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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Status of Claims
Claims 1-2, 6, 11-12, 15-16, 19, 20-21, 26, 28-30, 37, 40, 45-48, 51, and 53-54 are pending and under examination. Claims 3-5, 7-10, 13, 17-18, 22-25, 27, 31-36, 38-39, 41-44, 49-50, 52, and 55-62 are cancelled.
Claim Interpretation
Optional embodiments such as those recited in claim16 or 19 are not given patentable weight as these embodiments are not required by the claim.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 56 is rejected under 35 U.S.C. 101 because it is directed to a judicial exception without significantly more.
The rejection is withdrawn following cancellation of the claim.
Claim Rejections - 35 USC § 112
Claim 40 was rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim was rejected because it was asserted that from figures 2B and 10B show the inner layer to be epiblasts, while the middle and the outer layers seemed to be a mixture of both hypoblast-like and trophoblast-like cells. It was noted that [0027] of the specification pointed out “the presence of an inner domain surrounded by two concentric domains.” However, the presence of these markers and cell types were not conclusively shown at the interfaces claimed.
Applicants argued that “[a] person skilled in the art can unequivocally identify three layers categorized by their distinct biomarker expression: the SOX2-positive, epiblast-like inner domain (green), the GATA6-positive, hypoblast-like intermediate layer (orange), and the GATA3-positive, trophoblast-like outer layer (purple). Cells derived from inducible GATA3-AP2Y expressing GFP showed clear outer localization (see FIG. 2G, 4th col.). Furthermore, the GATA6-positive intermediate layer becomes more evident at Day 6 (see FIG. 3A). FIG. 2F (reproduced below) further depicts representative images of an in vitro cultured human embryo 9 days post-fertilization, showing clear lumenized SOX2 domain surrounded by a layer of GATA6-positive cells.”
The rejection is withdrawn following Applicant arguments.
Claims 12, 14, 30, 37 and 40 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 30 and 37 contained the trademark/trade names KnockOut Serum Replacement, or GlutaMax. The rejection is withdrawn following cancellation of the trademarked terms
Claims 12, 14, 40 require various embodiments like epiblast-like domain or trophoblast-like cells, or inner epiblast-like domain or peri- implantation-like pluripotent hESCs. The metes and bounds of such claims were unclear as it is not clear from the specification as to what constitutes a cell “like” the claimed cells. The rejection is withdrawn following cancellation of the rejected terms.
Claim Rejections - 35 USC § 103
Claims 1-2, 6, 15-16, 19, 21, 26, 28-30, 37, 45-48, 51, 53-54 and 56 were rejected under 35 U.S.C. 103 as being unpatentable over Sozen et al (Nat Cell Biol. 2018 Oct; hereinafter "Sozen;" See IDS filed 09/28/2023) in view of Kubaczka et al (Cell Stem Cell. 2015 Nov 5; hereinafter "Kubaczka;" See PTO-892) and Shimosato et al (BMC Dev Biol. 2007 Jul 3; hereinafter "Shimosato;" See PTO-892); further as evidenced by Dupont et al (Sci Adv. 2023 Jan 18; hereinafter "Dupont;" See PTO-892).
Claims 11-12 and 20 were rejected under 35 U.S.C. 103 as being unpatentable over Sozen et al (Nat Cell Biol. 2018 Oct; hereinafter "Sozen;" See IDS filed 09/28/2023) in view of Kubaczka et al (Cell Stem Cell. 2015 Nov 5; hereinafter "Kubaczka;" See PTO-892) and Shimosato et al (BMC Dev Biol. 2007 Jul 3; hereinafter "Shimosato;" See PTO-892)l; further as evidenced by Dupont et al (Sci Adv. 2023 Jan 18; hereinafter "Dupont;" See PTO-892) further in view of Nichols (Cell Stem Cell. 2009 Jun 5; hereinafter "Nichols;" See PTO-892).
The rejections are withdrawn in view of Applicants arguments. It is submitted teachings of Sozen, Shimosato and Kubaczka did not teach successful self-organization into the claimed synthetic embryo structure.
The prior art does not provide an adequate reason to combine the teachings of Sozen, Shimosato and Kubaczka in the manner required by the amended claims, nor does it establish a reasonable expectation of success that the resulting combination would generate a post implantation embryo structure comprising the claimed arrangement of inner epiblast, intermediate hypoblast and outer trophoblast layer. As such the outstanding 103 rejection is withdrawn.
