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 .
Response to Arguments and Amendments
Applicant’s arguments and amendments filed May 18, 2026 have been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With respect to the rejection of claims 26-29, 32 and 40-46 under 35 USC 102(a)(1), Applicants traverse the rejection on several grounds, each of which has been considered but was not found persuasive to overcome the rejection. In particular, Applicants contend that administration of the compound BX-912 occurs immediately after MCAO and the mice have not yet undergone changes that effectively amount to treating a pathological situation. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., treatment of a “pathological situation”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Notably, there is no limiting definition provided for what would constitute a subject being “in need thereof.” However, inflammation is a very broad bodily process that occurs even in healthy individuals without any disease. If the prior art teaches administration of the same compound, it necessarily anticipates the effect that the compound will have, as a compound and its properties are inseparable and the claim does not require that the subject actually have any disease or pathological state. The recited properties (e.g. treating inflammation or inhibiting interferons (which are present in the body absent any disease state) would be inherently met by prior art disclosure of an anticipatory compound being administered because a compound and its properties cannot be separated. See In re Papesch, 315 F.2d 381,391, 137 USPQ 43, 51 (CCPA 1963)(“a chemical compound and its properties are inseparable”). See also In re Spada, 911 F. 2d 705, 709, 15 USPQd 1655, 1658 (Fed. Cir. 1990)(“[p]roducts of identical chemical composition cannot have mutually exclusive properties”). Accordingly, the rejection is still deemed to be proper and is maintained herein.
With respect to the rejection of claims 26-28, 31 and 33 under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/018603 (“the ‘603 publication”), Applicants contend that the ‘603 publication does not teach the administration of PDK1 inhibitor to a subject, but rather to a population of isolated immune cells. Applicant’s traversal is persuasive and the rejection is withdrawn herein.
With respect to the rejection of claims 26-46 for nonstatutory double patenting over the claims of US Application 17/905,305, the rejection is withdrawn in view of the abandonment of the ‘305 application.
Election/Restrictions
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the examiner searched the compound based on the elected species above, wherein: no prior art was found on the elected species. Therefore, the scope of the search and consideration was expanded in accordance with MPEP 803.02 to also include the compounds described in the rejections herein. Since this scope was not found to be allowable, the scope of the search and examination was not extended further, although any additional anticipatory compounds in the same prior art, discovered incidental to the examination of the elected species, are also included in the rejections herein.
Status of Claims
Currently, claims 26-46 are pending in the instant application and under consideration herein to the extent they read on the elected species.
Claim Objections
Claims 30-31 and 33-39 are objected to for depending on a rejected base claim.
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.
Claim(s) 26, 28-29, 32 and 40-46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan et al.
The prior art teaches that BX-912 (identical to instant Formula (IV), the elected species) was dissolved in DMSO and administered into mice by intraperitoneal injection at 5 mg/kg/day. Intraperitoneal injection reads on the parenteral administration required by instant claim 32. Notably, since the instant claims just require treating inflammation, inhibition of interferons, or inhibiting secretion of inflammatory cytokines and interferons by immune cells in an individual the only active step requires administration of an anticipatory compound to a subject, regardless of the particular disease being disclosed as treated. Since the prior art teaches an identical active step, the methods of the instant claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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