DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 11/11/2025 wherein claims 7 and 8 have been amended, claims 5 and 6 have been cancelled and claims 9-11 have been added.
Claims 1-4 and 7-11 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 11/11/2025 overcome the rejection of claims 5-8 made by the Examiner under 35 USC 102(a)(1) over Wei et al. (CN 1895237). This rejection has been withdrawn.
Applicant’s amendments filed 11/11/2025 overcome the rejection of claims 5, 6 and 8 made by the Examiner under 35 USC 102(a)(1) over Chen et al. (CN 102178666). This rejection has been withdrawn.
Applicant’s amendments filed 11/11/2025 overcome the rejection of claim 7 made by the Examiner under 35 USC 112(b). This rejection has been withdrawn.
Applicant’s response filed 11/11/2025 cancelling claims 5 and 6 renders moot the rejection made by the examiner under 35 USC 103 over Chen et al. (CN 102178666) in view of Fathi et al. (Curr Neurol Neursci Rep, 2013, 337, 13, 1-8). This rejection is withdrawn.
Applicant’s arguments filed 11/11/2025 regarding the rejection of claims 1-4 and 8 made by the examiner under 35 USC 103 over Chen etal. (CN 102178666) in view of Fathi et al. (Curr Neurol Neursci Rep, 2013, 337, 13, 1-8) is MAINTAINED for the reasons of record in the office action mailed on 8/15/2025.
In regards to the 103 rejection, Applicant asserts the following:
A) Chen teaches that honokiol may be used in the treatment of gliomas and would not lead the skilled person to reasonably expect efficacy across all brain tumor types. This is supported by Exhibit 1 that demonstrates that gliomas are aggressive tumors whereas meningiomas are slow and mostly benign and Exhibit 2 that states that gliomas and meningioma have different diagnosis and treatment guidelines.
In response to A, Chen teaches that honokiol may be used in treating/resisting brain tumors in general with specific types of brain tumors being glioma and sarcoma (a glioma being a tumor of the glial cells and sarcoma being a tumor of soft tissues and/or bone). One of ordinary skill in the art would not restrict Chen’s teaching to only these types of tumors. Rather, one of ordinary skill in the art would be motivated to identify other known brain tumor types and administer honokiol with a reasonable expectation in providing a therapeutic benefit. Afterall, a meningioma is a tumor of the meninges. While gliomas have different diagnosis and treatment guidelines as well as different biology, these differences does not necessarily mean that one would not administer honokiol to treat both. If honokiol is useful for treating an aggressive glioma as taught by Chen, then it would be reasonable to expect that honokiol would also have some activity against the slower, less-aggressive meningioma. Evidence would be needed to demonstrate the criticality of the claimed invention. As of now, none has been provided.
The instant claims are to a method of treating a meningioma with honokiol. As honokiol is known to treat various types of brain tumors, it would be reasonable to expect that providing honokiol to a subject with meningioma would also provide a therapeutic benefit. Combining prior art elements according to known methods to yield predictable results is indicia of obviousness. See MPEP 2143(I)(A).
Maintained Rejections, of Record (claims 1-4 and 8) New Rejections, Necessitated by Amendment (claims 7 and 9-11)
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 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.
Claims 1-4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (CN 102178666; translation provided; of record) in view of Fathi et al. (Curr Neurol Neursci Rep, 2013, 337, 13, 1-8; of record).
Chen describes a medical composition comprising honokiol. The honokiol may be formulated as a liposome (see [0026, 0063, 0064]) (see instant claim 2) and is suitable for intravenous injection (see [0022] and claims 1-3) (see instant claims 3 and 8).
The honokiol liposome of Chen may be used in methods of treating brain tumors and intracranial granulomas (see abstract and [0006]). [0060 and 0064] states that administration of honokiol liposomes inhibit brain tumor cell proliferation (see instant claims 1 and 4).
Chen fails to teach the brain tumor as being a meningioma.
Fathi is a topical journal publication on meningioma. Fathi teaches that meningioma is ‘the most common primary brain tumor’ (see abstract) (see instant claims 1 and 4). It would have been obvious to modify the method of treating brain tumors using the honokiol liposome composition of Chen so as to encompass treating meningioma as meningioma represents the most common form of brain tumor. Such a modification of Chen would have been obvious and one would reasonably expect that the carrying forward of Chen’s method on subjects with meningioma would result in the treatment of said condition. See MPEP 2144.08 regarding obviousness relating to species (e.g. meningioma) and genus (e.g. brain tumors).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 7 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (CN 102178666; translation provided; of record) in view of Fathi et al. (Curr Neurol Neursci Rep, 2013, 337, 13, 1-8; of record) as applied to claims 1-4 above, and further in view of Sheu et al. (US 2019/0117587).
Chen and Fathi fail to teach the method comprising administering the hinokiol liposome in the form of a freeze-dried preparation, tablet, capsule or transdermal preparation.
Sheu teaches that honokiol is therapeutically useful in providing antioxidant and neuroprotective effects to the brain. Sheu’s teaches that the honokiol composition may be administered by injection or orally (see [0038-0039]) wherein the composition may be formulated as a lyophilized preparation (for resuspension and injection) (see instant claims 7 and 9), (see [0038]), sustained-release tablets (see [0039]) (see instant claims 7 and 10) and hard/soft capsules (see [0039]) (see instant claims 7 and 11). It would have been obvious to modify Chen and Fathi such that the honokiol liposome composition was formulated as a lyophilized preparation, a tablet or capsule as each of these dosage forms are capable of delivering honokiol to the brain (to treat a meningioma). The application of a known technique (e.g. administering tablet, administering capsule, etc.) to improve similar methods in the same way is supportive of obviousness. See MPEP 2143(I)(C). See also MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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