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 Application/Amendment/Claims
Claims 1-20 are pending.
Claims 1-5, 7-17, 19, and 20 have been amended in the claims filed June 16, 2025.
Claims 13-20 have been withdrawn as being drawn to a nonelected species, there being no allowable generic or linking claim.
No claims have been added or canceled.
Claims 1-12 read on the elected invention and are examined herein.
Applicant's response filed June 16, 2025 has been considered. Rejections and/or objections not reiterated from the previous office action mailed April 01, 2025 are hereby withdrawn.
The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a) -(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
A certified English translation of Japanese Patent Application No. 2019-190479 has not been provided.
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 is 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.
This is a new rejection as necessitated by the claim amendments filed June 16, 2025.
Claim 12 recites the limitation "the inflammatory disease" in the claim body. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Takeuchi et al (US 2018/0067099) as evidenced by Lancaster et al. (US 2021/0393853 Al) and as evidenced by Li et al (Cytotherapy(2019)21;3-16).
This is a new rejection as necessitated by the claim amendments filed April 01, 2025. A response to applicant’s traversal follows the rejection below.
Regarding claims 1 and 2: The claim recites “a mediator that connects the plurality of cells together into a sheet shape”. The instant specification is silent on an explicit definition of “a mediator”. The term “mediator” is therefore interpreted as a substance that connects cells such as extracellular matrix.
The intended use statement “for treating inflammatory disease” does not impose or imply a structural difference between the claim and the prior art. Therefor, “for treating inflammatory disease” is considered non-limiting for examination purposes in the following analysis.
Takeuchi teaches human skeletal muscle cells (a plurality of cells )are inoculated on a temperature-responsive culture dish to produce a sheet shaped culture that is detached from the culture dish (p8 para 0087).
Takeuchi teaches that cells constituting the sheet-shaped cell culture may require an intermediate substance which is preferably derived from cells (p2 0043). This reads on “a mediator that connects the plurality of cells together into a sheet shape” as recited in the instant claim 1.
As evidenced by Lancaster, skeletal muscle cells inherently secrete myokines, and thus the cell culture disclosed by Takeuchi inherently secretes myokines (page 15 Table 1). Thus the cell culture taught by Takeuchi reads on “the cell culture secretes myokines” of the instant claim 1.
Takeuchi discloses skeletal muscle cells cultured in a medium and the resulting sheet-shaped cell cultures are detached from the culture dish (p8 para 0087). Sheet sheet-shaped cell cultured detached from the culture dish reads on “the cell culture maintains physical integrity of the sheet shape without a scaffold”.
Takeuchi is silent on the claimed intended use “for treating inflammatory disease”, however the Takeuchi skeletal muscle cell cultures are in a form suitable for such intended use and thus read on the intended use “for treating inflammatory disease”.
Regarding claims 3 and 10: Takeuchi is silent on if the mediator is an extracellular matrix.
However, as evidenced by Li et al (Cytotherapy(2019)21;3-16), cell sheet structure is largely maintained by the formation of cell-to cell junctions and secretion of ECM proteins (p3 col2 para1).
Thus the cell sheets disclosed by Takeuchi are largely maintained by cell-to-cell junctions and extracellular matrix proteins, which reads on “the mediator is an extracellular matrix” of the instant claims.
Regarding claims 4 and 8: Example 1 of Takeuchi teach cells derived from human skeletal muscle cells are inoculated on a temperature-responsive culture dish (p8 0087). After cultivation some of the resulting cell cultures detached from the culture dish (p8 0087).
The cell culture sheets of Example 1 do not require substances derived from any substance other than the cells forming the cell culture, and thus read on the limitations of claim 4.
The temperature-responsive culture dish disclosed in example 1 reads on seeding cells on a substrate as required by claim 8.
Regarding claims 5-7: As stated supra, the intended use statement of claim 1 “for treating inflammatory disease” does not impose or imply a structural difference between the claim and the prior art. Therefor, “for treating inflammatory disease” is considered non-limiting for examination purposes in the following analysis.
Claims 5-7 further limit the intended use statement of claim 1, but do not impose or imply a structural difference between the claims and the prior art.
Furthermore, while Takeuchi is silent on the claimed intended use, the sheet-shaped cell culture disclosed by Takeuchi is in a form suitable for such intended use and thus reads on the instant claims.
Regarding claims 9-12: Lancaster is silent on a kit, however they do describe all the limitations of the kit claims in combination and thus read on the kit product as claimed.
Furthermore, it is well-known in the art to separately package ingredients to be combined together for the known advantage of improved storage and prevention of premature reaction.
Therefore, the teaching of Takeuchi anticipates Applicant’s invention as claimed.
Response to Arguments under 35 USC § 102:
Applicant argues that the claimed combination of features are lacking from Takeuchi. The argument has been fully considered and is found unpersuasive. As discussed supra in the new rejection over 35 USC § 102; the combination of features as disclosed in claim 1 are disclosed by Takeuchi.
Applicant also argues that Lancaster does not qualify as prior art to the instant application. The argument has been fully considered and is found unpersuasive. It is noted that for the rejection under USC § 102 Lancaster is not relied upon as prior art, but rather relied upon as an evidentiary reference to show that muscle cells inherently secrete myokines, and therefore the cell culture of muscle cells taught by Takeuchi also inherently secretes myokines.
MPEP 2124 reads “In certain circumstances, references cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism”.
The evidence relied upon that is disclosed by Lancaster is a property of muscle cells, and thus the priority date or disclosure in the provisional application of Lancaster is not relevant to instant rejection over 35 USC § 102.
Response to Arguments under 35 USC § 103:
Applicant argues that Lancaster does not qualify as prior art for a rejection made under 35 USC § 103, however Applicant provides an argument regarding myokines, which are not relied upon as prior art for the rejection under 35 USC § 103, but as an evidentiary reference under 35 USC § 102, as discussed supra.
Applicant does not address the aspects of Lancaster that are relied upon as prior art under 35 USC § 103 therefore the argument is found unpersuasive.
Furthermore, if Applicant wishes to rely upon Japanese Patent Application No. 2019-190479, filed on October 17, 2019, as the earliest priority date, Applicant must file a certified English translation of said application, as stated at the beginning of the action under the section entitled “Priority”.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631