DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
1-86
Pending:
87-107
Withdrawn:
89, 95, 97, 101, 103 and 106-107
Examined:
87-88, 90-94, 96, 98-100, 102 and 104-105
Independent:
87
Allowable:
none
Rejections applied
Abbreviations
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
XXDATE
date format
Priority
As detailed on the 12/8/2020 filing receipt, this application claims priority to no earlier than 11/17/2017. At this point in examination, all claims have been interpreted as being accorded this priority date.
Restriction/election
Applicant’s election with traverse in the 8/11/2025 reply is acknowledged.
Applicant timely traversed the restriction requirement. The traversal is on the grounds that the identified species are not mutually exclusive (applicant remarks: p. 6). This assertion is not found persuasive because as presented it is not clear that the claims are not mutually exclusive. The requirements are deemed proper for the above reasons and as described in the restriction requirement, and the requirements are made final.
Applicant may request an interview if it becomes clear during examination that examination would be advanced by relaxing the restriction requirement to re-join withdrawn subject matter, particularly with regard to a species election.
As listed above, claims are withdrawn as drawn to nonelected inventions pursuant to 37 CFR 1.142(b), and the remaining claims have been examined as listed above.
Information Disclosure Statement
The 6/3/2025 IDS included a size fee assertion under 37 CFR 1.17(v)(1) and asserted that a fee was included. No size fee occurs in the record, and it is believed that no size fee was due and that the corresponding assertion 37 CFR 1.17(v) should have been made.
All IDSs presently of record have been entered and considered, except as noted on the attached Forms 1449.
Objection to the specification: title
The title should be amended to more specifically reflect the claims, particularly referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example terms such as: cell, bead, optical and molecular barcodes, etc. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains).
Claim Rejections - 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 is incorrect, any correction of the statutory basis 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 USC 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 of this title, 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.
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 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention.
Claims 87-88, 90-94, 96, 98-100 and 104-105
Claims 87-88, 92-94, 96, 98-100 and 104-105 are rejected under 35 USC 103 as unpatentable over Krutzik (US 8,003,312 as cited on the 2/23/2021 IDS).
Regarding claim 87, the recited physical partitions are taught as "each individual sample" (Krutzik: abstract; and entire document).
The recited bead comprising two or more barcode molecules are taught as "analyte-bound beads" and "beads that can be labeled with the [detectable cell barcoding] labels" (Krutzik: 11:67; 22:54-60; ; and entire document), and the recited optical barcode is taught as "Fluorescent Cell Barcode labels" (Krutzik: 1:49; and entire document).
The recited cell is taught as "the cells may be fixed, permeabilized..." (Krutzik: 11:38; 18:45; and entire document).
The recited generate a barcoded nucleic acid molecule is taught as (Krutzik: 17:23-52; and entire document):
In certain embodiments, the fluorescent dyes employed as FCB markers are functionalized, meaning they contain a reactive group that promotes association (e.g., covalent attachment) with the cells being labeled. ...
"...label binds to a cell non-covalently. Examples of non-covalent association include interactions with cellular components such as DNA, RNA, lipids, membranes, organelles, etc. through hydrophobic, hydrogen-bonding, Van der Waals interactions, or other chemical interactions, etc. As such, any binding interaction between a cell and an FCB label may be used provided that it allows for marking of a cell for the duration of an FCB assay".
The recited generate sequence data is taught as "the analyte-specific binding agent is a nucleic acid, where in certain embodiments the nucleic acid is specific for a gene (or gene product) of interest in the cells being analyzed (e.g., a nucleic acid probe specific for an mRNA of interest)" (Krutzik: 20:23; and entire document), in which detection of binding identifies sequence data specific to an analyte and noting that the claim does not require sequencing the barcoded nucleic acid and also reads on sequence of derivatives of the barcoded nucleic acid.
The recited physical property of the cell is taught as a "detectable characteristic is the presence of one or more analytes in or on the cells (e.g., the presence of a cell Surface marker)" (Krutzik: 10:7; and entire document), and the recited "associating" would have been obvious over, for example, Krutzik's teaching of "associated with the detectable characteristic being assayed for in the cells," "can be categorized upon multiplex analysis" and multiplexing generally (Krutzik: 13:31; 14:9; 1:28; and entire document).
