DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 08/21/2025, is acknowledged.
3. Claims 1, 7-9, 11-22, 25-32, and 34 are pending.
4. Upon reconsideration, the Examiner has extended the search to cover the antibody species comprising SEQ ID NOs: 1-8 recited in claim s18-19
4. Applicant’s election without traverse of Group II, claims 18-22,32 and 34 directed to an anti-αvβ8 antibody, and the antibody species comprising SEQ ID NOs: 9, 2, 3, 105, 11, filed on 08/21/2025, is acknowledged.
5. Claims 1, 7-9, 11-17 and 25-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
6. Claims 18-22,32 and 34 are under examination as they read on an anti-αvβ8 antibody, and the antibody species comprising SEQ ID NOs: 9, 2, 3, 105, 11. And SEQ ID NOs: 1-8
7. Applicant’s IDS, filed 07/25/2025, is acknowledged.
8. Claims 18-19 are objected to under 37CFR 1.821(d) for failing to recite SEQ ID NOS. in the claims.
9. 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 his invention.
10. Claim 22 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 encompasses a broad genus of anti-αvβ8 integrin antibodies that competes with antibody B5-15 comprising the CDRs of SEQ ID NOs: 9, 2, 3, 105, 11.
However, there does not appear to be an adequate written description in the specification as-filed of the essential structural feature that provides the recited function of competing for binding to αvβ8 integrin. The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear that 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, reduction to drawings, 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 genus.
Claim 22 requires “an anti-αvβ8 integrin antibody . . . that competes for binding to αvβ8 integrin with the antibody” recited in claim 20 (i.e., B5-15). While the amino acid sequence of αvβ8 was known, immunizing an animal with αvβ8 will generate antibodies directed to a number of different epitopes within the amino acid residues at αvβ8 integrin and not necessarily to the same epitope which is bound by the claimed antibody B5-15. The knowledge of the amino acid sequence of αvβ8, by itself, did not put Applicants in possession of antibodies that compete for binding with claimed anti- αvβ8 antibodies.
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In determining that the Specification did not support the claimed anti-αvβ8 antibodies, the Specification disclosure is considered. The specification fails to disclose a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The Federal Circuit has recognized that "the written description requirement can in some cases be satisfied by functional description," it has made clear that "such functional description can be sufficient only if there is also a structure-function relationship known to those of ordinary skill in the art." In re Wallach, 378 F.3d 1330, 1335 (Fed. Cir. 2004); see also, Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (holding that the written description requirement would be satisfied "if the functional characteristic of preferential binding ... were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed"); Amgen Inc. v. Sanofi, 782 F.3d 1367, 1378 (Fed. Cir. 2017) (holding that an "adequate written description must contain enough information about the actual makeup of the claimed products"). Here, the specification provides a functional description of the claimed antibody- i.e., that it competes for binding to anti-αvβ8 antibody recited in the claim, but the specification does not identify any disclosure of a correlation between the claimed function and the structure of the antibodies that perform that function.
Moreover, there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed competing anti-αvβ8 antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). The Court reiterated that adequate written description must “contain enough information about the actual makeup of the claimed products . . . .” The Court simultaneously suggested that the “newly characterized antigen” test “flouts” section 112 because it “allows patentees to claim antibodies by describing something that is not the invention, i.e. the antigen.” The Court concluded that for written description of an antibody to be adequate when presented with “functional” terminology, there must be an established correlation in the art between structure and function.
This case is thus similar to Centocor Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341 (Fed. Cir. 2011). In Centocor, patentee claimed an antibody or antibody fragment that competitively inhibits binding of A2 (a mouse antibody) and that binds an epitope of TNF-α with a specified affinity. 636 F.3d at 1346. Both TNF-α protein and antibodies to that protein were known in the literature. Id. at 1352. Patentee argued that the patent at issue satisfied the written description for the claimed antibodies because it "not only describes the antibodies by their binding affinity for TNF-α, but further describes the antibodies by specifying that they competitively inhibit binding of the A2 mouse antibody to TNF-α." Id. At 1349. The Federal Circuit rejected this argument, finding that "[a]t bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-α antibody should have: high affinity, neutralizing activity, and the ability to bind in the same place as the mouse A2 antibody." Id. At 1351. The court explained that "[t]he specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations."
In finding that the specification at issue did not provide written description support for the claimed antibodies, the Centocor court recognized that the written description does not require examples or an actual reduction to practice, but clarified that "it does demand ... that one of skill in the art can 'visualize or recognize' the claimed antibodies based on the specification's disclosure." Id. at 1353. "In other words the specification must demonstrate constructive possession." Id; see also, AbbVie Deutschland GmbH & Co., KG., v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014) (reiterating requirement for structure-function correlation in functionally defined claims and finding that the patents at issue do not meet the written description requirement because they "do not describe any common structural features of the claimed antibodies.").
