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. The examiner of this application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Chun Dahle, Group Art Unit 1641, Technology Center 1600.
3. Applicant’s election without traverse of Group I (drawn to a multispecific antigen binding protein) in the Response filed on January 22, 2026 is acknowledged. Applicant’s species election in the REMARKS filed on September 9, 2026 is acknowledged. Applicant further elect clone G1(2C06) which comprises CDR-H1-3 of SEQ ID NOs: 598, 476, and 14, respectively, and CDR-L1-L3 of SEQ ID NOs: 599, 466, and 47, respectively. The elected species corresponds to the sequences recited in claim 1(d). In addition, the VH and Vl sequences recited in claims 258 (a)-(f) are also rejoined.
Upon further consideration, the following species of antigen binding regions amino acids sequences recited in claim 1(a)-(c) and (e)-(f) (in claims filed on September 9, 2026) have been rejoined. The sequences recited in claim 1(a)-(f) are searched and considered herein.
In view of the he rejoined species set forth above, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 4-14, 16-22, 25-27, 29, 30, 32-43, 45-77, 81-83, 85, 86, 88, 89, 104, 105, 107-110, 112-196, 198-203, and 205-257 have been canceled.
Claims 1-3, 15, 23, 24, 28, 31, 44, 78-80, 84, 87, 90, 103, 106, 111, 197, 204, and 258-265 are pending and currently under consideration.
4. The instant specification is objected to for following reasons:
The instant specification discloses:
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Since the "Sequence Listing" is not the text of the specification, but rather is sequence data in an XML file format, an incorporation by reference statement is needed to ensure that the content of the "Sequence Listing" submitted to the USPTO as an XML file, is considered part of the disclosure capable of providing 35 U.S.C. 112(a) support for the disclosure and any claims relating to nucleotide and/or amino acid sequences.
The incorporation by reference statement identifies: (i) the name of the file; (ii) the date of creation of the file; and (iii) the size of the file in bytes. Note that this requirement pertaining to applicant submission of a "Sequence Listing XML" does not apply to a sequence listing that is part of an international application and communicated to the USPTO under PCT Article 20, for a national phase application. See MPEP 2413.04.
Applicant is required to update this paragraph because the sequence submitted has been converted to Version 1.1 which is the current working copy:
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An example of the required paragraph is as follows: “The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on January 27, 2023, is named 18018400_1_1.txt and is 512703 bytes in size.”
5. 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.
6. Claims 1-3, 15, 23, 24, 28, 31, 44, 78-80, 84, 87, 90, 103, 106, 111, 197, 204, and 258-265 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.
A) Claims 1-3, 15, 23, 24, 28, 31, 44, 78-80, 84, 87, 90, 103, 106, 111, 197, 204, and 258-265 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of VH CDRs and VL CDRs recited in claims 1 and 44 for the fist antigen biding region and a second antigen binding region and the Markush grouping of the VH and VL in claim 258 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the first and/or the second antigen binding domains encompass structurally different CDRs and/or VH/VL as evidenced by the different amino acid sequences.’
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
B) Claims 3 and 80 are indefinite in the recitation of “optionally”. Claim 3 recites the first linker and second linker each consists of (GGGGS)n, wherein N=1-3, optionally wherein N=2. Because the claim recites N=1-3 which include 2, the recitation of “optionally wherein N=2” render the claim indefinite.
Claim 80 recites wherein the cell surface molecule is CD3, optionally the CD3 is CD3ε. It was known that CD3 has multiple components including CD3ε, CD3γ, CD3ζ, CD3η, or CD3δ (see Mini Review, Bio-Rad 2016, pages 1-4). Thus the list of potential alternatives of CD3 can vary and ambiguity arises.
6. The isolated multispecific antigen binding protein comprising a first antigen binding region and a second antigen binding region, a Fab that binds to an additional target, wherein the VH and VL domains of the first and second antigen binding domain each compares CDR-H1-H3 and CDR-L1-L3 comprising the amino acid sequences recited in claim 1 (a)-(f) and VH and VL sequences recited in claim 258 (a)-(f) are free of the prior art.
7. No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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.
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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/CHUN W DAHLE/Primary Examiner, Art Unit 1641
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