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 .
Priority
The instant application is a 371 National Stage Entry of PCT/EP2020/075180 filed on September 9, 2020 which claims priority to foreign application No. EP19382778.9 filed on September 9, 2019.
Status of Claims
Acknowledgement is made of previously presented (6-9, 12), amended (1, 10, 13), and cancelled (2-5, 11) claims filed November 6, 2025. Claims 1, 6-10, 12-13 are pending in instant application.
Response to Arguments
In light of Applicant’s amendments filed November 6, 2025, the following have been withdrawn:
The objection of claim 13
The 35 USC 112(b) rejection of claims 1-13
The 35 USC 102(a)(1) rejection of claims 1, 5, 7-9 over KR 101671502 B1 to Myeong et. al.
The 35 USC 103 rejection of claim 1 over Pitt
Applicant's arguments filed November 6, 2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the art teaches away from D-pinitol (see 11/6/25 Remarks at p. 6 ¶2), McLaurin teaches a method of treating a subject with a disorder in protein folding or aggregation or amyloid formation with D-pinitol (see McLaurin at claim 16). Pasinetti teaches administering D-pinitol for inhibiting the onset and progression of Alzheimer's disease, mild cognitive impairment, and related neurodegenerative disorders involving amyloidosis (see Pasinetti at Abstract). Pitt teaches that myo-inositol did not have a protective effect, unlike chiro-inositols such as D-pinitol, DCI, and INS-2 (see Pitt at p. 202 right col.).
In response to Applicant’s argument that inositols are not interchangeable (see 11/6/25 Remarks at p. 6 ¶5), while Pasinetti teaches d-chiro-inositol did not have an inhibitory effect on β-amyloid formation (see Pasinetti at p. 28 lines 25-26), Pasinetti still teaches that D-pinitol, the instantly claimed inositol species, is anti-amyloidogenic with a robust effect on γ-secretase activity and dose-dependent inhibition of Aβ production (see Pasinetti at Figure 8 and at p.28 lines 13-27). Inositols are still structurally similar, D-pinitol is known in the art to have an anti-amyloidogenic effect, so D-pinitol would be suitable to exchange with another inositol known to have an anti-amyloidogenic effect.
Claim Interpretation
Regarding tauopathy: Applicant defines “tauopathy” as:
a class of neurodegenerative diseases involving the aggregation of tau protein into neurofibrillary or gliofibrillary tangles (NFTs) in the human brain. Tangles are formed by hyperphosphorylation of the microtubule protein known as tau, causing the protein to dissociate from microtubules and form insoluble aggregates. (These aggregations are also called paired helical filaments.) Examples of tauopathies are selected from the list consisting of Pick disease, progressive supranuclear palsy, corticobasal degeneration, argyrophilic grain disease, globular glial tauopathies, primary age-related tauopathy which includes neurofibrillary tangle dementia, chronic traumatic encephalopathy
(CTE), and aging-related tau astrogliopathy. (see instant spec. at p. 9 lines 5-13).
Regarding D-pinitol, D-pinitol is understood to be CAS Registry No. 10284-63-61 which is also referred to in the art as 3-O-Methyl-D-chiro-inositol and pinitol.
Maintained/Modified Rejections
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 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.
Claims 1, 6-10, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2006/047544 A2 to Pasinetti et. al. 2 and in further view of US 2004/0204387 A1 to McLaurin et. al.3
Regarding claims 1, 12 and a method for treating tauopathy or slowing onset of MCI or tauopathy or clinical manifestations thereof, comprising administering d-pinitol, WO’544 claims a method of inhibiting (see WO’544 claim 1) or treating (see WO’544 claim 19) a symptom of Alzheimer’s comprising administering a composition comprising D-pinitol WO’544 further claims wherein the individual has MCI (see WO’544 claim 12), or the cognitive impairment comprises a learning deficit (see WO’544 claim 35), a memory deficit (see WO’544 claim 36). WO’544 teaches administering D-pinitol for inhibiting the onset and progression of Alzheimer's disease, mild cognitive impairment, and related neurodegenerative disorders involving amyloidosis (see WO’544 at Abstract).
Regarding claim 6 and further comprising a carrier, WO’544 discloses the effective agent may be combined with a pharmaceutically acceptable carrier (see WO’544 at p. 16 lines 23-25).
Regarding claims 7 and 8 and the intended use of dietary supplement or nutraceutical composition, WO’544 teaches d-pinitol is known to be useful in certain nutritional and medicinal compositions (see WO’544 at p. 17 lines 22-23). WO’544 teaches instantly claimed formulations fit for human consumption. There is nothing present in the prior art compositions that would prevent them from being used for such purposes, and the claims do not positively recite any other ingredients.
Regarding claim 9 and oral administration, WO’544 claims oral administration (see WO’544 claim 2).
Regarding claim 10 and a healthy subject that does not suffer any clinical manifestations of a tauopathy or mild cognitive impairment, WO’544 claims administering prior to the onset of Alzheimer’s (see WO’544 claim 3). Additionally, WO’544 claims a method for promoting healthy structure of a nervous system in a mammal, which method comprises administering to the mammal an effective amount of a composition comprising D-pinitol (see WO’544 claim 61), wherein the individual is asymptomatic (see WO’544 claim 62).
The prior art differs from the claims as follows: While WO’544 teaches administering d-pinitol for Alzheimer’s WO’544 does not specify embodiments of treating other tauopathies or for dietary or nutraceutical purposes.
However,
Regarding claims 1, 13 and treating tauopathies and cognitive impairments besides Alzheimer’s Disease, US’387 teaches a method of treating a subject with a disorder in protein folding or aggregation or amyloid formation with D-pinitol (see US’387 at claim 16) for treating or preventing tauopathies including diffuse neurofibrillary tangles with calcification, non-Guamanian Motor Neuron disease with neurofibrillary tangles, tangle only dementia (US’387 claim 27, compare with instant claim 13 and neurofibrillary tangle dementia) and head trauma with post-traumatic accumulation of amyloid beta peptide (US’387 claim 24, compare with instant claim 13 and CTE).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. It would have been obvious to one skilled in the art to apply a known treatment for Alzheimer’s disease (D-pinitol as taught by WO’544) to another tauopathy such as those listed in claims 1 and 13 because the prior art teaches D-pinitol is for treating Alzheimer’s and other tauopathies such as neurofibrillary tangle dementia and CTE (as taught by US’387).
Furthermore, it is well-within the ordinary skill in art to apply a known treatment for a known disease in a pathology class for use on another disease also in that pathology class.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claims 1, 6-10, 12-13 are obvious over WO’544 in view of US’387.
Conclusion
Claims 1, 6-10, 12-13 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.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 See attached NPL STN entry
2 Cite No. 2 in the IDS filed 12/2/24. Hereinafter WO’544. Cited in previous Office Action.
3 Filed February 26, 2004 Cite No. 1 in the IDS filed 7/17/24. Hereinafter US’387. Cited in previous Office Action.
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