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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because page 3, lines 27-28; page 21, line 7 of the specification contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Nucleotide and/or Amino Acid Sequence Disclosures - Drawings
The drawings filed on 11/21/2023 are deemed unacceptable and are objected to, because they do not comply with the sequence rules (37 CFR 1.831 - 1.834). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant's argument (Remarks, 06/11/2026, page 12-13), regarding Form PTO-2301, included in the Requirement for Restriction/Election (03/11/2026) has been considered but is not persuasive.
Applicant does not dispute that the drawings disclose nucleotide sequences. Applicant instead argues that the figures are presented to "convey the structure and functional
relationships of the constructs, and the depicted elements are not shown as nucleotide sequences requiring identification under 37 CFR l.82l(d)." (Remarks, page 12-13)
This is not persuasive. The sequence disclosure rules do not provide such exception.
37 CFR 1.831(c) states:
Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a) ), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a) ) in the Brief Description is clear.
Here, Figs. 3-7 contain nucleotide sequences with 10 or more specifically defined and enumerated residues, that are not identified with sequence identifiers, either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers in the Brief Description is clear.
Accordingly, the notice requiring compliance with the sequence disclosure rules is reiterated herein.
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. Specifically, Figs. 3-7 contain nucleotide sequences with 10 or more specifically defined and enumerated residues, that are not clearly identified with sequence identifiers either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Status of Claims
This office action is in response to Applicant's Amendment filed on June 11, 2026.
Claims 1-13 and 17-21 were previously pending. Applicant amended claim 12.
Claims 1-13 and 17-21 are currently pending, with claims 6, 17-21 withdrawn.
Claims 1-5 and 7-13 are under examination. This is the first action on the merits.
Election/Restrictions
Applicant’s election with traverse of Group I (claims 1-13) in the reply filed on June 11, 2026 is acknowledged 1.
The traversal is on the ground that "the Office Action does not identify what features constitute the contribution over the prior art for either Group I or Group II." (Remarks, page 8).
This argument is not persuasive, as it appears to reflect a misunderstanding of the unity of invention requirement and overlooks what was set forth in the restriction requirement. The reason the two invention groups lack unity is precisely that they do not share a common feature that makes a 'contribution' over the prior art.
MPEP§1893 states:
"[U]nity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. "
As stated in the restriction requirement (page 6):
“The inventions listed as groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features because they lack a common feature that makes a ‘contribution’ over the prior art. The common technical feature of Groups I-II is the bead construct of claim 1, which comprises visually detectable features and detachable oligo. But this is well-known in the art (see WO2019099908A1- Methods and systems for associating physical and genetic properties of biological particles, e.g., [0012], [0087], [0089], [00108]; see also Yuan et al. SCOPE-Seq: a scalable technology for linking live cell imaging and single-cell RNA sequencing. Genome Biol. 2018 Dec 24;19(1):227. doi: 10.1186/s13059-018-1607-x. PMID: 30583733; PMCID: PMC6305572). Since a special technical feature must define the invention over the prior art, there is no special technical feature that links the groups.”
Thus, the requirement is still deemed proper and is therefore made FINAL.
Applicant's election with traverse of the following species in the reply filed June 11, 2026 is acknowledged:
Species of 3′ terminal capture or anchor sequence: A) 3′ terminal capture or anchor sequence comprises a poly-A sequence (claim 2);
Species of visually detectable feature: E) Color of the bead (claim 3);
Species of bead: I) bead comprises one or several visually detectable features (claim 1)2;
Species of second oligonucleotide: K) second oligonucleotide comprising a terminal poly-T sequence (claim 8);
Species of composition: M) composition loaded to a well plate (claim 13).
Applicant's traversal is on the ground that "[t]he Office Action does not identify any specific feature that distinguishes the alleged species in terms of their contribution over the prior art, nor does it demonstrate that any such features are not shared."(Remarks, page 12)
Applicant's argument has been considered by is not persuasive. Applicant appears to misunderstand the unity requirement. The proper inquiry for unity of invention is whether the claimed species are linked by the same or corresponding special technical features so that they form a single general inventive concept.
Accordingly, the question is not whether each species separately includes its own feature that contributes over the prior art. Rather, the inquiry begins by identifying any feature common to the species. Only if such a common feature exists, is it necessary to determine whether that common feature qualifies as a special technical feature that makes a ‘contribution’ over the prior art. A proper analysis is detailed in MPEP 18503.
Here, the identified species in each species group recite different characteristics and do not share a common feature. As explained in the restriction requirement (page 6-7).
Therefore, the species election requirement is still deemed proper and is therefore made FINAL.
