ACCURAY INCORPORATEDDownload PDFPatent Trials and Appeals BoardJun 25, 20212020001506 (P.T.A.B. Jun. 25, 2021) 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. 14/991,759 01/08/2016 Shutian Li A102110 1880US.D1 1807 14420 7590 06/25/2021 WOMBLE BOND DICKINSON (US) LLP / Accuray, Inc. Attn: IP Docketing P.O. Box 7037 Atlanta, GA 30537-7037 EXAMINER BALI, VIKKRAM ART UNIT PAPER NUMBER 2663 NOTIFICATION DATE DELIVERY MODE 06/25/2021 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): IPDocketing@wbd-us.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SHUTIAN LI, YE SHENG, and SOHAIL SAYED Appeal 2020-001506 Application 14/991,759 Technology Center 2600 Before JOSEPH L. DIXON, DAVID M. KOHUT, and JON M. JURGOVAN, Administrative Patent Judges. KOHUT, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1,2 appeals from the Examiner’s decision to reject claims 1–16.3 We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Accuray, Inc. Appeal Br. 2. 2 We note that a prior appeal (Appeal 2017-010635) in a related case (US Appl. No. 14/991,428, claiming priority to the same parent application as US Appl. No. 14/991,759) was previously decided by the Board on May 9, 2018. That appeal involved the same references as the present appeal. 3 Throughout this Decision we refer to the Specification filed January 8, 2016 (“Spec.”), the Final Rejection mailed January 7, 2019 (“Final Act.”), the Appeal Brief filed September 3, 2019 (“Appeal Br.”), the Examiner’s Appeal 2020-001506 Application 14/991,759 2 We AFFIRM. INVENTION The present invention relates to systems for “tracking target movement in radiation treatment” of a patient, and “automatically control[ling] the timing of an image acquisition by an imaging system in developing a correlation model of movement of [the] target within a patient.” Spec. ¶ 2; Abstr. Claim 1 is representative of the invention and is reproduced below. 1. An apparatus, comprising: a data storage device to store a plurality of displacement points of an external marker indicative of a motion of the external marker during a periodic cycle; and a processing device operatively coupled to the data storage device, the processing device to determine a specified time in the periodic cycle, which corresponds to a first phase of the periodic cycle, in which to acquire an image of a target based on the plurality of displacement points, and to transmit a signal to automatically trigger an imaging system to acquire the image of the target at the first phase of the periodic cycle. Appeal Br. 10 (Claims App.).4 REFERENCES The prior art relied upon by the Examiner is: Answer mailed November 4, 2019 (“Ans.”), and the Reply Brief filed December 18, 2019 (“Reply Br.”). 4 The Appeal Brief pages are not numbered. We count the pages of the Appeal Brief (including the Claims Appendix) starting from the first page (the title page). Appeal 2020-001506 Application 14/991,759 3 Name Reference Date Schweikard et al. US 6,144,875 Nov. 7, 2000 Mostafavi WO 03/003796 A1 Jan. 9, 2003 REJECTIONS The Examiner interprets claims 1 and 14 under 35 U.S.C. § 112, 6th paragraph, as reciting means-plus-function limitations. Final Act. 6–7. Claims 1–16 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Schweikard in view of Mostafavi. Final Act. 7–11. OPINION Interpretation of Claims 1 and 14 as Including Means-Plus-Function Limitations The Examiner concludes the following claim limitations are means- plus-function limitations invoking 35 U.S.C. § 112, 6th paragraph: (1) “a data storage device,” (2) “a processing device,” and (3) “an imaging system” (claim 1); (4) “a motion tracking system,” (5) “an imaging system,” and (6) “a target locating system” (claim 14). Final Act. 6–7; Ans. 10. Appellant contends one of ordinary skill in the art would understand that the above limitations connote sufficiently definite structure to avoid interpretation under 35 U.S.C. § 112, 6th paragraph, such that the limitations do not invoke § 112, 6th paragraph. Appeal Br. 4–6; Reply Br. 2. Appellant’s arguments are persuasive. Failure to use the word “means” creates a rebuttable presumption that § 112, 6th paragraph is not invoked. Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc). This presumption can be overcome and § 112, 6th Appeal 2020-001506 Application 14/991,759 4 paragraph will apply, despite the lack of the word “means,” if “the challenger demonstrates that the claim term fails to ‘recite[ ] sufficiently definite structure’ or else recites ‘function without reciting sufficient structure for performing that function.’” Id. at 1349 (quoting Watts v. XL Sys., Inc., 232 F.3d 877, 880 (Fed. Cir. 2000)). Here, none of the disputed limitations use the word “means.” Therefore, Examiner, as challenger, bears the burden of demonstrating that § 112, 6th paragraph should apply to the claim terms. The Examiner finds “the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.” Final Act. 6–7. The Examiner’s rejection, however, has not overcome the presumption that means-plus-function analysis does not apply here. In addition, the record, which includes the claim language and Appellant’s disclosure, does not support the Examiner’s findings or conclusion that the disputed claim terms invoke § 112, 6th paragraph. When analyzing whether the presumption against applying § 112, 6th paragraph is overcome, we consider how a claim limitation is “used in the context of the relevant claim language.” Advanced Ground Info. Sys., Inc. v. Life360, Inc., 830 F.3d 1341, 1348 (Fed. Cir. 2016). Further, “[i]n undertaking this analysis, we ask if the claim language, read in light of the specification, recites sufficiently definite structure,” which avoids application of § 112, 6th paragraph. Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1372–73 (Fed. Cir. 2015) (analyzing specification to determine if term was described in specific structural terms). We address the interpretation of each of the disputed limitations below. Appeal 2020-001506 Application 14/991,759 5 (1) “a data storage device” (claim 1) The “data storage device” is used in a structural manner in the context of claim 1. See Appeal Br. 4. Specifically, claim 1 recites that the data storage device “store[s] a plurality of displacement points of an external marker indicative of a motion of the external marker during a periodic cycle.” In addition, the “data storage device,” when read in light of the Specification, recites sufficiently definite structure. See Appeal Br. 4–6. As noted by Appellant, the Specification describes the “data storage device” in a structural manner. See Appeal Br. 5 (citing Spec. ¶ 31); see also Spec. ¶¶ 69, 105–106. According to Appellant’s Specification, a data storage device is an electronic storage element, such as a magnetic or optical storage component, or a read-only, programmable, or flash memory. See Spec. ¶ 31. The description in the Specification demonstrates that claim 1 recites a “data storage device” of sufficiently definite structure, and avoids invoking § 112, 6th paragraph. (2) “a processing device” (claim 1), and (6) “a target locating system” (claim 14) The “target locating system” and its “processing device” are used in a structural manner in the context of claims 1 and 14. See Appeal Br. 4. Specifically, claim 14 recites that the target locating system is “operatively coupled to the motion tracking system and the imaging system” and “automatically trigger[s] the imaging system to trigger the acquisition of the image at a specified time,” and claim 1 recites that the processing device is “operatively coupled to the data storage device,” “determine[s] a specified time in the periodic cycle, which corresponds to a first phase of the periodic cycle, in which to acquire an image of a target,” and “transmit[s] a signal to Appeal 2020-001506 Application 14/991,759 6 automatically trigger an imaging system to acquire the image of the target at the first phase of the periodic cycle.” In addition, the “target locating system” and its “processing device,” when read in light of the Specification, recite sufficiently definite structure. See Appeal Br. 4–6. As noted by Appellant, the Specification describes the “target locating system” and the “processing device” in a structural manner, and the drawings depict the “target locating system” and its “processing device” as structures interacting or engaging with other structures. See Appeal Br. 5–6 (citing Spec. ¶¶ 34, 99); see also Spec. Figs. 9 and 16–17. We also note the Examiner has made no effort to address Appellant’s citations to the Specification and Appellant’s arguments that the Specification describes the “target locating system” and the “processing device” in a structural manner, and that “the claims . . . include structural modifiers (which have been ignored by the Examiner).” See Appeal Br. 4–6; Reply Br. 2. In the Final Action, the Examiner merely states that the “claim limitations . . . do not use the word ‘means,’ but are nonetheless being interpreted under 35 U.S.C. 112(f)” because “the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.” See Final Act. 6. The Examiner does not specifically respond to Appellant’s arguments in the Answer, and instead reproduces text from the Manual of Patent Examining Procedure (MPEP). See Ans. 10. Because the Examiner has failed to specifically address Appellant’s arguments regarding the claimed limitations and the description in Appellant’s Specification, the presumption (i.e., that Appeal 2020-001506 Application 14/991,759 7 “means-plus-function” analysis does not apply because the word “means” is not used) has not been rebutted by the Examiner. We further note, according to Appellant’s Specification, a “target locating system” and its “processing device” are structures interacting or engaging with other structures. For example, a target locating system (TLS) described in the Specification performs, via its processing device, “automatic triggering” by which, for example: a “result of the X-ray imaging is controlled by current LED signals (e.g., representative of the movement of the external markers), and when the LED moves into a desired triggering location, the triggering event happens and the images are at the desired triggering location” (see Spec. ¶ 34); commands and operating messages are automatically sent to an imaging system to acquire pretreatment images at specified times (id. ¶¶ 36, 48, 56–57, 72, 75, 78, Fig. 10 (“Window Gating Information 1006” and “Trigger Signal 1007” exchanged between server 1002, “server 1001, which may be the target location system 900,” and imagers)); timing of an X-ray image is controlled, based on a respiratory cycle, heartbeat cycle, or other periodic motion of a patient, to acquire a model point in a desired location on/in the body of the patient (id. ¶ 35); and phases of the respiratory (or other periodic) cycle at which to acquire images are automatically determined by the processing device, such that “the processing device 902 automatically acquires the model point (e.g., image) at the indicated phase of the respiratory cycle” (id. ¶¶ 61, 65, 69, Fig. 9). In addition, “the motion tracking system 904 is used in conjunction with the processing device 902 of the treatment delivery system 900 to deliver radiation beams to a target whose surrounding tissue is moving with respiration during treatment delivery.” Id. ¶ 68, Fig. 9. For Appeal 2020-001506 Application 14/991,759 8 example, the target locating system (e.g., TLS 900 in Fig. 9) enables movement of a LINAC to compensate for target/patient motion. Id. The processing device of the target locating system is coupled by communication channels (e.g., buses) to an imaging source and imaging detector, the processing device being configured to “send[] a trigger command or signal to the imaging system 905 on interface 909” in order to automatically acquire images at specified times. Id. ¶¶ 72, 98–99, 104, Figs. 9 and 16. Such processing device “may include one or more general-purpose processors (e.g., a microprocessor), special purpose processors such as a digital signal processor (DSP), or other type of devices such as a controller or field programmable gate array (FPGA)” and may “generate[] digital diagnostic images . . . in a standard format such as . . . DICOM.” Id. ¶¶ 98– 99. This description indicates that claims 1 and 14 recite a “target locating system” and “processing device” of sufficiently definite structure, and avoids invoking § 112, 6th paragraph. (3) “an imaging system” (claim 1), and (5) “an imaging system” (claim 14) The “imaging system” is used in a structural manner in the context of claims 1 and 14. See Appeal Br. 4. Specifically, claim 1 recites that the imaging system is “automatically trigger[ed] [by a signal] . . . to acquire the image of the target at the first phase of the periodic cycle,” and claim 14 recites that the imaging system “acquire[s] an image of a target within the patient” and is “automatically trigger[ed] . . . to trigger the acquisition of the image at a specified time.” In addition, the “imaging system,” when read in light of the Specification, recites sufficiently definite structure. See Appeal Br. 4–6. As noted by Appellant, the Specification describes the “imaging Appeal 2020-001506 Application 14/991,759 9 system” in a structural manner, and the drawings depict the “imaging system” as a structure interacting or engaging with other structures. See Appeal Br. 5–6 (citing Spec. ¶¶ 97–98, Figs. 9 and 16); see also Spec. ¶¶ 62–63, 71–73, 114, Figs. 1 and 17. According to Appellant’s Specification, an imaging system may be “a computed tomography (CT) system, a magnetic resonance imaging (MRI) system, a positron emission tomography (PET) system, an ultrasound system . . . a CT X-ray imaging system” or a LINAC (medical linear accelerator), including an “imaging source . . . [that] generates an imaging beam” and an “imaging detector . . . [that] detects and receives the imaging beam . . . [or] a secondary imaging beam or an emission stimulated by the imaging beam from the imaging source (e.g., in an MRI or PET scan).” See Spec. ¶¶ 73, 97–98, Fig. 9. This description demonstrates that claims 1 and 14 recite an “imaging system” of sufficiently definite structure, and avoids invoking § 112, 6th paragraph. (4) “a motion tracking system” (claim 14) The “motion tracking system” is used in a structural manner in the context of claim 14. See Appeal Br. 4. Specifically, claim 14 recites that the motion tracking system “track[s] motion of an external marker associated with a patient, the motion of the external marker . . . indicative of a periodic cycle of the patient” and is “operatively coupled” to the “target locating system.” In addition, the “motion tracking system,” when read in light of the Specification, recites sufficiently definite structure. See Appeal Br. 4–6. As noted by Appellant, the Specification describes the “motion tracking system” in a structural manner, and the drawings depict the “motion tracking system” as a structure interacting or engaging with other structures. See Appeal Br. 5–6 (citing Spec. ¶¶ 66–67); see also Spec. ¶¶ 33, 40–41, 52, 54, Appeal 2020-001506 Application 14/991,759 10 64, 68, Fig. 1 (illustrating a sensor 32), Fig. 9 (illustrating a motion tracking system 904 including sensor 32), Fig. 17 (illustrating a motion tracking system 904). According to Appellant’s Specification, a motion tracking system (i) is a structure (e.g., a SYNCHRONY® respiratory tracking system) in a LINAC or other medical scanning system, (ii) performs tracking (e.g., fiducial tracking, soft-tissue tracking, skeletal structure tracking, and/or real-time motion compensation) of physical targets, and (iii) may include “external sensors, such as a tracking sensor that tracks internal or external markers associated with a patient, a heart beat monitor, or the like,” the tracking sensor tracking location (e.g., upward and downward movements during inspiration and expiration intervals) of an “external marker” that is a “device such as a light source (e.g., light emitting diode (LED)) or a metal button attached to a vest worn by the patient.” See Spec. ¶¶ 33, 40–41, 64, 66–68. This description demonstrates that claim 14 recites a “motion tracking system” of sufficiently definite structure, and avoids invoking § 112, 6th paragraph. 