DETAILED ACTION
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
Claims 1-18 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group I, Claims 1-16, and with traverse of species allowing the gel to form a tissue further comprises controlling the contraction of the tissue (claim 8), and for implantation in a human or animal (claim 11), in the reply filed on 11/20/2025 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 § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-7 and 13-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1-4 and 8-12 are being examined in this application, insofar as they read on the elected species of allowing the gel to form a tissue further comprises controlling the contraction of the tissue (claim 8), and for implantation in a human or animal (claim 11).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 8-12 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Hoerstrup et al (WO 2019/042961 A1; 3/7/2019. Cited on IDS.).
The instant claims recite a process for producing regenerative tissue comprising combining extracellular matrix-producing cells with fibrinogen monomer and a polymerization catalyst, and allowing a fibrin gel to form; allowing the gel to be compacted by cells; allowing the fibrin to degrade to produce a cell-containing and ECM-containing tissue; and decellularizing the tissue, thereby forming a regenerative decellularized tissue.
Hoerstrup teaches a method for producing a tissue-engineered medical device (TEMD) (regenerative tissue) (Abstract, p.6 line 2-4), comprising combining fibroblasts (extracellular matrix-producing cells) (p.6 line 11-12, p.21 line 19) with fibrinogen and thrombin (a polymerization catalyst) to form a cell suspension (allowing a fibrin gel to form) (p.8 line 7-9, p.21 line 21-22), immediately after addition of thrombin, coagulation occurs, which results in an attachment of the cells to a polymer scaffold (allowing the gel to be compacted by cells) (p.8 line 13-14, p.21 line 25-26), during the presence of the TEMD in a bioreactor, an extracellular matrix (ECM) is formed (allowing the fibrin to degrade to produce a cell-containing and ECM-containing tissue, wherein the cells produce ECM and produce chemicals that clip fibrin fibers) (p.9 line 13-14), and the TEMD is decellularized (p.9 line 29). During the bioreactor phase the TEMD has the tendency to contract, most likely due to the formation of ECM, the mounting on a stabilizer is therefore useful to re-establish the original shape of the TEMD (p.9 line 1-6 & 20-22). The cells are seeded in a homogenous manner along the inner surface of a tubular polymer scaffold (p.8 line 20-21). The TEMD is subjected to a sterilization step (p.11 line 1). The TEMD is a vascular graft, a leaflet valve, or a tissue patch (p.3 line 24-26, p.16 line 23-25).
Therefore the reference anticipates the claimed subject matter.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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