DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-7 are pending and presently considered.
Examiner notes that the pending claim set is identical to the previously examined claim set filed 5/22/2020 in parent Application 16/882,059, and that Application was subsequently abandoned. The rejections of record have been reinstated as redrafted below. This action is non-final.
Election/Restrictions
The claims are directed to narrow scope of methods. Accordingly, an election/restriction requirement has not been set forth on record at this time. However, Applicant is directed to MPEP §§ 818, 818.02(a), 819, and 821.
The pending claims are understood to require the active method step of administering to a subject a therapeutically effective amount of a composition comprising the peptide of SEQ ID NO: 9, wherein said peptide is a (4,12:7,15) bicycle (see instant claim 1); wherein SEQ ID NO: 9 is XDECELCVNVACTGCX1, and X at position 1 is D-Asn, and X at position 16 is D-Leu, which is also known in the art as CAS NO. 1092457-65-22.
Priority
The priority claim to US Provisional Application 60/933,194 (06/04/2007) is acknowledged.
Information Disclosure Statement
The IDS filed 4/04/2024 is acknowledged and presently considered.
Claim Rejections
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.
Rejections [NSDP 01]-[NSDP 12] were first raised in parent Application 16/882,059, and the identical claims were rejected in the Action mailed 9/20/20223. Those rejections are redrafted as set forth below, but have been essentially maintained. This action is non-final.
[NSDP 01]
Claims 1, 4, and 6-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 7,879,802.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to peptides of SEQ ID NO. 9 (which is the same as applicant’s SEQ ID NO. 9) (see US’802 at claims 1-3) and methods of using the peptide to increase cGMP production in any cells in combination with a phosphodiesterase inhibitor selected from suldinac sulfone, zaprinast, motapizone, vardenafil and suldenifil (compare instant claims 1, 4, and 6-7 with US’802 at claims 4-6).
The difference between the issued claims and the instantly pending claims is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject or otherwise clarify that the cells may be cancer cells within a subject. Therefore, the issue is whether or not this difference is sufficient to patentably distinguish the instant claims from the issued claims.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and it is permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1); see also Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010)). The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). The courts have held that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The courts clarified that when a later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent”, that the asserted claims of the later patent are not “patentably distinct” from the claims of the earlier patent, and thus the later patent is invalid for obviousness-type double patenting (see, e.g., Pfizer, 518 F.3d at 1363-68 & n. 8; see also, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). Accordingly, an Examiner may look at the specification of the patent to determine the use of a claimed compound to identify obvious variants.
Here, the instant claims merely claim a particular use described in the earlier patent of the claimed compositions of the earlier patent. Specifically, the issued patent discloses the use of the same compound for the treatment of cancer (see, e.g., US’ 802 at col. 4, lines 4-53).
Accordingly, the pending claims are not patentably distinct from the issued claims (see, e.g., Pfizer, 518 F.3d at 1363-68 & n. 8; see also, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010)).
[NSDP 02]
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 7,879,802 in view of US 7,041,786.
The application of the primary reference to instant claims 1, 4, and 6-7 has been discussed above, and those discussions are incorporated in the instant rejection.
The difference between the issued claims and instant claims 2-3 and 5 is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject utilizing a daily dose, with a specific order of administration, or wherein the dosage is 1-10 mg.
With respect to the order of administration, since the patent claims discloses the combination, the selection of any order of mixing the components is obvious absent any unexpected results (MPEP 2144.04(IV)(C).
With respect to dosage and dosing frequency, US’786 teaches and discloses highly similar compounds, namely SEQ ID NO: 20, which is identical to instant SEQ ID NO: 9 except that SEQ ID NO: 9 comprises two D-amino acids (i.e., D-Asn and D-Leu) (compare US’786 at SEQ ID NO: 20 with instant SEQ ID NO: 9, showing 100% sequence identity, and noting the sequences are stereoisomers; see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (noting that stereoisomers are prima facie obvious). Critically, US’786 identifies that the highly similar compounds may be utilized in the treatment of cancers, wherein the dosing frequency may be daily, the dosage may be between 10 µg and 2 mg (see, e.g., US’786 at col. 14 at line 20 to col. 15 at line 20, claims 1-5). Accordingly, because US’786 informs artisans that highly similar compounds (i.e., stereoisomers, peptides sharing the same bicyclic structure and 100% sequence identity), could be utilized for the same purpose (i.e., treatment of cancer), at the same daily dosing regimes for cancer treatment, wherein the dosage may be between 10 µg and 2 mg, it would have been obvious to artisans that highly similar compounds could be utilized for the same purpose using the same dosage and dosing frequency, with a reasonable expectation of success (see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)).
