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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/20206 has been entered.
The rejections under section 103 are withdrawn. Namely, Applicant has excepted the applied WO and U.S. patent documents under section 102(b)(2)(c) as prior art under section 102(b)(2).
The applied WO and U.S. patent documents do not qualify as prior as under section 102(a)(1).
The obvious double patenting rejections over each of Application Nos. 17/413,965, 17/312,403, 17/312,311 and 18/262,994 are withdrawn since these applications have been abandoned.
The following double patenting rejections are maintained:
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.
The claims of Application No. 17312019 cover a conjugate comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 9, 11, 17, 19, 23, 24, 26, 28, 39-43 of copending Application No. 17312019 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 17312193 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-11, 13, 14, 16, 19, 26-30, 32-34, 43 of copending Application No. 17312193 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 17415759 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 9, 12, 13, 20-24, 29-31, 33, 35, 38, 43, 44 of copending Application No. 17415759 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although withdrawn, the claims of Application No. 17312104 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7, 11, 13, 14, 17-19, 23-26, 28, 29, of copending Application No. 17312104 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 18012723 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-77 of copending Application No. 18012723 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 18012729 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-80 of copending Application No. 18012729 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 18012754 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-76 of copending Application No. 18012754 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The binding molecule of Application No. 18012741 embraces fragments of immunoglobulins.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57-78 of copending Application No. 18012741 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 18012715 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-40 of copending Application No. 18012715 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of Application No. 18012760 cover conjugates comprising an immunoglobulin and a saponin.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 9, 11-14, 17, 21-26, 54 of copending Application No. 18012760 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Notwithstanding Applicant’s remarks, 18/044950 is not abandoned.
Claims 39-44 and 46-65 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 81-83 of copending Application No. 18044950 in view of Nessler. Although the claims at issue are not identical, they are not patentably distinct from each other.
The conflicting claims anticipate the instant conjugates since the conflicitng claims cover a conjugate comprising a saponin; and a single-domain antibody (sdAb) capable of binding to said cell, wherein the sdAb and the saponin are covalently bound via a linker, and wherein the saponin is a monodesmosidic triterpene glycoside or a bidesmosidic triterpene glycoside
Alternatively, the difference between the conflicting claims and the claimed inventions is that the conflicting claims may not recite the instant conjugates 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, advantages of single domain antibodies in therapeutics were known, see Nessler (“[b]iodistribution data, tumor histology images, spheroid experiments, in vivo single-cell measurements, and computational results demonstrate that a smaller size and slower internalization rate enabled higher tissue penetration and more cell killing”). Therefore, the prior art provides adequate reason to use single domain antibodies with the requisite expectation of success.
Moreover, the conflicting claims may recite conjugates whereas the rejected claims include methods of using the conjugates. However, the specification of the conflicting applications disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This is a continuing examination of the instant application. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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