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 .
Response to Amendment
Applicant's response, filed 03 June 2026, has been received and entered. Claims 1, 4-5, 7, 9 and 11 have been amended and claims 6, 8 and 11-13 have been canceled. Claims 1-5, 7, 9-10 and 14 are currently pending. Claims 1-5 and 14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 December 2025.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant's response and withdrawn.
Applicant's arguments filed 03 June 2026 have been fully considered but are not found to be persuasive.
Response to Arguments
Applicant continues to argue the Restriction requirement of 31 October 2025 (see pages 8-9 of the response). However, the requirement was made final in the Office action mailed 06 March 2026. Applicant may petition the Director to review the requirement (37 CFR 1.144) (see MPEP § 818.01(c) and 818.01(d)).
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 03 June 2026 have been considered by the examiner.
Drawings
The drawings remain objected to because they do not comply with 37 CFR 1.84 (a)(1), (l) and (p). Black and white drawings must be in black ink. Gray scale is not acceptable. See screenshot below as representative of these issues which are reflected in all of the Figures.
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Amendment
It is noted that Applicant filed “corrected” drawings, however, the drawings still do not comply with 37 CFR 1.84 (a)(1), (l) and (p) for the reasons of record.
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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is defective. See item 1) a) or 1) b) above. The file size must be recited in bytes. The substitute specification filed 03 June 2023 recites “6.88 KB” which is not compliant nor correct. The file size is 7055 bytes.
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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 incorporation-by-reference paragraph, 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.
Specification
The title of the invention is still not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The claims under examination are directed to antibodies which bind human caspase-4 protein isoform 4 and kits thereof. The current title has no details as to the actual claimed invention.
Response to Amendment
Applicant’s amendment to the abstract has been received and entered. The amendment avoids the previous grounds of objection.
Applicant’s amendment to the specification to remove the embedded hyperlink has been received and entered. The object to the specification is withdrawn in view of the amendment.
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 7 and 9-10 stand 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.
The instant claims are directed to an antibody or a fragment thereof capable of specifically binding the isoform 4 of the human caspase-4 protein and not the isoform 1 or a kit containing said antibody/fragment. The instant specification lacks an adequate written description of such antibodies/fragments which would bind human caspase-4, isoform 4 and not isoform 1. The instant specification discloses that isoform 4 of human caspase-4 differs from isoform 1 in that it lacks amino acids 264-377 and amino acids 261-263 differ from isoform 1 (ANR in isoform 1 and GEC in isoform 4; see specification at page 8). The specification envisions embodiments of an antibody (polyclonal or monoclonal) capable of specifically binding an epitope of isoform 4 which include the amino acids in positions 261-263 of the C-terminus as well as an epitope corresponding to SEQ ID NO:3, which is a 12 amino acid C-terminal fragment of isoform 4 (bottom of page 12). The specification in the paragraph spanning pages 18-19 states:
The presence of the isoform 4 of the caspase-4 was detected by sandwich-like ELISA method obtained by synthetizing a custom antibody based upon the different sequence of the isoform 4 from the isoform 1 (different nucleotide sequence shown in literature: GGTGGTGAGTGCTGA).
The specification at page 19 states:
In order to prove the presence of the isoform 4 but not the isoform 1, a custom antibody was used, capable of recognizing a specific epitope of the isoform 4 differing in 3 amino acids from the isoform 1.
The instant specification does not provide any structural information for the “custom antibody” which was used in the experiments. There is no teaching regarding the correlation of structure to antigen binding function and there is no disclosure of sufficient number of species commensurate with the scope of the genus because, while an antibody was made, there is no description of that antibody beyond a description of a potential antigen. Thus, the claims encompass a genus of molecules, which vary substantially in composition, which are only described by a function of binding isoform 4 and not isoform 1 of human caspase-4.
The structures of the antibody and fragments thereof which are claimed are not adequately described. In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., Ill USPQ2d 1780 (Fed. Cir. 2014) AbbVie had claims to functionally claimed antibodies and Centocor presented evidence that the antibodies described in AbbVie's patents were not representative of other members of the functionally claimed genus. The decision states, “When a patent claims a genus using functional language to define a desired result, ‘the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.’ Id. at 1349. We have held that '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.’ Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). Here, the claimed invention is a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human IL-12, a known antigen. AbbVie's expert conceded that the '128 and '485 patents do not disclose structural features common to the members of the claimed genus.” In the instant application, the is no disclosure of any structure of any antibody. While the specification indicates that an antibody was made, this antibody is only described as a “custom antibody” which provides no structural information to one of ordinary skill in the art because the structure of a generic “antibody” is not sufficient for binding any particular antigen. Therefore, the specification does not disclose even a single species of structurally defined antibody which metes the functional limitation of the claims.
