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 .
Applicant’s amendment filed on 03/04/2026 is acknowledged.
Claims 1-2, 5-6, 8, 12, 18, 21-23, 25, 27-28, 31, 33-34, 36, 38, 42, 48 and 51-54 are pending.
4. Applicant’s election without traverse of Group I, and the species of the antigen binding protein of SEQ ID NOs 7 and 8 in the reply filed on 03/04/2026 is acknowledged. It is noted that SEQ ID NOs 7 and 8 comprise the framework regions of SEQ ID Nos 17-24.
5. Claims 31, 33, 36, 38, 42, 48 and 53-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and claims 21-23, 25, 27-28 and 51-52 as being directed to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/04/2026.
6. Claims 1-2, 5-6, 8, 12, 18 and 34 are currently under consideration as they read on the antigen binding protein of SEQ ID NOs 7 and 8 which comprises the framework regions of SEQ ID Nos 17-24.
7. Applicant’s IDS documents filed on 04/03/2023, 08/16/2023 and 05/14/2025 have been considered.
Claim 1 recites:
An antigen binding protein that binds to or specifically binds to CLEC9A, wherein the antigen binding protein comprises:(a) a framework region (FR) 1 comprising a sequence at least about 58%, at least about 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least about 85%, at least 90%, at least 95% identical to a sequence set forth in SEQ ID NO: 17, a FR2 comprising a sequence at least about 95% identical to a sequence set forth in SEQ ID NO: 18, a FR3 comprising a sequence at least about 95% identical to a sequence set forth in SEQ ID NO: 19, and a FR4 comprising a sequence at least about 73%, at least about 75%, at least 80%, at least 85%, at least 90%, at least 95% identical to a sequence set forth in SEQ ID NO: 20; and/or (b) a FR1 comprising a sequence at least about 88%, at least 90%, at least 95% identical to a sequence set forth in SEQ ID NO: 21, a FR2 comprising a sequence at least about 88%, at least 90%, at least 95% identical to a sequence set forth in SEQ ID NO: 22, a FR3 comprising a sequence at least about 87%, at least 90%, at least 95% identical to a sequence set forth in SEQ ID NO: 23, and a FR4 comprising a sequence at least about 82%, at least 85%, at least 90%, at least 95% identical to a sequence set forth in SEQ ID NO: 24.
SEQ ID NO:17 is 26 amino acids in length and it may have up to 10 amino acid changes and be at least 58% identical to SEQ ID NO:17.
SEQ ID NO:18 is 17 amino acids in length: one amino acid change would be 94.11% identical, so there are no sequences that are at least 95% identical to SEQ ID NO:18 other than SEQ ID NO:18. As such there may be 0 amino acid changes.
SEQ ID NO:19 is 36 amino acids in length and it may have one amino acid change and be at least 95% identical to SEQ ID NO:19.
SEQ ID NO:20 is 11 amino acids in length and it may have up to 2 amino acid changes and be at least 73% sequence identical to SEQ ID NO:20.
SEQ ID NO:21 is 25 amino acids in length and it may have up to 3 amino acid changes and be at least 88% sequence identical to SEQ ID NO:21.
SEQ ID NO:22 is 17 amino acids in length and it may have up to 2 amino acid changes and be at least 88% sequence identical to SEQ ID NO:22.
SEQ ID NO:23 is 38 amino acids in length and it may have up to 5 amino acid changes and be at least 87% sequence identical to SEQ ID NO:23.
SEQ ID NO: 24 is 11 amino acids in length and it may have up to one amino acid change and be at least 82% sequence identical to SEQ ID NO:24.
8. 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.
9. Claims 1-2, 5-6, 8, 12, 18 and 34 are 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.
The recitations in claim 1 are unclear and indefinite for the following reasons:
SEQ ID NO:18 is 17 amino acids in length: one amino acid change would be 94.11% identical, so there are no sequences that are at least 95% identical to SEQ ID NO:18 other than SEQ ID NO:18. As such there may be 0 amino acid changes.
SEQ ID NO:20 is 11 amino acids in length and it may have up to 2 amino acid changes and be at least 73% sequence identical to SEQ ID NO:20. However, one amino acid change would be 90.9% identical, so there are no sequences that are at least 95% identical to SEQ ID NO:20 other than SEQ ID NO:20.
