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 Objections
Claims 5 – 22, 28 – 53, 58 – 83, and 85 – 91 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only--, and/or, --cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 5 – 22, 28 – 53, 58 – 83, and 85 – 91 have not been further treated on the merits.
Claims 19 and 44 are objected to because of the following informalities: “D99” lacks of antecedent basis and because of this reason, the 112(b) rejection is set forth below. 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 5, 7, 9, 24 – 27, 54 – 57, and 84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4, 7 – 9, 14 – 16 and 20 of U.S. Patent No. 12,214,218 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the above claims in the present application is anticipated by the above claims in the U.S. Patent.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19 and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As discussed above.
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, 24, 25, 27, 54 – 57, and 84 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulte (US 2016/0144201 A1; cited in the IDS).
With respect to independent claim 1, Schulte teaches in Figs. 4 – 5 a method of treating a tumor in a subject in need thereof, said tumor comprising:
a total planning target volume (PTVTOTAL) comprising the tumor's total volume , wherein the PTVTOTAL comprises a first planning target sub-volume (PTVHD) 525 and a second planning target sub-volume (PTVPMDS) 530;
wherein the method comprises delivering a radiation dose to each of the PTVPMDS and PTVHD as disclosed in paragraph [0069],
wherein the dose of radiation delivered to the PTVPMDS is lower as disclosed in paragraph [ 0069] than the dose of radiation delivered to the PTVHD, and
wherein the dose of radiation delivered to the PTVPMDS is insufficient as disclosed in paragraph [0069] to treat the tumor when delivered to the entirety of the PTVTOTAL.
With respect to dependent claims 2 – 3, Schulte teaches in paragraph [0092] wherein the PTVHD comprises at least 60% of the PTVTOTAL or wherein the PTVHD comprises at least 60% of the tumor's total volume.
With respect to dependent claim 4, Schulte teaches in paragraph [0092] wherein the PTVPMDS comprises 40% or less of the PTVTOTAL.
With respect to independent claim 24, Schulte teaches a system comprising:
a) a radiation source proton beam 510; and
b) an electronic device 128,132, the electronic device including at least a memory and a processor operatively coupled to the memory and configured to execute instructions stored on the memory, the processor configured to:
i) define a total planning target volume (PTVTOTAL) comprising the tumor's total volume, wherein said PTVTOTAL comprises a first planning target sub-volume (PTVHD) and a second planning target sub-volume (PTVPMDS);
ii) define a radiotherapy treatment plan for said PTVTOTAL; and
iii) send, to the radiation source, a signal indicative of an instruction to deliver radiation doses to the PTVTOTAL, wherein the dose of radiation delivered to the PTVPMDS is less the dose of radiation delivered to the PTVHD; wherein the dose of radiation delivered to the PTVPMDS is insufficient to treat the tumor when delivered to the entirety of the PTVTOTAL see the rejection justification to claim 1 above.
With respect to dependent claim 25, Schulte teaches wherein the radiation source is selected from the group consisting of an x-ray emitter, an electron beam emitter, a proton beam emitter 510, and a linear accelerator.
With respect to dependent claim 27, as discussed above Schulte teaches wherein the PTVHD comprises at least 60% of the PTVTOTAL.
With respect to independent claim 54, Schulte teaches in Figs. 4 – 5 a method of treating a tumor in a subject in need thereof comprising: defining, at a processor, a total planning target volume (PTVTOTAL) of the tumor; dividing, at the processor, the PTVTOTAL of the tumor into at least a first planning target sub-volume (PTVHD) and a second planning target sub-volume (PTVPMDS); sending, from the processor and to a radiation source, a signal associated with a perfusion modulated dose sculpting (PIMDS) radiotherapy plan; and delivering, from the radiation source, a dose of radiation to each of the PTVHD and the PTVPMDS based on the PMDS radiotherapy plan, wherein the dose of radiation covering 95% of the PTVPMDS (PTVPMDS-D95) is lower than the dose of radiation covering 95% of the PTVHD (PTVHD-D95).
With respect to dependent claims 55 – 56, see the rejection above.
With respect to dependent claim 57, see the rejection above.
With respect to independent claim 84, Schulte teaches in Figs. 1, 4 – 5 and 15 a method of defining a perfusion modulated dose sculpting (PMDS) radiotherapy plan for treating a tumor in a subject in need thereof, the method comprising: defining, at a processor, a total planning target volume (PTVTOTAL) of the tumor;
dividing, at the processor, the PTVTOTAL of the tumor into at least a first planning target sub-volume (PTVHD) and a second planning target sub-volume (PTVPMDS);
defining a dose of radiation for each of the PTVHD and the PTVPMDS; and
defining the PMDS radiotherapy plan for treating the tumor wherein the dose of radiation covering 95% of the PTVPMDS (PTVPMDS-D95) is lower than the dose of radiation covering 95% of the PTVHD (PTVHD-D95) and wherein the PTVPMDS-D95 is lower than the dose of radiation covering 95% of the total PTV (PTVTOTAL-D95) required to treat the tumor.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulte, and further in view of Grimm (DE 20014563 U1; see provided a translation copy).
The teaching of Schulte has been discussed above.
With respect to dependent claim 26, Schulte is silent with wherein the radiation source comprises a radioactive element selected from the group consisting of radioactive cesium, iridium, iodine, cobalt, and combinations thereof.
Grimm, a pertinent art, teaches in paragraph [0023] radioactive iodine. In view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Schulte in order to have desired radiation source for tumor treatment. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: Simple substitution of one known, equivalent element for another to obtain predictable results.
Conclusion
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KIHO KIM
Primary Examiner
Art Unit 2884
/Kiho Kim/ Primary Examiner, Art Unit 2884
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