The AbbVie decision considers how large of a genus is involved and what species of the genus are described in the patent. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “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.”).
In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification fails to describe even a single antibody which binds isoform and not isoform 1 of human caspase-4. No reasonable structure-function correlation has been established because no structure is described. The specification does not describe representative examples to support the full scope of the claims.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing 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.
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 of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.”
Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed human caspase-4 isoform 4 antibodies or fragments thereof. "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). 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. See, e.g., Eli Lilly.
Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus, which are antibodies or fragments which have the recited characteristics pointed out above. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. 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).
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).
Response to Arguments
Applicant argues at page 12 of the response that the claims recite "an antibody or a fragment thereof capable of specifically binding an epitope of isoform 4 of the human caspase-4 protein, wherein the epitope comprises an amino acid sequence GEC, and wherein the antibody or a fragment thereof binds to isoform 4 of the human caspase-4 protein and not to isoform 1 of the human caspase-4 protein." Applicant argues at page 13 of the response that the specification as filed describes how those antibodies can be generated (i.e. “according to any one of the conventional techniques known in the field”.
Applicant’s argument has been fully considered, but is not found persuasive. The ability of one of ordinary skill in the art to make antibodies which bind to isoform 4 of the human caspase-4 protein is an argument which relates to enablement (how to make) and not to whether or not the instant specification provides an adequate written description of the subject matter which is claimed.
At page 13 of the response, Applicant states that the Application as filed teaches the nucleotide sequence encoding for the C-terminal portion of the isoform 4 of the human caspase-4 protein. However, this information is not pertinent to the rejection of record and does not support an assertion that the claimed invention is adequately described.
At the bottom of page 13 of the response, Applicant asserts that the Example section of the specification describes synthesis of the antibodies of the present disclosure. Again, the rejection is not based on whether or not antibodies to the isoform 4 of the human caspase-4 protein can be produced, but rather, that the instant specification fails to provide an adequate written description of the claimed subject matter. As pointed out above, In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The instant claims follow the fact pattern in Regents of the University of California v. Eli Lilly because the antibodies which are claimed are defined by their function (binding an epitope of isoform 4 of the human caspase-4 protein).
Applicant asserts at page 15 of the response that:
the present Application as filed provides structural information for the antibody used in the experiments, because the Application as filed discloses the epitope that was used for the synthesis of the antibodies used in the experiments. In fact, the epitope binding specificity of an antibody provides structural information about the antibody, because epitope binding specificity provides information about the antigen binding site of the antibody and, therefore, about its structure. Information about the antigen binding specificity of an antibody provides structural information about the antibody, because the antigen binding specific necessarily correlates with the structure of, at least, the antigen binding site of the antibody.
Applicant’s argument has been fully considered but is not found persuasive. The epitope to which an antibody binds provides zero information as to the structure of the antibody which binds it. Neither the prior art nor the instant specification provides any information on how an epitope informs the structure of an antibody.
Applicant asserts at page 15 of the response that “the present Application as filed provides a sufficient description of the genus because the Application as filed discloses even more than a representative number of species and also describes structural features common to the members of the genus. Applicant’s arguments have been fully considered, but are not found persuasive. The instant specification does not provide any structural features common to antibodies which bind isoform 4 of the human caspase-4 protein and a recitation of the epitope to which the antibody binds is not a description of structural features of the antibody which binds said epitope.
Applicant asserts that the specification provides sufficient distinguishing characteristics of the claimed antibodies because it describes the antibodies and fragments thereof in terms of the structure of their antigen binding site, by describing the epitope binding specificity of the antibodies and fragments thereof. Applicant’s argument has been fully considered, but is not found persuasive. A description of the antigen binding site is not a description of the antibody which binds the antigen binding site.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiemann et al. (cited above) in view of Proetzel (cited above).
Claim 7 is directed to an antibody or a fragment thereof capable of specifically binding the isoform 4 of the human caspase-4 protein and not the isoform 1. Claim 9 is directed to a kit comprising an agent for detecting the expression levels of isoform 4 of the human caspase-4 protein wherein said agent is the antibody or a fragment thereof of claim 7.
Wiemann et al. sequenced and analyzed 500 human cDNAs containing the complete protein coding frame. The cDNA encoding human caspase-4, isoform 4 was isolated and sequenced and the deduced amino acid sequence was determined.
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Isoform-4 of human caspase 4 was known in the art (Wiemann et al. Genome Research 11: 422-435, 2001) as well as its structural relationship/differences with isoform-1 as evidenced by UniProt website (Identfier: P49662-4). Isoform-4 of human caspase 4 differs from the canonical sequence of caspase-4 (isoform-1) in that residues 261-263 are GEC instead of ANR, and in that residues 264-377 are missing. Wiemann et al. do not teach antibodies which bind to human caspase-4 isoform 4 and not isoform 1.
