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 .
Applicant’s filing of claims 1-20 on 12/21/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/6/24, 7/18/25 and 10/22/25 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pressure-fitted automated liquid handler (PF-ALH); a plurality of buffer exchange pipette tips situated in proximity to the PF-ALH; the buffer exchange pipette tips comprise a housing comprising (i) a proximal end comprising a lower opening; (ii) a distal end designed to fit the PF-ALH; and (iii) an inert resin for size exclusion chromatography (SEC) within the housing; the sample on top of the inert resin inside the buffer exchange pipette tip; means for creating a pressure differential; the distal end of the buffer exchange pipette tip (claim 1); plunger (claim 4); frit (claim 7); kit (claim 20) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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.
Claims 1-3 are rejected for indefiniteness because each claim merely recites a use, e.g., “using,” without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q). The Office recommends amending each “using” to active steps reciting how, e.g., the PF-ALH dispenses the sample. What structural feature of the PF-ALH is performing, e.g., the “dispense the sample” step?
Claims 1-4 are rejected because each claim is not clear as to what structure(s) of the PF-ALH is intended to achieve the “means for creating a pressure differential" function.
Claims 8-11, 18 and 19 contain the trademark/trade names IMCStips; Dynamic Devices PF-ALH; and Tecan PF-ALH. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe pipette tip for claims 8-11; and PF-ALH for claims 18 and 19 and, accordingly, the identification/description is indefinite.
Claim 20 is rejected because the scope of the claim is unclear. The scope of the preamble is unclear. The Office recommends including a colon to clearly indicate the scope of the preamble. The claim language, “designed for use” and “instructions for use,” make the claim indefinite. See MPEP 2173.05(q), as cited above.
Claim Interpretation under 35 U.S.C. 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” and is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses the word “means” or “step” that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: apply means for creating a pressure differential in claims 1-4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Interpretation of the examined claims
The Office asserts that terms and phrases like “designed to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “designed to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brewer et al. (“Brewer,” US Pub. No. 2022/0184525, cited in IDS).
As to claim 1, Brewer teaches a method of buffer exchange for a sample, the method comprising: providing a pressure-fitted automated liquid handler (PF-ALH) (see robotic liquid handler from Tecan in e.g., [0070]) and a plurality of buffer exchange pipette tips (e.g., [0058] et seq.) situated in proximity to the PF-ALH, wherein the buffer exchange pipette tips comprise a housing comprising (i) a proximal end comprising a lower opening (fig. 1A and [0061] et seq.); (ii) a distal end designed to fit the PF-ALH (fig. 1A and [0061] et seq.); and (iii) an inert resin for size exclusion chromatography (SEC) within the housing (e.g., [0016] et seq.); using the PF-ALH to dispense the sample on top of the inert resin inside the buffer exchange pipette tip (e.g., [0058] et seq.); using the PF-ALH to apply means for creating a pressure differential (e.g., [0017] et seq.); and using the PF-ALH to engage the distal end of the buffer exchange pipette tip to facilitate movement of the sample through the inert resin (e.g., [0058] et seq.); to thereby buffer exchange the sample (e.g., [0005] et seq.).
As to claim 2, Brewer teaches prior to dispensing the sample on top of the inert resin: using the PF-ALH to dispense an equilibrium buffer on top of the inert resin in the buffer exchange pipette tip; using the PF-ALH to apply means for creating a pressure differential; and using the PF-ALH to engage the distal end of the buffer exchange pipette tip to facilitate movement of the equilibrium buffer through the inert resin. See [0018] et seq.
As to claim 3, Brewer teaches after movement of the sample through the inert resin: using the PF-ALH to dispense an elution buffer on top of the inert resin in the buffer exchange pipette tip; using the PL-ALH to apply means for creating a pressure differential; and using the PF-ALH to engage the distal end of the buffer exchange pipette tip to facilitate movement of the elution buffer through the inert resin; to thereby elute the sample from the inert resin into the elution buffer. See [0018] et seq.
As to claim 4, Brewer teaches the PF-ALH comprises a plunger and the means for creating a pressure differential comprises moving the plunger prior to engaging the distal end of the buffer exchange pipette tip. See e.g., [0062] et seq.
As to claims 5 and 6, Brewer teaches the inert resin is comprised of a base material selected from the group consisting of agarose, cellulose, dextran, polystyrene, polyacrylamide, polyacrylate, Sephadex, or Sepharose. See e.g., [0008] et seq.
As to claim 7, Brewer teaches the housing comprises a frit inside the housing positioned above the lower opening and the inert resin is positioned within the housing above the frit. See e.g., [0025] et seq.
As to claims 8-11, see 112 rejection above, but see [0015] et seq.
As to claims 12-17, see e.g., [0073] et seq.
As to claims 18-19, see 112 rejection above, but see [0015] et seq.
As to claim 20, see e.g., [00058] et seq.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
7/25/2026
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