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 .
DETAILED ACTION
Responsive to communication entered 11/14/2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 11/14/2025 have been entered.
Priority
This application, filed 06/05/2024, Pub. No. US 2024/0361310 A1, published 10/31/2024, which claims benefit of 63/624,181, filed 01/23/2024, is a continuation-in-part of 18/195,049, filed 05/09/2023, Pub. No. US 2024/0301490 A1, published 09/12/2024, which claims benefit of 63/339,782, filed 05/09/2022, and a continuation of PCT/US2024/32014, filed 05/31/2024, Pub. No. WO 2025/159784, published 07/31/2025.
Request for Prioritized Examination (Track I Request) filed 06/05/2024 and granted 08/09/2024.
Status of Claims
Claims 10-17 and 30-41 are currently pending. Claims 1-29 have been originally
pending and subject to restriction/election requirement mailed 09/23/2024. Claims 1, 3, 10 and 17 have been amended, and Claims 2, 7-9 and 18-29 have been canceled, as set forth Applicant’s amendment filed 11/25/2024. Claims 1, 3, 10, 11, 16 and 17 have been amended; Claim 6 has been canceled; and new Claims 30-35 have been added, as set forth Applicant’s amendment filed 05/19/2025. Claims 10, 14, 17, and 30-35 have been amended; Claims 1 and 3-5 have been canceled; and new Claims 36-41 have been added, as set forth Applicant’s amendment filed 11/14/2025. Claims 13, 14, 16, 34, 35 and 40 are withdrawn from further consideration. Claims 10-12, 15, 17, 30-33, 36-39 and 41 are examined.
Election/Restrictions
The Examiner notes that the newly added Claim 40 does not encompass the elected species W, which is optically detectable silica microchip or a set of optically detectable silica microchips, which species W has been elected without traverse in the reply filed on 11/25/2024.
Accordingly, Claim 40 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to the nonelected species, there being no allowable generic or linking claim.
Withdrawn Objections/Rejections
I. The rejections of Claims 1 and 3-5 are moot in view of Applicant’s cancellation of the claims.
II. The rejection of Claim 30 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of Applicant’s amendment of the claim.
Information Disclosure Statement
The information disclosure statemen submitted 11/14/2025 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statements is being considered by the Examiner. Please note that Art Unit and Examiner Name have been corrected by the Examiner.
Drawings
The drawings are objected to because they purport to be color drawings; however, the requirements for having color drawings in an application have not been satisfied. Note, e.g., the references to colors in the drawings at paragraph [0087] of the specification:
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Specification filed 06/05/2024; Emphasis added.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action.
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.
Claims 10-12, 15, 31-33, 36-39 and 41 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.
The subject matter of Claim 10 is indefinite because it is unclear whether “a population of capture beads” recited in the preamble is the same or different from a genus of the capture beads represented by generic Formula I recited in the body of the claim.
Claims 11, 12, 15, 31-33, 36-39 and 41 are rejected as being dependent upon the rejected Claim 10 and failed to cure the indefiniteness of Claim 10.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10-12, 15, 17, 30-33, 36 and 37 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Spuhler et al., WO 2023/154694, published 08/17/2023, priority data: US 63/307,727, 02/08/2022 (IDS filed 08/28/2024); which US counterpart is Spuhler et al., US 2025/0066761 A1, published 02/27/2025.
The Examiner notes that neither application 18/195,049, filed 05/09/2023, Pub. No. US 2024/0301490 A1, published 09/12/2024, nor application 63/339,782, filed 05/09/2022, provide a support for the instantly claimed bead.
Claims 10-12, 15, 31-33, 36 and 37, as recited in independent Claim 10, are drawn to:
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Claims 17 and 30, as recited in independent Claim 17, are drawn to:
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Spuhler et al., throughout the publication, teach:
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Emphasis added.
Therefore, Spuhler et al. teach each and every of element of the instantly claimed capture bead and all elected species except of an optically detectable silica microchip as a label. However, Spuhler et al. teach the use of nanoparticles as labels, whereas silica microchips of up to 2 nm are known in the art:
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Claim 38 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by Spuhler et al., WO 2023/154694, published 08/17/2023, priority data: US 63/307,727, 02/08/2022 (IDS filed 08/28/2024); which US counterpart is Spuhler et al., US 2025/0066761 A1, published 02/27/2025; as evidenced by Bergo, US 2014/0323330 A1, published 10/30/2014.
The teachings of Spuhler et al., discussed in the 102(a)(1)/102(a)(2) rejection above, are incorporated herein in its entirety. Although, as indicated above, in paragraph [0007], Spuhler et al. teach the beads transparent to visible spectrum light, such as, for example, the beads comprising polystyrene, and imaging comprising microscopy, time-lapse imaging microscopy, fluorescence microscopy, multi-photon microscopy, quantitative phase microscopy, surface enhanced Raman spectroscopy, videography, manual visual analysis, automated visual analysis, and combinations thereof (See, for example, Claim 42), this reference does not specifically teach brightfield microscopy as recited in the instant Claim 38.