Claims 6, 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Examination on the merits commences on claims 1-5 and 7-13.
Priority
For the instant claims 1-5 and 7-13 in this U.S. Application, the applicant claims priority of Foreign Application EP 21175329.8, which has a filling date on May 21, 2021.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, the specification defines the term "bead," introduced in claim 1, as follows:
"The term “bead” refers herein to a solid support which may encompass any type of solid, porous, or hollow sphere, ball, bearing, cylinder, or other similar configuration composed of plastic, ceramic, metal, or polymeric material (e.g., hydrogel) onto which a nucleic acid can be immobilized (e.g., covalently or non-covalently). The bead may comprise a discrete particle that may be spherical (e.g., microspheres) or have a non-spherical or irregular shape, such as cubic, cuboid, pyramidal, cylindrical, conical, oblong, or disc-shaped, and the like." (page 6-7)
Accordingly, the term "bead" under BRI is interpreted as any solid object of any shape, size, and material that can allow a nucleic acid to be immobilized onto, either covalently or non-covalently, encompassing, for examples, sequencing flow cells, or a cell with oligonucleotide attached onto its surface.
For the purpose of applying prior art, the specification defines the term "amplification handle," introduced in claim 1 as follows:
"The term “amplification handle” generally refers to a functional component of the oligonucleotide sequence in the construct of the present disclosure that provides an annealing site for amplification of the oligonucleotide sequence." (page 7)
Any nucleotide sequence could serve as an annealing site for primer extension amplification.
Accordingly, because the application's disclosure does not define the term "amplification handle" with any structural features that distinguishes it from nucleotide sequences known in the art, the term "amplification handle sequence" is interpreted under BRI and in light of the specification as encompassing any nucleotide sequence.
Claim 7 further recites "wherein said amplification handle sequence is complementary to a PCR primer, said primer comprising a next generation sequencing compatible adapter sequence."
Claim 8 provides the same description with respect to a "second amplification handle sequence."
However, the application's disclosure does not define any structural features of the PCR primer, nor is the claimed construct required to comprise such a PCR primer.
Accordingly, under BRI, the terms "amplification handle sequence" and "second amplification handle sequence" in claims 7 and 8 are interpreted as encompassing sequences complementary to any nucleotide sequence, because a PCR primer may comprise any nucleotide sequence, including, for example, a random primer sequence.
The further description of the primer is therefore not considered limiting on the scope of the claimed construct, because the construct itself is not required to comprise the primer, and the "next generation sequencing compatible adapter sequence" could be a sequence separate from the portion of the primer that is complementary to the amplification handle sequence.
For the purpose of applying prior art, claim 1 recites a oligonucleotide comprising "3' terminal capture or anchor sequence."
The application's disclosure does not define the terms "3' terminal capture" or "anchor sequence" with any structural features. Accordingly, under BRI, these elements, as recited in the oligonucleotide, are interpreted as encompassing any sequences.
In particular, "3' terminal capture" is a functional description rather than a structural limitation. Under BRI, it encompasses any element capable of capturing a 3' terminus, or have captured a 3' terminus, including any nucleotide sequence, because any sequence portion of a nucleic acid could be used to capture the 3' terminus of another nucleic acid, for example, through hybridization with a primer.
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 1-5, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Stoeckius (Stoeckius et al., Simultaneous epitope and transcriptome measurement in single cells. Nat Methods. 2017 Sep;14(9):865-868. doi: 10.1038/nmeth.4380. Epub 2017 Jul 31. PMID: 28759029; PMCID: PMC5669064).
Regarding claim 1, Stoeckius teaches a construct comprising:
a bead (Figure 1a-b; Figure 2C; a cell attached to CITE-seq antibody conjugates; accordingly to the specification’s definition, a cell qualifies as a bead),
wherein said bead comprises one or several visually detectable features (Figure 2C; page 3, para 2, lines 3-5, cell incubated with CITE-seq antibody conjugates and fluorophore-conjugated antibodies, so that some CD8a epitopes on each cell would be labeled by fluorophore and some by oligo.) ,
wherein said bead comprises an oligonucleotide (Figure 2C; Figure 1a-b),
wherein said oligonucleotide comprises
a) an amplification handle sequence (Figure 1a);
b) a barcode sequence specific to one or several of said visually detectable features (Figure 1a, antibody barcode) and/or entities; and
c) an anchor sequence (Figure 1a, poly A), and
wherein said oligonucleotide is arranged to be detachable from said bead (Figure 1a, oligonucleotide comprises disulfide bond, which allows separation of the oligo; see page 5, para 4, lines 11-12).
