DETAILED ACTION
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 filing of PCT/EP2022/051650, filed January 25, 2022, which claims priority under 35 USC 119(a)-(d) from European Application EP21305085.9, filed January 25, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated September 13, 2023 and March 19, 2025 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant’s election of the compounds maraviroc as the CCR5 antagonist and trifluoperazine as the AQP4 antagonist, in the reply filed February 25, 2026 is acknowledged. 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)). Applicant notes that each of claims 1, 3-6 and 9-16 read on the elected species.
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 and the claims drawn to the elected species are allowable, 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 claimed invention based on the elected species above, wherein: the elected species was not found to be allowable over the prior art. Thus the scope of the search and examination was not expanded beyond the elected species.
Status of Claims
Currently, claims 1, 3-6 and 9-16 are pending in the instant application. Each of the pending claims reads on an elected species and are therefore are under consideration in the instant application to the extent that they read on the elected embodiment.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 3-6 and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Joy et al. in view of Kitchen et al.
Applicant’s claims are drawn to a method of treating damage to the central nervous system, comprising administering a CCR5 antagonist (elected maraviroc) and an AQP4 antagonist (elected trifluoperazine).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Joy et al. describes that CCR5 is a translational target for neural repair in stroke and traumatic brain injury (Summary) and specifically that the elected CCR5 antagonist maraviroc promotes improved motor control and motor recovery in cases of chronic stroke (see Results). The art teaches maraviroc exerts its recovery effects through enhancing cortical plasticity in pre-motor cortex and concludes that maraviroc and other CCR5 blocking antagonists point to this receptor system as a target for stroke and TBI recovery approach.
Kitchen et al. disclose that hypoxia-induced swelling in the central nervous system (CNS edema) is directly linked to AQP4 on the cell surface, where treatment with trifluoperazine inhibited AQP4 localization to the blood-spinal cord barrier, effectively targeting the mechanism for the swelling and providing a viable therapy approach for CNS edema (see Summary). Trifluoperazine was found to have a protective effect against sensory and locomotor deficits after spinal cord injury (Introduction). The reference concludes that targeting the mechanism of cell-surface localization of AQP4 mediated by calmodulin is a viable strategy for developing CNS edema therapies (Summary).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The difference between the prior art and the instant claims is that the art does not explicitly describe the combination of maraviroc or a CCR5 antagonist with an AQP4 antagonist for the treatment of the claimed condition.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
To this end, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention." Further, MPEP 2144.06 states that it is obvious to substitute art-recognized equivalents which are known for the same purpose.
In the present case, the skilled artisan conducting the method of the instantly claimed invention would merely be carrying out the explicit teaching or suggestion of the prior art as in rationale (G) above. In particular, Joy et al. describes that CCR5 is a translational target for neural repair in stroke and traumatic brain injury (Summary) and specifically that the elected CCR5 antagonist maraviroc promotes improved motor control and motor recovery in cases of chronic stroke (see Results). The art teaches maraviroc exerts its recovery effects through enhancing cortical plasticity in pre-motor cortex and concludes that maraviroc and other CCR5 blocking antagonists point to this receptor system as a target for stroke and TBI recovery approach.
Kitchen et al. disclose that hypoxia-induced swelling in the central nervous system (CNS edema) is directly linked to AQP4 on the cell surface, where treatment with trifluoperazine inhibited AQP4 localization to the blood-spinal cord barrier, effectively targeting the mechanism for the swelling and providing a viable therapy approach for CNS edema (see Summary). Trifluoperazine was found to have a protective effect against sensory and locomotor deficits after spinal cord injury (Introduction). The person of ordinary skill in the art would have had a reasonable expectation of success in combining the art-known CCR5 and AQP4 antagonists to treat CNS damage associated with stroke or TBI. It would not have been considered inventive to utilize the compounds described in the Joy et al. and Kitchen et al. for the treatment said conditions since each active ingredient is separately disclosed as being capable of treating the same condition(s). Therefore, the claimed invention is prima facie obvious as it would not have been inventive to combine two pharmaceuticals already known to treat the same condition in an attempt to more effectively treat that same condition.
Further, concerning this matter, MPEP 2166.04 states the following: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Absent a showing of surprising or unexpected results, the instantly claimed invention would have been prima facie obvious to the person of ordinary skill in the art.
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
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