Accordingly, such limitations do not patentably distinguish the instant claims over the issued claims.
[NSDP 03]
Claims 1, 4 and 6-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,901,075.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to peptides of SEQ ID NO. 9 (which is the same as applicant’s SEQ ID NO. 9) (see US’075 at claims 1-3) and methods of using the peptide to increase cGMP production in any cells in combination with a phosphodiesterase inhibitor selected from suldinac sulfone, zaprinast, motapizone, vardenafil and suldenifil (compare instant claims 1, 4, and 6-7 with US’075 at claims 4-6).
The difference between the issued claims and the instantly pending claims is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject or otherwise clarify that the cells may be cancer cells within a subject. Therefore, the issue is whether or not this difference is sufficient to patentably distinguish the instant claims from the issued claims.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and it is permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1); see also Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010)). The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). The courts have held that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The courts clarified that when a later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent”, that the asserted claims of the later patent are not “patentably distinct” from the claims of the earlier patent, and thus the later patent is invalid for obviousness-type double patenting (see, e.g., Pfizer, 518 F.3d at 1363-68 & n. 8; see also, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). Accordingly, an Examiner may look at the specification of the patent to determine the use of a claimed compound to identify obvious variants.
Here, the instant claims merely claim a particular use described in the earlier patent of the claimed compositions of the earlier patent. Specifically, the issued patent discloses the use of the same compound for the treatment of cancer (see, e.g., US’ 802 at col. 4, lines 4-60).
Accordingly, the pending claims are not patentably distinct from the issued claims (see, e.g., Pfizer, 518 F.3d at 1363-68 & n. 8; see also, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010)).
[NSDP 04]
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,901,075 in view of US 7,041,786.
The application of the primary reference to instant claims 1, 4, and 6-7 has been discussed above, and those discussions are incorporated in the instant rejection.
The difference between the issued claims and instant claims 2-3 and 5 is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject utilizing a daily dose, with a specific order of administration, or wherein the dosage is 1-10 mg.
With respect to the order of administration, since the patent claims discloses the combination, the selection of any order of mixing the components is obvious absent any unexpected results (MPEP 2144.04(IV)(C).
With respect to dosage and dosing frequency, US’786 teaches and discloses highly similar compounds, namely SEQ ID NO: 20, which is identical to instant SEQ ID NO: 9 except that SEQ ID NO: 9 comprises two D-amino acids (i.e., D-Asn and D-Leu) (compare US’786 at SEQ ID NO: 20 with instant SEQ ID NO: 9, showing 100% sequence identity, and noting the sequences are stereoisomers; see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (noting that stereoisomers are prima facie obvious). Critically, US’786 identifies that the highly similar compounds may be utilized in the treatment of cancers, wherein the dosing frequency may be daily, the dosage may be between 10 µg and 2 mg (see, e.g., US’786 at col. 14 at line 20 to col. 15 at line 20, claims 1-5). Accordingly, because US’786 informs artisans that highly similar compounds (i.e., stereoisomers, peptides sharing the same bicyclic structure and 100% sequence identity), could be utilized for the same purpose (i.e., treatment of cancer), at the same daily dosing regimes for cancer treatment, wherein the dosage may be between 10 µg and 2 mg, it would have been obvious to artisans that highly similar compounds could be utilized for the same purpose using the same dosage and dosing frequency, with a reasonable expectation of success (see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)).
Accordingly, such limitations do not patentably distinguish the instant claims over the issued claims.
[NSDP 05]
Claims 1 and 4-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-10 and 12-14 of U.S. Patent No. 9,486,494.
