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 .
Applicant’s amendment, filed on 10/14/2025, is acknowledged.
Claims 2, 4, 5, 8, 10-12, 25, 29, 30, 35, and 40-42, are cancelled.
Claims 1, 3, 6, 7, 9, 13-24, 26-28, 31-34, 36-39, and 43 are currently pending.
Claims 14-16, 21, 26, 27, 31-34, and 36 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and/or species.
Claims 37 has been amended to depend on instant claim 1, and claim 38 has been amended to depend on claim 38. The limitations of these claims will now be examined. Additionally, claim 1(a) has been amended to recite the elected species of antibody, which will continued to be examined.
Claims 1-3, 6, 7, 9, 13, 17-20, 22-24, 28, 37-39, and 43 are under examination.
Claim 1 is the only independent claim.
Applicant’s amendments are remarks have obviated the previous 35 U.S.C. 112(a) and 103 rejections, and these rejections are hereby withdrawn. Applicant has amended claim 1 to recite a method of conditioning a subject in need of a genetically modified stem cell transplant comprising administration of specific antibody structures that bind to CD117, which are recited in instant claim 1(a)-(k), obviating the rejections.
Applicant’s amendments and remarks have obviated the previous double patenting rejections for the following: U.S. Patent Nos. 10,882,915, 11,572,411, 10,111,966, 11,958,908; and U.S. Application Nos. 17/173,119, 18/276,325, and 18/702,078. These rejections are hereby withdrawn. Applicant has amended claim 1 to recite a method of conditioning a subject in need of a genetically modified stem cell transplant comprising administration of specific antibody structures that bind to CD117, which are recited in instant claim 1(a)-(k), obviating the rejections.
Applications 17/507,618 and 17/508,759 have been abandoned. The non-statutory double patenting rejections concerning these applications are hereby withdrawn.
Claim Objections
Claim 1 is objected to because the claims recites (claim 1(a)): “…comprising a cytotoxin-and…” and should most likely recite “…comprising a cytotoxin and…” to correct a minor typographical error. Appropriate correction is required.
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.
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Claims 1, 3, 6, 7, 9, 13, 22-24, 37-39, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10,899,843 (herein Pat ‘843) in view of Nixon et al. (WO2017219029, on IDS submitted 5/05/2025, in Office Action mailed 6/11/2025) and Cornetta et al. (Hum Gene Ther. 1996 Jul 10;7(11):1323-9. doi: 10.1089/hum.1996.7.11-1323, in Office Action mailed 6/11/2025). This is a new grounds of rejection necessitated by applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘843 in view of Nixon et al. and Cornetta et al. for the same reasons discussed in the Office Action mailed 6/11/2025. Briefly, Pat ‘843 claims anti-CD117 ADCs with identical heavy and light chain sequences to the instant elected species of antibody conjugated to pyrrolobenzodiazepine. Pat ‘843 additionally claims methods comprising administration of the ADC to condition a subject by depleting a population of CD117 cells, followed by HSC transplantation to treat disorders such as cancer. Nixon et al. provides motivation to coupling antibodies to drugs via a linker to meet the limitations of instant claim 43 as well as providing motivation to treat hematological cancers via HSC transplantation, and Cornetta et al. provides motivation to treat hematological cancer by transplanting genetically modified stem cells.
Regarding instant claims 37 and 38, Pat ‘843 claims anti-CD117 antibodies comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 178 (claim 11), which comprises the L234A, L235A, D265C, and H435A Fc mutations (bolded below, Fc region underlined), meeting the limitations of the claims:
EVQLVQSGAEVKKPGESLKISCKGSGYSFTNYWIGWVRQMPGKGLEWMAIINPRDSDTRYRPSFQGQVTISADKSISTAYLQWSSLKASDTAMYYCARHGRGYEGYEGAFDIWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVCVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNAYTQKSLSLSPGK
Therefore, the invention as a whole was prima facia obvious variant of the invention claimed by Pat ‘843 in view of Nixon et al. and Cornetta et al., especially in the absence of evidence to the contrary.
Filing a terminal disclaimer for this reference application will overcome this rejection.
Claims 1, 3, 17-20, 22-24, 28, 37-39, and 43 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 10,899,843 (Pat '843, in Office Action mailed 6/11/2025) in view of Nixon et al. (WO2017219029, on IDS submitted 5/05/2025, in Office Action mailed 6/11/2025) and Dever et al. (Nature. 2016 Nov 17;539(7629):384-389. doi: 10.1038/nature20134. Epub 2016 Nov 7, in Office Action mailed 6/11/2025). This is a new grounds of rejection necessitated by applicant’s amendments.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘843 in view of Nixon et al. and Dever et al. for the same reasons discussed in the Office Action mailed 6/11/2025. Briefly, Pat ‘843 claims an anti-CD117 ADCs with identical heavy and light chain sequences to the instant elected species of antibody conjugated to pyrrolobenzodiazepine, as well as methods of conditioning patients by administering the ADC followed by an HSC transplant to treat disorders such as hemoglobinopathy. Nixon et al. provides motivation to coupling antibodies to drugs via a linker to meet the limitations of instant claim 43, and Dever et al. provides motivation to genetically modify the HSCs via CRISPR/Cas9 to correct a defective beta-globin gene before transplantation to treat hemoglobinopathies such as sickle-cell disease.
