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 .
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 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,828,410 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘410 is drawn to the same compounds claimed herein and stereoisomers thereof, but fails to claim any salts.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,000,523 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘523 is drawn to the same compounds claimed herein, but fails to claim any salts.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,005,811 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘811 is drawn to the same compounds claimed herein, but fails to claim any salts.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,239,911 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘911 is drawn to the use of the same compounds claimed herein or pharmaceutically acceptable salts thereof. What is not claimed is the actual salts claimed herein. However, when looking to the specification of ‘911 to see what is embraced by the term “pharmaceutically acceptable salts”, ‘911 states that examples of these salts can be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see column 117, lines 9-29).
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,815,266 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘266 is drawn to the same compounds claimed herein or stereoisomers thereof, or pharmaceutically acceptable salts thereof. What is not claimed is the actual salts claimed herein. However, when looking to the specification of ‘266 to see what is embraced by the term “pharmaceutically acceptable salts”, ‘266 states that examples of these salts can be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see column 117, lines 38-58).
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,870,673 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘673 is drawn to the same compounds claimed herein or pharmaceutically acceptable salts thereof. What is not claimed is the actual salts claimed herein. However, when looking to the specification of ‘673 to see what is embraced by the term “pharmaceutically acceptable salts”, ‘673 states that examples of these salts can be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see column 116, lines 9-29).
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,870,672 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘672 is drawn to compositions comprising the same compounds claimed herein or pharmaceutically acceptable salts thereof. What is not claimed is the actual salts claimed herein. However, when looking to the specification of ‘672 to see what is embraced by the term “pharmaceutically acceptable salts”, ‘672 states that examples of these salts can be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see column 115, lines 34-54).
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,875,885 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘885 is drawn to compositions comprising the same compounds claimed herein or stereoisomers thereof, or pharmaceutically acceptable salts thereof. What is not claimed is the actual salts claimed herein. However, when looking to the specification of ‘885 to see what is embraced by the term “pharmaceutically acceptable salts”, ‘885 states that examples of these salts can be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see column 116, lines 26-47).
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,084,473 in view of US 7,456,155 and 2014/0303108.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘473 is drawn to the similar compounds claimed herein or stereoisomers thereof, or pharmaceutically acceptable salts thereof. What is not claimed is the actual salts claimed herein. However, when looking to the specification of ‘073 to see what is embraced by the term “pharmaceutically acceptable salts”, ‘073 states that examples of these salts can be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
‘108 teaches that phosphoramidate and phosphorothioate derivatives of their compounds increase activity of the parent compounds and both have similar activity over the parent compound.
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application. Likewise, changing the phosphorothioates of ‘073 to the phosphoramidates claimed herein would be prima facia obvious as ‘108 teaches the similar activities of the two.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of U.S. Patent No. 10,519,186 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘186 is drawn to hemi sulfate salts of the compounds claimed herein or stereoisomers thereof. What is not claimed is the actual salts claimed herein.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application compared to the salts of ‘186.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,894,804 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘804 is drawn to hemi sulfate salts of the compounds claimed herein or stereoisomers thereof. What is not claimed is the actual salts claimed herein.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application compared to the salts of ‘804.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,906,928 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘928 is drawn to hemi sulfate salts of the compounds claimed herein or stereoisomers thereof. What is not claimed is the actual salts claimed herein.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application compared to the salts of ‘928.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,741,984 in view of US 7,456,155.
The claims of the present application are drawn to salts of the compounds of claim 12 wherein the salts are optionally tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate.
‘984 is drawn to hemi sulfate salts of the compounds claimed herein or stereoisomers thereof. What is not claimed is the actual salts claimed herein.
‘155 is drawn to various HCV inhibitors having the same antiviral activity claimed herein and provides they can optionally be any salts such as tosylate, methanesulfonate, acetate, citrate, malonate, tartrate, succinate, benzoate, ascorbate, α-ketoglutarate, α-glycerophosphate, sulfate and nitrate (see claims 16-17 for example).
As such, it would have been obvious to one of skill in the art at the time of the invention to provide the claimed salts of the compounds claimed herein with these references before them. It is prima facia obvious to make a salt of a known compound, and applicants have not shown anything unexpected or surprising about any salts made in the present application compared to the salts of ‘984.
Due to the large number of copending applications/patents containing similar subject matter to that as above, the following made for the same reasons as above.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11,738,038 in view of 7,456,155.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,813,278 in view of 7,456,155.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,226,429 in view of 7,456,155.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 12,551,499 in view of 7,456,155.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,946,033 in view of 7,456,155.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,975,016 in view of 7,456,155.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,690,860 in view of 7,456,155.
Claims 12-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/132,300 in view of 7,456,155.
This is a provisional nonstatutory double patenting rejection.
Claims 12-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 21-26 of copending Application No. 18/540,608 in view of 7,456,155.
This is a provisional nonstatutory double patenting rejection.
Claims 12-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/957,362 in view of 7,456,155.
This is a provisional nonstatutory double patenting rejection.
Claims 12-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,458,656 in view of 7,456,155.
Claims 12-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/350,774 in view of 7,456,155.
This is a provisional nonstatutory double patenting rejection.
It is noted that all of the above patents and copending applications claim the compound claimed herein or generic salts thereof, or provides methods of use of the same compound or salts thereof. As noted above, the art also teaches that the present salts are obvious choices for structurally similar compounds having the same activity. Applicants have not shown anything surprising or unexpected regarding any of the claimed salts herein. As such, these salts are all seen to be prima obvious over the compounds/compositions/methods of using the same parent compound or salts thereof in the recited patents/applications above.
Conclusion
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/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693
