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 .
Acknowledgment of Papers Received: Amendment/Response dated 9/12/25.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9, 10, 21, 22, 33 and 39-43 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Farokhzad et al (US 8,709,483 hereafter Farokhzad).
Farokhzad discloses a method for delivering a GCP-II inhibitor to a subject comprising delivering a glutamate carboxypeptidase II inhibitor to a subject via an intranasal route, wherein the GCP-II inhibitor is delivered to an olfactory region of a nasal cavity, where the GCP-II inhibitor is a thiol 2-MPPA or 2-PMPA and the delivery route is intranasal (col. 25, lin. 50-col. 26, lin. 10; col. 60, lin. 30-60), meeting the limitations of claims 1-4. The steps of the method, delivering to a subject a dose of GCP-II inhibitor intranasally would accomplish the method of claim 1. Regarding claim 7, the claim recites that the method of claim 1, results in an increase in the total concentration of the GCP-II compound in the brain and/or peripheral system by accomplishing the steps of claim 1. As such, Farokhzad delivers the same compounds, in the same way to the same parts of the body, accomplishing the steps of the method, thus the results of accomplishing this method would be in increase in the GCP-II concentration meeting the limitations of claim 7. The GCP-II reaches target organs for treatment including lungs, brain and prostate (col. 49, lin. 60-col. 50, lin. 23) meeting the limitations of claims 9 and 10. The method disclosed by Farokhzad is also used for diagnosing a neurotological disease by labeling a GCP-II inhibitor with a fluorescent isotope that allows for imaging organs and tissues (col. 50, lin. 25-67), meeting the limitations of claim 41 and 42. The isotopes for this method include 125I, 123I, 18F, 14C and 68Ga (col. 42, lin. 60-67) meeting the limitations of claims 33 and 43. The method is used to alleviate side effects such as neuropathic inflammation and pain associated with other disorders and an excess of GCP-II activity (col. 49, lin. 35-47) meeting the limitations of claims 5, 6, 21.
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.
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.
Claim(s) 1-11, 21-23, 33 and 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farokhzad et al.
As discussed above the Farokhzad reference discloses a method for the delivery of GCP-II inhibitor compounds intranasally to treat and diagnose certain conditions. The reference does not explicitly recite a ratio between the brain or peripheral system and their concentration of the GCP-II inhibitors, however such limitations are the result of routine experimentation. The reference also does not explicitly describe the inhibition of the GCP-II activity in the specific tissue, although treating pain and cancers are disclosed by the reference. The reference discloses various embodiments with various constituent components in ranges that would indicate to an artisan of ordinary skill that such modifications could be made within the scope of the invention resulting in many varied desirable treatment outcomes. The general conditions of the claims have been met by the prior art such that an intranasal formulation comprising GCP-II inhibitors that can treat various conditions including brain cancer and neuropathic pain. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind it would have been obvious to follow the prior art to at a method for both diagnosing and treating conditions nasally. It would have been obvious to modify the compositional components through routine experimentation to achieve specific release kinetics and treatment effects. One of ordinary skill in the art would have been motivated to modify the disclosure of Farokhzad, as suggested by the reference in order to achieve such a dosage form useful in a method of both diagnosing conditions with radiolabeled compounds and treating brain conditions like cancer.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, 21-23, 33 and 39-43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618