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
The Preliminary Amendment filed on 21 January 2024 has been entered; claims 1-28 remain pending.
Claim Objections
Claims 1, 3, 7, 11, 14, 25, and 27 are objected to because of the following informalities: regarding claim 1, step c is missing a comma before step d; regarding claim 3, it ends with a comma instead of a period; claims 7, 14, and 27 are objected to because “an electrolyte in such a(n organic or inorganic) solvent” would be more clearly recited as “an electrolyte in said organic or inorganic solvent”; regarding claim 11, steps c’, d’, e’, f’, and g’ are all missing commas before the next step; regarding claim 25, steps c’, d’, f’, and g’ are all missing commas before the next step; and regarding claim 27, “increased linearly increased” (line 23) should be recited with one instance of “increased”. Appropriate correction is required.
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.
Claims 1-28 are 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.
With respect to claim 1, the limitations “a feed mixture consisting of the product and at least two further components representing weakly adsorbing impurities and strongly adsorbing impurities” renders the claim indefinite, as “consisting of” should limit the feed mixture to only those components recited, and therefore is incompatible with the usage of open language “at least two further components…”).
With continued reference to claim 1, the limitations “wherein the Recycling Phase consists of at least one recycling sequence comprising the following steps” renders the claim indefinite, as the usages of open language “at least one recycling sequence” and “recycling sequence comprising” are incompatible with “wherein the Recycling Phase consists of…”.
With respect to claims, 9, 10, 24, and 25, the limitations “said adsorbers” and “the adsorber section” (multiple instances of each) render the claims indefinite, as it is unclear whether these limitations refer to the first or second adsorber sections. Applicant is respectfully asked to designate each adsorber (section) as a first or second adsorber section to be consistent throughout all the claims.
With continued reference to claims 10 and 25, the limitations “said first batch start-up timespan” and “said second batch start-up timespan” render the claim indefinite as first and second batch start-up timespans are not recited in claims 9 and 24, therefore they lack antecedent basis in the claim language.
With respect to claims 11 and 25, the limitations “the other adsorber section” (in steps a’, g’, and h’) render the claims indefinite, as either “upstream” or “downstream” designations should be used to enhance clarity.
With respect to claim 12, the limitations “the other adsorber section” (occurs twice in second to last clause and last clause) render the claim indefinite, as either “upstream” or “downstream” designations should be used to enhance clarity.
With respect to claim 13, it is unclear what “linear gradients” in line 2 refers to; Applicant may wish to recite “linear eluent gradients” to enhance clarity.
With respect to claims 14 and 27, the limitations “most or all…interconnected steps” renders the claim indefinite, as the term “most” is a relative term which renders the claims indefinite. The term “most” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, the Examiner will interpret “most” as being met according to Paragraph [0126] of the Specification.
With continued reference to claims 14 and 27, it is unclear to the Examiner what is meant by the limitations “recycling except for the case of a following final shutdown batch step and if applicable, of product elution and, if applicable, further recycling, wherein during said recycling the modifier concentration can be varied or just for the recycling kept constant to a highest concentration before the beginning of elution of the strongly adsorbing impurities” (end of each claim). Clarification is respectfully requested regarding what is being recycled and how that pertains to product elution and further recycling.
Claims 15 and 28 provide for a process, but, since the claim does not set forth any steps involved in the method/process of use, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Regarding claims 2-8, 16-23, and 26, they are rejected for being dependent on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15 and 28 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131,149 USPQ 475 (D.D.C. 1966)
Allowable Subject Matter
Claims 1-28 are allowed pending resolution of the claim objections, 112(b) rejections, and 101 rejections set forth above, as none of the prior art teaches or suggests the cyclic chromatographic purification method as recited in claim 1.
The Examiner acknowledges D2 and D3 cited on the ISR and Written Opinion of the International Searching Authority: EP 2925419 A1 (see Abstract) and WO 2019/096622 A1 (see Abstract; Pages 5-6), in which are disclosed steps c through f of claim 1 without the inline dilution steps in the case of EP ‘419; however, these references do not disclose the a recycling phase as required by claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLARE M PERRIN whose telephone number is (571)270-5952. The examiner can normally be reached 9AM-6PM EST M-F.
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/CLARE M. PERRIN/
Primary Examiner
Art Unit 1779
/CLARE M PERRIN/Primary Examiner, Art Unit 1779 23 June 2026
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