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 .
Status of Claims
Currently, claims 1-3, 45-46, 60, 65, 72, 73, 76, 84, 86, 88, 92, 95, and newly added claims 105-108 are pending in the instant application. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are newly applied, as necessitated by amendment. They constitute the complete set being presently applied to the instant Application. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
Claims 1-3, 45-46, 60, 65, 72, 73, 76, 84, 86, 88, 92, 95, and 105-108 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (Williams et al; Acta Neuropathologica, vol 140, pages 89-93; May 13, 2020) in view of Goldbrunner (Goldbrunner et al; The Lancet, vol 17; 2016, pages e383-e391).
With regard to claims 1-3, Williams teaches human (claim 95) meningioma subjects with papillary features were assessed for PBRM1 mutations (abstract, page 89-90, table 1), detected by CGP on hybridization captured, adaptor ligation-based libraries (claims 45-46). Williams teaches detecting allelic loss as well as truncation, frameshift, etc mutations including R146* (claims 60, 65) in meningioma patients with papillary features. Williams teaches obtaining tumor tissue (claims 72, 73, and 76). Williams teaches detecting additional mutations in BAP1 (page 92)(claims 84, 86). Williams teaches analysis of histologic features of the tumors, including detecting papillary and heterogenous features (claims 88, 92). With regard to claim 1, Williams does not teach whether the subjects analyzed had been treated for papillary meningioma (PM), however Williams does teach to treat PM (page 89, col 1). Although Williams does not teach therapy including aggressive tumor resection, with Simpson grade I, II, or III, Goldbrunner teaches EANO guidelines for the treatment of meningiomas (see whole document). Goldbrunner teaches that WHO grade III meningiomas include papillary meningioma (Panel 1). Goldbrunner teaches that WHO grade III meningiomas should be treated with radical surgical resection, with a Simpson grade I as the primary goal (see pages e386-e387). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date, to have treated patients with papillary meningioma, or meningioma with papillary features (WHO grade III as evidenced by Goldbrunner) as taught by Williams, including those with PBRM1 mutations, with aggressive tumor resection (Simpson grade I being the primary goal) as taught by Goldbrunner because Goldbrunner teaches that WHO grade III meningiomas, which include meningioma with papillary histology, should be treated with surgical resection that is as radical as possible.
It is noted that claims 105, 106, and 108 are not distinguished from the teachings of the cited prior art because they do not require that that therapy be administered.
Conclusion
No claims are allowed.
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 examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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