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 1-9 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Election was made without traverse of Group I, claims 1-8, in the reply filed on Aug. 15, 2025, and claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected subject matter, there being no allowable generic or linking claim.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 1-8 have been considered on the merits and all arguments were considered fully.
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., using epithelial cells not cultured in a plate culture, epithelial cells not cultured with a thermoreversible gelation polymer, and/or without a step of combing different cultured epithelial cells prior to use, such as for administering to a subject. See MPEP 2113.
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 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 6 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 pre-AIA the applicant regards as the invention.
Claim 6 recites the term “the oral mucosa”, which lacks sufficient antecedent basis in the claim itself or claim from which it depends.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The claims are interpreted as provided in a previous section.
Claim 1 is directed to a product, not a process of using a product. When the preamble phrase “for repairing damage to an epithelial tissue” in claim 1 is considered, it is determined to merely represent intended use language for the claimed product which does not imply any additional limitation not expressly recited in claim 1. See MPEP 2111.02. Similarly in claim 1, the phrase “combined prior to administering the composition to a subject” is not interpreted to limit the product to a use comprising “administering the composition to a subject.” Thus, in claim 4 wherein “the epithelial tissue to be repaired” is further limited also does not imply any additional limitation not recited in claim 1. As claim 4 merely narrows the intended use of claim 1 and fails to provide or imply any additional limitation to the product of claim 1, then it is an improper dependent claim form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 1-2, 4-5, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ajuwon (Ajuwon et al., J Nutr Biochem 14: 522-30 (2003)).
The claims are interpreted as provided in a previous section. In claim 1, the preamble phrase “for repairing damage to an epithelial tissue” and “administering the composition to a subject” are not interpreted to limit the claimed product with any implied limitation not expressly recited in the claim as the intended use/purpose does not imply any additional structural limitation.
Ajuwon discloses a composition comprising epithelial cells from the same epithelial tissue (liver) (pg. 524, left col., last para., to right col., 1st para.), e.g., hepatocytes. Claims 1-8 are 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, e.g., epithelial tissue cells from the same or different epithelial tissues regardless of how the cells are obtained regarding mixing, plate culturing and/or polymer culturing steps.
Regarding claim 2, the phrase “cells cultured in plate culture produce insulin-like growth factor 1 (IGF-1)” implies that at least some of the cells in the composition maintain expression of IGF-1 or at least are a type of IGF-1 expressing cell. Ajuwon discloses wherein the composition comprises cells (hepatocytes) secreting IGF-1 (Fig. 2; pg. 527, right col., 1st para.).
Ajuwon anticipates claims 4 and 7-8 by virtue of anticipating claim 1 as set forth above because none of claims 4 and 7-8 imply any additional structural limitation to the claimed composition.
Regarding claim 5, Ajuwon discloses wherein the cells in the compositions are from the same epithelial tissue (liver) (pg. 524, left col., last para., to right col., 1st para.).
Thus, Ajuwon anticipates the claimed invention.
Claims 1 and 3-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oda (Oda et al., In Vitro Cell Dev Biol Anim 34: 46-52 (1998)).
Oda discloses a composition comprising epithelial cells from the same epithelial tissue (oral or esophageal) (pg. 46, right col., last para., to pg. 47, left col., 3rd para.), such as expressing epithelial markers (Abstract). Claims 1-8 are 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, e.g., epithelial tissue cells from the same or different epithelial tissues regardless of how the cells are obtained regarding mixing, plate culturing and/or polymer culturing steps.
Regarding claim 3, the phrase “cell cultured in a thermoreversible gelation polymer are positive for epithelial cell markers AE1 and AE3” imply that at least some of the cells in the composition maintain expression of AE1 and AE3 after combination to form the claimed composition. Oda discloses wherein the composition comprises epithelial cells positive for AE1 and AE3 (Tables 2-3, Abstract).
Oda anticipates claims 4 and 7-8 by virtue of anticipating claim 1 as set forth above because none of claims 4 and 7-8 imply any additional structural limitation to the claimed composition.
Regarding claim 5, Oda discloses wherein the cells in the compositions are from the same epithelial tissue (pg. 46, right col., last para., to pg. 47, left col., 3rd para.).
Regarding claim 6, Oda discloses wherein all of the cells in the composition are derived from an oral mucosa (pg. 46, right col., last para., to pg. 47, left col., 3rd para.; Table 2).
Thus, Oda anticipates the claimed invention.
Response to Arguments
Applicant traverses lack of novelty by arguing the prior art Kataoka does not disclose, teach or reasonably suggest wherein there are cells cultured in plate culture and cells cultured in the thermoreversible gelation polymer are combined prior to the application to a subject. This is not found persuasive as noted above because the claimed composition product does not reveal the process by which it was made by the presence of any structural feature implied by the process of making recited in current claim 1. Applicant also argues the that claim 1 recites a composition that is a combination of two types of cells with different properties, i.e., cells which have been cultured in plate culture and cells which have been cultured in a thermoreversible gelation polymer. However again this is not how the claims are interpreted as set forth fully above. Instead the composition may comprise the same cell type cultured in plate culture combined with ones cultured in polymer without any indication as to which is which due to its provenance. Furthermore, even if there is a difference, as time passes any difference may completely disappear.
Applicant also argues an unexpected result from said combination of cells in the form of a use of administering to a subject whereby improved engraftment of a composition comprising buccal mucosal squamous epithelial cells at a site of urethral incision where there was a stenosis in comparison to either non-combined cell type. However the claims are not commensurate in scope with this purported unexpected result when the claims encompass any use of the composition. Furthermore, the purported unexpected result is only evidenced with a single type of epithelial tissue (oral buccal mucosal), wherein the polymer is made with N-isopropylacrylamide, n-butyl methacrylate, and polyethylene glycol dimethacrylate, and wherein the epithelial tissue to be repaired is urethral.
Note, for patentability purposes product-by-process claims are treated paramountly as products, while, for patent infringement purposes, product-by-process claims are treated as process claims. See Abbott v. Sandoz, 566 F.3d 1282 (Fed. Cir. 2009).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of copending Application No. 17/801,102 (the reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of the reference application discloses compositions comprising cells from an epithelial tissue, such as oral mucosa, corneal, gastrointestinal mucosa, skin, or hepatic tissues.
Regarding instant claim 5, the reference claims teach wherein the cells are from a single epithelial tissue. Regarding instant claim 6, the reference claims teach wherein all the cells are from an oral mucosa tissue. The reference claims render claims 4 and 7-8 obvious by virtue of anticipating claim 1 as set forth above because none of claims 4 and 7-8 imply any additional structural limitation to the claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC J ROGERS/
Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638