35 U.S.C. § 103(a) Rejection With respect to independent claim 1, Appellant argues Mostafavi does not teach a processing device “to transmit a signal to automatically trigger an imaging system to acquire the image of the target at the first phase of the periodic cycle,” as claimed. Appeal Br. 7. In particular, Appellant argues “the image acquisition taught in Mostafavi is not automatically triggered. Rather, it is the application of the radiation treatment beam that is automatically triggered based on the target being in a known position (i.e., gating).” Id. (citing Mostafavi 18). Appellant references Appeal 2020-001506 Application 14/991,759 11 Mostafavi’s marker tracking in video frames, asserting that merely teaches “a manual triggering operation” such that “triggering of images in Mostafavi cannot be inherently automatic.” Id. at 8 (citing Mostafavi 9:24–33); see also Reply Br. 3. Appellant further argues the Examiner’s combination of Schweikard and Mostafavi lacks articulated reasoning and “does not provide a valid analysis of why or how the result obtained [by Examiner’s asserted combination] would be predictable.” Appeal Br. 6; see also Reply Br. 3. Appellant additionally argues the Examiner’s asserted rationale to combine the references is “incorrect” because “Schweikard and Mostafavi [are] directed to solving different problems,” and a skilled artisan “would not be motivated to modify the system of Schweikard to perform the gating taught by Mostafavi.” Appeal Br. 7; see also Reply Br. 3. We do not agree with Appellant’s arguments. Instead, we agree with the Examiner’s findings. Final Act. 8–9; Ans. 11–12. Particularly, we agree with the Examiner that Mostafavi’s system for physiological gating “transmit[s] a signal to automatically trigger an imaging system to acquire the image of the target at the first phase of the periodic cycle,” as recited in claim 1. See Ans. 12 (citing Mostafavi 16:10–16); Final Act. 8 (citing Mostafavi 14:14–16, 15:30–33, 16:11–16, 16:30–33, 17:12–13, 19:10–27, 23:4–27). For example, page 16, lines 10–16 and lines 30–33, page 19, lines 10–27, and page 23, lines 4–27 of Mostafavi describe automatically triggering image acquisition of a target’s image (in addition to automatically triggering a radiation treatment beam, as Appellant argues). See Mostafavi 16:10–16, 16:30–33, 19:10–27, 23:4–27; Final Act. 8; Ans. 12. Specifically, Mostafavi explains its “description of physiological gating applies to controlling radiation in radiation therapy/imaging and to controlling the Appeal 2020-001506 Application 14/991,759 12 image acquisition process in imaging applications.” See Mostafavi 16:30– 33 (emphasis added). More particularly, Mostafavi’s tracking of a marker block (an external marker) “allows monitoring of the patient motion in diagnostic and therapy imaging applications where image data acquisition is gated or synchronized with periodic motion” that corresponds to “the motion and phase of patient physiological activity,” thereby “trigger[ing] image acquisition . . . at specific points during [a] normal periodic cycle (e.g., breathing cycle).” See Mostafavi 16:7–16 (emphasis added). For example, a “phase of the physiological movement signal . . . from 30 degrees to 300 degrees” and a “‘beam on’ portion of the treatment interval” direct a switch “to gate . . . acquisition of images from the patient using an imaging device.” See Mostafavi 19:19–23; 23:8–10 and 17–18; Figs. 3 and 9. Appellant’s arguments (that Mostafavi’s page 9, lines 24–33 teaches manual triggering, and that “triggering of images in Mostafavi cannot be inherently automatic,” see Appeal Br. 8) have not addressed the portions of Mostafavi cited in the rejection and the Examiner’s specific findings. We are also unpersuaded by Appellant’s argument that the Examiner’s combination of Schweikard and Mostafavi lacks articulated reasoning and “does not provide a valid analysis of why or how the result obtained [by Examiner’s asserted combination] would be predictable.” See Appeal Br. 6–7. We find the Examiner has articulated sufficient reasoning for combining the references to produce claim 1’s limitations. See Ans. 11–12; Final Act. 8–9. Particularly, the Examiner finds Schweikard images a target (e.g., a patient’s internal organ) to map the target to the position of an external marker during a respiratory cycle. Final Act. 3–4, 8 (citing Schweikard Appeal 2020-001506 Application 14/991,759 13 7:41–46, 8:4–13, Figs. 10 and 11); Ans. 11–12. Further, the Examiner finds Mostafavi uses displacement of an externally attached marker to determine a portion (interval) in a periodic cycle (e.g., a breathing cycle) in which to acquire images of a target (e.g., a tumor or tissue in a patient) with fewer image errors caused by patient movement. Final Act. 3–4, 8–9 (citing Mostafavi 14:14–16, 