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 .
Claim Status
Rejected Claims: 38-46, 48-53, and 58-61
Cancelled Claims: 1-37, 47, and 54-57
Response to Amendment
The amendment filed on 29 DECEMBER 2025 has been entered.
In view of the amendment to the claims, the amendment of claims 38-43, 48, 50, 52, and 61 and the cancellation of claim 47 have been acknowledged.
In view of the amendment to the specification, the objections to the specification have been withdrawn.
In view of the amendment to claims 38-43, 48, 50, and 52, the objections to the claims have been withdrawn.
In view of the amendment to claims 38 and 61, the rejections under 35 U.S.C. 112(b) have been withdrawn.
In view of the amendment to claim 38, the rejections under 35 U.S.C. 103 have been modified.
Response to Arguments
Applicant’s arguments filed on 29 DECEMBER 2025 have been fully considered.
Applicant argues, regarding Stone et al (Stone MC, Borman J, Ferreira G, Robbins PD. Effects of pH, conductivity, host cell protein, and DNA size distribution on DNA clearance in anion exchange chromatography media. Biotechnol Prog. 2018 Jan;34(1):141-149. doi: 10.1002/btpr.2556. Epub 2017 Sep 30. PMID: 28884511; PMCID: PMC5836906) hereinafter Stone, that the prior art teaches the use of a conductivity range for the exclusion of DNA rather than for the elution of granulocyte colony stimulating factor (GCSF) and thus would not be considered in a purification process for GCSF (Arguments filed 29 DECEMBER 2025, Page 8 to Page 9, Paragraph 2, and Page 9, Paragraph 5 to Page 10 Paragraph 2).
Applicant argues, regarding Gillespie et al (US Patent Application No. 20120149878 A1) hereinafter Gillespie, that there is no motivation to combine Gillespie with Richter Gedeon Nyrt (US Patent Application No. 20150057439 A1) hereinafter Richter for the temperature range cited in Gillespie because Gillespie pertains to antibody isolation (Arguments filed 29 DECEMBER 2025, Page 9, Paragraphs 3-4).
Applicant argues that there are unexpected results from the disclosed conditions of the method because the temperature and conductivity were found to have an impact on the purity of the resulting GCSF, the SEC % main, the CEX % main, and reduced E. coli host cell protein which would not be expected from prior art involving antibody isolation, such as Gillespie, and reduction of DNA binding, such as Stone (Arguments filed 29 DECEMBER 2025, Page 10, Paragraph 4 to Page 12).
Applicant argues, regarding the dependent claims, that claim 38 is allowable and so the dependent claims are also allowable (Arguments filed 29 DECEMBER 2025, Page 12, Paragraph 5).
The Examiner respectfully disagrees.
Applicant’s arguments with respect to claim 38 regarding the conductivity and the prior art Stone have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Trotta et al (US Patent No. 5391706 A) hereinafter Trotta teaches the use of 5-10 mS as a conductivity range for anion exchange purification of granulocyte-macrophage colony stimulating factor (GM-CSF) and an increase in conductivity for the elution of the GM-CSF. It would be obvious to try a lower conductivity of the range to bind the GCSF and then try higher conductivities than the lowest value for elution, which would include the range of instant claim 38. GM-CSF has a similar structure to GCSF and is in the same class of biomolecules, glycoprotein cytokines.
Applicant’s arguments with respect to claim 38 regarding the temperature as taught by Gillespie have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Trotta teaches the temperature range of 2°C -15°C for anion exchange purification of granulocyte-macrophage colony stimulating factor (GM-CSF). GM-CSF has a similar structure to GCSF and is in the same class of biomolecules, glycoprotein cytokines.
Regarding Applicant’s arguments for unexpected results, the optimization of purity of the resulting GCSF is the main goal of anion exchange chromatography for the molecule. Temperature and conductivity are known optimizable variables towards this goal and are, as taught by Trotta, used in overlapping ranges for a similar molecule GM-CSF. It would be obvious to one of ordinary skill in the art to utilize the range taught by Trotta for temperature because the temperature helps prevent denaturation of the protein sample and the range taught by Trotta for conductivity because the conductivity is well known to impact binding of molecules to the anion exchange resin, with lower conductivity facilitating binding and higher conductivity facilitating elution.
