DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
3. Applicant’s election without traverse of Group/Invention I – claims 1-9 and 28-32 (drawn to an isolated dehydrated corneal tissue) in the reply filed on 10 November 2025 is acknowledged.
4. Dependent claim 28 depends from WITHDRAWN claims 10 to 27 (i.e., “according to the method of any of claims 10 to 27”).
Therefore, claims 10-28 and 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups/inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 November 2025.
Claim Objections
5. Claims 4-9 and 29-32 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only--, and/or, --cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 4-9 and 29-32 have not been further treated on the merits.
Additionally, claims 29-32 indicate a potential dependency on a WITHDRAWN claim (i.e., claim 28).
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Regarding claim 1, the recitation “wherein the stroma contains cellular material” (lines 2-3) is vague and unclear, rendering claim 1 indefinite as to the scope of the invention.
(i) It is not entirely clear what exactly is meant by “cellular material”. Said “cellular material” will be broadly interpreted as any material derived from cells.
(ii) At present, it is assumed the dehydrated corneal tissue of independent claim 1 does not comprise living or viable cells.
Claims 2-3 depend from claim 1.
b. Regarding claim 32, the recitation “for the use of claim 31” (preamble) is vague and unclear, rendering claim 32 indefinite as to the scope of the invention.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Wang et al. (CN 104 001 215; presented in Applicant’s IDS) or, in the alternative, under 35 U.S.C. 103 as obvious over Wang et al. (CN 104 001 215; presented in Applicant’s IDS) in view of Dong et al. (WO 2018/107485 A1; cited in PTO-892 of 11 June 2025).
Regarding independent claim 1, Wang et al. ‘215 discloses an isolated dehydrated corneal tissue, wherein harvested animal cornea is put into water and shaked to make the epithelial layer fall off. Subsequently the water is replaced by a decellularization reagent and shaked. Water and decellularization reagent are used alternately to make stromal cells and endothelial cells fall off. A dehydrating agent is added to obtain a decellularized cornea. The decellularized cornea was cut to obtain an acellular corneal stroma - see paragraphs [0029]-[0055].
Therefore, Wang et al. ‘215 discloses an isolated dehydrated corneal tissue comprising a full thickness corneal stroma, and substantially all, or all, of the Bowman's membrane (i.e., the “front elastic layer” – Abstract), wherein the stroma contains cellular material (e.g., any remnants or residue(s) from keratocytes/fibroblasts).
Further, this is already well known in the art. For example, Dong et al. ‘485 discloses a decellularized dried swine lamellar cornea, constituted by the anterior elastic lamina and the stroma of swine cornea; wherein the stroma retains a regularly arranged structure of collagen fibers (i.e., cellular material); and wherein the water content of the dried cornea is no greater than 20% (Abstract). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the stroma contains cellular material, as taught by Dong et al. ‘485, with the invention of Wang et al. ‘215, in order to obtain an optimal combination of essential characteristics of a cornea product, and facilitated is the implementation of normativeness in the quality of a decellularized dried swine cornea product (Abstract).
Regarding claim 2, since the method of Wang et al. ‘215 emphasis (i.e., target) is removal of epithelial layer and/or endothelial layer, with NO indication of removal of posterior membrane/ lamina (i.e., Descemet’s membrane), then the tissue comprises some of the Descemet's membrane (at the least, as remnant or residual Descemet's membrane).
Regarding claim 3, Wang et al. ‘215 discloses wherein the tissue does not comprise an epithelium or an endothelium (paragraphs [0029]-[0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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