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 .
Remarks
The amendments and remarks filed on 04/21/2025 and 10/01/2025 have been entered and considered. 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 rejections and/or objections presented herein are the only rejections and/or objections currently outstanding. Any previously presented objections or rejections that are not presented in this Office Action are withdrawn. Claims 1-14 are pending; Claim 15 is cancelled; Claims 1 and 11 are amended; and Claims 1-14 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/21/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Withdrawal of Objections
The objection to the specification is withdrawn due to the amendment to the specification filed on 10/01/2025.
Withdrawal of Rejections
The rejection of claims 1-6, 11, and 15 under 35 U.S.C. 112(b) is withdrawn due to the amendment to or cancellation of the claims filed on 04/21/2025.
The rejection of claims 11 and 15 under 35 U.S.C. 112(d) is withdrawn due to the amendment to or cancellation of the claims.
The rejection of Claims 1-15 under 35 U.S.C. 103 as being unpatentable over Gurtner et al. in view of Suzuki et al. and Alves et al. is withdrawn due to Applicant’s persuasive arguments in the 04/21/2025 response (page 7/paras 2-3). Specifically, as Applicant pointed out, Gurtner et al. teach printing protein ligands on the surface of the collagen-pullulan hydrogel (i.e. on the top of the hydrogel), but not mosaic distribution of solid films/membrane matrix in the hydrogel. There is no evidence to support that films possibly formed from printed protein ligands become deformed via dynamic liquid surface tension and deformed films further enclose the cell population into the hydrogel of Gurtner et al. Accordingly, the combined teachings of the cited prior art do not render the claims to be obvious.
Claim Interpretation
Claims 2 and 8 recite the limitation “a super hydrophobic material”. The interpretation of this term is according to Applicant’s clarification based on the Wikipedia document (retrievable from the URL: https://en.wikipedia.org/wiki/Ultrahydrophobicity, and cited in pages 7-8 of the 04/09/2020 response in the parent Application #14/973283), Specifically, the term “super hydrophobic material” is interpreted as a material having superhydrophobic surfaces, on which the contact angles of a water droplet exceed 150°.
Double Patenting
Claims 1-14 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US 11174460 in view of Altman et al. (Stem Cells 2009, 27:250 –258, cited in IDS) and Wong et al. (Macromol Biosci, 2011, 11(11): 1458 – 1466, cited in IDS). This rejection is maintained.
The claims of the ‘460 patent are directed in part to a method of seeding stem, progenitor and/or tissue specific cells, comprising: providing an aqueous solution having a cell population comprising stem, progenitor and/or tissue specific cells, maintained or suspended within the aqueous solution to form an aqueous cell mixture solution; providing a superhydrophobic substance and placing the aqueous cell mixture solution on or in the superhydrophobic substance; placing a porous hydrogel or bioscaffold comprising a lyophilized 5% collagen in a pullulan hydrogel, which has a mosaic distribution of a solid film or membrane matrix, into contact with the aqueous cell mixture solution that is placed on or in the hydrophobic substance such that at least a portion of the cell population is drawn via a capillary force into micropores of the porous hydrogel or bioscaffold, and each solid film or membrane matrix deforms around the aqueous cell mixture solution and the portion of the cell population via the capillary force; and maintaining contact of the porous hydrogel with the aqueous solution such that the aqueous solution and the portion of the cell population are enclosed within the deformed solid film or membrane matrix via dynamic liquid surface tension, such that the aqueous solution and the portion of the cell population are retained/engrafted within the porous hydrogel or bioscaffold; wherein the hydrophobic substance is a hydrophobic patterned wax material, a super hydrophobic material, a hydrophobic liquid, or a perfluorocarbon liquid; wherein each solid film or membrane matrix is a collagen, silk, or other polymer microdomain; wherein each solid film or membrane matrix is a biodegradable microfilm; wherein the aqueous cell mixture solution comprises an aqueous nutrient medium that is placed on top of the superhydrophobic substance; wherein the porous hydrogel is a hydrated and washed lyophilized collagen-pullulan hydrogel; wherein the bioscaffold is a dry carbohydrate gel, and wherein the mosaic distribution of the solid film or membrane matrix is imprinted on the dry carbohydrate gel; wherein the cell population comprise adipose-derived mesenchymal stem cells or bone marrow-derived mesenchymal stem cells; and wherein the adipose-derived mesenchymal stem cells or bone marrow-derived mesenchymal stem cells comprise autologous cell sources.
Regarding the step of providing a hydrophobic substance within a tray recited in the instant claim 1, the claimed method of the ‘460 patent necessarily and inherently comprises providing a container/tray and placing the hydrophobic substance within the container/tray, because the liquid aqueous medium and hydrogel must be contained in a tray/container for the seeding.
The claimed method of the ‘460 patent differs from the instantly claimed method in that the claims of the ‘460 patent do not expressively describe the cell-engrafted porous hydrogel or bioscaffold as being a dressing, and the porous hydrogel is sized for placement within or upon a wound. However, it would have been obvious to apply the adipose-derived stem cell-engrafted porous hydrogel or bioscaffold produced by the method of the ‘460 patent as a dressing for treating a wound, wherein the porous hydrogel is sized for placement upon the wound, because it is well known in the art that a porous hydrogel or bioscaffold engrafted with adipose-derived stem cells (ASCs) enhances wound repair in animals, as supported by Altman et al., who demonstrate that a ASCs-seeded bioscaffold enhances wound repair after being applied to a wound in a mouse (title, abstract, Fig. 1). Furthermore, the pullulan hydrogel comprised in the porous hydrogel or bioscaffold in the method of the ‘460 patent has the benefit of improving stem cell delivery into wounds, as supported by Wong et al., who demonstrate that pullulan hydrogels improve stem cell delivery into high-oxidative stress wounds (title, abstract).
Therefore, in view of the teachings of the cited prior art, the method of Claims 1-14 of the instant application is deemed obvious over the method of Claims 1-16 of U.S. Patent No. US 11174460.
Response to Arguments
Applicant's arguments about the rejection of the claims 1-6, 11 and/or 15 under 35 U.S.C. 112(b) and 112(d) in the response filed on 04/21/2025 (page 6) have been fully considered but they are moot, because the rejection has been withdrawn as indicated above.
Applicant's arguments about the 103 rejections of Claims 1-15 in the 04/21/2025 response (page 7) have been fully considered but they are moot, because the rejection has been withdrawn as indicated above.
Applicant’s comments about the double patenting rejection over the claims of U.S. Patent No. 11174460 in the 04/21/2025 response (page 8) are acknowledged.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656