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 .
Amendment filed January 22, 2026.
Claims 1-2, 6, 8, 10, 21-22, 25-26, 33-34, 36-37, 65-66, 81-82, 87-88, 94-95, 99 are pending. Claims 3-5, 7, 9, 11-20, 23-24, 27-32, 35, 38-64, 67-80, 83-86, 89-93, 96-98 are canceled. Claims 1-2, 6, 8, 10, 25-26, 33-34, 36-37, 65-66, 87-88, 94-95 are withdrawn. Claims 21-22, 81-82, 99 are examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-22, 81-82, 99 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for method for ameliorating specific aging phenotype comprising increasing ZIP11 nucleic acid (elected group) by transgenic overexpression in zebra fish and mice, does not reasonably provide enablement for method for ameliorating generic aging by administering generic substance to increase expression of nucleic acid level of Zip11. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to to make and use the invention commensurate in scope with these claims.
The first paragraph of § 112 requires that the patent specification enable "those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation."' Genentech, Inc. v. Novo Nordisk AIS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art."). Whether making and using the invention would have required undue experimentation, and thus whether the disclosure is enabling is a legal conclusion based upon several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Likewise, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), the court affirmed the holding of invalidity of claims to analogs of the EPO gene under § 112 for lack of enablement where applicants had claimed every possible analog of the EPO gene but had disclosed only how to make EPO and a very few analogs. "[D]espite extensive statements in the specification concerning all analogs of the EPO gene that can be made, there is little enabling disclosure of the particular analogs and how to make them .... There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them." Id., 927 F.2d at 1213-14, 18 USPQ2d at 1027.
Claims encompass a method for ameliorating generic aging by administering generic substance to increase expression of nucleic acid level of Zip11. However, one skilled in the art cannot treat the large genus aging phenotype claimed with generic substance to increase the nucleic acid level of Zip11. The specification does not teach method for ameliorating generic aging by administering generic substance to increase expression of nucleic acid level of Zip11. The amount of direction and example provided in the specification is limited to prophetic methods and transgenic overexpression of Zip11 in zebra fish or mice. One skilled in the art would require empirical experimentation in order to determine whether generic substance would increase Zip11 nucleic acid level and result in the ameliorating of generic aging. The state of the art is silent with regard to the correlation of Zip11 overexpression and ameliorating aging (Pohlner et al., US 2009/0255003). The state of the art is such that one skilled in the art cannot predict the outcome of treatment with generic substance the increase in Zip11 nucleic acid level and prolonged aging (elected species) in humans. While such measurements of mice and zebra fish are possible, no such longitudinal study of overexpression of Zip 11 nucleic acid can be performed with humans. No such data exists. Thus, one skilled in the art cannot treat with generic substance to increase the Zip11 nucleic acid level in humans to prolong aging. No working example is provided for treatment of with generic substance to increase the Zip11 nucleic acid level in humans to prolong aging as encompassed by claims. The state of the art is silent with respect to the treatment of human aging.
In view of the extent and the unpredictability of the experimentation required to practice the invention as claimed, one skilled in the art could not make the invention without undue experimentation. Therefore, based on the above Wands analysis, a preponderance of the evidence supports a conclusion that one skilled in the art would not have been enabled to make and use the claimed invention without undue experimentation.
Applicants argue that enablement analysis premised on “administering generic substance” is inapplicable to the amended claim 21. However, claims 81-82 still encompass the term.
Applicants argue that use of well-established animal models to demonstrate biological causation and therapeutic potential is standard practice in the art of aging and age-related disease research. However, the state of the art is such that substance effect on all generic aging phenotype is not correlated. Furthermore, the relationship of the phenotypes to actual aging changes due to the substance administration is not correlated. Furthermore, the correlation of phenotype of one animal species to another animal species is not correlated for aging.
Applicants argue that claims 81-82 are directed to assessment methods, not treatment methods and enablement concerns regarding treatment of “generic aging” in humans do not apply to these claims. However, the claims specifically assess generic aging conditions.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 99 is/are rejected under 35 U.S.C. 102(A1) as being anticipated by Pohlner et al. (US 2009/0255003).
Pohlner teach the method of increasing the level of SLC39A11(ZIP 11) mRNA levels in neurodegenerative diseases (fig 1-3; para 52-53, 60, 68) with treatment with modulators or agents (para 36-37). The increasing of the Zip11 inherently ameliorate aging (elected species). Pohlner teach the method of administering gene coding for SLC39A11. Pohlner nucleic acid encoding SLC39A1 inherently comprise a nucleotide sequence as s et forth in SEQ ID No.1.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674
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