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 .
Specification
The disclosure is objected to because of the following informalities:
On page 1 of the specification, the status of co-pending applications should be updated.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 74-93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 11648418. Although the claims at issue are not identical, they are not patentably distinct from each other because the inventions are directed to medical treatment applications utilizing dose-volume histograms for more accurately characterizing the applied radiotherapy treatment. The claims of the patent, such as claim 1, are narrower in that they refer to use of the DVH curves during a radiotherapy procedure, displaying a comparison of the DVH to a user, and updating the radiotherapy plan in real time. However, it would have been obvious to one of ordinary skill in the art to omit these features, as one of ordinary skill in the art would recognize that the DVH calculations may be performed during or outside of the radiotherapy procedure.
Claim 1 of the instant application also differs in that it refers to functional imaging data comprising one or more of genetic expression data and antigen binding data, however it is noted that the patent refers to these limitations in claims 14 and 27-29 for example. The claims of the instant application would have been an obvious variation of the invention defined in the claims of the parent application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 74-80, 89, and 91-93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mazin (US 2011/0291015) in view of Olcott et al. (US 2014/0046179; hereinafter Olcott).
Mazin shows a method for adapting radiotherapy (abstract), the method comprising: generating a radiotherapy treatment plan for a patient comprising a plurality of treatment sessions and a treatment plan dose distribution (pre-treatment planning stage; [0017], [0021]-[0022]); acquiring functional imaging data at every treatment session using imaging detectors (PET imaging, [0018]-[0019]; PET radiotracers, [0026]-[0027]); evaluating changes to an expected delivered dose using the acquired functional imaging data (accumulation of the detected positron emission events can be used to image the volume; [0025]); and updating the radiotherapy treatment plan by adjusting the treatment plan dose distribution according to the acquired functional imaging data (image data used to modify subsequent treatment; [0025]).
Mazin also shows wherein evaluating changes to the expected delivered dose comprises calculating a radiation dose from the acquired functional imaging data and determining whether the calculated radiation dose meets a clinical goal (until a prescribed dosage of radiation has been directed to volume; [0025]); wherein the imaging detectors comprise one or more of PET detectors, SPECT detectors, MR detectors, and CT detectors ([0028]); wherein acquiring functional imaging data occurs at a beginning of a treatment session (imaging throughout procedure is considered to encompass beginning and end of treatment session; [0022], [0030]); wherein acquiring functional imaging data occurs at an end of a treatment session (imaging throughout procedure is considered to encompass beginning and end of treatment session; [0022], [0030]).
Mazin fails to show wherein the functional imaging data comprises one or more of genetic expression data and antigen binding data.
Mazin also fails to show wherein antigen binding data comprises PSMA antigen concentration levels; wherein acquiring functional imaging data comprises providing an F18-PSMA tracer or Ga68-PSMA tracer to the patient at one or more treatment sessions; wherein the F18-PSMA tracer is 18F-PyL; wherein genetic expression data comprises human growth factor receptor type 2 (HER2) genetic expression levels; wherein HER2 genetic expression levels are derived from standard uptake values (SUV) of voxels in the acquired functional imaging data; wherein acquiring functional imaging data comprises providing a radiolabeled 5F7 antibody to the patient.
Olcott discloses positron emission tomography for disease evaluation. Olcott teaches wherein the functional imaging data comprises one or more of genetic expression data and antigen binding data ([0024], [0029]). Olcott also teaches wherein antigen binding data comprises PSMA antigen concentration levels ([0024], [0029); wherein acquiring functional imaging data comprises providing an F18-PSMA tracer or Ga68-PSMA tracer to the patient at one or more treatment sessions ([0023]); wherein genetic expression data comprises human growth factor receptor type 2 (HER2) genetic expression levels ([0024], [0029]); wherein HER2 genetic expression levels are derived from standard uptake values (SUV) of voxels in the acquired functional imaging data ([0024], [0029]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Mazin to utilize functional imaging data comprising genetic expression data or antigen binding data as taught by Olcott, as Olcott teaches that identifying genetic expression data or antigen binding data aids in identifying cancerous tissue, thereby providing an improved diagnosis ([0006], [0029]). Furthermore, it would be within the level of one of ordinary skill in the art and an obvious design choice to one of ordinary skill in the art, to utilize any known types diagnostic imaging agents, such as 18F-PyL or 5F7 antibody, depending on the patient’s specific cancerous state, depending on the availability of the diagnostic agents, etc., as there are a variety of known imaging agents which may be selected without undue experimentation by one of ordinary skill in the art to provide functional imaging data for the radiation treatment monitoring purposes of Mazin.
