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 preliminary amendment filed on 04/30/2024 is acknowledged.
Claims 1, 12, 24, 31-35 and 37-44 are pending.
3. Applicant’s attention is drawn to subclause (a) of claim 12, where the recitation “sequence set forth in SEQ ID NO: 43 or to SEQ ID NO: 43” appears to contain an error.
4. 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.
5. Claims 24, 31, 33-34, 37-40 and 43-44 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 24 is indefinite in the recitation of an antibody or antigen-binding fragment thereof which comprises a heavy chain variable region “and/or” a light chain variable region in the preamble of the claim, for the following reasons:
Claim 24 depends on claim 12, which requires that the antibody or fragment comprises both heavy and light variable regions. Therefore, the conjunction “or” in claim 24 crates an ambiguity as to whether the antibody or fragment of claim 24 may comprise only one of heavy and light variable regions.
(ii) Claim 31 is indefinite in the recitation of an Fc region “derived from” the specified isotypes, because neither the nature not the degree of acceptable derivation is defined.
(iii) Claim 33 is indefinite in the recitation of an “anti-idiotypic” antibody, because the binding specificity of the antibody is unclear. A person of skill in the art would be aware that an anti-idiotypic antibody is specific to the antigen-binding region of another antibody. L1CAM is not an antibody, and therefore it is unclear what the anti-idiotypic antibody of claim 33 binds to.
(iv) Claim 34 is indefinite for the following reasons:
The claim, as presently recited, is directed to a combination of two distinct “conjugates:” a conjugate of the antibody of claim 1 to an unspecified “drug,” and an additional conjugate of an unspecified “effector molecule” to another unspecified substance. The combined recitation of several extremely broad generic categories in a single claim creates an ambiguity as to what exactly is being claimed.
(v) Claims 37-39 are indefinite as being dependent on canceled claims. Applicant may cancel the claims, rewrite the claims in independent form to include the relevant limitations of the base claims, or amend the claims to depend on other pending claims.
It appears that claims 37-39 were intended to depend on claim 35, which dependence is provisionally assumed for examination purposes.
(vi) Claim 40 is indefinite because of the inconsistency between the preamble of the claim directed to detecting the “expression” of L1CAM and the resolution step reciting the “presence” of L1CAM.
(vii) Claim 44 is indefinite as being dependent on canceled claims. Applicant may cancel the claim, rewrite the claim in independent form to include the relevant limitations of the base claims, or amend the claim to depend on other pending claims.
It appears that claim 44 was intended to depend on claim 43, which dependence is provisionally assumed for examination purposes.
(viii) Claims 43 and 44 are indefinite, because it is unclear how, if at all, the result of the “detecting” step of claim 44 relates to treatment of cancer.
(ix) Claim 44 is indefinite in the recitation of “L1-CAM,” because inconsistent use of terminology crates ambiguity as whether “L1-CAM” of claim 44 is the same molecule as “L1CAM” recited in other claims.
(x) Claim 44 is further indefinite, because the recitation of “the medicament” lacks proper antecedent basis in the base claim.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation 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.
7. Claims 43-44 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treating an L1CAM-expressing cancer does not reasonably provide enablement for a method of treating a generically recited cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
The claims encompass treatment of any cancer whatsoever without limitation.
The specification does not appear to provide sufficiently specific guidance, direction or working examples of treating cancer by the claimed method.
The state of the art included knowledge that while L1CAM is expressed in a number of cancers and may constitute an attractive therapeutic target (e.g. reviewed by Altevogt et al. 2020), there is a wide variability between tumor types in the frequence of L1CAM positivity (Buyucek et al. 2025, e.g. the Abstract). A person of ordinary skill in the art would readily understand that an anti-L1CAM antibody is highly unlikely to have a therapeutic effect against tumors which do not express L1CAM. Therefore, an ordinary artisan would reasonably conclude that experimentation aimed at treating non-L1CAM-expressing cancer with anti-L1CAM antibodies would almost certainly be unsuccessful, and as such unnecessary, improper, and undue.
8. The following is noted regarding the novelty of presently claimed invention:
Amino acid sequences similar to those recited in the present claims were known in the prior art. For example, claim 12, subclause (a) recites an antibody with a VH at least 90% identical to SEQ ID NO: 43 and a VL at least 90% identical to SEQ ID NO: 44. Antibodies with a VH over 90% identical to SEQ ID NO: 43 are taught e.g. in US 20120156194 (SEQ ID NO: 1) and in US 20230220102 (SEQ ID NO: 448) (see SCORE). Antibodies with a VL over 95% identical to SEQ ID NO: 44 are taught e.g. in US 20100226884 (SEQ ID NO: 8) and in US 20160251419 (SEQ ID NO: 82).
Based on available data, prior art does not appear to teach antibodies comprising the specified combinations of all six CDR amino acid sequences recited in claim 1, antibodies comprising both a VH and a VL at least 90% identical to the specified amino acid sequences recited in claim 12, or antibodies comprising both a VH and a VL as specified in claim 24 (see SCORE).
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1, 12, 24, 31-35 and 37-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 19/124802, published as US 20260166166.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘802.
The later are directed to L1CAM-targeting antibody-drug conjugates comprising the presently claimed anti-L1CAM antibodies. For example, USSN ‘802 recites the VH and VL of the antibody as SEQ ID NOS: 21 and 22 (claims 1, 8 and 9), which are identical to instant SEQ ID NOS: 56 and 59, respectively.
USSN ‘802 further recites pharmaceutical compositions and methods of treating L1CAM-related cancer (claims 20 and 22).
Nucleic acids, vectors and host cells are inherent in teachings of recombinantly produced antibodies, and kits and methods of detecting would be at once envisaged by those skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. The following post-filing-date documents are cited of record as pertinent to the present invention:
Brauer et al. (2026) Novel L1CAM-antibody drug conjugates exert potent anti-tumor activity in preclinical models of even advanced pancreatic cancer. Biomedicine & Pharmacotherapy 198: 119257, 1-15.
Piccand et al. (2026) Optimized L1CAM-CAR T cells enhance activity against moderate-antigen-density rhabdomyosarcoma models. Cancer Letters 657: 218691, 1-12.
12. Conclusion: no claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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