DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Applicant’s response dated 10/23/2025 has been received and entered into the application file.
Claims 1-7, 14, 16-17, and 19 are pending and examined on the merits.
Claims 8-13, 15, and 18 are cancelled.
Election/Restrictions
Applicants elected Group I, drawn to claims 1-7, 13-17, and 19, without traverse in a phone call made on 07/11/2025 and confirmed in the reply filed on 10/23/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: The phrase “relative to a corresponding unmodified placental stem cells” should read “relative to a corresponding unmodified placental stem cell[[s]].” Appropriate correction is required.
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 7 remains 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 7 recites the phrase “enhanced placental cells” (line 3). As outlined in the previous Office Action, this term is not recited in claims 1 or 6, from which claim 7 depends. Therefore, it is unclear whether claim 7 imposes a further limitation on the isolated modified placental stem cells of claim 1, the isolated population of cells of claim 6, or whether “enhanced placental cells” refers to a narrower species cells than those recited in claims 1 and 6. Furthermore, the description “enhanced” is not a well-known term in the art and does not impose a structural limitation to the placental stem cell of claim 7, and therefore renders the claims indefinite.
For purposes of examination, given the definition in para 5 of the specification (“Such modified placental stem cells are herein termed “enhanced placental stem cells.”), the phrase “enhanced placental stem cells” in claims 7 is interpreted to be referencing the “isolated modified placental stem cell” in line 1 of claim 1.
Claim Rejections - 35 USC § 112(a)
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 1-7, 14, 16-17, and 19 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.
From M.P.E.P. § 2163, the analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention from the standpoint of one of skill in the art at the time the application was filed. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
For claims drawn to a genus, possession may be shown (for example) through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus, and is an inverse function of the skill and knowledge in the art. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
Claim 1 is drawn to an isolated modified placental stem cell, wherein said isolated modified placental stem cell is a placental stem cell modified to comprise or express a non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G, and said modified isolated placental stem cell demonstrates increased survival relative to a corresponding unmodified placental stem cell when cultured under one or more conditions that cause cell death.
Claim 1 recites a structure: a placental stem cell modified to comprise or express a non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G. Claim 1 also recites a function: said modified isolated placental stem cell demonstrates increased survival relative to a corresponding unmodified placental stem cell when cultured under one or more conditions that cause cell death. Thus, the claim is drawn to a very large genus of modified placental stem cells (i.e., a placental stem cell modified to comprise or express any non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G) demonstrating the claimed function of increased survival relative to a corresponding unmodified placental stem cell when cultured under condition(s) that cause cell death.
However, neither the specification nor the prior art establishes a structure-function relationship between a placental stem cell comprising or expressing a non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G, and the claimed function of increased survival relative to a corresponding unmodified placental stem cell when cultured under condition(s) that cause cell death, with any degree of predictability.
The instant specification appears to disclose only three microRNA molecules comprising the nucleotide sequence AGCAGXCA, in which X is C or G, wherein the expression of said microRNA molecule in a placental stem cell results in increased survival of the cell relative to a corresponding unmodified cell when cultured under condition(s) that cause cell death. These three microRNA molecules, which are hsa-miR-16, hsa-miR-424, and hsa-miR-29a (para 303, Table 4), were found to share similar seed sequences (i.e., AGCAGXCA, in which X is C or G) that bind to their target mRNA (para 303). The specification does not disclose any other species with the claimed function, which would be encompassed within the pending claim. Although the specification recites that “Accordingly, it was expected that these microRNA target and modulate a similar subset of target genes and pathways/biological functions” (para 303), this amounts to a mere speculation of a relationship between the sequence AGCAGXCA, in which X is C or G, and the increased survival of the transfected stem cell. As such, the instant specification does not provide a sufficient representative sampling of a placental stem cell modified to comprise or express a non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G, that demonstrate the claimed function of increased survival relative to a corresponding unmodified placental stem cell when cultured under condition(s) that cause cell death.
The prior art is unpredictable. The prior art does not teach a relationship between the expression in a stem cell of a non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G, and increased survival of said stem cell when cultured under condition(s) that cause cell death.
Accordingly, neither the specification nor the prior art establishes that the broad genus of a modified placental stem cell comprising or expressing a non-naturally occurring microRNA molecule comprising the nucleotide sequence AGCAGXCA, in which X is C or G, has the claimed function of demonstrating increased survival relative to a corresponding unmodified stem cell when cultured under one or more conditions that cause cell death. Therefore, the skilled artisan would not have reasonably concluded at the time of the invention that the applicant was in possession of the invention as claimed.
Claims 2-7, 14, 16-17, and 19 are included in the rejection because they depend from claim 1.
