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
1. Applicant’s election without traverse of Group I and species of antibody identified by reference to SEQ ID NOS: 1, 39, 3, 40, 5 and 6 in the reply filed on September 28, 2026, is acknowledged.
2. Claims 20 and 28-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 28, 2026.
3. Claims 1-19 are under examination.
Claim Objections
4. Claim 1 is objected to because of the following informalities: the claim does not end with a period.
MPEP 608.01(m), Form of Claims, states,
Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 2, 12, 14 and 16 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.
6. Regarding claim 2, the term "other" renders the claim(s) indefinite because the claim(s) include(s) or exclude(s) elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
7. Claims 12 and 16 are indefinite wherein they recite functional language. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” In the instant case, the claims recite a product of claim 1 but then define it —antibody has cellular cytotoxicity or compliment dependent cytotoxicity, or has reduced effector function— by functional language. While a functional limitation can provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action, in the instant case it is unclear what material/structural or manipulative differences are encompassed by recitation of desired functions of the product. Since the claims fail to meet the criteria set forth in MPEP 2173.05(g), then the claims are rejected as being indefinite.
8. Applicant is advised that one of the purposes of the 112, second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
9. The term “increased” in claim 14 is a relative term which renders the claim indefinite. The term “increased” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claim would obviate this ground of rejection.
10. Similarly, the term “reduced” in claim 16 is a relative term which renders the claim indefinite. The term “reduced” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claim would obviate this ground of rejection.
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.
11. Claims 2-4, 6 and 7 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.
Claims 2-4 specifically require possession of the antibodies that specifically bind to human CLDN6 but do not bind to other CLDN protein family members, do not bind to human CLDN9 and have high selectivity for human CLDN6 over human CLDN9. Claim 6 encompasses a genus of antibodies with at least 90% sequence identity to the fully disclosed sequences of SEQ ID NO: 34, 44, 7, 8, 24, 12, 41, 42, 46 and 47, and claim 7 is drawn to antibodies with up to ten amino acid substitutions in their variable chains. The claims do not require that these antibodies possess any particular clearly disclosed structure, conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of antibodies that is defined only by reference to their binding ability or to the partial structure of the binding epitope. However, disclosing an antigen does not satisfy the written description requirement for a claim to an antibody. See Amgen v Sanofi, 872 F.3d 1367 (Fed.Cir.2017).
Section 112 states that “[t]he specification shall contain a written description of the invention … in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same . . . .” This requirement ensures “that the inventor actually invented the invention claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). To show invention, a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date.” Id. at 1350. Demonstrating possession “requires a precise definition” of the invention. Id. To provide this “precise definition” for a claim to a genus, a patentee must disclose “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.
MPEP 2163, II A3(a)(ii) states,
For each claim drawn to a genus:
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.
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 gen[us]”. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
In the instant case, the specification provides the description of the binding antigen; however, knowing that an antibody binds, or does not bind, to a particular amino acid does not tell you anything at all about the structure of the antibody.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying 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. In this case, the only factor present in the claims is a reference to the partial structure of the binding substrate, or, in case of claim 2, the requirement not to possess a certain structure. However, there is no identification of any particular portion of the structure of what is actually in the claims, the recited antibodies. The specification does not provide a complete structure of those antibodies that specifically bind to human CLDN6 but do not bind to other CLDN protein family members, do not bind to human CLDN9 and have high selectivity for human CLDN6 over human CLDN9, antibodies with at least 90% sequence identity to the fully disclosed sequences of SEQ ID NO: 34, 44, 7, 8, 24, 12, 41, 42, 46 and 47, or antibodies with ten amino acid substitutions in their variable chains, and fails to provide a representative number of species within the recited genus Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
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, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of antibodies, 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 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.
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.
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).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
12. Claim(s) 1-4, 9-13, 15 and 17-19 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 9,274,119, 2016.
Claim(s) 1-4, 9-13, 15 and 17-19 encompass anti human CLDN6 antibodies. The ‘119 patent teaches anti-CLDN6 antibody, see title, that recognizes human CLDN6, see abstract, meeting the limitations of the instant claim 1. The antibody of the ‘119 patent binds to CLDN6 and not to CLDN9, c. 10, anticipating the instant claims 2-4. Next, the anti- CLDN6 antibody of the ‘119 patent can be chimeric or humanized, c. 21, and the instant claim 9; bispecific and multi-specific, c. 24, and claims 10-11; the anti-CLDN6 antibody exhibits cytotoxicity, see abstract of the patent, meeting the limitations of claim 12; the anti-CLDN6 antibody is hypofucosylated, c.21, as in the instant claim 13. Further, the anti-CLDN6 antibody of the ‘119 patent is modified to comprise Fc domain that is an IgG1 or IgG4, c. 23, meeting the limitations of claims 15 and 17. Finally, the pharmaceutical compositions that include stabilizers, buffers and polyoxyethylene compounds are recited at c. 25, fully meeting the limitations of claims 18 and 19.
Conclusion
13. Claims 5 and 8 are allowed. Claims 1-4, 6, 7 and 9-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
October 7, 2026
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