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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 January 2026 has been entered.
Claims 1-18, 40, 48, and 49 are currently under consideration. The Office acknowledges the amendments to claims 1-6 and 9-11.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 5-7, 12, 13, 18, 40, and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (U.S. Pub. No. 2019/0105516 A1).
Regarding claim 1, Nguyen discloses a method of treating a cancer in a subject (Abstract), the method comprising: providing a first ablative dose of radiation therapy to a first region comprising the cancer followed by a sub-ablative dose to a second region, wherein the sub-ablative dose is administered after the first ablative dose, wherein the first ablative dose comprises between 20 and 100 Gy at the first region ([0028]; [0031]; [0034]; [0037]; [0042]; Table 4; the doses may be delivered over a number of treatment sessions; the doses may be increased or reduced from one treatment to the next; the first region may be considered the hypoxic region and the second region may be considered the sensitive region; thus, Nguyen teaches providing a first dose to the first region as part of a first treatment session which may be 20 Gy, 30 Gy, 40 Gy, or 80 Gy, meeting the claimed ablative range; then, after this first dose, administering a second, sub-ablative dose to the second region as part of a second treatment session, which may be 2 Gy if the dose is kept the same, or less than 2 Gy if the dose is reduced or if the dose reflects the total dose delivered over a number of treatment sessions).
Regarding claim 5, Nguyen discloses that a cumulative amount of radiotherapy delivered to the second region throughout a course of treatment comprises less than the first ablative dose (Table 4; e.g., examples 5 and 6).
Regarding claim 6, Nguyen discloses that the cumulative amount comprising less than the first ablative dose comprises a plurality of sub-ablative doses ([0034]; Table 4).
Regarding claim 7, Nguyen discloses that the first region comprises a region of a tumor and optionally wherein the second region comprises the region of the tumor ([0028]; first region comprises a region of a tumor).
Regarding claim 12, Nguyen discloses that the second region comprises a different region from the first region ([0028]; the first region may be considered the hypoxic region and the second region may be considered the sensitive region).
Regarding claim 13, Nguyen discloses that the second region comprises a region of a tumor ([0028]; e.g., sensitive region of a tumor.
Regarding claim 18, Nguyen discloses that the first region comprises an identified tumor and the second region does not comprise an identified tumor (Fig. 4; [0021]; the first region may be considered the hypoxic region and the second region may be considered the neighboring structure or the tissue between the tumor boundary and the neighboring structure; this second region receives some dose but less than that of the sensitive region, so it also receives a sub-ablative dose).
Regarding claim 40, Nguyen discloses that the sub-ablative dose comprises between 0.1 and 2 Gy and optionally wherein the sub-ablative dose comprises a plurality of sub-ablative doses and each of the plurality of sub-ablative doses comprises between 0.1 and 2 Gy at the second region ([0034]; Table 4).
Regarding claim 48, Nguyen discloses that the radiation therapy is selected from the group consisting of x-ray radiation, gamma ray radiation, alpha particle radiation, beta particle radiation, neutron particle radiation, external beam radiation and brachytherapy ([0025]).
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.
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.
Claims 2-4 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen as applied to claim 1 above, and further in view of Skokos et al. (U.S. Pub. No. 2017/0327567 A1; hereinafter known as “Skokos”).
Regarding claims 2-4, Nguyen discloses the invention as claimed, see rejection supra, and (as detailed supra) teaches multiple treatment sessions. Nguyen fails to expressly disclose that the sub-ablative dose is administered at least 1 hour or at least 1 day, but no more than 4 days, after the first ablative dose. Skokos discloses a method of treating a cancer in a subject (Abstract) wherein radiation therapy over multiple sessions may comprise 2 or more fractions that are administered every 2 days, every 3 days, or every 4 days ([0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Nguyen with the timing taught by Skokos in order to provide a desired outcome. Administering the doses taught by Example 5 (in Table 4) of Nguyen over two fractions administered every 2, 3, or 4 days would meet all the claimed limitations; the doses taught by Example 6 (in Table 4) over three or four fractions would also meet all of the limitations.
Regarding claim 49, Nguyen discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the subject has been treated with a prior method for treating cancer. Skokos discloses a method of treating a cancer in a subject (Abstract) wherein the subject has been treated with a prior method for treating cancer in order to treat relapse and/or those who cannot receive chemotherapy ([0042]; [0066]; [0193]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Nguyen by treating a subject who has been treated with a prior method for treating cancer, as taught by Skokos, in order to treat relapse and/or those who cannot receive chemotherapy.
Allowable Subject Matter
Claims 8-11 and 14-17 are 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.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 8-11, 16, and 17, none of the prior art of record teaches or reasonably suggests providing such a first ablative dose to a region of a first tumor and then later administering a sub-ablative dose to a region of a second tumor. Typically multiple tumors are treated with similar doses; further, sub-ablative doses are typically provided before a first ablative dose (e.g., for radioprotection of healthy tissue), rather than after. Similarly, regarding claims 14 and 15, none of the prior art of record teaches or reasonably suggests providing such a first ablative dose to a first region and then later administering a sub-ablative dose to a region likely to develop a metastatic tumor or to a whole body of the subject.
Response to Arguments
Applicant’s arguments with respect to the objection to claim 6 have been fully considered and are persuasive in light of the amendments. The objection has been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made, as detailed supra.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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