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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “not detectable”. It is unclear what is meant by “not detectable” and how this would be determined.
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 1, 2, 4-16 are rejected under 35 U.S.C. 103 as being unpatentable over Katz et al. (WO2017/044397) and further in view of Fraunhoffer et al. (US Pub. No. 2013/0156760).
Claims 1, 14, 15, and 16: Katz et al. teach a method of stabilizing a protein the method comprising providing an aqueous solution comprising a protein [0028, 0033] and the surfactant of formula I [0026].
They do not teach the separating steps.
Fraunhoffer et al. teach an aqueous formulation comprising water and a protein (abstract) and excipients (abstract) wherein excipients are formulations that improve protein stability [0004]. Excipients include surfactants [0025]. They teach using diafiltration/ultrafiltration to selectively separate the solutions based on the molecular size of the components [0151]. Protein is retained in the retentate [0161]. When/if Formula I has a smaller size than the protein, it will pass through the membrane [0151]. The surfactant is reduced in the final solution [0162] by membrane separation. The excipient passes through the membrane [0260].
Katz et al. and Fraunhoffer et al. do not teach the outcome of using the Formula I in the protein solution. However, assuming the same protein, the compound will function in the same way that is to reduce aggregation as "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
One of ordinary skill in the art at the time of the invention would have found it obvious to use Faunhoffer et al.’s diafiltration and/or ultrafiltration method to separate Katz et al.’s protein from the aqueous and surfactant solution in order to either exchange the buffer as is needed for further studying or use or to isolate the protein for clinical use.
One of ordinary skill in the art at the time of the invention would have also found it obvious to modify Fraunhoffer et al. by Katz et al. to and try Katz et al.’s protein stabilizing compound because Fraunhoffer et al. discusses the use of surfactants for stabilizing proteins and “The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).”
Katz et al. do not teach that the amount of surfactant in the aqueous solution is from 0.01 mg/mL to about 0.05 mg/mL.
Katz et al. teach that the concentration of the surfactant, also known as an excipient in the art, in a protein/surfactant aqueous solution is a result effective variable that is routinely optimized based on the amount of protein in the solution, the buffer type, and the desired aggregation/non-aggregation or other solution dynamics that the excipient affects. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). There is no evidence that the concentration of the surfactant in the aqueous solution is critical or particularly relevant to the claimed invention.
Fraunhoffer et al. teach that the membrane cut-off is 30 kDa [0151], which is the same as disclosed by Applicant for performing the separation.
Katz et al. do not expressly teach that the concentration of the surfactant in the retentate is no more than 0.01 mg/mL, no more than 0.005 mg/mL, no more than 0.001 mg/mL or non-detectable.
However, Fraunhoffer et al. teach that the membrane have an “idea 100% excipient membrane permeability” [0260]. This clearly teaches that he goal is a theoretical 100% excipient reduction while in practice there may be some that is retained. While the concentration retained is not specified, it is clear that this is a result effective variable that is reduced as much as possible and wherein the goal would be complete removal, or non-detectable amounts or minimal amounts such as claimed. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). There is no evidence that the concentration of the surfactant in the aqueous solution is critical or particularly relevant to the claimed invention.
Claim 2: the surfactant is reduced by at least 95% with respect to the protein in the initial solution [0162].
Claim 4: Fraunhoffer et al. teach that the membrane cut-off is a result effective variable that is optimized depending on the size of the protein molecule being separated/concentrated [0151]. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 5: Fraunhoffer et al. teach that the concentration of the surfactant, also known as an excipient in the art, in a protein/surfactant aqueous solution is a result effective variable that is routinely optimized based on the amount of protein in the solution, the buffer type, and the desired aggregation/non-aggregation or other solution dynamics that the excipient affects. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Fraunhoffer et al. teach that the membrane cut-off is 30 kDa [0151].
Claim 7: Fraunhoffer et al. teach the concentration of the surfactant, also known as an excipient in the art, in a protein/surfactant aqueous solution is a result effective variable that is routinely optimized based on the amount of protein in the solution, the buffer type, and the desired aggregation/non-aggregation or other solution dynamics that the excipient affects. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Fraunhoffer et al. teach that the membrane cut-off is 30 kDa [0151]. They teach that diafiltration can be followed by ultrafiltration [0083-0084].
Claim 8: Fraunhoffer et al. teach the concentration of the surfactant, also known as an excipient in the art, in a protein/surfactant aqueous solution is a result effective variable that is routinely optimized based on the amount of protein in the solution, the buffer type, and the desired aggregation/non-aggregation or other solution dynamics that the excipient affects. The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Fraunhoffer et al. teach that the membrane cut-off is 30 kDa [0151]. Ultrafiltration is not required in a separation process depending on the needs of the system and the goal of the separation [0083-0084]. Therefore, ultrafiltration is not required before and/or after diafiltration; that is diafiltration can be performed on its own.
Claims 9-13: Katz et al. teach the structure recited in claims 9-13 is taught in the depiction of Formula I as explained in the rejection of claim 1, and the iterations and definitions of the groups of Formula I as described in Katz et al.
Claim 9 is taught in [0020].
Claim 10 is taught in at least [0023]
Claim 11 is taught in at least Claim 7 of Katz et al.
Claim 12 is taught in at least [0047].
Claim 13 is taught in at least [0023] and [0047].
Response to Arguments
Applicant's arguments filed 3/5/2026 have been fully considered but they are not persuasive.
The amendments are addressed in the rejection above.
Applicant does not present any detailed or specific rejections with respect to the prior art that can be responded to.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON FITZSIMMONS whose telephone number is (571)270-1767. The examiner can normally be reached M-F 9:30 am - 2:00 pm.
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ALLISON FITZSIMMONS
Primary Examiner
Art Unit 1773
/ALLISON G FITZSIMMONS/ Primary Examiner, Art Unit 1773
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