Regarding Applicant’s arguments for the dependent claims, claim 38 is not allowable and so the dependent claims are also not allowable.
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 (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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 38-41, 43-45, 48-53 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Richter Gedeon Nyrt (US Patent Application No. 20150057439 A1) hereinafter Richter in view of Trotta et al (US Patent No. 5391706 A) hereinafter Trotta in view of Gillespie et al (US Patent Application No. 20120149878 A1) hereinafter Gillespie.
Regarding Claim 38, Richter teaches a method for removing a solubilizing agent from granulocyte colony stimulating factor (i.e., a method for purifying granulocyte colony-stimulating factor (GCSF)) involving an anion exchange resin (i.e., wherein the method comprises an anion exchange chromatography (AEX) process comprising; a chromatography vessel comprising an anion exchange chromatography material) and binding the granulocyte colony stimulating factor to the resin (i.e., loading a GCSF-containing sample onto; capable of binding the GCSF in the GCSF-containing sample) as the solubilizing agent remains in the flow through (Paragraph 0059) followed by elution of the bound granulocyte colony stimulating factor (i.e., eluting the GCSF from the AEX material with an elution buffer to obtain the purified GCSF; Paragraph 0060).
Richter does not teach at least a portion of the chromatography vessel is set a temperature of about 7°C to about 13°C and wherein the elution of the GCSF from the AEX material is carried out at a conductivity ranging between about 7.4 to about 8.2 mS/cm.
However, Trotta teaches that operations are performed at 2°C -15°C (i.e., at least a portion of the chromatography vessel is set a temperature of about 7°C to about 13°C; Col. 4, Lines 51-52) and that the conductivity of the granulocyte-macrophage colony stimulating factor (GM-CSF) extract is adjusted to 5-10 mS before suitable anion exchange and is eluted by increasing the conductivity (i.e., wherein the elution of the GCSF from the AEX material is carried out at a conductivity ranging between about 7.4 to about 8.2 mS/cm; Col. 5, Lines 15-32) with the procedure generating a good yield of GM-CSF and retaining its biological activity (Col. 2, Lines 45-50).
Trotta is analogous to the claimed invention because it pertains to GM-CSF purification (Col. 1, Lines 15-35), which is a glycoprotein cytokine that is very similar in structure to G-CSF. It would have been obvious to one of ordinary skill in the art to modify the method as taught by Richter with the temperature and conductivity as taught by Trotta because the temperature and conductivity would contribute to generating a good yield of the G-CSF while retaining its biological activity.
Richter in view of Trotta does not teach wherein the chromatography vessel is encased in a temperature-controlled enclosure.
However, Gillespie teaches that protein ion exchange chromatography (Abstract) can occur with buffers at temperature ranges of 1°C to 10°C and 8°C to 15°C (Paragraph 0014) performed in a walk-in temperature controlled room (i.e., wherein the chromatography vessel is encased in a temperature-controlled enclosure; Paragraph 0113) to reduce protein denaturation (Abstract).
Gillespie is analogous to the claimed invention because it pertains to protein purification using ion exchange chromatography (Abstract). It would have been obvious to one of ordinary skill in the art to modify method made obvious by Richter in view of Trotta to have a temperature-controlled room as taught by Gillespie because the temperature-controlled room would reduce protein denaturation.
Richter in view of Trotta in view of Gillespie does not teach the explicit temperature range of at least a portion of the enclosure of the chromatography vessel is set a temperature of about 7°C to about 13°C. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the temperature range of the chromatography vessel that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Trotta in view of Gillespie.
Richter in view of Trotta in view of Gillespie does not teach explicitly wherein the elution of the GCSF from the AEX material is carried out at a conductivity ranging between about 7.4 to about 8.2 mS/cm. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected conductivity of the elution step that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Trotta in view of Gillespie.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 39, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches a method of solubilizing and refolding the granulocyte colony stimulating factor followed by purification using ion exchange chromatography (i.e., wherein the GCSF-containing sample is loaded onto the chromatography vessel using a fluidic channel; Paragraph 0035).
