DETAILED ACTION
Claims 1, 5-17, submitted 18 December 2025, are pending in the application. Claims 1 and 5-9 are under examination in the instant Office Action. Claims 2-4 have been cancelled.
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 .
Rejections – Withdrawn and New
The status of the rejected claims of the previous Office Action is set out below.
Rejections under 35 U.S.C. § 112(a)
The Applicant’s arguments in view of an updated prior art search, were found to be sufficient to overcome the objection in the previous Office Action.
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.
(New) Claims 1 and 5-9 are rejected under 35 U.S.C. 103 as being obvious over
Tripathy et al ("Thrombin, a mediator of cerebrovascular inflammation in AD and hypoxia." Frontiers in aging neuroscience 5 (2013): 19.) in view of Alam et al. ("Inflammatory process in Alzheimer’s and Parkinson's diseases: central role of cytokines." Current pharmaceutical design 22.5 (2016): 541-548.) and Ball et al. ("Parkinson's disease and the environment." Frontiers in neurology 10 (2019): 421551.).
The applied reference has a common inventor with the instant application. Based
upon the earlier effectively filed date of the reference, it constitutes prior art under
35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Tripathy teaches a method of administration of dabigatran, at a dose of 100 mg/kg), to Alzheimer disease mice (Abstract; Pg. 2, Section “Administration of Thrombin Inhibitor to Mice and Immunofluorescent Staining of Mice Brain Sections”, Right Col., 1st paragraph). This reference also teaches wherein the administration of dabigatran to AD mice resulted in reduced vascular expression of the inflammatory protein, IL-6, and further supports an important role for thrombin as a mediator of neuroinflammation. (Pg. 6, Section “Discussion”, Left Col., 1st paragraph).
Tripathy does not teach wherein the disease is Parkinson’s disease, however, Alam et al. cures this deficiency by teaching “The detection of IL-6 in significant amounts is usually considered to be harmful and could contribute to the pathological effects associated with AD and PD” (Pg. 545, Section “Role of Interleukin-6 in AD & PD”, Left Col., 1st paragraph).
Tripathy also fails to teach wherein the inflammatory IL-6 proteins are targeted in the patient’s hippocampus. Instead, this reference teaches wherein brain samples were collected from the cerebral and frontal cortex (Pg. 2, Section Administration of Thrombin Inhibitor to Mice…”, Right Col., 2nd paragraph). As such, it could be reasoned that, once past the blood brain barrier, dabigatran isn’t targeting a specific section of the brain (i.e., the hippocampus) but instead is targeting the pro-inflammatory cytokines in multiple regions of the brain.
A person having ordinary skill in the art would have been motivated to combine the teachings of Tripathy with the teachings of Alam to treat symptoms associated with Parkinson’s disease through administration of a sufficient amount of dabigatran to inhibit vascular activation by targeting at least one or both of the inflammatory IL-6 or IL-8 proteins in said patient’s hippocampus. A skilled artisan would have a reasonable expectation of success because, as Alam teaches, “The detection of IL-6 in significant amounts is usually considered to be harmful and could contribute to the pathological effects associated with AD and PD” (Pg. 545, Section “Role of Interleukin-6 in AD & PD”, Left Col., 1st paragraph). Therefore, it would have been prima facie obvious for a person having ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to combine the teachings of Tripathy with the teachings of Alam to arrive at the instantly claimed invention.
With regards to claim 5, Tripathy teaches wherein inhibiting thrombin generation could have therapeutic value in AD and other disorders where hypoxia, inflammation, and oxidative stress are involved (Pg. 3, Section “Discussion”, Right Col., 1st paragraph). Additionally, this reference also teaches wherein oxidative stress results in increased vascular expression of IL-6 and IL-8 in apolipoprotein E-deficient mice which demonstrates the link between oxidative stress and vascular inflammation (Pg. 7, Section “Discussion”, Right Col., 1st paragraph). In view of the aforementioned teachings of Alam, one skilled in the art would have an expectation of success in reducing oxidative stress in a patient with Parkinson’s disease.
With respect to claim 6, Tripathy teaches wherein the dabigatran was orally administered to the AD mice (Pg. 2, Section Administration of Thrombin Inhibitor to Mice…”, Right Col., 1st paragraph).
Regarding claim 7, Tripathy and Alam fail to teach wherein the Parkinson’s disease is Parkinson’s disease chemically induced by exposure to environmental, however, Ball et al., teaches that there are two forms of Parkinson’s disease (PD) and genetically linked PD accounts for ~10-15% of all PD cases with the remainder being classed as sporadic (idiopathic) (Pg. 1, Section “Introduction”, 1st paragraph). It can be reasoned then that, in view of Tripathy and Alam, one skilled in the art would at least attempt to treat the symptoms associated with various types of Parkinson’s disease.
With respect to claim 8, Ball teaches wherein pesticides and heavy metals display a negative effect and increase PD by causing gene variations linked to familial PD (Pg. 2, Section “Introduction”, Left Col., 1st paragraph). Again, it can be reasoned then that, in view of Tripathy and Alam, one skilled in the art would at least attempt to treat the symptoms associated with various types of Parkinson’s disease. Further, Ball teaches the limitations of instant claim 9 which recite wherein said metal are selected from the group consisting of copper and manganese (Pg. 2, Section “Heavy Metals”, Right Col., 3rd paragraph to Pg. 3, Right Col., 3rd paragraph).
Conclusion
No claims allowed.
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./ Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622