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 § 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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ellis et al. (US 2013/0228534). This rejection was applied in Paragraphs 5-10 of the Non-Final Rejection mailed 08/27/25. The rejection remains in effect. Please see Response to arguments below.
Claims 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zougman et al. (US 2016/0266137). This rejection was applied in Paragraphs 11-15 of the Non-Final Rejection mailed 08/27/25. The rejection remains in effect. Please see Response to arguments below.
Inventorship
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 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 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zougman et al. (US 2016/0266137) in view of Ellis et al. (US 2013/0228534). This rejection was applied in Paragraph 20 of the Non-Final Rejection mailed 08/27/25. The rejection remains in effect. Please see Response to arguments below.
Response to Arguments
Applicant’s arguments, filed 11/26/25, with respect to the rejection of claims under 35 U.S.C. 112(b) have been fully considered and are persuasive. Applicant has amended claims 5 and 14 to address the issues set forth in Paragraph 4 of the Non-Final Rejection mailed 08/27/25. Applicant has amended claims 5 and 14 recite “wherein a mild chaotrope is a chaotropic agent that does not fully denature biomolecules” and “wherein a strong chaotrope is a chaotropic agent that fully denatures biomolecules” to clarify the claims. Therefore, the rejection has been withdrawn.
Applicant’s arguments, filed 11/26/25, with respect to the rejection of claims 1-4 under 35 U.S.C. 102(a)(1) as being anticipated by Ellis et al. (US 2013/0228534) have been fully considered but they are not persuasive. Applicant has argued that the prior art Ellis does not teach “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 matrix” because “fluid is flushed through the filter and into the plunger”. See pages 8-9 of Applicant’s Remarks. The Examiner respectfully disagrees. The Examiner agrees with Applicant’s reading of the sequence shown in Figures 5A-5C of Ellis and described in Paragraphs 0066-0070. Figure 5B shows that the projection (14) of the outer vial (vial 10) does indeed work with the bottom (57) portions of the cap (50) of the inner vial (plunger 18) to force fluid through the filter (70) of the inner vial (plunger 18) as the plunger is being inserted into the vial. The Examiner, however, directs Applicant to Figure 5C which shows the inner vial (plunger 18) fully inserted such that a that inner vial is sealed by the protrusion (14) of the outer vial (vial 10). The Examiner submits this is what claim 1 requires as currently written. The Examiner submits Figure 5C of Ellis teaches 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 matrix”. Therefore the claims remain rejected.
Applicant’s arguments, filed 11/26/25, with respect to the rejection of claims 5-13 under 35 U.S.C. 102(a)(1) as being anticipated by Zougman in view of Ellis et al. (US 2013/0228534) have been fully considered but they are not persuasive. Applicant has argued that Zougman does not teach or suggest "collecting non-coagulated and unbound molecules into a first removable vesicle and eluting a class or category of coagulated captured molecules from the matrix into a second removable vesicle." See pages 9-10 of Applicant’s Remarks. The Examiner respectfully disagrees and again directs Applicant to Paragraphs 0151-0167; 0192-0228; and 0261-0289 of Zougman which recite methods that include all of the steps recited in instant claims.
Applicant’s arguments, filed 11/26/25, with respect to the rejection of claims 5-13 under 35 U.S.C. 103 as being unpatentable over Zougman et al. (US 2016/0266137 in view of Ellis et al. (US 2013/0228534) have been fully considered but they are not persuasive. Applicant has argued that one of ordinary skill in the art would not combine the device from Ellis with the device and method of Zougman. The Examiner respectfully disagrees and submits the filter device of Ellis is an improvement over the device of Zougman. Zougman teaches a base filtration device. As previously noted by the Examiner, In Paragraph 0077, Ellis teaches Ellis teaches a filtration device that forces much more fluid through the filter (70) than other filter vials, which provides an improvement of filtering more material for a given volume of fluid. The Examiner submits providing this improvement falls under the rationale of “Use of known technique to improve similar devices in the same way”. See MPEP 2143, Section I, C.
Conclusion
THIS ACTION IS MADE FINAL. 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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 March 21, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798