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 1-19 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10-12 recite the limitation "the method of claim 10" in the preamble. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 5, 9, 11, 13-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamei, S. et al. (Clin. Neuropharmacol. 19, 5, 1996; “Kamei”).
Kamei teaches a method of treating vascular dementia associated wandering with fasudil (Summary), as required by instant claims 9 and 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 14, 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.
Therefore, claims 1, 5, 9, 11, 13-17, and 19 are anticipated by Kamei.
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, 7-11, and 13-19 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 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 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 cortical dementia, as taught by Kamei, and apply it to another type of cortical dementia caused by ischemia, not hemorrhage, as taught by Turk. Therefore, claims 1, 3-5, 7-11, and 13-19 would be obvious to a person skilled in the art at the time.
Claims 1-11, and 13-19 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, and 7-19 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, and 7-19 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1-19 are rejected.
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.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621