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 .
The claims filed 4/17/2023 are under consideration.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6 and 8-10 in the reply filed on 11/4/2025 is acknowledged. The traversal is on the ground(s) that the similarities between the groups was not sufficiently considered with regards to ease of searching the different groups in relation to the elements of the methods and that the groups are related such that any additional burden on the office is not so serious to require restriction. This is not found persuasive because all the inventions listed in Restriction Requirement are independent or distinct for the reasons given and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention; and/or
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
While the different groups may be “related” each of the inventions of the groups are distinct for the reasons outlined in the Restriction Requirement and there is nothing of record establishing that the groups are obvious variants of one another.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7 and 11-33 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/4/2025.
Priority
The present application claims priority to US provisional application 63/291,045 (filed 12/17/2021).
Priority is not recognized because the ‘045 provisional application does not disclose “multi-tissue organoids” but rather focuses on “embryoid bodies” or the use of first and second mammals of the same species rather than different species as encompassed by claim 1.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the body the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Specification
The disclosure is objected to because of the following informalities: the specification describes the drawings as including color, in particular in the descriptions of Fig. 1 (para. 11), Fig. 3 (para. 13), Fig. 5 (para. 15), Fig. 12 (para. 22) and Fig. 19 (para. 29). However, the drawings are not presented in color and the specification is objected to because of this discrepancy.
Appropriate correction is required.
Claim Interpretation
The steps of claim 1 are interpreted as not being performed in the order they are listed. While some steps, such as c, are performed after previously recited steps, i.e., steps a and b, not all the step refer to elements of a previously recited step.
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 1-6 and 8-10 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.
Regarding claim 1, the claim in step (d), in particular parts (1) and (2), references gene “expression” that is used to “cluster” cells and “annotate” cell types. However, there is no previous element that refers to “gene expression”. It is unclear if step (e), which describes an analysis that generates data for the transcriptome, is required prior to step (d). If not, the claim is incomplete as step (d) requires data and that is not generated as part of the method as a whole. The result being a gap between steps and elements in the claims.
Claims 2-6 and 8-10 depend from claim 1 and are rejected for the same reason.
Regarding claims 1 and 3, the claims recite “the data” in step (f) of claim 1 and in line 1 of claim 3. It is unclear if the “data” is referring to the “generated data” described in step (e) of claim 1.
Claims 2-6 and 8-10 depend from claim 1 and are rejected for the same reason.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 depends from claim 1 as it references performing the claim.
Claim 8 includes the performance of the method of claim 1 as its only active method step. The claim includes a “wherein” clause stating an intended use or result of the method, which is that the genome or transcriptome is associated with a disease-state. The clause does not limit the scope of how the method of claim 1 is performed. Thus, the scope of claim 1 and the scope of claim 8 does not differ as the active method steps are identical between the two claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Velasco (WO 2020/243657 A1).
Regarding claims 1, 4, 6 and 10, Velasco teaches forming “multi-tissue organoids” from two different “pluripotent stem cells” from two different mammals by using and culturing the PGP1 and HUES66 stem cell lines (para. 122). It is noted the organoids of Velasco are “multi-tissue” as they contain projection neurons, callosal PNs, intermediate progenitor cells, corticofugal PNs, intemeurons, radial glia, outer radial glia (para. 33, 124, and 131)
Velasco teaches letting the “multi-tissue organoids” differentiate into self-patterned whole-brain organoids (para. 121-122).
Velasco teaches performing single cell analysis using RNA-seq to generate expression data representing the transcriptome of the cell (para. 122).
Velasco teaches identifying cells by clustering cells based on the expression data (para. 122) and classified or “annotated” using pre-existing datasets (para. 122).
Velasco further teaches applying a model-based analysis of single cell transcriptomics algorithm (para. 153) as encompassed by step (d)(3) and claim 6.
Velasco further teaches comparing data between the different multi-tissue organoids (para. 130).
Regarding claim 2, Velasco teaches the stem cells may be induced pluripotent stem cells (par. 30, 34 and 79).
Regarding claim 3, Velasco teaches the data includes an association between a “genetic variant” or mutation and a molecular phenotype for a neurological disease or condition (para. 11 and 70).
Regarding claim 5, Velasco teaches using at least three different cell lines in the analysis (para. 25, 28, 90 and 121).
Regarding claim 8, the claim only requires performing the method of claim 1. Claim 8 is anticipated for the same reason as claim 1.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Velasco (WO 2020/243657 A1).
Regarding claim 9, Velasco teaches forming “multi-tissue organoids” from two different “pluripotent stem cells” from two different mammals by using and culturing the PGP1 and HUES66 stem cell lines (para. 122). It is noted the organoids of Velasco are “multi-tissue” as they contain projection neurons, callosal PNs, intermediate progenitor cells, corticofugal PNs, intemeurons, radial glia, outer radial glia (para. 33, 124, and 131)
Velasco teaches letting the “multi-tissue organoids” differentiate into self-patterned whole-brain organoids (para. 121-122).
Velasco teaches performing single cell analysis using RNA-seq to generate expression data representing the transcriptome of the cell (para. 122).
Velasco teaches identifying cells by clustering cells based on the expression data (para. 122) and classified or “annotated” using pre-existing datasets (para. 122).
Velasco further teaches applying a model-based analysis of single cell transcriptomics algorithm (para. 153) as encompassed by step (d)(3) and claim 6.
Velasco further teaches comparing data between the different multi-tissue organoids (para. 130).
While Velasco teaches RNA-seq and a transcriptome analysis, Velasco does not specifically teach data generated for the genome of the “multi-tissue organoids”.
However, RNA-seq provides information regarding the genome of the cells of the “multi-tissue organoids” that reflects any coding sequence variations and the structure of the genome regarding whether it is in an open or closed state related to gene expression.
Thus, claim 9 is an obvious variant of the methods of Velasco.
Conclusion
No claims allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682