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 .
Election/Restrictions
Applicant’s election with traverse of Group I (to a method of treatment or prevention of a brain tumor), in the reply filed on 03/19/2025 is acknowledged.
Claims 1-26 are pending of which claim 12-26 in Group II, is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-3,5 and 9-13 have been examined on the merits.
Please note, for clarity of the record, Applicant ’s election of compound ETP-47037
PNG
media_image1.png
192
226
media_image1.png
Greyscale
During the course of examination, prior art was identified that relates to the elected subject matter.
Withdrawn Rejections
The rejection of claims 1-3, 5 and 9-13 under 35 U.S.C. 102(a)(l) as being unpatentable
over Fernandez et al. US9073927B2 is withdrawn in view of the claim amendment.
New Grounds of Rejection due to the Claim Amendments
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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.
Claims 1-3, 5, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. US9073927B2, in view of Bejarano et al. Cancer Cell, vol. 32, no. 5, Nov. 2017, pp. 590-607.e4.
Regarding claim 1-3, 5 and 9-13, Fernandez (abstract; col. 54, line 51 and line 61) teaches compounds of formula I, PI3K inhibitors, for treating cancers, including but not limited to brain cancer such as glioblastoma (brain tumor). Fernandez (col. 55, lines 28-31) teaches that the method comprises administration of a therapeutically effective amount of the compounds to a patient in need thereof. Fernandez (col. 56, line 55) also teaches compound of formula I, a PI3K inhibitor, can be combined with other therapeutic agents, including docetaxel.
In Table 4, Fernandez (col. 87, Table 4) provides examples of PI3K inhibitors such as compound 3-10 wherein A1 is carbon, A4 is nitrogen, A5 is carbon, A4a is ethyl substituted with Ra and Rb; Ra and Rb are linked to together to from a piperazine substituted with a sulfone; R3 is pyridazine substituted with an amine; B1, B1a, B2, B2a, B3, B3a, B4, B4a are hydrogen.
PNG
media_image2.png
291
710
media_image2.png
Greyscale
Although Fernandez does not explicitly mention compound 3-10 as TRF1 inhibitor or teach “reducing TRF 1 protein levels and inhibiting tumor growth,” such properties are inherent to the compound discloses. Because Fernandez teaches the same compounds, which are identical to the claimed invention. Thus, it would have been reasonable to anticipate that Fernandez’s teachings necessarily possess the same mechanism of action, including “reducing TRF 1 protein levels and inhibiting tumor growth,” or compound 3-10 to be identified as TRF1 inhibitor. Furthermore, given that the claimed compound and Fernandez are identical in structure, they cannot possess mutually exclusive properties, and the claimed TRF1 inhibitor and docetaxel function is deemed to be inherently disclosed. See MPEP 2112.01.
Fernandez, however, does not explicitly teach treatment of recurrence of glioblastoma multiforme (GBM).
Bejarano (abstract) teaches administering TRF1 inhibitors as an effective therapeutic strategy to treat glioblastoma multiforme (GBM), which is linked or driven by glioma stem cells (GSCs). Bejarano (page 602) also discloses TRF1 inhibitors, including but not limited to ETP-47037. Furthermore, Bejarano (page 509, 601-602 and 605) discloses TRF1 inhibitors, including ETP-47037, as a promising GBM treatments, since that current treatment do not eliminate glioma stem cells and thus allow tumor recurrence, suggesting that ETP-47037 acts also on GSCs. Therefore, it would have been obvious to a POSITA to modify Fernandez’s teachings in view of Bejarano to arrive at the claimed invention, because Fernandez teaches the same compound as Bejarano for treating glioblastoma, while Bejarano emphasizing its use against GBM or recurrence thereof.
Response to Argument
Applicant argues that Fernandez does not teach GBM or glioma stem cells, or GSC biology, thus the 103 rejection is not valid. Applicant’s argument is not persuasive because the newly added 103 rejection above addresses the amended claim subject matter, as the combined teachings of Fernandez and Bejarano clearly teaches the amended claim limitation. Thus, the rejection remains.
Applicant argues that while the prior art teaches the same compound but it does not mention TRF1 and the instant invention identifies a novel TRF1-based mechanism. Applicant’s argument is not persuasive because Fernandez explicitly discloses the same compound for the same therapeutic purpose such cancer and tumors. Therefore, any newly discovered mechanism of action for a known compound does not confer patentability when the compound and its utility are already disclosed. In addition, the Fernandez’s classification of the compound as a PI3K inhibitor, does not exclude additional biological activities, including TRF1 inhibition. Furthermore, Bejarano (page 602) discloses ETP-47037 as a TRF1 inhibitor, thus the TRF1 mechanism is not novel, contrary to Applicant’s assertation.
Applicant argues under inherency doctrine and MPEP 2112.01 that inherency cannot be established unless the claimed compound property is explicitly stated by the prior art. Applicant’s argument is not persuasive because the cited MPEP does not require that the inherence property is disclosed, but only that it is necessarily present in the disclosed subject matter. Fernandez clearly teaches the same compound for the same utility, thus the compound biological activities including any molecular interactions such as TRF1 inhibition are inherently present regardless Fernandez explicitly disclosed them. It is important to highlight that Applicant has not provided evidence that TRF1 inhibition is absent from Fernandez’s teachings, rather the argument is only expressed for the alack of explicit disclosure. It is also important to remind Applicant that the newly discovered TRF1 mechanism does not change the fact that the combined teachings of Fernandez and Bejarano already disclosed the claimed therapeutic effect and benefits of the claimed invention, such as treating GBM by targeting glioma stem cells.
Conclusion
THIS ACTION IS MADE FINAL. 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 PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights