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 .
This is a FINAL REJECTION in response to applicant’s claim amendments and arguments filed May 8, 2026. Claims 1, 3, 4, and 9 are currently amended. Claims 2 and 12 have been canceled from consideration. Claims 1, 3-11, and 13-17 are pending review in this correspondence.
Response to Amendment
Rejection of claims 3 and 4 for being indefinite is withdrawn in view of applicant’s amendments to the claims.
Rejection of claims 1-3, 6-11, and 13-17 as being unpatentable over Haun et al (US 2019/0070605 A1) in view of Haun et al (US 2020/0283723 A1) is withdrawn in view of applicant’s amendments to claims 1 and 9 and cancelation of claim 2.
Rejection of claim 5 as being unpatentable over Haun et al (US 2019/0070605 A1) and Haun et al (US 2020/0283723 A1) in view of Qiu et al (“Microfluidic filter device with nylon mesh membranes efficiently dissociates cell aggregates and digested tissue into single cells, Lab Chip. 2018 September 11, 18(18): 2776-2786, doi:10.1039/c8ic00507a) (submitted by applicant in IDS dated 4/25/2023) is withdrawn in view of applicant’s amendments to claim 1.
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, 3-11 and 13-17 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.
Claim 1 recites “tubing or conduit” in line 23. However, applicant has previously recited a “first tubing or conduit” in line 20, and it is unclear if the recitation in line 23 is intended to be a different, or second, tubing or conduit, or if the recitation in line 23 is the same as the “first tubing or conduit” recited in line 20. Clarification is requested.
Claims 3-8 are ultimately dependent upon claim 1, and thus, inherit the same deficiencies.
Claim 9 recites “effluent” in lines 24 and 32. However, it is not clear if the use of the term “effluent” in line 32 is intended to encompass the same term used in line 24, or if the use of the term in line 32 is intended to refer to a different (or “second”) effluent. Clarification is requested.
Claims 10, 11, and 13-17 are ultimately dependent upon claim 9, and thus, inherit the same deficiencies.
Allowable Subject Matter
Claims 1, 3-11 and 13-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 1, the closet cited prior art of reference is to Haun et al (US 2019/0070605 A1) and Haun et al (US 2020/0283723 A1), the combination of which teaches a microfluidic system comprising a microfluidic digestion device comprising an inlet and an outlet and a flow path defined between the inlet and the outlet, wherein the flow path comprises a tissue chamber and a plurality of upstream fluidic channels communicating with the tissue chamber on the inlet side of the flow path and a plurality of downstream fluidic channels communicating with the tissue chamber on the outlet side of the flow path; a first pump; and a microfluidic dissociation/filter device. However, the cited art fails to disclose, teach, or suggest that the first pump is configured to recirculate fluid from the outlet of the microfluidic digestion device via tubing or conduit fluidically coupled to the one or more valves disposed in the first tubing or conduit and wherein the second pump is further configured to recirculate fluid from the first outlet of the microfluidic dissociation/filter device to thein let of the microfluidic dissociation/filter device via tubing or conduit fluidically coupled to the one or more valves disposed in the first tubing or conduit. Specifically, the system of claim 1 includes two pumps each with its own "circuit" that can recirculate the fluid and contents therein either to the digestion device or the dissociation/filter device. This allows the operator to process samples independently and separately through the two devices. This provides a number of benefits not taught or disclosed by the prior art. First, the claimed system is able to process a variety of different tissue types and collect different types of single cells. Some tissue types are processed with better results by getting recirculated by one or both devices. For example, strongly cohesive cell types (e.g., certain types of breast cancer - [00114]) may require recirculation through the digestion device. Other tissue samples such as liver tissue are more delicate and may not need any recirculation (See [0093]. Still, another benefit of the claimed system is that interval recovery can be performed whereby different types of cells may be recovered in different fractions eluted at different times. Interval collection may also reduce the amount of stress on cells, thereby mitigating possible stress responses in certain cell types. For example, it was found that substantially more hepatocytes and cardiomyocytes were obtained if sample is recovered at discrete intervals, most likely because these cell types are sensitive to shear forces (See [0009]). The claimed integrated system provides a way to process a wide variety of tissue types to improve the recovery of single cells and/or reduce processing time. Note that in the FIG. 2 device of Haun-605, there is only a single pump so recirculation can't be performed independently in both the microfluidic device 10 and the downstream microfluidic device 100.
With respect to claim 9, the closet cited prior art of reference is to Haun et al (US 2019/0070605 A1) and Haun et al (US 2020/0283723 A1), the combination of which teaches a method of using a microfluidic system comprising the combination of which teaches a microfluidic system comprising a microfluidic digestion device comprising an inlet and an outlet and a flow path defined between the inlet and the outlet, wherein the flow path comprises a tissue chamber and a plurality of upstream fluidic channels communicating with the tissue chamber on the inlet side of the flow path and a plurality of downstream fluidic channels communicating with the tissue chamber on the outlet side of the flow path; a first pump; and a microfluidic dissociation/filter device, the method comprising loading the tissue sample into the tissue chamber of the microfluidic digestion device, pump buffer-containing fluid and/or an enzyme-containing fluid into the inlet of the microfluidic digestion device, and transferring fluid containing processed tissue sample to the microfluidic dissociation/filter device. However, the cited art fails to disclose, teach, or suggest that pumping the buffer-containing fluid and/or an enzyme-containing fluid into the inlet of the microfluidic digestion device is performed in intervals where effluent is removed from the microfluidic digestion device at the end of each interval and replacement enzyme-containing fluid is pumped into the microfluidic digestion device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 August 4, 2026
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