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 .
Priority
The instant application is a 35 USC 371 National Stage entry of international application No. PCT/EP2021/058039, filed March 26, 2021, which claims priority under 35 USC 119(a)-(d) from French application FR 2003087, filed March 27, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 26, 2022 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant’s election of the invention of Group II, (originally claims 6-8 and 12-18, now claims 26-46), drawn to methods of treatment comprising administration of ROCK-PDK1 inhibitors in the replies filed on August 6, 2025 is acknowledged. Further, Applicant’s election of the compound of formula (IV) in the same reply is also acknowledged. The elected species reads on each of claims 26-46 within the elected group. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The restriction requirement is still deemed proper and is therefore made FINAL.
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 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) 26-29, 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.
Claim(s) 26-28, 31 and 33-46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/018603 (“the ‘603 publication”).
The ‘603 publication teaches administration of compouds for immune cell modulation and adoptive immunotherapy (see Title). To this end, the administration of PDK1 inhibitors is disclosed (paragraph [00013]), while the instantly elected species of Formula (IV) is exemplified (BX-912) as well as the anticipatory compounds GSK2334470 (instant Formula (V), also see table 1, Compound No. 21) and BX-795 (instant Formula (III) (see paragraph [000139]). 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. A method of treating a subject comprising administering the compounds disclosed for use therein is taught, for example, in claims 89-90, where the subject is disclosed as having an autoimmune disorder, hematological malignancy, solid tumor, or an infection, which reads on instant dependent claims 33-39, which require the subject to have one of the claimed conditions. Regarding instant claim 31, which requires administration in combination with at least one second active, combinations of active ingredients are disclosed throughout the reference (paragraph [00012], [00053], [000110] and [000147]). Accordingly, since the prior art teaches all required limitations of the claimed invention, the claims are anticipated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 26-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent Application 17/907,305. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims relate to an inhibitor of ROCK-PDK1 protein kinase for use as an anti-inflammatory and anti-intereron agent, as well as methods for administering compositions thereof for treating particular inflammatory diseases (conflicting claim 13), particular bacterial infections (conflicting claims 15-16), or particular autoimmune diseases (conflicting claim 18). Notably, the compounds of Formula (VII), (VIII), (IX) and (X) anticipate instant claim 26 and any dependent claim generically reciting a ROCK-PDK1 inhibitor. Further, examples taught in support of the claimed genus of ROCK-PDK1 inhibitors in the conflicting application anticipate the instantly claimed inhibitors, including the elected species. Anticipatory dosage amounts are recited in conflicting claims 6-7 and anticipatory administration routes are disclosed in conflicting claim 11. Since the inhibitors of the conflicting claims and the methods of their administration are overlapping in scope, with examples which anticipate those of the instant claims, a double patenting rejection is appropriate.
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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699