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 .
The objection to the Specification is withdrawn in view of the substitute specification correcting terminology associated with trademarks.
The rejections under section 112(a) are withdrawn in view of the amendments and remarks in connection with these grounds of rejection.
The rejections under section 112(b) are withdrawn in view of the amendments and remarks in connection with these grounds of rejection.
The rejection under section 103 over U.S. Publication No. 20170035906 based on an application by Naito et al. (Naito) in view of: Kushner et al., Canadian Journal of Physiology and Pharmacology (1999), 77(2), 79-88; US 6,603,008; US 6,221,335;US 20070082929; US 20070197695; US 7,517,990; Tonn, Biological Mass Spectrometry Volume 22 Issue 11, Pages 633 – 642 (1993);Haskins, Biomedical Spectrometry Volume 9 Issue 7, Pages 269 – 277 (1982);Wolen, Journal of Clinical Pharmacology 1986; 26: 419-424;Browne, Journal of Clinical Pharmacology 1998; 38: 213-220;Baillie, Pharmacology Rev.1981; 33: 81-132; US 6,440,710; and Gouyette, Biomedical and Environmental Mass Spectrometry, Vol. 15, 243-247 (1988); in further view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg) is withdrawn in vie of Applicant’s amendments distinguishing the instant conjugates from those disclosed by these references.
The rejection under section 103 over WO 2021190480 (WO 480) in view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg) is withdrawn since Applicant has perfected priority in view of a certified translation, and WO 2021190480 and its counterparts do not qualify as prior art under any sub-paragraph of section 102 against the instant application.
The rejection under 35 U.S.C. 103 as being unpatentable over: WO 2020063673 and counterparts; CN 111689980; WO 2020244657 and counterparts; WO 2021115426 and counterparts; WO 2021121204 and counterparts; or WO 2021190480 (WO 480)
in view of: Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg);
in further view of: WO 2021148003 and counterpart U.S. Publication No. US 20230144203 to Huang et al (collectively “Huang”) is withdrawn since Applicant has perfected priority in view of a certified translation, and WO 2021148003 and its counterparts do not qualify as prior art under any sub-paragraph of section 102 against the instant application.
The following rejections under section 103 are maintained:
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 12-14, 16, 33, 34, 36-39 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2020063673 and counterparts US 12377163 and U.S. Publication No. 20210347894 based on an application by Ying et al. (collectively “Ying”) in view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg).
References to Ying are based on the U.S. Publication.
Ying discloses anti-B7H3 antibody-drug conjugates for cancer treatment:
See for example:
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See pages 7+.
The primary references may not explicitly teach conjugates with anti-TROP-2 antibodies. However, the secondary references demonstrate that Trop-2 is a transmembrane glycoprotein overexpressed in many solid tumors (e.g., breast, lung, urothelial), making it an ideal target for antibody-drug conjugates. It is for that proposition that the rejection joins the secondary references.
See Starodub (“Sacituzumab govitecan (IMMU-132) is a novel ADC comprising SN-38, the active metabolite of the topoisomerase inhibitor, irinotecan, conjugated to an anti-Trop-2 humanized antibody. Its uniquely very high drug:antibody ratio of 7.6 allows delivering up to 136-fold more SN-38 than its parent drug, irinotecan, in a human cancer xenograft. The mAb and ADC are immunotherapeutic in vitro (ADCC). Expression of Trop-2 is increased in most epithelial cancers (>80%), including SCLC.”).
See Goldenberg (“Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers… A novel target in multiple solid cancers for an ADC is trophoblast cell-surface antigen, or Trop-2, also known as tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor-associated antigen (GA733-1), and surface marker 1 (M1S1)”).
In this way, those of ordinary skill could have applied the recited anti-TROP-2-antibodies in the manner required and in a predictable fashion for the purposes of providing the instant ADC’s. As outlined above, the primary references teach that ADC’s with the core linker-drugs were known. The secondary references are added for the proposition that the recited targeting antibodies, i.e., anti-TROP-2, are applicable to these ADC’s. Specifically, the secondary references teach that the particular known technique of using anti-TROP-2 antibodies in ADC’s was recognized as part of the ordinary capabilities of one skilled in the art. In this manner those of ordinary skill would have recognized that applying the known technique to ADC’s, such as those taught by the primary references, would have yielded predictable results. Accordingly, using the recited anti-TROP-2 antibodies for the purposes of preparing the instant ADC’s would have been prima facie obvious.
Applicant has perfected priority by filing a certified translation of the priority document. However, the WIPO and any counterpart U.S. Patent documents (i.e., U.S. Patent and U.S. Patent Publications) still are available as prior art against the instant application under section 102(b)(2). Therefore, the rejection is maintained.
Claims 1, 4, 12-14, 16, 33, 34, 36-39 remain rejected under 35 U.S.C. 103 as being unpatentable over CN 111689980 (CN 980) in view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg).
CN 980 teaches the following linker-drugs:
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See page 14.
The primary references may not explicitly teach conjugates with anti-TROP-2 antibodies. However, the secondary references demonstrate that Trop-2 is a transmembrane glycoprotein overexpressed in many solid tumors (e.g., breast, lung, urothelial), making it an ideal target for antibody-drug conjugates. It is for that proposition that the rejection joins the secondary references.
See Starodub (“Sacituzumab govitecan (IMMU-132) is a novel ADC comprising SN-38, the active metabolite of the topoisomerase inhibitor, irinotecan, conjugated to an anti-Trop-2 humanized antibody. Its uniquely very high drug:antibody ratio of 7.6 allows delivering up to 136-fold more SN-38 than its parent drug, irinotecan, in a human cancer xenograft. The mAb and ADC are immunotherapeutic in vitro (ADCC). Expression of Trop-2 is increased in most epithelial cancers (>80%), including SCLC.”).
See Goldenberg (“Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers… A novel target in multiple solid cancers for an ADC is trophoblast cell-surface antigen, or Trop-2, also known as tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor-associated antigen (GA733-1), and surface marker 1 (M1S1)”).
In this way, those of ordinary skill could have applied the recited anti-TROP-2-antibodies in the manner required and in a predictable fashion for the purposes of providing the instant ADC’s. As outlined above, the primary references teach that ADC’s with the core linker-drugs were known. The secondary references are added for the proposition that the recited targeting antibodies, i.e., anti-TROP-2, are applicable to these ADC’s. Specifically, the secondary references teach that the particular known technique of using anti-TROP-2 antibodies in ADC’s was recognized as part of the ordinary capabilities of one skilled in the art. In this manner those of ordinary skill would have recognized that applying the known technique to ADC’s, such as those taught by the primary references, would have yielded predictable results. Accordingly, using the recited anti-TROP-2 antibodies for the purposes of preparing the instant ADC’s would have been prima facie obvious.
The CF3 group of CN 111689980 corresponds to haloalkyl group of the instant R1 group. Therefore, the rejection is maintained.
Claims 1, 4, 10, 12-14, 16, 33, 34, 36-39 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2020244657 and counterpart U.S. Publication No. 20230072897 based on an application by Hua et al. (collectively “Hua”) in view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg).
References to Hua are based on the U.S. Publication.
Hua discloses anti-B7H4 antibody-drug conjugates for cancer treatment:
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See pages 12+.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record.
Namely, unlike pre-AIA law, the AIA provides that a foreign priority date can be the effective filing date of a claimed invention. The foreign priority date is the effective filing date of the claimed invention IF
-the foreign application supports the claimed invention under 112(a), AND
-the applicant has perfected the right of priority by providing:
a certified copy of the priority application, and
a translation of the priority application (if not in English).
When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate.
The primary references may not explicitly teach conjugates with anti-TROP-2 antibodies. However, the secondary references demonstrate that Trop-2 is a transmembrane glycoprotein overexpressed in many solid tumors (e.g., breast, lung, urothelial), making it an ideal target for antibody-drug conjugates. It is for that proposition that the rejection joins the secondary references.
See Starodub (“Sacituzumab govitecan (IMMU-132) is a novel ADC comprising SN-38, the active metabolite of the topoisomerase inhibitor, irinotecan, conjugated to an anti-Trop-2 humanized antibody. Its uniquely very high drug:antibody ratio of 7.6 allows delivering up to 136-fold more SN-38 than its parent drug, irinotecan, in a human cancer xenograft. The mAb and ADC are immunotherapeutic in vitro (ADCC). Expression of Trop-2 is increased in most epithelial cancers (>80%), including SCLC.”).
