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 .
Election/Restrictions
Claims 17-18 have been canceled.
Regarding a prior amendment to claim 1, reciting a series of 4 alternative detected components/characteristics, the examiner selected detecting decreased Amyloid Beta for further examination. The limitations are no longer recited in claim 1.
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 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.
Claim(s) 1, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Constantinidis (“Treatment of Alzheimer’s Disease by Zinc Compounds”; 1992; Drug Dev. Res.; 27:1-14; cited in a prior Office action) in view of Novak et al. (US 2016/0151415 A1; 06/02/2016; IDS reference); and Lee et al. (“Zinc Inhibits Amyloid β Production from Alzheimer’s Amyloid Precursor Protein in SH-SY5Y Cells”; 2009; Korean J. Physiol. Pharmacol; 13:195-200; cited in a prior Office action).
The claims are directed to a method of treating Alzheimer’s disease comprising administering a composition comprising 64Zne or as an aspartate salt, where the 64Zn enrichment level is at least 95%, and specific doses are also required, as alternate choices.
Constantinidis teaches administering inter alia intravenously (i.e., by injection) to a patient suffering from Alzheimer’s disease zinc aspartate (page 8, paragraph 5). The administration resulted in improvements in memory, understanding, communication, and social contact in the patient (page 9, paragraph 1).
Constantinidis does not teach administering 64Zn-enriched aspartate, where the enrichment is at least 80% 64Zn. The skilled artisan would have recognized that naturally occurring Zn contains lower relative amount of this isotope (48.63% relative abundance); i.e., some 64Zn-enriched aspartate was injected into the AD subject, but not the claimed levels of “at least 95%” (claim 1) or more (dependent claim 3) of 64Zn.
Novak et al. teach a pharmaceutical composition in the form of a solution for improving degenerative disease comprising an isotope selected from, inter alia, Zn-64 in an amount of 0-100% (claims 1-2, 5). Degenerative pathologies include Alzheimer disease which are also age related [0007].
It would have been prima facie obvious to one of ordinary skill in the art at the time of the filing of the instant application to utilize the composition of Novak et al. in the method of Constantinidis and have a reasonable expectation of success. One would have been motivated to do so since Novak et al. teach that the composition can be used for treatment of Alzheimer’s disease and Constantinidis teach that zinc compositions treat Alzheimer’s disease. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
.
Lee teaches zinc inhibits Amyloid β production from Alzheimer’s Amyloid Precursor Protein in SH-Sy5Y Cells (title). Alzheimer’s disease (AD) is the most common cause of dementia. The pathologic hallmarks of AD are neurofibrillary tangles and senile plaques, the main components of which are tau (a microtubule-associated protein) and amyloid beta peptide (Aβ) respectively )195; 1st paragraph). Lee documents that one effect of zinc influx on Aβ levels was decrease of Aβ40 levels in a dose dependent manner; similarly, concentration of Aβ42 also decreased to a level similar to the level of Aβ 40 (196, right, 4th paragraph).
The reduction of Aβ levels as a result of zinc uptake into cells is consistent with benefits of zinc treatment of AD taught by Constantinidis, and provides a rationale rendering obvious the further detection of decreased Amyloid Beta after obvious administration of administering 64Zn-enriched aspartate. The motivation to include this detection would have been to verify this reduction of Aβ is a result of treatment.
Regarding claim 13 dosing, zinc aspartate was dosed with 3 pills a day, each contains 50 mg of zinc bis (DL-hydrogen aspartate); this would have been an obvious starting point to select zinc-64 aspartate, and the dosing would have resulted in an amount withing the claimed range.
Regarding claim 14, Zn-64 concentrations include 2 mg/mL (Figure 7), rendering obvious this or obvious similar concentrations (i.e., 2.25 mg/ml), close to the amount of claim 1.
Regarding claim 15, for a typical patient of 65 or 70 kg, 50 mg dosing corresponds to 0.76 or 0.71 mg/kg, rendering obvious the range of claim 1.
Doses, concentrations of aqueous solutions and mg/kg amounts are also obvious as a result of routine optimization, starting with amounts discussed above.
Applicant alleges that none of the references teach Zn-64 enrichment of the level of at least 95%; somehow the teachings do not enable this level of enrichment. The Examiner disagrees. Levels of Zn-64 up to 100% are clearly taught. Novak et al. teach a pharmaceutical composition in the form of a solution for improving degenerative disease comprising an isotope selected from, inter alia, Zn-64 in an amount of 0-100% (claims 1-2, 5). The teachings of Novak explicitly include AD.
MPEP 2144.04 VII discusses purity of a product: Pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are nonobvious over the prior art. In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious. In the instant case, the argument amounts to mere purity of the Zn64 compound administered, which does not render the claimed method nonobvious.
Applicant further argues that disclosure of certain dosage and route of administration must be for treating Alzheimer’s disease in a patient, not generic degenerative disease. The Examiner does not agree, and notes that the examples cited provide amounts of the claims or close to the claims, suitable to render the claimed concentrations prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614
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