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 .
Election/Restrictions
Claims 42-46 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/25.
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, 3, 4, 20, 21, 25-27 and 62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazutis (US 2012/0108721). This rejection was applied to claims 1, 3, 4, 20, 21, and 25-27 in Paragraphs 5-13 of the Non-Final Rejection mailed 12/23/25. The rejection remains in effect for claims 1, 3, 4, 20, 21, and 25-27; and also applies to new claim 62. 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 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mazutis (US 2012/0108721) in view of Oguchi (US 2011/0257026). This rejection was applied in Paragraph 18 of the Non-Final Rejection mailed 12/23/25. The rejection remains in effect. Please see Response to Arguments below.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mazutis (US 2012/0108721) in view of Frey et al. (US 2019/0060522). This rejection was applied in Paragraph 19 of the Non-Final Rejection mailed 12/23/25. The rejection remains in effect. Please see Response to Arguments below.
Response to Arguments
Applicant’s arguments, filed 04/17/26, with respect to the rejection of claims under 35 U.S.C. 102(a)(1) as being anticipated by Mazutis (US 2012/0108721) have been fully considered but they are not persuasive.
Applicant has amended claim 1 to recite “A closed system for producing cell culture scaffolds comprising” and “wherein the housing defines an atmosphere outside of the housing and a separate aseptic atmosphere within the housing, the aseptic atmosphere created by the at least one alcohol solvent present in one or more of the plurality of modular components” and then argued these features are not taught by the cited prior art, Mazutis. See pages 7-8 of Applicant’s Arguments. Applicant has argued that Mazutis does not teach a closed system.
The Examiner respectfully disagrees and directs Applicant to the Examples, in particular Paragraphs 0181 and 0217. Paragraphs 0181 and 0217 recite a PDMS layer having channels sealed by glass. In addition, the injection lines are each connected to a closed syringe pump which would provide a “closed” system. The Examiner submits the recited use of the alcohol solvent is an intended use of the device. The Examiner reminds Applicant a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding new claim 62 – Figures 1C, 3A, 3B, 8A and 14A of Mazutis show embodiments of the device having an intersection defined by opposing fluid paths of a first solution and a fluid path of a different second solution the intersects the opposing fluid paths.
Applicant’s arguments, filed 04/17/26, with respect to the rejection of claims under 35 U.S.C. 103 as being unpatentable over Mazutis (US 2012/0108721) in view of Oguchi (US 2011/0257026) have been fully considered but they are not persuasive.
Applicant has argued one of ordinary skill in the art would not combine the Oguchi reference with the Mazutis reference. The Examiner respectfully disagrees. The Examiner submits Mazutis and Oguchi both teach microfluidic devices having filter structures. Oguchi teaches a removable filter structure which the Examiner considers to be an improvement over the filter structure taught by Mazutis. Therefore, the Examiner submits the addition of the filter of Oguchi to the device of Mazutis to be “applying a known technique to a known device ready for improvement to yield predictable results”. See MPEP 2143, Section I, Rationale D.
Applicant has also argued the Oguchi does not teach “wherein a critical cell dimension of each cell culture scaffold is determined by a pore size of the porous membrane”. The Examiner respectfully disagrees and submits the term “critical cell dimension” is broad and does not confer a specific dimension or size of the pore or other feature of the membrane. Therefore, the Examiner submits that, in the claim as currently written, any pore size that allows for the formation of a scaffold results in “a critical dimension of each scaffold” that is “determined by the pore size” since each scaffold is actually formed and Applicant has not specified the “critical dimension”. Therefore, the pores of the membrane of Mazutis and Oguchi determine “a critical cell dimension” of the formed scaffold. The Examiner notes that if Applicant wishes to claim a specific pore size for forming the scaffolds, Applicant should recite the pore size in the claim.
Applicant’s arguments, filed 04/17/26, with respect to the rejection of claims under 35 U.S.C. 103 as being unpatentable over Mazutis (US 2012/0108721) in view of Frey et al. (US 2019/0060522) have been fully considered but they are not persuasive. Applicant has argued that the combination of Mazutis and Frey does not teach the features of a pump and mass flow controller. The Examiner respectfully disagrees and submits the syringe pump element as taught by Mazutis provides the function of pumping and a mass controller as recited in the claims. See Paragraphs 0181 and 0217 of Mazutis.
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 July 30, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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