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 .
Status of the Claims
Claims 1-8, 10-13, 15-19 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a CON of and claims priority to Application Serial No. 17/144,861, filed 01/08/2021; and further claims priority to provisional Patent Application numbers 63/004,305, 62/971,697, and 62/958,985, filed on 04/02/2020, 02/07/2020, and 01/09/2020, respectively.
Information Disclosure Statement
All references from IDS(s) received 04/14/2023, 02/12/2024, and 02/25/2025, have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 6/29/2026 have been fully considered but they are not persuasive.
In a non-final dated 12/30/2025, Claims 1-19 were examined upon their merits.
In a non-final dated 12/30/2025, Claims 1-19 were rejected under 35 U.S.C. 103, Claims 1, 5, 9, 11, 13-17, and 19 under 35 U.S.C. 102, and Claims 10-2 under 35 U.S.C. 102. In response, Applicant amended claims 10 and 13. Applicant also cancelled claims 9 and 14, so any previous rejection for these claims is moot and withdrawn.
With respect to the 112 rejection, Applicant amended claim 10 to be independent and therefore the 112 rejection is moot and withdrawn.
With respect to the 102 rejection, the Applicant argues that the prior art cited by the Examiner (“Kamei”) fails to teach patients with cortical dementia. The Applicant points out that the patients treated in Kamei have Binswanger and lacunar dementia, which are subcortical dementias. The Applicant also argues that Kamei fails to teach the patients without a wayfinding effect as the patients failed to find their way home. The Examiner argues that the Specification does not provide a definition for wayfinding and the Examiner’s understanding is that wayfinding is the ability to navigate or “find the way home.” Therefore, because the patients in Kamei struggle to find their way home without an escort, the Examiner argues they do not have a wayfinding ability. Further, the Examiner previous had used Kamei because of the broad use of “vascular dementia” which is considered a cortical dementia and that Kamei does teach cortical atrophy, but in light of the Applicants arguments that the two patient examples do not have cortical dementia, the Examiner finds the argument persuasive. Therefore, the rejection is withdrawn. However, the arguments are incorporated into a 103 rejection as discussed below.
With respect to the 103 rejection, the Applicant argues that that the patients treated in Kamei have Binswanger and lacunar dementia, which are subcortical dementia. However, the Examiner argues that the secondary reference provided (“Turk”) teaches fasudil in Alzheimer’s disease, which is considered a cortical dementia. The Examiner argues that although Kamei provides patient examples of subcortical dementia, it does teach examples of cortical atrophy and conceptually vascular dementia, a cortical dementia. The Applicant argues that Turk fails to mention “wandering.” The Examiner argues that Kamei teaches the broad genus of vascular dementia, which includes wandering. Further, the Examiner argues that wandering is a well-known symptom in Alzheimer’s (Cipriani et al. PSYCHOGERIATRICS 2014; 14: 135–142). Therefore, a person skilled in the art would expect that if fasudil can treat Alzheimer’s symptoms and wandering in other types of dementia patients, they would have a reasonable expectation that fasudil would treat wandering in Alzheimer’s patients. The same argument applies to “Barlow” and multi-infarct dementia, as well as “Sladojevic” and vascular dementia caused by hemorrhagic stroke. Therefore, the 103 rejections are maintained, including a small amendment to incorporate the previous 102 rejection.
NEW/MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 7-8, 10-11, 13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kamei, S. et al. (Clin. Neuropharmacol. 19, 5, 1996; “Kamei”) in further view of Turk, M. (The Effect of Rho Kinase Inhibitors on Alzheimer's Disease; Arizona State University Dissertation, 2017; “Turk”).
Kamei teaches the limitations of instant claims 1, 5, 9, 11, 13-17, and 19, as seen in the 102 rejection above, and those teachings are incorporated herein.
Kamei teaches a method of treating vascular dementia associated wandering with fasudil (Summary), as required by instant claim 13. With respect to claims 1 and 5, vascular dementia is a type of cortical dementia, as defined by the instant Specification (Page 21, line 5-10). Therefore, Kamei teaches the limitations of claims 1 and 5, as well.
Kamei teaches examples of subjects treated for wandering dementia with fasudil, neither of the subjects were disclosed of being treated with fasudil for chronic stroke, as required by instant claim 11. Both subjects held full-time jobs, implying they were in movement for 20% of the waking day, as required by instant claim 17. Both subjects did not display a wayfinding effect, as required by instant claim 13, as they were not able to make their way home from work during the episodes without being escorted. Both subjects were reported to leave their house in the middle of the night and therefore engaging in elopement, escape, and sporadic wandering (Case reports, pages 6-7), as required by instant claims 15-16. Kamei does not mention any symptoms of a pseudobulbar effect, as required by instant claim 19.
