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 08/19/2025 is acknowledged.
The terminal disclaimer filed on 08/19/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,773,176 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claims 35-36 and 38-50 are pending and under consideration for their full scope.
Applicant’s IDS document filed on 08/19/2025 has been considered.
Claim Objections
6. Claims 35, 39, 44 and 49 are objected to because of the following informalities:
In claim 35 the phrase “scFv” is introduced. Claim 36 then does on to define the phrase. This definition should be in claim 35 and not in dependent claim 36.
In claims 39 and 44, the phrase “comprising an amino acid sequence of SEQ ID NO:48” should be changed to “comprising the amino acid sequence of SEQ ID NO:48” since it is only referring to one sequence.
In claim 49, the phrase “comprising an amino acid sequence of” in lines 2 and 3 should be changed to “comprising the amino acid sequence of” since each recitation is only referring to one sequence.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 41-44 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.
A. Claims 41-44 recite the limitation "linker". There is insufficient antecedent basis for this limitation in claim 35. The recitation of claim 35 should be changed to claim 40.
In claim 41 the phrase “claims 35,” should be changed to “claim 40,”;
In claim 42 the phrase “claim 35,” should be changed to “claim 40,”;
In claim 43 the phrase “claim 35,” should be changed to “claim 40,”; and
In claim 44 the phrase “antobody of claim 35,” should be changed to “antibody of claim 40”.
9. Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 36 depends from independent claim 35. Claim 35 recites “wherein each of the R1 and R2 is an anti-CD40L hu5c8 scFv” after amendment. Claim 36 recites “wherein R1 and R2 are same or different single-chain variable fragments (scFv)” and this recitation is not further limiting to claim 35. At a minimum claim 36 should recite that the scFv are anti-CD40L hu5c8 scFv because otherwise this recitation opens up the claims to R1 and R2 being scFv which are unrelated to anti-CD40L hu5c8 scFv. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 35-36 and 38-50 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: the multispecific antibody of claim 35 comprising an anti-CD40L hu5C8 scFv of SEQ ID NO: 48 or SEQ ID NO:47.
Applicant is not in possession of: the multispecific antibody of claim 35 comprising: 1.) an anti-CD40L hu5C8 scFv comprising “an” amino acid sequence of SEQ ID NO:48 or SEQ ID NO:47; 2.) an anti-CD40L hu5C8 scFv comprising “an” amino acid sequence having at least 80% sequence identity to of SEQ ID NO: 48 or SEQ ID NO:47; or 3.) an anti-CD40L hu5C8 scFv 80% sequence identical to SEQ ID NO:48 or SEQ ID NO:47.
The claims encompass antibodies with variants of the recited amino acid sequences. The claims recite variable region sequences containing amino acids not found in the anti-CD40L hu5c8. The skilled artisan cannot envision all the antibody and method possibilities recited in the instant claims.
The specification teaches in paragraph [0004] “hu5c8 IgGI (BG-9588, ruplizumab, AntovaTM, Biogen, Cambridge, Massachusetts” and in paragraph [0006] that hu5c8 is a ruplizumab antibody binding to CD40. Then in paragraph [0016] the specification teaches that “an anti-CD40L hu5c8” may comprise an amino acid sequence having at least 80% identity to SEQ ID NO:47 or SEQ ID NO:48. As such, the term an anti-CD40L hu5c8 encompasses 80% variants to SEQ ID NOs 47 and 48 which do not require the CDRs present within hu5c8.
The specification has not described anti-CD40L hu5c8 scFv with 80% sequence identity to SEQ ID NO:47 or 48. 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 has neither demonstrated a structure function relationship nor provided a representative number of species of antibodies with the recited binding specificity.
The specification must set forth the structural features that allow one of ordinary skill in the art to identify and produce the recited antibodies. 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.
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 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. 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 CD40L and being an svFv of hu5c8 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.
Thus it is unpredictable as to what amino acids can be changed in the original intact antibodies disclosed in the specification wherein the scFv 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.
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 functions of binding to binding to CD40L and being an scFv of hu5c8 such that a skilled artisan would have known what antibody structures possess the claimed functions.
"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.
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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November 29, 2025
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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