DETAILED ACTION
Claims 1-20 are pending in the instant application.
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 .
Priority
The instant application is a 371 of PCT/JP2023/022993 filed on 06/21/2023 which claims priority to JAPAN 2023-054932 filed 03/30/2023 and JAPAN 2022-100731 filed 06/22/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement was considered by the examiner. Please see attached initialed Forms 1449.
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.
(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 1-2 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Russo et al. (Amniotic epithelial stem cell biocompatibility for electrospun poly(lactide-co-glycolide), poly(caprolactone), poly(lactic acid) scaffolds, Materials Science and Engineering, 2016)
Russo discloses nonwoven sheets of PCL for tissue regeneration impregnated with epithelial stem cells (Abstract). Average fiber diameter for PCL was 1.5 micrometer (Abstract).
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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ide et al. (JP 2016/087100 A, translated) and Dhanaraj et al. (US 7749204 B2).
Ide discloses a tissue regeneration promoting sheet made of a nonwoven fabric made of a bioabsorbable material. Fibers have an average fiber diameter of 0.1 to 0.7 μm. The tissue regeneration promoting sheet layers are laminated (pg 1, claims). The material can be polycaprolactone and chitin. These materials may be used alone or in combination of two or more (pg 2, 7th paragraph). Although the thickness of the said cell penetration layer is not specifically limited, A preferable minimum is 400 micrometers and a preferable upper limit is 1.5 mm (pg 3, 6th paragraph). Ide discloses seeding the tissue regeneration promoting sheet with cells (FIG. 5).
Ide does not explicitly mention impregnating with stem cells.
Dhanaraj discloses a multilayered fabric comprising a first nonwoven fabric and a second fabric in tissue repair and regeneration (Abstract). The present invention is directed to a method of using a reinforced absorbable multilayered fabric comprising a first absorbable nonwoven fabric reinforced by a second absorbable woven or knitted fabric for tissue repair and regeneration. The method comprises first preparing a repair site for implantation, then disposing the reinforced absorbable multilayered fabric at the site (col 2, lines 25-30). The fabric can be seeded or cultured with stem cells (col 5, lines 40-45). The nonwoven fabric can be polycaprolactone (col 2, line 51) and the reinforced fabric can be a polysaccharide (col 3, line 25). The basis weight of the nonwoven fabric ranges from about 0.01 to 0.2 g/in2 (col 3, lines 17-20).
Ide discloses a tissue regeneration promoting sheet comprising a nonwoven fabric polycaprolactone and Dhanaraj discloses that impregnating with a cell suspension solution containing stem cells is routine practice. Therefore, it would have been obvious to one of ordinary person in the art before the effective filing date of the claimed invention to have combined teachings of above to arrive at the present invention. This is taking 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.
Regarding claim 2, diameter of the fibers is taught above.
Regarding claim 3, the technical effect of the specific basis weight is to allow cell retention while permitting filtration of the cell suspension (paragraph [0022] of the present application). Ide discloses a tissue regeneration promoting sheet comprising two layers with different porosities to promote cell retention wile allowing fluid passage (pg 2, 3rd paragraph). One of ordinary skill in the art would routinely adjust characteristics that affect cell retention including porosity and weight of the nonwoven fabric.
Regarding claim 4, thickness is taught above.
Regarding claim 5, reinforcement sheet is taught above.
Regarding claims 6-7, Ide discloses combinations of nonwoven fabrics and lamination as taught above. Dhanaraj discloses reinforcement sheet and one of ordinary skill in the art would expect a reinforcing sheet to be more durable or thicker.
Regarding claim 8, basis weight is discussed above.
Regarding claims 9-11, thickness is discussed above.
Regarding claims 12-18, reinforcement sheet is taught above.
Regarding claims 19-20, reinforcement sheet is discussed above. Dhanaraj discloses that the reinforcement sheet can have an average thickness of between about 0.75 and 3.0 mm compared to the nonwoven fabric thickness of about 0.25 to 2 mm (col 4, line 61 and col 3, line 17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN SEUNGJAI KWON whose telephone number is (571)272-7737. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/JOHN SEUNGJAI KWON/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