SEQ ID NO:22 is 17 amino acids in length and it may have up to 2 amino acid changes and be at least 88% sequence identical to SEQ ID NO:22. However, one amino acid change would be 94.11% identical, so there are no sequences that are at least 95% identical to SEQ ID NO:22 other than SEQ ID NO:22.
SEQ ID NO: 24 is 11 amino acids in length and it may have up to one amino acid change and be at least 82% sequence identical to SEQ ID NO:24. However, one amino acid change would be 90.9% identical, so there are no sequences that are at least 95% identical to SEQ ID NO:24 other than SEQ ID NO:24
Correction is required.
10. 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.
11. Claims 1-2, 5-6, 8, 12, 18 and 34 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.
Applicant is in possession of: anti-CLEC9A antibodies which comprise all 6 CDRs of SEQ ID NOs 1-6 including the antibody of SEQ ID NOs 7 and 8 and the antibody of SEQ ID NOs 33 and 34 which comprise all 6 CDRs of SEQ ID NOs 1-6; and antibodies which comprise all 6 CDRs of SEQ ID NOs 1-6 and the framework regions of SEQ ID NOs 17-24.
Applicant is not in possession of: anti-CLEC9A antibodies which comprise less than all 6 CDRs of SEQ ID NOs 1-6 with or without the framework regions of SEQ ID NOs 17-24, including framework regions which are variants of the framework regions of SEQ ID NOs 17-24.
The specification describes anti-CLEC9A antibodies which comprise all 6 CDRs of SEQ ID NOs 1-6 including the antibody of SEQ ID NOs 7 and 8 and the antibody of SEQ ID NOs 33 and 34 which comprise all 6 CDRs of SEQ ID NOs 1-6; and antibodies which comprise all 6 CDRs of SEQ ID NOs 1-6 and the framework regions of SEQ ID NOs 17-24.
The claims encompass antibodies with variants of the recited amino acid sequences and combinations of CDRs and combinations of heavy and light chains not found in the antibodies
that were actually produced in the specification which actually bind CLEC9A. The skilled artisan cannot envision all the antibody possibilities recited in the instant claims.
Consequently, conception cannot be achieved until a representative description of the structural and functional properties of the claimed invention has occurred, regardless of the complexity or simplicity of the method.
The specification must set forth the structural features that allow one of ordinary skill in the art to identify and produce the recited CLEC9A antigen binding molecules. In the instant case, definition by function does not suffice to define the genus because it is only an indication of what the antibodies do, rather than what they are.
Sailer et al. (PTO-892; Reference U) teaches that “proteins exist as ensembles of similar conformations. The effect of a mutation depends on the relative probabilities of conformations in the ensemble, which in turn, depend on the exact amino acid sequence of the protein. Accumulating substitutions alter the relative probabilities of conformations, thereby changing the effects of future mutations. This manifests itself as subtle but pervasive high-order epistasis. Uncertainty in the effect of each mutation accumulates and undermines prediction. Because conformational ensembles are an inevitable feature of proteins, this is likely universal” (In particular, abstract, whole document); and that “a key point from our work is that unpredictability can arise even in this extraordinary simple system. The problem of predicting evolution will only become harder as the complexity and realism of the models increase. Using a larger protein, for example, would increase the number of possible options and degeneracy of trajectories, making predictions more challenging.” (In particular, page 11942, left column, whole document).
According to MPEP 2163 (II)(A)(3)(a)(ii) 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 (see i)(A), reduction to drawings (see i)(B), 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 (see i)(C). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
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 disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
The specification has not adequately described the structure of antibodies which bind CLEC9A or CLEC9A of SEQ ID NO:35 wherein the CDRs have variable CDRs residues as recited in claim 8 or a single heavy or light chain as recited in claim 12.
It is well established in the art that it is highly unpredictable which changes in amino acid sequence can be made in complementarity determining regions (CDRs) of a parental antibody such that the derived antibody retains the binding specificity and affinity of the parent antibody. The art of Mariuzza et al. (PTO-892; Reference V) reviews the structural basis of antigen-antibody recognition and teaches that a naturally occurring antibody comprises light and heavy chains. The antigen-combining site of an antibody is a three-dimensional structure, which fully comprises six "complementarity-determining regions" (CDRs), three each from the light and heavy chains. The amino acid sequences of the CDRs are hypervariable, as the amino acid residues contained within the CDRs determine much of antibody's antigen-binding specificity. Of the amino acid residues of the antibody contacting the antigen, six are within the light chain, nine are within the heavy chain, and two are within the constant or nearly constant "framework" regions (In particular, whole document). As such, one of skill in the art would not know which of the recited antibody variants would have the claimed function of binding to CLEC9A or SEQ ID NO:35 because it is the 6 CDRs together which determine the antibody's antigen-binding specificity.
