DETAILED ACTION
Notice of Pre-AIA or AIA Status
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. Claim 1, 3, 5-6, 13-14, 16-17 and 19-20 are pending. Claims 2, 4, 7-12, 15, 18 and 21-38 are canceled.
3. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are under examination.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 1/25/2024, 8/30/2024 and 12/11/2024 have been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
5. Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See page 6, last line, page 7, last line, pages 8, 9, 62, 72, 79 and 81.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
6. Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. See Figs. 30, 31, 44, 50 and 55
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Abstract
7. The abstract of the disclosure is objected to because it refers to purported merits and compares the invention with the prior art. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
Claim Objections
8. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are objected to because of the following informalities:
Claim 1 is objected to for a typographical error, see the term “22-126” in line 5.
Claims 3, 5-6, 13-14, 16-17 and 19-20 are objected to as they depend from claim 1 and include all the limitations of claim 1.
Claim Rejections - 35 USC § 112
9. 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.
10. Claim 6 is 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.
Claim 6 is rejected as vague and indefinite for reciting the term “3E8” as the sole means of identifying the claimed antibody. The use of laboratory designations only to identify a particular molecule renders the claims indefinite because different laboratories may use the same laboratory designations to define completely distinct molecules. Furthermore, 3E8 could refer to a scFv, IgG, diabody, triabody or tetrabody. The specification does not explicitly define the term “3E8”. The rejection can be obviated by amending the claims to specifically and uniquely identify 3E8, for example, by SEQ ID NO.
Claim Rejections - 35 USC § 103
11. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
12. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Magliery et al. (US 9,718,888B2, Date of Patent: 8/1/2017, effectively filed date: 7/23/2013), in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
The applied reference has a common inventor/applicant 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.
Regarding claim 1, Magliery et al. teaches a single chain antibody 3E8.scFv that binds to the sialy-Tn epitope of TAG-72 and comprises SEQ ID NO:1.
Regarding claim 3, 3E8.scFv would necessarily have increased tissue penetrance compared to IgG and Fab due to its smaller size.
Regarding claim 5, Magliery teaches that 3E8.scFv comprises a VH of SEQ ID NO:10 and a VL of SEQ ID NO:11 (the paragraph bridging columns 1 and 2, and Example 1). The amino acid sequences of SEQ ID NOs: 10 and 11 are 100% identical to instant SEQ ID NOs: 10 and 11, respectively (see sequence alignment below).
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Regarding claim 6, Magliery teaches that 3E8.scFv has an antigen binding affinity for sialy-Tn which is at least 25% that of 3E8 (column 13, lines 12-15).
Regarding claim 14, Magliery teaches a composition comprising 3E8.scFv and a pharmaceutically acceptable carrier (column 2, lines 8-10).
Regarding claims 16-17, Magliery teaches that 3E8.scFv is directly or indirectly associated or linked to an effector moiety having therapeutic activity, the effector moiety is a radionuclide, or an anti-cancer drug (column 14, lines 1-5)
Regarding claim 19 and 20, Magliery et al. teaches that 3E8.scFv can be linked to a detectable label such as a radionuclide (claims) for in vivo imaging of a tumor (column 21, lines 13-21).
The amino acid sequence of SEQ ID NO:1 of Magliery differs from instant SEQ ID NO: 35 in that the order of the VH and VL is different, and the VH of the instant SEQ ID NO:35 comprises a A76S mutation. In SEQ ID NO:1 of Magliery, the order is VH-205C linker-VL (VH and VL regions are underlined). In instant SEQ ID NO:35, the order is VL-205C linker-VH (VH and VL regions are underlined).
MKYLLPTAAAGLLLLAAQPAMAAHHHHHHGSSGGGENLYFQGSSGDIVMTQSPDSLAVSLGERATINCKSSQSVLYSSNNKNYLAWYQQKPGQPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQQYYSYPLTFGGGTKVEIKLSADDAKKDAAKKDDAKKDDAKKDLQVQLVQSGAEVKKPGASVKVSCKASGYTFTDHAIHWVRQAPGQRLEWMGYFSPGNDDFKYSQKFQGRVTITADKSASTAYMELSSLRSEDTAVYYCARSWIMQYWGQGTLVTVSS (SEQ ID NO: 1 of the prior art)
MKYLLPTAAAGLLLLAAQPAMAAHHHHHHGSSGGGENLYFQGSSGQVQLVQSGAEVKKPGASVKVSCKASGYTFTDHAIHWVRQAPGQRLEWMGYFSPGNDDFKYSQKFQGRVTITADKSSSTAYMELSSLRSEDTAVYYCARSWIMQYWGQGTLVTVSSLSADDAKKDAAKKDDAKKDDAKKDLDIVMTQSPDSLAVSLGERATINCKSSQSVLYSSNNKNYLAWYQQKPGQPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQQYYSYPLTFGGGTKVEIK (instant SEQ ID NO:35)
Choo et al. teaches that a scFv may be in VH-linker-VL format or VL-linker-VH format ([0088]).