Gillespie further teaches that protein ion exchange chromatography (Abstract) can occur with buffers at temperature ranges of 1°C to 10°C and 8°C to 15°C (i.e., wherein at least a portion of the temperature-controlled enclosure of the fluidic channel is set at a temperature about 7°C to about 13°C; Paragraph 0014) performed in a walk-in temperature controlled room (i.e., placed in a temperature-controlled enclosure; Paragraph 0113).
Richter in view of Trotta in view of Gillespie does not explicitly teach a fluidic channel. However, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by or made obvious by the prior art device. In this case, Richter teaches the loading of samples onto columns in an example (Paragraph 0273), Trotta teaches applying and loading a sample to the column (Col. 5, Lines 15-32), and Gillespie teaches loading protein samples into ion exchange columns (Paragraph 0008), which all require some form of fluidic channel as the protein sample is contained within a loading buffer solution. As the fluid starts outside of the chromatography column and then is transferred into the chromatography column, there must be a fluidic channel between the sample and the chromatography column, which could take the form of a pipette tip, tubing, and/or sample loops, among other solutions. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process (In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986); MPEP §2112.02). In this case, there are prior steps of solubilizing the granulocyte colony stimulating factor taught by Richter to the temperature taught by Trotta with a whole room temperature control taught by Gillespie. There must be a fluidic channel by which the sample containing the granulocyte colony stimulating factor is transferred from a sample location to the ion exchange column and, since the entire room is temperature controlled, both the fluidic channel and the ion exchange column are controlled to the same temperature.
Regarding Claim 40, Richter in view of Trotta in view of Gillespie make obvious the method of claim 39. Gillespie further teaches that protein ion exchange chromatography (Abstract) can occur with buffers at temperature ranges of 1°C to 10°C and 8°C to 15°C (Paragraph 0014) performed in a walk-in temperature controlled room (i.e., where the temperatures of the temperature-controlled enclosure of the vessel and the temperature-controlled enclosure of the fluidic channel are the same; Paragraph 0113).
Regarding Claim 41, Richter in view of Trotta in view of Gillespie make obvious the method of claim 40. Trotta further teaches that operations are performed at 2°C -15°C (Col. 4, Lines 51-52).
Gillespie further teaches that protein ion exchange chromatography (Abstract) can occur with buffers at temperature ranges of 1°C to 10°C and 8°C to 15°C (Paragraph 0014) performed in a walk-in temperature controlled room (Paragraph 0113).
Richter in view of Trotta in view of Gillespie does not teach the explicit temperature where at least one of the temperature-controlled enclosure of the chromatography vessel and the temperature-controlled enclosure of the fluidic channel is set at a temperature of about 10°C. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the temperature of the chromatography vessel and/or the fluidic channel that corresponds to the claimed temperature while experimenting with the range made obvious by Richter in view of Trotta in view of Gillespie.
Regarding Claim 43, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Gillespie further teaches the use of a wash buffer to be passed over the ion exchange material after loading a solution and prior to elution for the purpose of removing contaminants from the ion exchange without significant elution of the desired protein (i.e., wherein the method further comprises, prior to eluting the GCSF, washing the AEX material with a wash buffer to remove unbound or weakly bound contaminants; Paragraph 0074).
Regarding Claim 44, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches that “decreased/increased pH” or “increased salt concentration” refers to a buffer used for elution, equilibration, sample loading, or washing (Paragraph 0242) with examples 9 to 10 describing the adjustment of conductivity and pH (i.e., wherein the GCSF-containing sample comprises a loading buffer) for refolding prior to loading into a DEAE column (Paragraphs 0274-0275).
Regarding Claim 45, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches refolding of the protein is preferably performed at low conductivity below 2 mS/cm (Paragraph 0205) and that the second refolding step has a buffer at low conductivity which is ideal for AEX polishing in the binding mode (i.e., wherein the loading of the GCSF sample onto the chromatography vessel is carried out at a conductivity ranging between about 1.5 to about 3.0 mS/cm; Paragraph 0221).
