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 .
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 49-59, 68-76 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims encompass methods of transfecting cells by forming polymer-DNA complex by addition of a cationic polymer to DNA, then subsequently adding a stabilizing agent to form a stabilized complex, then incubating the mixture between 30 minutes to 18 hours before transfection of cells, e.g. as recited in claim 49. According to the definitions in the specification the “cationic polymer” and “stabilizing agent” can each be selected from a vast number of potential compounds.
However, applicant was not in possession of the claimed genera of methods wherein any given combination of a “cationic polymer” or “stabilizing agent” could be used as claimed to form a stabilized polyplex functional for the transfection of cells. In the absence of providing sufficient structural and functional characteristics of the genera of each of these elements broadly encompassed by the instant claim language, there is no disclosed correlation between function and structure.
However, the instant application has not provided a sufficient description showing possession of the necessary 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 genera of methods using any given combination of a “cationic polymer” or “stabilizing agent” to form a stabilized polyplex functional for the transfection of cells.
"It is not sufficient to define the recombinant molecule by its principal biological activity, e.g. having protein A activity, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property." Colbert v. Lofdahl, 21 USPQ2d, 1068, 1071 (BPAI 1992).
The claims do not recited sufficient written description of the structural and functional characteristics coupled with a known or disclosed correlation between function and structure, since the disclosure fails to describe the common attributes or characteristics that identify each member of the genera of combinations of a “cationic polymer” or “stabilizing agent” that form a stabilized polyplex functional for the transfection of cells.
Therefore, there is insufficient written description of the claimed genera of transfection methods in the absence of defining the relevant identifying characteristics such as the structure or other physical and/or chemical characteristics of the claimed genera.
Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear 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, reduction to drawings, 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 genus.
In the absence of sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, the claimed invention is not described in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required
With respect to reliance upon screening for structural and/or functional equivalents, the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Applicant is relying upon certain activities and functional features, and the disclosure of a single species (e.g., PEI as the cationic polymer and HSA as the stabilizing agent) to support entire genera.
The problem here is that the instant specification fails to provide a sufficient disclosure of
each combination of a “cationic polymer” or “stabilizing agent” that could be used as claimed to form a stabilized polyplex functional for the transfection of cells in order for these reagents to retain the appropriate structural and functional requirements for stabilized polyplex formation and cell transfection.
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genera that exhibit the appropriate structural and functional elements for stabilized polyplex formation and cell transfection.
Therefore, there is insufficient written description for the genus of a “cationic polymer” or “stabilizing agent” combinations that could be used as claimed to form a stabilized polypex functional for the transfection of cells.
Allowable Subject Matter
Claims 60, 62, 64-66, 77-82 are allowed.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638