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 1) semiconductor as the solid support material species; 2) a time delay integration (TDI) device as the optical detector as the optical detector species; and 3) an antibody as the binding reagent species (thus claim 241 is withdrawn as being drawn to a non-elected species), in the reply filed on 12/17/2025 is acknowledged
3. Claims 214-243 are pending in the application. Claim 241 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 214-240 and 242-243 are currently under examination.
Specification
4. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see paragraph [00444] of the specification filed on 4/22/2022). 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.
5. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
6. Claims 214, 242 and 243 are objected to because of the following informalities:
Claim 214, line 6: “a dynamic range of at least 104” should be changed to “a dynamic range of at least 104” to correct the typographical error.
Claim 242, line 6: “a dynamic range of at least 104” should be changed to “a dynamic range of at least 104” to correct the typographical error.
Claim 243, line 6: “a dynamic range of at least 104” should be changed to “a dynamic range of at least 104” to correct the typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 221 and 226 are rejected 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.
Claim 221 recites the limitation “the algorithm” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 226 recites the limitation “the layer” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Statutory Double Patenting
9. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
10. Claims 214-240 and 242-243 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 192-218 and 220-221 of copending Application No. 19/429,409 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Nonstatutory Double Patenting
11. 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.
12. Claims 214-240 and 242-243 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12,071,618. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-32 of U.S. Patent No. 12,071,618 teach or render obvious all the features as recited in instant claims 214-240 and 242-243. Specifically, claims 1, 13-14 and 17-18 of U.S. Patent No. 12,071,618 teach, along with a method, a system (used in said method) that comprises all the structural elements as recited in instant claim 214. In addition, the other features as recited in instant claims 215-240 and 242-243 are also taught or rendered obvious by claims 1-32 of U.S. Patent No. 12,071,618.
13. Claims 214-240 and 242-243 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 12,503,694. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-35 of U.S. Patent No. 12,503,694 teach or render obvious all the features as recited in instant claims 214-240 and 242-243. Specifically, claims 1, 14-15 and 21-22 of U.S. Patent No. 12,503,694 teach, along with a method, a system (used in said method) that comprises all the structural elements as recited in instant claim 214. In addition, the other features as recited in instant claims 215-240 and 242-243 are also taught or rendered obvious by claims 1-35 of U.S. Patent No. 12,503,694.
Claim Rejections - 35 USC § 102
14. 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.
15. 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.
16. Claims 214-231, 233-240 and 243 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mallick (WO 2019/236749 A2).
Regarding claim 214
Mallick teaches, throughout the whole document, a system, comprising: a) a solid support comprising a plurality of sites, wherein a plurality of polypeptides is immobilized at the plurality of sites of the solid support, wherein each site of the plurality of sites is optically resolvable from any other site of the plurality of sites, wherein each site is attached to only one polypeptide of the plurality of polypeptides, wherein the plurality of polypeptides comprises a first polypeptide species and a second polypeptide species (see paragraph [0004] and claim 1), and wherein the first polypeptide species and the second polypeptide species have a dynamic range of at least 104 with respect to each other (see paragraph [0049] disclosing that the sample containing the proteins can be “blood plasma” and paragraph [0053] disclosing that the sample may be taken from a subject which is a “human”. As evidenced by paragraph [00496] of the instant specification as filed on 3/14/2022, the dynamic range for all proteins in “human plasma” is estimated to span “more than 10 orders of magnitude”.); b) a first fluidic medium comprising a first plurality of binding reagents (e.g., first set of affinity reagents), wherein binding reagents of the first plurality of binding reagents are configured to provide a first optical signal (e.g., via an “identifiable tag” such as a “fluorescent tag”), and wherein the first fluidic medium is deliverable to the solid support (see paragraphs [0004] and [0009]); c) a second fluidic medium comprising a second plurality of binding reagents (e.g., nth set of affinity reagents), wherein binding reagents of the second plurality of binding reagents are configured to provide a second optical signal (e.g., via an “identifiable tag” such as a “fluorescent tag”), wherein the second optical signal is distinguishable from the first optical signal, and wherein the second fluidic medium is deliverable to the solid support (see paragraphs [0004] and [0009]); and d) an optical detector, wherein the optical detector is configured to detect at each individual site of the plurality of sites a presence or an absence of a first optical signal from a binding reagent of the first plurality of binding reagents, and wherein the optical detector is configured to detect at each individual site of the plurality of sites a presence or an absence of a second optical signal from a binding reagent of the second plurality of binding reagents (see paragraphs [0023], [00125]-[00126] and [00153]).
Regarding claim 215
The system according to Mallick, wherein the sites of the plurality of sites are separated by at least 500 nanometers (see paragraph [0072]).
Regarding claim 216
The system according to Mallick, further comprising a processor that is configured to receive measurements of the presences or absences of the first optical signals and the second optical signals for each site of the plurality of sites from the optical detector (see paragraphs [00126]-[00127] and [00215]-[00216]).
Regarding claim 217
The system according to Mallick, wherein the processor is configured to characterize the polypeptide at each site of the plurality of sites based upon the measurements of the presences or absences of the first optical signals and the second optical signals for each site of the plurality of sites from the optical detector (see paragraphs [00126]-[00127] and [00215]-[00216]; Figures 1-2).
Regarding claim 218
The system according to Mallick, wherein characterizing each polypeptide at each site of the plurality of sites comprises identifying each polypeptide at each site of the plurality of sites (see Figures 1-2).
Regarding claims 219-220
The system according to Mallick, wherein characterizing each polypeptide at each site of the plurality of sites further comprises quantifying the polypeptides attached to the solid support (see paragraphs [0009] and [00214]; Figures 1-2), wherein the quantifying would necessarily provide the dynamic range of the first polypeptide species and the second polypeptide species.
Regarding claim 221
The system according to Mallick, wherein the algorithm comprises a machine learning algorithm (see paragraphs [00134]-[00136] and [00158]).
Regarding claim 222
The system according to Mallick, wherein the solid support comprises a material selected from the group consisting of ceramic, glass, polymer, and semiconductor (see paragraphs [0071] and [0078]).
Regarding claim 223
The system according to Mallick, wherein the solid support further comprises a layer disposed upon the material (see paragraph [0078]).
Regarding claim 224
The system according to Mallick, wherein the layer comprises a metal or metal oxide (see paragraphs [0071] and [0078]).
Regarding claim 225
The system according to Mallick, wherein the layer has a thickness of at least 10 nanometers (see paragraphs [0071]-[0078]).
Regarding claim 226
The system according to Mallick, wherein the layer comprises a plurality of wells, wherein each well of the plurality of wells individually comprises a site of the plurality of sites (see paragraph [0061], [0071]-[0071] and [0074]-[0077]).
Regarding claim 227
The system according to Mallick, wherein the plurality of sites of the solid support is attached to a plurality of particles (see paragraphs [0070], [0074] and [0081]-[0082]).
Regarding claim 228
The system according to Mallick, wherein each site of the plurality of sites is attached to only one particle of the plurality of particles (see paragraphs [0070], [0074] and [0081]-[0082]).
Regarding claim 229
The system according to Mallick, wherein the only one particle is attached to the only one polypeptide (see paragraphs [0070], [0074] and [0081]-[0082]).
Regarding claim 230
The system according to Mallick, wherein a particle of the plurality of particles comprises a nucleic acid nanostructure (see paragraphs [0081]-[0082]).
Regarding claim 231
The system according to Mallick, wherein the only one polypeptide is attached to a linking moiety of the nucleic acid nanostructure (see paragraphs [0080]-[0082]).
Regarding claim 233
The system according to Mallick, wherein the only one particle comprises a surface-interacting moiety (see paragraphs [0070], [0074] and [0081]-[0082]).