Kamei fails to teach an example where the dementia is caused by ischemia and/or not caused by hemorrhage.
Turk teaches the use of fasudil in Alzheimer’s disease which is a type of cortical dementia, as defined by the Specification. Alzheimer’s is also not a subcortical dementia such as Binswanger’s disease or lacunar dementia, as required by instant claims 10 and 18. Alzheimer’s disease is a genetic type of disease and is not caused by traumatic events such as hemorrhage. Therefore, it would be obvious to a person skilled in the art that the patient treated with fasudil did not suffer from hemorrhage, as required by instant claims 4 and 8.
Turk teaches the use of a ROCK inhibitor, similar to fasudil, is used to treat ischemic subjects. Turk also teaches the use of fasudil in Alzheimer’s disease which is a type of cortical dementia, as defined by the Specification. Although Turk does not explicitly teach the use of fasudil in ischemic subjects, it would be obvious to a person skilled in the art at the time to substitute the other ROCK inhibitor for fasudil in the treatment of ischemic subjects, as required by instant claims 3 and 7.
The combined teachings of Kamei and Turk show fasudil for use in a broad variety of dementia, including cortical, subcortical, and vascular dementias. Therefore, a person skilled in the art would be motivated to use fasudil in any different type or variation of dementia that may be related to these.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of 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.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of treating wandering-associated with vascular dementia, as taught by Kamei, and apply it to another type of dementia, such as Alzheimer’s, which caused by ischemia, not hemorrhage, as taught by Turk.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the combined teachings of Kamei and Turk, which teach fasudil for use in a broad variety of dementia, including cortical, subcortical, and vascular dementias. These combined teachings would motivate a person skilled in the art to use fasudil in any different type or variation of dementia that may be related to these.
Therefore, claims 1, 3-5, 7-8, 10-11, 13, 15-19 would be obvious to a person skilled in the art at the time.
Claims 1-8, 9-11, 13, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kamei, S. et al. (Clin. Neuropharmacol. 19, 5, 1996; “Kamei”) in further view of Turk, M. (The Effect of Rho Kinase Inhibitors on Alzheimer's Disease; Arizona State University Dissertation, 2017; “Turk”) and Barlow, C. et al. (US20110269717A1; cited in the IDS filed 4/14/2023; “Barlow”).
The combined teachings of Kamei and Turk teaches the limitations of instant claims 1, 3-5, 7-11, and 13-19, as seen in the 102/103 rejections above, and those teachings are incorporated herein.
Kamei and Turk both fail to explicitly teach using fasudil in the treatment of multi-infarct dementia.
Barlow teaches treating multi-infarct dementia (para 0156-0158) with fasudil (para 1196). It would be obvious to a person skilled in the art to extract the methods of Kamei and Turk, and apply it to patients with multi-infarct dementia, as taught by Barlow.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of treating wandering-associated with cortical dementia, as taught by Kamei and Turk, and apply it to another type of cortical dementia, including multi-infarct dementia, as taught by Barlow. Therefore, claims 1-11, and 13-19 would be obvious to a person skilled in the art at the time.
Claims 1, 3-5, 7-8, 10-11, 13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kamei, S. et al. (Clin. Neuropharmacol. 19, 5, 1996; cited in the IDS filed 4/14/2023; “Kamei”) in further view of Turk, M. (The Effect of Rho Kinase Inhibitors on Alzheimer's Disease; Arizona State University Dissertation, 2017; cited in the IDS filed 4/14/2023; “Turk”) and Sladojevic, N. et al. (Expert Rev Neurother. 2017 Oct 30;17(12):1167–1177; cited in the IDS filed 4/14/2023; “Sladojevic”)
The combined teachings of Kamei and Turk teaches the limitations of instant claims 1, 3-5, 7-11, and 13-19, as seen in the 102/103 rejections above, and those teachings are incorporated herein.
Kamei and Turk both fail to explicitly teach using fasudil in the treatment of vascular dementia caused by hemorrhagic stroke without ischemic stroke infarcts.
Sladojevic teaches that stroke survivors are more likely to develop dementia (page 9, para. 2), as well as the treatment of stroke caused by hemorrhage with ROCK inhibitors, including fasudil (page 10, para 3). It would be obvious to a person skilled in the art to extract the methods of Kamei and Turk, and apply it to patients with dementia caused by hemorrhagic stroke, as taught by Sladojevic.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of treating wandering-associated with cortical dementia, as taught by Kamei and Turk, and apply it to another type of cortical dementia, including dementia caused by hemorrhagic stroke, as taught by Sladojevic. Therefore, claims 1, 3-5, 7-8, 10-13, 15-19 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1-8, 10-13, and 15-19 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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, Clint Brooks can be reached at (571) 270-7682. 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.
/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights