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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16, 22, and 31, in the reply filed on December 10, 2025 is acknowledged.
Claims 26 and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 10, 2025.
Claims 1-16, 22, and 31 are under consideration in this office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The application is the national stage entry of PCT/CN2021/089059, which claims benefit to CN202010324783.4, filed April 22, 2020.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on February 5, 2024, July 9, 2024, July 23, 2025, and August 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency –Amino acid sequences appearing in claim 4 and the specification are not identified by sequence identifiers (e.g., “SEQ ID NO: X” or the like) in accordance with 37 CFR 1.821(d). Claim 4 and the specification (pg 12, 25, 55) include the sequence (GGGGS)n or GGGGS without a sequence identifier. Although there are sequences in the sequence listing corresponding to (GGGGS)n, where n=3 or 4, there are no sequences listed for (GGGGS)n where n is any other number.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1, 5-9, and 11-16 are objected to because of the following informalities:
Claims 1, 9, 12-13, and 16 use acronyms without first defining what they represent in the independent claims (see for example, “HCDR”, “LCDR”, “CDR”, “scFv”). While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym.
Claims 5-9 and 11-15 includes a limitation directed to a “single chain fragment variable”. As conventionally used in the art, scFv refers to a “single-chain variable fragment”. Applicant may consider updating the claim language when defining the abbreviation scFv.
Preferably is misspelled as “preferably” in claim 16.
Claim Rejections - 35 USC § 112(b)
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 1-16, 22, and 31 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.
Claim 1 is directed to anti-CD73 and anti-PD-1 antibodies comprised of six CDRs from parental heavy chain variable and light chain variable regions. Since CDRs are typically defined within the same numbering method (e.g., Kabat, Chothia, IMGT), and applicant has not indicated the numbering method used, it is unclear which specific combination of amino acid sequences will support the minimum structure necessary for antigen binding.
Claims 1-2, 14-16, and 31 are directed to antibodies or antibody fragment thereof comprised of amino acid sequences. As set forth in the claims, these amino acids are not clearly defined, and a person of ordinary skill in the art could not interpret the metes and bounds of the claims so as to understand how to avoid infringement. For example, in claim 1, the first functional protein comprises a heavy chain variable region having an amino acid sequence set forth in SEQ ID NO: 44.” The phrase “an amino acid sequence” is unclear because the sequence of the antibody could read on any part of SEQ ID NO: 44, and not the entire recited sequence. To set forth clearly what sequences are claimed, applicant may consider amending the claim to instead recite “a heavy chain variable region having the amino acid sequence set forth in SEQ ID NO: 44.” Other sequences of claim 1 and sequences in claims 2 and 16-16 also improperly define the amino acid sequences. Appropriate correction is required.
Regarding claims 12 2, 4-5, 7-12, 16, 22, and 31, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
In claim 4, 10, 16, and 22 the phrases "for example" and “such as” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 4, 10, and 22, the abbreviation “e.g.” renders the claim indefinite because it is unclear whether the limitations following the abbreviation are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 22, the term “optionally” renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claims 1 and 2 use parentheses to enclose “preferably 1, 2 or 3” and “preferably substitutions, insertions or deletions”, claim 6 uses parentheses to enclose “or via a linker”, claim 9 uses parentheses to enclose “or the N terminus of the heavy chain, the C terminus of CH1 of the heavy chain constant region”, claim 9 uses parentheses to enclose “such as NH2-VL-linker-VH-COOH or NH2-VH-linker-COOH”, and claim 31 uses parentheses to enclose “hG1TM”. The use of parentheses that encompass a limitation in the claim is found indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention or are just set forth as possible examples.
Claim 3, which is dependent on claim 1, recites the limitation "the numbers” in ln 2. There is insufficient antecedent basis for this limitation in the claim, which renders claim 3 indefinite.
Claims 6-7, which are dependent on claim 1, recite “the antigen-binding fragment”. There is no antigen-binding fragment limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6 and 9, which are dependent on claim 1, recite “the N terminus”. There is no N terminus limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6, 9, and 11-15, which are dependent on claim 1, recite “the C terminus”. There is no C terminus limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6 and 9-16, which are dependent on claim 1, recite “the immunoglobulin”. There is no antigen-binding fragment immunoglobulin limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6 and 16, which are dependent on claim 1, recite “the light chain constant region”. There is no light chain constant region limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6, 9, and 16, which are dependent on claim 1, recite “the heavy chain constant region”. There is no heavy chain constant region limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6, 9, and 11-14, which are dependent on claim 1, recite “the heavy chain of the immunoglobulin”. There is no heavy chain of the immunoglobulin limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 6, which are dependent on claim 1, recites “the light chain of the immunoglobulin”. There is no light chain of the immunoglobulin limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claims 11-14, which are dependent on claim 1, recite “the single chain fragment variable”. There is no single chain fragment variable limitation in claim 1. There is insufficient antecedent basis for this limitation in these claims.
Claim Rejections - 35 USC § 112(b)
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.
Written Description
Claims 1-16, 22, and 31 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.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
Claims 1-2, 14-16, 22, and 31 are directed to PD-1/CD73 bispecific antibodies that are comprised of heavy chain variable regions and light chain variable regions comprised of “an amino acid”, “a heavy chain amino acid sequence”, or “a light chain amino acid sequence”. As written, these antibodies are directed to amino acid sequences that do not necessarily include the entire sequence and possibly do not include the six CDRs essential for comprising the antigen binding site. The phrase “an amino acid sequence set forth in SEQ ID NO: 44”, as recited in claim 1, does not explicitly include the entire sequence; rather, broadest reasonable interpretation of this limitation is not bound to the full specific amino acid sequence set forth in the sequence identifiers. Since HCDR1-3 and LCDR1-3 of claims 1-2, 14-16, and 22 are not properly defined, the claims are directed to broad genera of antigen-binding domains that bind PD-1 or CD73.