Regarding instant claims 1, 4, and 6-7, although the claims at issue are not identical, they are not patentably distinct from each other because the issued patent claims are directed to peptides of SEQ ID NO. 9 (which is the same as applicant’s SEQ ID NO. 9) and methods of using the peptide to treat conditions, including cancer, in combination with a phosphodiesterase inhibitor selected from suldinac sulfone, zaprinast, motapizone, vardenafil and suldenifil (see, e.g., US’494 at claims 1-2, 4, 6-10, 12-14; note that claim 10 recites colon cancer). Regarding instant claim 5, with respect to the order of administration, since the patent claims discloses the combination, the selection of any order of mixing the components is obvious absent any unexpected results (MPEP 2144.04(IV)(C).
Accordingly, the pending claims are not patentably distinct from the issued claims.
[NSDP 06]
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-10 and 12-14 of U.S. Patent No.9,486,494 in view of US 7,041,786.
The application of the primary reference to instant claims 1 and 4-7 has been discussed above, and those discussions are incorporated in the instant rejection.
The difference between the issued claims and instant claims 2-3 is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject utilizing a daily dose, wherein the dosage is 1-10 mg.
With respect to dosage and dosing frequency, US’786 teaches and discloses highly similar compounds, namely SEQ ID NO: 20, which is identical to instant SEQ ID NO: 9 except that SEQ ID NO: 9 comprises two D-amino acids (i.e., D-Asn and D-Leu) (compare US’786 at SEQ ID NO: 20 with instant SEQ ID NO: 9, showing 100% sequence identity, and noting the sequences are stereoisomers; see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (noting that stereoisomers are prima facie obvious). Critically, US’786 identifies that the highly similar compounds may be utilized in the treatment of cancers, wherein the dosing frequency may be daily, the dosage may be between 10 µg and 2 mg (see, e.g., US’786 at col. 14 at line 20 to col. 15 at line 20, claims 1-5). Accordingly, because US’786 informs artisans that highly similar compounds (i.e., stereoisomers, peptides sharing the same bicyclic structure and 100% sequence identity), could be utilized for the same purpose (i.e., treatment of cancer), at the same daily dosing regimes for cancer treatment, wherein the dosage may be between 10 µg and 2 mg, it would have been obvious to artisans that highly similar compounds could be utilized for the same purpose using the same dosage and dosing frequency, with a reasonable expectation of success (see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)).
Alternatively, per MPEP § 804(II)(B)(1), it is permissible to use the specification it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Critically, the phrase “therapeutically effective amount” (see, e.g., US’494 at claims 9-10) is not defined in the claims; however, the meaning of the phrase is delineated in view of the guidance provided by the specification, which allows an artisan to learn the meaning of the claim terms. Specifically, US’494 identifies that the dose may be between about 1 µg and 10 mg per kilogram (see, e.g., US’494 at col. 101 at line 58 to col. 102 at line 62; see id. esp. at col. 102 at lines 5-15) and that dosing frequency may be provided on a daily basis (see, e.g., US’494 at col. 101 at line 58 to col. 102 at line 62; see id. esp. at col. 102 at lines 54 to 60). Accordingly, such limitations as presently claimed would be necessarily understood to be within the meaning of the phrase “therapeutically effective amount” as utilized in the issued claims of US’494.
Accordingly, such limitations do not patentably distinguish the instant claims over the issued claims.
[NSDP 07]
Claims 1-2 and 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16 and 19 of U.S. Patent No. 10,232,011.
Although the claims at issue are not identical, they are not patentably distinct from each other as follows: Regarding instant claims 1-2 and 4, the issued patent claims are directed to peptides of SEQ ID NO. 9 (which is the same as applicant’s SEQ ID NO. 9) and methods of using the peptide to treat conditions, including cancers, in combination with a cGMP-specific phosphodiesterase inhibitor, wherein SEQ ID NO: 9 is administered at 0.1 mg to 10 mg (see, e.g., US’011 at claims 1-14, 16, and 19; see esp. id. at claims 1, 9, 10-11, 12-14, and 16, wherein claim 14 recites gastric and colon cancers). Claims 1-8 of the primary reference make the peptide utilized obvious. Regarding instant claim 5, with respect to the order of administration, since the patent claims discloses the combination, the selection of any order of mixing the components is obvious absent any unexpected results (MPEP 2144.04(IV)(C).