Proetzel teach methods of making antibodies to an antigen or target protein. Proetzel do not teach antibodies which bind to human caspase-4 isoform 4 and not isoform 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make antibodies which bind to human caspase-4 isoform 4 and not isoform 1 as taught by Wiemann using methods which were known in the art before the effective filing date and taught by Proetzel and using the unique C-terminal end of the isoform. One would be motivated to make an antibody which bound human caspase-4 isoform 4 and not isoform 1 in order to further study the expression patterns of the isoform. One would have had a reasonable expectation of success in generating an antibody which binds human caspase-4 isoform 4 and not isoform 1 because methods of making antibodies to antigens are old and well-known in the art as evidenced by Proetzel. It would also have been obvious to include the antibody in a kit because the antibody would be useful for identifying and detecting human caspase-4 isoform 4. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wiemann et al. (cited above) in view of Proetzel (cited above) and further in view of WO 2015/125098 (cited by Applicant).
The disclosures of Wiemann et al. and Proetzel are provided above. The combination of Wiemann et al. and Proetzel do not teach a kit which comprises an antibody which binds human caspase-4 isoform 4 and not isoform 1 and an antibody which binds human caspase-4 isoform 1.
WO 2015/125098 teach antibodies which bind the active form of human caspase-4 isoform 1 (see page 9). Antibodies were generated to the identified peptide antigens which are present in human caspase-4 isoform 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in a kit an antibody which binds human caspase-4 isoform 4 and not isoform 1, as made obvious by Wiemann et al. and Proetzel, along with an antibody which binds human caspase-4 isoform 1 because a kit with both antibodies would provide a tool for studying the expression of the different isoforms of caspase-4. One would be motivated to make such a kit because caspase-4 is an enzyme associated with lung tumors and the kit would provide a means for study the expression of the different isoforms of caspase-4. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
Applicant argues at page 17 of the response that Wiemann does not disclose antibodies but rather Wieman reports the sequencing and analysis of 500 novel human cDNAs. Applicant argues that none of the references cited disclose or suggest antibodies against human caspase-4 or antibodies which bind a specific epitope of isoform 4 of the human caspase-4 protein.
Applicant’s argument has been fully considered, but is not found persuasive. Wiemann was not cited for teaching antibodies but rather, Wiemann was cited for teaching isoform 4 of the human caspase-4 protein.
Applicant asserts that one of skill in the art would have had no suggestion or motivation to combine the disclosure of Wiemann with the disclosure of Proetzel to generate an anti-human caspase-4 protein at all. Applicant’s argument has been fully considered, but is not found persuasive. Motivation was provided in the rejection because antibodies would provide a tool for studying the expression of the different isoforms of caspase-4.
Applicant asserts that Wiemann discloses at least one isoform of human caspase-4 protein amount the disclosed 500 human cDNAs and one of skill in the art would not have been motivated to specifically select human caspase-4 protein among them. Applicant’s argument has been fully considered, but is not found persuasive. One of ordinary skill in the art of human caspase-4 would have clear motivation for making antibodies to an isoform of caspase-4 for the purposes of studying the isoform.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Proetzel was not cited for teaching antibodies which bind to human caspase-4 isoform 4 but rather, Proetzel was cited for its teaching on making antibodies.
Applicant argues at page 18 of the response that the UniProt database only provides the sequences of human caspase-4 proteins and nothing in the database would have suggested to the skilled artisan to make an antibody that is specific for one of the isoforms. Applicant’s argument has been fully considered, but is not found persuasive. As stated in the rejection above, one of ordinary skill in the art of caspase-4 would be motivated to make an antibody which bound human caspase-4 isoform 4 and not isoform 1 in order to further study the expression patterns of the isoform.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues at page 19 of the response that WO 2015/125098 does not cure the deficiencies of Wiemann and Proetzel because WO 2015/125098 solely discloses, "the use as a biomarker of the active form of a human caspase protein, preferably the human caspase-4 or caspase-1" and does not disclose or suggest antibodies capable of binding to one isoform, but not another isoform of the caspase-4 protein. Applicant’s argument has been fully considered, but is not found persuasive. ‘098 was not cited for a teaching of antibodies which bind to one isoform over another, but rather for the teaching of antibodies which bind the active form of human caspase-4 isoform 1.
Applicant further argues why one of kill in the art would have been motivated to combine the two antibodies in a kit. Applicant’s argument has been fully considered, but is not found persuasive. . As stated in the rejection, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in a kit an antibody which binds human caspase-4 isoform 4 and not isoform 1, as made obvious by Wiemann et al. and Proetzel, along with an antibody which binds human caspase-4 isoform 1 because a kit with both antibodies would provide a tool for studying the expression of the different isoforms of caspase-4.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
