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 14 – 26 are pending.
Claim Rejections - 35 USC § 102
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 14 – 16 and 24 – 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Allogeneic Stem Cell Transplantation Combined With Transfusion of Mesenchymal Stem Cells in Primary Myelofibrosis: A Multicenter Retrospective Study. Front. Oncol. (2022); cited on IDS, hereinafter Wang).
Regarding claim 14 – 16 and 24, Wang discloses a retrospective study on a clinical trial in which subjects with primary myelofibrosis were administered mesenchymal stem cells (MSC) in combination with allogeneic stem cell transplantation for treatment (p. 1; p. 2, Introduction). Wang further discloses that the MSCs were obtained from the umbilical cord (p. 3, Preparation of Mesenchymal Stem Cells).
Regarding claims 25 – 26, The outcome(s) of claims 25 and 26 flow naturally from performing the method of claim 14, thereby rendering the claims inherent to the method.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 17 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Noronha et al. (Priming approaches to improve the efficacy of mesenchymal stromal cell-based therapies, Stem Cell Res Ther. (2019) May 2;10(1):131.; hereinafter Noronha).
Regarding claims 17 – 18, Wang teaches all of the elements of the current invention as stated above except the umbilical cord-derived mesenchymal stem cells being “primed” or not. However, Noronha discloses (UCMSC) (p. 3 – 4, 2nd col., last para on p. 3 to p.4) that IFN-γ-primed cells showed higher migration rates to inflammatory sites and a significant reduction of mucosal damage and inflammatory responses, compared with non-primed MSCs. Noronha further discloses/provides motivation by disclosing that priming with IFN-γ or other inflammatory cytokines leads to upregulation of class I and class II HLA molecules, which makes the MSCs more immunogenic and therefore more susceptible to recognition by host immune cells, and subsequent clearance of the cells in vivo following administration.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the knowledge from Noronha about the disadvantages of priming the MSCs and incorporate that in the UCMSC treatment method of Wang. Doing so would allow for an additional embodiment with the potential to treat myelofibrosis without the “more immunogenic” MSC phenotype disclosed by Noronha.
Regarding claims 19 – 22, Noronha discloses that upon IFN-γ priming, MSC upregulate IDO (p. 2 – 3, IFN-γ-priming section). Noronha further discloses/provides the motivation for retinoic acid to be used as a culture medium supplement and priming factor (p. 11, col.1, last paragraph). Noronha even notes that retinoic acid upregulated COX-2, HIF-1, CXCR4, CCR2, etc. and enhanced wound healing in vivo, demonstrated significant therapeutic benefits in emphysema, and improved lung tissue repair.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the MSC culturing method (retinoic acid) of Noronha in the UCMSC treatment method of Wang. Doing so could potentially enhance the therapeutic benefits of using the MSCs in the myelofibrosis treatment protocol of Wang.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Kim et al. (Reduced-intensity conditioning versus myeloablative conditioning allogeneic stem cell transplantation for patients with myelofibrosis; Blood Research, Vol. 57, No. 4, pp. 264 – 271, (2022); hereinafter Kim).
Regarding claim 23, Wang teaches all of the elements of the current invention as stated above except the subject not having a myeloablative transplantation. However, Kim discloses an alternative curative option that does not include myeloablative conditioning (p. 1). It is well known that myelofibrosis is a disease of older adults, and most patients are not fit for myeloablative conditioning (p. 265, col. 1, continued paragraph from p. 264).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the knowledge/motivation of Kim and eliminate the myeloablative transplantation of Wang. Doing so would eliminate a myeloablative conditioning step that the majority of myelofibrosis patients are not fit for.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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