See Goldenberg (“Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers… A novel target in multiple solid cancers for an ADC is trophoblast cell-surface antigen, or Trop-2, also known as tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor-associated antigen (GA733-1), and surface marker 1 (M1S1)”).
In this way, those of ordinary skill could have applied the recited anti-TROP-2-antibodies in the manner required and in a predictable fashion for the purposes of providing the instant ADC’s. As outlined above, the primary references teach that ADC’s with the core linker-drugs were known. The secondary references are added for the proposition that the recited targeting antibodies, i.e., anti-TROP-2, are applicable to these ADC’s. Specifically, the secondary references teach that the particular known technique of using anti-TROP-2 antibodies in ADC’s was recognized as part of the ordinary capabilities of one skilled in the art. In this manner those of ordinary skill would have recognized that applying the known technique to ADC’s, such as those taught by the primary references, would have yielded predictable results. Accordingly, using the recited anti-TROP-2 antibodies for the purposes of preparing the instant ADC’s would have been prima facie obvious.
Applicant has perfected priority by filing a certified translation of the priority document. However, the WIPO and any counterpart U.S. Patent documents (i.e., U.S. Patent and U.S. Patent Publications) still are available as prior art against the instant application under section 102(b)(2). Therefore, the rejection is maintained.
Claims 1, 4, 10, 12-14, 16, 18, 33, 34, 36-39 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2021115426 and counterpart U.S. Publication No. 20230054458 based on an application by Yang et al. (collectively “Yang”) in view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg).
References to Yang are based on the U.S. Publication.
Yang discloses anti-claudin18.2 antibody-drug conjugates for cancer treatment:
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See pages 6+.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record.
Namely, unlike pre-AIA law, the AIA provides that a foreign priority date can be the effective filing date of a claimed invention. The foreign priority date is the effective filing date of the claimed invention IF
-the foreign application supports the claimed invention under 112(a), AND
-the applicant has perfected the right of priority by providing:
a certified copy of the priority application, and
a translation of the priority application (if not in English).
When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate.
The primary references may not explicitly teach conjugates with anti-TROP-2 antibodies. However, the secondary references demonstrate that Trop-2 is a transmembrane glycoprotein overexpressed in many solid tumors (e.g., breast, lung, urothelial), making it an ideal target for antibody-drug conjugates. It is for that proposition that the rejection joins the secondary references.
See Starodub (“Sacituzumab govitecan (IMMU-132) is a novel ADC comprising SN-38, the active metabolite of the topoisomerase inhibitor, irinotecan, conjugated to an anti-Trop-2 humanized antibody. Its uniquely very high drug:antibody ratio of 7.6 allows delivering up to 136-fold more SN-38 than its parent drug, irinotecan, in a human cancer xenograft. The mAb and ADC are immunotherapeutic in vitro (ADCC). Expression of Trop-2 is increased in most epithelial cancers (>80%), including SCLC.”).
See Goldenberg (“Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers… A novel target in multiple solid cancers for an ADC is trophoblast cell-surface antigen, or Trop-2, also known as tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor-associated antigen (GA733-1), and surface marker 1 (M1S1)”).
In this way, those of ordinary skill could have applied the recited anti-TROP-2-antibodies in the manner required and in a predictable fashion for the purposes of providing the instant ADC’s. As outlined above, the primary references teach that ADC’s with the core linker-drugs were known. The secondary references are added for the proposition that the recited targeting antibodies, i.e., anti-TROP-2, are applicable to these ADC’s. Specifically, the secondary references teach that the particular known technique of using anti-TROP-2 antibodies in ADC’s was recognized as part of the ordinary capabilities of one skilled in the art. In this manner those of ordinary skill would have recognized that applying the known technique to ADC’s, such as those taught by the primary references, would have yielded predictable results. Accordingly, using the recited anti-TROP-2 antibodies for the purposes of preparing the instant ADC’s would have been prima facie obvious.
Applicant has perfected priority by filing a certified translation of the priority document. However, the WIPO and any counterpart U.S. Patent documents (i.e., U.S. Patent and U.S. Patent Publications) still are available as prior art against the instant application under section 102(b)(2). Therefore, the rejection is maintained.
Claims 1, 4, 10, 12-14, 16, 18, 33, 34, 36-39 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2021121204 and counterpart U.S. Publication No. 20230055408 based on an application by Ying et al. (collectively “Ying”) in view of Starodub et al., Abstract, J Clin Oncol 34, 8559(2016) (Starodub) and Goldenberg et al., Oncotarget. 2015 Jun 18;6(26):22496–22512 (Goldenberg).
