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 with traverse of Group II in the reply filed on 17 December 2025 is acknowledged. The traversal is on the ground(s) that the claims have unity of invention in view of the amendment to claim 1 which requires the same antibody/fragment recited in claim 7. This is not found persuasive because the technical feature in common between Groups I and II (antibody/fragment which binds isoform 4 and not isoform 1 of human caspsase-4 protein) does not make a contribution over the prior art, and therefore, it is not a special technical feature and cannot serve as the basis for Unity of Invention. As pointed out in the written opinion, 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. 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). As isoform-4 of human caspase 4 is a truncated splice variant of the active form of caspase-4, it would have been obvious to the skilled artisan to generate an antibody which specifically bound isoform-4, using its unique C-terminal end, and well-known procedures as taught in “Antibody Methods and Protocols” (Proetzel, G. (Ed.). (2012). Antibody Methods and Protocols. Humana Press). Therefore, the technical feature which is common to both Groups I and II is not considered a special technical feature as it does not make a contribution over the prior art of Wiemann et al. and “Antibody Methods and Protocols”.
The requirement is still deemed proper and is therefore made FINAL.
Group III, claims 9 and 10, have been rejoined with the elected invention as the kits of Group III comprise the antibody of Group II.
Claims 1-5 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 17 December 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 January 2023 has been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because they do not comply with 37 CFR 1.84 (a)(1), (l) and (p). The drawings appear to be scanned versions of color drawings because the text and lines are not clear and are fuzzy as well as background “noise” appearing in the figures. See screenshot below as representative of these issues which are reflected in all of the Figures.
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The entire X-axis of Figure 2B is illegible. Additionally, it seems that the X-axis may actually be a nucleotide sequence which does not have a Sequence identifier and does not seem to be included in the Sequence Listing.
Figure 5 has two different lines which are supposed to be different in color, but because the entire Figure is now in grayscale, it is not clear which line is ISO1 and which line is ISO4.
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.
Nucleotide and/or Amino Acid Sequence Disclosures
Figure 2B may contain a nucleic acid sequence (see X-axis). Because the quality of the Figure is so poor, it cannot be determined if this is a sequence which must be included in the Sequence listing or not. SEQ ID NO:4 is the nucleic acid sequence of “ggtggtgagtgctga” which may be the sequence between the dotted lines, but because the text is so blurry, this cannot be concluded with confidence. In so far as Figure 2B contains a nucleic acid sequence which is not included in the Sequence Listing, the application is not in compliance with the Sequence rules.
The specification refers to an inhibitor: Ac-VVDC-NH2 at pages 5 and 16. It would appear that “VVDC” is an amino acid sequence. Therefore, this inhibitor must be included in the Sequence listing. If the inhibitor is not an amino acid sequence, Applicant should make clear what the inhibitor is and why it is not necessary to include it in the Sequence listing.
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 - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures which are missing are located in Figure 2B and at page 5 of the specification.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it contains speculative applications (i.e. prevention of lung cancer). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see bottom of page 20 and top of page 21). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure appears to contain a typographical error on page 9 (middle of page). The recitation “SEQ ID Nr.2” is not an acceptable notation for a sequence identifier (the “Nr” appears to be a typographical error). This notation is also found at pages 12, 13, 15, 17 and 19. Correction is required.
The disclosure at page 14 of the specification (middle of page) contains an amino acid sequence without a Sequence identifier. This sequence is included in the Sequence listing, therefore, the specification should be amended to include the Sequence identifier with the recited amino acid sequence.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: a kit “comprising means for detecting the expression levels of the isoform 4 of the human caspase-4 protein in a biological sample, said kit comprising an agent for detecting the expression levels of said isoform 4 of the human casepase-4 protein, wherein said agent is the antibody or a fragment thereof of claim 7” in claim 9.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
It is noted that claim 7, from which claim 9 depends, is directed to an antibody or a fragment thereof capable of specifically binding the isoform 4 of human caspase-4 protein and not the isoform 1.
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 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.
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 bottom of page 7). 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).
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.
Claim 9 is 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 9 recites a kit “comprising means for detecting the expression levels of the isoform 4 of the human caspase-4 protein in a biological sample” and further recites “said kit comprising an agent for detecting the expression levels of said isoform 4 of the human caspase-4 protein, wherein said agent is the antibody or a fragment thereof of claim 7”. The claim is indefinite and confusing as it is not clear if the “means” is the “agent” or if the two components are intended to be different. The claim has been interpreted as the “means” being the “agent” as the “means” and “agent” perform the same function.
Claim 9 does not invoke 112(f) because while the claim recites a “means”, the claim also provides a structure for achieving said means (antibody or a fragment thereof of claim 7).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 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 9 is directed to a kit which comprises the antibody or fragment thereof of claim 7. However, the recitation of a “kit” and an intended use does not further limit the subject matter of the claim from which it depends (claim 7). While claim 9 includes a means plus function recitation, the claim has been interpreted as not invoking 112(f) for the reasons provided above. 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.
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.
Citation of Prior Art
Kim et al. Human Pathology 40: 868-871, 2009.
Smith et al. Frontiers in Pharmacol. 13: 1-18, 2022.
Soung et al. Human Pathology 39: 895-900, 2008.
Conclusion
No claim is allowed.
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/Christine J Saoud/Primary Examiner, Art Unit 1645