Janne Nord et al.Download PDFPatent Trials and Appeals BoardOct 24, 201914039413 - (D) (P.T.A.B. Oct. 24, 2019) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/039,413 09/27/2013 Janne Nord 8632-131569-US (13-007) 2568 76260 7590 10/24/2019 FITCH EVEN TABIN & FLANNERY, LLP VARIAN MEDICAL SYSTEMS 120 SOUTH LASALLE STREET SUITE 2100 CHICAGO, IL 60603-3406 EXAMINER DORNA, CARRIE R ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 10/24/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): ipdocket@varian.com mail@fitcheven.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JANNE NORD, JUHA KAUPPINEN, and JARKKO PELTOLA Appeal 2019-000829 Application 14/039,413 Technology Center 3700 Before JENNIFER D. BAHR, MICHAEL J. FITZPATRICK, and LEE L. STEPINA, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision rejecting claims 1–3, 5–14, and 16–19, which are all of the pending claims. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Varian Medical Systems International AG. Appeal Br. 3. Appeal 2019-000829 Application 14/039,413 2 CLAIMED SUBJECT MATTER Appellant’s invention “relates generally to the therapeutic irradiation of a patient’s target volume.” Spec. ¶ 2. Appellant’s invention is intended to improve upon conventional optimization means, which typically optimize treatment plans “using the administered dose as the optimization objective and as the measure of the result.” Id. ¶ 6. Such conventional optimization seeks to assure that a particular specified dose is being uniformly administered through the target volume while avoiding undue dosing of other patient tissues (or, in other cases, that a series of dose histograms that specify acceptable dosing ranges for a variety of locations both in and external to the target volume are met). Such an approach presumes that the specified dose itself is going to be therapeutically effective. Id. However, the effect of a given dose with respect to a patient’s expectations or goals “(i.e., their quality of life and expected longevity, for example) can vary with a variety of anecdotal circumstances such as the patient’s age and their ability (and/or willingness) to deal with various side effects, for example.” Id. ¶ 7. Appellant’s invention seeks to address the need to meet such patient expectations or goals by providing a “method and apparatus for using patient-experience outcomes when developing radiation-therapy treatment plans.” Id. ¶ 8. Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. An apparatus comprising: a memory having information stored therein correlating a plurality of patient-experience outcomes with corresponding delivered-radiation metrics; a control circuit operably coupled to the memory and configured to use the plurality of patient-experience outcomes in conjunction with developing a radiation-therapy treatment plan for a particular patient by, at least in part, using a particular Appeal 2019-000829 Application 14/039,413 3 one of the patient-experience outcomes as an optimization goal when optimizing at least one candidate radiation-therapy treatment plan by automatically modifying treatment plan parameters while using an automated incremental methodology where various optimization results are incrementally calculated and tested against the optimization goal to develop the radiation-therapy treatment plan, such that the radiation-therapy treatment plan is optimized as a specific function of the particular one of the patient-experience outcomes; and a radiation-treatment platform configured to receive the radiation-therapy treatment plan and to use the radiation- therapy treatment plan to treat a corresponding patient. EVIDENCE The prior art relied upon by the Examiner is: Saracen Frielinghaus Wu US 2006/0293583 A1 US 2007/0156453 A1 US 2012/0014507 A1 Dec. 28, 2006 July 5, 2007 Jan. 19, 2012 REJECTIONS I. Claims 1–3, 5, 7–14, and 17–19 stand rejected under 35 U.S.C. § 103 as being unpatentable over Frielinghaus and Saracen. II. Claims 6 and 16 stand rejected under 35 U.S.C. § 103 as being unpatentable over Frielinghaus, Saracen, and Wu. OPINION Rejection I—Obviousness: Frielinghaus and Saracen The Examiner finds that Frielinghaus discloses an apparatus and method in which a plurality of patient-experience outcomes are used “in conjunction with developing a radiation-therapy treatment plan for a particular patient by, at least in part, using a particular one of the patient- experience outcomes as a goal when evaluating candidate radiation-therapy Appeal 2019-000829 Application 14/039,413 4 treatment plans,” but that Frielinghaus “does not specify the candidate treatment plans are optimized with the particular patient-experience outcome used as a goal of the optimization,” as recited in Appellant’s claims 1 and 12. Final Act. 3, 6. The Examiner finds that Frielinghaus also does not disclose “using a radiation-treatment platform to receive the radiation- therapy treatment plan and to use the radiation-therapy treatment plan to treat a corresponding patient.” Id. at 3. The Examiner finds that Saracen teaches an apparatus and method in which a memory is provided and has “stored therein a plurality of patient- experience outcomes and corresponding delivered-radiation metrics (‘successful’, previously accepted treatment plans stored in library used for optimization of proposed plan, [0036]; [0044]; [0057]; [0063])” and