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 .
Applicant is requested to note that the Examiner for this application has changed.Future correspondence should be directed to Laura Schuberg, Art Unit 1631, whosecontact information can be found below.
This action is responsive to papers filed 04/24/2026.
Claims 1-22 are currently pending.
Claims 3-6, 9 and 12 have been amended. No claims have been newly added or newly canceled.
Election/Restrictions
Applicant’s election of Group I (claims 1-12 and 21-22) in the reply filed on 04/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s reference to a species election appears to be a mistake as the restriction mailed out did not include a specie election requirement.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/24/2026.
Claims 1-12 and 21-22 have been examined on their merits.
Drawings
The renewed petition for color drawings filed 03/25/2024 has been reviewed and granted with the petition decision filed 04/19/2024.
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.
Claim(s) 1-2, 4, 6-10, 12, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bual et al (Materiala 2018) as evidenced by Ijima et al (Gels, 2018).
Regarding claims 1-2, 7, 9-10, Bual disclose liver-derived extracellular matrix nanofibers used as a scaffold for in vitro culture of primary hepatocytes that are electrospun and the liver ECM is obtained from decellularized porcine liver tissue (Title, page 519-520, sections 2.1-2.3).
Regarding claim 4, Bual disclose wherein their decellularized ECM liver fiber contains collagen. Ijima provide evidence that the extracellular matrix of decellularized liver inherently contains collagen type I (page 2 section 2.1-page 4 section 2.2, Figure 2).
Regarding claim 6, Bual disclose wherein polymer chains within the fiber are crosslinked (page 520 section 2.4-2.5).
Regarding claim 8, Bual disclose a device comprising the fiber wherein the device is a microwell of a cell culture plate (page 520 section 2.6.3).
Regarding claim 12, Bual disclose wherein the in vitro liver cell culture is used for testing drug metabolism (page 520, section 2.6.1-2.6.4) and thus is suitable for use as a liver model system for drug or chemical screening system.
Regarding claim 21, Bual disclose wherein their liver ECM fiber is obtained from a decellularized porcine ECM, dissolved in a solvent and electrospun to form a fiber (page 519-520 sections 2.1-2.3).
Therefore, the teaching of Bual et al anticipates Applicant’s invention as claimed.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-5, 11 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bual et al (Materiala 2018) in view of Atala et al (US 2006/0204445).
Regarding claims 3-5, Bual disclose liver-derived extracellular matrix nanofibers used as a scaffold for in vitro culture of primary hepatocytes that are electrospun and the liver ECM is obtained from decellularized porcine liver tissue (Title, page 519-520, sections 2.1-2.3).
Bual disclose embodiments wherein the fibers containing liver ECM are less than 1 micron (nanofiber) or greater than 1 micron (microfiber) (see Figure 2A), but do not specifically disclose wherein the fiber has an average diameter of 1000 nm (1 micron microfiber) or an average diameter of 200 nm (nanofiber) or wherein the fibers further include collagen type I.
Atala disclose methods and composition for monitoring remodeling of an artificial tissue construct using a three-dimensional matrix scaffold of interconnected fibers (abstract, page 1 para 6-12), wherein the matrix is an electrospun matrix and a decellularized matrix (page 1 para 12). The decellularized matrix is obtained from liver (page para 29, para 31) and used to culture liver cells (page para 118). The fibers can have a diameter of about 200 nanometers or 1000 nanometers (1 micron) (page para 64). The matrix can further comprise collagen selected from a group consisting of collagen I (page para 10).
One of ordinary skill in the art would have been motivated to include fiber diameters with an average diameter of about 1000 nm or 200 nm in the liver ECM fibers of Bual because Atala teach and suggest that these are suitable and desirable fiber diameters for a decellularized ECM fiber matrix intended for cell culture. One of ordinary skill in the art would have been motivated to further include fibers comprising collagen type I in the liver ECM fibers of Bual because Atala teach and suggest that these are suitable and desirable for a decellularized ECM fiber matrix intended for cell culture. One of ordinary skill in the art would have had a reasonable expectation of success because both Bual and Atala are directed to liver-derived extracellular matrix fibers that are electrospun and have an intended use as a scaffold for in vitro cell culture and the liver ECM is obtained from decellularized liver tissue.
Regarding claims 11 and 22, Bual do not specifically disclose the use of supportive cells in the in vitro liver cell culture comprising the fibers.
Atala disclose that it is desirable and beneficial to include cells that are capable of supporting growth and development of at least one additional cultured cell population (page para 30).
One of ordinary skill in the art would have been motivated to include supporting cells in the in vitro liver cell culture comprising electrospun liver-derived fibers of Bual because Atala teach that it is beneficial to include cells that are capable of supporting growth and development of at least one additional cultured cell population (page para 30). One of ordinary skill in the art would have had a reasonable expectation of success because both Bual and Atala are directed to liver-derived extracellular matrix fibers that are electrospun and have an intended use as a scaffold for in vitro cell culture and the liver ECM is obtained from decellularized liver tissue.
Therefore, the combined teachings of Bual et al and Atala et al render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Otsuka et al., “Contribution of Fibroblasts Cultured on 3D Silica Nonwoven Fabrics to Cocultured Hepatocytes Function”, Chemistry. Letters. 2014, Vol. 43, pp. 343–345. (Regarding the use of fibroblasts as a supportive cell type for hepatocytes).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631
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