Regarding instant claims 37 and 38, Pat ‘843 claims anti-CD117 antibodies comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 178 (claim 11), which comprises the L234A, L235A, D265C, and H435A Fc mutations (see rejection supra).
Applicant’s remarks, filed 10/14/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that Dever et al. teaches administration of genetically modified HSCs into immunodeficient mice, and would therefore not require conditioning (remarks pg. 20). Furthermore, Applicant argues that Dever et al. teaches that tNGFR selection strategy has the potential advantage over chemoselection because it avoids exposing edited cells and patients to potentially toxic chemotherapy (remarks pg. 20).
This has been found to be not persuasive. Dever et al. is relied upon to teach genetically modified HSCs that can be used in transplantation after conditioning. Pat ‘843 claims such conditioning methods. Additionally, Dever et al. teaches that the tNGFR gene is introduced into modified stem cells with a corrected beta-globin gene to enrich such stem cells (pg. 386, Col 1, first full ¶): “Although GFP is not a clinically relevant reporter gene, the truncated nerve growth factor receptor (tNGFR), in which the cytoplasmic intracellular signalling (sic) domain is removed, could be used to enrich for targeted HSPCs.”
Dever et al. teaches that the genetically modified HSCs can be enriched via the tNGFR, which removes the need for chemoselection of these cells via chemotherapy (Discussion ¶2): “Although GFP is an unsuitable marker for gene therapy, our enrichment protocol using tNGFR (Figs 2c, 3f, g) (or other similar signalling-inert cell surface markers) represents a strategy for the next generation of β-haemoglobinopathy therapies that are based on gene editing. These studies show that this methodology can enrich corrected SCD patient-derived HSPCs that can differentiate into erythrocytes that express HBB anti-sickling mRNA from the endogenous HBB promoter. This tNGFR selection strategy has the potential advantage over chemoselection strategies because it avoids exposing edited cells and patients to potentially toxic chemotherapy13. The strategy of knocking in a HBB cDNA along with a selectable marker to enrich for modified cells would be applicable to both SCD and almost all forms of β-thalassemia.”
Dever et al. does not teach conditioning of patients prior to administration of HSCs, and therefore does not propose an alternative to conditioning. However, Dever et al. does teach enriching for genetically modified cells via an introduced tNGFR gene.
Additionally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, Pat ‘843 claims a method of conditioning a subject prior to transplantation by administering an anti-CD117 ADC that has the same structure as the instant claimed elected species of ADC, Nixon et al. teaches methods of transplanting genetically modified HSCs via CRISPR/Cas9, and Dever et al. teaches methods of genetically correcting the beta-globin gene in HSCs via CRISPR/Cas9.
Therefore, the invention as a whole was prima facia obvious variant of the invention claimed by Pat ‘843 in view of Nixon et al. and Dever et al., especially in the absence of evidence to the contrary.
Filing a terminal disclaimer for this reference application will overcome this rejection.
Claims 1, 3, 6, 7, 9, 13, 22-24, 28, and 37-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46 and 67-80 of copending Application No. 18/626,765 (herein App ‘765, in Office Action mailed 6/11/2025) in view of Nixon et al. (supra) and Cornetta et al. (supra). This is a new grounds of rejection necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 3, 6, 7, 9, 13, 22-24, 28, and 39 was a prima facia obvious variant of the invention claimed by App ‘765 in view of Nixon et al. and Cornetta et al. for the same reasons discussed in the Office Action mailed 6/11/2025.
Regarding claims 37 and 38, App ‘765 claims antibody Fc regions comprising D265C, H435A, L234A, and L235A (claim 78).
Therefore, the invention as a whole was prima facia obvious variant of the invention claimed by App ‘765 in view of Nixon et al. and Cornetta et al., especially in the absence of evidence to the contrary. This is a provisional double patenting rejection. Filing a terminal disclaimer for this reference application will overcome this rejection.
Claims 1, 3, 17-20, 22-24, 28, and 37-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46 and 67-80 of copending Application No. 18/626,765 (App ‘765, supra) in view of Nixon et al. (supra) and Dever et al. (supra). This is a new grounds of rejection necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 3, 6, 7, 9, 13, 22-24, 28, and 39 was a prima facia obvious variant of the invention claimed by App ‘765 in view of Nixon et al. and Dever et al. for the same reasons discussed in the Office Action mailed 6/11/2025.
Regarding claims 37 and 38, App ‘765 claims antibody Fc regions comprising D265C, H435A, L234A, and L235A (claim 78).
Therefore, the invention as a whole was prima facia obvious variant of the invention claimed by App ‘765 in view of Nixon et al. and Dever et al., especially in the absence of evidence to the contrary. This is a provisional double patenting rejection. Filing a terminal disclaimer for this reference application will overcome this rejection.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641