Accordingly, the pending claims are not patentably distinct from the issued claims.
[NSDP 08]
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16 and 19 of U.S. Patent No. 10,232,011 in view of US 7,041,786.
The application of the primary reference to instant claims 1-2 and 4-5 has been discussed above, and those discussions are incorporated in the instant rejection.
The difference between the issued claims and instant claims 3 and 6-7 is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject utilizing a daily dose, with a specific order of administration, wherein the cGMP-specific phosphodiesterase inhibitor may be selected from suldinac sulfone, zaprinast, and motapizone.
With respect to dosage and dosing frequency, US’786 teaches and discloses highly similar compounds, namely SEQ ID NO: 20, which is identical to instant SEQ ID NO: 9 except that SEQ ID NO: 9 comprises two D-amino acids (i.e., D-Asn and D-Leu) (compare US’786 at SEQ ID NO: 20 with instant SEQ ID NO: 9, showing 100% sequence identity, and noting the sequences are stereoisomers; see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (noting that stereoisomers are prima facie obvious). Critically, US’786 identifies that the highly similar compounds may be utilized in the treatment of cancers, wherein the dosing frequency may be daily, the dosage may be between 10 µg and 2 mg, and wherein the highly similar compounds may be administered in combination with a cGMP-specific phosphodiesterase inhibitor selected from suldinac sulfone, zaprinast, and motapizone (see, e.g., US’786 at col. 4 at lines 30-40, col. 13 at lines 30-40, col. 14 at line 20 to col. 15 at line 20, col. 16 at lines 55-65, claims 1-5). Accordingly, because US’786 informs artisans that highly similar compounds (i.e., stereoisomers, peptides sharing the same bicyclic structure and 100% sequence identity), could be utilized for the same purpose (i.e., treatment of cancer), at the same daily dosing regimes for cancer treatment, wherein the dosage may be between 10 µg and 2 mg, it would have been obvious to artisans that highly similar compounds could be utilized for the same purpose using the same dosage and dosing frequency, with a reasonable expectation of success (see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)).
Alternatively, with respect to instant claims 6-7, per MPEP § 804(II)(B)(1), it is permissible to use the specification it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim and to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1)). Critically, the specific members of the genus implied by “cGMP-specific phosphodiesterase” (see, e.g., US’011 at claim 16) is not explicitly stated in the claims; however, the meaning and members of this of the genus is delineated in view of the guidance provided by the specification, which allows an artisan to learn the meaning of the claim terms. Specifically, the primary reference identifies that a “cGMP-specific phosphodiesterase” includes at least suldinac sulfone, zaprinast, motapizone, vardenafil, and suldenifil (see, e.g., US’011 at col. 6 at lines 44-50, col. 11 at lines 45-55, col. 54 at lines 30-40). Accordingly, such limitations as presently claimed would be necessarily understood to be within the meaning of the phrase “cGMP-specific phosphodiesterase” as utilized in the issued claims, or otherwise readily understood to be obvious variants of the recited genus (see, e.g., MPEP § 804(II)(B)(1)).
Accordingly, such limitations do not patentably distinguish the instant claims over the issued claims.
[NSDP 09]
Claims 1 and 4-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9 and 12-14 of U.S. Patent No. 10,238,712.
Although the claims at issue are not identical, they are not patentably distinct from each other as follows: Regarding instant claims 1, 4, and 6-7, the issued patent claims are directed to compositions comprising peptides of SEQ ID NO. 9 (which is the same as applicant’s SEQ ID NO. 9) and methods of using the peptide containing compositions to treat conditions, including cancers (i.e., colon, lung, bladder, liver, salivary gland, and skin cancers), in combination with a cGMP-dependent phosphodiesterase inhibitor selected from suldinac sulfone, zaprinast, motapizone, vardenafil and suldenifil (see, e.g., US’712 at SEQ ID NO: 9, claims 1-5, 7-9, 12-14; note that claim 5 recites types of cancer, and claim 9 recites types of cGMP-dependent phosphodiesterase inhibitors). Regarding instant claim 5, with respect to the order of administration, since the patent claims discloses the combination, the selection of any order of mixing the components is obvious absent any unexpected results (MPEP 2144.04(IV)(C).