It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. MacCallum, et al. (PTO-892; Reference W) analyzed many different antibodies for interactions with antigen and state that although CDR3 of the heavy and light chain dominate, a number of residues outside the standard CDR definitions make antigen contacts (see page 733, right column) and non-contacting residues within the CDRs coincide with residues as important in defining canonical backbone conformations (see page 735, left column). De Pascalis, et al.
(PTO-892; Reference X) demonstrate that grafting of the CDRs into a human framework was performed by grafting CDR residues and maintaining framework residues that were deemed essential for preserving the structural integrity of the antigen binding site (see page
3079, right column). Although abbreviated CDR residues were used in the constructs, some residues in all 6 CDRs were used for the constructs (see page 3080, left column). Thus it is unpredictable as to what amino acids can be changed in the original intact antibodies disclosed in the specification wherein the antibodies would still function. Thus, the skilled artisan cannot envision the detailed structure of the encompassed invention and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation.
It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function.
As evidenced by the art of Goel et al. (PTO-892; Page 2; Reference U), Khan et al. (PTO-892; Page 2; Reference V) and Poosarla et al. (PTO-892; Page 2; Reference W), antibody specificity for a particular antigen does not correlate with any particular structure for the antibodies themselves. It was well known to those skilled in the art at the time the invention was made that minor structural differences among structurally related antibodies or compositions thereof could result in substantially different binding activities. Given the lack of guidance in the specification, it is unpredictable which antibodies with which structures would exhibit the recited functions. The specification does not disclose a correlation between the structure of the antibodies themselves and their function of binding CLEC9A such that a skilled artisan would have known what antibody structures possess the claimed functions.
The specification does not disclose a correlation between the antibody structure and the function of binding to CLEC9A or SEQ ID NO:35 such that a skilled artisan would have known what antibody variants possess the claimed function. "Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features" Ex parte Kubin (83 U.S.P.Q.2d 1410 (BPAI 2007)), at page 16. In this instant case, Applicants have not provided the requisite identifying structural features of the antibodies encompassed. "Without a correlation between structure and function, the claim does little more than define the claimed invention by function" supra, at page 17.
U.S. Court of Appeals for the Federal Circuit recently decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed,
35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen"
test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. , the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872
F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345
(Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly\ characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. Id.
The specification does not provide adequate written description of the claimed invention.
The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 U.S.P.Q.2d 1111
(Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the applicant had possession at the time of invention of the claimed invention.
Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. In the instant application, the amino acid sequence itself or isolated protein is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016. In view of the aforementioned problems regarding description of the claimed invention, the specification does not provide an adequate written description of the invention claimed herein.
See The Regents of the University of California v. Eli Lilly and Company, 43 USPQ2d 1398,
1404-7 (Fed. Cir. 1997). In University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d 1225
(Fed. Cir. 1995) the inventors claimed a genus of DNA species encoding insulin in different vertebrates or mammals, but had only described a single species of cDNA which encoded rat insulin. The court held that only the nucleic acids species described in the specification (i.e. nucleic acids encoding rat insulin) met the description requirement and that the inventors were not entitled to a claim encompassing a genus of nucleic acids encoding insulin from other vertebrates, mammals or humans, id. at 1240. The Federal Circuit has held that if an inventor is "unable to envision the detailed constitution of a gene so as to distinguish it from other materials.
. .conception has not been achieved until reduction to practice has occurred", Amgen, Inc. v.
Chugai Pharmaceutical Co, Ltd., 18 U.S.P.Q.2d 016 (Fed. Cir. 1991). Attention is also directed to the decision of The Regents of the University of California v. Eli Lilly and Company (CAFC,
July 1997) wherein is stated: "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 222 USPQ 369, 372-373 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Thus, as we have previously held, a cDNA is not defined or described by the mere name "cDNA," even if accompanied by the name of the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA." See
Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606.
As such, there is insufficient written description of the required kind of structure identifying information about the corresponding makeup of the claimed antibodies to demonstrate possession.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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May 31, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights