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 .
1. Claims 1-17 as filed on February 20, 2024, are pending and under consideration.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on January 21, 2022. It is noted, however, that Applicants have not filed a certified copy of the PCT/CN2022/077029 application as required by 37 CFR 1.55.
Drawings
3. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1 A-B, 3 A-B, 8 A-B, 17 A-B, 22 A-F, 26 A-C, 27 A-D, and 28 A-E. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
4. The use of the term nanobody, which is a trade name or a mark used in commerce (see NANOBODY (Ser. No. 85573029, Reg. Date Dec. 13, 2016) and NANOBODIES (Ser. No. 79004985, Reg. Date Dec. 20, 2005)), has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
5. Claims 1-14 and 17 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-15 of co-pending Application No. 18/582,578 (reference application, published as US 2024/0209109 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘578 claims are drawn to:
1. A method of treating cancer in a patient in need thereof, comprising administering to the patient an effective amount of a single domain antibody or a polypeptide comprising the single domain antibody, wherein the single domain antibody has binding specificity to the human cluster of differentiation 40 (CD40) protein and comprises a complementarity determining region 1 (CDR1), a CDR2 and a CDR3, wherein the CDR1, CDR2 and CDR3 comprise, respectively, (1) the amino acid sequences of SEQ ID NO: 14, 15 and 16; (1a) the amino acid sequences of SEQ ID NO: 14, 63 and 16; (1b) the amino acid sequences of SEQ ID NO: 14, 64 and 16; (2) the amino acid sequences of SEQ ID NO: 17, 18 and 19; (3) the amino acid sequences of SEQ ID NO: 20, 21 and 22; (4) the amino acid sequences of SEQ ID NO: 23, 24 and 25; (5) the amino acid sequences of SEQ ID NO: 26, 27 and 28; (6) the amino acid sequences of SEQ ID NO: 29, 30 and 31; (7) the amino acid sequences of SEQ ID NO: 32, 33 and 34; (8) the amino acid sequences of SEQ ID NO: 35, 36 and 37; (9) the amino acid sequences of SEQ ID NO: 38, 39 and 40; (10) the amino acid sequences of SEQ ID NO: 41, 42 and 43; (11) the amino acid sequences of SEQ ID NO: 44, 45 and 46; (12) the amino acid sequences of SEQ ID NO: 47, 48 and 49; or (13) the amino acid sequences of SEQ ID NO: 50, 51 and 52.
2. The method of claim 1, wherein the CDR1, CDR2 and CDR3 comprise, respectively, (1) the amino acid sequences of SEQ ID NO: 14, 15 and 16; (1a) the amino acid sequences of SEQ ID NO: 14, 63 and 16; (1b) the amino acid sequences of SEQ ID NO: 14, 64 and 16; (2) the amino acid sequences of SEQ ID NO: 17, 18 and 19; (3) the amino acid sequences of SEQ ID NO: 20, 21 and 22; (4) the amino acid sequences of SEQ ID NO: 23, 24 and 25; (5) the amino acid sequences of SEQ ID NO: 26, 27 and 28; or (10) the amino acid sequences of SEQ ID NO: 41, 42 and 43.
3. The method of claim 2, wherein the CDR1 comprises the amino acid sequence of SEQ ID NO:14, the CDR2 comprises the amino acid sequence of SEQ ID NO: 15, 63 or 64, and the CDR3 comprises the amino acid sequence of SEQ ID NO: 16.
4. The method of claim 3, wherein the CDR1 comprises the amino acid sequence of SEQ ID NO: 14, the CDR2 comprises the amino acid sequence of SEQ ID NO: 15, and the CDR3 comprises the amino acid sequence of SEQ ID NO:16.
5. The method of claim 4, which comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 53, 54, 57 and 60.
6. The method of claim 3, wherein the CDR1 comprises the amino acid sequence of SEQ ID NO: 14, the CDR2 comprises the amino acid sequence of SEQ ID NO:63, and the CDR3 comprises the amino acid sequence of SEQ ID NO:16.
7. The method of claim 6, which comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 55, 58 and 61.
8. The method of claim 3, wherein the CDR1 comprises the amino acid sequence of SEQ ID NO:14, the CDR2 comprises the amino acid sequence of SEQ ID NO:64, and the CDR3 comprises the amino acid sequence of SEQ ID NO: 16.
9. The method of claim 8, which comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 56, 59 and 62.
10. The method of claim 2, wherein the CDR1 comprises the amino acid sequence of SEQ ID NO:17, the CDR2 comprises the amino acid sequence of SEQ ID NO:18, and the CDR3 comprises the amino acid sequence of SEQ ID NO:19.
11. The method of claim 10, which comprises an amino acid sequence selected from the group consisting of SEQ ID NO:65-68.
