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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Claims 1-66, 70-81, 84-85, and 95 have been cancelled. Claims 102-105 have been newly introduced.
Applicant's arguments filed 11/25/2025 have been fully considered but they are not fully persuasive.
Antibody KC18Hu18VH has the heavy chain CDR1 of SEQ ID NO: 70, CDR2 of SEQ ID NO: 297; and CDR3 of SEQ ID NO: 301 and the light chain CDR1 of SEQ ID NO:302, CDR2 of SEQ ID NO: 74, and CDR3 of SEQ ID NO: 75. The VH (120 amino acids) corresponds to SEQ ID NO: 18. The VL (112 amino acids) corresponds to SEQ ID NO: 19. See at least Table 1 of the specification. The heavy chain of SEQ ID NOS: 63 contains the CDRs of SEQ ID NOS: 70, 297, and 301. The light chain of SEQ ID NO: 67 contains the CDRs of SEQ ID NOS: 302, 74, and 75. SEQ ID NO: 56 is identical to SEQ ID NO: 18. SEQ ID NOS: 56, 57, and 58 contain the heavy chain CDRs of SEQ ID NOS: 70, 297, and 301. SEQ ID NOS: 153, 170, 179, 188, 197, 206, 215, 224, 233, 242, 251, 260, 269, 278, and 287 each contain SEQ ID NO: 18 within a larger sequence ranging from 216-230 amino acids. SEQ ID NO: 67 (219 amino acids) contains SEQ ID NO: 19. SEQ ID NO: 54 is the human IgG1 Fc region corresponding to amino acids 121-449 of SQE ID NO: 63.
The claims dependent upon claim 67 have been interpreted as requiring the entirety of the CDRs (i.e. the complete CDR sequences) recited in claim 67 even where the claim recites at least about 90% or 95% identical. (See at least claims 87-88.) Otherwise, the claims would not be properly dependent.
Claim Objections
Applicant is advised that should claim 68 be found allowable, claim 82 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 68 and 82 are both directed to two separate expression vectors of the same scope.
Applicant is advised that should claim 83 be found allowable, claim 102 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 83 and 102 are both directed to a single expression vector encoding a VH and a VL of the same scope.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 67-68, 82-83, 86-94, 96, and 99-101 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claim 67 is directed to two separate isolated nucleic acid molecules. These two independent products having no association to each other. The claims are not directed to a single composition of matter. Claims 82-83, 86-94, 96, and 99-101 are directly or ultimately dependent upon claim 67.
Claim 68 is directed to two separate expression vectors. These two independent products having no association to each other. The claim is not directed to a single composition of matter. See also claim 82.
Applicant is reminded that a patent eligible claim should be directed to single product.
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 69, 97-98, and 105 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 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.
Claim 69 was amended on 11/25/2025 to recite two separate expression vectors with different nucleic acid molecules.. No basis was pointed to for this amendment and none is apparent.
Claim 105 is not an original claim. It was added by amendment on 11/25/2025. No basis was pointed to for this claim and none is apparent.
The originally filed specification and claims did not disclose a composition comprising two isolated nucleic acid molecules having the characteristics recited in claim 105.
Original claims 67-69 (10/12/2022 claim set) are presented below:
67. An isolated nucleic acid molecule encoding the antigen binding protein or antigen- binding fragment thereof of any one of the preceding claims.
68. An expression vector comprising the nucleic acid molecule of claim 67.
69. A host cell comprising the expression vector of claim 68.
Original claims 67-69 were directed to a single isolated nucleic acid molecule, a single expression vector containing that single isolated nucleic acid molecule, and a host cell containing that single expression vector.
Applicant’s response points to paragraphs [0234-0238] of PGPUB 2023/0303704. Paragraph [0236] recites “Polynucleotides encoding the binding proteins disclosed herein are typically inserted in an expression vector…” This is not a disclosure of a composition as recited in new claim 105. In addition, “an expression vector” is a disclosure of a single expression vector encoding the binding protein and not the host cell of claim 69 having two expression vectors with different nucleic acid molecules. It is not agreed that the recitation “expression vectors comprising polynucleotides disclosed herein and host cells comprising these vectors and polynucleotides” provides basis for what is now specifically claimed. Claims 97-98 depend upon claim 69.
The claims constitute new matter.
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.
Claims 82-83, 86-94, 96, and 99-104 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.
Claims 82-83, 86-94, 96, and 99-104 are directly or ultimately dependent upon claim 67. Claims 82-83, 86-91, 94, 96 recite “The isolated nucleic acid molecule of claim 67…” However, claim 67 is directed to two separate isolated nucleic acid molecules and not a single isolated nucleic acid molecule. These dependent claims are confusing, particularly with respect to proper and clear antecedent basis. Claim 101 depends from claim 89 and recites “The isolated nucleic acid molecule of claim 89…” It is confusing for the same reason. Claims 92-93 and 99-100 depend from claim 91 and recite “The isolated nucleic acid molecule of claim 91…” They are confusing for the same reason.