Regarding claim 2, Stoeckius teaches anchor sequence comprises a poly-A sequence (Figure 1a, poly A).
Regarding claim 3, Stoeckius teaches visually detectable features comprise color (Figure 2C; page 3, para 2, lines 3-5).
Regarding claim 4, Stoeckius teaches oligonucleotide is linked to said bead via a cleavable linkage (Figure 1a, oligonucleotide comprises disulfide bond, which is cleavable; see page 5, para 4, lines 11-12).
Regarding claim 5, Stoeckius teaches bead is further coupled to an antibody (Figure 2C; Figure 1a-b).
Regarding claim 7, Stoeckius teaches amplification handle sequence is complementary to a primer (Figure 1a).
Regarding claim 9, Stoeckius teaches a composition comprising the construct according to claim 1 (Figure 1b).
Claims 1-5, 7-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bharadwaj (WO2019099908A1- Methods and systems for associating physical and genetic properties of biological particles; Published 2019-05-23), as evidenced by Gao (Gao et al., The Comparison of Two Single-cell Sequencing Platforms: BD Rhapsody and 10x Genomics Chromium. Curr Genomics. 2020 Dec;21(8):602-609. doi: 10.2174/1389202921999200625220812. PMID: 33414681; PMCID: PMC7770630).
Regarding claim 1, Bharadwaj teaches a construct comprising:
a bead, wherein said bead comprises one or several visually detectable features ([00106] particles comprising optical barcodes that confer optical properties such as a color ; see also [00103]- [00104]),
wherein said bead comprises an oligonucleotide ([0099] particles comprising a plurality of nucleic acid barcode molecules.),
wherein said oligonucleotide comprises:
a) an amplification handle sequence ([0099] nucleic acid barcode molecule can comprise additional sequences. The additional sequences can include a primer binding site,);
b) a barcode sequence specific to one or several of said visually detectable features and/or entities ([00106]; [00103]- [00104] “lookup table (LUT) can be used to associate the shape, color, or a combination of shape and color ( or other
optical properties) of the particle (e.g., round or square bead) with the barcode sequence (e.g., first or second barcode sequence).”); and
c) a 3' terminal capture or anchor sequence ([00108] plurality of nucleic acid barcode molecules attached to a given particle may each comprise a poly(T) sequence, which poly(T) sequences are configured to interact with a plurality of RNA molecules (e.g., messenger RNA (mRNA) molecules)), and
wherein said oligonucleotide is arranged to be detachable from said bead ([00109] “beads may each comprise a plurality of nucleic acid barcode molecules releasably coupled thereto.”).
Regarding claim 2, Bharadwaj teaches said a 3' terminal capture comprises a poly-A sequence by teaching oligonucleotide comprising poly(T) that hybridizes with poly (A) sequence in mRNA ([00108]). A skilled artisan would readily understand that poly(T) sequence captures and forms hybridization complex with a poly(A) tail, naturally comprised by a mRNA. See Fig. 2 in Gao.
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Regarding claim 3, Bharadwaj teaches visually detectable features comprise color (([00106] particles comprising optical barcodes that confer optical properties such as a color ; see also [00103]- [00104]).
Regarding claim 4, Bharadwaj teaches oligonucleotide is linked to said bead via a cleavable linkage ([00158]).
Regarding claim 5, Bharadwaj teaches bead is further coupled to a chemical compound ([0089] lines 17-20, the first particle covalently coupled to the second particle via a chemical bond, the particles each comprise nucleic acid barcode molecules, which are organic chemical compounds).
Regarding claim 7, Bharadwaj teaches amplification handle sequence is complementary to a primer ([0099] a primer binding site).
Regarding claim 8, Bharadwaj teaches construct comprises a second oligonucleotide coupled to said bead ([0099] “the particle can comprise a plurality of nucleic acid barcode molecules” thus skilled artisan would readily understand the each particle comprises at least a first oligonucleotide and a second oligonucleotide),
said second oligonucleotide comprising:
a) a second amplification handle sequence complementary to a PCR primer ([0099] lines 9-12) comprising a next generation sequencing compatible adapter sequence;
b) a barcode sequence specific to the one or several visually detectable features and/or entities of the bead ([00106]; [00103]- [00104]);
c) a barcode sequence specific to the bead ([00102] lines 4-6; [00103] lines 11-16);
e) a terminal poly-T sequence or a template switching compatible sequence (([00108] nucleic acid barcode molecules attached to a given particle each comprise a poly(T) sequence).
Regarding claim 9, Bharadwaj teaches a composition comprising the construct according to claim 1 ([00106]).
Regarding claim 10, Bharadwaj teaches composition comprises a mixture of at least two constructs according to claim 1 providing a mixture of distinct visually detectable features or entities ([00103] two particles having different optical properties).