Accordingly, the pending claims are not patentably distinct from the issued claims.
[NSDP 10]
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9 and 12-14 of U.S. Patent No.10,238,712 in view of US 7,041,786.
The application of the primary reference to instant claims 1 and 4-7 has been discussed above, and those discussions are incorporated in the instant rejection.
The difference between the issued claims and instant claims 2-3 is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject utilizing a daily dose, with a specific order of administration, wherein the cGMP-specific phosphodiesterase inhibitor may be selected from suldinac sulfone, zaprinast, and motapizone.
With respect to dosage and dosing frequency, US’786 teaches and discloses highly similar compounds, namely SEQ ID NO: 20, which is identical to instant SEQ ID NO: 9 except that SEQ ID NO: 9 comprises two D-amino acids (i.e., D-Asn and D-Leu) (compare US’786 at SEQ ID NO: 20 with instant SEQ ID NO: 9, showing 100% sequence identity, and noting the sequences are stereoisomers; see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (noting that stereoisomers are prima facie obvious). Critically, US’786 identifies that the highly similar compounds may be utilized in the treatment of cancers, wherein the dosing frequency may be daily, the dosage may be between 10 µg and 2 mg (see, e.g., US’786 at col. 14 at line 20 to col. 15 at line 20, claims 1-5). Accordingly, because US’786 informs artisans that highly similar compounds (i.e., stereoisomers, peptides sharing the same bicyclic structure and 100% sequence identity), could be utilized for the same purpose (i.e., treatment of cancer), at the same daily dosing regimes for cancer treatment, wherein the dosage may be between 10 µg and 2 mg, it would have been obvious to artisans that highly similar compounds could be utilized for the same purpose using the same dosage and dosing frequency, with a reasonable expectation of success (see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)).
Alternatively, per MPEP § 804(II)(B)(1), it is permissible to use the specification it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim and to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1)). Critically, the phrase “therapeutically effective amount” (see, e.g., US’712 at claims 4-5) is not defined in the claims; however, the meaning of the phrase is delineated in view of the guidance provided by the specification, which allows an artisan to learn the meaning of the claim terms. Specifically, the primary reference identifies that the dose may be between about 1 µg and 10 mg per kilogram (see, e.g., US’712 at col. 101 at line 63 to col. 102 at line 65; see id. esp. at col. 102 at lines 10-15) and that dosing frequency may be provided on a daily basis (see, e.g., US’712 at col. 101 at line 63 to col. 102 at line 65; see id. esp. at col. 102 at lines 60-66). Accordingly, such limitations as presently claimed would be necessarily understood to be within the meaning of the phrase “therapeutically effective amount” as utilized in the issued claims of US’712.
Accordingly, such limitations do not patentably distinguish the instant claims over the issued claims.
[NSDP 11]
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,745,441.
Although the claims at issue are not identical, they are not patentably distinct from each other as follows: Regarding instant claim 1, the issued patent claims are directed to compositions comprising peptides of SEQ ID NO. 9 (which is the same as applicant’s SEQ ID NO. 9) (see, e.g., US’441 at SEQ ID NO: 9, claims 1-12).
The difference between the issued claims and the instantly pending claims is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject or otherwise clarify that the cells may be cancer cells within a subject. Therefore, the issue is whether or not this difference is sufficient to patentably distinguish the instant claims from the issued claims.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and it is permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1); see also Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010)). The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). The courts have held that a “claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The courts clarified that when a later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent”, that the asserted claims of the later patent are not “patentably distinct” from the claims of the earlier patent, and thus the later patent is invalid for obviousness-type double patenting (see, e.g., Pfizer, 518 F.3d at 1363-68 & n. 8; see also, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). Accordingly, an Examiner may look at the specification of the patent to determine the use of a claimed compound to identify obvious variants.
