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 contains the language where the organic acid and/or the organic solvent is acetic acid. Claim 16 is unclear because acetic acid is not an organic solvent.
Claim 13 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “dielectric constant of 40 to 1”, and the claim also recites “or 30 to 2” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 and 10-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al (US 2006/0102561) and in further view of Leng et al (CN 111068634).
Larsen teaches a process for regenerating a chromatographic stationary phase where the chromatographic stationary phase is a reverse phase-HPLC matrix comprising silica or substituted silica material or a pressure stable polymeric material (i.e., resin) (see [0065]) where the process comprises:
Contacting with a Wash 1 comprising ethanol;
Contacting with a regeneration solution;
Leaving the column to stand for 30 minutes;
Contacting with a regeneration solution; and
Contacting with a Wash 2 solution comprising ethanol (i.e., an organic solvent)
Flushing the column with 20% w/w ethanol in water (See Table 3 and Example 72).
Larsen further teaches a process where a regeneration step comprises more than one regeneration solutions (see [0036]).
Larsen further teaches a process where the regeneration solution comprises comprising at least one organic acid and an organic solvent (see [0059-0060] and Examples in Table 4). Larsen also teaches a process where a sodium hypochlorite (i.e., a bleaching agent) is used as a regeneration solution (see Table 4, Examples 55-57).
Larsen therefore differs from claim 1 where it does not disclose a process specifically combining a step for contacting the chromatography material with a regeneration solution comprising the bleaching agent and at least organic solvent with the step for contacting with the regeneration solution comprising the organic acid and organic solvent. Larsen also does not disclose where the wash solution comprises purified water with the ethanol organic solvent.
Regarding combining a sodium hypochlorite step with the organic acid/organic solvent step,
Leng teaches a regeneration method of an alumina column comprising adding 20% to 60% sodium hypochlorite solution into the alumina column and then a step using a large amount of water and a step using an anhydrous alcohol to wash the neutral alumina column (see Abstract). Leng therefore discloses using a sodium hypochlorite solution comprising a sodium hypochlorite solution having a pH of 11 since the molarity ranges from 2.7M to 8.1M and the Kb of NaClO is2.86x10-7. Leng discloses a method that can effectively recover the alumina column so that the alumina column to recycle, simple technique purifying effect and easy to realize industrial application (see Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform the process for regeneration of a chromatography material comprising regenerating with an organic acid/organic solvent where regeneration further comprises regenerating with a sodium chlorite solution as disclosed by Leng as the mere combination of two known regeneration processes known to regenerate chromatography column material.
Further regarding the sodium hypochlorite regeneration solution comprising an organic acid, Larsen discloses regeneration solutions comprising organic solvent. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform the process as suggested by Larsen and Leng comprising a step for regenerating with a sodium hypochlorite solution where the solution further comprises an organic solvent since Larsen discloses the regenerating solution comprising organic solvent is preferred.
Regarding purified water, Leng discloses the use of purified water for washing (see Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention where the ethanol/water wash solution as taught by Larsen comprises purified water as taught by Leng to perform “washing” without introducing contaminants.
Regarding claim 2, Larsen discloses a method where the chromatographic stationary phase is contacted with the regeneration solution inside the chromatographic column (see [0063]).
Regarding claim 3, as applied above, Leng teaches a regeneration method of an alumina column comprising adding 20% to 60% sodium hypochlorite solution. Leng therefore teaches using a sodium hypochlorite solution having a pH of 11 because the molarity ranges from 2.7M to 8.1M since the molecular weight of NaClO is 74.5 g/mol and the pH is 11 since the Kb of NaClO is 2.86x10-7.
Regarding claim 4-5, Larsen further discloses where the chromatographic stationary phase is contacted with the regeneration solution for 10 to 60 minutes (See [0068]). Larsen further discloses an example where contacting with the regeneration solution comprises leaving the column to stand for 30 minutes (see Table 3).
Regarding claim 6, Larsen teaches a process where the regeneration solution is passed over and/or through the chromatography material where it discloses contacting inside the column (see [0063]).
Regarding claim 7, Larsen teaches a process for regenerating a chromatographic stationary phase where the chromatographic stationary phase is a reverse phase-HPLC matrix comprising a pressure stable polymeric material (i.e., resin) (see [0065]).
Regarding claim 8, Larsen teaches a process for regenerating a chromatographic stationary phase where the chromatographic stationary phase is a reverse phase-HPLC matrix comprising silica or substituted silica material where the substituted silica is a C4, C8, C12, and C18 silica (see [0065]).
Regarding claim 10, Larsen teaches sodium hypochlorite.
Regarding claim 11, Larsen teaches a process where the organic acid and organic solvent regeneration solution is passed over and/or through the chromatography material where it discloses contacting inside the column (see [0063]).
Regarding claim 12, Larsen discloses a process where the organic acid is at least 25% w/w and preferably formic acid and acetic acid (see [0059]). Therefore, Larsen discloses regenerating solution that has a pH of 0.9 or less for at least 25% w/w formic acid or pH = 1.56 for at least 25% w/w acetic acid.
Regarding claim 13, Larsen teaches a process where the organic solvent is ethanol (dielectric constant of about 24.5) or acetonitrile (dielectric constant of about 36) (see [0061]).
Regarding claim 14, Larsen teaches processes for regeneration wherein the solvent is acetonitrile.
Regarding claim 15, Larsen teaches a process where the organic acid is acetic acid (see [0059]). Acetic acid has a pKa around 4.7.
Regarding claim 16, Larsen teaches a process where the organic acid is acetic acid (see [0059]).
Regarding claim 17, Larsen further teaches where the chromatographic stationary phase is contacted with the regeneration solution at a temperature of 18°C to 25°C (see [0070]). It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform the process as taught by Larsen where contacting is any workable or optimum range overlapping with 18°C to 25°C including the claimed range absent evidence of new and unexpected results.
Regarding claim 18, Larsen further teaches a process for regeneration where the chromatographic stationary phase was used for the production of therapeutic polypeptides including human insulin, analogues and derivatives (See [0075-0092]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen and Leng as applied to claim 1 above, and further in view of Brekken et al (US 2014/0243498).
As applied to claim 1, Larsen and Leng disclose a process for regenerating a chromatographic stationary phase comprising washing with a sodium hypochlorite and organic solvent, washing with an organic acid and organic solvent, and washing with an organic solvent and purified water.
Regarding claim 19, Larsen further teaches where the chromatographic stationary phase is contacted with the regeneration solution until the pressure drop over the length of the chromatographic column at a normal flow rate decreases by at least 10% (See [0069] and Claim 26). Larsen does not disclose a flow rate of 220 cm/hr.
Brekken discloses a process for chromatographic purification of insulin comprising absorbing insulin and eluting insulin from the chromatography medium at a flow rate of 100-1000 cm/h (see [0009]). Larsen also relates to chromatographic columns for purification of human insulin (see [0092]) and therefore Brekken relates to Larsen as disclosing normal flow rates. It would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform the process as taught by Larsen and Leng where the chromatographic stationary phase is contacted with the regeneration solution until the pressure drop over the length of the chromatographic column is at least 10% where the flow rate is any range overlapping with 100 to 1000 cm/h as taught by Brekken including 220 cm/h as claimed as a normal flow rate for insulin purification by chromatographic column.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL FORREST whose telephone number is (571)270-5833. The examiner can normally be reached Monday-Friday (10AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sally A Merkling can be reached at (571)272-6297. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL FORREST/Primary Examiner, Art Unit 1738