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 1-7, 14, 16-17, and 19 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,329,529.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to an isolated placental stem cell, wherein said placental stem cell has been modified to comprise or express miR-16 or miR-424, and wherein said placental stem cell demonstrates increased survival relative to corresponding unmodified placental stem cells when cultured under one or more conditions that cause cell death. miR-16 and miR-424 comprise the nucleotide sequence AGCAGXCA, in which X is C or G (Specification, para 303, Table 4). The isolated placental stem cell of claims 1-7, 14, 16-17, and 19 of the instant application are generic to the species of isolated placental stem cells, or methods of making thereof, in the issued claims. The claim under examination is anticipated by the reference claim(s) when the claim being examined is generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. See MPEP §804 (II)(B)(2).
Claims 1-7, 14, 16-17, and 19 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,512,282.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to an isolated placental stem cell, wherein said placental stem cell has been modified to comprise or express miR-29a, and wherein said placental stem cell demonstrates increased survival relative to corresponding unmodified placental stem cells when cultured under one or more conditions that cause cell death. miR-29a comprises the nucleotide sequence AGCAGXCA, in which X is C or G (Specification, para 303, Table 4). The isolated placental stem cell of claims 1-7, 14, 16-17, and 19 of the instant application are generic to the species of isolated placental stem cells, or methods of making thereof, in the issued claims. The claim under examination is anticipated by the reference claim(s) when the claim being examined is generic to a species or sub-genus claimed in a conflicting patent or application, i.e., the entire scope of the reference claim falls within the scope of the examined claim. See MPEP §804 (II)(B)(2).
Terminal Disclaimer- Disapproved
The Applicant filed Terminal Disclaimers (TDs) with respect to U.S. Patent No. 10,329,529 and U.S. Patent No. 11,512,282, which were disapproved by the Office. The reason for disapproval, as given by the Office, is as follows:
Regarding the TDs filed 10/23/2025:
1.TD's file should have 100 percent interest.
2. The person who signed the terminal disclaimer is not the applicant, patentee or an attorney or agent of record. 37 CFR 1.321 (a) and (b). (See FP 14.26.08)
Please resubmit the TD. No fee is required.
Regarding the TDs filed 11/05/2025:
The applicant name listed on the TD form is not the same name on the ADS. No additional fees are required with the resubmission.
The terminal disclaimer identifies a party who is not the applicant (only for applications filed on or after September 16, 2012; See FP 14.26.10):
For cases filed on/after 9/16/12, 37 CFR 1.321 specifies that the applicant can disclaim, and the terminal disclaimer must specify the extent of the applicant's ownership.
A request under 37 CFR 1.46(c) to change the applicant needs to be filed, which is (1) a request, signed by a 1.33(b) party, (2) a corrected ADS (37 CFR 1.76(c)) that identifies the "new" applicant in the applicant information, and is underlined since it is new, and (3) a 3.73(c) statement showing chain of title to the new applicant. Along with the§ 1.46(c) request we need a POA that gives power to the attorney who is signing the TD, along with another copy of the TD, unless they file a TD that is signed by the applicant.
Response to Arguments
RE: Claim Objections
The objection of Claim 5 regarding minor informalities is withdrawn in light of the amendment to claim 5.
RE: Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-6, 14-17, and 19 under 35 U.S.C. 112(b) is withdrawn in light of the amendment to claim 1. The rejection of claim 7 is maintained, as set forth above. The cancellation of claims 13 and 15 renders the rejections thereof moot.
RE: Claim Rejections - 35 USC § 101
The rejection of claims 1-7, 14, and 16-17, and 19 under 35 U.S.C. 101 is withdrawn in light of the amendment to claim 1, which distinguishes the product of claim 1 markedly different from its closest naturally occurring counterpart, which is a placental stem cell, per se (e.g., stem cells isolated from mammalian placentas; see Abbott, US 2012/0230959 A1, para 3, 27). The cancellation of claims 13 and 15 renders the rejections thereof moot.
RE: Claim Rejections - 35 USC § 102
The rejection of claims 1, 5-7, 14, 16-17, and 19 are under pre-AIA 35 U.S.C. 102(a) and 35 U.S.C. 102(e) as being anticipated by Abbot (US 2012/0230959 A1; cited in IDS filed 11/29/2022) is withdrawn in light of the amendment to claim 1. The cancellation of claims 13 and 15 renders the rejections thereof moot.
RE: Claim Rejections - 35 USC § 103
The rejection of claims 2-4 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wang (Experimental Hematology, 2008; cited in IDS filed 11/29/2022), in view of Abbot (US 2012/0230959 A1), is withdrawn in light of the amendment to claim 2.
RE: Double Patenting
The rejection of claims 1-7, 14, 16-17, and 19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 896,9315, is withdrawn in light of the amendment to claim 1, which is effective to differentiate the instant claims from the claims in U.S. Patent No. 896,9315. The cancellation of claims 13 and 15 renders the rejections thereof moot.
The rejection of claims 1-7, 14, 16-17, and 19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,329,529 is maintained, as outlined above. The cancellation of claims 13 and 15 renders the rejections thereof moot.
The rejection of claims 1-7, 14, 16-17, and 19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,512,282 is maintained, as outlined above. The cancellation of claims 13 and 15 renders the rejections thereof moot.
Conclusion
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 Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632