Richter in view of Trotta in view of Gillespie does not teach the explicit conductivity range between about 1.5 to about 3.0 mS/cm. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the conductivity range of the loading of the GCSF sample that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Trotta in view of Gillespie.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 48, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches that suitable AEX resins include diethylaminoethyl (DEAE) (i.e., wherein the AEX material comprises diethylaminoethyl (DEAE); Paragraph 0163).
Regarding Claim 49, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Gillespie further teaches stripping the column with a strong base as a standard procedure for chromatography runs (i.e., further comprising one or more phases of stripping and/or sanitation of the AEX material; Paragraphs 0109-0110).
Regarding Claim 50, Richter in view of Trotta in view of Gillespie make obvious the method of claim 48. Gillespie further teaches that ion exchange is known to be performed over a linear gradient to predetermined conditions (Paragraph 0003) with an example with a linear flow rate for loading, elution, and strip phases (i.e., wherein the DEAE ion-exchange chromatography is operated at a linear flow rate for all phases; Paragraph 0109).
Regarding Claim 51, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches that “G-CSF” refers to human G-CSF (i.e., wherein the GCSF is a recombinant human GCSF (hGCSF) or a variant thereof; Paragraph 0089).
Regarding Claim 52, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches the combination of anion exchange with cation exchange (i.e., wherein the method further comprises at least one additional purification process; Paragraph 0045).
Regarding Claim 53, Richter in view of Trotta in view of Gillespie make obvious the method of claim 52. Richter further teaches the combination of anion exchange with cation exchange in this order (i.e., wherein the at least one additional purification process is performed prior to and/or after the AEX chromatography process; Paragraph 0045).
Regarding Claim 61, Richter in view of Trotta in view of Gillespie make obvious the method of claim 48. Richter further teaches that suitable AEX resins include diethylaminoethyl (DEAE) Sepharose FF (i.e., wherein the AEX material comprises DEAE resin; Paragraph 0163).
Claims 42, 46, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Richter in view of Trotta in view of Gillespie as applied to claim 38 and 44 above, and further in view of Chipman (US Patent Application No. 20160296632 A1) hereinafter Chipman.
Regarding Claim 42, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches that the AEX column is equilibrated with a low conductivity buffer preferably with Tris-HCl at pH 8 (i.e., wherein the method further comprising, prior to loading of the GCSF sample, equilibrating the AEX material with an equilibration buffer comprising Tris, and at pH of about 7.0 to about 8.0; Paragraph 0249).
Richter in view of Trotta in view of Gillespie does not explicitly teach equilibration buffer comprising from about 30 mM to about 50 mM Tris.
However, Chipman teaches an example modified human granulocyte-colony stimulating factor purification involving equilibrating the anion exchange column with 50 mM Tris (i.e., equilibration buffer comprising from about 30 mM to about 50 mM Tris; Paragraph 0319).
Chipman is analogous to the claimed invention because it pertains to therapeutically useful polypeptides and their purification (Abstract), with an explicit example for modified human granulocyte-colony stimulating factor (Paragraph 0319). It would have been obvious to one of ordinary skill in the art to modify the Tris buffer concentration made obvious by Richter in view of Trotta in view of Gillespie with the concentration as taught by Chipman because the concentration is a known variable for optimization of the anion exchange process.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 46, Richter in view of Trotta in view of Gillespie make obvious the method of claim 38. Richter further teaches that the G-CSF was eluted with a linear NaCl gradient from 0 mM to 200 mM in Tris-HCl at a pH of 8 (i.e., wherein the elution buffer comprises Tris, about 30 mM - 80 mM sodium chloride, and a pH of about 7.4 to about 8.0; Paragraph 0275).
Richter in view of Trotta in view of Gillespie does not explicitly teach the elution buffer comprises about 30 mM - 60 mM Tris.
