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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 26 January 2026.
APPLICANT’S ELECTION
Applicants’ election without traverse of Group I (Claims 1-6; drawn to a cell sheet support) in the reply filed on 26 January 2026 is acknowledged. Claim 7 is rejoined.
Claims 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
CLAIMS UNDER EXAMINATION
Claims 1-7 have been examined on their merits.
PRIORITY
Foreign document JP2021-023164 filed on 17 February 2021 is acknowledged. A foreign translation has not been provided.
Claim Rejections - 35 USC § 112
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.
Claims 5-6 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.
Claim 5 recites the cell sheet support of claim 1, “for use in transfer of a cell sheet”. Claim 6 recites the cell sheet support of claim 1, “for use in layering of a cell sheet”. Attempts to claim a process without setting forth any steps involved in the process raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05. The metes and bounds of the claim are unclear. Appropriate correction is required.
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.
Claims 1 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuoco et al. (Poly(ε-caprolactone- co- p-dioxanone): a Degradable and Printable Copolymer for Pliable 3D Scaffolds Fabrication toward Adipose Tissue Regeneration. Biomacromolecules. 2020 Jan 13;21(1):188-198. Epub 2019 Oct 4).
Fuoco et al. teach a scaffold support for adipose stem cell attachment (Abstract). The support is made of a copolymer comprising ε-caprolactone (CL) and p-dioxanone (DX) and (page 189, left column, third paragraph). Therefore the art teaches a polymer comprising a structural unit derived from p-dioxanone. Claim 1 is anticipated. Regarding claims 5-6: Claim 1 is directed to a product. Claims 5-6 recite a use of the claimed product. Because the art anticipates the cell sheet support recited in claim 1, it meets the limitations of claims 5 and 6. Therefore claims 5-6 are included in this rejection.
Regarding independent claim 7: The cell sheet support recited in claim 1 is anticipated. The art also teaches the following:
The scaffold has a sheet design (page 189, right column, last paragraph). The scaffold is seeded with adipose stem cells (see page 1490, right column “Cell Seeding, Attachment and Proliferation). The art teaches the scaffold is entirely covered by ASCs (Figure 11a; page 196, last paragraph of left column, bridging first paragraph of right column). A sheet-shaped scaffold that is entirely covered by cells reads on a cell sheet placed on a cell sheet support. Claim 7 is anticipated.
Therefore Applicant’s Invention is anticipated as claimed.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landgrebe et al. (Randomly Uniform Three Dimensional Tissue Scaffold of Absorbable and Non-Absorbable Material. US-20140277575-A1) as evidenced by Pubchem (Polyglactin 910. Pages 1-5).
Landgrebe teaches an implantable structure for tissue repair or augmentation (Abstract; [0005]). The art teaches a woven structure comprising a first and second yarn ([0066]). The first yarn is made from polyglactin 910 and poly(p-dioxanone) and the second yarn may be made from polyglactin 910, poly(p-dioxanone) and polypropylene ([0066]). Poly(p-dioxanone is interpreted to be a polymer comprising a structural unit derived from p-dioxanone. Therefore claim 1 is anticipated.
As evidenced by Pubchem, polyglactin 910 is synonymous with poly(glycolic acid-lactic acid). Therefore claim 2 is anticipated.
Landgrebe teaches the initial woven structure may include filaments of a first absorbable fiber and a second absorbable fiber, with the materials present in amounts of about 1-7 parts (by weight) first absorbable fiber to about 1 part second absorbable fiber, and more desirably about 3-5 parts (by weight) first absorbable fiber to about 1 part second absorbable fiber. In this embodiment, the art teaches poly(p-dioxanone) as the first absorbable fiber and polyglactin 910 as the second absorbable fiber ([0061]). Therefore the ratio recited in claim 3 is anticipated.
Regarding claims 5-6: Claim 1 is directed to a product. Claims 5-6 recite a use of the claimed product. Because the art anticipates the cell sheet support recited in claim 1, it meets the limitations of claims 5 and 6. Therefore claims 5-6 are included in this rejection.
Therefore Applicant’s Invention is anticipated as claimed.
Claim Rejections - 35 USC § 103
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.
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Landgrebe et al.
Claim 2 is rejected on the grounds set forth above. The teachings of Landgrebe are reiterated. Landgrebe teaches an implantable structure for tissue repair or augmentation (supra).
The art teaches the woven structure is a sheet ([0041] [0070]). Said sheet may be trimmed to the desired size and shape by a user prior to implantation ([0070]).
The woven structure can have any desired thickness, and is preferably between about 0.1 mm and about 5 mm thick ([0041]). Examiner notes 0.1 mm is 100 µm. The thickness may be modified depending upon the intended use and site of implantation ([0041]). For example, the device has a thickness in a desired range for the particular application for which it is being used. The thickness is such that the device is contiguous with ingrown tissue once ingrowth has taken place and the absorbable material has been absorbed by the body ([0029]).
The art does not anticipate the thickness recited in claim 4.
It would have been obvious to prepare a sheet that is 100 µm. One would optimize the thickness taught by Landgrebe based on the site of implantation. One would have had a reasonable expectation of success since Landgrebe teaches structure thickness. MPEP 2133.03 and MPEP 2144.05 .Therefore claim 4 is rendered obvious.
Regarding independent claim 7: A cell sheet support as recited in claim 1 is anticipated.
Landgrebe teaches the structure can be used as a scaffold for cells to form tissues ([0024]). The art teaches cells can be dispersed on the device([0081]).
It would have been obvious to use the structure as a support for a sheet of cells. One would do so when preparing a tissue. One would have had a reasonable expectation of success since Landgrebe teaches cells can be dispersed on the structure. Therefore claim 7 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653