DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 10/07/22 and 05/07/25.
Election
2) Acknowledgment is made of each of Applicants’ election filed 12/22/25 in response to the restriction requirement filed 10/22/25. Applicants have elected, without traverse, invention I.
Status of Claims
3) Claims 5 and 8 have been amended via the preliminary amendment filed 05/07/25.
Claims 1-9 are pending.
Claims 6-9 are withdrawn from consideration as being directed to a non-elected invention. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-5 are examined on the merits.
Sequence Listing
4) Acknowledgment is made of Applicants’ sequence listing which has been entered on 05/14/2015.
Information Disclosure Statements
5) Acknowledgment is made of Applicants’ Information Disclosure Statements filed 07/18/23 and 10/07/22. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Substitute Specification
6) Acknowledgment is made of Applicants’ substitute specification filed 05/07/2025.
Priority
7) The instant AIA application, filed 10/07/22, is the national stage 371 application of PCT/JP2021/014591 filed 04/06/21, which claims priority to application 2020-069825 filed 04/08/2020 in Japan. A certified copy of the foreign priority application is of record, but not a certified English translation of the same. Should Applicants desire to obtain the benefit of foreign priority under 35 U.S.C 119(a)-(d), a certified copy of the foreign priority application and a certified English translation thereof should be submitted under 37 CFR 1.55 in reply to this Office Action. Failure to do so may result in no benefit being accorded.
Objection(s) to Specification
8) The instant specification is objected to for the following reason(s):
The as-filed specification in the last sentence of section [0035] recites what appears to be a four amino acid-long sequence “PPHP” that is not in compliance with the Sequence Rule and as required under 37 C.F.R 1.821 through 1.825. Any sequences recited in the instant specification which are encompassed by the definitions for nucleotide and/or amino acid sequences as set forth in 37 C.F.R. 1.821(a)(1) and (a)(2) must comply with the requirements of 37 C.F.R 1.821 through 1.825. Note that branched sequences are specifically excluded from this definition. It is suggested that Applicants examine the whole specification to identify similar sequences with SEQ ID numbers wherever such sequences appear.
APPLICANTS MUST COMPLY WITH THE SEQUENCE RULES WITHIN THE SAME TIME PERIOD AS IS GIVEN FOR RESPONSE TO THIS ACTION, 37 C.F.R 1.821 - 1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 C.F.R 1.821(g).
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ), First Paragraph
9) The following is a quotation 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 35 U.S.C § 112 (pre-AIA ), first paragraph:
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 the invention.
10) Claims 1-5 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant case, the claims include a broad genus of monoclonal antibodies and antigen binding fragments thereof which recognize two different antigens, i.e., P1 protein and P30 protein of Mycoplasma pneumoniae. However, the as-filed specification does not disclose the broad and variant monoclonal antibody genus as claimed.
An analysis of the scope of instant claims and of the monoclonal antibody genus encompassed therein indicates the following. Instant claims claim an immunoassay method of Mycoplasma pneumoniae which utilizes an antigen-antibody reaction between a monoclonal antibody that specifically reacts with P1 protein and P30 protein of Mycoplasma pneumoniae and that specifically reacts with a peptide containing an amino acid sequence composed of PPQPG (SEQ ID NO: 1), SEQ ID NO: 2 and SEQ ID NO: 3 as claimed. The recited ‘a monoclonal antibody’ represents a huge genus encompassing species of divergent structure. Example 1 of the as-filed specification discloses generating mouse monoclonal anti- Mycoplasma pneumoniae antibodies. Table 1 lists these antibodies, of which clones P1-30Aab and P1-30Bab are depicted as reacting with P1,P30 antigens. Sections [0035] and [0033] of the specification document that the P1-30Aab monoclonal of the present invention strongly reacted with peptide 1-10 (SEQ ID NO: 2) and peptide 1-13 (SEQ ID NO: 3), whereas P1-30Bab monoclonal showed reactivity with a peptide which does not contain the PPQPG (SEQ ID NO: 1). The sensitivities of these monoclonals are shown in Example 4 as tested using immunoassay instruments. Thus, the only monoclonal antibody that showed the unique specific binding with the PPQPG-containing peptide 1-10 (SEQ ID NO: 2) and peptide 1-13 (SEQ ID NO: 3) and hence with both the P1 protein and the P30 protein of Mycoplasma pneumoniae and that was in Applicants’ possession at the time of the invention was the P1-30Aab monoclonal antibody. However, the disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated”). When there is substantial variation within the genus as in the instant case, one must describe a sufficient variety of species to reflect the variation within the genus. The single P1-30Aab monoclonal antibody species is not representative of the claimed huge genus. Cleary, the as-filed specification does not adequately describe a representative number of members of the monoclonal antibody genus or provide a written description of the broad genus encompassing structurally divergent monoclonal antibodies that bind to SEQ ID NOs: 1, 2 and 3. 