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 .
Status of claims
Claims 1-7 as amended and new claims 8 as filed on 7/16/2025 are currently pending.
Claims 5-7 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 on 4/10/2025.
Clams 1-4 as amended and new claim 8 as filed on 7/16/2025 are under examination in the instant office action.
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.
Claims 1-4 as amended and new claim 8 are/remain rejected under 35 U.S.C. 102 (a) (1) as being anticipated by CN 104774903 (Zhou).
The cited document CN 104774903 (Zhou) discloses a method of manufacturing a cell sheet or 3D cell culture (see English abstract at section “description”); wherein the method comprises:
a) step of seeding, sedimenting or depositing cells into a growth medium comprising hyaluronic acid a growth comprising hyaluronic acid (HA) and culturing or maintaining the cells in the medium comprising HA; and
b) step of adding a growth medium comprising polyethylene glycol (PEG) to the medium with cells and HA of the previous step.
The PEG solution (or Peg-containing medium) is clearly added 10-15 minutes after the cells were combined with the HA-containing solution (or HA-containing medium) as described by the cited document. Thus, the sequence of steps as described by the cited document is the same as claimed. The claimed growth medium solely contains HA. The claimed culturing step does not include any structural elements or specific limitations that would provide for cell proliferation or cell viability during “culturing” as claimed.
Therefore, the disclosure of the cited document is considered to anticipate the method of claim 1.
As applied to claim 2: the cells are mesenchymal stem cells which are “mesodermal stem cells” as intended (see par. 0015 of published application US 2022/0409770).
As applied to claim 3: the 3D cell culture is formed in 6-well plates as disclosed by the cited document. Thus, same the cell 3D sheets are formed in plates by the cited method. The claimed method does not recite any dimension of final cell sheets to established difference, if any, comparatively to the cited disclosure. Thus, the cited method provides for a 3D cell sheet having a plate shape within the broadest meaning of the claims reciting that “the cell sheet has a plate shape”.
As applied to claims 4 and 8: the cell culture of the cited document is made from the same materials and in the same sequence of adding components; and, thus, it is reasonably expected to have the same properties with regard to “suppression cell aggregation” (claim 4), The same materials such as HA and PEG are used in the cited method; and, thus, the same materials provide for the same effects on cells with regard to dispersion and/or repulsive force within the broadest meaning of the claims.
Thus, the disclosure of the cited document is considered to anticipate the claimed method.
Response to Arguments
Applicant's arguments filed 7/16/2025 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 102 (a) (1) as being anticipated by CN 104774903 (Zhou) Applicants main argument is that in the claimed method the step of adding PEG- containing medium is after and sequential to the step of seeding and culturing cells in HA-containing medium but in the cited method the 3D hydrogel with encapsulated cells is formed by mixing HA and PEG solutions.
This argument is not persuasive because in the cited method the PEG solution (or Peg-containing medium) is clearly added 10-15 minutes after the cells were combined with the HA-containing solution (or HA-containing medium) as described by the cited document. Thus, the sequence of steps as described by the cited document is the same as it is recited the claim 1. Further, the claimed growth medium solely contains HA in a first seeding-culturing step. The claimed “culturing” does not include any structural elements or specific limitations that would provide for cell proliferation or cell viability during “culturing” as claimed. Thus, the differences, if any, between two sequential steps as claimed, as disclosed and as argued cannot be established.
Applicants also argue that sequential order allows for making a plate-shaped cell sheet.
However, the cell culture of the cited document is made from the same materials and in the same order of adding components sequentially; and, thus, it is reasonably expected to have the same properties. The cited 3D cell culture is formed in 6-well plates as disclosed by the cited document. Thus, the same 3D sheets of cells are formed in the plates by the cited method. The claimed method does not recite any dimension of final cell sheets to established difference, if any, comparatively to the cited disclosure. Thus, the cited method provides for a 3D cell sheet having a plate shape within the broadest meaning of the claims reciting that “the cell sheet has a plate shape”.
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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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Vera Afremova
October 2, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653