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
Claim 1 is pending.
Claim 1 is newly amended.
Claims 1 has been examined on its merits.
Claim Interpretation
Claim 1 as amended recites and is drawn to “Isolated cells” derived from placenta. Since the word “cells”” is plural, it necessarily implies a population of isolated cells. Continuing, the claim recites “wherein said placental derived stem cell” and then “wherein the stem cell expresses CD34-, CD45-, CD44-, CD90+, CD29+, and CD105+”. Both the terms “said placental derived stem cell” and “the stem cell” are singular.
The issue is whether a “said placental derived stem cell” and “the stem cell (that) expresses CD34-, CD45-, CD44-, CD90+, CD29+, and CD105+” refer to the whole population of stem cells or if they can refer to individual cells within the population of stem cells.
According to the specification, a stem cell is isolated if “at least 50% . . . of the non-stem cells . . . are removed” (paragraph [0009]). Continuing, the specification states, a population of stem cells is isolated if “at least 50% . . . of the cells with which the population of stem cells are naturally associated are removed from the population of stem cells” (paragraphs [0010]).
Thus, according to the specification, both populations of stem cells and even isolated stem cells may in fact be mixed populations.
Additionally, it is well-understood in the art that a population of cells can be heterogeneous, and that distinct subpopulations, with different phenotypes, can exist in that population
Therefore, giving the terms their broadest reasonable interpretations in view of the specification and art, references to the “said placental derived stem cell” and “the stem cell” have been interpreted as referencing individual cells, not the population of stem cells as a whole.
Furthermore, in regards to cell derived from a placenta, the specification states, “Unless otherwise noted herein, the term ‘placental’ includes the umbilical cord (paragraph [0011]).” Therefore, claim 1 includes cells derived from the placenta as well.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn. Prior objections have been addressed by amendment.
The prior rejection of claim 1 under rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Edinger et al. (US20140017211A1, 2014) is withdrawn due to amendment of the claims and in order to address the teachings of Kang et al. (Journal of Tissue Engineering and regenerative medicine, 2013) and Fischer et al. (Scientific Reports, 2016) as discussed below.
The prior rejection of claim 1 under 35 USC 101 is withdrawn due to Applicant’s persuasive arguments as discussed below.
The prior rejection of claim 1 under 35 USC 102 is withdrawn in order to address the claims as amended.
Response to Arguments
Applicant argues that the claimed invention is non-naturally occurring (Remarks, p4-5).
Applicant’s arguments, see Remarks, p4-5, filed 03/03/2026, with respect to the rejection under 35 USC 101 have been fully considered and are persuasive. The rejection of claim 1 under 35 USC 101 has been withdrawn.
Specifically, Applicant argues that Edinger et al. (US2014001711) does not disclose cells that are harvested from genetically modified mammal and are themselves genetically modified (Remarks, p5-6).
In regards to Applicant’s arguments regarding Edinger et al. (US2014001711), Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on Edinger et al. (US2014001711) for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102 or in the alternative 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 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.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer et al. (Scientific Reports, 2016) as evidenced by Kang et al. (Journal of Tissue Engineering and regenerative medicine, 2013), Huang et al. (Stem Cell Research and Therapy, 2015), and Stange et al. (Cells, 2025), or, in the alternative, under 35 U.S.C. 103 as obvious over Fischer et al. (Scientific Reports, 2016) in view of Kang et al. (Journal of Tissue Engineering and regenerative medicine, 2013) and Liu et al. (Clinical and Translational Immunology, 2014), as evidenced by Huang et al. (Stem Cell Research and Therapy, 2015) and Stange et al. (Cells, 2025).
In regards to claim 1, Fischer discloses genetically modified pigs with modifications to overcome hyperacute rejection during xenotransplantation (Abstract, p1).
While Fischer is silent as to whether a placental cell within these pigs have a CD34-CD45+CD44-CD90+CD29+CD105+ phenotype, the specification does not suggest that a CD34-CD45+CD44-CD90+CD29+CD105+ phenotype (referred to as a sPDAC-B cell) is the result of genetic modification, but only states that these cells are isolated from tissues (placentas) harvested from genetically modified pigs, expanded, and then characterized (paragraphs [0052-0054]).
Furthermore, the claimed markers are all known placental stem cell phenotypes.
Kang evidences that cells within the populations of umbilical cord stem cells (a type of placental stem cell, as defined by the instant specification (see paragraph [0011]) express CD29 (98%, 3.1. Phenotypic profile of UCM-MSCs and BM-MSCs, p173, Figure 2, p174) and CD90 (about 85%, 3.1. Phenotypic profile of UCM-MSCs and BM-MSCs, p173, Figure 2, p174).
Kang further evidences that that 83.3 ± 0.7% of cells express CD44 (Results, p174; Fig. 2C, p174), and therefore, greater than 16% of these cells are negative for this marker.
Additionally, Huang evidences that the majority of porcine placental stem cells are highly positive for at least CD34-, CD45-, CD90+, and CD29+ (Figure 1, p6), and Stange evidences that porcine umbilical cord stem cells also express CD105 in high percentages (Fig. 5, p10).
Moreover, the specification explicitly states “We have demonstrated the feasibility of establishing swine PDAC cells from full term GM-pig placentas” (and noting which explicitly includes sPDACs) which indicates that CD34-CD45+CD44-CD90+CD29+CD105+ stem cells are in fact found in pig placental tissues, and therefore, not a result of their isolation.
Therefore, a placental stem cell with a CD34-CD45+CD44-CD90+CD29+CD105+ phenotype is a cell naturally found in the placental tissues of the genetically modified pig as disclosed by Fischer.
However, in the event that Fischer does not suggest an isolated CD34-CD45+CD44-CD90+CD29+CD105+ placental stem cell specifically, a person of ordinary skill in the art would have been motivated to isolate stem cells in order to study them or use them for therapies.
Furthermore, isolation of placental stem cells was routine in the art before the effective filing date.
Specifically, Kang teaches that pig umbilical cord stem cells were isolated from umbilical cord tissue fragments, cultured in media, and then assessed for phenotype (2.2. Isolation and culture of UCM-MSCs and BM-MSCs; 2.3. Phenotypic analysis by flow cytometry, p170-171).
Moreover, Liu teaches that placenta-derived adherent cells can be obtained by digesting placental tissues, incubated in a medium comprising DMEM, 2% FBS, human EGF and human PDGF-BB, passaged, and assessed for phenotype (Methods, p9-10) which mirrors the method for isolating the claimed placental stem cels. While Liu teaches isolating human placental stem cells, it is noted that the reference Liu includes instant inventors, and appears to the same “protocol based on human PDAC establishment” as referenced in the instant specification (paragraph [0052]). Therefore, the isolation methods are isolation methods known in the prior art.
Therefore, a person of ordinary skill in the art could have isolated populations of placental stem cells, which would have naturally included a stem cell with a CD34-CD45+CD44-CD90+CD29+CD105+ phenotype, with predictable results and a reasonable expectation of success.
Therefore, Fischer anticipates the invention or in the alternative the combined teachings of Fisher, Kang, and Liu renders the invention unpatentable as claimed.
Conclusion
No claims are 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 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 JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631