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 .
Claims 1-22 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-6) in the reply filed on 12/02/2025 is acknowledged. Claims 7-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/02/2025.
Claims 1-6 were examined on their merits.
Claim Objections
Claim 1 is objected to because of the following informalities: The word “annular” should be inserted between the words “”the” and “layer” in line 9 of the claim. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The word “the” should be inserted between the words “from” and “plurality” in line 2 of the claim and between the words “of” and “second” in Line 3.
Claim 4 is objected to because of the following informalities: The word “annular” should be inserted between the words “”an” and “outer” in line 3 of the claim and between the words “the” and “inner” in line 4 of the claim. Appropriate correction is required.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Selahi et al. (11/23/2021).
Selahi et al. teaches perfusing a collagen hydrogel (substrate) comprising lymphatic muscle cells (LMC) into a microfluidic channel defined by an inner surface and extending along a longitudinal axis, then positioning the channel/substrate in a vertical orientation forming an acute angle between the longitudinal axis and the direction of gravity and culturing the cells in the device while the substrate is so positioned,
whereby an annular layer of the cells is formed in the channel and defines a lumen having an elliptical cross-section extending longitudinally through the channel (Pg. 123, Fig. 2 and Pgs. 129-130, Paragraphs 5.2 and 5.3), and reading on Claims 1, 2 and 6.
With regard to Claims 3 and 4, the reference further teaches culturing lymphatic endothelial cells (LEC) in the microfluidic channel, forming an annular inner layer surrounded by an annular outer layer of LMC positioned between the inner layer and the inner surface of the microfluidic channel (Pg. 125, Fig. 5A and Pg. 130, Paragraph 5.3).
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.
Claims 1-4, 5 and 6 are rejected under 35 U.S.C. § 103 as being unpatentable over Selahi et al. (11/23/2021).
The teachings of Selahi et al. were discussed above.
Selahi et al. did not teach a method comprising the sequential steps of:
forming a substrate that defines a microfluidic passage therein extending
along a longitudinal axis and defined by an inner surface;
culturing a plurality of second cells that are different from a plurality of first cells in the microfluidic passage whereby an annular layer of the plurality of second cells is formed in the microfluidic channel;
positioning the substrate in a vertical orientation whereby an acute angle
is formed between the longitudinal axis of the microfluidic passage and the direction of
gravity; and
culturing a plurality of first cells in the microfluidic passage while the
substrate is disposed in the vertical orientation whereby an annular layer of the plurality
of first cells is formed in the microfluidic channel, wherein the layer of the plurality of first
cells defines a lumen extending longitudinally through the microfluidic channel, as required by Claim 5.
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Selahi et al. wherein a first plurality of cells is cultured in the microfluidic channel forming an annular layer prior to culturing a plurality of different second cells in the microfluidic channel and forming an annular layer to reverse the process steps because the selection of any order of culturing the cells is prima facie obvious in the absence of new or unexpected results. See the MPEP at 2144.04, IV, C. Those of ordinary skill in the art would have been motivated to make this modification in order to form a desired order of cell layers in a coculture. There would have been a reasonable expectation of success in making this modification because the reference already teaches coculturing two cells types and a particular order of culturing the cells to form the coculture.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 12/17/2025