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 .
Response to Arguments
Applicant's arguments filed March 23, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 27 to recite a flow path having a constant width from the inlet to the outlet, and argued that reference to Grisham et al., (US 2017/0209864) does not teach the limitation of the amended claim. Th Examiner respectfully disagrees.
With respect to claim 27, Applicant has argued that reference to Grisham et al., teach obstacles formed in a channel, and therefore does not teach a flow path having a uniform width. The Examiner notes that the width of the flow path is determined by the width of the channel, and contends that the obstacles taught by Grisham et al., do not alter or change the overall width of the channel. As such, the Examiner has not found Applicant’s arguments regarding the width of the flow path to be persuasive.
Applicant has also argued that reference to Grisham et al., teaches multiple outlets, and therefore does not teach a fluid that flows from an inlet to an outlet. Here, the Examiner contends that Applicant’s arguments are not commensurate with the scope of the claim as claim 27 does not require a device having a single inlet or outlet. Given this view, the Examiner has not found Applicant’s arguments regarding the number of outlets taught by Grisham et al., to be persuasive.
With respect to claim 36, Applicant has argued that Grisham et al., teach collecting cells separately, and therefore does not teach the limitation of “collecting at the outlet of the flow path, the fluid containing all of the dissociated cell mass.” The Examiner again notes that the claim does not require a single outlet, thus collecting all the dissociated cell mass at multiple outlets, or separately still reads on the claim. As such, Applicant’s arguments regarding claim 36 are not persuasive. With respect to claim 37, Applicant has amended the claim to recite a cell mass being reciprocated in the flow path, and argued that Grisham et al., do not teach the amended limitation. . The Examiner notes that the amendments to claim 37 are indefinite as the instant specification does not define or describe what it means for a cell mass to be “reciprocated” in a flow path. As such, the Examiner is unable to determine the metes and bounds of claim 37.
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 Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the process steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 37, the term “reciprocated” is unclear as the specification does not define or describe what “reciprocated” means. The Examiner believes that Applicant intends to describe a back and forth flow of the cell mass through the flow path, but notes that specification does not provide a definition for “reciprocated” thus the broadest reasonable interpretation is a flow in which the cells do not flow unobstructed through a flow path. Given this view, the Examiner contends that cells flowing past the obstacles in the channel of Grisham et al., meets the claim limitation.
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.
Claim 37 is 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.
For claim 37, the metes and bounds for the term “reciprocated” cannot be determined as the specification does not define or describe what “reciprocated” means. For the purposes of examination, the Examiner has interpreted reciprocated as meaning a flow in which cells do not flow unobstructed through a flow path. Given this view, the Examiner contends that cells flowing past obstacles in the channel of Grisham et al., meets the claim limitation.
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, and 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grisham et al., (US 2017/0209864).
For claim 27, 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). 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 claim 37, Grisham et al., teach cells flowing past an array of obstacles that deflects cells in a flow stream (paragraphs 0085, 0087-0089) which reads on the cells being reciprocated in the flow path. The Examiner notes that the claim is being read in light of the rejection under 35 U.S.C. 112(b) in which the term “reciprocated” is indefinite.
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).
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 Page 7 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.
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 DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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