However, as evidenced by Bergo, imaging by brightfield microscopy of TENTAGEL® beads, which beads comprise a polystyrene core with grafted polyethylene glycol (PEG) and are also employed in the instant application, is well-known in the art:
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Emphasis added.
Accordingly, one of ordinary skill in the art would have expected that the beads, taught by Spuhler et al., which beads comprise polystyrene are imageable by brightfield microscopy.
Claims 10-12, 15, 17, 30-33 and 36-38 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Brower et al., WO 2020/243160 A1, published 12/03/2020; which US counterpart is Brower et al., US 2022/0235406 A1, published 07/28/2022.
Brower et al., throughout the publication, teach:
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Emphasis added.
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Therefore, Brower et al. teach each and every of element of Claims 10-12, 15, 17, 30-33 and 36-38 and all elected species except of an optically detectable silica microchip as a label.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-12, 15, 17, 30-33, 36-38 and 41 are rejected under 35 U.S.C. 103 as obvious over Spuhler et al., WO 2023/154694, published 08/17/2023, priority data: US 63/307,727, 02/08/2022 (IDS filed 08/28/2024); which US counterpart is Spuhler et al., US 2025/0066761 A1, published 02/27/2025; as evidenced by Bergo, US 2014/0323330 A1, published 10/30/2014, further in view of Vijayan et al., US 2019/0093103 A1, published 03/28/2019 (IDS filed 08/28/2024).
The teachings of Spuhler et al. and Bergo, discussed in the 102(a)(1)/102(a)(2) rejections above, are incorporated herein in its entirety.
Although, as indicated above, in paragraphs [0004] and [0005], Spuhler et al. teach a particle comprising one or more detectable moieties, and a particle indexing oligonucleotide, wherein the particle indexing oligonucleotide comprises a particle type identifier (PTI), wherein the particle type identifier identifies the one or more detectable moieties associated with the particle, this reference does not specifically teach that the particle type identifier ( = the capture bead index in the context of Claim 41) comprises a plurality of oligonucleotide strands sequentially attached to each other, and wherein each oligonucleotide strand, of the plurality of oligonucleotide strands, corresponds to a different optically detectable label of the set of optically detectable labels.
However, as evidenced by Vijayan et al., throughout the publication, and, for example, at FIG. 7, creating a bead-bound concatenated DNA barcode was known in the art before the effective filing date of the claimed invention:
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Accordingly, it would have been obvious for one of skill in the art to implement a bead-bound concatenated DNA barcode for identifying more than the one detectable moiety associated with the particle, taught by Spuhler et al., wherein DNA barcode modules identifying the detectable moieties are assembled in a row in order to create the particle type identifier oligonucleotide.
Double Patenting
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.
Claims 10-12, 15, 17, 30-33, 36-39 and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 30-36 of copending Application No. 18/734,832 (‘832 application), Pub. No. US 2024/0327824 A1, published 10/03/2024 (PTO-892 mailed 02/18/2025); a Notice of Allowance mailed 10/24/2025.
Although the claims at issue are not identical, they are not patentably distinct from
each other because ‘832 application claims an optically labeled perturbation bead comprising the structural elements of the instantly claimed capture bead:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Claim Rejection - 35 USC § 102
At pages 11 and 13 of the Remarks, Applicant argues that:
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Emphasis added.
The Examiner respectfully disagrees for the following reasons.
First, Applicant’s argument is not sustainable at least because it is limited to the only embodiment of Spuhler et al. shown at FIG. 7 and does not take into consideration other embodiments shown, for example, at FIGs. 1 and 2 of Spuhler et al. as follows:
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Second, as indicated above, Spuhler et al., throughout the publication, and, for example, in paragraph [0070] teach a nucleotide sequence configured to hybridize with at least one perturbation component of one or more perturbation components released from a cell during the assay, wherein the one or more perturbation components comprise mRNA released from the cell, and wherein the second nucleotide sequence comprises a poly-T oligonucleotide configured to hybridize with a poly-A region of the mRNA:
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Spuhler et al., paragraph [0070]; Emphasis added.
Double Patenting
At page 14 of the Remarks, Applicant argues that:
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The Examiner respectfully disagrees because, according to MPEP § 804 I.B.1, complete response to a nonstatutory double patenting rejection is either a reply by Applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action:
“A complete response to a nonstatutory double patenting (NDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995.” Emphasis added.
Accordingly, the rejections of the claims are maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678