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 .
Claim Status
Claims 1-3 and 8-9 are currently pending in this application.
Election/Restrictions
Election was made without traverse of Group I, claims 1-8, in the reply filed on Aug. 15, 2025, and claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected subject matter, there being no allowable generic or linking claim. Claims 1-3 and 8 have been considered on the merits and all arguments were considered fully.
Status of Rejections
Status of the rejections: the previous claim rejections under 35 USC 112(b), 102, and double patenting rejections are withdrawn in view of the claim amendments.
Claim Objection
Claim 1 is objected to because of the following informalities: claim 1 recites the phrase “the thermoreversible gelation polymer including a plurality of blocks . . .; a hydrophilic block.” For grammatical reasons, this would be clearer if rewritten with the conjunction ‘and’ as in “alcohol; and a hydrophobic block,” especially because prior to “hydrophilic block” is a listing of block species separated by commas. Thus, meaning “including” (1) and (2). Appropriate correction is required.
Claim Interpretation
Claim 1 is interpreted as a product-by-process with no structural feature(s) expressly recited or implied in the claim that would distinguish the claimed composition made by another process, e.g., deriving cells not via culturing in a plate culture or with a thermoreversible gelation polymer. See MPEP 2113. Therefore, claim 1 is directed to a composition comprising a combination of oral mucosa derived cells derived from the same oral mucosa, the composition comprising (1) such cells which do not express p63 (i.e., the “2D plate-cultured” cells) and (2) p63-expressing oral mucosa derived cells (i.e., the “3D plate-cultured” cells).
In the claims, the term “block” is interpreted as commonly used in the prior art as meaning a portion of a polymer molecule in which each monomeric unit has at least one constitutional or configurational feature absent from an adjacent portion of the polymer, such as a block derived from a species of monomer used in making the polymer.
Claim 2 and 3 are interpreted as requiring the first or second cells, respectively, of the claimed composition, respectively, are producing IGF-1 or be/remain positive for the epithelial cell markers AE1 and AE3 regardless of their process of making.
Claim Rejections - 35 USC § 112(b), (new)
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 1-3 and 8 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 1 recites the phrase “over the amount of p63 expressed from the cells derived from the oral mucosa,” which lacks a clear antecedent basis as there are both first and second cells derived from the oral mucosa as well as such cells prior to the culturing as compared to after the culturing. Claims 2-3 and 8 are included in this rejection for depending from indefinite claim 1.
Claim 1 recites wherein “the epithelial engraftment of a urinary tract,” which lacks sufficient antecedent basis in the claim. Claims 2-3 and 8 are included in this rejection for depending from indefinite claim 1.
Claim 1 recites wherein “at a site for an epithelial engraftment provides the epithelial engraftment of a urinary tract” and the phrase “at the site of the epithelial engraftment provides no epithelial engraftment,” which are each incoherent and unclear as to whether the combination of cells are being administered to a urinary tract or subject comprising it and whether each of the cells alone is being administered to the same urinary tract. Claims 2-3 and 8 are included in this rejection for depending from indefinite claim 1.
Claim Rejections - 35 USC § 102, (new)
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 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 1-3 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Promprasit (Promprasit et al., Curr Eye Res 40: 274-81 (2014)) and as evidence by Ivan (Ivan et al., Mod Pathol 18: 137-42 (2005), Rudman (Rudman et al., J Invest Dermatol 109: 770-7 (1997) and Clausen (Clausen et al., J Invest Dermatol 86: 249-54 (1986)).
The claims are interpreted as provided in a previous section. Claim 1 is interpreted as a product-by-process with no structural feature(s) recited in these claims that would distinguish the claimed composition made by another process, i.e., merely directed to a composition having oral mucosa derived cells as structurally limited in the claims regardless of how the composition is obtained, e.g., regarding mixing, plate culturing and/or polymer culturing steps. Furthermore, the phrase of providing “epithelial engraftment” in a urinary tract in 6-12 days is considered but is not limiting as an intended use of the product as well as merely referring to an inherent capability of the claimed product as recited with structural limitations.
Regarding claim 1, Promprasit discloses a cell composition from a single donor (oral mucosal biopsy or oral mucosal explant), such as a cultured explant shown to have p63 expression in some cells (basal) but not others (superficial) based on position (Fig. 1B,D; Fig. 2B,D; pg. 275, right col., last para., to pg. 276, left col.; pg. 277, 1st para.).
Regarding claim 2, as evidenced by Ivan and Rudman, the mammalian oral mucosa epithelium has p63- keratinocytes that express IGF-1. Ivan shows normal stratum granulosum epithelial cells (granular layer) lack p63 expression (pg. 138, last para.), and Rudman shows normal stratum granulosum epithelial cells express IGF-1 (Fig. 1). Thus, oral mucosal biopsy of Promprasit comprises cells matching the first cell type of claim 2.
Regarding claim 3, as evidenced by Clausen, the basal layer (comprising p63+ cells as noted above) of the mammalian oral mucosa epithelium extensively expresses AE1 and AE3 (Abstract, Fig. 2-3).
Regarding claim 8 as interpreted as a product-by-process with no structural feature(s) recited that would distinguish the claimed composition made by another method lacking 3D cultured cells using such a polymer, Promprasit anticipates claim 8 by virtue of anticipating claim 1 as set forth above.
Thus, Promprasit anticipates claims 1 and 8 as well as claims 2-3 in view of secondary evidence.
Response to Arguments
Applicant’s remarks filed 2/5/26 regarding the previous rejections were found persuasive, however applicant’s claim amendment necessitated the new grounds of rejection presented above.
Note, for patentability purposes product-by-process claims are treated as products, while, for patent infringement purposes, product-by-process claims are treated as process claims. See United Therapeutics Corp. v. Liquidia Technologies, Inc., 74 F.4th 1360, 1373 (Fed. Cir. 2023) (“a product-by-process claim is a product claim, even if claimed by a process by which it can be made” and “anticipated by a disclosure of the same product irrespective of the processes by which they are made”). Also see Abbott v. Sandoz, 566 F.3d 1282, 1318 (Fed. Cir. 2009) (Newman, J., dissenting) (“The court today acts en banc to overturn a century of precedent and practice, and holds that a new product that is difficult to describe without reference to how it was made, but that is nonetheless a new and unobvious product, cannot be protected as a product if its description is aided by reference to how it was made”).
The claims are being analyzed merely as a product as positively recited in the claims and including any implied structure(s) and feature(s) by the claim limitations. As noted above, it is not clear what, if any, structure of the product is implied by these urinary tract related phrases regarding the “passive” ability and reference to the lack of ability of intermediate components of the process of making the product. Also, applicant admits on the record an inability to fully describe the claimed product by structure alone, referring to MPEP 2173.05(p), while apparently guessing that an essential structural difference to ensure the unexpected and synergistic result is the altered/differential expression of p63 (Response of 2/5/26, pg. 7). This is not persuasive, however it is recommended that the claimed product is more narrowly limited to more closely approximate the composition providing the empirically shown unexpected result, such as by instead of “comprising” using “consisting” the two cell types as a mixture.
Further, it is noted that indefiniteness issues may arise in these claims still precariously close to falling within mixed subject matter of a process of both making a product and using the product.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROGERS whose telephone number is (571)272-8338. The examiner can normally be reached Monday - Friday 9:00-6:00.
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/ERIC J ROGERS/
Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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