12. The method of claim 2, wherein the CDR1 comprises the amino acid sequence of SEQ ID NO:41, the CDR2 comprises the amino acid sequence of SEQ ID NO:42, and the CDR3 comprises the amino acid sequence of SEQ ID NO:43.
13. The method of claim 12, which comprises an amino acid sequence selected from the group consisting of SEQ ID NO:69-72.
14. The method of claim 2, which comprises the amino acid sequence of SEQ ID NO:3, 4 or 5.
The sequences of the CD40 single domain antibodies of the ‘578 claims are the same as the instant claims. See Table 1 of the ‘578 application. Thus, the CD40 single domain antibodies of the ‘578 claims anticipate the currently claimed CD40 single domain antibodies.
Regarding claim 17, one of skill in the art would immediately envision placing the antibody or polypeptide of the ‘578 claims in a pharmaceutically acceptable carrier like phosphate buffered saline for storage and use.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 15-17 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-15 of co-pending Application No. 18/582,578 (reference application, published as US 2024/0209109 A1), as applied to claims 1-14 and 17 above, in further view of US 2006/0211088 A1 (Hermans et al. Sep. 21, 2006). “Hermans”.
The ‘578 claims teach as set forth above, but do not teach polynucleotides encoding the single domain antibodies or cell comprising the polynucleotide.
Hermans teaches a method for generating or cloning a nucleic acid or nucleotide sequence that encodes a heavy chain antibody or an antigen-binding fragment thereof, wherein said heavy chain antibody or antigen-binding fragment is directed against a specific antigen, said method comprising the steps of providing a sample or population of cells from a Camelid immunized with said antigen, isolating from said sample or population said at least one cell that expresses or is capable of expressing a heavy chain antibody directed against said antigen, and obtaining from said at least one cell a nucleic acid or nucleotide sequence that encodes a heavy chain antibody directed against antigen or that encodes an antigen-binding fragment thereof directed against said antigen. See abstract and claims 1-21.
Hermans teaches a method for producing a heavy chain antibody or antigen-binding fragment thereof, said method comprising expressing a nucleic acid that encodes a heavy chain antibody or antigen-binding fragment thereof, in a suitable host cell or host organism. See ¶¶ 0174, 0175 and 0179 and claims 11 and 20.
Hermans teaches making pharmaceutical compositions with pharmaceutically acceptable carriers with the single domain antibodies. See ¶¶ 0356 and 0365.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘578 claims and Hermans and obtain the nucleic acids encoding the single domain antibodies of the ‘578 claims with the methods of Hermans and use the methods of Hermans to produce the antibodies from recombinant cells expressing the antibodies so that one would have sufficient single domain antibodies in pharmaceutical compositions for treatment of cancer of the ‘578 claims.
This is a provisional nonstatutory double patenting rejection.
7. Claims 1-4, 6, 8 and 15-17 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/582,582 (reference application, published as US 2024/0287208 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘582 claims are drawn to:
1. A multi-specific antibody comprising a first antibody or antigen-binding fragment having binding specificity to a CD40 protein, and a second antibody or antigen-binding fragment having binding specificity to a 5T4 protein, wherein the multi-specific antibody activates CD40 on a target cell that expresses the 5T4 protein more effectively than CD40 on a reference cell that does not express the 5T4 protein, or wherein the multi-specific antibody does not activate CD40 on a reference cell that does not express the 5T4 protein.
8. The multi-specific antibody of claim 1, wherein the first antibody or antigen-binding fragment comprises two separate (VHH) anti-CD40 antibodies, each is fused to the C-terminus of each of the two chains of a Fc fragment, and wherein the second antibody or antigen-binding fragment comprises two conventional VH/VL Fab fragments, each is fused to the N-terminus of each of the two chains of the Fc fragment.
11. The multi-specific antibody of claim 1, wherein the first antibody or antigen-binding fragment comprises one or more single domain (VHH) anti-CD40 antibodies, each comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 14, a CDR2 comprising the amino acid sequence of SEQ ID NO: 15, 63 or 64, and a CDR3 comprising the amino acid sequence of SEQ ID NO: 16.
16. One or more polynucleotide encoding the multi-specific antibody of claim 1.
17. A cell comprising the polynucleotide of claim 16.
18. A composition comprising the multi-specific antibody of claim 1 and a pharmaceutically acceptable carrier.
The sequences of the CD40 single domain antibodies of the ‘582 claims are the same as the instant claims. See Table 1 of the ‘582 application. Thus, the CD40 single domain antibodies of the ‘582 claims anticipate the currently claimed CD40 single domain antibodies.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Related Prior Art
8. US 2016/0355596 A1 (Honczrenko et al. Dec 8, 2016) teaches a single domain antibody to human CD40. See abstract, ¶¶ 0036-0038 and Fig. 1A. Honczrenko does not teach or suggest the currently claimed single domain antibody.
Conclusion
9. No claims allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time.
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/PETER J REDDIG/Primary Examiner, Art Unit 1646
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