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 election without traverse of Group I (drawn to an anti-glycol-LAMP antibody) and the species listed below in the Response filed on September 30, 2025 is acknowledged.
Claims 1-6, 8-10, 17-23, 26, 28, 29, 33, and 43-54 have been canceled.
Claims 7, 11-16, 24, 25, 27, 30-32, 34-42, and 55 are pending.
Upon further consideration, the species of CDRs recited in claim 7 (k) and (l) and the CAR sequences of SEQ ID NOs: 205 and 207 recited in independent claim 36 have been rejoined.
As shown in Table 1A in pages 4-6 of the instant specification as-filed, the CDR sequences recited in independent claim 7 (j), (k), and (l) are all CDRs from the antibody clone 3C7.1C8.1C9 comprising VH of SEQ ID NO:23 and VL of SEQ ID NO:24. These CDRs are based on different numbering systems: IMGT, Kabat, and Chothia from the same VH of SEQ ID NO:23 and VL of SEQ ID NO:24.
Claims 13, 39-41, and 55 have been withdrawn under 37 CFR 1.142(b) as being drawn to nonelected inventions.
Claims 7, 11, 12, 14-16, 24, 25, 27, 30-32, 34-38, and 42 are currently under consideration as they read on the elected invention.
2. The instant specification disclose:
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Applicant is required to update this paragraph [0001] 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 XML format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on March 1, 2024, is named 18688464_1_1.xml and is 231913 bytes in size.”
Further, the specification is objected to including amino acid sequences with only three amino acids which is prohibited under ST.26. Specifically, SEQ ID NO:29 consists of three amino acids KVS which must not be included in a sequence listing.
Note that under ST.26 amino acid sequences less than 4 residues cannot be identified via SEQ ID number. The instant specification and instant claims discloses/recite sequences shorter than 4 residues by reference to SEQ ID numbers.
For example, in independent claim 7, the CDR-L2 sequence is referred to as “SEQ ID NO:29” which stands for the polypeptide sequence “KVS”. Given that under ST.26 sequences shorter than 4 residues cannot be given SEQ ID numbers, the recitation of SEQ ID:29 in the claims for such a sequence is improper.
It is suggested that the SEQ ID numbers (e.g. SEQ ID NOs: 7, 29, 51, 71, 113, 115, 119, 125, 127, and 131 Tables 1-3) in question be deleted as only the tripeptide sequence in single letter code is appropriate nomenclature in a specification that conforms to the convention of ST.26.
More explicitly, the preferred language based upon claim 77 as presently constructed is " … the CDR-L2 comprises the amino acid sequence KVS …” and note that SEQ ID NO:29 appears multiple times in the claims and all occurrences must be corrected.
In addition to the claims, the specification also should not refer to such short sequences via SEQ ID number. In other words, anywhere “SEQ ID NO:29” appears in the specification it should be replaced with “KVS”.
Applicant is requested to carefully review the specification for any and all sequences which require compliance with the rules under ST.26.
3. 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.
4. Claims 7, 11, 12, 14-16, 24, 25, 27, 30-32, 34-38, and 42 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 7, 11, 14-16, 24, 25, 27, 30-32, 34, 35, 37, 38, and 42 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 the anti-glyco lysosome associated member protein-1 (anti-glyco-LAMP1) antibodies with different CCDRs is 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: Each of the antibodies has unique antigen binding domain including CDRs sequences which are not shared by other antibodies with CDRs. The elected antibody having CDRs set forth in claim 7(i) does not share the CDRs with the other antibodies
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) Claim 27 contains the trademark/trade names CrossMab, BiTE, and DART. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the antibody and, accordingly, the identification/description is indefinite.
Further, claim 27 is indefinite in the recitation of “(e.g., a CrossMab) The phrase "for example" or “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, Claim 27 recites the limitation “wherein the multispecific antibody is a bispecific antibody that binds to a second epitope…..” in lines 2-7. There is insufficient antecedent basis for this limitation in the claim.
5. The elected species of an anti-glyco-LAMP1 antibody comprising VH of SEQ ID NO:23 and VL of SEQ ID NO:24 with following CDRs sequences based on different numbering systems is free of the prior art. Further the corresponding CAR comprising amino acid sequence of SEQ ID NO:206 is free of the prior art.
The corresponding CDRs are recited in independent claim 7:
(j) a VH comprising CDR-H1, CDR-H2, and CDR-H3 having the amino sequences of SEQ ID NOS:25-27, respectively, and a VL comprising CDR-L1, CDR-L2, and CDR-L3 having the amino acid sequences of SEQ ID NOS:28-30, respectively;
(k) a VH comprising CDR-H1, CDR-H2, and CDR-H3 having the amino sequences of SEQ ID NOS:31-33, respectively, and a VL comprising CDR-L1, CDR-L2, and CDR-L3 having the amino acid sequences of SEQ ID NOS:34-36, respectively;
(l) a VH comprising CDR-H1, CDR-H2, and CDR-H3 having the amino sequences of SEQ ID NOS:37-39, respectively, and a VL comprising CDR-L1, CDR-L2, and CDR-L3 having the amino acid sequences of SEQ ID NOS:40-42, respectively.
6. No claim is allowed.
7. 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
