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 .
This is the first action on the merits.
Election/Restrictions
Applicant’s election of fasudil and argyripholic grain disease (AGD) in the reply filed on May 1, 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)).
Fasudil and argyrophilic grain disease (AGD), embraced by claims 1, 2 and 4-11, was elected by Applicant. However, claim 6 is drawn to M3, a derivative of fasudil, which is not embraced by the species election.
Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 are pending and claims 1, 2, 4, 5 and 7-11 are under examination. Claims 3 and 6 are withdrawn based on the species election.
Specification
The abstract of the disclosure is objected to because the term “of” is required between treatment and patient in line 1. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 4 and 5 is/are rejected under 35 U.S.C. 10(a)(1) as being anticipated by Alzforum (February 09, 2016, <https://alzforum.org/news/research-news/rockn-tau-pathway>, downloaded June 13, 2026) as evidenced by Rodriguez et al. (J. Neuropathol. Exp. Neurol., 2016, 25(7), 628-635).
The present claims are drawn to a method of treating a 4-repeat tauopathy, where Applicant elected argyrophilic grain disease (AGD), comprising administering a rho kinase inhibitor, where Applicant elected fasudil.
Alzforum teaches “Inhibiting Rho kinases with the drug fasudil should have the same effects as the siRNA knockdown, the authors reasoned. Indeed, treating wild-type mouse primary cortical neurons with the drug increased levels of the autophagy marker LC3-II, and lessened both soluble and insoluble tau, they report. Then Gentry and colleagues tested fasudil in a Drosophila line expressing human 4R tau in its eyes. This causes degradation and buildup of autophagic vacuoles (see image above). Treating the flies before they emerged from their pupae, the authors found that the eyes of fasudil-treated flies looked more intact, and contained 60 percent less tau, than the eyes of untreated flies.
The study drew praise from Matt Huentelman of the Translational Genomics Research Institute in Phoenix, who was not involved in it. Huentelman suggested fasudil might work best if given before neurodegeneration takes off. Herskowitz believes ROCK inhibition has promise to alleviate 4R tauopathies, and likely 3R ones as well,” see pages 2-3 (bridged).
Argyrophilic grain disease (AGD) is a 4-repeat tauopathy as evidenced by Rodriguez et al.
Therefore, the claims are anticipated.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 2, 4, 5 and 7-11 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Alzforum (February 09, 2016, <https://alzforum.org/news/research-news/rockn-tau-pathway>, downloaded June 13, 2026) is evidenced by Rodriguez et al. (J. Neuropathol. Exp. Neurol., 2016, 25(7), 628-635).
The present claims are drawn to a method of treating a 4-repeat tauopathy, where Applicant elected argyripholic grain disease (AGD), comprising administering a rho kinase inhibitor, where Applicant elected fasudil.
Alzforum teaches “Inhibiting Rho kinases with the drug fasudil should have the same effects as the siRNA knockdown, the authors reasoned. Indeed, treating wild-type mouse primary cortical neurons with the drug increased levels of the autophagy marker LC3-II, and lessened both soluble and insoluble tau, they report. Then Gentry and colleagues tested fasudil in a Drosophila line expressing human 4R tau in its eyes. This causes degradation and buildup of autophagic vacuoles (see image above). Treating the flies before they emerged from their pupae, the authors found that the eyes of fasudil-treated flies looked more intact, and contained 60 percent less tau, than the eyes of untreated flies.
The study drew praise from Matt Huentelman of the Translational Genomics Research Institute in Phoenix, who was not involved in it. Huentelman suggested fasudil might work best if given before neurodegeneration takes off. Herskowitz believes ROCK inhibition has promise to alleviate 4R tauopathies, and likely 3R ones as well,” see pages 2-3 (bridged).
Argyrophilic grain disease (AGD) is a 4-repeat tauopathy as evidenced by Rodriguez et al.
Claim 7 embraces treatment for 6 months, claims 8 and 10 embrace dosages, e.g. at least 70 mg per day, and claim 9 embraces three equal portions per day. These are result-effective variables, and considered obvious based on optimization. Moreover, sustained-release formulations as found in claim 11 are conventional and well-known in the art.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "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." In re Aller, 220 F.2d 454, 105 USPQ 233, 235 (CCPA 1955). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the solvents taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Thus, a skilled artisan would take the teachings of Alzforum that teach inhibiting Rho kinases with the drug fasudil treats AGD as evidenced by Rodriguez. Therefore, said claims are rendered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
Prosecution Insights