DETAILED ACTION
This action is in reply to papers filed 8/11/2026.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20250144136A1, Published 5/8/2025.
Election/Restrictions
Applicant’s election without traverse of Group IV, claims 31-34 and 37, in the reply filed on 8/11/2026 is acknowledged.
Claims 17-30 and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/11/2026.
Accordingly, claims 17-37 are pending with claims 31-34 and 37 examined herein.
Drawings
The drawings are objected to because Figs. 8A-B and Figs. 28A-B are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Prior Art Rejection 1
Claim(s) 31, 34 and 37 are rejected under 35 U.S.C. 103 as obvious over Mogami et al. (Scientific Reports volume 7, Article number: 13139 (2017)).
Mogami et al. teach preterm premature rupture of membrane (pPROM) is associated with 30–40% of preterm births. Mogami teaches infection is considered a leading cause of pPROM due to increased levels of proinflammatory cytokines in amniotic fluid. This is reasonably considered to read on and inflammatory disease (as in claim 31, in-part). Moreover, Mogami teaches in some pregnancies complicated by preterm premature rupture of membranes (pPROM), membranes heal spontaneously and pregnancy continues until term. In this report, Mogami investigated mechanisms of amnion healing (Abstract; Pg. 1, para. 1). Using a preclinical mouse model, Mogami found that small ruptures of the fetal membrane closed within 72 h. Moreover, Mogami teaches small rupture induced transient upregulation of anti-inflammatory cytokines in the fetal membranes. Mogami teaches this healing was induced by amniotic fluid derived fetal M2 type macrophages (which reads on the cellular preparation of claim 31 and claim 34) that were recruited to the wounded amnion where macrophage adhesion molecules were highly expressed (Pg. 1, para. 2; Pg. 5, para. 2). Mogami teaches recruited macrophages released limited and well-localized amounts of IL-1β and TNF which facilitated epithelial-mesenchymal transition (EMT) and epithelial cell migration (as further in claim 34) (Abstract). And while Mogami’s teaches an in vivo method of treating, Mogami establishes the therapeutic capacity of amniotic fluid derived fetal macrophages. Therefore, it would have been prima facie obvious for one of ordinary skill in the art to isolate fetal macrophages from the amniotic fluid for the purposes of treating pPROM (as in claim 37).
It is noted that although Mogami is silent as to presence of positive surface markers in the derived fetal macrophages derived from amniotic fluid as cited in withdrawn claim 26, the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' generated cells differ, and if so to what extent, from the cells of the prior art. The prior art cells are the same or similar because they are derived from the same source as claimed by applicant. Specifically, the cells are obtained from amniotic fluid. The cited art taken as a whole demonstrates a reasonable probability that the amniotic fluid source for deriving the fetal macrophages and the fetal macrophages resulting therefrom are either identical or sufficiently similar to the claimed cells that whatever differences exist are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. Clear evidence that the fetal macrophages from amniotic fluid of the cited prior art does not possess a critical characteristic that is possessed by the claimed cells (for example, that the fetal macrophages obtained by Mogami's method lacks the surface markers listed in claim 26) would advance prosecution.
Accordingly, the teachings of Mogami makes the claimed invention prima facie obvious.
Prior Art Rejection 2
Claim(s) 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Mogami et al. (Scientific Reports volume 7, Article number: 13139 (2017)) as applied to claims 31, 34 and 37 and further in view of Scheffer et al. (HK1210425B, Published 4/22/2016).
The teachings of Mogami et al. are relied upon as detailed above. However, Mogami fails to teach the fetal macrophages treats inflammatory bowel disease or chronic inflammatory disease (as in claim 32) or that the fetal macrophages treats graft-versus-host disease, systemic lupus erythematosus, liver cirrhosis, pulmonary fibrosis, atopic dermatitis, or aging (as in claim 33).
Before the effective filing date of the claimed invention, Scheffer et al. teach treatment methods are described herein, comprising administering macrophages that have been modulated by the methods provided herein for modulating macrophage activity. Scheffer teaches such methods for modulating macrophage activity include promoting the expression of IL-10 in polarized macrophages from an M1 to an M2 phenotype (Pg. 8, para. 3). Scheffer teaches M2 macrophages, or "alternatively activated" macrophages, exhibit wound healing and tissue regeneration properties and are characterized by low IL-12/IL-23 and high IL-10 or roughly equal ratios of IL-12 to IL-10 (bottom of Pg. 86). In one embodiment, Scheffer teaches treatment of chronic inflammation (as in claim 32 ) and treatment of GVHD (as in claim 33) (bottom of Pg. 27).
When taken with the teachings of Mogami et al., wherein Mogami teaches amniotic fluid derived fetal M2 type macrophages have therapeutic ability, one of ordinary skill in the art would have found it prima facie obvious to use the macrophages of Mogami in the treatment of chronic inflammation and GVHD, as set forth in Scheffer. The skilled artisan would have found it prima facie obvious to do in order to determine if the macrophages of Mogami could treat chronic inflammation and GHVD. A reasonable expectation is present given that Scheffer teaches M2 macrophages exhibit would healing and tissue regeneration properties.
Thus, the combination would have been prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
