DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of “RNA” as the analyte species in the reply filed on 7/21/2026 is acknowledged.
3. Claims 2-21 are pending in the application. Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2-15 and 18-21 are currently under examination.
Claim Objections
4. Claims 3-4 are objected to because of the following informalities:
Claim 3, lines 3-4: “the determined sequence of (i) and (ii)” should be changed to “the determined sequences of (i) and (ii)” to correct the grammatical error.
Claim 4, line 4: “the determined sequence of (i) and (ii)” should be changed to “the determined sequences of (i) and (ii)” to correct the grammatical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 2, 5-15 and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential step(s), such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted step(s) is: a “determining” step that actually accomplishes the intended purpose/use of “determining a location of an analyte in a cell” as recited in the preamble of claim 2.
Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. Claims 2-15 and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,702,693. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-18 of U.S. Patent No. 11,702,693 teach or render obvious all the features as recited in instant claims 2-15 and 18-21. Specifically, claim 1 of U.S. Patent No. 11,702,693 teaches a method that has all the steps and elements required by the method of instant claims 2-3 and is more specific. In addition, the other features as recited in instant claims 4-15 and 18-21 are also taught or rendered obvious by claims 1-18 of U.S. Patent No. 11,702,693.
Claim Rejections - 35 USC § 102
9. 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.
10. 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.
11. Claims 2-15 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vickovic et al. (Nat. Commun. 2016, 7:13182).
Regarding claims 2-3 and 13-15
Vickovic et al. teach, throughout the whole document, a method for determining a location of an analyte in a cell comprising: (a) separating (e.g., separating via FACS or pipetting and smearing) the cell from a plurality of cells (see Figure 1); (b) printing the cell onto a surface comprising an array (e.g., barcoded microarray), wherein the array comprises a plurality of capture probes, wherein a capture probe of the plurality of capture probes comprises: (i) a spatial barcode (e.g., barcode (labeled as “ID” region in the probe schematically shown on the right side of Figure 1) consisting of “a uniquely designed 18 nt sequence”) and (ii) a capture domain (e.g., oligo-dTVN sequence (labeled as “Poly-T capture sequence” in the probe schematically shown on the right side of Figure 1)) (see page 2, column 2, paragraph 2; Figure 1); (c) hybridizing the analyte (e.g., mRNA) to the capture domain (see Figures 1-2); and (d) determining (via sequencing) (i) all or a part of the sequence of the analyte bound to the capture domain, or a complement thereof, and (ii) all or a part of the sequence of the spatial barcode, or a complement thereof, and using the determined sequences of (i) and (ii) to identify the location of the analyte in the cell (see page 2, column 2, paragraph 2; page 8, column 1, paragraphs 4-6; Figures 1-2).
Regarding claim 4
The method according to Vickovic et al., wherein determining comprising sequencing (i) all or a part of the sequence of the analyte or analyte derivative bound to the capture domain, or a complement thereof, and (ii) the sequence of the spatial barcode, or a complement thereof, and using the determined sequence of (i) and (ii) to identify the location of the analyte in the cell (see page 2, column 2, paragraph 2; page 8, column 1, paragraph 4; Figure 1).
Regarding claims 5-6
The method according to Vickovic et al., wherein the step of separating the cell from a plurality of cells comprises filtering a cell through a mold (e.g., nozzle associated with FACS sorter) (see Figure 1; page 7, column 1, paragraph 4); further comprising removing the mold (i.e., the mold/nozzle, as part of the FACS sorter, would be moved away from the barcoded microarray) after printing the cell onto a surface (see Figure 1).
Regarding claim 7
The method according to Vickovic et al., wherein the mold comprises a network of channels (see Figure 1).
Regarding claim 8
The method according to Vickovic et al., wherein the individual microfluidic channels of the network comprise trap spacing, wherein the trap spacings in individual channels proximal to the surface are narrower in diameter than the trap spacings in individual channels distal to the surface (see Figure 1).
Regarding claim 9
The method according to Vickovic et al., wherein the plurality of cells has at least 80% viability (see page 7, column 1, paragraphs 2-5).
Regarding claim 10
The method according to Vickovic et al., wherein the cell is from a heterogeneous cell population (see page 7, column 1, paragraphs 2-5).
Regarding claim 11
The method according to Vickovic et al., wherein the cell is from a tissue sample (see page 7, column 1, paragraphs 2-3).
Regarding claim 12
The method according to Vickovic et al., wherein the cell is from a formalin-fixed, paraffin-embedded (FFPE) sample, a frozen sample, or a fresh sample (see page 7, column 1, paragraph 3).
Regarding claim 18
The method according to Vickovic et al., further comprising amplifying all or part of the analyte or the analyte derivative hybridized to the capture domain (see Figure 1; page 2, column 2, paragraph 2).
Regarding claims 19-20
The method according to Vickovic et al., further comprising imaging the cell, wherein the imaging is used to determine the morphology of the cell (see page 2, column 2, paragraph 2: “After attachment, a high-resolution image is taken, which links the position of each barcode sequence with each individual cell, and provides information concerning cell morphology.”).
Regarding claim 21
The method according to Vickovic et al., wherein the capture probe comprises a unique molecular identifier (labeled as “UMI” in the probe schematically shown on the right side of Figure 1), a cleavage domain (labeled as “Cleavage site” in the probe schematically shown on the right side of Figure 1), and/or a functional domain (see Figure 1; page 2, column 2, paragraph 2).
Conclusion
12. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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