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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 6, 7, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. U.S. PGPUB No. 2009/0180589.
Regarding claim 1, Wang discloses a computer-implemented method (“Certain embodiments may be implemented as a computer program product which may include instructions stored on a machine-readable medium” [0027]) of obtaining a radiation therapy treatment plan (“radiation treatment source 102 may deliver a dose of radiation as prescribed by a treatment plan” [0033]) for a patient (“System 100 may be used to perform radiotherapy or radiosurgery to treat a cardiac target within a patient” [0033]), including the following steps: obtaining a 4D image of a heartbeat (“the image data is… a cardiac-gated 4D CT image study… A cardiac-gated 4D CT image study has 3D CT images at different phases in the cardiac cycle” [0056]), deriving from the 4D image a treatment phase of the heartbeat in which radiation should be delivered to the patient (“Radiation treatment can then be delivered to the cardiac target taking into account the movement of the cardiac target” [Abstract]), obtaining an optimization problem (“the treatment plan is developed and optimized by enabling a planning algorithm that selects a set of treatment beam parameters to best satisfy the dose constraints” [0060]), said optimization problem defining planning objectives (“The treatment plan may include an optimization process that includes finding the beam parameters that best meets the specified objectives (i.e., dose constraints)” [0060]), including information about the treatment phase (“…a set of treatment beam parameters” [0060]), and optimizing the values of a set of planning parameters (“a set of dose masks giving discretized estimates of dose/MU for each beam may be used as input. A set of dose constraints, input by the user to determine the desirable dose distribution for that planning task, may also be provided to the treatment planning algorithm” [0063]) to achieve the planning objectives (“(i.e., dose constraints)” [0060], in such a way that the radiation will be delivered only during the treatment phase (“The beam on/off status can also be defined if the beam is to be gated based on different phases of the cardiac cycle” [0060]).
Regarding claim 2, Wang discloses that the set of planning parameters includes model parameters (“a cardiac motion model is computed during registration of the image data” [0057] – “The correlation model can be adapted to changes in cardiac target position and motion to adjust the treatment delivery in real-time” [0071]) defining the properties of an energy modulating device that is to be used to modulate the beam energy during delivery (“At each location, radiation treatment source 102 may deliver a dose of radiation as prescribed by a treatment plan” [0033]).
Regarding claim 5, Wang discloses that the optimization step is performed in such a way that the radiation will be delivered from two or more directions (“the user may specify particular directions and intensities for the radiation beams to be generated by the radiation treatment delivery system, choosing from a subset of available beams determined by constraints on the delivery system itself” [0061]).
Regarding claim 6, Wang discloses a computer program product comprising anon-transitory computer-readable medium storing instructions which, when run in a computer, will cause the computer to perform the method (“Certain embodiments may be implemented as a computer program product which may include instructions stored on a machine-readable medium” [0027]) according to claim 1 (see the rejection of claim 1, above).
Regarding claim 7, Wang discloses a computer system for optimizing a radiotherapy treatment plan, said computer system comprising a program memory holding a computer program product according to claim 6 (see the rejection of claim 6, above) and a processor arranged to execute said program (“Certain embodiments may be implemented as a computer program product which may include instructions stored on a machine-readable medium. These instructions may be used to program a general-purpose or special-purpose processor to perform the described operations” [0027]).
Regarding claim 8, Wang discloses a radiotherapy delivery system for delivering a radiotherapy treatment plan, said radiotherapy delivery system comprising a data memory holding a treatment plan (“Certain embodiments may be implemented as a computer program product which may include instructions stored on a machine-readable medium. These instructions may be used to program a general-purpose or special-purpose processor to perform the described operations. A machine-readable medium includes… read-only memory (ROM); random-access memory (RAM); erasable programmable memory (e.g., EPROM and EEPROM); flash memory;” [0027]) obtained according to the method of claim 1 (see the rejection of claim 1, above), and a control unit arranged to control the radiotherapy delivery system according to the treatment plan (“a digital processing system 430 to control radiation source 105, imaging system 420, and a patient support device such as a treatment couch 110” [0048]).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. U.S. PGPUB No. 2009/0180589.
Regarding claim 3, Wang discloses that the optimization step is performed in such a way that the radiation will be delivered based on a heartbeat (“a method and system are presented to correlate respiration movements and cardiac movements (such as heartbeat) of a patient to track the location of the cardiac target. The model can then be used to deliver radiation treatment more effectively to the target” [0031]). Wang discloses the claimed invention except that there is no explicit disclosure that the radiation will be delivered during the treatment phase of only one heartbeat. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to deliver radiation during the treatment phase of only one heartbeat since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One would have been motivated to deliver radiation during the treatment phase of only one heartbeat for the purpose of ensuring a desired amount of radiation treatment dose at a pathological anatomy while maintaining a comparatively low dose of radiation to healthy tissue – where it may be optimal to treat a patient only during a single heartbeat, and treating the patient during multiple heartbeats would result in undue harm to the patient. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Regarding claim 4, Wang discloses that the optimization step is performed in such a way that the radiation will be delivered based on a heartbeat (“a method and system are presented to correlate respiration movements and cardiac movements (such as heartbeat) of a patient to track the location of the cardiac target. The model can then be used to deliver radiation treatment more effectively to the target” [0031]). Wang discloses the claimed invention except that there is no explicit disclosure that the radiation will be delivered during the treatment phases of two or more heartbeats. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to deliver radiation during the treatment phases of two or more heartbeats since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. One would have been motivated to deliver radiation during the treatment phases of two or more heartbeats for the purpose of ensuring a desired amount of radiation treatment dose at a pathological anatomy while maintaining a comparatively low dose of radiation to healthy tissue – where it may be optimal to treat a patient only during a particular number of heartbeats, where treating the patient during additional heartbeats would result in undue harm to the patient, and treating the patient during fewer heartbeats would deliver an ineffective dose of radiation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235.
Conclusion
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/JASON L MCCORMACK/Examiner, Art Unit 2881
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