DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed May 27, 2025 and May 29, 2025. Currently, claims 1, 3-4, 7-9, 12, 14, 16-17 are pending. Claims 4, 17 have been withdrawn as drawn to non-elected subject matter.
This action is FINAL.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow.
Any objections and rejections not reiterated below are hereby withdrawn.
The 101 rejection has been withdrawn in view of the particular treatments recited in the claims.
The Written Description rejection has been withdrawn in view of the amendments to the claims to require 6 gene expression levels; 2 methylation status and age to determine the GPI score (see paragraphs 80 and 93 also).
Election/Restrictions
Applicant's election with traverse of COL1A2, IGFBP3, NGFR, WIF1, claims 1-3, 5-6, 12-16, 20 in the paper filed August 16, 2024 is acknowledged. The response argues there would be no serious search and/or examination burden to search additional combinations. This argument has been reviewed but is not persuasive. A search of IBSP alone would require an entirely different search from the search for the elected combination. Therefore, the requirement is maintained.
Claims 4, 11, 17, 19 have been withdrawn as drawn to non-elected subject matter as directed to combinations not elected. When claim to the elected subcombination are found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Drawings
The color drawings are acceptable.
New Matter
Claims 1, 3, 7-9, 12, 14, 16 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the amended claims, reference to “if” the GPI score indicates good prognosis, the drug or intervention comprises temozolomide, radiation or TTFields and “if” the GPI score indicates a poor prognosis, the drug intervention comprises “increasing a radiation dose or initiating a radiation treatment regimen with accelerated radiation schedule….” are included. The amendment proposes that the new claim language is supported by the specification, para 5, 38, 50, 68, for example. However, the specification does not describe or discuss any differential treatment for good and poor prognosis. The specification lists many of the treatments added to the claim, however the specification does not provide which treatments should be administered to poor or good prognosis patients. There is no description of the treatments for different GPI scores. The concept of which drugs should be administered to which patents does not appear to be part of the originally filed invention. Therefore, the differential treatments constitutes new matter.
The claims require “increasing a radiation dose or initiating a radiation treatment regimen with an accelerated radiation schedule”. The response points to paragraph 38 for support of the new language. Paragraph 38 provides adjusting treatment (e.g. schedule, dose or discontinuation). There is no disclosure of increasing a radiation dose or accelerating a radiation schedule, as claimed, based on an indication of poor prognosis.
Applicant is required to cancel the new matter in the reply to this Office Action.
Response to Arguments
The response traverses the rejection. The response asserts the claims do not contain new matter because the specification reasonably conveys to one of skill in the art that the inventors had possession of the claimed invention at the time the application was filed. This argument has been considered but is not convincing. The response cites ASCO guidelines and Osarogiagbon to support their assertion that standard care treatments should be used when prognosis is good and aggressive treatments should be used for poor prognosis. The references cited are post filing date. The Osarogiagbon reference is dated May 2021. The instant filing date is August 2020. Thus, Osarogiagbon was not the state of the art at the time the invention was made. Post-filing date references do not establish the state of the art at the time the invention was made.
The response points to modulators of WNt signaling as treatments for poor prognosis. The specification points to modulators of Wnt signaling also as standard care. In paragraph 4, the specification teaches enrolling on a clinical trial to test novel therapies such as a Wnt pathway inhibitor is additional therapy beyond the standard chemo-radiation (page 1, para 4). Then in paragraph 13, the specification provides standard of care agents such as agents that specifically interact with or modulate Wnt signaling (e.g. an inhibitor to the Wnt signaling pathway) (para 13). Thus, the specification does not describe a clear distinction between modulators of Wnt signaling that are administered if the GPI score is a poor prognosis.
As noted previously, the claims require “increasing a radiation dose or initiating a radiation treatment regimen with an accelerated radiation schedule”. The response points to paragraph 38 and 50. Paragraph 38 provides adjusting treatment (e.g. schedule, dose or discontinuation). There is no disclosure of increasing a radiation dose or accelerating a radiation schedule, as claimed, based on an indication of poor prognosis. Paragraph 50 similarly does not teach increasing doses or acceleration of the radiation schedule when prognosis is poor. The specification only acknowledges changes may be made. Similarly, the administration of radiation to subjects with good prognosis does not provide any criteria such that the radiation is a standard of care. Thus, the administration of radiation to good prognosis patients encompasses any dose or schedule and is not limited to “standard” of care, as the response argues.
Thus for the reasons above and those already of record, the rejection is maintained.
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.
Claims 1, 3, 7-9, 12, 14, 16 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.
The claims have been amended to add cutoffs for poor and good prognosis however these limits are arbitrary given there is no formula or algorithm. The cut offs are not tied to any particular formula or algorithm and thus the cut offs are arbitrary. Without a formula or algorithm, the cut offs do not have any meaning. Therefore, the cut off score is indefinite.
Conclusion
No claims allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
October 23, 2025