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 .
The amended claims dated 12/1/2025 are under consideration.
The amendments and arguments presented in the papers filed 12/1/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 9/2/2025 listed below have been reconsidered as indicated.
a) The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendments.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Election/Restrictions
Applicant elected without traverse Group I, claims 1-4, 8, 9 and 12-15, in the reply filed on 3/26/2024.
Claims 16-18, 20-21 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/26/2024.
The election of species requirement from 2/5/2024 was previously withdrawn.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the body of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on the submitted IDS(s), they have not been considered.
Claim Interpretation
The term “diaphragm” is interpreted in view of the instant specification’s description in lines 1-5 on page 5.
Claim 15 recites “other cell types selected from pluripotent cells and central nervous, peripheral nervous, lymphoreticular, immune, urinary, respiratory, reproductive, gastrointestinal, endocrine, skin, musculoskeletal, cardiovascular, and mammary cell types”. The claim is interpreted as encompassing “other cell types selected from pluripotent cells, central nervous [cell types], peripheral nervous [cell types], lymphoreticular [cell types], immune [cell types], urinary [cell types], respiratory [cell types], reproductive [cell types], gastrointestinal [cell types], endocrine [cell types], skin [cell types], musculoskeletal [cell types], cardiovascular [cell types], and mammary cell types”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4, 8 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The following are new rejections necessitated by amendments to the claims.
The above claims depend from claim 27, which is not a “claim previously set forth”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Independent claim(s) 27 and dependent claims 2, 4, 8, 9 and 12 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Webster (WO 89/05417; previously cited).
The following are new rejections necessitated by amendment to the claims.
Regarding independent claim 27, the claim uses the term “microfluidic”, which is interpreted in view of the specification as being in the sub-millimeter range (p. 4 of the specification as originally filed).
Webster teaches a microfluidic device that involves “sub-millimeter” dimensions, e.g. 0.03 inches (0.762 millimeters) and 0.005 inches (0.127 millimeters) (p. 14).
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The device is depicted in Fig. 2 of Webster. The claimed structural elements are mapped using reproductions of Fig. 2 below.
The device includes a “base” or valve body portion 4 highlighted below:
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The device includes a “microfluidic channel” in the form of the elongated passageway made up of elements 22, 40 and 20 highlighted below:
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The device includes “a cover” in the form of upper body portion 2 highlighted below:
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The base of the device includes a “non-porous diaphragm” in the form of flexible valve sheet member 8 highlighted below:
The flexible valve sheet member 8 forms an inner surface of the elongated channel as it passes through the void 40.
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The channel has a capillary pressure barrier, which is a “ridge protruding form an internal surface of the microfluidic channel” as highlighted below:
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The channel has a sub-volume defined by the flexible valve sheet member 8 and the capillary pressure barrier as highlighted below:
The base is configured to operatively connect the flexible valve sheet member 8 to a pressure & vacuum source as a “source of positive or negative pressure” as highlighted below:
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Regarding claim 2, the above identified flexible valve sheet member 8 of the device is an “elastomer” because it is flexible and as noted above it defines at least part of the surface of the sub-volume characterized above.
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Regarding claim 4, the valve body member 4 comprises an “aperture” in the form of passageway 50 highlighted below:
The flexible valve sheet member 8 does not extend the entire length of valve body member 4 as depicted above.
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Regarding claim 8, the device includes a second sub-volume comprising a flow channel and a third sub-volume that is separated by the sub-volume noted above. The two other sub-volumes are highlighted below:
Regarding claim 9, the device includes a “well” in the form of conduit 12 and the left “sub-volume” extends into this well.
Regarding claim 12, the device the above depicted “sub-volumes” that are defined in part by flexible valve sheet member 8. The “sub-volumes” are confined by a capillary pressure barrier in the form of the interface between conduits 12 and elongated passageways 22 or 20.
Examiner’s response to the traversal of the 102 rejections
The Remarks argue Claim 1 has been cancelled, and the remaining claims have been made dependent on claim 27, which the Examiner deems to be allowable (p. 7).
The arguments have been fully considered but are not persuasive. Claim 27 as presented in the 7/11/2025 claims was considered allowable and the Examiner’s previous comment is rendered moot by the amendments to claim 27.
The Remarks argue claim 27 is amended to recite that the capillary pressure barrier comprises "a ridge protruding from an internal surface of the microfluidic channel; a groove in an internal surface of the microfluidic channel; a region of material of different wettability to an internal surface of the microfluidic channel; or a plurality of pillars at regular intervals." The Remarks further argue none of the cited documents teach or suggest the features of claim 27 as amended. See p. 7 and 8.
The arguments have been fully considered but are not persuasive. Claim 27 is rejected as Webster teaches a “ridge protruding from an internal surface of the microfluidic channel” as described above, thus teaching a structural element that satisfies the structure of a “capillary pressure barrier” as defined in the claim.
Conclusion
Claims 3 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 3 and 15 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682