DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment filed 04/18/2024 is acknowledged. Claims 1-13 are canceled and claims 14-26 are new. No restriction is being imposed in this case. Claims 14-26 are under examination.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Europe on 10/18/2021. It is noted, however, that applicant has not filed a certified copy of the EP21425051.6 application as required by 37 CFR 1.55. Therefore, the priority date of the instant claims is 10/17/2022.
Specification
The disclosure is objected to because of the following informalities. Any new application (including continuations and divisionals) with an actual filing date (application filed under 111(a)) or an international filing date (application filed under 371) on or after July 1, 2022, must submit sequence listings under ST.26. See MPEP 2412. While sequence listings previously submitted under ST.25 (filed before July 1, 2022) permitted sequences having less than 10 nucleotides or less than 4 amino acids, such sequences are prohibited under ST.26. In the instant case, the original application discloses SEQ ID NO: 5 at p. 15. Applicant must amend the disclosures of skipped sequences in the instant specification with either the three- or one-letter codes for peptides. For instance, SEQ ID NO: 5 would appear as just “Tyr-Thr-Ser” or “YTS”.
Claim Interpretation
In claim 14, the phrase “directed against” is interpreted as meaning “binds to”. Thus, the recited antibody binds to the alpha folate receptor
The phrase “defined by” in conjunction with the recited sequences in claims 14, 21 and 22 is interpreted as “set forth in SEQ ID NO: X”. The phrase “as set forth in SEQ ID NO: X is customary when referring to sequences.
Claim Objections
Claims 14-26 are objected to because of the following informalities. The claims are missing indefinite and definite articles, which is grammatically awkward. For instance, claim 14 should recite “A monoclonal antibody”; claim 15 should recite “The monoclonal antibody”; claims 16-24 should recite “The monoclonal antibody” and claim 25 should recite “A pharmaceutical composition comprising the monoclonal antibody”. For the sake of parallel structure and consistency, the claims should recite “the monoclonal antibody” throughout, as is recited in claims 1 and 2.
Claim 26 recites “A method” twice. In addition, claim 26 should recite “a therapeutically effective amount of the monoclonal antibody as defined in claim 14”.
Claim 14 recites a “[m]onoclonal antibody directed against the alpha folate receptor (FRα), characterized by comprising”, which is redundant and grammatically awkward. The phrase “characterized by” should be deleted.
Claims 15, 17 and 18 recite “aminoacid” as one word, but it should be written “amino acid”.
Claims 19 and 20 recite the “[a]ntibody with improved compatibility”, which is grammatically awkward. For the sake of parallel structure and consistency, the claims should be amended to recite something like: “The antibody according to claim…, which has improved compatibility”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 14-26 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.
(i) Any new application (including continuations and divisionals) with an actual filing date (application filed under 111(a)) or an international filing date (application filed under 371) on or after July 1, 2022, must submit sequence listings under ST.26. See MPEP 2412. While sequence listings previously submitted under ST.25 (filed before July 1, 2022) permitted sequences having less than 10 nucleotides or less than 4 amino acids, such sequences are prohibited under ST.26. Independent claim 1 recites SEQ ID NO: 5, which is a peptide comprising 3 amino acid residues and is thus a skipped sequence. The original application discloses SEQ ID NO: 5 at p. 15. Applicant must amend the disclosures of skipped sequences in the instant specification with either the three- or one-letter codes for peptides. For instance, SEQ ID NO: 5 would appear as just “Tyr-Thr-Ser” or “YTS”.
(ii) The phrase “the conditions according to” followed by Tables 1 and 2 with the heading “amino acid” and “at position” in claim 15 is unclear because the claim does not set forth what the actual “condition” is. Similarly, claims 17 and 18 refer to “the additional conditions” followed by Tables with the heading “amino acid” and “at position”. The specification discloses “this improvement has been obtained by introducing specific amino acids in the Vh and Vl chains, in areas laying outside the aforementioned CDRs, i.e. without modifying the [CDRs]” (see p. 4, lines 20-22). This phrase suggests that the listed amino acid residues have been “introduced” at the recited position, e.g., in claim 15, a V at position 5 in the Vh. It is further unclear, however, whether this constitutes an additional amino acid introduced at position 5, or whether the original amino acid at position 5 has been substituted. It is noted that the specification as originally filed is silent with respect to substitutions and mutations, therefore the metes and bounds of the recited “conditions” cannot be known. The claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant (see MPEP 2171).
