Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 11/28/2025 has been entered. Claims 1, 3-9, 11-18, 23-27, and 93-96 are pending and currently under consideration.
Withdrawn Objections and/or Rejections
The rejection of claims 1, 3-18, 23-27, and 93 under 35 U.S.C. 112(a) for new matter is withdrawn in view of amended claim 1.
Claim Rejections under 35 USC § 112 (a)
(i). The following is a quotation of the first paragraph of 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.
(ii). Claims 1, 3-9, 11-18, 23-27, and 93-96 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention. The basis for the rejection is set forth in the office action mailed on 07/31/2025.
(iii). Response to Applicant’s argument
Applicant argues that the claimed invention is a method of making an antibody, not the final antibody product (e.g., its amino acid structure associated with antigen binding, binding affinity, or therapeutic mechanism). Applicant argues that possession of a method claim is established when the specification describes the requisite steps with enough clarity and detail that a person skilled in the art can reasonably and confidently conclude the inventor had the invention in hand. Applicant argues that unlike claims directed to novel antibody compositions, method claims such as those claimed, require only a description of the steps necessary to carry out the process. Applicant argues that the specification establishes this possession by clearly disclosing a sequence of steps that are routine, conventional, and well-known in the established field of antibody engineering. Applicant argues that the method involves the distinct, common molecular biology techniques of introducing a glycosylation site via genetic engineering and modifying an antibody sugar chain using an enzyme (e.g., neuraminidase) that alters the sugar chain to have a terminal galactose or mannose.
Applicant argues that a person skilled in the art, reading the detailed description of these steps - genetic engineering followed by protein expression, recovery, enzymatic treatment and assaying for antigen binding activity under varying ion concentration conditions - would immediately understand how to practice the claimed method. Applicant argues that a person skilled in the art, enlightened by the disclosure of the subject application would have clearly concluded that the Applicant was in possession of the claimed method on the filing date.
Applicant’s argument has been fully considered but is not deemed to be persuasive. MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. Adequate written description requires more than a mere statement that it is part of the invention are reference to a potential method of isolating it. 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 (Fed. Cir.1991).
A "representative number of species" means that the species which are adequately described are representative of the entire 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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). 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."). "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).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under pre-AIA 35 U.S.C. 112, first paragraph.
In the instant case, the claims are drawn to a method for producing an antigen-binding molecule comprising a sugar chain linking motif comprising the sequence Asn-X-Ser/Thr, wherein X is any amino acid residue other than proline, and wherein a sugar chain is linked to the sugar chain linking motif, and wherein the sugar chain comprises a terminal galactose or terminal mannose. The claims do not require that an antigen-binding molecule produced by the method, an antigen-binding domain, or an FcRn binding domain possess any structural/functional features. The specification states that the antigen-binding molecules of the present invention has one or more binding domains to a sugar chain receptor. The binding domain to a sugar chain receptor is not particularly limited in type and number, as long as the antigen-binding molecule has a binding activity to the sugar chain receptor in a neutral pH range and as long as he binding activity to the sugar chain receptor in an acidic pH range is lower than the binding activity to the sugar chain receptor in the neutral pH range (page 156, paragraph [0205]). Thus, the claims encompass a method for producing a genus of antigen-binding molecules without any characteristic structural/functional features.
The specification discloses an antibody as an antigen-binding molecule (paragraph [0246] on page 191), in particular anti-human IL-6 receptor antibody (examples), and two pairs of sugar chain receptor binding domain and sugar chain receptor: a sugar chain receptor binding domain having N-linked sugar chain with a terminal galactose and an asialoglycoprotein receptor; a sugar chain receptor binding domain having N-linked sugar chain with a terminal mannose and a mannose receptor (pages 155 and 157). Example 2 discloses preparation of anti-human IL-6 receptor antibody being capable of binding in a pH-dependent manner and having a galactose-ended complex linked sugar chain introduced in variable region. However, no other antigen-binding molecules are disclosed.
The specification does not describe a sufficient variety of species to reflect the variation within the genus. The instant disclosure of an antigen-binding molecule comprising an anti-human IL-6 receptor antibody is insufficient to support the broad genus of antigen-binding molecules. Moreover, the specification does not disclose a correlation of structure and function (for example, the properties recited in claims 3-9) of the genus of recited antigen-binding molecules. Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other antigen-binding molecules might be. One of skilled in the art cannot envision the structure of other antigen-binding molecule with recited properties.
Applicant submits that a person skilled in the art, enlightened by the disclosure of the subject application, would have clearly concluded that the Applicant was in possession of the claimed method on the filing date. Applicant’s argument has been fully considered but is not deemed to be persuasive for the reasons set forth above.
Conclusion
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, please contact the Electronic Business Center (EBC) at the toll-free phone number 866-217-9197.
/RUIXIANG LI/Primary Examiner, Art Unit 1646 December 12, 2025