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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/26 has been entered.
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 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zougman et al. (US 2106/0266137). This rejection was applied in Paragraphs 11-15 of the Non-Final Rejection mailed 078/27/25 and maintained in Paragraphs 5 and 13 of the Final Rejection mailed 03/27/26. The rejection remains in effect. Please see Response to Arguments below.
Response to Arguments
Applicant’s arguments, filed 06/26/26, with respect to the rejection(s) of claim(s) 1-4 under 35 U.S.C. 102(a)(1) as anticipated by Ellis et al. (US 2013/0228534) have been fully considered and are persuasive.
Applicant has amended claim 1 to include the additional limitations of “an inner vial, wherein the inner vial comprises an inner chamber and a capture matrix, wherein the capture matrix is configured to capture molecules when a molecule coagulant is present” and “when the system is in the lower parked position of the inner vial, the outer vial seals the inner vial, wherein the pin of the outer vial is configured to seal the inner vial and remove the dead space of an output of the inner vial up to the bottom of the capture matrix such that no channel or dead volume remains downstream of the capture matrix” and then argued that the additional features are not taught or suggested by the prior art, Ellis. See pages 7-12 of Applicant’s Remarks. The Examiner agrees; therefore, the rejection has been withdrawn.
Applicant’s arguments, filed 06/26/26, with respect to the rejection(s) of claim(s) 14-20 under 35 U.S.C. 102(a)(1) as anticipated by Zougman et al. (US 2016/0266137) have been fully considered but they are not persuasive.
Applicant has argued “Zougman describes a single, integrated spin-tip or column-type device in which flow-through is discarded or collected downstream during centrifugation, and subsequent digestion and elution occur through a conventional spin-column workflow and collected via a single downstream receiving vessel during centrifugation, as shown in Fig. 3C”. See page 13 or Applicant’s Remarks.
The Examiner respectfully disagrees and submits the argument directed to the type of device (highlighted above) is beyond the scope of the claim as currently written. The claim as currently written simply requires collecting the unbound material into a first removable vesicle and later eluting captured molecules into a second removable vesicle.
Applicant has argued that Zougman does not teach the collecting and eluting steps: “Zougman fails to disclose a two-step process of fractionation involving (1) ‘collecting non-coagulated and unbound molecules into a first removable vesicle, where the classes of non-coagulated molecules are dependent on the choice of molecule coagulant’ and (2) ‘eluting a class or category of coagulated captured molecules from the capture matrix into a second removable vesicle with extraction solvents chosen to match the solubilities of the coagulated captured molecules’ as recited in claim 14”. See pages 13-14 of Applicant’s Remarks.
The Examiner respectfully disagrees and directs Applicant to Paragraphs 0192-0221, especially Paragraphs 0206-0208 and 0217-0221. Paragraphs 0206-0208 of Zougman describe contacting the sample material with the capture matrix and collecting the flow through (non-coagulated and unbound molecules) in a tube (Paras 0207-0208). The Examiner considers the recited collection tube to be a first removable vessel. Later in Paragraphs 0217-0221, Zougman recites eluting the captured molecules into another, different O-tube. The Examiner consider the tube collecting the eluted molecules is “a second removable vesicle” as recited in the claim. The Examiner also directs Applicant to Paragraphs 0260-0289, especially Paragraphs 0269-0271 and 0284-0289. Paragraphs 0260-0289 of Zougman describe contacting the sample material with the capture matrix and collecting the flow through (non-coagulated and unbound molecules) in a tube (Paras 0270-0271). The Examiner considers the recited collection tube to be a first removable vessel. Later in Paragraphs 0284-0289, Zougman recites eluting the captured molecules into another, different O-tube. The Examiner consider the tube collecting the eluted molecules is “a second removable vesicle” as recited in the claim. Therefore, Zougman teaches the cited collecting step (1) using a first removable vesicle and the cited eluting step (2) using a second removable vesicle from claim 14.
Allowable Subject Matter
Claims 1-13 are allowed. The following is a statement of reasons for the indication of allowable subject matter: Applicant has amended claim 1 to recite a system comprised of “an outer vial, wherein the outer vial is configured to receive an inner vial within the outer vial, wherein the outer vial optionally comprises a pin; an inner vial, wherein the inner vial comprises an inner chamber and a capture matrix, wherein the capture matrix is configured to capture molecules when a molecule coagulant is present, and wherein the inner vial is configured to be positioned within the outer vial in a first state and a second state, wherein the first state is a lower parked position within the outer vial, and the second state is an upper parked position within the outer vial; and when the system is in the lower parked position of the inner vial, the outer vial seals the inner vial, wherein the pin of the outer vial is configured to seal the inner vial and remove the dead space of an output of the inner vial up to the bottom of the capture matrix such that no channel or dead volume remains downstream of the capture matrix; and when the system is in the upper parked position of the inner vial, the outer vial does not seal the inner vial”. The Examiner submits the cited prior art does not teach or suggest a system having the combination of features highlighted above in claim 1. With respect to method claims 5-13, claim 5 recites a method that includes the allowable system of claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 25, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
