Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 189, 201, 205, 207, 208, and 210-216 are pending.
Claims 215 and 216 are newly added.
Claim 189 is currently amended.
Claims 189, 201, 205, 207, 208, and 210-216 are under examination on the merits.
Rejections Withdrawn
35 U.S.C. 112(a) - Enablement
The rejection of claims 189, 201, 205, 207, 208, and 210-214 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, is withdrawn.
As indicated at p. 5 of the Non-Final Rejection, dated 12/11/2025, “according to the Sequence Listing, dated 05/09/2022, SEQ ID NO: 105 is a humanized 31.1 antibody light chain, and SEQ ID NO: 106 is a humanized 31.1 antibody heavy chain. SEQ ID NO: 108 is a humanized NEO 302 light chain, and SEQ ID NO: 110 is a humanized NEO 302 heavy chain. Given that SEQ ID NO(s): 105, 106, 108, and 110 correspond to 31.1 and NEO 302 antibodies and not 16C3 antibodies, one skilled in the art would be subject to undue experimentation to practice the invention as currently claimed.”
Claim 189 has been amended to strike the recitation of SEQ ID NO(s): 108 and 110. Furthermore claim 189 has been amended to properly recite that the antibody or fragment thereof that recognizes a 16C3 epitope comprises a light chain (LC) polypeptide that comprises the LC CDR1, 2 and 3, respectively of SEQ ID NO: 77, 78 and 79; and comprises a heavy chain (HC) polypeptide that comprises the HC CDR1, 2 and 3 peptides respectively of SEQ ID NO: 82, 83 and 84; or comprises a light chain (LC) polypeptide that comprises the LC CDR1, 2 and 3, respectively of SEQ ID NO: 97, 98 and 99; and comprises a heavy chain (HC) polypeptide that comprises the HC CDR1, 2 and 3 peptides respectively of SEQ ID NO: 102, 103 and 104; and said antibody or fragment thereof that recognizes a 31.1 epitope comprises the identical light chain and heavy chain CDRs as the light chain polypeptide of SEQ ID NO: 105 and the heavy chain polypeptide of SEQ ID NO: 106. As such the rejection of the claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, is withdrawn.
Rejections Maintained
35 U.S.C. 112(a) – Written Description
The rejection of claims 189, 201, 205, 207, 208, and 210-214 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, is maintained. Newly added claims 215 and 216 are included in this rejection, because these claims depend from claim 189 but do not remedy the written description issues of claim 189.
Response to Arguments
With respect to the rejection of the claims under 35 U.S.C. 112(a) – written description, Applicant asserts that “the sole independent claim 189 as currently amended defines the CDRs of each of the NPC-1, 16C3 and 31.1 antibodies or fragments thereof embraced by the claimed methods based on the CDRs of exemplary NPC-1, 16C3 and 31.1 antibodies which are referenced in the application, and having the sequences contained in the Sequence Listing. Applicant submits that this amendment should further render the basis for the written description rejection moot.”
These arguments have been fully considered but are not deemed persuasive. Amended claim 189 recites a step of contacting a test sample with an anti-NPC-1 binding antibody, or fragment thereof, that is detectably labeled, wherein said NPC-1 binding antibody or fragment thereof comprises a light chain (LC) polypeptide that comprises the LC CDR1, 2 and 3, respectively of SEQ ID NO: 53, 54 and 55; and comprises a heavy chain (HC) polypeptide that comprises the HC CDR1, 2 and 3 peptides respectively of SEQ ID NO: 58, 59 and 60; or wherein said antibody or fragment thereof comprises a light chain (LC) polypeptide that comprises the LC CDR1, 2 and 3 peptides, respectively of SEQ ID NO: 63, 64 and 65; and comprises a heavy chain (HC) polypeptide that comprises the HC CDR1, 2 and 3 peptides, respectively of SEQ ID NO: 68, 69 and 70. The claim goes on to recite that “if the patient is determined in the assay of step (b) to comprise a carcinoma-associated NPC-1 epitope and at least one of a 16C3 epitope or a 31.1 epitope based on the detection of antibody-NPC-1 epitope complexes and either or both of 16C3 and/or 31.1 antibody-epitope complexes which comprise said detectable label, initiating or continuing an anti-cancer treatment in the patient, which treatment includes the administration of an antibody which targets carcinoma cells which express the NPC-1 epitope (emphasis added).” It is not clear whether the antibody that targets carcinoma cells that express the NPC-1 epitope is the same as the detectably labeled anti-NPC-1 binding antibody recited earlier in the claim. This is problematic with respect to 35 U.S.C. 112(a), because if the two anti-NPC-1 antibodies are not the same, one of ordinary skill in the art would be unable to readily envision which heavy and light chain CDRs should be combined such that a resultant antigen-binding region is capable of both binding to NPC-1 and treating carcinoma. As indicated in the Non-Final Rejection, dated 03/11/2026, “[o]ne skilled in the art would reason that while some anti-NPC-1 antibodies are likely capable of treating carcinoma, other anti-NPC-1 antibodies will likely not be capable of treating carcinoma. Applicant has not provided any general structure of an anti-NPC-1 antibody that is capable of treating carcinoma. This is a significant omission, because the ability of an antibody to bind a particular antigen, alone, does not characterize what other properties the antibody may or may not possess. It is well-recognized in the art that antibodies will display markedly different and unpredictable properties depending on the epitope in an antigen to which a particular antibody specifically binds. Stancovski et al. (PNAS, 88: 8691-8695, 1991) developed a panel of monoclonal antibodies specific to HER-2, an art-known tumor antigen, and Stancovski et al. discovered that although each antibody bound the HER-2 antigen, said antibodies displayed a range of different properties, see Abstract and p. 8694, Table 1. Two of the anti-HER-2 antibodies almost completely inhibited tumor growth, two anti-HER-2 antibodies displayed moderate inhibitory effects, and yet another anti-HER-2 antibody accelerated tumor growth, p. 8694, Table 1. Additionally, said panel of anti-HER-2 antibodies demonstrated a range of apparent affinities and a range of abilities to induce complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and tyrosine phosphorylation, p. 8694, Table 1, and p. 8692, second column, second full paragraph. Furthermore, similar to Stancovski et al., Jiang et al. (J. Biol. Chem., 280: 4656-4662, 2005) teach that while many anti-HER-2 antibodies inhibit the proliferation of cancer cells, other anti-HER-2 antibodies actively stimulate cancer growth, see p. 4656, second column, final paragraph. Importantly, Jiang et al. add that “[i]t is well known that different biological effects are associated with the epitope specificity of the antibodies.” See p. 4656, second column, final paragraph. Based upon the teachings of Stancovski et al. and Jiang et al., one skilled in the art would reason that antibodies specific for the same target protein may have different effects depending upon the epitope specificity of a particular target protein-specific antibody. Accordingly one skilled in the art would be unable to readily envision which heavy and light chain CDRs should be combined such that a resultant antigen-binding region is capable of both binding to an epitope of NPC-1 and treating carcinoma.
Applicant is informed that the rejection of the claims under 35 U.S.C. 112(a) may be overcome by amending claim 189 to recite heavy and light chain CDRs that, when combined, form an antigen-binding region is capable of both binding to an epitope of NPC-1 and treating carcinoma.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F 9:00 am - 6:00 pm EST
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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