” (emphasis added). For the purposes of examination, due to the phrase “or any combination thereof” (emphasis added), these steps are interpreted to be recited in the alternative, such that the claim merely rarely requires a minimum of one of the steps to be performed in the method, and does not require each of these steps, as written.
The same issue appears in claims 12 and 18.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 12-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1, 12, and 18 each recite a process of developing a supervising dataset for a brachytherapy treatment based on a comparison between a planned dose distribution and an actual dose distribution.
The limitations of “receive a planning dataset…”, “determine a brachytherapy treatment plan…”, “register the supervision dataset and the planning dataset”, “determine an actual dose distribution…”, and “provide a supervision information…”, followed by at least one of “adapt…”, “control…”, “redefine…”, “retract…”, or combinations thereof (and corresponding limitations of claims 12 and 18) as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind or on paper by hand but for the recitation of generic processor components. That is, other than reciting “a processing unit is configured to” in claim 1, “acquiring, by a medical imaging system, wherein…” in claim 12, and “executable by one or more processors” and “by a medical imaging system” in claim 18, no limitations in the claim elements of claims 1, 12, and 18 preclude the steps from practically being performed in the mind or on paper by hand. For example, but for the “processing unit”, “receive a planning data set…” in the context of claim 1 encompasses the practitioner obtaining a printed image of a target region of the patient prior to treatment. The limitation “determine a brachytherapy plan…” in the context of these claims encompasses the practitioner mentally or drawing on paper 2-D isodose contours and/or markings indicating the location of radioactive sources constituting a brachytherapy treatment plan. The limitations “register…”, “determine an actual dose…”, and “provide a supervision information…” in the context of these claims encompass a practitioner aligning or aggregating on paper an intra-procedural representation of radiation source(s) in applicator(s) at the target region and the printed image of the target region prior to treatment, mentally evaluate an actual dose distribution, and on paper or verbally “providing” some information based on the comparison between the planned and actual dose distributions. Since, as written, the steps of “adapt…”, “control…”, “redefine…”, and “retract…” are required in the alternative, the practitioner may mentally or on paper, in some manner, adapt or redefine the plan markings constituting the brachytherapy treatment plan. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, these claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 positively recites two additional elements – “medical imaging system” (comprising at least one of a SPECT unit and a CT unit) and “processing unit”, claim 12 positively recites “a medical imaging system” (comprising at least one of a SPECT unit and a CT unit), and claim 18 positively recites “one or more processors”. Note, the “at least one radiation source” and “at least one medical guide instrument” are not positively required as they are recited in functional language. These elements are recited at a high-level of generality (i.e., as generic processing circuitry performing generic processor functions of obtaining, processing, and producing data) such that it amounts to no more than mere instructions to apply the exception using a generic processor component. The step of “the medical imaging system configured to acquire a supervision dataset…” and “acquiring, by a medical imaging system, a supervision dataset…” amount to receiving data for performance of the abstract idea, thus amount to mere data gathering, which has been found by the courts to be insignificant extra-solution activity. See MPEP 2106.04(d) and 2106.05(g). These additional elements when considered alone or in combination do not integrate the abstract idea into a practical application because they do not impose any meaningful limit on practicing the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processing unit, one or more processor, and medical imaging system used to perform the steps amount to no more than mere instructions to apply the exception using generic computer and imaging elements. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. See MPEP 2106.05(f). Under the 2019 Patent Eligibility Guidelines, a conclusion that an additional element is insignificant extra-solution activity in Step 2A, thus is reevaluated in Step 2B to determine if it is more than what is well-understood, routine, and conventional activity in the field. The original specification and claim language provides no indication that the steps of acquiring a dataset by the medical imaging system is anything other than mere data gathering as is well-known in the art, especially when claimed at a high-level of generality, as indicated by US 2014/0275713 (Bask et al.) (“…information regarding a patient target volume. Various approaches are known in the art to collect and render such information including, by way of example, X-ray computed tomography”, [0024]). The original disclosure further provides no indication that the processor unit and processor(s) are anything other than well-understood, routine, and conventional components, as indicated by US 2013/0289332 (Purdie et al.) (conventional treatment planning systems include a processor and memory-stored instructions, [0036]). See MPEP 2106.05(d). Accordingly, these additional elements when considered alone and in combination do not amount to significantly more than the judicial exception, thus do not provide an inventive concept.
The examiner notes that if either of the steps of “control repositioning of the at least one radiation source based on the supervision information” and “retract the at least [one] radiation source based on the supervision information” would positively require the radiation source(s) and consequently constitute an integration of the abstract idea into a practical application.