References to Ying are based on the U.S. Publication.
Ying discloses anti-CEA antibody-drug conjugates for cancer treatment:
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See pages 9+.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record.
Namely, unlike pre-AIA law, the AIA provides that a foreign priority date can be the effective filing date of a claimed invention. The foreign priority date is the effective filing date of the claimed invention IF
-the foreign application supports the claimed invention under 112(a), AND
-the applicant has perfected the right of priority by providing:
a certified copy of the priority application, and
a translation of the priority application (if not in English).
When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate.
The primary references may not explicitly teach conjugates with anti-TROP-2 antibodies. However, the secondary references demonstrate that Trop-2 is a transmembrane glycoprotein overexpressed in many solid tumors (e.g., breast, lung, urothelial), making it an ideal target for antibody-drug conjugates. It is for that proposition that the rejection joins the secondary references.
See Starodub (“Sacituzumab govitecan (IMMU-132) is a novel ADC comprising SN-38, the active metabolite of the topoisomerase inhibitor, irinotecan, conjugated to an anti-Trop-2 humanized antibody. Its uniquely very high drug:antibody ratio of 7.6 allows delivering up to 136-fold more SN-38 than its parent drug, irinotecan, in a human cancer xenograft. The mAb and ADC are immunotherapeutic in vitro (ADCC). Expression of Trop-2 is increased in most epithelial cancers (>80%), including SCLC.”).
See Goldenberg (“Trop-2 is a novel target for ADC therapy because of its high expression by many solid cancers… A novel target in multiple solid cancers for an ADC is trophoblast cell-surface antigen, or Trop-2, also known as tumor-associated calcium signal transducer (TACSTD2), epithelial glycoprotein-1 (EGP-1), gastrointestinal tumor-associated antigen (GA733-1), and surface marker 1 (M1S1)”).
In this way, those of ordinary skill could have applied the recited anti-TROP-2-antibodies in the manner required and in a predictable fashion for the purposes of providing the instant ADC’s. As outlined above, the primary references teach that ADC’s with the core linker-drugs were known. The secondary references are added for the proposition that the recited targeting antibodies, i.e., anti-TROP-2, are applicable to these ADC’s. Specifically, the secondary references teach that the particular known technique of using anti-TROP-2 antibodies in ADC’s was recognized as part of the ordinary capabilities of one skilled in the art. In this manner those of ordinary skill would have recognized that applying the known technique to ADC’s, such as those taught by the primary references, would have yielded predictable results. Accordingly, using the recited anti-TROP-2 antibodies for the purposes of preparing the instant ADC’s would have been prima facie obvious.
Applicant has perfected priority by filing a certified translation of the priority document. However, the WIPO and any counterpart U.S. Patent documents (i.e., U.S. Patent and U.S. Patent Publications) still are available as prior art against the instant application under section 102(b)(2). Therefore, the rejection is maintained.
The double patenting rejections remain outstanding:
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.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. 12377163 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub Goldenberg and Huang demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45-57 of U.S. Application No. 17596239 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub, Goldenberg and Huang demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Application No. 17782980 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub, Goldenberg and Huang demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-20, 22-25 of U.S. Application No. 17785373 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub Goldenberg and Huang demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Application No. 17914087 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub and Goldenberg demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 18-20 of U.S. Application No. 17914209 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub and Goldenberg demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Application No. 17913928 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub, Goldenberg and Huang demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
Claims 1, 4, 5, 7, 8, 12-14, 16, 18, 19, 33-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of U.S. Application No. 18032086 in view of Starodub, Goldenberg and Huang.
Although the claims at issue are not identical, they are not patentably distinct from each other since the rejected claims cover linker-drug constructs that anticipate those covered by the rejected claims. Alternatively, the difference between the rejected claims and the conflicting claims is that the conflicting claims do recite the instant conjugates and methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the structural elements of the claimed conjugates with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, Starodub, Goldenberg and Huang demonstrate that ADC’s with the recite anti-TROP-2 antibody were within the purview of those of ordinary skill, and thus, prima facie obvious, as outlined above.
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 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.
Conclusion
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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