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 – 4, 8 – 9, 11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kutuk (Cancers, published on 15 June 2022, Cited in IDS filed on 1/28/26).
With respect to independent claim 1, Kutuk teaches in Simple Summary a method for re-treatment of a tumor, comprising:
providing therapy pulses to the tumor in accordance with a pulsed reduced dose rate (PRDR) PRDR therapy pattern, wherein the therapy pulses are PRDR intensity modulated proton therapy (IMPT) IMRT pulses comprising proton pulses provided to the tumor.
With respect to dependent claim 2, Kutuk teaches in Simple Summary (see “recurrent” and “re-irradiation” wherein the tumor was previously treated by applying pulsed reduced dose rate (PRDR) photon therapy pulses to the tumor.
With respect to dependent claim 3, Kutuk teaches in Fig. 2 and under 2.3 “PRDR treatment planning and delivery” on p. 3 wherein the PRDR photon therapy pulses are about 0.2 Gy/pulse (2 Gy/fx) with an interval of at least 3 minutes between the PRDR photon therapy pulses.
With respect to dependent claim 4, Kutuk teaches under 2.3 “PRDR treatment planning and delivery” on p. 3 wherein the PRDR-IMPT pulses have an averaged effective treatment dose rate of approximately 7 cGy/min over one treatment fraction.
With respect to dependent claim 8, Kutuk teaches in the second paragraph on p. 10 wherein the pulsed reduced dose rate (PRDR) therapy pattern comprises delivery of a dose of about 50 GyRBE to about 75 GyRBE divided between about 20 fractions to about 40 fractions.
With respect to dependent claim 9, Kutuk teaches in Fig. 2 wherein the fractions are delivered to a patient over a period of time of about 20 minutes to about 50 minutes.
With respect to dependent claim 11, Kutuk teaches wherein the therapy pulses are provided according to one or more of the following therapies: stereotactic radiosurgery (SRS), fractionated SRS in the first paragraph on p. 11, hypofractionated treatment in the first paragraph on p. 11, fractionated proton therapy, or particle therapy.
With respect to dependent claim 13, Kutuk teaches in the second paragraph on p. 11 administering an effective amount of at least one of bevacizumab and ivosidenib to a patient for treatment of the tumor.
Claim(s) 1 – 7 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wroe (International Journal of Radiation Oncology / Biology / Physics, November, 2022, Cited in IDS filed on 1/28/26).
With respect to independent claim 1, Wroe teaches under 3208 on p. e540 a method for re-treatment of a tumor, comprising:
providing therapy pulses to the tumor in accordance with a pulsed reduced dose rate (PRDR) PRDR therapy pattern, wherein the therapy pulses are PRDR intensity modulated proton therapy (IMPT) IMRT pulses comprising proton pulses provided to the tumor.
With respect to dependent claim 2, Wroe teaches in (see “re-irradiation” ) under 3208 wherein the tumor was previously treated by applying pulsed reduced dose rate (PRDR) photon therapy pulses to the tumor.
With respect to dependent claim 3, Wroe teaches under “materials/Methods” on p. e540 wherein the PRDR photon therapy pulses are about 0.2 Gy/pulse (2 Gy/fx) with an interval of at least 3 minutes between the PRDR photon therapy pulses.
With respect to dependent claim 4, Wroe teaches under “materials/Methods” on p. e540 wherein the PRDR-IMPT pulses have an averaged effective treatment dose rate of approximately 7 cGy/min over one treatment fraction.
With respect to dependent claim 5, Wroe teaches under “materials/Methods” on p. e540 wherein there is a temporal gap of about 4 minutes to about 5 minutes between the PRDR-IMPT pulses.
With respect to dependent claim 6, Wroe teaches under “materials/Methods” on p. e540 wherein the PRDR-IMPT pulses are provided to repaint a treatment field previously treated by PRDR photon therapy pulses.
With respect to dependent claim 7, Wroe teaches under “materials/Methods” on p. e540 wherein the tumor comprises a central nervous system (CNS) tumor and/or an intracranial tumor.
With respect to dependent claim 12, Wroe teaches wherein providing the therapy pulses comprises directing a radiation beam to at least one of the following areas of a patient's body: brain, brainstem under Results on p. e540, optic chiasm, ipsilateral and/or contralateral optic nerves, ipsilateral and/or contralateral cochlea, or ipsilateral and/or contralateral hippocampus.
Allowable Subject Matter
Claim 10 is 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 14 – 20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to dependent claim 10, the prior art of record fails to teach or reasonably suggest:
wherein at most about 70% of a total dose of proton therapy pulses delivered to the tumor is controlled by each beam of an ion beam applicator and a remaining at least 30% of the total dose is modulated for organs-at-risk (OAR) sparring.
With respect to independent claim 14 and its dependent claim 15 – 20, the prior art of record (including Wroe and Kutuk) fails to teach or reasonably suggest:
a system for re-treatment of a tumor, comprising:
a first sub-beam emitter for providing a first plurality of intensity modulated proton therapy (IMPT) pulses in accordance with a pulsed reduced dose rate (PRDR) therapy pattern;
a second sub-beam emitter for providing a second plurality of intensity modulated proton therapy (IMPT) pulses in accordance with the PRDR therapy pattern; and
a controller electrically connected to the first and second sub-beam emitters, wherein the controller is configured to cause the first plurality of IMPT pulses and the second plurality of IMPT pulses to be provided to the tumor sequentially with a temporal gap between delivery of one or more of the first plurality of IMPT pulses and one or more of the second plurality of IMPT pulses.
Conclusion
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KIHO KIM, Ph.D.
Primary Examiner
Art Unit 2884
/Kiho Kim/ Primary Examiner, Art Unit 2884
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