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 .
Claims 1-20 are pending and will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 3, 2024 and May 8, 2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11898194 (‘194 patent herein). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the method of the ‘194 patent cover extremely similar subject matter. The primary difference between independent claim 1 of the instant claims and the primary claims of the ‘194 patent is, in the instant method, the extraction solution is sealed in the wells with the target molecule, useful for downstream lysis, extraction and isolation steps. Compare instant claims 7-18 and 20 to claims 4-15 and 17 of the ‘194 patent. The subject matter of each of these claims cover exactly the same subject matter, including an immunoassay (instant claim 5, as compared to claim 8 of the ‘194 patent), signal amplification (instant claim 10 as compared to claim 7 of the ‘194 patent) and where the target molecule is nucleic acid (instant claim 15 as compared to claim 12 of the ‘194 patent), among other dependent claims.
Therefore, the instant claims are not patent eligible in view of the claims of the ‘194 patent.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fathollahi et al. (WO2016149639; September 2016, subsequently published as US 20180067038 A1).
With regard to claim 1, Fathollahi teaches a method for detecting a target molecule, comprising:
preparing a fluid device having a plurality of wells arrayed in the fluid device such that the plurality of wells contains an extracting substance and a liquid dispersion of a structural substance including a target molecule (p 21, Example 1, paragraph 103 especially, where the sealing of wells with oil is described; p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed);
supplying a sealing solution into the plurality of wells arrayed in the fluid device such that a layer of the sealing solution is formed on the extracting substance and the liquid dispersion in the wells and that the extracting substance and the liquid dispersion are sealed in the wells (p 21, Example 1, paragraph 103 especially, where the sealing of wells with oil is described);
extracting the target molecule from the structural substance in the plurality of wells in the fluid device such that the liquid dispersion in the plurality of wells includes the structural substance and the target molecule extracted from the structural substance (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed);
and detecting the target molecule extracted from the structural substance in the plurality of wells in the fluid device (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 2, Fathollahi teaches a method according to claim 1, wherein the preparing of the fluid device includes supplying the extracting substance into the wells in the fluid device such that the extracting substance is introduced into the plurality of wells in the fluid device, and supplying the liquid dispersion into the wells in the fluid device such that the structural substance is introduced into the plurality of wells in the fluid device after the supplying of the extracting substance (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed; see also Example 1 and p 21, where the device is described; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 3, Fathollahi teaches a method according to claim 1, wherein the preparing of the fluid device includes preparing a mixture comprising the extracting substance and the liquid dispersion, and supplying the mixture comprising the extracting substance and the liquid dispersion into the wells in the fluid device such that the mixture is introduced into the plurality of wells in the fluid device (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed; see also Example 1 and p 21, where the device is described; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 4, Fathollahi teaches a method according to claim 1, wherein the extracting of the target molecule is conducted after the supplying of the sealing solution (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed; see also Example 1 and p 21, where the device is described; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 5, Fathollahi teaches a method according to claim 2, wherein the detecting of the target molecule is conducted after the extracting of the target molecule (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 6, Fathollahi teaches a method according to claim 3, wherein the detecting of the target molecule is conducted after the extracting of the target molecule (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 7, Fathollahi teaches a method according to claim 3, wherein the extracting of the target molecule includes adjusting an extraction condition in the plurality of wells (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed; see also Example 1 and p 21, where the device is described; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 8, Fathollahi teaches a method according to claim 1, wherein the detecting of the target molecule includes immunoassay (see paragraph 2, where immunoassay is described).
With regard to claim 9, Fathollahi teaches a method according to claim 1, wherein the detecting of the target molecule includes an ICA reaction (see paragraph 2, where immunoassay is described).
With regard to claim 10, Fathollahi teaches a method according to claim 1, wherein the detecting of the target molecule includes a signal amplification reaction (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification).
With regard to claim 11, Fathollahi teaches a method according to claim 1, further comprising: detecting the structural substance (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 12, Fathollahi teaches a method according to claim 11, wherein the detecting of the target molecule and the detecting of the structural substance are conducted in a same process (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification; see Figure 6 and paragraph 50, where the workflow using the device is described).
With regard to claim 13, Fathollahi teaches a method according to claim 1, wherein the structural substance includes a second target molecule, and the detecting includes detecting the target molecule and the second target molecule (paragraph 6, 58 and 106, see Figure 14, where detection of target is described following amplification).
With regard to claim 14, Fathollahi teaches a method according to claim 1, wherein the structural substance is at least one of an exosome, cell, bacterium, virus, fungus, and endoplasmic reticulum (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed).
With regard to claim 15, Fathollahi teaches a method according to claim 1, wherein the target molecule is a nucleic acid or a protein (paragraph 6, where the biomolecules and single cells include DNA, RNA and proteins).
With regard to claim 16, Fathollahi teaches a method according to claim 1, wherein the introducing introduces at most one structural substance into each well of the well array (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed).
With regard to claim 17, Fathollahi teaches a method according to claim 1, wherein the extracting of the target molecule is conducted by at least one of physical, chemical, and biological techniques (p 16, paragraph 88, where the wells include lysis reagents and cells were subsequently lysed).
With regard to claim 18, Fathollahi teaches a method according to claim 1, further comprising: bringing the structural substance into contact with a capture substance having a specific binding substance to the structural substance such that the capture substance binds to the structural substance (paragraph 88 and 93, p 16 and p 18, where antibodies can be used for capture of cells).
With regard to claim 19, Fathollahi teaches a method according to claim 18, wherein the introducing of the structural substance comprises introducing the capture substance into the plurality of wells in the fluid device (paragraph 88 and 93, p 16 and p 18, where antibodies can be used for capture of cells).
With regard to claim 20, Fathollahi teaches a method according to claim 18, wherein the specific binding substance is an antibody (paragraph 88 and 93, p 16 and p 18).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Goto et al (US 11097269 B2; August 2021). Oblath et al. (Lab Chip, 2013, 13, 1325-1332). Verbruggen et al. (Microfluid Nanofluid, 2015, 18:293-303).
Conclusion
No claims are allowed. All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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