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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/3/2025 has been entered.
Claims 1-31, 34, 36, 41-45, 50 have been canceled, claims 53-67 are newly added, and claims 32-33, 35, 37-40, 46-49, 51-67 have been considered on the merits. All arguments have been considered.
Response to Amendment
The declaration under 37 CFR 1.132 filed 10/3/2025 is sufficient to overcome the rejection of claims 32-33, 35, 37-42 and 44-52 based upon Wang et al. in view of Atala et al. and Doering et al.
The claim rejection under 103 has been withdrawn.
Double Patenting
Applicant is advised that should claims 34-37 be found allowable, claims 41-44 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 32-33, 35, 37-40, 46-49, 51-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23-24, 26-36 and 39-41 of copending Application No. 18/129,398 (reference application; now allowed) in view of Wang et al. (supra) and Waddington et al. (2004, Gene Therapy)
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘398 application disclose the method of treating a subject diagnosed having hemophilia A and the steps of the method are identical to the method disclosed in the instant application except the claims of the ‘398 application are directed to post-natal treatment whereas the instant application is directed to prenatal treatment. The claims of the ‘398 applicant discloses the same source of MSCs; marker expression (c-kit+; CD90+; CD47+), the use of viral vector with constitutively active promoter; administration routes; and cell concentration for the administration the same as the claims of the instant application. The claims of the ‘398 application discloses SEQ ID NO:12 (claim 21) which is identical to the SEQ ID NO:12 (claim 50) of the instant application.
While the claims of the ‘398 application do not disclose in utero administration, it is known in the art that hemophilia A treatment can be in utero according to Wang et al. (para. 114). Furthermore, Waddington et al. teach a gene therapy for monogenetic diseases including hemophilia A can be either fetal or neonatal application (Introduction). Thus, it would have been obvious to a person skilled in the art to use the method steps of the ‘398 application for in utero gene therapy taught by Wang et al. and Waddington et al. with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments in view of the declaration filed 10/3/2025, with respect to the 103 rejection have been fully considered and are persuasive. The claim rejection was withdrawn as indicated above.
The double patenting rejection is maintained based on the ‘398 application (now allowed). However, the double patenting rejection based on ‘624 patent has been withdrawn.
Considering the previously presented claims (claims 32-33, 35, 37-40, 46-49 and 51-52) being substantially similar in their scope to the newly added claims (claims 53-67), applicant is advised to cancel claims 32-33, 35, 37-40, 46-49 and 51-52. It is also noted that there was an examiner’s amendment on the claims in 18/129,398 (Notice of allowability issued on 2/3/2026). Applicant is advised to amend claims 53-67 consistent with the ‘398 application.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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