a control circuit is operably coupled to the memory and is configured to use a particular one of the patient-experience outcomes as an optimization goal when optimizing at least one candidate radiation-therapy treatment plan by automatically modifying treatment plan parameters while using an automated incremental methodology where various optimization results are incrementally calculated and tested against the optimization goal to develop the radiation-therapy treatment plan, such that the radiation-therapy treatment plan is optimized as a specific function of the particular one of the patient-experience outcomes. Id. at 3–4. The Examiner notes that, in Saracen: A candidate treatment plan is matched with a similar plan pulled from a library of “successful”, previously accepted treatment plans, where the optimization constraints for the candidate plan are modified to match those of the library plan, Appeal 2019-000829 Application 14/039,413 5 and then the candidate plan is optimized with respect to a matched plan parameter as the optimization goal. Id. at 3–4, 6 (citing Saracen ¶¶ 35–36, 44, 47, and 61–63). The Examiner considers the parameters (i.e., “a set of beam weights, sizes, and positions that result in successfully balancing treatment of the pathological anatomy while minimizing radiation dose to critical structures”) “of the ‘successful’, ‘accepted’ library plan selected as optimization constraints” to be “the ‘patient-experience outcomes’ as they are parameters that created an outcome of ‘successfully balancing treatment of the pathological anatomy while minimizing radiation dose to critical structures’ experienced by a patient.” Id. at 4, 6; see also Ans. 3. The Examiner also finds that Saracen teaches “a radiation-treatment platform . . . configured to receive the radiation-therapy treatment plan and to use the radiation-therapy treatment plan to treat a corresponding patient.” Final Act. 4, 6–7 (citing Saracen, Fig. 14, treatment delivery system 4000; ¶¶ 57, 66–67). The Examiner determines it would have been obvious to modify Frielinghaus to have the control “circuit automatically and iteratively optimize[] the candidate treatment plan with respect to a particular one of the patient-experience outcomes selected by the user to develop the treatment plan as taught by Saracen” because Saracen “teaches automatically optimizing a candidate treatment plan with respect to a patient-experience outcome from a previously accepted, successful treatment plan [to identify] the best treatment parameters for the patient’s individual needs to achieve a beneficial treatment outcome.” Id. at 4–5, 7. The Examiner determines that it also would have been obvious to further modify Frielinghaus “to include Appeal 2019-000829 Application 14/039,413 6 the radiation-therapy platform of Saracen . . . because providing the memory, control circuit, and radiation-treatment platform in an integrated apparatus centralizes treatment planning and delivery for efficient treatment of the patient.” Id. at 5, 7. Appellant submits that Saracen “goes no further than what [Appellant] acknowledges to be typical of the prior art, in that Saracen optimizes radiation-therapy treatment plans as a function of dosing goals.” Appeal Br. 10. Appellant adds “that Frielinghaus does not describe, directly or indirectly, the idea of using a patient-experience outcome as an objective by which such a treatment plan can be optimized.” Id. at 11. According to Appellant, “Frielinghaus only describes using patient-experience outcomes as a way of selecting a particular treatment approach from amongst a plurality of different kinds of treatment approaches.” Id. Appellant argues the ordinarily-skilled person would understand that a fair combination of Saracen with Frielinghaus would provide for selecting from amongst a variety of different ways to treat a particular condition (per Frielinghaus), where one of those ways consisted of radiation therapy, and if that radiation therapy approach is selected, then optimizing the radiation-therapy treatment plan as a function of something other than patient outcomes (per Saracen). Id. at 12. For the reasons that follow, Appellant’s arguments are persuasive of error in the rejection set forth by the Examiner. Frielinghaus discloses storing a medical condition table, a treatment table, and a result table in a database containing entries correlating particular medical conditions to expected disease progressions without treatment, recommended treatment options for the particular patient (including surgical Appeal 2019-000829 Application 14/039,413 7 resection, therapeutic application of energy (e.g., radiosurgery, radiotherapy, thermotherapy, light therapy), drug therapy (e.g., chemotherapy, immunotherapy), diagnostic procedures (e.g., imaging or targeted diagnostics), and supportive care (e.g., reduction of pain or tissue swelling)), and side effects, risks, and benefits of each treatment, based on results obtained from treating different patients. See Frielinghaus ¶¶ 7, 16–20, 26, 31, 37–40, 45. “The recommended treatment plan can be based on experience and/or actual results obtained with similar patients experiencing similar medical conditions.” Id. ¶ 37. Frielinghaus’s system permits entry of patient-specific data, such as biographic data, diagnostic data, and imaging