Here, the instant claims merely claim a particular use described in the earlier patent of the claimed compositions of the earlier patent. Specifically, the issued patent discloses the use of the same compound for the treatment of cancer (see, e.g., US’ 441 at col. 2 at lines 23-30, col. 53 at lines 10-50, col. 56 at lines 4-10, col 57 at lines 35-45).
Accordingly, the pending claims are not patentably distinct from the issued claims (see, e.g., Pfizer, 518 F.3d at 1363-68 & n. 8; see also, Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010)).
[NSDP 12]
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,745,441 in view of US 7,041,786.
The application of the primary reference to instant claim 1 has been discussed above, and those discussions are incorporated in the instant rejection.
The difference between the issued claims and instant claims 2-7 is as follows: The issued claims do not explicitly recite a method of treating cancer in a subject utilizing a daily dose, with a specific order of administration, wherein the dosage is 1-10 mg, and wherein the cGMP-specific phosphodiesterase inhibitor may be selected from suldinac sulfone, zaprinast, and motapizone.
Regarding claims 2-7, with respect to dosage, dosing frequency, and combination with cGMP-specific phosphodiesterases, US’786 teaches and discloses highly similar compounds, namely SEQ ID NO: 20, which is identical to instant SEQ ID NO: 9 except that SEQ ID NO: 9 comprises two D-amino acids (i.e., D-Asn and D-Leu) (compare US’786 at SEQ ID NO: 20 with instant SEQ ID NO: 9, showing 100% sequence identity, and noting the sequences are stereoisomers; see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (noting that stereoisomers are prima facie obvious). Critically, US’786 identifies that the highly similar compounds may be utilized in the treatment of cancers, wherein the dosing frequency may be daily, the dosage may be between 10 µg and 2 mg (see, e.g., US’786 at col. 14 at line 20 to col. 15 at line 20, claims 1-5), and wherein such treatments may be made in combination with a cGMP-specific phosphodiesterase inhibitor selected from suldinac sulfone, zaprinast, and motapizone (see, e.g., US’786 at col. 4 at lines 30-40, col. 13 at lines 30-40, col. 14 at line 20 to col. 15 at line 20, col. 16 at lines 55-65, claims 1-5). Accordingly, because US’786 informs artisans that highly similar compounds (i.e., stereoisomers, peptides sharing the same bicyclic structure and 100% sequence identity), could be utilized for the same purpose (i.e., treatment of cancer), at the same daily dosing regimes for cancer treatment, wherein the dosage may be between 10 µg and 2 mg, it would have been obvious to artisans that highly similar compounds could be utilized for the same purpose using the same dosage and dosing frequency, with a reasonable expectation of success (see MPEP § 2144.09(I)-(II); see In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)).
In addition, or alternatively, regarding instant claim 5, with respect to the order of administration, since the patent claims discloses the combination, the selection of any order of mixing the components is obvious absent any unexpected results (MPEP 2144.04(IV)(C).
Accordingly, such limitations do not patentably distinguish the instant claims over the issued claims.
Closest Prior Art
The Examiner concurs with the Examiner of record4 in that the closest prior art is US 7,041,786, which discloses a highly similar compound5. This reference does not anticipate the instant claims because instant SEQ ID NO. 9 includes two D-amino acids, one at position 1 and one at position 16 relative to prior art compound CAS Registry Number: 467426-54-6. The ‘786 patent does not teach or suggest modifying the first and last amino acids with D-amino acids.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 D-Asn-Asp-Glu-Cys-Glu-Leu-Cys-Val-Asn-Val-Ala-Cys-Thr-Gly-Cys-D-Leu
2 This compound was disclosed or otherwise known in the art as follows Dolcanatide; SP333; or SP 333.
3 See, e.g., Parent Application 16/882,059 in Action mailed 9/20/2022 at pages 2-12.
4 See, e.g., Parent Application 16/882,059 in Action mailed 9/20/2022 at page 13.
5 CAS Registry Number: 467426-54-6, L-Leucine, L-asparaginyl-L-α-aspartyl-L-α-glutamyl-L-cysteinyl-L-α-glutamyl-L-leucyl-L-cysteinyl-L-valyl-L-asparaginyl-L-valyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (4→12),(7→15)-bis(disulfide) (9CI, ACI)