Prosecution Insights
Last updated: April 19, 2026
Application No. 18/374,415

Microfluidic Device And Method For Generating A Skin Construct

Non-Final OA §102§103
Filed
Sep 28, 2023
Examiner
BOWERS, NATHAN ANDREW
Art Unit
1799
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Wisconsin Alumni Research Foundation
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
91%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
796 granted / 1346 resolved
-5.9% vs TC avg
Strong +32% interview lift
Without
With
+32.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
66 currently pending
Career history
1412
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
54.3%
+14.3% vs TC avg
§102
14.3%
-25.7% vs TC avg
§112
16.7%
-23.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1346 resolved cases

Office Action

§102 §103
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. Claim Objections 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. Claims 11-23 are objected to because of the following informalities: there are two claims marked as claim no. 11. It is requested that Applicant renumber claims 11-23 as claims 11-24. Appropriate correction is required. Claims 11-13 are written as being dependent on “the method of claim 10”. Claim 10, however, is an apparatus claim. 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, 5, 6, 9 and 10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kamm (US 20140057311) . With respect to claim 1, Kamm discloses a device for tissue engineering comprising a body that includes a chamber defined by opposing first and second surfaces. The first surface and second surfaces are configured as sidewalls, and are spaced apart by the inner surface of a base and the inner surface of a cover . A fluidic network is created between the first and second surfaces and includes a first portion adapted for receiving a cell culture, a second portion adapted for receiving polymerizable material therein, and a third portion adapted for receiving a media therein. This is described in paragraphs [0109]-[0111]. The first, second and third portions are configured as flow channels separated by barriers, and the second portion is configured to accommodate a polymerizable hydrogel. The barriers form first and second flow restrictions that project from the inner surface and discourage flow of polymerizable material from the second portion. The first flow restriction is disposed between the first and second portions, and the second flow restriction is disposed between the third and second portions. It is further noted that limitations relating to how the claimed device is intended to be used (e.g., “for generating a skin construct”, “for receiving a cell culture”, “for receiving a polymerizable material”, “for receiving a media”) are afforded reduced patentable weight in the context of an apparatus claim. It is well established that apparatus claims cover what a device is, not what a device does . A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim . See MPEP 2114. With respect to claims 5 and 6, Kamm discloses the apparatus as described above. Kamm further shows in at least Fig. 1 that the lengths of the first and third portions are each greater than the length of the second portion. With respect to claims 9 and 10, Kamm discloses the apparatus as described above. Kamm further shows in Fig. 1 that the width of the second portion is greater than both the width of the first portion and the width of the third portion. 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. Claims 2-4, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kamm (US 20140057311) as applied to claims 1 and 5, and further in view of Kujala (US 20200269234) . Kamm discloses the apparatus as described above. Kamm further teaches that ports are provided for delivering cells, polymerizable materials and media through the first, second and third portions. See Fig. 1. Kamm, however, does not show that the sidewalls of the device are the inner walls and that first and second projections extend from the sidewalls to function as flow restrictions. Kujala discloses a device for tissue engineering comprising a body that includes a chamber configured to retain a polymerizable gel material suitable for supporting cell growth and development. Kujala states in paragraphs [0221] and [0228] that at least a first flow restriction and a second flow restriction project inwardly from the chamber sidewalls and serve to anchor the polymerizable gel material. Before the effective filing date of the claimed invention, it would have been obvious to provide the Kamm device with at least first and second projections that extend towards each other from sidewall surfaces for the purpose of restricting the movement of the polymerizable material to the second portion. Kujala teaches that projections oriented according to this configuration are beneficial because they may be used to anchor a gel matrix in a desired location in communication with cell and media flow channels. Kujala indicates that it is well within the ability of one of ordinary skill to position such flow restriction projections in a variety of configurations (“ The projections serve as anchors for the gel. The projections , in one embodiment, project outward from the sidewalls. The projections , in another embodiment, project upward. The projects, in another embodiment, project downward. The projections can take a number of forms (e.g. a T structure, a Y structure, a structure with straight or curving edges, etc.). In some embodiments, there are two or more projections ; in other embodiments, there are four or more projections to anchor the gel matrix ”). Claims 11 - 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kamm (US 20140057311) in view of Varone (US 20180346859) . Kamm discloses a method for tissue engineering in which a chamber in a body is provided, such that the chamber a fluidic network comprising a first portion adapted for receiving a cell culture, a second portion adapted for receiving polymerizable material therein, and a third portion adapted for receiving a media therein. This is described in paragraphs [0109]-[0111]. The first, second and third portions are configured as flow channels separated by barriers, and the second portion is filled with a polymerizable hydrogel. A cell media is deposited within the first portion, and a media is disposed in the third portion. The polymerizable material is discouraged from flowing through the barriers, however media is allowed to permeate the barriers from the first and third portions so that the media contacts the polymerized material in the second portion. Kamm, however, does not expressly state that a skin construct is formed in the first portion or that cell media is removed from the first portion to allow ambient air to interface with the skin construct. Varone discloses a method for generating a skin construct comprising the steps of providing a chamber in a body, filling a portion of the chamber with a polymerizable material (Figure 5D:550) and allowing the material to polymerize, and depositing cell media in another portion of the chamber and supporting a skin construct on the polymerized material. This is described in paragraph [0082]. Varone states that cell media is removed so that ambient air forms an interface with the skin construct. Before the effective filing date of the claimed invention, it would have been obvious to use the Kamm method to develop different biological tissue models, including skin constructs. Varone teaches that this may be accomplished by providing an open-top configuration that allows cells to communicate directly with ambient air, and thereby more accurately simulate in vivo conditions. Varone indicates that skin construct development and modeling is desirable because it allows one to simulate one or more functions of sk in , for example, in testing compound transport and absorption through the sk in , the effect of topical treatments on sk in aging or healing, modeling sk in disease, or observing sk in response such as damage or sensitization . Allowable Subject Matter Claims 14-23 are allowable over the prior art. The prior art does not disclose the claimed method for generating and imaging a skin construct. The Varone (previously cited), Tolias (US 20130143230), Warren (US 20090011455), Matheu (US 20190010463), Hinojosa (US 20260002109), Bigliardi (US 20190177678), Chien (US 20220403315) and Hannen (US 20210380912) disclose the state of the art regarding skin culturing methods and systems. These references, however, do not describe providing a chamber having first, second and third portions, loading the chamber in a horizontal position, orienting the chamber in a vertical position, and then establishing an air-liquid interface and imaging the skin construct. Although individual elements of the claim may be independently described in the prior art, there does not appear to be a suggestion or motivation to combine isolated teachings to arrive at the claimed combination. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Young (US 20230193182) reference teaches the state of the art regarding microfluidic tissue development systems. The Krauss (US 20240368517) reference teaches the state of the art regarding cell culture devices in communication with a movement system. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NATHAN ANDREW BOWERS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8613 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 7am-5pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Marcheschi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-1374 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
Read full office action

Prosecution Timeline

Sep 28, 2023
Application Filed
Mar 10, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
59%
Grant Probability
91%
With Interview (+32.2%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 1346 resolved cases by this examiner. Grant probability derived from career allow rate.

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