Regarding claim 13, Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have switched the order of the VH and VL in SEQ ID NO:1 in view of Choo. One would have been motivated to do so with a reasonable expectation of success because Choo et al. teaches that a scFv may be in VH-linker-VL format or VL-linker-VH format ([0088]). The modified SEQ ID NO:1 differs from instant SEQ ID NO:35 by a single amino acid (A76S). It comprises all CDR sequences of SEQ ID NO:35 and is at least 99.8% identical to SEQ ID NO:35, see sequence alignment below.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies based on 3E8.scFv in view of Choo. One would have been motivated to do so to increase valency and binding affinity of 3E8 scFv. One would have had a reasonable expectation because method of making diabodies and triabodies were well known in the art as shown by Choo.
Double Patenting
13. 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.
14. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,787,872, in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
Regarding claims 1, 3, 5-6, 14 and 19-20, claims 1-10 of U.S. Patent No. 11,787,872 disclose a method for in vitro immunodetection of TAG-72-expressing cancer cells comprising a step of contacting the cancer cells with an antibody fragment which specifically binds tumor-associated glycoprotein 72 (TAG-72), wherein the antibody fragment comprises an amino acid sequence with 98% or more identity to SEQ ID NO: 13, 33, 35, 37, 39, 41, 43, or 45, wherein said antibody fragment comprises complementarity determining regions (CDRs), wherein said CDRs comprise amino acid residues 53-57, 72-88, 122-126, 166-182, 198-204, and 237-245 of SEQ ID NO: 13; residues 76-80, 95-111, 144-149, 189-205, 221-227, and 260-268 of SEQ ID NO: 33; residues 76-80, 95-111, 144-149, 209-225, 241-247, and 280-288 of SEQ ID NO: 35; residues 76-80, 95-111, 144-149, 204-220, 236-242, and 275-283 of SEQ ID NO: 37; residues 76-80, 95-111, 144-149, 199-215, 231-237, and 270-278 of SEQ ID NO: 39; residues 76-80, 95-111, 144-149, 188-204, 220-226, and 259-267 of SEQ ID NO: 41; residues 76-80, 95-111, 144-149, 188-204, 220-226, and 259-267 of SEQ ID NO: 43; and residues 76-80, 95-111, 144-149, 189-205, 221-227, and 260-268 of SEQ ID NO: 45, wherein the antibody fragment comprises a heavy chain variable region comprising SEQ ID NO: 10, and a light chain variable region comprising SEQ ID NO: 11, wherein said antibody fragment has an antigen binding affinity for sialyl-Tn which is at least 25% that of 3E8. The amino acid sequences of SEQ ID NOs: 10, 11, 13, 33, 35, 37, 39, 41, 43, or 45 are 100% are identical to instant SEQ ID NOs: 10, 11, 13 33, 35, 37, 39, 41, 43, or 45, respectively.
The instant application is a continuation of Application No. 16/694,052 (US patent No. 11,787,872). The preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of a patent application containing such patentably indistinct claims.
Regarding claims 13 and 16-17, the claims of the patent do not disclose diabody or triabody, and linking the antibody fragment to an anti-cancer drug.
Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1). Choo et al. teaches that antibody may carry a detectable label or may be conjugated to a toxin (an anti-cancer drug) ([0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies using the antibody fragments of the patent or conjugated the antibody fragments of the patent to a toxin in view of Choo. One would have been motivated to do so to increase the valency and binding affinity of the antibody fragments of the patent or deliver a toxin to cancer cells. One would have had a reasonable expectation because method of making diabodies, triabodies and antibody-drug conjugates were well known in the art as shown by Choo.
15. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,487,151, in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
Regarding claims 1, 3, 5-6, 14 and 19-20, claims 1-10 of U.S. Patent No. 10,487,151 disclose an antibody fragment which specifically binds tumor-associated glycoprotein 72 (TAG-72), wherein the antibody fragment comprises SEQ ID NO: 13, 33, 35, 37, 39, 41, 43, or 45, wherein the fragment has increased tissue penetrance compared to full-length antibodies (IgG) and fragment antigen binding (Fab) domains, the antibody fragment comprises a heavy chain variable region comprising SEQ ID NO: 10, and a light chain variable region comprising SEQ ID NO: 11, said antibody fragment has an antigen binding affinity for sialyl-Tn which is at least 25% that of 3E8, said antibody fragment is, directly or indirectly, associated with or linked to a detectable label, and the composition is suitable for detection of cancer, the detectable label is a radionuclide or an enzyme. The amino acid sequences of SEQ ID NO: 10, 11, 13, 33, 35, 37, 39, 41, 43, or 45 are 100% identical to instant SEQ ID NO: 10, 11, 33, 35, 37, 39, 41, 43, or 45, respectively.
The instant application is a continuation of Application No. 16/694,052 (US patent No. 11,787,872) which is a continuation of Application No. 15/328,222 (US patent No. 10,487,151). The preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of a patent application containing such patentably indistinct claims.
Regarding claims 13 and 16-17, the claims of the patent do not disclose diabody or triabody, and linking the antibody fragment to an anti-cancer drug.
Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1). Choo et al. teaches that antibody may carry a detectable label or may be conjugated to a toxin (an anti-cancer drug) ([0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies using the antibody fragments of the patent or conjugated the antibody fragments of the patent to a toxin in view of Choo. One would have been motivated to do so to increase the valency and binding affinity of the antibody fragments of the patent or deliver a toxin to cancer cells. One would have had a reasonable expectation because method of making diabodies, triabodies and antibody-drug conjugates were well known in the art as shown by Choo.
16. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,718,888B2, in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
Claims 1-19 of U.S. Patent No. 9,718,888B2 disclose a method of in vivo immunodetection of TAG-72-expressing cancer cells in a mammal comprising a step of administering to the mammal a diagnostically effective amount of a composition comprising an antibody fragment comprising SEQ ID NO: 1 or SEQ ID NO: 2, wherein the antibody fragment is directly or indirectly attached to a radionuclide, the antibody fragment specifically binds tumor-associated glycoprotein 72 (TAG-72).
The amino acid sequence of SEQ ID NO:1 of the patent differs from instant SEQ ID NO: 35 in that the order of the VH and VL is different, and the VH of the instant SEQ ID NO:35 comprises a A76S mutation. In SEQ ID NO:1 of the patent, the order is VH-205C linker-VL. In instant SEQ ID NO:35, the order is VL-205C linker-VH.
Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1). Choo et al. teaches that antibody may carry a detectable label or may be conjugated to a toxin or enzyme ([0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have switched the order of the VH and VL in SEQ ID NO:1 in view of Choo. One would have been motivated to do so with a reasonable expectation of success because Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). The modified SEQ ID NO:1 differs from instant SEQ ID NO:35 by a single amino acid (A76S). It comprises all CDR sequences of SEQ ID NO:35 and is at least 99.8% identical to SEQ ID NO:35.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies using modified SEQ ID NO:1 or conjugated modified SEQ ID NO:1 to a toxin in view of Choo. One would have been motivated to do so to increase valency and binding affinity of modified SEQ ID NO:1 or to deliver a toxin to cancer cells. One would have had a reasonable expectation because method of making diabodies, triabodies and antibody-drug conjugates were well known in the art as shown by Choo.
17. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,919,979, in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
Claims 1-7 of U.S. Patent No. 10,919,979 disclose an antibody fragment which specifically binds tumor-associated glycoprotein 72 (TAG-72), wherein the antibody fragment comprises SEQ ID NO: 1 or SEQ ID NO: 2, wherein the antibody fragment is directly or indirectly attached to an effector moiety, said effector moiety is a detectable label such as a radionuclide or an enzyme, and is suitable for detection of cancer.
The amino acid sequence of SEQ ID NO:1 of the patent differs from instant SEQ ID NO: 35 in that the order of the VH and VL is different, and the VH of the instant SEQ ID NO:35 comprises a A76S mutation. In SEQ ID NO:1 of the patent, the order is VH-205C linker-VL. In instant SEQ ID NO:35, the order is VL-205C linker-VH.
Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1). Choo et al. teaches that antibody may carry a detectable label or may be conjugated to a toxin or enzyme ([0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have switched the order of the VH and VL in SEQ ID NO:1 in view of Choo. One would have been motivated to do so with a reasonable expectation of success because Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). The modified SEQ ID NO:1 differs from instant SEQ ID NO:35 by a single amino acid (A76S). It comprises all CDR sequences of SEQ ID NO:35 and is at least 99.8% identical to SEQ ID NO:35.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies using modified SEQ ID NO:1 or conjugated modified SEQ ID NO:1 to a toxin in view of Choo. One would have been motivated to do so to increase valency and binding affinity of modified SEQ ID NO:1 or to deliver a toxin to cancer cells. One would have had a reasonable expectation because method of making diabodies, triabodies and antibody-drug conjugates were well known in the art as shown by Choo.
18. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,370,273, in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
Claims 1-5 of U.S. Patent No. 12,370,273 disclose a method of performing surgical removal of a tumor in a subject comprising: a. administering to a subject intraperitoneally an anti-tumor-associated glycoprotein 72 (TAG-72) imaging agent comprising the formula Y-R, wherein Y comprises an anti-TAG-72 binding moiety and R comprises a first detectable label, wherein the anti-TAG-72 binding moiety comprises 3E8.scFv. The specification of the patent defines the antibody 3E8.scFv as comprising SEQ ID NO:1 (column 2, lines 30-37).
The amino acid sequence of SEQ ID NO:1 of the patent differs from instant SEQ ID NO: 35 in that the order of the VH and VL is different, and the VH of the instant SEQ ID NO:35 comprises a A76S mutation. In SEQ ID NO:1 of the patent, the order is VH-205C linker-VL. In instant SEQ ID NO:35, the order is VL-205C linker-VH.
Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1). Choo et al. teaches that antibody may carry a detectable label or may be conjugated to a toxin or enzyme ([0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have switched the order of the VH and VL in SEQ ID NO:1 in view of Choo. One would have been motivated to do so with a reasonable expectation of success because Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). The modified SEQ ID NO:1 differs from instant SEQ ID NO:35 by a single amino acid (A76S). It comprises all CDR sequences of SEQ ID NO:35 and is at least 99.8% identical to SEQ ID NO:35.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies using modified SEQ ID NO:1 or conjugated modified SEQ ID NO:1 to a toxin in view of Choo. One would have been motivated to do so to increase valency and binding affinity of modified SEQ ID NO:1 or to deliver a toxin to cancer cells. One would have had a reasonable expectation because method of making diabodies, triabodies and antibody-drug conjugates were well known in the art as shown by Choo.
19. Claims 1, 3, 5-6, 13-14, 16-17 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-28 of copending Application No. 19/256,293, in view of Choo et al. (US2012/0301899A1, pub. date: 11/29/2012).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-28 of copending Application No. 19/256,293 disclose a method of monitoring recurrence of a cancer in a subject following surgical removal of said tumor the method comprising: administering to a subject intraperitoneally an anti- tumor-associated glycoprotein 72 (TAG-72) imaging agent comprising the formula Y-R, wherein Y comprises an anti- TAG-72 binding moiety and R comprises a first detectable label, wherein the anti-TAG-72 binding moiety comprises 3E8.scFv. The specification of the copending application defines the antibody 3E8.scFv as comprising SEQ ID NO:1 (column 2, lines 30-37).
The amino acid sequence of SEQ ID NO:1 of the copending application differs from instant SEQ ID NO: 35 in that the order of the VH and VL is different, and the VH of the instant SEQ ID NO:35 comprises a A76S mutation. In SEQ ID NO:1 of the copending Application, the order is VH-205C linker-VL. In instant SEQ ID NO:35, the order is VL-205C linker-VH.
Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). Choo et al. teaches various antibody fragments including diabodies and triabodies ([0087] and Fig. 1). Choo et al. teaches that antibody may carry a detectable label or may be conjugated to a toxin or enzyme ([0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have switched the order of the VH and VL in SEQ ID NO:1 in view of Choo. One would have been motivated to do so with a reasonable expectation of success because Choo et al. teaches that a scFv may be in VH-linker-VL format or in VL-linker-VH format ([0088]). The modified SEQ ID NO:1 differs from instant SEQ ID NO:35 by a single amino acid (A76S). It comprises all CDR sequences of SEQ ID NO:35 and is at least 99.8% identical to SEQ ID NO:35.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made diabodies and triabodies using modified SEQ ID NO:1 or conjugated modified SEQ ID NO:1 to a toxin in view of Choo. One would have been motivated to do so to increase valency and binding affinity of modified SEQ ID NO:1 or to deliver a toxin to cancer cells. One would have had a reasonable expectation because method of making diabodies, triabodies and antibody-drug conjugates were well known in the art as shown by Choo.
Conclusion
20. No claims are allowed.
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/HONG SANG/Primary Examiner, Art Unit 1643
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