Double Patenting
Claim 56 was provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 60 of copending Application No. 18/485,192 (reference application).
The rejection is withdrawn following cancellation of the claim.
MAINTAINED OBJECTIONS
Drawings
The application contains at least one color drawing or color photograph. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
It is noted that a Petition for color drawings was filed by the Applicants on 09/1/2023, which was dismissed by the Office in the Petition Decision of 2/14/2024 specifically indicating that no color drawings are submitted or are found.
It is noted that the latest Petition was submitted on 6/8/2026 and the decision is pending. As such the objection is maintained.
Specification
The disclosure is objected to because of reference to colored referenced points within the drawings, [0019]. The specification must be amended to clearly reference the same figures without use of color identifiers, and to be in accordance with the changes in the drawings. Correction is required. See MPEP § 608.01(b).
NEW REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 6, 11-12, 14-16, 19-21, 26, 28-30, 37, 40, 45-48, 51, and 53-54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 and 2: encompass an in vitro method of generating a post-implantation embryo structure comprises an inner epiblast domain, a single outer layer of trophoblast cells, and an intermediate hypoblast domain between the epiblast domain and the single outer layer of trophoblast cells comprising coculturing the following two groups of ESCs:
1
first modified mammalian ESC comprising GATA6 gene
second modified mammalian ESC comprising GATA3 gene
2
first modified mammalian ESC comprising GATA6 gene
second modified mammalian ESC comprising TFAP2c gene
3
first modified mammalian ESC comprising inducible SOX17 gene
second modified mammalian ESC comprising GATA3 gene
4
first modified mammalian ESC comprising inducible SOX17 gene
second modified mammalian ESC comprising TFAP2c gene
5
first modified mammalian ESC comprising GATA6 gene and inducible SOX17 gene
a second modified mammalian ESC comprising GATA3 gene and TFAP2C gene
6
first modified mammalian ESC comprising GATA6 gene and inducible SOX17 gene
second modified mammalian ESC comprising GATA3 gene
7
first modified mammalian ESC comprising GATA6 gene and inducible SOX17 gene
second modified mammalian ESC comprising TFAP2c gene
8
first modified mammalian ESC comprising GATA6 gene
a second modified mammalian ESC comprising GATA3 gene and TFAP2C gene
9
first modified mammalian ESC comprising inducible SOX17 gene
a second modified mammalian ESC comprising GATA3 gene and TFAP2C gene
It is submitted that the specification did not provide support for each of the claimed embodiments.
The specification provided support for co-culture of wildtype ESC with inducible GATA6-SOX17 and inducible GATA3-TFAP2C cells (combination #5). The specification did not demonstrate production of the claimed embryo by co culturing a first modified mammalian ESC comprising GATA6 gene and a second modified mammalian ESC comprising TFAP2c gene. Similarly, other combinations lack explicit support in the specification. Although the specification described experiments evaluating GATA6 alone and SOX17 alone in the context of hypoblast-like cell identity, these experiments relate to the regulation of hypoblast subpopulation markers and do not clearly demonstrate that such modified ESC populations when cocultured with trophoblast-inducing ESCs generate the claimed post-implantation embryo structure. Neither does the specification identify that the disclosed transcription factors are interchangeable. Thus, disclosure of one specific combination of transcription factor does not reasonably convey possession of the broader genus encompassing any combination of the GATA6, SOX17, GATA3 and TFAP2C recited in the claims.
Accordingly, the specification fails to provide adequate written description support for the full scope of the claimed genus.
Claims 21, 30 and 37 require analogs of various molecules such as glutamine, insulin, progesterone, 3-estradiol, estrone, estriol, estetrol IGF-I, and IGF-II. The specification did not provide support for culturing ESCs in DMEM supplemented with the claimed ingredients, but does not describe or identify structural, functional or provide other guidance regarding which compounds would serve as analogs for supporting the ESC culture. Accordingly, the specification fails to provide adequate written description support for the full scope of the claimed genus.
Claims 6, 11-12, 14-16, 19, 20-21, 26, 28-30, 37, 40, 45-48, 51, and 53-54 are rejected for their dependency.
Conclusion
Pending claims appear free of art, however, lack written description.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M. Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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