DETAILED ACTION
Claim Status
As of the Non-Final Office Action mailed 4/7/2026, claims 1, 4-5, and 8-9 were pending and claims 8-9 were withdrawn for being drawn to nonelected invention.
In Applicant's Response filed on 6/26/2026, claims 1 and 4-5 were amended.
As such, claims 1, 4-5, and 8-9 are pending and claims 1 and 4-5 have been examined herein.
Withdrawn Objections/Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of record of claim 1 and 4-5 under 35 USC § 112(b) have been withdrawn in view of Applicant’s amendment to claim 1.
The rejection of record of claim 4-5 under 35 USC § 112(a) have been withdrawn in view of Applicant’s amendment to claim 4.
The rejection of record of claims 1 and 4-5 under 35 USC § 103 as being unpatentable over Meise et al (US 2006/0135419 A1, 3 Dec 2003; Ref. 1 of US Patent Documents in IDS filed 5 Oct 2022; previously cited) in view of Ichim et al (US 20120269774 A1, 20 Sept 2007; Published 25 Oct 2012; previously cited) and Brandebourg et al (Prolactin upregulates its receptors and inhibits lipolysis and leptin release in male rat adipose tissue. Biochem Biophys Res Commun. 2007 Jun 1;357(2):408-13) have been withdrawn in view of Applicant’s amendments to claim 1 and 4-5 and arguments in the Remarks filed 6/26/2026.
Claim Rejections - 35 USC § 112(a) New Matter – Necessitated by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163 provides a procedure for evaluating the adequacy of written description to support the claim elements: a) determining what the claim covers as a whole, b) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and 3) determining whether there is sufficient written description to inform a skilled artisan that inventor was in possession of the claimed invention as a whole at the time the application was filed. The proscription against the introduction of new matter in a patent application serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 3232, 326 (CCPA 1981).
Mere rephrasing of a passage does not constitute new matter. Accordingly, a rewording of a passage where the same meaning remains intact is permissible. In re Anderson, 471 F.2d 1237, 176 USPQ 331 (CCPA 1973) (see MPEP 2163.07(I)). The mere inclusion of dictionary or art recognized definitions known at the time of filing an application may not be considered new matter. The subject matter of the claim need not be described literally (i.e., using the same terms or in haec verba) in order for the disclosure to satisfy the description requirement. However, if a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, conclusion that the claimed subject matter is not described in that application is appropriate, resulting in the rejection of the claims affected under 35 U.S.C. 112(a).
In the instant case, Applicant has amended the scope of independent claims 1 and 4 beyond what is supported by the original specification as filed. Claims 1 and 4 originally stated “wherein the genetically engineered placenta-derived mesenchymal stem cell has enhanced ability . . . wherein the enhanced ability comprises reduced expression levels of adipogenesis-related genes.” The original specification as filed shows support for the instantly claimed cell reducing levels of adipogenesis related genes in other cells (normal and TAO-patient derived orbital fibroblasts) when co-cultured (i.e., reducing adipogenesis-related genes as a function of the MSCs; see working examples and Fig. 11-13). The claims were amended to remove, inter alia, “has enhanced ability” and to recite “the genetically engineered placenta-derived MSCs exhibit [reduced expression levels]” (i.e., a property of the cells themselves). In this regard, the newly filed amendments materially change the scope of the instant claims, constituting new matter because there is no support anywhere in the original specification as filed of the MSCs having reduced expression of adipogenesis related genes.
Accordingly, the amendments to the claims constitute new matter to the scope of the instant claims.
Conclusion
No claim is 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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/G.R./Examiner, Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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