In particular, claim 82 is confusing in that the preamble is directed to a single isolated nucleic acid molecules, yet the body of the claims requires two separate expression vectors.
In particular, claim 83 is confusing in that the preamble is directed to a single isolated nucleic acid molecule, but the body of the claim appears to be an intended use (“VH domain and VL domain are expressed on a single expression vector.” It appears that claim 83 intended to claim an expression vector having the same limitations as in claim 102. However, the claim language does not clearly set this forth.
As set forth in the final Office action mailed 4/28/2025, the following claims would be allowable.
106. An isolated nucleic acid molecule encoding an antigen binding protein or antigen-binding fragment thereof that specifically binds to fibroblast growth factor receptor 3 (FGFR3), comprising an antibody heavy chain variable (VH) domain and an antibody light chain variable (VL) domain, wherein:
the VH domain comprises
a CDR-H1 sequence comprising the amino acid sequence of GDTFTDFE (SEQ ID NO: 70),
a CDR-H2 sequence comprising the amino acid sequence of VDPETGGT (SEQ ID NO: 297), and
a CDR-H3 sequence comprising the amino acid sequence of TRTYDGYPYAFDY (SEQ ID NO:301); and
the VL domain comprises
a CDR-L1 sequence comprising the amino acid sequence of QSVLYSNNNKNY (SEQ ID NO:302,
a CDR-L2 sequence comprising the amino acid sequence of WAS, and
a CDR-L3 sequence comprising the amino acid sequence of QQYYSYRT (SEQ ID NO: 75).
107. An expression vector comprising the nucleic acid molecule of claim 106.
108. A host cell comprising the expression vector of claim 107.
109. The isolated nucleic acid molecule of claim 106 wherein the antibody heavy chain comprises the amino acid sequence of SEQ ID NO: 63 and the antibody light chain comprises the amino acid sequence of SEQ ID NO: 67.
110. The isolated nucleic acid molecule of claim 106 wherein the VH domain is at least about 90% identical or at least about 95% identical to the amino acid sequence of SEQ ID NO: 57 and wherein the VL domain is at least about 90% identical or at least about 95% identical to the amino acid sequence of SEQ ID NO: 19.
111. The isolated nucleic acid molecule of claim 106 wherein the antibody heavy chain is at least about 90% identical or at least about 95% identical to the amino acid sequence of SEQ ID NO: 63, and the antibody light chain is at least about 90% identical or at least about 95% identical to the amino acid sequence of SEQ ID NO: 67.
112. The isolated nucleic acid molecule of claim 106 wherein the antibody comprises a full-length antibody heavy chain.
113. The isolated nucleic acid molecule of claim 106 wherein the antigen-binding fragment comprises an antibody F(ab) or scFv fragment.
114. The isolated nucleic acid molecule of claim 106 wherein the antigen-binding binding fragment comprises an antibody F(ab) fragment.
115. The isolated nucleic acid molecule of claim 114 wherein the antibody F(ab) fragment heavy chain comprises the amino acid sequence of SEQ ID NO: 155, 171, 180, 189, 198, 207, 216, 225, 234, 243, 252, 261, 270, 279, or 288, and the antibody F(ab) fragment light chain comprises the amino acid sequence of SEQ ID NO: 67.
116. The isolated nucleic acid molecule of claim 114 encoding a chimeric or humanized antibody or antigen-binding binding fragment thereof.
117. The isolated nucleic acid molecule of claim 114 encoding a monoclonal antibody or antigen-binding binding fragment thereof.
118. The host cell of claim 108, which is a cell line of mammalian origin.
119. A method of producing an antigen binding protein or antigen- binding fragment that specifically binds to fibroblast growth factor receptor 3 (FGFR3), comprising culturing the host cell of claim 108 under conditions such that the antigen binding protein or antigen-binding fragment thereof is expressed and assembled, and purifying the antigen binding protein or antigen-binding fragment thereof from the host cell.
120. The isolated nucleic acid molecule of claim 114 wherein the antibody F(ab) fragment heavy chain comprises the sequence of SEQ ID NO: 56 followed by the first about 100 to about 110 amino acids of SEQ ID NO: 54.
121. The isolated nucleic acid molecule of claim 114 wherein the antibody F(ab) fragment heavy chain comprises the sequence of SEQ ID NO: 57 followed by the first about 100 to about 110 amino acids of SEQ ID NO: 54.
122. The isolated nucleic acid molecule of claim 114 wherein the antibody F(ab) fragment heavy chain comprises the sequence of SEQ ID NO: 58 followed by the first about 100 to about 110 amino acids of SEQ ID NO: 54.
123. The isolated nucleic acid molecule of claim 112, wherein the Fc region is a human IgG1 Fc region.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa