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 .
Status of claims
Claims 41-48 (preliminary amendment) as filed on 2/29/2024 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 112
Claims 41-48 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 41 recites the limitation "said lower channel” in step c). There is insufficient antecedent basis for this limitation in the claim that solely recites the first and second channels.
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 41-48 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 2017/0101628 (Ingber et al).
US 2017/0101628 (Ingber et al) teaches a method for co-culturing mammalian cells and anaerobic bacteria in a microfluid device (abstract and par. 0014).
The cited method comprises steps of:
A) providing:
i) a microfluidic device comprising a first microchannel and a second microchannel separated by a membrane, said membrane comprising first and second sides, wherein said first side serves as a surface for said first microchannel and said second side serves as a surface for said second microchannel (see figure 5, for example);
ii) a plurality of living mammalian cells comprising intestinal epithelial cells (figure 5; par. 0106) and/or colon epithelial cells (such as Caco-2 cells, par. 0106, par. 0200);
ii) a plurality of anaerobic bacterial cells (par. 0112, 0013); and
iv) endothelial cells (figure 5, par. 0107; par. 0200);
B) seeding said living mammalian cells on said first side of said membrane in said microfluidic device so as to provide a cell layer comprising said living mammalian cells, and having a barrier function (figure 5, par. 0107);
C) producing or establishing “oxygen gradient” in the first microchannel (par. 0116, lines 10-12) while culturing the endothelial cells in the second microchannel under flow of media containing oxygen (see par. 0116, last 2 lines). As a result of providing oxygenated media in the second channel and creating anaerobic conditions in the first channel, the endothelial cells consume oxygen from the media, oxygen in the media diffuses into the cell layer of the first channel and is consumed by the basal end of epithelial cells and is depleted in the apical end of epithelial cells in the cell layer of the first channel, thereby, producing a gradient of oxygen the first microchannel within the broadest reasonable method of the claims;
d) contacting the epithelial cell layer with bacterial cells (par. 0111), wherein bacterial cells are from intestine or gut of mammalians (0111); and thus, the bacterial cells are inherently capable to adhere to the intestinal epithelial cells in the first channel within the broadest reasonable method of the claims; and
e) culturing the anaerobic bacteria “without an anaerobic chamber” within the meaning of the claims. This is practiced because anaerobic conditions in the first chamber are established after sealing the first channel so that the only points of entry or exit to the first chamber are the pores of membrane (page 14, col. 2, lines 1-5), wherein concentration of oxygen, if originally present, is reduced by aerobic bacteria in the inoculum of gut derived bacteria (par. 0117, last 3 lines). Or, in alternative embodiment, an inert gas is flowing through the channel (see par. 0117, lines 5-3 from the bottom of the paragraph). Or, in one more alternative embodiment, the use of “anaerobic chamber” in the first channel is/can be eliminated by occupying the whole first channel with a fluid of media (par. 0116, lines 4-5).
Thus, the cited US 2017/0101628 (Ingber et al) anticipates claim 41.
As applied to claim 42: the culturing of seeded gut bacteria of step d) can be done in the presence of some oxygen such as “hypoxic conditions” (page 14, col.2, lines 1-2).
As applied to claims 43-44: “a portion of said microfluidic device is oxygen permeable” or “oxygen impermeable” since the use of the device in the cited method allows for presence of oxygen as well as for absence of oxygen inside the device.
As applied to claims 45-46: the cited method further comprises flowing a first fluid in the first microchannel and is/might be deoxygenated (par. 0017, lines 1-2).
As applied to claim 47: in the cited method the fluid in the second microchannel is oxygenated (par. 0116, last 2 lines).
As applied to claim 48: in a particular embodiment the cited document discloses the use of colon epithelial cells such as Caco-2 cell line (0200) but the cited document also teaches the use of “primary” intestinal epithelial cells of large intestines that would be colon cells (par. 0106, liens 12-14).
Thus, the cited US 2017/0101628 (Ingber et al) anticipates the claimed method.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila 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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Vera Afremova
February 17, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653