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 .
Claim Status
Claim 1 was canceled.
Claims 2-12 are pending and under consideration.
Withdrawn Rejections
Rejection of Claims 1 under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more is withdrawn. Applicant canceled claim 1 and therefore, this rejection is moot.
Rejection of Claims 1-12 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Abad et al (WO2008/070179) is withdrawn. Applicant canceled claim 1 and therefore, this rejection is moot.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 10 and 12 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 10 depends from claim 5 and appears to further limit step b of claim 5 for determination of concentration of AFT-YJFZ01. However, step b of claim 5 is step for preparation of sample and step e of claim 5 is step for determination of concentration. Therefore, it is not clear if claim 10 further limits step b or step e of claim 5.
Same reasoning applies to claim 12.
MAINTAINED - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 2-12 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.
“[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.
For a claim 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. Regents 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., binding to antigen, 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).
“[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.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Anaylsis
Instant claims are drawn to a method for identifying an aflatoxin-producing ability of aflatoxin-producing strains of genus Aspergillus, specifically comprising: (1) providing VHH or monoclonal antibody of the indicator molecule AFT- YJFZ01 for toxigenicity of aflatoxigenic fungi; (2) providing a polyclonal antibody of the indicator molecule AFT-YJFZ01 for toxigenicity of aflatoxigenic fungi; (3) preparation of a to-be-tested solution of a strain to be identified: culturing the strain to be identified, and diluting to obtain the to-be-tested solution of the strain to be identified; and (4) determination of the aflatoxin-producing ability of the strain to be identified.
Amended claim 2 now recites “the indicator molecule AFT-YJFZ01 for toxigenicity of aflatoxigenic fungi consisting of the amino acid sequence shown in SEQ ID NO: 1”. Therefore, the indicator molecule AFT-YJFZ01 has full-length of SEQ ID NO: 1 which is 33,172 amino acid residues. Instant specification did not disclose any experimental data for this molecule AFT-YJFZ01 of SEQ ID NO: 1, such as SDS-PAGE, western blot, and mass spectrum to show that the molecule AFT-YJFZ01 actually consists of 33,172 amino acid residues. Because it is hard to believe that a single protein consists of 33,172 amino acid residues and because instant specification did not disclose any experimental data to show that Applicant in possession of the protein of 33,172 amino acid residues, instant specification did not provide adequate written description for AFT-YJFZ01 of SEQ ID NO: 1 which has 33,172 amino acid residues. Furthermore, Moore et al (BMC Genomics 2015 Jul 28;16(1):551; PTO-892) shows Aspergillus genome structure with mean gene length, and protein coding genes (Table 1; reproduced below). Based on the genome information shown at the table 1, it is highly unlikely that a Aspergillus species encodes the instant SEQ ID NO: 1.
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It is noted that claim 3 and 6 recite “a VHH or monoclonal antibody of the indicator molecule AFT- YJFZ01” and “a polyclonal antibody of the indicator molecule AFT-YJFZ01”. Therefore, claims 3 and 6 recite antibodies by the antigen they bind, i.e., the function they have. In this case, the specification does not adequately describe such antibodies as binding a well-characterized antigen as it does not describe representative structures of antibodies that have these functions.
The disclosure of a fully characterized antigen is not sufficient written description of an antibody that binds to that antigen because one could not envision the structure of other antibodies that bind the fully characterized antigen. Therefore, reciting an antibody that binds to a well-characterized antigen is insufficient to describe the genus of antibodies as any species of antibody that binds to an antigen is not representative of other antibodies that bind that antigen as the structure of one antibody that binds an antigen is not representative of the structure of antibodies in general that bind that antigen.
Notably, the Amgen decision holds that the existence of one or a few examples of an antibody having a specific combination of functional characteristics is not sufficient to describe the genus of antibodies having the same functional characteristics. These conclusions are supported by knowledge of antibody structure. It is known in the art that antibodies have a large repertoire of distinct structures and that a huge variety of antibodies can be made to bind to a single antigen.
For example, Lloyd et al (Protein Engineering, Design & Selection, 22:159-168, 2009) teach that hundreds of functional antibody fragments can be isolated from an antibody library that bind to the same antigen wherein these antibodies have distinct heavy and light chain sequences (see, e.g., Discussion). Similarly, Edwards et al (J Mol Biol, 14;334(1):103-118, 2003) found that over 1000 antibodies, all different in amino acid sequence, were generated to a single protein with 568 different amino acid sequences identified for the V(H) CDR3 domains of these antibodies (see Abstract). Furthermore, Goel et al. (The Journal of Immunology (2004) 173(12):7358-7367) showed that three antibodies that bind to the same 12-mer peptide have very different CDRs (see entire document, especially Abstract, Figure 3 and Table 1). Given that hundreds of unique antibody structures may bind a single antigen, the structure of an antibody cannot be predicted from the structure of the antigen, and a single species, or small group of species, cannot define a structure-function relationship so as to be representative of all the antibodies that bind to that antigen.
It is well established in the art that the formation of an intact antigen-binding site in an antibody usually requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs (or hypervariable regions), which provide structure of the antigen binding site and the majority of the contact residues for the binding of the antibody to its target epitope (Malia et al., Proteins 2016; 84;427-434; entire document, especially see Abstract). Malia et al. cocrystallized anti-tau antibody AT8 Fab with a phosphorylated peptide and showed that the interaction interface involves all six CDRs.
As discussed above, it is apparent that all six CDRs that form the antigen binding site of a conventional antibody are needed to describe the particularly identifying structural features of an antibody that correlates with the antibody's ability to bind to the antigen. Absent a description of at least minimal structural features correlating with a functional ability to bind to a particular antigen, which are shared by members of a genus commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize or distinguish antibodies that bind to the indicator molecule AFT-YJFZ01 from those that do not bind to the indicator molecule AFT-YJFZ01. For these reasons, the specification would not reasonably convey to the skilled artisan that Applicant had possession of the claimed invention at the time the application was filed. It is for this reason that claims that recite only antigen AFT-YJFZ01 without specific amino acid sequences for 6 CDRs of the antibody that binds to AFT-YJFZ01 are included in this rejection.
As discussed above, different antibodies that bind to the same antigen need not share any CDR sequences. It is six CDRs of an antibody that define the structure required for the specific binding and each different antibody raised independently to the same antigen will have a different set of six CDRs. Accordingly, defining antibodies by the antigen it binds is insufficient to describe the structure of the genus of antibodies that binds that antigen.
Accordingly, it is submitted that the specification would not reasonably convey to the skilled artisan that Applicant had possession of the claimed invention at the time the application was filed.
Response to Arguments
In the response filed on 7/3/2026, Applicant argued at page 16, “Thus, Applicant believes that the claimed invention is the practical detection method as a whole. The antibodies are only reagents used in the specifically disclosed assay.”
Applicant's arguments have been fully considered but they are not persuasive. The claimed method contains the antibodies. If Applicant is not in possession of the antibodies, Applicant cannot perform the claimed method and therefore Applicant is not in possession of the claimed method, either.
Applicant argued at page 17, “Furthermore, Examples 2, 3, and 4 of the present application disclose concrete procedures for preparing the VHH antibody, monoclonal antibody, and polyclonal antibody recited in claims 3 and 6, respectively.”
Applicant's arguments have been fully considered but they are not persuasive. Disclosure of procedure for preparation of the antibody does not prove that Applicant is in possession of the claimed antibody. Furthermore, Examples 2-4 disclosed by instant specification are generic procedures for preparation of the antibody. As discussed above, the written description provision of 35 U.S.C § 112 is severable from its enablement provision.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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