Krutzik teaches each of the limitations as described above, however Krutzik does not teach the limitations in a single embodiment in the same, consecutive sequence as recited. It would have been prima facie obvious to try the recited sequence as an example of combining prior art elements taught within the same reference according to known methods to yield predictable results.
Regarding claim 88, the recited associating the optical barcode with the phenotypic data reads on "...analyzed for... FCB fluorescence, to identify the sample origin of the cells. Simultaneous deconvolution and analysis allows rapid identification of samples that display the desired phenotype..." (Krutzik: 2:50-54; and entire document) and "...samples are selected for a desired phenotypic effect and then deconvoluted based on their FCB signature..." (Krutzik: 25:13-22; and entire document).
Regarding claim 92, the recited live cell reads on "...cells are alive..." (Krutzik: 4:32-34; and entire document).
Regarding claims 93-94, the recited fluorescence imaging reads on "fluorescent dye" and "imaging applications" (Krutzik: 14:26; and entire document).
Regarding claim 96, the recited performance in a physical partition reads on "Cells are placed into distinct wells..." (Krutzik: 2:1; and entire document).
Regarding claim 98, the recited droplets read on "flow cytometry... experiments" (Krutzik: 4:33; and entire document).
Regarding claim 99, at least one of the recited phenotypic properties reads on "physical parameters (e.g., size, shape, density, etc.)" (Krutzik: 11:24-25; and entire document).
Regarding claim 100, the recited optical properties read on "By 'fluorescent label' is meant any molecule that may be detected via its inherent fluorescent properties" (Krutzik: 6:1-2; and entire document).
Regarding claims 104-5, the recited identity of a protein and its cell read on "indicative of the identity of the activatable protein" (Krutzik: 5:9; also 4:66-5:30; and entire document).
Claims 90-91 and 102
Claim 90-91 and 102 is rejected under 35 USC 103 as unpatentable over Krutzik as applied to claims 87-88, 92-94, 96, 98-100 and 104-105 above and further in view of Zheng (as cited on the 2/23/2021 IDS).
Regarding claims 90-91, Zheng teaches the recited sequencing and data analysis as "Reverse transcription takes place inside each droplet, and barcoded complementary DNAs (cDNAs) are amplified in bulk. The resulting libraries then undergo Illumina short-read sequencing" (Zheng: p. 2, 2nd para.; and entire document).
Regarding claim 102, Zheng teaches the recited barcoding and gel bead as "Droplet-based platform enables barcoding of cells. ... The core of the technology is a Gel bead in EMulsion (GEM)" (Zheng: p. 2, first col., penultimate para.; and entire document).
Combining Krutzik and Zheng
In the absence of a secondary consideration to the contrary, it would have been prima facie obvious for PHOSITA to modify the Zzz teaching of Krutzik using the related teaching of Zheng. As motivation to combine, an advantage taught by Zheng of modifying methods such as those of Krutzik would have been the teaching of Zheng that "...builds on the GemCode technology, which has been used for genome haplotyping, structural variant analysis and de novo assembly of a human genome" (Zheng: p. 2, first col., penultimate para.). Thus, PHOSITA would have been motivated to modify Krutzik using the above techniques of Zheng in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Krutzik and Zheng are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Zheng to the related teaching of Krutzik.
101 -- NO REJECTION
Referring to 101 analysis as organized in MPEP 2106, the claims satisfy 101 and are patent eligible at least in view of the analysis Step 2A, 1st prong regarding claim interpretation leading to identification of judicial exceptions (JEs) (MPEP 2106.04), the claims being interpreted as not directed to any JEs.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
Double patenting rejections of instant claims 87-88, 90-94, 96, 98-100, 102 and 104-105
Instant claims 87-88, 90-94, 96, 98-100, 102 and 104-105 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patent 8,003,312 (from application 16/228,261) in view of Krutzik and Zheng.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed. A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
Inquiries
Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further information is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx.
The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686