Here, as in Centocor, Applicant seeks to ground written description support for a claimed antibody in its competitive inhibition of another antibody (here, the anti-αvβ8 antibody B5-15, in Centocor, mouse A2 antibody) and in the description of a known antigen (here αvβ8`, in Centocor, TNF-α). While the state of the art has progressed since the Federal Circuit's decision in Centocor, the basic problem remains that the description at issue must allow one of skill in the art to "visualize or recognize" the claimed antibodies. Here, the evidence of record does not support that the skilled artisan would have visualized or recognized the claimed antibodies based on the description provided. As in Centocor, the Specification provides only a plan for identifying the claimed antibodies.
Possession is not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Sufficient description to show possession of such a genus may be achieved by means of a recitation of anti-TIM-3 competing antibodies falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. See Eli Lilly, 119F.3d at 1568, 43 USPQ2d at 1406.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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 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.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
11. 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. Claims 18 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. 9492569.
The `569 patent teaches and claims anti-αvβ8 antibody, humanized 37E1B5 (Hu37E1B5) comprising the VH-CDR1-3 of SEQ ID NO: 1-3 and VL-CDR1-3 of SEQ ID NO: 4-6 (see issued claims 1-9).
Alignment claimed VH-CDR1-3 of SEQ ID NO: 1-3 with patented SEQ ID NO: 8.
Qy 1 RYWMS--------------EINPDSSTINYTSSL-------------------------- 20
||||| |||||||||||||||
Db 31 RYWMSWVRQAPGKGLEWIGEINPDSSTINYTSSLKDRFTISRDNAKNSLYLQMNSLRAED 90
Qy 21 --------LITTEDY 27
|||||||
Db 91 TAVYYCASLITTEDY 105
Alignment claimed VL-CDR1-3 of SEQ ID NO: 4-6 with patented SEQ ID NO: 9.
Qy 1 KASQDINSYLS---------------YANRLVD--------------------------- 18
||||||||||| |||||||
Db 24 KASQDINSYLSWYQQKPGKAPKLLIYYANRLVDGVPARFSGSGSGQDYTLTISSLEPEDF 83
Qy 19 -----LQYDEFPYT 27
|||||||||
Db 84 AVYYCLQYDEFPYT 97
Claim 22 is included because the humanized 37E1B5 (Hu37E1B5) would compete with the B5-15 antibody. Humanized 37E1B5 (Hu37E1B5) is parent antibody of B5-15 which binds the same epitope and thus compete with B5-15.
The reference teachings anticipate the instant claims.
13. Claims 18 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. 9290572.
The `572 patent teaches anti-αvβ8 antibody, clone 37E1B5 comprising the VH-CDR1-3 of SEQ ID NO: 1-3 and VL-CDR1-3 of SEQ ID NO: 4-6.
Alignment claimed VH-CDR1-3 of SEQ ID NO: 1-3 with patented SEQ ID NO: 1
Qy 1 RYWMS--------------EINPDSSTINYTSSL-------------------------- 20
||||| |||||||||||||||
Db 31 RYWMSWVRQAPGKGLEWIGEINPDSSTINYTSSLKDRFTISRDNAKNSLYLQMNSLRAED 90
Qy 21 --------LITTEDY 27
|||||||
Db 91 TAVYYCASLITTEDY 105
Alignment claimed VL-CDR1-3 of SEQ ID NO: 4-6 with patented SEQ ID NO: 4
Qy 1 KASQDINSYLS---------------YANRLVD--------------------------- 18
||||||||||| |||||||
Db 24 KASQDINSYLSWYQQKPGKAPKLLIYYANRLVDGVPARFSGSGSGQDYTLTISSLEPEDF 83
Qy 19 -----LQYDEFPYT 27
|||||||||
Db 84 AVYYCLQYDEFPYT 97
Claim 22 is included because the humanized 37E1B5 (Hu37E1B5) would compete with the B5-15 antibody. Humanized 37E1B5 (Hu37E1B5) is parent antibody of B5-15 which binds the same epitope and thus compete with B5-15.
The reference teachings anticipate the instant claims.
14. The anti-αvβ8 antibody, MEDI-hu37E1B5 comprising the VH of SEQ ID NO: 7 and VL of SEQ ID NO: 8 and the anti-αvβ8 antibody comprising B5-15 comprising the VH CDR1-3 of SEQ ID NO: 9, 2, 3 and VL CDR1-3 of SEQ ID NO: 105, 11 are free from prior art.
15. Claims 19-21, 32 and 34 are allowable.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 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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September 25, 2025
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644