The dependent claims are hereby included in this rejection for depending upon indefinite claims without resolving the indefiniteness.
Notice for all US Patent Applications filed on or after March 16, 2013: In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14 and 23-26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Spicer et al. (WO2021214329—on IDS filed 04/18/2024). The WO document by Spicer and colleagues was published on 28 October 2021, which is prior to the effective filing date of 17 October 2022 (see Priority, above). In addition, Spicer et al. was filed 23 April 2021, prior to the effective filing date.
The applied reference has a common inventor (Figini, Mariangela) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Spicer et al. disclose the heavy chain CDRs set forth in SEQ ID NOs: 1-3 and light chain CDRs set forth in SEQ ID NOs: 4-6. The heavy chain CDRs (underlined) are contained within SEQ ID NO: 4 of Spicer and colleagues (see Figure 4): QVQLQQSGAELARPGASVKLSCKASDYIFTNYDITWVKQRPGQGLEWIGEIDPRSGKSYYNEKFKGKSTLTADKSSSTAYMELRSLTSEDSAVYFCATMYYYGSSPPMDYWGQGTSVTVSS
This sequence shares 99.4% sequence identity with instant SEQ ID NO: 7:
US-18-702-344-7
Query Match 99.4%; Score 635; DB 1; Length 123;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQSGAELARPGASVKLSCKASDYIFTNYDITWVKQRPGQGLEWIGEIDPRSGKSYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQSGAELARPGASVKLSCKASDYIFTNYDITWVKQRPGQGLEWIGEIDPRSGKSYY 60
Qy 61 NEKFKGKSTLTADKSSSTAYMELRSLTSEDSAVYFCATMYYYGSSPPMDYWGQGTSVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFKGKSTLTADKSSSTAYMELRSLTSEDSAVYFCATMYYYGSSPPMDYWGQGTSVTVS 120
Therefore, the sequence disclosed by Spicer et al. does not comprise the full sequence defined by SEQ ID NO: 7. In addition, the light chain CDRs (underlined) are contained within SEQ ID NO: 3 of Spicer et al. (see Figure 3):
DIQMTQTTSSLSASLGDRVTISCRASQDINNFLNWYQQKPDGTVKLLIYYTSRLHSGVP
SRFSGSGSGTDYSLTIINLEQEDIAIYFCQQSSTIPRTFGGGTKLEIK
This sequence shares 98.5% sequence identity with instant SEQ ID NO: 8:
US-18-702-344-8
Query Match 98.5%; Score 543; DB 1; Length 107;
Best Local Similarity 99.1%;
Matches 106; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 DIQMTQTTSSLSASLGDRVTISCRASQDINNFLNWYQQKPDGTVKLLIYYTSRLHSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQTTSSLSASLGDRVTISCRASQDINNFLNWYQQKPDGTVKLLIYYTSRLHSGVPS 60
Qy 61 RFSGSGSGTDYSLTIINLEQEDIAIYFCQQSSTIPRTFGGGTKLEIK 107
||||||||||||||||||||||||||||||||||||||| |||||||
Db 61 RFSGSGSGTDYSLTIINLEQEDIAIYFCQQSSTIPRTFGQGTKLEIK 107
Therefore, the sequence disclosed by Spicer et al. does not comprise the full sequence defined by SEQ ID NO: 8 and meets the limitation of claim 14. Spicer et al. teach that the antibodies can be expressed as single chain antibodies (see p. 27, 2nd full paragraph) and that the antibodies can be formulated with a targeting molecule into a fusion protein (i.e., conjugate—see p. 26, 3rd paragraph), thereby meeting the limitations of claims 23 and 24. Spicer et al. also teach formulating the antibodies into a pharmaceutical composition (see p. 29, 3rd paragraph). Finally, Spicer et al. teach the antibodies can be administered to treat cancer (see p. 31, 3rd and 4th paragraphs).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
