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 .
Claims 1, 2, 8, 9, 21-24, 30-35, 51, 52, and 57-60 are pending and currently under consideration.
Claim Objections
Claim 24 is objected to because of an apparent typographical error. The term “claims” (plural) should be replaced by “claim” (singular) because recited “21” is a single claim. Appropriate correction is required.
Claim 32 is objected to because the claim awkwardly recites a target cell “has a disease or disorder.” It is not standard to indicate the a “cell” has a disease or disorder or disease. Rather, the terms “disease” and “disorder” are reserved for a subject that comprises cells. In an effort to expedite prosecution, the following amendment to claim 32 is suggested to obviate this objection: “The method of claim 30, wherein the target cell is a cell of a subject that has a disease or disorder.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 59 is 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 59 recites “…wherein the at least one payload comprises a small….” There is insufficient antecedent basis for “the at least one payload” in the claim. In an effort to expedite prosecution, the following amendment to claim 59 is suggested to obviate this rejection: “The pharmaceutical composition of claim 58, wherein the at least one payload comprises a small….”
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, 2, 9, 21-24, 30-35, 51, 52, and 57-60 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. In the instant case, the claims are inclusive of: (i) a genus of cell targeting constructs comprising a binding agent comprising a protein as little as 95% identical to SEQ ID NO:6 or SEQ ID NO:12 wherein the constructs target nucleic acid on the surface of a cell; and (ii) a genus of nucleic acids encoding cell targeting constructs comprising a binding agent comprising a protein as little as 95% identical to SEQ ID NO:6 or SEQ ID NO:12 wherein the constructs target nucleic acid on the surface of a cell. However, the written description in this case only sets forth the following members of the genera: (i) cell targeting constructs comprising SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12 that target nucleic acid on the surface of a cell; and (ii) nucleic acids encoding cell targeting constructs comprising SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12 that target nucleic acid on the surface of a cell. The specification does not disclose, and the art does not teach, the genera as broadly encompassed in the claims.
The specification discloses (i) SEQ ID NOs: 4 and 6 as zinc finger protein sequences that bind wild-type KRAS DNA and (ii) SEQ ID NOs: 10 and 12 as zinc finger protein sequences that bind G12D KRAS DNA ([0052] spanning pages 17-18, in particular). The specification and the prior art do not disclose or teach any other constructs 95% identical to SEQ ID NO:6 or SEQ ID NO:12 that target nucleic acid. The specification further acknowledges zinc finger proteins (like SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12) comprise a zinc-finger domain that binds to DNA by juxtaposing base pairs of the DNA to amino acids in a zinc finger structure, that identity of the amino acids at the contact site define DNA sequences recognized by a zinc finger protein, and that changing these amino acids changes the selectivity towards a given DNA sequence ([0009], in particular). Neither the specification nor the prior art teach the genus of cell targeting constructs comprising a binding agent comprising a protein 95% identical to SEQ ID NO:6 or SEQ ID NO:12 that target nucleic acid on the surface of a cell (or the genus of nucleic acids encoding said targeting constructs) because (other than SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12) one cannot envision which changes to the recited sequences would (or would not) result in cell targeting constructs that target nucleic acids.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
In regards to claims to a product defined by function, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 at1568 USPQ2d at 1406 (“definition by function…does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genera. That is, the specification provides neither a representative number of members that encompass the genera nor does it provide a description of structural features that are common to the genera so that one of skill in the art can ‘visualize or recognize’ the members of the genera. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the 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 to provide a "representative number” of species.
The functional requirements of the claimed targeting constructs (and nucleic acids encoding said targeting constructs) is the sort of wish list of properties which fails to satisfy the written description requirement because targeting constructs with those properties have not been adequately described. The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.”Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genera, and because the genera are highly variant, the disclosure is insufficient to describe the genera. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genera as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, even though Applicant may propose methods of screening for possible members of the genera, the skilled artisan cannot envision the detailed chemical structure of the encompassed genera, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112
Claims 1, 2, 9, 21-24, 30-35, 51, 52, and 57-60 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 making and using (i) cell targeting constructs comprising SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12 that target nucleic acid on the surface of a cell; and (ii) nucleic acids encoding cell targeting constructs comprising SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12 that target nucleic acid on the surface of a cell, does not reasonably provide enablement for making a using (i) just any cell targeting construct comprising a binding agent comprising a protein as little as 95% identical to SEQ ID NO:6 or SEQ ID NO:12 wherein the constructs target nucleic acid on the surface of a cell; and (ii) just any nucleic acids encoding cell targeting constructs comprising a binding agent comprising a protein as little as 95% identical to SEQ ID NO:6 or SEQ ID NO:12 wherein the constructs target nucleic acid on the surface of a cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed.
The instant claims are drawn to (i) a genus of cell targeting constructs comprising a binding agent comprising a protein 95% identical to SEQ ID NO:6 or SEQ ID NO:12 wherein the constructs target nucleic acid on the surface of a cell; and (ii) a genus of nucleic acids encoding cell targeting constructs comprising a binding agent comprising a protein 95% identical to SEQ ID NO:6 or SEQ ID NO:12 wherein the constructs target nucleic acid on the surface of a cell. This includes genera that are not adequately described.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The specification discloses (i) SEQ ID NOs: 4 and 6 as zinc finger protein sequences that bind wild-type KRAS DNA and (ii) SEQ ID NOs: 10 and 12 as zinc finger protein sequences that bind G12D KRAS DNA ([0052] spanning pages 17-18, in particular). The specification and the prior art do not disclose or teach any other constructs 95% identical to SEQ ID NO:6 or SEQ ID NO:12 that target nucleic acid. The specification further acknowledges zinc finger proteins (like SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12) comprise a zinc-finger domain that binds to DNA by juxtaposing base pairs of the DNA to amino acids in a zinc finger structure, that identity of the amino acids at the contact site define DNA sequences recognized by a zinc finger protein, and that changing these amino acids changes the selectivity towards a given DNA sequence ([0009], in particular). Neither the specification nor the prior art teach the genus of cell targeting constructs comprising a binding agent comprising a protein 95% identical to SEQ ID NO:6 or SEQ ID NO:12 that target nucleic acid on the surface of a cell (or the genus of nucleic acids encoding said targeting constructs) because (other than SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12) one cannot envision which changes to the recited sequences would (or would not) result in cell targeting constructs that target nucleic acids. Further, one cannot envision which nucleic acids would (or would not) be targeted by members of the genus of cell targeting constructs encompassed by the claims (other than SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:10, or SEQ ID NO:12) in order to use said (nucleic acid-targeting) cell targeting constructs (or nucleic acids encoding said cell targeting constructs).
One cannot extrapolate the teachings of the specification to the scope of the claims because the claims are broadly drawn to genera of cell targeting constructs and nucleic acids encoding said constructs that are not adequately described, and Applicant has not enabled the claims because it would require undue experimentation to identify and characterize the genus of cell targeting constructs encompassed by the claims (and nucleic acids encompassed by the claims) in order to make and use claimed invention.
Similar to claims at issue in Amgen Inc. v Sanofi, the instant specification does not enable the full scope of the claims.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
