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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 26-29, and 37-39) in the reply filed on 07/17/2025 is acknowledged.
Claims 1-25, and 30-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 on07/17/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was filed before the mailing date of the non-final first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(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 26-29, 37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaacson et al (Experimental Eye Research, 2018), as evidenced by Advanced BioMatrix product data sheet.
Regarding claim 26, Isaacson et al disclose a 3D bioprinting method for producing artificial corneal stromal equivalents with the same curvature, thickness, and transparency as recited in instant claim. The method of Isaacson et al involves bioprinting corneal keratocytes encapsulated in composite bioink comprising of natural alginate and methacrylated type I collagen. Isaacson et al’s method also involves employing a support structure with an anatomically fabricated corneal scaffold that closely resembles human corneal anatomy to generate curved corneal stromal equivalents. (See Fig.1 F, and sections “2.1.” and “3.1.). Isaacson et al demonstrate that the thicknesses of the 3D bioprinted corneal constructs are dependent on the nozzle diameter. As such, using a 200 µm nozzle generates corneal constructs with central and peripheral thickness of 609.4 µm and 711.2 µm, respectively, while a 300 µm nozzle generates constructs with 518.5 µm and 584.7µm. Therefore, Isaacson et al’s corneal constructs have a thickness more than 50 µm. Isaacson et al further explain that the printed corneal constructs were generated using a support structure with a corneal scaffold, which has a horizontal diameter of 12.385 mm. In the drawing section of instant disclosure, a scaffold with 12mm diameter has a curvature (k) of 0.16. (See the table incorporated in Fig.1 of instant disclosure). Therefore, Isaacson et al’s method generates corneal constructs with 0.16 mm-1, which falls within the recited numerical range of 0.04 to about 0.5 mm-1. (See section 2.1.). Isaacson et al do not provide a visible light transmittance value for the corneal constructs, however Isaacson et al demonstrate that the generated corneal constructs demonstrated a high degree of transparency. (See Fig.2G). Isaacson et al also teach using stromal cell isolated from human corneal stromal cells (i.e. first species), this reads on element (a) of instant claim. (See section 2.4.). In addition, the method of Isaacson et al involves encapsulating the stromal cells in a hydrogel comprising methacrylated type I collagen. Isaacson et al disclose collagen I obtained from Advanced Biomatrix as a source of the methacrylated type I collagen. According to The Advanced Biomatrix product data sheet , collagen type I is derived from bovine (i.e. second species). It should be noted that collagen I is an extracellular matrix that has a naturally occurring cell adhesion motif. Thus, using hydrogel comprising of collagen I extracted from bovine, reads on the presence of cell adhesion motif from a second species. (See Biomatrix product data sheet on page 2).
Regarding claims 27-29, Isaacson et al’s corneal constructs comprise of human corneal keratocytes ( also referred to it as corneal fibroblasts) encapsulated in collagen I extracted from bovine.
Regarding claims 37 and 39, The method of Isaacson et al involves encapsulating the human keratocytes in hydrogel comprising of collagen I, which is an extracellular matrix protein containing natural cell adhesion motif, and wherein the collagen is extracted from bovine (i.e. second species).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al (Experimental Eye Research, 2018), in view of Echalier et al ( Material Today, 2017).
The teachings of Isaacson et al are set forth above. Isaacson et al anticipated claims 26-29, 37 and 39.
Regarding claim 38, The method of Isaacson et al do not involves encapsulating stromal cells in hydrogel comprising synthetic adhesion motif.
Echalier et al demonstrate how to prepare fully synthetic hydrogel that mimics collagen by utilizing a peptide derived from a common collagen repeat (Pro-Hyp-Gly). The method of Echalier et al also involves chemically modifying the peptide so that it can undergo a sol-gel process in a physiological buffer, allowing for the embedding of stem cell in the matrix. Echalier et al demonstrate that the resulting hydrogel provides an environment comparable to the natural collagen in terms of cell growth, making it potentially useful as a biomimetic scaffold for bioprinting and tissue engineering applications. (See abstract, conclusion, and Figs.4-5). Echalier et al state that “the natural polymers are usually costly, they encounter low batch-to-batch reproducibility, microbial contaminants during the isolation process and potential immunogenicity in the case of animal extracts” and propose the use of the synthetic hydrogels to overcome such issues. Therefore, claim 38 would have been obvious to one of ordinary skill in the art at the time the invention was filed, as there was some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art
reference or to combine prior art reference teachings to arrive at the claimed invention. Isaacson et al used 3D bioprinting to create artificial corneal stromal equivalents by encapsulating corneal keratocytes in composite bioink comprising of natural alginate and collagen I. Echalier et al demonstrate how to make fully synthetic hydrogel capable of providing an environment comparable to the natural collagen in terms of cell growth, and directly suggest that synthetic hydrogels could be useful as a biomimetic scaffold for bioprinting and tissue engineering applications. Therefore, there is a reasonable expectation of success in replacing the natural hydrogel comprising of natural extracellular matrix protein, such as collagen, with a synthetic hydrogel comprised of synthetic collagen peptides, because doing so would avoid the purification problems associated with the extraction of natural biopolymers.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638