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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/30/26 has been entered.
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) 1-7, 9-11, 21-23, 33 and 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosure of Farokhzad et al (US 8,709,483 hereafter Farokhzad) in view of Eskandari et al (Brain delivery of valproic acid via intranasal administration of nanostructured lipid carriers: in vivo pharmacodynamic studies using rat electroshock model, International Journal of Nanomedicine, 363-371, 2011).
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 ¹²⁵, ¹²³, ¹⁸F, 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.
The reference, while the reference discloses a method for the delivery of a glutamate carboxypeptidase II inhibitor to a subject via an intranasal route, the reference is silent to a comparison of the plasma partition as it would relate to an intraperitoneal delivery route. However, it is known in the art that intranasal delivery of active agents is vastly more effective and increases the plasma partition as it relates to intraperitoneal delivery. This increase is seen in the Eskandari study.
Eskandari discloses a study comparing the brain delivery of an active agent compound via intranasal routes vs an intraperitoneal route (abstract). The study finds that upon delivery, after 60 minutes, there is a more than 100-fold increase in the brain: plasma ratio with intranasal concentration of 8.4 + 0.32 with intraperitoneal being 1.65 + 0.09 [Table 3]. This establishes the level of skill in the art such that intranasal delivery vastly increases the brain: plasma ratio and would have been present in the Farohkzad reference.
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 arrive upon a method for both diagnosing and treating conditions nasally. Following the teachings of Eskandari, it would have been clear that the intranasal administration would have been an improvement on standard intraperitoneal delivery. 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, see Remarks, filed 6/30/26, with respect to the rejection(s) of claim(s) 1-7, 9-11, 21-23, 33 and 39-43 under 35 US 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection as the claims have been amended. Eskandari is applied to establish the level of skill in the art regarding the increase in blood: plasma ratio between the intranasal delivery of and a hypothetical intraperitoneal delivery. Applicant argues that such limitations are not present in the Farokhzad, so as such, Eskandari study is applied to establish the level of skill in the art regarding the blood: plasma ratio showing the intranasal delivery shows an almost 800-fold increase in the ratio as compared to intraperitoneal delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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