DETAILED ACTION
Reassignment of the Application
1. Please note that this application has been reassigned to Examiner Kaijiang Zhang, in Art Unit 1684. In order to expedite accurate processing of the application papers, all future correspondence with the Office should reflect this change.
Notice of Pre-AIA or AIA Status
2. 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
3. Applicant’s election without traverse of Group I (claims 1-4 and 7-14) in the reply filed on 8/22/2025 is acknowledged.
4. Claims 1-4, 7-14 and 17-24 are pending in the application. Claims 17-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-4 and 7-14 are currently under examination.
Claim Objections
5. Claim 10 is objected to because of the following informalities: “according claim 1” in line 1 should be changed to “according to claim 1” to correct the grammatical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 2-4, 7-8 and 13 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.
(1). Claim 2 refers to “[t]he micro-particle, plurality of micro-particles, or fluidic compartment of claim 1” which would include each of the two different types of micro-particles as specified in (A) and (D) (of claim 1) respectively, or each of the two different pluralities of micro-particles as specified in (C) and (D) (of claim 1) respectively. However, the wherein clause, reciting “a linker that is cleavable to provide a free 3' hydroxyl group on the polynucleotide after cleavage”, appears to be only applicable to the micro-particle as specified in (A) of claim 1 (but not the micro-particle as specified in (D) of claim 1), or the plurality of micro-particles as specified in (C) of claim 1 (but not the plurality of micro-particles as specified in (D) of claim 1).
(2). Claim 3 refers to “[t]he micro-particle, plurality of micro-particles, or fluidic compartment according to claim 1” which would include each of the two different types of micro-particles as specified in (A) and (D) (of claim 1) respectively, or each of the two different pluralities of micro-particles as specified in (C) and (D) (of claim 1) respectively. However, the wherein clause, reciting “the linker”, appears to be only applicable to the micro-particle as specified in (A) of claim 1 (but not the micro-particle as specified in (D) of claim 1), or the plurality of micro-particles as specified in (C) of claim 1 (but not the plurality of micro-particles as specified in (D) of claim 1).
(3). Claim 4 refers to “[t]he micro-particle, plurality of micro-particles, or fluidic compartment according to claim 1” which would include each of the two different types of micro-particles as specified in (A) and (D) (of claim 1) respectively, or each of the two different pluralities of micro-particles as specified in (C) and (D) (of claim 1) respectively. However, the wherein clause, reciting “the linker”, appears to be only applicable to the micro-particle as specified in (A) of claim 1 (but not the micro-particle as specified in (D) of claim 1), or the plurality of micro-particles as specified in (C) of claim 1 (but not the plurality of micro-particles as specified in (D) of claim 1).
(4). Claim 7 refers to “[t]he array of polynucleotides according to claim 1” (see line 1). Since claim 1 recites “an array of polynucleotides” in (A) and “an array of polynucleotides” in (B) which are structurally different, it is not clear which of the two structurally different arrays claim 7 refers to. If claim 7 refers to the “array of polynucleotides” as specified in (A) of claim 1, then it is not further limiting from claim 1 because (A) of claim 1 has already indicated that the array is bound to a micro-bead.
(5). Claim 8 recites a list of five features (i.e., (a)-(e)) without using the term “and” or “or”. Thus, it is unclear whether the “3' and/or 5' end analyte capture region” comprises one or all of the listed features.
(6). Claim 13 recites a list of four features (i.e., (i)-(iv)) without using the term “and” or “or”. Thus, it is unclear whether claim 13 requires one or all of the listed features.
8. 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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
9. Claim 7 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 7, which depends from claim 1 by referring to “[t]he array of polynucleotides according to claim 1”, recites “wherein the array is bound to a micro-bead”. If claim 7 refers to the “array of polynucleotides” as specified in (A) of claim 1, it is not further limiting because (A) of claim 1 (see lines 2-3) has already indicated that the array is bound to a micro-bead.
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
10. 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 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.
11. 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.
12. Claims 1 and 7-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macosko et al. (Cell 2015, 161:1202-1214, with 37 pages of Supplemental Information).