Regarding claim 11, Bharadwaj teaches wherein said mixture of at least two constructs comprises at least six, separate visually detectable features and/or entities ([00107] “plurality of optical barcodes may comprise at least 1,000 different optical codes, such as at least 10,000 different optical codes or at least 100,000 different optical codes.”).
Regarding claim 13, Bharadwaj teaches the composition according to claim 9 loaded to a well plate (page 77, 15. wherein said plurality of partitions is a plurality of wells; see also [0084]).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj (WO2019099908A1- Methods and systems for associating physical and genetic properties of biological particles; Published 2019-05-23), in view of Gorfinkel (US20090203148A1 - Methods and Devices For Detection and Identification of Encoded Beads and Biological Molecules; published 2009-08-13).
The teachings of Bharadwaj are recited above and applied as for base claim 11/10/9/1.
Regarding claim 12, Bharadwaj teaches beads having different visually detectable features (e.g., optical properties) such as color ([00103]; [00106] lines 12-14; see also [0084]).
Although Bharadwaj does not explicitly teach beads having 16 colors, this feature is obvious in view of the knowledge in the prior art.
Gorfinkel teaches using color-coded beads for detecting nucleic acids, wherein the beads are encoded using 16 colors ([0046] lines 9-10).
Accordingly, a skilled artisan would have found it prima facie obvious that the color-coded beads in Bharadwaj can have 16 different colors, as using 16 color-coded beads for nucleic acid detection is known in the art. There would have been a reasonable expectation of success because both references use color-coded beads for nucleic acid detection, and the modification merely involves applying a known number of color codes in the same technological context to achieve the same function of visually distinguishing barcoded beads.
This modification would have been obvious as it represents the KSR principle of predictable use of prior art element according to a known method to yield predictable results. (See MPEP §2143).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
Using color coded beads for nucleic acid detection is well-known in the art.
See Hardt (WO2021094421A1 - Color and barcoded beads for single cell indexing ; Published on: 2021-05-20 ; [0011]; [0014]-[0019] for examples;
See Bashir (WO2020190871A1 - Spatially mapped rna sequencing from single cells; Published: 2020-09-24); teaches generating spatial map of colors using color-coded beads in wells; see Fig. 1; [0011]; [0059]; [0079]; [0082] for examples ;
See Regev (WO2020160044A1 - In-situ spatial transcriptomics; Published on 2020-08-06); see [000117]; [00131] for examples;
See Frenz (WO2020123316A2 - Methods for determining a location of a biological analyte in a biological sample; Published 2020-06-18);
See Yuan et al. SCOPE-Seq: a scalable technology for linking live cell imaging and single-cell RNA sequencing. Genome Biol. 2018 Dec 24;19(1):227. doi: 10.1186/s13059-018-1607-x. PMID: 30583733; PMCID: PMC6305572; See Fig. 1 for example;
See Binan et al., Exploiting Molecular Barcodes in High-Throughput Cellular Assays. SLAS Technol. 2019 Jun;24(3):298-307. doi: 10.1177/2472630318824337. Epub 2019 Feb 1. PMID: 30707854.; see Abstract for example;
See Han et al, Quantum-dot-tagged microbeads for multiplexed optical coding of biomolecules. Nat Biotechnol. 2001 Jul;19(7):631-5. doi: 10.1038/90228. PMID: 11433273; see Figure 1 and Figure 5 for examples.
The concept of combinatorial barcoding is well-known in the art, particularly in nucleic acid sequencing analysis.
See Withey (US20180320171A1 - Combinatorial sets of nucleic acid barcodes for analysis of nucleic acids associated with single cells); FIGs. 3-4, 13, 14 for examples ;
See Fu (US20160289740A1 - Methods and compositions for combinatorial barcoding) teaches combinatorial spatial barcoding using color; see [0060]; [0082]; [0104]; [0109]-[0110]; [0145]; [0162] for examples ;
See Lareau et al. Droplet-based combinatorial indexing for massive-scale single-cell chromatin accessibility. Nat Biotechnol 37, 916–924 (2019); Fig. 3.
Conclusion
The specification and drawings are objected to in this Office Action. Claims 1-5 and 7-13 are rejected. No claims are allowed.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Claims 17-21 are withdrawn as being drawn to non-elected group II.
2 Claim 6 is withdrawn as being drawn to non-elected species J.
3 MPEP 1850 states:
Lack of unity of invention may be directly evident “a priori,” i.e., before considering the claims in relation to any prior art, or may only become apparent “a posteriori,” i.e., after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.
Prosecution Insights