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 amended (1-10) and new (11-13) claims filed on August 29, 2022. Claims 1-13 are pending in instant application.
Information Disclosure Statement
The information disclosure statements filed on July 5, 2023; July 17, 2024; December 2, 2024 have been considered except where lined through.
Claim Interpretation
Regarding “cognitive impairment” and tauopathy: Applicant defines “cognitive impairment” as deficit in cognitive abilities (including learning, memory, perception, and problem solving) that are acquired (as opposed to the normal developmental aging associated “cognitive decline”), and may have an underlying brain pathiology (see instant spec. at p. 4 lines 10-13). Applicant goes on to list Alzheimer’s as a preferred disease embodiment (see instant spec. at p. 4 lines 17-20). Applicant also uses Alzheimer’s as an exemplified tauopathy (see instant spec. at p. 9 lines 14-20). A subject with Alzheimer’s is understood to meet the limitation of a subject with “cognitive impairment” and “a tauopathy”.
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.
Claim Objections
Claim 13 objected to because of the following informalities:
Claim 13 recites “CLE”, but the Examiner assumes a typographical error and the intended acronym is “CTE”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-13 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.
Claim 1 recites “…a composition comprising D-pinitol, D-chiro inositol, myo-inositol, any salt thereof, or any combination thereof.” It is unclear if the claim reads as any salt thereof pertains to all the listed compounds or just to myo-inositol Claims 2-13 do not rectify the issue of indefiniteness and are thus included in instant rejection.
For the purposes of applying art, the claim is construed to read as “…a composition comprising one or more compound, or salt thereof, selected from the group consisting of: D-pinitol, D-chiro inositol, and myo-inositol.”
Claim Rejections - 35 USC § 102
(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 1-3, 5, 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/047544 A22.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding claims 1, 2, 3, 5, 11, 12 and a method for treating cognitive impairment 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).
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 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).
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.
Accordingly, claims 1-3, 5, 6-12 are anticipated by WO’544.
Claims 1, 5, 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR 101671502 B13.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding claims 1, 5 and administering d-pinitol, KR’502 claims a pharmaceutical composition for preventing or treating female menopausal symptoms comprising pinitol or D-chiro-inositol (see KR’502 claim 1). KR’502 discloses administering to mice and middle-aged women.
Regarding claim 1 and a method of preventing cognitive impairment in a subject, KR’502 claims utility of the composition for treating menopause (see KR’502 claim 1), which is encompassed by the instant patient population of anyone who desires to prevent cognitive impairment.
Regarding claim 9 and oral administration, KR’502 discloses dosages of 600, 1200, and 2400 mg via an unspecified administration route (see KR’502 at ¶[0068]) and 10 mg/kg, 20 mg/kg, and 40 mg/kg oral dosages (see KR’502 at ¶[0066]).
Regarding claims 7 and 8 and the intended use of dietary supplement or nutraceutical composition, KR’502 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.
Accordingly, claims 1, 5, 7-9 are anticipated by KR’502.
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 4, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over WO’544 as applied to claims 1-3, 5, 6-12 above and in further view of US 2004/0204387 A14.
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
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 4, 13 and treating tauopathies and cognitive impairments besides Alzheimer’s Disease, US’387 teaches epi-inositol and scyllo-inositol decrease the astrogliotic response in mice (see US'387 at pp.9-10 Example 4). US’387 also claims 1,2,3,4,5,6-cyclohexanehexol (US’387 claim 2), including d-chiro-inositol (US’387 claim 3) 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 claims 4, 13 and neurofibrillary tangle dementia) and head trauma with post-traumatic accumulation of amyloid beta peptide (US’387 claim 24, compare with instant claims 4, 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 (as taught by WO’544) to another tauopathy such as those listed in claims 4 and 13 because the prior art teaches structurally similar inositols are used 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 4 and 13 are obvious over WO’544 in view of US’387.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Pitt et. al.5
Claim interpretation: The claim interpretations set forth in the “claim interpretation” section above are hereby incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding d-pinitol and d-chiro-inositol for treating cognitive impairment, Pitt teaches that mature cultures of hippocampal neurons respond to D-chiro-inositol, pinitol (3-O-methyl DCI), and the inositol glycan INS-2 (pinitol b-1-4 galactosamine) (see Pitt at Abstract). Pitt also teaches restoring neuroprotective function of CNS insulin signaling has been shown to protect against the synaptic damage of Aβ oligomers offers a new and useful treatment for Alzheimer’s Disease (see Pitt at p. 205 left col.).
The prior art differs from the claim as follows: While Pitt teaches the instantly claimed utility of d-pinitol and d-chiro-inositol, Pitt does specify or fails to exemplify administering to a subject.
However,
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)(D), a prima facie case of obviousness exists for applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. It would have been obvious to one skilled in the art to improve upon Pitt’s neuronal testing by administering to subjects with cognitive deficits because the prior art teaches the motivation of using d-pinitol or d-chiro-inositol for treating Alzheimer’s.
Furthermore, it is well-within the ordinary skill in art to begin testing a known potential treatment for use in humans for the same purpose as taught by the prior art (treating a cognitive impairment).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claim 1 is obvious over Pitt.
Conclusion
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KORTNEY KLINKEL can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
1 See attached NPL STN entry
2 Cite No. 2 in the IDS filed 12/2/24. Hereinafter WO’544.
3 See translation of corresponding application KR 20150099062, Translated by Global Dossier, Accessed 4/21/25, 32 pages. Cite No. 2 in the IDS filed 7/5/23. Hereinafter KR’502.
4 Filed February 26, 2004 Cite No. 1 in the IDS filed 7/17/24. Hereinafter US’387.
5 Pitt et. al. "Protection against the synaptic targeting and toxicity of Alzheimer's-associated Aβ oligomers by insulin mimetic chiro-inositols" FASEB J. 2013, 27, 1, 199-207. DOI: 10.1096/fj.12-211896. Cite No. 1 in the IDS filed 12/2/24. Hereinafter Pitt.