Regarding claim 1
Macosko et al. teach each of the products as specified in (B), (D) and (E). Specifically, Macosko et al. teach each of the following:
(B) an array of polynucleotides (e.g., an array of barcoded primers attached to a microparticle) comprising, from 3' to 5': (a) a 3' hydroxyl group (e.g., the oligo-dT at the 3’-end of each barcoded primer comprises a 3’-hydroxyl group to enable reverse transcription after the barcoded primer hybridizes to the mRNA); (b) a 3' end analyte capture region (e.g., the oligo-dT at the 3’-end of each barcode primer captures mRNA by hybridizing to its poly-A region); (c) optionally a first polymerase chain reaction (PCR) handle sequence; (d) a barcode sequence (BC), wherein the barcode sequence of each of the polynucleotides is the same (e.g., all the barcoded primers on each microparticle has the same “cell barcode”); and a unique molecular identifier sequence (UMI), wherein the UMI of each polynucleotide is different (e.g., each barcoded primer has a different UMI); and wherein the UMI is 3' to the BC; (e) optionally a second PCR handle sequence (e.g., PCR handle that is 5’ to the cell barcode); and (f) optionally a 5' end analyte capture region (see Figures 1-2 and the corresponding paragraphs);
(D) a plurality of micro-particles each comprising a micro-bead bound to an array of polynucleotides according to (B), wherein the array of each micro-particle has a different BC (e.g., cell barcode) from the array of essentially each other micro-particle (see Figures 1-2 and the corresponding paragraphs);
(E) a fluidic compartment, optionally a microfluidic compartment, comprising a single array of polynucleotides according to (B) and optionally a single cell, a single cell nucleus, a single vesicle, a single cell lysate, a single cell nucleus lysate, or a single vesicle lysate (see Figures 1-2 and the corresponding paragraphs).
Regarding claim 7
The array of polynucleotides according to Macosko et al., wherein the array is bound to a micro-bead (e.g., microparticle or microbead) (see Figures 1-2).
Regarding claim 8
The micro-particle or array of polynucleotides according to Macosko et al., wherein the 3'-end analyte capture region comprises: (a) a polythymidine sequence (e.g., oligo-dT); or (c) a sequence of at least 10 nucleotides (e.g., T30 or oligo-dT of 30 nucleotides) for hybridising to a target polynucleotide analyte (e.g., mRNA) (see Figures 1-2; page 1203, column 2, paragraph 1).
Regarding claim 9
The micro-particle or array of polynucleotides according to Macosko et al., wherein the PCR handle sequence(s) are at least 15 nucleotides in length (see the PCR handle sequence of “Barcoded Bead SeqA” or “Barcoded Bead SeqB” listed in Table S6).
Regarding claim 10
The micro-particle or array of polynucleotides according to Macosko et al., wherein the BC is 10-14 nucleotides (e.g., 12 nucleotides) in length and/or the UMI is 6 to 10 nucleotides (e.g., 8 nucleotides) in length (see Figure 1).
Regarding claim 11
The array of polynucleotides according to Macosko et al., wherein the 3' end analyte capture region is hybridised to a polynucleotide analyte (e.g., mRNA) (see Figure 2, panel A).
Regarding claim 12
The array of polynucleotides according to Macosko et al., wherein the 3' end analyte capture region is bound to analyte (e.g., mRNA), optionally wherein the analyte is mRNA (see Figure 2, panel A).
Regarding claim 13
The array of polynucleotides according to Macosko et al., wherein: (i) the 3' end analyte capture regions are polythymidine (e.g., oligo-dT) and the analytes comprise mRNA bound to the polythymidines; and (iii) the 3' end capture regions are polynucleotide (e.g., oligo-dT) sequences and the analytes comprise polynucleotides (e.g., mRNAs) hybridised to the polynucleotide capture regions (see Figure 2, panel A; page 1203, column 1, last paragraph).
Regarding claim 14
The array of polynucleotides according to Macosko et al., wherein the analytes bound to the polynucleotides of the array are from a single cell or cell nuclei (see Figure 2, panel A).
Conclusion
13. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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