Regarding claim 234
The system according to Mallick, wherein the surface-interacting moiety comprises an inorganic nanoparticle, a carbon nanoparticle, a polymer nanoparticle, or a biopolymer (see paragraphs [0070], [0074] and [0081]-[0082]).
Regarding claim 235
The system according to Mallick, wherein the optical detector comprises a time delay integration (TDI) device, a complementary metal oxide semiconductor (CMOS) detector, an avalanche photodiode (APD) detector, a Geiger-mode photon counter, a photomultiplier tube (PMT), a charge injection device (CID) sensor, or a JOT image sensor (see paragraphs [00206]).
Regarding claims 236-237
The system according to Mallick, wherein the system further comprises a light-emitting source, wherein the light-emitting source comprises a laser, a light-emitting diode (LED), or a lamp from one of the various types of detectors (see paragraphs [00114], [00126] and [00128]).
Regarding claims 238-239
The system according to Mallick, wherein the binding reagents of the first plurality of binding reagents have a binding specificity for the first polypeptide species, and wherein the binding reagents of the second plurality of binding reagents have a binding specificity for the second polypeptide species (see the whole document, e.g., paragraphs [0047] and [0095]-[0098]; Figure 6).
Regarding claim 240
The system according to Mallick, wherein a binding reagent of the first plurality of binding reagents or the second plurality of binding reagents comprises an antibody or an antibody fragment (see paragraphs [0095] and [0097]).
Regarding claim 243
Mallick teaches, throughout the whole document, a system, comprising: a) a solid support comprising a plurality of wells, wherein a plurality of polypeptides is immobilized in the plurality of wells of the solid support, wherein each well is attached to only one polypeptide of the plurality of polypeptides, wherein the plurality of polypeptides comprises a first polypeptide species and a second polypeptide species (see paragraph [0004]: “…method comprises obtaining a substrate with portions of one or more proteins conjugated to the substrate such that each individual protein molecule has a unique, resolvable, spatial address. In some cases, each individual protein molecule may have a unique, optically resolvable, spatial address”; paragraph [0070]: “…proteins may be conjugated to beads (e.g., one protein per bead) and the beads may be captured on a surface (e.g. in microwells and/or nanowells)”; paragraph [0074]: “…proteins may be conjugated to beads (e.g., one protein per bead) and the beads may be captured on a surface (e.g. in microwells and/or nanowells).”), and wherein the first polypeptide species and the second polypeptide species have a dynamic range of at least 104 with respect to each other (see paragraph [0049] disclosing that the sample containing the proteins can be “blood plasma” and paragraph [0053] disclosing that the sample may be taken from a subject which is a “human”. As evidenced by paragraph [00496] of the instant specification as filed on 3/14/2022, the dynamic range for all proteins in “human plasma” is estimated to span “more than 10 orders of magnitude”.); b) a first fluidic medium comprising a first plurality of binding reagents (e.g., first set of affinity reagents), wherein binding reagents of the first plurality of binding reagents are configured to provide a first optical signal (e.g., via an “identifiable tag” such as a “fluorescent tag”), and wherein the first fluidic medium is deliverable to the solid support (see paragraphs [0004] and [0009]); c) a second fluidic medium comprising a second plurality of binding reagents (e.g., nth set of affinity reagents), wherein binding reagents of the second plurality of binding reagents are configured to provide a second optical signal (e.g., via an “identifiable tag” such as a “fluorescent tag”), wherein the second optical signal is distinguishable from the first optical signal, and wherein the second fluidic medium is deliverable to the solid support (see paragraphs [0004] and [0009]); and d) an optical detector, wherein the optical detector is configured to detect at each individual site of the plurality of sites a presence or an absence of a first optical signal from a binding reagent of the first plurality of binding reagents, and wherein the optical detector is configured to detect at each individual site of the plurality of sites a presence or an absence of a second optical signal from a binding reagent of the second plurality of binding reagents (see paragraphs [0023], [00125]-[00126] and [00153]).
Conclusion
17. No claim is allowed.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684