DETAILED ACTION
Applicants claims filed 4/18/2024 are acknowledged and entered into the record.
Accordingly, Claims 1-19 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are drawn to a method for treating a subject having a metabolic syndrome comprising administering to the subject an agent that inhibits the activity of PHD3, wherein the activity inhibited is hydroxylation of ACC2 at proline 450 relative to SEQ ID NO: 2 by PHD3.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. “Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species.” Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010).
The claims are broadly drawn to a method of treatment comprising administering a broad genus of agents without describing a structure to function correlation required to inhibit hydroxylation of ACC2 at proline 450, which features constitute a substantial portion of the genus because the instant specification fails to disclose guidance on what structures can inhibit PHD3 and treat a metabolic syndrome. The instant specification shows examples of knockdown of PHD3 using shRNA against PHD3, however the sequence of one shRNA does not provide guidance on what other shRNA sequences can target and inhibit PHD3, however the specification fails to provide any structure to function correlation of the shRNA targeting PHD3 (see figures). The sequences of one shRNA does not predict the sequence or sequences of other nucleic acid inhibitors that will target and knockdown PHD3. Although it is possible to screen for nucleic acid sequences which can inhibit PHD3, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.”
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The specification fails to describe any structure to function correlation of which shRNA sequences can inhibit PHD3 activity and function as claimed. The described species therefore cannot be considered representative the recited genera of nucleic acid inhibitors use in the instantly claimed method of treatment. E.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
In the absence of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics; i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe structural features that convey the claimed activity, a prerequisite for utility in the recited methods of treatment.
For all of the reasons presented above, one of skill in the art would not know which of the countless agents encompassed by the independent claims would be able to show a measurable inhibition of PHD3 activity and treat a subject afflicted with a metabolic syndrome when administered. And none of the dependent claims provide sufficient additional structure or a structure/function correlation to provide an adequate written description of the genera of agents used in the claimed method of treatment. Therefore, the skilled artisan would not reasonably conclude that the inventors, at the time the application was filed, had full possession of inhibitors as broadly claimed. Given the lack of shared structural properties that provide the claimed activity, the limited number of species described, and the fact that the species that were described cannot be considered representative of the broad genus, Applicant was not in possession of the invention as claimed.
Conclusion
Claims 1-19 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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