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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-11, drawn to a three dimensional microcompartment in the reply filed on 04/09/2026 is acknowledged. The traversal is on the ground(s) that the present claims are novel and non-obvious over US 2019/0330589. This is not found persuasive because applicant has not provided an argument to refute the previously mentioned reference. Moreover, claims 12 and 13 will be examined because they include the features of claim 1. However, the methods claims, 14-24 remain withdrawn from consideration, and therefore, for the purposes of examination, claims 1-13 will be examined.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/04/2019 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
The term “type” in claim 2 is a relative term which renders the claim indefinite. The term “type” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “preferentially” in claim 6 is a relative term which renders the claim indefinite. The term “preferentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 10 recites the limitation "the encapsulation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0330589 A1-Feyeux et al (hereinafter “Feyeux”).
Regarding claim 1, Feyeux discloses a three-dimensional microcompartment (para. [0001], lines 1-5, Figs. 1A and 1B; para. [0008]) of ovoid, cylindrical, spheroid or spherical shape or substantially ovoid, cylindrical, spheroid or spherical shape (the microcompartment can have any shape compatible with cell encapsulation, para. [0038], lines 3-5, Figs. 1A and 1B), comprising an external hydrogel layer (outer hydrogel layer that gives the cellular microcompartment its size and shape, para. [0038], lines 2-3, Figs. 1A and 1B) defining an internal part (shown in Figs. 1A and 1B, where outer hydrogel layer 1, defines an internal region), said internal part comprising at least:
- extracellular matrix elements (para. [0010], Figs. 1A and 1B; para. [0023], line 3), and - at least two cysts, each cyst being formed by at least one layer of human or animal cells, excluding human embryonic stem cells, organised three-dimensionally around a lumen (the invention proposes to produce cellular microcompartments containing pluripotent stem cells organized into cysts directly from pluripotent stem cells, or from differentiated cells, para. [0044], lines 4-7), the smallest radius of the internal part being at least 100 µm (the cellular microcompartment has a spherical shape with a radius of 100 um, para. [0042], lines 1-2).
Regarding claim 2, Feyeux discloses characterised in that the cells of each layer are epithelial cells or cells having epithelial-type morphology and capable of forming a cyst (the encapsulated cells are pluripotent stem cells, such as induced pluripotent stem, IPS, cells, multilineage-differentiating stress enduring MUSE, cells found in the skin and bone marrow of adult mammals, or embryonic stem, ES, cells, para. [0032]; and Feyeux teaches the cells are differentiated into one or more cell types of interest, within the microcompartment, para. [0077], lines 8-10).
Regarding claim 3, Feyeux discloses characterised in that the cells of each layer are chosen from induced pluripotent stem (iPSC) cells and the following cells: glandular epithelial cells, renal epithelial cells, intestinal epithelial cells, skin epithelial cells, retinal pigment epithelial cells, epicardial cells, and endocardial cells (the encapsulated cells are pluripotent stem cells, such as induced pluripotent stem, IPS, cells, multilineage-differentiating stress enduring MUSE, cells found in the skin and bone marrow of adult mammals, or embryonic stem, ES, cells, para. [0032]; and Feyeux discloses the cells are differentiated into one or more cell types of interest, within the microcompartment, para. [0077], lines 8-10).
Regarding claim 4, Feyeux discloses characterised in that the internal part (14) also comprises liquid areas without extracellular matrix elements (the developed microcompartments allow cells to be cultured in liquid medium, para. [0007], lines 5-6; culture medium fills the spaces left between the layers, para. [0011], line 2).
Regarding claim 5, Feyeux discloses characterised in that the smallest radius of the internal part is at least 200 µm (the diameter of such a micro compartment is comprised between 10 um and 1 mm, para. [0039], lines 4-5).
Regarding claim 6, Feyeux discloses characterised in that the volume of the internal part represents at least 20% of the total volume of the microcompartment, preferentially at least 40% (the lumen then represents 5 to 30% of the radius of the microcompartment, para. ]0041], lines 11-12).
Regarding claim 7, Feyeux discloses characterised in that it is closed (the cellular microcompartment is closed, para. [0038], lines 1-2).
Regarding claim 8, Feyeux discloses characterised in that the external layer comprises alginate (the outer hydrogel layer contains alginate, para. [0027], lines 8-9).
Regarding claim 9, Feyeux discloses characterised in that at least one cyst comes from the fusion of two cysts (the invention proposes to produce cellular microcompartments containing pluripotent stem cells organized into cysts directly from pluripotent stem cells, or from differentiated cells, para. [0044], lines 4-7; cysts of a few dozen cells are formed in the capsules, para. [0108], lines 1-2).
Regarding claim 10, Feyeux discloses characterised in that the cells present in the microcompartment were obtained by the encapsulation, in the internal part of an external hydrogel layer, of 2 to 30 cells (the cell density in the microcompartment is comprised between 1 and several thousand cells per microcompartment, para. [0043], lines 19-21).
Regarding claim 11, Feyeux discloses for use thereof as a medication (the cellular microcompartments, and more precisely the cells they contain, can be used for research and development purposes, both in the form of a 3D cell network and more conventionally in 2D culture; they can also be used for therapeutic purposes, para. [0078]).
Regarding claim 12, Feyeux discloses an assembly of microcompartments comprising at least two three-dimensional cellular microcompartments, characterised in that at least one microcompartment is a microcompartment according to claim 1 (a 3D cellular microcompartment comprising human pluripotent cell, para. [0024], lines 1-2; para. [0023], describes the microcompartment assembly and the four layers, (1: hydrogel layer; 2: extracellular matrix layer; 3: layers of pluripotent cells; 4: lumen).
Regarding claim 13, Feyeux discloses characterised in that the microcompartments are arranged in a culture medium in a bioreactor (the cellular microcompartments concerned by the present invention can be used for many applications, para. [0077], lines 1-2, that is, the applications may include bioreactors. Also, Feyeux discloses it is possible to prepare microcompartments by adapting the microfluidic method and device, para. [0045], lines 5-6).
Therefore, the reference of Feyeux meet the limitations of claims 1-13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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