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 the Claims
This action is in response to the communication of 4/24/2026
Claims 1-20 are pending.
Claims 1-7, 15-20 are withdrawn.
Applicant’s election without traverse of group II claims 8-14 in the reply filed on 4/24/2026 is acknowledged. Claims 1-7, and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 8-14 are under examination.
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.
Kurn
Claims 8-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Ingber (US20180298317A1) (Provided in IDS of 1/22/2026)
As evidenced by Kurn (Kurn, Heidi; Daly, Daniel T. (2025), "Histology, Epithelial Cell", StatPearls, Treasure Island (FL): StatPearls Publishing )
Regarding claim 8, Ingber teaches an in vitro model of a blood-brain barrier using neurovascular cells seeded on a micropatterned extracellular matrix. For Ingber, the term “micropatterned” refers to a permeable matrix or scaffold material comprising at least one or more lumens. In some embodiments, Ingber’s matrix or scaffold material can comprise a gel or hydrogel. (Ingber [0188, FIG 2A, Example 1]). Thus, Ingber teaches that their system comprises a micropatterned matrix on a substrate, supporting attachment of biological cells.
Ingber teaches that to create the blood-brain-barrier device, at least one or more endothelial cell-lined or pericyte/endothelial cell-lined lumens can be formed in the first permeable matrix disposed in the first channel. (Ingber [0191], Example 1). Thus, Ingber teaches a plurality of biological cells in a layer upon the micropatterned matrix.
Ingber teaches that in some embodiments, the first channel can be filled with a pericyte-containing viscous solution of collagen I (e.g., at a concentration of about 5 mg/ml). It is contemplated that other gels of proteins and synthetic material may also be used including, but not limited to, MATRIGEL®, high concentration laminin, fibrin gels, pluronic gel, porous plastic materials, polymeric matrices, or any combination thereof. (Ingber [0192], Example 1). Thus, Ingber teaches a medium in contact with the cells, the medium comprising suspended matrix (pericyte-containing solution comprising collagen).
Further regarding the limitations of a 1) micropatterned matrix for supporting cells and 2) overlaying a medium/ suspended matrix onto those cells, a better figure to illustrate Ingber’s disclosure may be FIG 7.A. Here Ingber’s Collagen gel (micropatterned matrix) is formed around a central liquid flow artery, comprising a second less viscous medium/suspended matrix. According to FIG 2B, Ingber’s method of forming this scaffold comprises forming a hollow tube within a block of hydrogel (“permeable matrix”), and then seeding this tube with cells/ and causing media to flow through the structure formed by the solid hydrogel. (Fig 2B, 7A). In any event, this embodiment at least reads on the “micropatterned matrix” and “medium comprising suspended matrix” components of claim 1.
Thus, Ingber anticipates claim 8.
Regarding claim 9, Ingber teaches that in some embodiments, in these embodiments, the lumen(s) can be lined with tissue-specific cells (e.g., ductal epithelial cells) (Ingber, [0022])
Regarding claim 10, As discussed in MPEP § 2112, citing In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594), the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, there is reason to believe that Ingber’s ductal epithelial cells fall into one of the three epithelial cell shape categories, since they are epithelial cells. There are three principal shapes of epithelial cell: squamous (scaly), columnar, and cuboidal. (Kurn). So, as epithelial cells, it is reasonable that Ingber’s ductal epithelial cell falls into one of the three epithelial cell shapes.
Regarding claim 11, Ingber teaches that the condition of the endothelial cell monolayer can be assessed by staining for any art-recognized cell-cell adhesion markers in endothelial cells including, but not limited to, VE-cadherin. (Ingber [0114]). Thus, Ingber teaches that their cells express adhesion molecule proteins (in that Ingber teaches detecting them to discern the condition of the interconnected cell monolayer).
Regarding claim 12, Ingber teaches that in some embodiments, the lumen(s) can be lined with at least one layer of cells comprising blood vessel-associated cells and/or tissue-specific cells (e.g., tissue-specific epithelial cells). Examples of blood vessels-associated cells include, but are not limited to, endothelial cells. (Ingber [0017]). Thus, Ingber teaches that the plurality of cells may be endothelial cells.
Regarding claim 13, Ingber teaches that the micropatterned matrix may be a hydrogel or gel. (Ingber, [0188]). Ingber then specifies that the hydrogel may comprise collagen (Ingber [0028])
Regarding claim 14, Ingber teaches that their “viscous solution” component (i.e., suspended matrix medium) may comprise collagen I, laminin, fibrin gels, pluronic gel, porous plastic materials, polymeric matrices, or any combination thereof. (Ingber, [0192])
Conclusion
Claims 8-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS R. AMICK/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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