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 .
Status of the Claims
Claims 1-20 are pending and examined herein.
Priority
This application, filed 04/24/2023, is a CON of 15/724,203, filed 10/03/2017, which is a CON of PCT/US2016/025785, filed 04/02/2016, which claims benefit of 62/142,858, filed 04/03/2015. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 04/03/2015.
Information Disclosure Statement
The Information Disclosure Statements filed 11/14/2023 and 01/07/2025 are acknowledged and have been considered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to§ 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is "directed to," we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a
fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical
application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an "'inventive concept' sufficient to 'transform"' the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not "well-understood,
routine, conventional" in the field (see MPEP § 2106.0S(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 19 recites “calculating a ratio of the solid supports bound to the analyte of interest to solid supports not bound to the analyte of interest.” The step of “calculating a ratio” is characterized as an abstract idea. In particular, “calculating” is considered to be a mathematical concept.
Step 2A, Prong 2
The above-discussed step of “calculating a ratio” is insufficient itself to integrate into a practical application because it is, itself, directed to an abstract idea; such a step represents a judicial exception and is not a practical application thereof.
Regarding independent claim 16, the recited steps of “introducing a liquid”, “introducing the solid supports”, “moving the plurality of solid supports”, “loading the plurality of solid supports”, and “imaging the array of wells” fail to amount to a practical application of the indicated judicial exception. Specifically, these steps are considered to be insignificant extra-solution activity, as they are merely data gathering steps which are necessary in order to gather the data.
ELIGIBILITY OF STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN “INVENTIVE CONCEPT”
Further, the additional elements of the claims (the active method steps/limitations recited in addition to the judicial exceptions themselves) do not add significantly more to the judicial exception(s); the additional recited claim elements are recited at a high level of generality, and are not, for example, limited to any particular testing technique or platform as claimed.
US 2016/0289669 A1, “DEVICES AND SYSTEMS FOR MOLECULAR BARCODING OF NUCLEIC ACID TARGETS IN SINGLE CELLS” (priority to 62/106,680 filed on Jan. 22, 2015. Referred to herein as Fan), as cited in more detail below under 35 U.S.C. 102, supports that calculating the number of bound and non-bound beads in wells during image-based well analysis (Figure 79B and Figures 88A and B) was routine and conventional activity previously performed by those of skill in the art.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well-understood, conventional or routine in the field of particle binding analysis.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception into practical application thereof, or amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-2 and 5-16 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2016/0289669 A1, “DEVICES AND SYSTEMS FOR MOLECULAR BARCODING OF NUCLEIC ACID TARGETS IN SINGLE CELLS” (priority to 62/106,680 filed on Jan. 22, 2015. Referred to herein as Fan).
Regarding claim 1, Fan teaches an analyte detection device with a first and second substrate with a gap in-between (para. 0072, lines 1-8, Figure 29A), an array of wells dimensioned to hold a single solid support (para. 0007, lines 1-8). Fan teaches that each well comprises a first sidewall and bottom surface (para. 0242, lines 1-4, Figures 57 and 81). Fan teaches that the sidewall is oriented at an obtuse angle, i.e. angled such that the diameter at the bottom of the well is smaller than the diameter at the top of the well (Figure 81, para. 0242, lines 1-7). Fan teaches a device with an actuation component to facilitate the movement of the solid supports to the wells, i.e. magnetic field control (para. 0289, lines 4-10).
Regarding claim 2, Fan teaches that the entire sidewall is oriented at an obtuse angle with reference to the bottom surface (Figure 81, para. 0242, lines 1-7).
Regarding claim 5, Fan teaches that the well has a frustoconical shape, i.e. slanted walls with a positive draft angle (Figure 81, para. 0242, lines 4-7).
Regarding claim 6, Fan teaches that the well has an inverted frustoconical shape, i.e. slanted walls with a negative draft angle (Figure 52C, para. 0242, lines 7-8).
Regarding claim 7, Fan teaches the substrate has a first portion where the liquid containing the analyte of interest in introduced (p. 2, col. 2, lines 10-13) and a second portion toward which the liquid is moved (Figure 12, “Inlet”) wherein the well array is proximate of the second portion (Figure 12, middle region for imaging).
Regarding claim 8, Fan teaches a device with a transparent window on the substrate cartridge for use in optical interrogation (para. 0308, lines 39-41, feature (xii)).
Regarding claim 9, Fan teaches a device with an optical imaging component that can determine the number of beads per well (para. 0386, lines 1-9).
Regarding claims 10 and 11, Fan teaches that a magnetic field is used to facilitate the movement of magnetic beads into the wells (para. 0383, lines 8-12).
Regarding claim 12, Fan teaches a reagent reservoir on the substrate (para. 0457, lines 11-14. Figure 29B).
Regarding claim 13, Fan teaches loading the reagent reservoir with beads (para. 0457, lines 9-14) which contain a fluorescent dye label (para. 0204, lines 1-4).
Regarding claim 14, Fan teaches reagent reservoirs pre-loaded with beads or a reagent (para. 0457, lines 9-14). In this case, “pre-loaded” is being interpreted to mean “dried” based on the teaching that pre-loading wells with beads is accomplished by drying beads into the wells (para. 0537, lines 1-4).
Regarding claim 15, Fan teaches that beads are washed in a mix containing BSA (para. 0490, lines 1-5), which would create a passivating layer on the beads.