data, then proceeds to search the database for data that matches or is similar to the patient’s data, and prepares a report for medical personnel and/or the patient, including treatment options, the likelihood of success of the medical treatment, possible side effects of the treatment, possible complications, expected quality of life following the treatment, and risk factors and their likelihood of occurring. Id. ¶¶ 45–47. Frielinghaus’s planning system can also run simulations for one or more treatment plans providing “data corresponding to how a disease may respond and/or progress after treatment.” Id. ¶ 48. Further, weighting criteria (such as probabilities or likelihood of a particular risk or benefit) for data in the database may be altered and the effects of such alterations shown on the display. Id. Based on these reports and simulations, “a decision can be made on how to treat the disease.” Id. ¶¶ 41, 47; see also id. ¶ 54 (“Based on the recommended treatment plan and/or simulation results, a treatment is selected and executed.”). Appeal 2019-000829 Application 14/039,413 8 Saracen teaches a radiation treatment planning method and apparatus for optimizing a radiation treatment plan using inverse planning, to deliver at least a preselected minimum dose to the target tissue (the pathological anatomy, such as a tumor) while not exceeding a preselected maximum dose to healthy tissue, once it has been decided that radiation treatment is to be performed. See Saracen ¶¶ 1, 5, 10. The goal is to achieve a dose volume histogram (DVH) that reflects as high a degree of homogeneity (i.e., uniformity of the radiation dose over the volume of the target) as possible, as well as a desirable DVH for a critical region of healthy tissue that reflects the volume of the critical anatomical structure receiving as little of the prescribed dose as possible. Id. ¶ 8; see id., Figs. 2, 3 (showing the theoretical ideal DVH profiles for pathological anatomy and critical region anatomy, respectively). Adjusting treatment plan parameters (e.g., beam orientations, sizes, weights) iteratively until an acceptable DVH has been established can be very tedious; thus, Saracen’s system allows treatment plans, once optimized, to be saved in a library to be referenced for future treatment plan development. Id. ¶¶ 10, 38. The Examiner’s position that “[t]he parameters of the ‘successful’, ‘accepted’ library plan selected as optimization constraints are considered the ‘patient-experience outcomes’ as they are parameters that created an outcome of ‘successfully balancing treatment of the pathological anatomy while minimizing radiation dose to critical structures’ experienced by a patient” (Ans. 3) is unreasonable. Even assuming that the accepted treatment plans stored in Saracen’s library represent treatment plans that have been applied to patients with successful outcomes (i.e., successful treatment of the pathological anatomy while minimizing radiation dose to Appeal 2019-000829 Application 14/039,413 9 critical structures) as the Examiner states,2 the parameters of such treatment plans are inputs, not outcomes, and certainly not patient-experience outcomes. Thus, the Examiner fails to set forth sufficient findings and reasoning to establish that the combination of Frielinghaus and Saracen renders obvious certain subject matter of independent claims 1 and 12—namely, “a memory having information stored therein correlating a plurality of patient- experience outcomes with corresponding delivered-radiation metrics” and using a particular one of the patient-experience outcomes as an optimization goal when optimizing at least one candidate radiation-therapy treatment plan by automatically modifying treatment plan parameters . . . such that the radiation-therapy treatment plan is optimized as a specific function of the particular one of the patient-experience outcomes. See Appeal Br. 14, 16 (Claims App.). Accordingly, we do not sustain the rejection of claim 1 or claim 12, or their dependent claims 2, 3, 5, 7–11, 13, 14, and 17–19, as unpatentable over Frielinghaus and Saracen. Rejection II—Obviousness: Frielinghaus, Saracen, and Wu The Examiner does not articulate any additional findings or reasoning in rejecting claims 6 and 16, which depend from claims 1 and 12, respectively, that would cure the aforementioned deficiency in the rejection of claims 1 and 12. See Final Act. 9–10. Accordingly, we do not sustain the 2 Saracen’s teaching that “[a]fter one or more treatment constraints have been optimized as reflected in a desirable DVH, the operator may . . . add the treatment plan to a particular library of accepted treatment plans for use by other operators as part of a treatment plan optimization process” appears to support Appellant’s contention that Saracen’s treatment plans become “‘accepted’ merely by having been optimized.” See Saracen ¶ 38; Appeal Br. 10. Appeal 2019-000829 Application 14/039,413 10 rejection of claims 6 and 16 as unpatentable over Frielinghaus, Saracen, and Wu. DECISION The Examiner’s decision rejecting claims 1–3, 5–14, and 16–19 is REVERSED. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1–3, 5, 7–14, 17–19 103 Frielinghaus, Saracen 1–3, 5, 7– 14, 17–19 6, 16 103 Frielinghaus, Saracen, Wu 6, 16 Overall Outcome 1–3, 5–14, 16–19 REVERSED Copy with citationCopy as parenthetical citation