Claims 1-2 and dependent claims 3-16 and 22 are directed to PD-1/CD73 bispecific antibodies that are comprised each of six CDRs having one or more conservative amino acid mutations, including substitutions, insertions, or deletions. Claims 1-2 and dependent claims 3-16 and 22 are broadly drawn to PD-1/CD73 bispecific antibodies that are comprised each of six CDRs that are at least 80% sequence identity to specific sequences; by virtue of the percent identity language, these claims encompasses variants that do not require all six CDRs from a particular parental antibody. As such, the claims encompass vast genera of anti-PD-1 and anti-CD74 binding domains comprised of numerous combinations of HCDR1-3 and LCDR1-3.
According to the specification, the applicant has disclosed one species of anti-CD73 antibody and one species of anti-PD-1 antibody that are comprised of specific combinations of the claimed HCDR1-3 and LCDR1-3 amino acid sequences. The specification does not provide adequate written description for the entire claimed genera of anti-PD-1 and anti-CD73 antibodies, because one skilled in the art would be unable to immediately envision, recognize, or distinguish most of the members comprised within the genera claimed. While the prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains.
As detailed below, applicant’s disclosure is not sufficient to demonstrate possession of the entire claimed genera, and as such, applicant’s disclosure does not satisfy the written description requirement of 35 U.S.C. 112(a).
Antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. 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 complementarity determining regions that 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 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 (see Almagro et al, Section 3 “Antibody Structure and the Antigen Binding Site” and Figure 1; instant PTO-892).
The art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. See for example Kussie (instant PTO-892), who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-azophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (see abstract).
Furthermore, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (pg 7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on pg 11).
As another example, see Chen et al., 1995 (instant PTO-892), which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody. See also Koenig 2017 (instant PTO-892), which provides a large mutation analysis study where every amino acid in both variable regions are substituted with every other amino acid. Looking at figure 1 of Koenig, the bottom half of each section (labeled VEGF) relates to the ability of the mutant to bind the original target, with blue meaning a reduced affinity and black meaning a complete loss of binding ability. In VH-CDR2, for example, mutating any given residue to cysteine, resulted in reduced binding at 12 residues and a complete loss of binding at 5 residues. That is, at 100% of the positions, mutation to cysteine reduced or ablated the antibody’s ability to bind the target. Looking at a specific position, in 100% of the mutations of residue 55, binding was reduced (15/19) or eliminated (4/19). While residues 56-65 appear more tolerant of change, residues 50-55 are generally intolerant of change.
It is appreciated that Koenig is studying one specific antibody and there is no evidence that the instant antibodies would react in the same way. However, this is part of the problem. It is entirely unclear from the specification which residues of applicant’s CDRs are tolerant or intolerant to change, and whether those tolerant positions are only tolerant to conservative mutations. The fact that some residues might tolerate mutation does not convey to the skilled artisan that applicant knew which of the claimed residues were tolerant of such, i.e. does not convey that Applicant was in possession of those sequences that are mutated yet preserve the claimed function. The specification fails to convey possession of an invention commensurate in scope with what is now claimed and therefore fails to meet the written description requirement.
Looking at Koenig figure 2A, ~200 mutations in the CDR region of the VH chain completely abrogate any binding. While 2B appears to indicate that the CDRs of VL are more tolerant of change than the heavy chain CDRs, still over half of the mutations reduce binding compared to the parent. Thus, making changes to the CDR sequences of an antibody is a highly unpredictable process, and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
As specificity of an antibody stems from the interaction of six CDRs, sufficient information must be provided to show that the inventor had possession of the invention as claimed. MPEP §2163(II)(A)(3)(a) also discusses Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004), where a method of using a PGHS-2 inhibitor did not meet the written description as the inhibitor itself was not sufficiently described, clearly indicating that written description of the compound is still required in a method of using that compound. In this case, it is clear from the specification that the invention comprises new antibodies, or at the least disclosure of new antibodies that could not have been envisaged from the prior art, which indicates that the prior art was not in possession of all anti-PD-L1 and anti-CD73 antibodies with amino acid mutations (including substitutions, insertion, and deletions) and at least 80% sequence identity to known CDRs.
Thus, the prior art cannot provide sufficient written description of this genus of compounds and the specification as filed does not sufficiently describe the genus either as there is an unknown amount of structurally distinct antibodies in this genus (see Amgen and Centocor decisions discussed above).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genera of anti-PD-L1 and anti-CD73 antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art, as evidenced by Edwards et al., 2003 (instant PTO-892), teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 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”).
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies that bind the disclosed epitope. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
For claims drawn to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011). An antibody described only by functional characteristic, such as antibody that binds PD-L1, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, 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 isolating it. The product 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.
A key role played by the written description requirement is to prevent “attempt[s] to preempt the future before it has arrived.” Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of antibodies that includes members not previously characterized or described could negatively impact the future development of species within the claimed genus of antibodies. In the instant application, neither the art nor the specification provide a sufficient representative number of antibodies or a sufficient structure-function correlation to meet the written description requirements.
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. 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).
Therefore, claims 1-16, 22, and 31 do not meet the written description requirement.
Conclusion
No claim is allowed.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675