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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 14, 2026 has been entered.
Response to Arguments
Applicant's arguments filed September 14, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to recite a flow path having a single inlet and a single outlet, and argued that the cited prior art does not meet the claim limitations. The Examiner respectfully disagrees.
The Examiner notes that because the claims are drafted with open-ended “comprising” language, they do not preclude a device that comprises multiple outlets. Furthermore, the Examiner notes that the number of inlets and outlets on a device are immaterial provided that the cell mass flows through a single inlet and a single outlet. In reviewing reference to Grisham et al., the Examiner notes that the reference teaches a single flow stream originating from a single inlet (paragraph 0412) and products from a first outlet (single outlet, paragraph 0412) wherein the second outlet is a waste outlet. In light of these teachings, the Examiner contends that reference to Grisham et al., meets the limitations of the amended claims. Therefore, in light of the teachings of the prior art, and the arguments provided here, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the rejection is maintained.
Claim Rejections - 35 USC § 102
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.
Claim(s) 27, 29, 36, 37, 40, 45, 46 48, 49, and 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grisham et al., (US 2017/0209864).
For claims 27, 37, and 50, Grisham et al., teach a method for processing particles comprising flowing stem cell (paragraphs 0124, 0134) through a channel having a serpentine path, and an array of obstacles that deflects cells in a flow stream (paragraphs 0085, 0087-0089). Grisham et al., also teach a single flow stream originating from a single inlet (paragraph 0412) and products from a first outlet (single outlet, paragraph 0412). The Examiner notes that the instant specification defines an underflow as "a flow that rubs against objects" and contends that the cells flowing through the device of Grisham et al., rubs against the obstacles thereby causing an underflow. Grisham et al., also teach collecting cells at an outlet (paragraph 0511) from a channel having a uniform width (paragraph 0005).
For claim 29, Grisham et al., teach stem cells contained in a cryopreservation solution (paragraph 0634).
For claims 36 and 45, Grisham et al., teach collecting cells after flowing through the channel (paragraphs 0321, 0398, 0735).
For claims 39 and 40, Grisham et al., teach embryonic stem cells and induced pluripotent stem cells (paragraph 0131).
For claim 46, Grisham et al., teach the flow path comprising a filter (paragraphs 0330, 0720).
For claim 48, Grisham et al., teach the fluid flowing from an inlet through a serpentine channel to a plurality of outlets (paragraph 0085).
For claim 49, Grisham et al., teach the channel having a linear part between the inlet and outlet (figure 54B, part of channel immediately downstream of inlet).
For claim 51, Grisham et al., teach the flow path not comprising a filter (paragraph 0720).
Claim Rejections - 35 USC § 103
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.
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(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grisham et al., (US 2017/0209864) in view of Hinojosa et al., (US 2020/0181555).
Regarding claim 30, Grisham et al., do not teach a cell detachment solution.
Hinojosa et al., a process wherein embryonic and, induced pluripotent stem cells are treated with accutase (paragraphs0440, 0466). Hinojosa et al., teach that it is advantageous to treat stem cells with accutase as a means of dissociating cells after cell density reaches 70-80% confluence (paragraph 0451).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grisham et al., wherein stem cells are treated with accutase in order to dissociate cells after the desired confluence is reached as taught by Hinojosa et al.
Claim(s) 41 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grisham et al., (US 2017/0209864) in view of Klapperich et al., (US 2010/0203521).
Regarding claims 41 and 42, Grisham et al., do not teach a flow path composed of a groove in a substrate and having a cover.
Klapperich et al., teach a microfluidic device wherein the flow path can be a groove (paragraph 0142). Klapperich et al., also teach the microfluidic device having a cover (paragraph0069). The Examiner is reading this combination as a simple substitution of one known element for another to obtain predictable results which would have been obvious to one of ordinary skill in the art. Reference to Klapperich et al., teach that microfluidic channels can be any capillary, channel, tube, or groove deposed within or on a substrate (paragraph 0142), thus one of ordinary skill in the art would have found it obvious within the teachings of Klapperich et al., to form a flow path as a groove. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grisham et al., wherein the flow path is a groove as taught by Klapperich et al., as simple substitution of one known element for another requires only routine skill in the art.
Claim(s) 43 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grisham et al., (US 2017/0209864) in view of Wang et al., (US 2011/0287976).
Regarding claims 43 and 44, Grisham et al., do not teach a rotary pump.
Wang et al., teach a microfluidic device comprising a rotary pump (paragraphs 0067, 0071). Wang et al., teach that it is advantageous to utilize a rotary pump as a means of allowing for assay miniaturization by removing reliance on inefficient fluidic couplings and external pumping systems (paragraph 0067).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grisham et al., to include a rotary pump in order to provide assay miniaturization by removing reliance on inefficient fluidic couplings and external pumping systems as taught by Wang et al.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grisham et al., (US 2017/0209864) in view of Gale et al., (US 2017/0306288).
Regarding claim 47, Grisham et al., do not explicitly teach a flow path connected to a cryopreservation container.
Gale et al., teach a tissue sample and processing system wherein a cryopreservation unit is connected to a microfluidic separating system (paragraphs 0042, 0043, figure 4 #420). The Examiner notes that the claim does not require a flow path having a direct connection with a cryopreservation container, and that the indirect connection taught by Gale et al., meets the claim limitation. Gale et al., teach that it is advantageous to provide a flow path connected to a cryopreservation unit as a means of delivering and storing a tissue sample after separation (paragraph 0042).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grisham et al., wherein a flow path is connected to a cryopreservation unit in order to deliver and store a tissue sample after separation as taught by Gale et al.
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grisham et al., (US 2017/0209864) in view of Klapperich et al., (US 2010/0203521) as applied to claim 41 above, and further in view of Dieguez et al., (US 2019/0275522).
Regarding claim 52, Grisham et al., in view of Klapperich et al., do not teach the lid being a glass plate.
Dieguez et al., teach a microscale filter comprising a cover made of glass (paragraph 0059). Dieguez et al., teach that it is advantageous to provide a glass cover as a means of forming a cover that is transparent (paragraph 0059).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Grisham et al., in view of Klapperich et al., for form a glass cover in order to provide a cover that is transparent as taught by Dieguez et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