Claims 2-10 and 13-17 include all the limitations of claims 1 or 12, thus are directed to the same abstract idea. These claims further limit additional elements or steps practically performed by hand or in the mind of a practitioner of the abstract idea, thus do not provide additional elements that integrate the abstract idea into a practical application of the abstract idea or amount to significantly more than the abstract idea.
Response to Arguments
Applicant’s arguments, see page 13, filed 17 December 2025, with respect to the informality objection and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments to the claims. The objection and rejections of 17 September 2025 have been withdrawn.
The examiner notes the amendments to the claims to convert “processing unit” to --one or more processors-- no longer invokes 35 U.S.C. 112(f).
Applicant's arguments filed 17 December 2025 with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant contends the new limitations of “adapt…”, “control…”, “redefine…”, and/or “retract…” integrate the abstract idea into a practical application thereof, and further present a technical improvement by “improving the accuracy and safety of brachytherapy treatment, enabling real-time verification and correction of the brachytherapy treatment, and solving the problem of deviations between planned and actual doses” (arguments, pages 14-15). The examiner does not find these arguments to be persuasive. As noted above, the newly added steps as currently written are required in the alternative in their broadest reasonable interpretation due to the term “or” in the phrase “or any combination thereof” (emphasis added) at the end of the clause. The two steps of “adapt…” and “redefine…” would each be performable in the mind or on paper by the practitioner, thus would fall within the “Mental Processes” grouping, and consequently would not overcome the rejection. The two steps of “control…” and “retract…”, if either were positively recited, would require manipulation of the radiation source(s) based on results of the performed method, thus would overcome the rejection. However, since the BRI merely requires one of those added steps to be performed as presently written, and only some of those steps extend beyond the abstract idea, the claims remain directed to an abstract idea without significantly more.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., enabling real-time verification and processing of a data set for plan manipulation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant contends the rejection has erroneously conflated 35 U.S.C. 101 and 103 in relying on Bask and Purdie, and further asserts the claimed limitations are not well-understood, routine, and conventional (arguments, pages 15-16). The examiner does not find this argument to be persuasive. In Step 2A of 35 U.S.C. 101 eligibility analysis, the steps of “the medical imaging system configured to acquire a supervision dataset…” and “acquiring, by a medical imaging system, a supervision dataset…” were determined to constitute receiving data for performance of the abstract idea, thus amount to mere data gathering, which has been found by the courts to be insignificant extra-solution activity. See MPEP 2106.04(d) and 2106.05(g). Under the 2019 Patent Eligibility Guidelines, a conclusion that an additional element is insignificant extra-solution activity in Step 2A is reevaluated in Step 2B to determine if it is more than what is well-understood, routine, and conventional activity in the field. The original specification and claim language provides no indication that the steps of acquiring a dataset by the medical imaging system is anything other than mere data gathering as is well-known in the art, especially when claimed at a high-level of generality, as indicated by US 2014/0275713 (Bask et al.) (“…information regarding a patient target volume. Various approaches are known in the art to collect and render such information including, by way of example, X-ray computed tomography”, [0024]). The original disclosure further provides no indication that the processor unit and processor(s) are anything other than well-understood, routine, and conventional components, as indicated by US 2013/0289332 (Purdie et al.) (conventional treatment planning systems include a processor and memory-stored instructions, [0036]). See MPEP 2106.05(d). Bask and Purdie are not relied upon as references under 35 U.S.C. 103, but rather as evidence showing the additional elements identified in Step 2A, when re-evaluated in Step 2B, are not more than what is well-understood, routine, and conventional activity in the field, consistent with subject matter eligibility analysis (see Bask, “…information regarding a patient target volume. Various approaches are known in the art to collect and render such information including, by way of example, X-ray computed tomography”, [0024]; see Purdie, conventional treatment planning systems include a processor and memory-stored instructions, [0036]) (emphasis added). Accordingly, the noted teachings of Bask and Purdie constitute a showing that the additional elements for data gathering when considered alone or in combination do not amount to significantly more than the judicial exception, thus do not provide an inventive concept.
Allowable Subject Matter
Claim 11 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: No prior art of record teach and/or fairly suggest the system of claim 11, comprising an afterloader unit, wherein the processing unit is configured to provide the adapted and/or redefined brachytherapy treatment plan to the afterloader unit, wherein the at least one medical guide instrument is connected to the afterloader unit, and wherein the afterloader unit is configured to reposition the at least one radiation source along the at least one medical guide instrument in accordance with the adapted and/or redefined brachytherapy treatment plan, within the context of all the remaining limitations of claim 11 and the limitations of parent claims 1 and 10.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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