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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/437,748
This Office Action is in response to the original claims of 02/09/2024.
Claims 1-2 are examined in this office action.
Priority
Effective filing date is 11/30/2009.
Information Disclosure Statement
No IDS have been submitted as of 04/28/2026.
Claim Interpretation
Examiner is interpreting claims 1-2 as product by process claims. See MPEP 2113(I).
Objection to Specification
The title is objected. The title contains the phrase “Novel” and should be deleted from the title. See MPEP 606.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
Schmitt et.al. (US 7,098,331).
1. Determining the scope and contents of the prior art.
Schmitt et.al. teaches the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7) . Schmitt further teaches citrate salt as pharmaceutical acceptable salt (column 10, line 15-20). Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I).
2. Ascertaining the differences between the prior art and the claims at issue.
Although Schmitt teaches the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7) . Schmitt does not teach mono citrate salt of R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7).
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing pharmaceutical composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop mono citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl) pyrimidine (reference claims 5-7) because citrate is pharmaceutical acceptable salt. More over the specification does not treat mono citrate to be different from other pharmaceutical acceptable salt. Therefore it would be prima facia obvious for person skilled in the art to develop (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate from prior art of Schmitt since Schmitt teaches the product (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine(reference claims 5-7) thus teaching claims 1-2.
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.
Claim 1-2 rejected on the ground of obvious-type-nonstatutory double patenting as being obvious over claim 1-7 of U.S. Patent No (US-7098331-B2). Instant claim of 02/09/2024 was used to write this rejections.
1. Determining the scope and contents of the prior art.
Reference claim 1-7 the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7) and its pharmaceutical acceptable salt (reference claim 5) . Reference patent further teaches citrate salt as pharmaceutical acceptable salt (column 10, line 15-20). Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I).
2. Ascertaining the differences between the prior art and the claims at issue.
Although reference claims teaches the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 1-7) and its pharmaceutical acceptable salt (reference claim 5) . Reference claims do not teach mono citrate salt of R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7).
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing pharmaceutical composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop mono citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl) pyrimidine (reference claims 1-7) because citrate is pharmaceutical acceptable salt. More over the specification does not treat mono citrate to be different from other pharmaceutical acceptable salt. Therefore it would be prima facia obvious for person skilled in the art to develop (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate from reference claims 1-7 since reference claims teaches the product (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine(reference claims 5-7) thus teaching claims 1-2.
Claim 1-2 rejected on the ground of obvious-type-nonstatutory double patenting as being obvious over claim 1 of U.S. Patent No (US-10421745-B2). Instant claim of 02/09/2024 was used to write this rejections.
1. Determining the scope and contents of the prior art.
Reference claim 1 the compound mono orate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine. Reference patent further teaches mono-citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine. (column 33-34, example 14-19). Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I).
2. Ascertaining the differences between the prior art and the claims at issue.
Although reference claims teaches mono orate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claim 1). Reference claims do not teach mono citrate salt of R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7).
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing pharmaceutical composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop mono citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl) pyrimidine (reference claim 1) Reference patent further teaches mono-citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine. (column 33-34, example 14-19). Therefore it would be prima facia obvious for person skilled in the art to develop (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate from reference claims 1 and specification, thus teaching claims 1-2.
Claim 1-2 rejected on the ground of anticipate-nonstatutory double patenting as being anticipated over claim 1-7 of U.S. Patent No (US-8604191-B2). Instant claim of 02/09/2024 was used to write this rejections
Reference claim 1-7 the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate same as instant claims 1-2. Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I). Therefore reference claim 1-7 anticipates instant claims 1-2.
Claim 1-2 rejected on the ground of anticipate-nonstatutory double patenting as being anticipated over claim 1-3 of U.S. Patent No (US-9145396-B2). Instant claim of 02/09/2024 was used to write this rejections
Reference claim 1-3 the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate same as instant claims 1-2. Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I). Therefore reference claim 1-3 anticipates instant claims 1-2.
Claim 1-2 rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1 and 12-14, of U.S. Patent No (US-9981949-B2). Instant claim of 02/09/2024 was used to write this rejections
Reference claims 1 and 12-14 method of making compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate(reference claim 14) same as instant claims 1-2. Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I). Therefore reference claims 1 and 12-14 anticipates instant claims 1-2.
Claim 1-2 rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 2-3,22-23 and 42-43 of U.S. Patent No (US-10709707-B2). Instant claim of 02/09/2024 was used to write this rejections
Reference claims 2-3,22-23 and 42-43 teaches compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate same as instant claims 1-2. Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I). Therefore reference claims 2-3,22-23 and 42-43 anticipates instant claims 1-2.
Claim 1-2 rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1-7 U.S. Patent No (US-10919879-B2). Instant claim of 02/09/2024 was used to write this rejections
Reference claims 1-7 teaches compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate same as instant claims 1-2. Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I). Therefore reference claims 1-7anticipates instant claims 1-2.
Claim 1-2 rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1-7 U.S. Patent No (US-11542253-B2). Instant claim of 02/09/2024 was used to write this rejections
Reference claims 1 teaches compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate same as instant claims 1-2. Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I). Therefore, reference claims 1 anticipates instant claims 1-2.
Claims 1-2, provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18559518.
1. Determining the scope and contents of the prior art.
Reference claim 3 the compound (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine and pharmaceutically acceptable salt . Reference application further teaches mono-citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (paragraph [15]). Instant claims 1-2 are interpreted as a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)" MPEP 2113(I).
2. Ascertaining the differences between the prior art and the claims at issue.
Although reference claims teaches pharmaceutical salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claim 1). Reference claims do not teach mono citrate salt of R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (reference claims 5-7).
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing pharmaceutical composition.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop mono citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl) pyrimidine (reference claim 1) Reference application further teaches mono-citrate salt of (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine (paragraph [15]). . Therefore it would be prima facia obvious for person skilled in the art to develop (R)-5-(E)-2-pyrrolidin-3-ylvinyl)pyrimidine mono citrate from reference claims 3 and specification of copending application, thus teaching claims 1-2.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowable as written.
US-7714001-B2 not a double patenting because the compound is not the same.
US-8063068 not a double patenting because the compound is not the same.
US-8067443 not a double patenting because the compound is not the same.
US-8633222 not a double patenting because the compound is not the same.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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