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 .
Claims 1-16 are pending.
Priority
This application is a 371 of PCT/CN2018/082545 filed 4/10/2018 and claims priority to CN20180051385.2 to People’s Republic of China filed 1/19/2018.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 16 is rejected under 35 U.S.C. 102( a) (1) as being anticipated by CN101747338A to Yu Jiangyue et al .
The reference discloses total ginkgolide. Even though the reference is to a preparation, it does disclose the ginkgolide.. See English abstract.
“Abstract
The invention relates to a method for preparing ginkgolide compound, belonging to the medicine field. The invention is characterized in that ginkgolide compound raw materials are prepared through the following method that: ginkgo leaves or ginkgo leaf extracts are taken and are extracted in aqueous solution, the obtained extract liquid is filtered and is extracted by using organic solvent, the obtained extract liquid is concentrated and is mixed with 200-mesh to 1,000-mesh silica gel, the obtained mixture is dried, eluent rich in ginkgolide compound is collected by adopting silica column chromatography, the collected eluent is crystallized to respectively obtain ginkgolide A, ginkgolide B, ginkgolide C, ginkgolide J, ginkgolide M and ginkgolide K raw materials, “
Claim Rejections - 35 USC § 103
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 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.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over CN101747338A to Yu Jiangyue et al and CN102295651A to Wang Haitao et al .and Lou Fengchang et al 2004 . Cto
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N102295651A
Applicants claim is directed to a process of making Ginkgolide and claim 16 is directed to the Ginkogolide itself.
Scope and Content of Prior Art and the claims MPEP 2141.02
CN 101747338 Yu Jiangyue et al discloses a process of preparing ginkgolide, extract liquid is concentrated and is mixed with 200-mesh to 1,000-mesh silica gel The difference is that the prior art does not centrifuge and also does not recrystallize.
Lou et al discloses Cl2-MeOH can be used as an eluting solvent and total lactones are obtained by means of recrystallization.
CN102295651A to Wang Haitao et al teaches the extraction and separation substance are flavone as well as ginkgo diterpenoids. The preparation method comprises the steps of extraction, ethanol precipitation, water precipitation, macroporous resin separation and silica gel substrate bonding material separation.
Prima Facie Obviousness, Rational and Motivation MPEP 2142-2413
The CN 101747338 to Yu Jiangyue et al relates to a method for preparing ginkgolide compound, Ginkgo leaves or ginkgo leaf extracts are taken and are extracted in aqueous solution, the obtained extract liquid is filtered and is extracted by using organic solvent, the obtained extract liquid is concentrated and is mixed with 200-mesh to 1,000-mesh silica gel, the obtained ginkgolide compound is collected by adopting silica column chromatography, the collected eluent is crystallized to respectively obtain ginkgolide A, ginkgolide B, ginkgolide C, ginkgolide J, ginkgolide M and ginkgolide. The reference does not disclose recrystallize.
Lou teaches recrystallization and also the same chloromethane solvent and centrifuging.
CN102295651A to Wang Haitao et al also teaches purification using solvents and centrifuging “the medicinal extract that alcohol precipitation is intact adds entry 16.8L, fully stirs 30 minutes, and 4 ℃ of refrigeration were left standstill 72 hours, filters, and sample solution is centrifugal through 20000 rev/mins super centrifuge”.
All three references teach the purification of Ginkolide using solvents, silica gel column, and recrystallization. The ratio of the solvents and temperature at which recrystallization is done are within the scope of routine experimentation. Even CN’651 teaches refrigeration that is low temperature 1-5 degrees.
All the variations are routine experimentations and to a person of skill in the art extraction with a known solvent and at a specific temperature would be an prima facie obvious .
Therefore the claimed invention is obvious. Claim 16 is drawn to a product and the product is known. A product made by any process is still drawn to the same product.
Close additional art:- CN 102911185 to Qin Yong. English abstract. The reference teaches a process of making Ginkgolide . It uses dicloromethane . It includes recrystallization. It includes refrigeration, which means it is at a lower temp. It uses filtration, sonicating.
Conclusion
Claims 1-16 are rejected.
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/RITA J DESAI/Primary Examiner, Art Unit 1625
May 25, 2021.