DETAILED ACTION
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The rejection under section 112(a) is withdrawn in view of the amendments limiting the saponin to quillaic acid or gypsogenin.
The rejection under section 103 is maintained, below:
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 39-65 are rejected under 35 U.S.C. 103 as being unpatentable over each of the following WO documents and their counterpart U.S. published applications, listed below:
WO 2020126620 (US 20220313834);
WO 2020126626 (US 20220072149; US 20230357310);
WO 2020126627 (US 20250195682);
WO 2020126064 (US 20220054643);
WO 2020126600 (US 20220111066);
WO 2020126604 (US 20230173085);
WO 2020126609 (US 20220218837);
WO 2020126610 (US 20220023433);
WO 2021014019 (US 20230357310; US 20230277612; US 20230365617);
WO 2021014026 (US 20220249674);
all in view of Nessler et al., Cancer Res. 2020 Mar 15;80(6):1268-1278 (Nessler).
The above references each describe 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.
The difference between the applied references and the claimed inventions is that the applied references may not teach 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 applied references teach 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.
Applicant argues that The Office has failed to consider the cited references in their entirety, including portions that would lead away from the claims. See MPEP § 2141(VI). Nessler clearly identifies significant disadvantages.
However, Applicant is arguing that Nessler provide an absolute expectation of success, when all that is required is a reasonable expectation of success, see MPEP 2143 (“Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) (“To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’”); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) (“This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness.” (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that “the expectation of success need only be reasonable, not absolute”))
In this regard, 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. Accordingly, the references provide the requisite expectation of success.
Applicant also argues unexpected results. However, the examples given are not probative of unexpected results across the entirety of the conjugate genus.
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 39-65 are 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.
Claims 39-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of copending Application No. 17413965 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.
Claims 39-65 are 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.
Claims 39-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8, 12, 15-18, 21-28, 36-39 of copending Application No. 17312403 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.
Claims 62 and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 8, 15, 17-19, 22-25, 33-35, 38 of copending Application No. 17312311 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 conflicting 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are 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.
Claims 39-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of copending Application No. 18262994 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 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