Claim(s) 81-88 is/are rejected under 35 U.S.C. 103 as being unpatentable Mazin (US 2011/0291015) in view of Olcott et al. (US 2014/0046179; hereinafter Olcott) as applied to claim 74 above, and further in view of Bal et al. (US 2012/0323599; hereinafter Bal).
Mazin fails to show wherein updating the radiotherapy treatment plan comprises adjusting the number of treatment sessions in the treatment plan; adjusting the treatment plan dose distribution comprises expanding radiation dose to around a target volume; wherein adjusting the treatment plan dose distribution comprises increasing radiation dose to a target volume; wherein adjusting the treatment plan dose distribution comprises reducing radiation dose to a target volume; wherein adjusting the treatment plan dose distribution comprises increasing radiation dose to regions of increased genetic expression levels or increased antigen binding levels; wherein adjusting the treatment plan dose distribution comprises shifting the treatment plan dose distribution; wherein adjusting the treatment plan dose distribution comprises scaling the treatment plan dose distribution; wherein updating the radiotherapy treatment plan comprises reducing a duration of a treatment session.
Bal discloses scheduling of dose calculation tasks. Bal teaches wherein updating the radiotherapy treatment plan comprises adjusting the number of treatment sessions in the treatment plan ([0003], [0056]); adjusting the treatment plan dose distribution comprises expanding radiation dose to around a target volume (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]); wherein adjusting the treatment plan dose distribution comprises increasing radiation dose to a target volume (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]); wherein adjusting the treatment plan dose distribution comprises reducing radiation dose to a target volume (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]); wherein adjusting the treatment plan dose distribution comprises increasing radiation dose to regions of increased genetic expression levels or increased antigen binding levels (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]); wherein adjusting the treatment plan dose distribution comprises shifting the treatment plan dose distribution (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]); wherein adjusting the treatment plan dose distribution comprises scaling the treatment plan dose distribution (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]); wherein updating the radiotherapy treatment plan comprises reducing a duration of a treatment session (adjust dose optimization to account for any changes, tumor shrinkage, organ movement; [0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mazin and Olcott to update the radiotherapy treatment plan dose distribution as taught by Bal, as Bal teaches that the radiotherapy treatment plan may be updated to account for imaging acquired during the therapy, thereby providing a more accurate treatment plan representing the most recent data on the patient. Bal teaches adjusting dose optimization to account for any changes, such as tumor shrinkage or organ movement ([0056]) and it would be an obvious design choice to one of ordinary skill in the art, to modify any parameters of the radiation treatment plan including the number of treatment sessions, expanding radiation dose, increasing radiation dose, reducing radiation dose, shifting, scaling, or reducing duration of the treatment sessions, or modifying any other known parameters of a radiation treatment session, without undue experimentation, in order to provide the desired result of adjusting dose optimization to account for any changes.
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable Mazin (US 2011/0291015) in view of Olcott et al. (US 2014/0046179; hereinafter Olcott) as applied to claim 74 above, and further in view of Zhang et al. (US 2014/0275704; hereinafter Zhang).
Mazin fails to show wherein evaluating changes to the expected delivered dose comprises calculating a plan quality index (PQI) from the functional imaging data and determining whether the PQI is within an acceptable range.
Zhang discloses methods and systems for radiation therapy. Zhang teaches evaluating changes to the expected delivered dose comprises calculating a plan quality index (PQI) from the functional imaging data and determining whether the PQI is within an acceptable range ([0065], [0073]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Mazin and Olcott to utilize a PQI as taught by Zhang, as Zhang teaches that by dynamically changing the dose rates according the to PQI of each individual phase, the composite plan can be further improved over the original plan, and increase flexibility without significantly increasing the complexity of the control system ([0065]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Frangioni (US 2006/0108509) discloses that .sup.18F can be used in the form of 2-[.sup.18F]fluoro-2-deoxy-D-glucose (.sup.18FDG), or an .sup.18FDG linked to a targeting ligand, such as an antibody or other protein or peptide, or a carbohydrate or other moiety that binds specifically to a target, such as a cell surface marker on a tumor (e.g., HER2 on breast cancer cells) ([0052]).
Hefti (US 2009/0257949) discloses radiopharmaceutical imaging and the use of .sup.18F-fluoropropyl dihydrotetrabenazine ([0055])
Tersigni (US 8197471) discloses PET imaging of HER2 (column 13).
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797