Regarding claim 16, Fan teaches a method of detecting an analyte of interest (para. 0028, lines 1-2) with an analyte device with a first and second substrate with a gap in-between (para. 0072, lines 1-8, Figure 29A), an array of wells dimensioned to hold a single solid support (para. 0007, lines 1-8). Fan teaches that each well comprises a first sidewall and bottom surface (para. 0242, lines 1-4, Figures 57 and 81). Fan teaches that the sidewall is oriented at an obtuse angle, i.e. angled such that the diameter at the bottom of the well is smaller than the diameter at the top of the well (Figure 81, para. 0242, lines 1-7). Fan teaches a device with an actuation component to facilitate the movement of the solid supports to the wells, i.e. magnetic field control (para. 0289, lines 4-10).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Fan.
Regarding independent claim 1, the teachings of Fan as discussed regarding claim 1 under 35 U.S.C. 102(a)(1) and (a)(2), are incorporated herein.
Regarding claims 3 and 4, Fan teaches that the walls of the wells can be shapes that combine two geometries (para. 0243, lines 1-2). Fan teaches that wells can be rectangular, i.e. have a sidewall that is perpendicular to the base (para. 0241, lines 5-7). Fan teaches that walls of the wells can have negative draft angle, i.e. have an acute angle relative to the base (para. 0242, lines 7-8). Fan teaches that the well shape can be fabricated into “a variety of shapes and sizes…[which] impact cell loading and bead loading/retrieval efficiencies” (para. 0241, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wells taught by Fan to have walls at a positive, negative, or perpendicular angle relative to the base, or any combination thereof. An artisan would be motivated to customize the array well shape in order to optimize bead or cell loading, as taught by Fan. An artisan would have a reasonable expectation of success because Fan teaches that customizing well shape is effective to optimize cell and bead loading.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Witters et al., “Digital microfluidics-enabled single-molecule detection by printing and sealing single magnetic beads in femtoliter droplets" Lab on a Chip (published Apr. 03, 2013. Referred to herein as Witters).
Regarding claim 16, Fan teaches a method of detecting an analyte of interest (para. 0028, lines 1-2) with an analyte device with a first and second substrate with a gap in-between (para. 0072, lines 1-8, Figure 29A), an array of wells dimensioned to hold a single solid support (para. 0007, lines 1-8). Fan teaches that each well comprises a first sidewall and bottom surface (para. 0242, lines 1-4, Figures 57 and 81). Fan teaches that the sidewall is oriented at an obtuse angle, i.e. angled such that the diameter at the bottom of the well is smaller than the diameter at the top of the well (Figure 81, para. 0242, lines 1-7). Fan teaches a device with an actuation component to facilitate the movement of the solid supports to the wells, i.e. magnetic field control (para. 0289, lines 4-10). Fan teaches moving the cells and the beads into the array (para. 0028, lines 1-5) and imaging the array of wells to determine the number of beads in each well bound to cells (para. 0348, lines 8-10. Figure 31 “Quality Statistics Including Bead-Cell Correlations”).
Regarding claim 17 and 20, Fan teaches the use of a device with a transparent window on the substrate cartridge for use in optical interrogation (para. 0308, lines 39-41, feature (xii)).
Regarding claim 18, Fan teaches that a magnetic field is used to facilitate the movement of magnetic beads into the wells (para. 0383, lines 8-12).
Regarding claim 19, Fan teaches calculating a ratio of bound and unbound beads (Figure 79B and Figures 88A and B).
Fan does not teach introducing the solid supports to the liquid comprising the analyte of interest and moving the solid supports bound to the analyte towards the array of wells (claim 16).
However, Witters teaches a method of analyte detection with magnetic beads in a microfluidic device wherein the beads and analyte are mixed then transported to wells (p. 2050, col. 1, para. 3, lines 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Fan by mixing the analyte and beads before transporting them to the wells, as taught by Witters. An artisan would be motivated to make this change in order to reduce the number of loading steps to save time. An artisan would have a reasonable expectation of success in making this change because the ordering of steps in analyte detection methods are routinely altered in an attempt to optimize the number of steps and time.
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 1-4, 7, 8, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 11-13 of U.S. Patent No. 11,633,738 B2 (referred to herein as ‘738). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘738 discloses a species of the genus claimed in the instant application.
Regarding claims 1 and 14 of the instant application, ‘738 discloses An analyte detection device, comprising: a first substrate and a second substrate aligned to define a gap therebetween; an array of wells disposed in the second substrate, wherein: each well is of the array of wells is dimensioned to hold a single solid support of a plurality of solid supports, the plurality of solid supports being configured to bind to an analyte of interest; each well of the array of wells comprises a first sidewall and a bottom surface; and at least a top portion of the first sidewall is oriented at an obtuse angle with reference to the bottom surface; and an actuation component configured to facilitate movement of the plurality of solid supports to the array of wells (‘738 claims 1 and 2).
Regarding claim 2 of the instant application, ‘738 discloses a bottom portion of the first sidewall is oriented at the obtuse angle with reference to the bottom surface (claim 11).
Regarding claim 3 of the instant application, ‘738 discloses each well comprises a second sidewall that is perpendicular to the bottom surface (‘738 claim 12).
Regarding claim 4 of the instant application, ‘738 discloses each well comprises a second sidewall that is oriented at an acute angle with reference to the bottom portion (‘738 claim 13).
Regarding claim 7 of the instant application, ‘738 discloses the first substrate comprises a first portion at which a liquid containing the analyte of interest is introduced and a second portion toward which the liquid is moved, wherein the array of wells is disposed proximate the second portion (‘738 claim 3).
Regarding claim 8 of the instant application, ‘738 discloses at least one of the first and second substrates is substantially transparent to facilitate optical interrogation of the wells (‘738 claim 4).
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 October 27, 2025
/PATRICIA MALLARI/Director, Technology Center 1600