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 .
Status of the Claims
Claims 1, 26-27, 29-30, 32, 34-36, 38-41, and 44-52 are pending (claim set as filed on 07/17/2026).
Priority
This application is a 371 of PCT/EP2022/057244 filed on 03/18/2022, which has a foreign application to UK 2103890.6 filed on 03/19/2021.
Withdrawal of Rejections
The response and amendments filed on 07/17/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previously applied double patenting rejection over application no. 18/551,061 has been withdrawn necessitated by abandonment of said application.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 26-27, 29-30, 32, 34-36, 38-41, and 44-52 are rejected under 35 U.S.C. 103 as being unpatentable over McIntosh (WO 99/47163) in view of Larsson (US 2016/0030489 A1) and Campagne (US 2016/0328515 A1).
McIntosh’s general disclosure relates to “to the field of preventing, reducing or treating an immune response caused by immune effector cells to foreign tissue and/or cells and/or organs. The invention further relates to preventing, reducing or treating transplant rejection and/or graft versus host reaction” (see abstract & page 1, lines 18-22, & page 2, lines 26-30).
McIntosh teaches that “mesenchymal stem cells are used to suppress or ameliorate an immune response to a transplant (tissue, organ, cells, etc.) by administering to the transplant recipient mesenchymal stem cells in an amount effective to suppress or ameliorate an immune response
against the transplant. The mesenchymal stem cells may be autologous to the transplant recipient or may be allogeneic to the transplant recipient” (see page 3, lines 29-35).
McIntosh teaches the mesenchymal stem cells can be administered to the recipient before or at the same time as the transplant or subsequent to the transplant. The mesenchymal stem cells may be autologous or may be allogeneic to the recipient and can be obtained from the donor (see page 4, lines 4-8) and the mesenchymal stem cells can also be administered to the recipient as part of the transplant such as ex vivo (see pages 4-5, lines 24-30)
McIntosh teaches “donor tissue, organs or cells to be transplanted is the transplant. As examples of transplants may be included skin, bone marrow, and solid organs such as heart, pancreas, kidney, lung and liver” (see pages 7-8, bridging ¶).
McIntosh teaches further comprising administering to the recipient immunosuppressive agents (see page 40, lines 25-26).
McIntosh teaches multiple administrations of mesenchymal stem cells may be employed (see page 13, lines 5-6) and further teaches “the dosage of the mesenchymal stem cells varies within wide limits and will, of course be fitted to the individual requirements in each particular case. In general, in the case of parenteral administration, it is customary to administer from about 0.01 to about 5 million cells per kilogram of recipient body weight. The number of cells used will depend on the weight and condition of the recipient, the number of or frequency of administrations, and other variables known to those of skill in the art. The mesenchymal stem cells can be administered by a route which is suitable for the tissue, organ or cells to be transplanted. They can be administered systemically, i.e., parenterally, by intravenous injection” (see page 13, lines 20-35).
McIntosh teaches the mesenchymal stem cells can be isolated and stored frozen until needed. The mesenchymal stem cells may also be culture-expanded to desired amounts and stored until needed (see page 6, lines 1-4).
However, McIntosh does not teach: term amniotic fluid (TAF) mesenchymal stem cells (MSCs) (claims 1 and 29’s limitation); or the cell characteristics such as seen in claims 41-52.
Larsson’s general disclosure relates to obtaining biological material, including amniotic
fluid and cells, including at birth, and in some aspects relates to safe, high-yield collection of sterile amniotic fluid and devices and methods for the same (see abstract & ¶ [0002]-[0010]). Larsson teaches amniotic fluid was collected from a healthy pregnant woman during full term caesarean delivery where “For isolation of cells, the 400 mL amniotic fluid was filtered through a 100-micron nylon mesh to separate the vernix and larger tissue debris aggregates. The filtered material was then put onto a Ficoll 400 sucrose gradient and centrifuged at room temperature for
5 minutes at 500 g” (see ¶ [0128]-[0134]: Example 3 which is a similar process to the instant specification at Figure 1).
It would have been first obvious to one of ordinary skill in the art to employ or use the cell isolation method for obtaining mesenchymal stem cells such as taught by Larsson in the method of McIntosh. Note that McIntosh discloses “Although the invention is not limited thereof, mesenchymal stem cells can be isolated, preferably from bone marrow, purified, and expanded in culture, i.e. in vitro, to obtain sufficient numbers of cells for use in the methods described herein. Mesenchymal stem cells, the formative pluripotent blast cells found in the bone, are normally present at very low frequencies in bone marrow (1: 100,000) and other mesenchymal tissues” (see McIntosh at page 14, lines 6-11). Therefore, the ordinary artisan would have been motivated to use Larsson’s collection method because Larsson teaches a safe and high-yield collection method of sterile amniotic fluid cells. Thus, it would have been deemed to be a simple substitution using Larsson’s TAF-MSCs populations in McIntosh’s method for treating a transplant rejection.
Furthermore, regarding the organ-specific surface marker characteristics, Campagne teaches “an allogenomics mismatch scoring method that estimates the genomic incompatibility between potential organ donors and a transplant recipient. The allogenomics method addresses immunological concerns and compares genotype information from matched, or potential,
donors and recipients” (see abstract & ¶ [0007]). At Table 5, Campagne discloses several genes that can be evaluated such as TBC1 domain, CD248, DDR1, HAVCR1, CRB3, et. al. Therefore, it would have been further obvious to determine and select organ-specific surface markers of the TAF-MSC following the guidance of the cited references to arrive at the claimed invention. The ordinary artisan would have been motivated to do so is because Campagne teaches the evaluation potential organ donors and a transplant recipient and thus, selecting and optimizing the amount and appropriate surface markers in Larsson’s TAF-MSCs populations would allow for reduced risk of transplantation rejection.
Conclusion
No claims were 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 extension fee 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 date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (EST).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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