However, Chipman teaches an example modified human granulocyte-colony stimulating factor purification involving eluting products with 50 mM Tris-HCl (i.e., the elution buffer comprises about 30 mM - 60 mM Tris; Paragraph 0319).
It would have been obvious to one of ordinary skill in the art to modify the Tris buffer concentration made obvious by Richter in view of Trotta in view of Gillespie with the concentration as taught by Chipman because the concentration is a known variable for optimization of the anion exchange process.
Richter in view of Trotta in view of Gillespie in view of Chipman does not teach the explicit sodium chloride range of about 30 mM - 80 mM. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the sodium chloride range of the loading of the GCSF sample that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Gillespie in view of Chipman.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 58, Richter in view of Trotta in view of Gillespie in view of Chipman make obvious the method of claim 42. Richter further teaches that the equilibrium buffer is preferably above pH 7 with a Tris-HCl concentration of 10 mM (i.e., wherein the equilibration buffer comprises at pH of about 7.6; Paragraph 0249).
Chipman further teaches the use of 50 mM Tris for equilibrating an anion exchange column (i.e., wherein the equilibration buffer comprises about 40 mM Tris; Paragraph 0319).
Richter in view of Gillespie in view of Chipman does not teach the explicit pH of 7.6 nor the explicit Tris concentration of 40 mM of the equilibrium buffer. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the pH and Tris concentration of the equilibrium buffer that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Trotta in view of Gillespie in view of Chipman.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 59, Richter in view of Trotta in view of Gillespie make obvious the method of claim 44. Richter further teaches that the G-CSF was loaded to the DEAE column after refolding and buffering in a solution containing 20 mM Tris at a pH of 8 (i.e., wherein the loading buffer comprises Tris and a pH of about 7.4 to about 8.0; Paragraphs 0274-0275).
Richter in view of Trotta in view of Gillespie does not explicitly teach the loading buffer comprises about 40 mM Tris.
However, Chipman teaches an example modified human granulocyte-colony stimulating factor purification involving each feedstock buffered with 50 mM Tris-HCl (i.e., the loading buffer comprises about 40 mM Tris; Paragraph 0319).
It would have been obvious to one of ordinary skill in the art to modify the Tris buffer concentration made obvious by Richter in view of Trotta in view of Gillespie with the concentration as taught by Chipman because the concentration is a known variable for optimization of the anion exchange process.
Richter in view of Trotta in view of Gillespie in view of Chipman does not teach the explicit the explicit Tris concentration of 40 mM of the loading buffer. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the Tris concentration of the loading buffer that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Gillespie in view of Chipman.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Regarding Claim 60, Richter in view of Trotta in view of Gillespie in view of Chipman make obvious the method of claim 46. Richter further teaches that the G-CSF was eluted with a linear NaCl gradient from 0 mM to 200 mM in 10 mM Tris-HCl at a pH of 8 (i.e., wherein the elution buffer comprises about 40 mM Tris, about 50 mM sodium chloride; Paragraph 0275).
Gillespie further teaches that elution buffers have a pH range between about 6.5 and about 8.5 (i.e., the elution buffer comprises pH of about 7.7; Paragraph 0038).
Chipman further teaches the use of 50 mM Tris for equilibrating an anion exchange column (i.e., wherein the equilibration buffer comprises about 40 mM Tris; Paragraph 0319).
Richter in view of Trotta in view of Gillespie in view of Chipman does not teach the explicit pH of 7.6 nor the Tris concentration of 40 mM nor the concentration of NaCl of the elution buffer. However, a prima facie case of obviousness exists for claimed ranges that overlap or lie inside ranges disclosed by prior art (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976))(See MPEP 2144.05(I)). It would have been obvious to one having ordinary skill in the art to have selected the pH, Tris concentration, and the NaCl concentration of the elution buffer that corresponds to the claimed range while experimenting with the range made obvious by Richter in view of Gillespie in view of Chipman.
Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation absent unexpected results or evidence indicating such optimum or workable ranges are critical (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP§2144.05).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.A.G./ Examiner, Art Unit 1777
/Ryan B Huang/ Primary Examiner, Art Unit 1777