15:30–33, 16:11–16, 17:12–13, 19:10–27, 23:4–27); Ans. 11–12; see Mostafavi 16:11–16 (“amplitude and/or phase of the marker block coordinates vs. time, corresponding to the motion and phase of patient physiological activity, can be used to trigger image acquisition or non- acquisition at specific points during normal periodic cycle (e.g., breathing cycle) to minimize image distortion effects of patient motion”), 19:10–27 (“imaging procedures . . . are subject to a range of image errors due to patient movement” but “treatment intervals or range intervals . . . are established over the imaging cycle to gate the collection of image data from the patient . . . [m]otion within the boundaries of the treatment interval is predicted to correspond to fewer image errors”). The Examiner then reasons the skilled artisan would have “incorporated [Mostafavi’s teaching of determining intervals in a periodic cycle in which to acquire images] in to the Schweikard’s system in place of step 218 of figure 10 for acquiring images” to “yield[] a system that will compensate the movements of the patients such as respiration or heart movements thereby helping the overall treatment of the patients.” Final Act. 9. The Examiner also reasons the skilled artisan would understand that the use of Mostafavi’s gating technology in Schweikard would provide a predictable result of decreasing imaging errors due to patient movement, since Appeal 2020-001506 Application 14/991,759 14 Mostafavi explicitly recites that these [medical imaging] technologies are subject to image errors due to patient movement and offers the gating as a solution to the problem . . . [and] one of ordinary skill in the art, looking to solve imaging errors due to patient movement during the imaging with such medical imaging modalities, would reasonably look to and expect the solution (i.e. gating) of Mostafavi to correct the errors. Ans. 11–12; see also Final Act. 4. Thus, Examiner’s rationale to combine the references is explicitly supported by Mostafavi’s disclosure. See Mostafavi 16:10–16, 17:12–26, 18:18–20, 19:19–27, 23:4–27. We are also unpersuaded by Appellant’s argument that Schweikard and Mostafavi cannot logically be combined because they are “directed to solving different problems” and Schweikard teaches an entirely different method to gating that tracks the position of the target and directs treatment towards the target to compensate for motions of the target. In contrast, the different gating method taught by Mostafavi waits for the target to move to a known position in a patient’s breathing cycle and then only applies radiation when the target is thought to be at the known position of the patient’s breathing cycle. See Appeal Br. 7. We note that Mostafavi is not so restricted (as Appellant argues). As discussed supra, Mostafavi also determines intervals in a periodic cycle in which to acquire images of a target with fewer image errors due to patient movement. Thus, we agree with the Examiner that “both Schweikard and Mostafavi are directed to medical imaging, particularly the imaging of a moving patient” and the references “are analogous because they are solving [a] similar problem of imaging patients during the radiological treatments.” Ans. 12 (citing Schweikard 2:25–30); Final Act. 8–9. Appeal 2020-001506 Application 14/991,759 15 Consequently, Appellant’s arguments do not show error in the Examiner’s factual findings or conclusion of obviousness of independent claim 1. We therefore sustain the Examiner’s obviousness rejection of independent claim 1, independent claims 10 and 14 argued for the same reasons, and dependent claims 2–9, 11–13, 15, and 16 not separately argued. Appeal Br. 8. See 37 C.F.R. § 41.37(c)(1)(iv). CONCLUSION The Examiner interpretation of claims 1 and 14 under 35 U.S.C. § 112, 6th paragraph, as reciting means-plus-function limitations, is REVERSED. The Examiner’s decision rejecting claims 1–16 under 35 U.S.C. § 103(a) is AFFIRMED. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 14 112 means-plus- function claim construction 1, 14 1–16 103(a) Schweikard, Mostafavi 1–16 Overall Outcome 1–16 Appeal 2020-001506 Application 14/991,759 16 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation