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
Claims 2-3, 5-8, 10, and 16-20 are pending.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-3, 5-8, 10-11, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2005/0258097 by Gjerde et. al (Gjerde).
In regard to claim 2, 5-6, and 16-17, Gjerde teaches a method of purifying peptides and/or polypeptides bound to mixed-phase SPE material (abstract; [0002]-[0003]; [0057]; [0097]; [0100]). Gjerde teaches said mixed-phase SPE material comprising reversed phase material and ion exchange material ([0100], reverse-phase, ion-exchange).
Gjerde teaches method comprising washing with an acidic aqueous solution and acidic composition comprising organic solvent ([0157], [0174], wash solution, can include solvents having a specific pH or containing components that promote removal of materials that interact lightly with the extraction phase; [0234], washes, organic solvent, methanol; [0161], methanol and acetonitrile) wherein said organic solvent is a nitrile ([0161]).
Gjerde does not explicity teach the wash solution is acidic or that there is at least 50% (v/v) organic solvent. Gjerde teaches the solvents are chosen to be compatible with the analyte and the ultimate detection method ([0161]). Gjerde teaches strong acids, strong bases, mixtures of acids/bases ([0161]). Gjerde teaches acidic or basic methanol ([0161]). Gjerde teaches tuning the pH ([0174]). Gjerde teaches pH influences protein stability ([0237).
As the protein stability, compatibility, and detection parameters are variables that can be modified, among others, by adjusting said pH of the wash solution, the precise wash solution pH would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. Further, adjusting the volume percentage of organic solvent is directly related to the pH. As such, without showing unexpected results, the claimed wash solution pH cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the wash solution pH in the method of Gjerde to obtain the desired balance between the protein stability, compatibility, and detection parameters (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). Reading on claims 5-6 and 16.
Gjerde teaches eluting the peptides and/or polypeptides from said mixed-phase SPE material with a composition comprising an organic solvent wherein said organic solvent is nitrile ([0234]).
Gjerde does not explicitly teach the eluting solution is alkaline or that there is at least 50% (v/v) organic solvent. Gjerde teaches the solvents are chosen to be compatible with the analyte and the ultimate detection method ([0161]). Gjerde teaches strong acids, strong bases, mixtures of acids/bases ([0161]). Gjerde teaches acidic or basic methanol ([0161]). Gjerde teaches tuning the pH ([0174]). Gjerde teaches pH influences protein stability ([0237).
As the protein stability, compatibility, and detection parameters are variables that can be modified, among others, by adjusting said pH of the eluting solution, the precise elution solution pH would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. Further, adjusting the volume percentage of organic solvent is directly related to the pH. As such, without showing unexpected results, the claimed elution solution pH cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the elution solution pH in the method of Gjerde to obtain the desired balance between the protein stability, compatibility, and detection parameters (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). Reading on claims 7 and 17.
In regard to claim 3, Gjerde teaches said mixed-phase SPE material is sulfonated DVB or SDB ([0097], polystyrene/divinylbenzene; [0085]).
In regard to claims 8 and 18-19, Gjerde teaches the organic solvent for washing and the organic solvent for eluting are independently selected from the group consisting of primary or secondary unbranched, branched or cyclic C1 to C6 nitriles such as acetonitrile ([0161]; [0174]; [0234]).
In regard to claim 10, Gjerde teaches said purifying results in the reduction of the amount or the removal of one or more of contaminants ([0003]), specifically salt ([0252]).
In regard to claim 11, Gjerde teaches washing and/or eluting are carried out in columns (abstract; [0002]-[0003]; [0057]; [0097]; [0100]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2005/0258097 by Gjerde et. al (Gjerde), as noted above, in view of U.S. Patent Publication No. 2009/0126466 by Gilar et al. (Gilar).
In regard to claim 20, modified Gjerde teaches the limitations as noted above. Gjerde teaches the solvents are chosen to be compatible with the analyte and the ultimate detection method ([0161]). Gjerde teaches strong acids, strong bases, mixtures of acids/bases ([0161]). Gjerde teaches acidic or basic methanol ([0161]). Gjerde teaches tuning the pH ([0174]). Gjerde teaches pH influences protein stability ([0237).
Gjerde does not teach the alkaline composition further comprises 5% (v/v) ammonia.
Gilar teaches SPE of polypeptides ([0095]; [0011]). Gilar teaches adjusting the pH of the mobile phase ([0058]). Gilar teaches ammonia is a common base for adjusting the mobile phase pH ([0058]).
It would be obvious to one of ordinary skill in the art before the effective filing date to utilize ammonia, as taught by Gilar, in the method of Gjerde since it is a known and common based for adjusting the mobile phase pH.
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
The 112b rejections are removed in light of the claim amendments.
In regard to the Applicant’s argument that Gjerde does not teach a washing step; paragraph [0157] is directed to binding; paragraph [0161] is directed to desorption; [0174] does not teach washing with a pH of 1 to 4; a wash solution is to maintain the analyte bound to the extraction surface; the Examiner does not find this persuasive.
The claims require “(a) washing with (aa) an acidic aqueous solution having a pH ranging from 1 to 4; and (ab) an acidic composition comprising at least 50% (v/v) organic solvent, wherein said organic solvent is a nitrile”.
As noted above: Gjerde teaches method comprising washing with an acidic aqueous solution and acidic composition comprising organic solvent ([0157], [0174], wash solution, can include solvents having a specific pH or containing components that promote removal of materials that interact lightly with the extraction phase; [0234], washes, organic solvent, methanol; [0161], methanol and acetonitrile) wherein said organic solvent is a nitrile ([0161]).
Gjerde does not explicity teach the wash solution is acidic or that there is at least 50% (v/v) organic solvent. Gjerde teaches the solvents are chosen to be compatible with the analyte and the ultimate detection method ([0161]). Gjerde teaches strong acids, strong bases, mixtures of acids/bases ([0161]). Gjerde teaches acidic or basic methanol ([0161]). Gjerde teaches tuning the pH ([0174]). Gjerde teaches pH influences protein stability ([0237).
As the protein stability, compatibility, and detection parameters are variables that can be modified, among others, by adjusting said pH of the wash solution, the precise wash solution pH would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. Further, adjusting the volume percentage of organic solvent is directly related to the pH. As such, without showing unexpected results, the claimed wash solution pH cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the wash solution pH in the method of Gjerde to obtain the desired balance between the protein stability, compatibility, and detection parameters (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Gjerde teaches a “wash step” to “improve the purity of the final product” ([0174]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a wash solution is to maintain the analyte bound to the extraction surface) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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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/KARA M PEO/Primary Examiner, Art Unit 1777