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 by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, 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.” The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, any disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. The court has since clarified that this standard applies to also compounds other than cDNAs. See University of Rochester v. G.D. Searle & Co., Inc., F.3d, 2004 WL 260813, at *9 (Fed. Cir. February 13, 2004). The instant specification fails to provide sufficient descriptive information, such as definitive structural features of monoclonal antibody species that are common to the genus. That is, the specification provides neither a representative number of members of the genus nor does it provide a description of structural features that are common to genus. “[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. Furthermore, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo entitled Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf clarifying written description guidance for claims drawn to functional antibodies, adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. As discussed in Amgen, knowing that an antibody binds to a residue of a protein antigen does not tell one anything about the structure of the antibody. As further discussed in Amgen, where an antibody binds to an antigen tells one nothing about the structure of any other antibody.
In the instant claims, the recited monoclonal antibody is defined only by its epitope sequence to which it binds, not by its specific structure or CDRs. The function of antibody binding to an antigen does not describe the structure of the antibody that binds per se. When a product is defined by its function, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 at 1568 USPQ2d at 1406 (“definition by function …. does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”). Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the entire broad genus, and because the monoclonal antibody genus is highly variant, the disclosure of generating monoclonal antibodies that bind specifically to P1 and P30 proteins is insufficient to describe the entire genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number and variety of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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 is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. 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. As discussed above, even though Applicants may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See 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.”) One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicants are 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). Note that a mere plan or wish is insufficient to satisfy the provisions of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph. With regard to the written description of a genus, 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 entire 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."). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
In sum, the as-filed specification is limited to the monoclonal antibody produced by the P1-30Aab cloned hybridoma. At the time of the invention, Applicants were not in possession of the broad monoclonal antibody genus that specifically recognizes and reacts or binds with the PPQPG sequence (SEQ ID NO: 1) and the PPQPG-containing peptide 1-10 (SEQ ID NO: 2) and peptide 1-13 (SEQ ID NO: 3) and the broadly claimed method that uses said monoclonal antibody genus.
Rejection(s) under 35 U.S.C § 112(b) or (pre-AIA ) Second Paragraph
11) 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.
12) Claims 1-5 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 inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 1 is vague, ambiguous and indefinite in the limitations: an immunoassay method “of Mycoplasma pneumoniae”. Claim 1 fails to distinctly claim the subject matter. It is unclear how can a method be “of Mycoplasma pneumoniae”. Do Applicants intend to convey that the claimed method is an immunoassay method for detecting Mycoplasma pneumoniae? Clarification is requested.
(b) Claim 1 is indefinite for lacking sufficient antecedence in the limitations “P1 protein” and “P30 protein” in line 5. For proper antecedence, it is suggested that Applicants replace the above-identified limitations with --the P1 protein-- and --the P30 protein-- respectively.
(c) The dependent claim 3 is indefinite for lacking sufficient antecedence in the limitations “an antigen-binding fragment thereof”. See line 2. For proper antecedence, it is suggested that Applicants replace the above-identified limitations with --the antigen-binding fragment thereof--.
(d) The dependent claim 5 is indefinite for having improper antecedence in the limitations: “said” two or more kinds of antigens. Claim 5 depends from claim 1, which does not recite “two or more kinds of antigens”.
(e) Claims 2-5, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim.
Claim Objection
13) Claim 1 is objected to for the incomplete or incorrect phrase: “and P1 protein and P30 protein derived from Mycoplasma pneumoniae”, i.e., for missing the limitation --are--. It is suggested that Applicants replace said phrase with the limitations –and wherein the P1 protein and the P30 protein are of Mycoplasma pneumoniae--.
Conclusion
14) No claims are allowed.
Correspondence
15) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 7.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Acting Supervisor of AU 1645 Vanessa Ford, can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
16) Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
January, 2026
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