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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Claim Status-
Claims 1-9, 13-18, 20, and 22-24 are pending.
Claims 15-18, 20, 22-24 are withdrawn as being directed to a non-elected invention, as asserted in the Office action dated 02/11/2025.
Claims 10-12, 19, and 21 are cancelled by the Applicant.
Claims 1-9 and 13-14 are currently being examined.
All previous objections and rejections not set forth below have been withdrawn in view
of applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b)
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 1-9 and 13-14 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.
Claim 1 recites, “A matrix comprising a plurality of bioprinted plant cells, wherein the plurality of plant cells comprises at least one plant stem cell, and wherein the plurality of bioprinted plant cells are deposited in the matrix according to a pre-determined spatial pattern sufficient to induce the plurality of plant cells to form a callus.”
As written, the claim is confusing. For example, the claim as written, indicates that the plurality of already bioprinted plant cells comprise at least one plant stem cell. It is not clear to the Examiner if bioprinted cells have been deposited again in the same matrix.
The confusion arises because, both in the claims and in the specification, it is unclear if the recitation, “the plurality of plant cells” refers back to a “plurality of bioprinted plant cells”, or is referring to a plurality of plant cells FOR bioprinting, as part of a bioink composition, or from which the cells in a bioink are derived.
This confusion is also reflected from the limitations in dependent claims 3-5. Claim 3, for example, states that “the plurality of plant cells” COMPRISES at least one plant cell obtained from a meristematic region of a root. But if the plurality of cells are already bioprinted, it cannot comprise a cell from a root. The cell is bioprinted. A similar issue arises from claims 4 and 5, which state the plurality of plant cells comprises at least one cell obtained from a shoot and/or root stem cell niche (claim 4) or apical meristem (claim 5), as such cells are not bioprinted.
Further, see claim 7, which states, “the plurality of cells are contained within a bioink composition”. But a bioink composition does not contain bioprinted cells. Rather, bioink contains material TO BE bioprinted, according to paragraph [0041] of the specification.
Paragraph [0042] of the specification states that “bioprint” refers to printing using a material comprising biological substances, and “printing” refers to a process of depositing a material according to a pre-determined pattern, design or scheme. Paragraph [0041] teaches that “bioink” refers to a composition that is suitable for bioprinting, and contains material to be bioprinted, including plant cells or protoplasm. Paragraphs [0041] and [0042] indicate that it is bioink that contains the plant cells/material that are deposited on a matrix, in a pre-determined spatial pattern, to obtain bioprinted cells. Claim 1, however, indicates that it is bioprinted cells that are deposited in the matrix according to a pre-determined spatial pattern.
The meets and bounds of the claim 1 and its dependent claims, even when considering the instant specification, are unclear to the Examiner. In the ‘SUMMARY’ section, paragraph [0006] indicates that an embodiment of the disclosure includes a matrix comprising a plurality of bioprinted plant cells, and the plurality of bioprinted plant cells are deposited in the matrix to a pre-determined spatial pattern. But note that paragraph [0009] recites, “the plurality of plant cells are contained in a bioink composition, and deposited into the matrix in the bioink composition”. The recitation, “the plurality of plant cells” cannot be referring back to “the plurality of bioprinted cells”, as the material in a bioink composition if FOR bioprinting.
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 1-9 and 13-14 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 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 recites, “…. the plurality of plant cells comprises at least one plant stem cell…”. This recitation is being interpreted for this rejection, such that “the plurality of plant cells” is FOR bioprinting.
The Applicant describes using various markers including GFP, YFP, RFP and mCherry fluorescent proteins fused to different promoters allegedly “marking QC cells, CEIs, LRC/EPI, xylem, CSCs, protophloem, SCN, phloem initials, sieve element cells, and cambium” (spec, page 23, para 0084, line 6-7). It is known in the art that identity and fate of a cell in a plant is intimately linked to its relative position within the plant (Efroni, I, 2018, A Conceptual Framework for Cell Identity Transitions in Plants, Plant Cell Physiol. 59:696–706; Abstract). It implies that a specific cell type including a stem cell dissociated from its positional cue and isolated to make or sort individual cells would lose its cellular identity. It is also known in the art that expression of specific stem cell markers including WOX5, as used by the Applicant (spec, page 22, para 0084, line 3), does not imply or assign stem cell identity because such expression for stem cells marker genes like WOX5 is observed in Arabidopsis roots where stem cell niche or the root quiescent center (QC) are ablated or abscised in a specific temporal fashion (Efroni, I., bridging paragraph between page 700, right column, last para and page 701, left column, first para). Moreover, analysis of gene markers and transcriptomic assays have revealed callus cells expresses many root meristem-specific markers (Efroni, I; page 702, left column, para 5, line 3-7).
The Applicant describes fluorescence activated cell sorting (FACS) to isolate different stem cell-types (page 23, para 0084, line 1-2) using expression of different fluorescent proteins (e.g., GFP, YFP, RFP and mCherry) fused to different promoters (page 23, para 0084, line 3-5). These cells are already isolated from its actual positions (including in QC) in the plant. The cells are used to make isolated protoplasts before bioprinting (page 23, para 0085, line 1). It is highly unlikely that these isolated protoplasts, maintained in a culture media (PIM) containing auxin (2, 4-D) (Spec, page 32, para 0121; page 32, para 0129, line 6) before being suspended in different bioinks comprising auxin (e.g., 2,4-D, NAA, and IAA) and cytokinin (BAP and Kinetin) (spec, page 31, para 0105; page 31-32, para 0107-0125) prior to bioprinting, would maintain its specific (initial) cellular identity including that of a stem cell. The cells immersed in exogenously applied plant hormone (auxin and cytokinin) and detached from its actual in-vivo positional cues suspended in the liquid medium is more of a cell in a callus or cell suspension culture, which is often derived from callus. There is practically no difference between a protoplast isolated from a stem cell with the ones isolated from any other plant cell or a callus.
The applicant does not describe maintaining cellular identity of a plant stem cell among isolated protoplasts. The plant cells and/or the protoplasts used for bioprinting does not include the at least one stem cell. The protoplasts (aka, cells) used for bioprinting might have been obtained from plurality of plant cells comprising at least one stem cell but those cells/protoplasts neither comprise from plurality of plant cells (all are protoplasts) nor any stem cells. It is not possible for a skilled artisan to identify the characteristics of plurality of plant cells or that of a stem cell by observing/analyzing isolated protoplasts.
Regarding claim 6, the Applicant indicates that in an embodiment of the invention, a plurality of plant cells are deposited in a matrix in a pre-determined temporal pattern (page 20, para 0070). Working examples describe depositing/bioprinting isolated protoplasts (page 33, para 0126) on a matrix but do not describe depositing the cells/protoplasts according to pre-determined temporal pattern. Examples of such matrices made by depositing plant cells or protoplasts in “temporal” pattern are lacking in the prior art, and are not reduced to practice in the instant specification.
Considering the breadth of the claims, lack of structure-function relationship of the broad genus claimed, the Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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Jay Chatterjee
Patent Examiner
Art Unit 1662
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662