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 .
Response to Amendment
Applicant’s amendment and remarks filed on 07/08/26 have been entered. Claims 4-9 and 15 are cancelled. Claims 1-3 and 10-14 remain pending and examined herein. Applicant’s amendment and remark have overcome the restriction requirement mailed on 04/14/26. The restriction requirement mailed on 04/14/26 is hereby withdrawn.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features shown in claim 3 and 12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Examiner requests the new submission include an illustration of the two lines and overlapping area disclosed in claims 3 and 12.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claim 1-3 and 10-14 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.
Regarding claim 1, the term "dissolvable elements" used in the claims is not clear, the claims fail to define what elements are attached to the discrete locations of the device, and in which solvents they are supposed to be soluble, let alone to specify the features of the elements necessary for the device to be operative.
Furthermore, regarding claims 1, 3, and 12, the relative term "closer to a centre" is ambiguous and renders the scope of the claims unclear. The geometry of the device surface is not defined in the claims, thus, the features about the position of the discrete locations and areas with respect to a centre and the features pertaining to different angles and lines are vague and open to interpretation.
Claims 2-3 and 10-14 are rejected due to their dependency on Claim 1 as well.
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.
Claim(s) 1-3, 10-11, and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glezer (US 20110015091 A1) as cited in previous Office Action.
Regarding claims 1-2, Glezer discloses multi-well assay plate comprising:
a plane detection surface (well 100, Fig. 1) and having thereon a plurality of elements, the plurality of elements including
a plurality of dissolvable elements which are dissolvable upon applying the liquid sample to the plane detection surface (reconstitutable dry reagents 170, Fig. 1 c-d), the plurality of dissolvable elements being attached to the plane detection surface at first discrete locations (walls 110, Fig. 1c-d) of the plane detection surface, the plurality of dissolvable elements one or more first components (control analyte 180, Fig. 1c-d), and
a plurality of immobilized binding elements (First dry reagent 130, Fig. 1) immobilized at second discrete locations (Floor 120, Fig. 1) on the plane detection surface, each immobilized binding element including one or more binding components, each binding component configured to attach to one or more analytes of the multiple analytes and/or the one or more first components (The method may also include immobilizing one or more additional capture reagents so as to form an array of binding domains on said binding surface that differ in their specificity or affinity for binding partners. Para. [0022]),
wherein at least one first discrete location or all of the first discrete locations is/are located closer to the centre of the plane detection surface than each/any of the second discrete locations (Fig. 1c-d).
Regarding claim 3, Glezer discloses the claimed invention as discussed above in claim 1. Due to the vagueness and indefiniteness of claim 3 as highlighted above in the 112(b) rejection. It is Examiner’s position that that the embodiment disclosed in Fig. 1 c-d disclose the claimed invention.
Regarding claim 10, Glezer discloses the claimed invention as discussed above in claim 1. Glezer discloses a method for determining one or more analytes of multiple analytes in a liquid sample using the device according to claim 1 (See the rejection of claim 1 above), the method comprising:
Applying the liquid sample to or at the centre of the plane detection surface (adding liquid samples to one or more wells of a plate; para. [0074]; for purpose of examination, the liquid sample needs to flow through the center at minimum and doesn’t necessarily have to be injected at the center),
performing a first guiding step of guiding the liquid sample to the plurality of dissolvable elements to at least partly dissolve the plurality of dissolvable elements to release the one or more first components into the liquid sample (…reconstituting reconstitutable dry reagents in the wells… para. [0074]),
performing a second guiding step of guiding the liquid sample with the one or more first components to the plurality of immobilized binding elements to have the one or more binding components attach to the one or more analytes of the multiple analytes and/or one or more first components (…reconstituting reconstitutable dry reagents in the wells… para. [0074]; Optionally, second dry reagent 150 comprises a plurality of detection reagents that differ in affinity or specificity for binding partners. Para. [0076]; adding liquid sample to the reagent also reconstituting the dry reagent),
detecting a signal, wherein the signal (measuring an analyte-dependent assay signal so as to measure analyte in the sample…. para. [0074]) is output by at least one of,
the one or more binding components attached to the one or more analytes of the multiple analytes and or the one or more first components, and/or
the one or more analytes and/or the one or more first components attached to the one or more binding components (…employ an immobilized capture reagent and a detection reagent that can bind simultaneously to an analyte of interest so as to have the effect of sequestering the detection reagent on the binding surface. Thus, the presence of the analyte can be measured by measuring the accumulation of the detection reagent on the surface. Para. [0070]); and
determining, based on the signal, a presence or amount of at least one analyte of the multiple analytes in the liquid sample (para. [0104]).
Regarding claim 11, Glezer discloses the claimed invention as discussed above in claim 10. Glezer discloses the first and second guiding step each include guiding the liquid sample in a direction away from the centre (the liquid sample will end up resting at the bottom of the well, hence “away from the centre”, Fig. 1c-d).
Regarding claim 13, Glezer discloses the claimed invention as discussed above in claim 10. Glezer discloses the device further comprises, on the plane detection surface:
the plurality of dissolvable reference elements comprising one or more reference components (reference reagent is interpreted as another reagent in the reconstitutable dry reagents 170, Fig. 1 c-d), and
a plurality of immobilized reference elements and having one or more reference binding components (interpreted to be another distinct reagent in the first dry reagent 130, Fig. 1),
the method includes an additional guiding step of guiding the liquid sample from the plurality of dissolvable reference elements to the plurality of immobilized reference elements to the one or more reference binding components, the one or more reference binding components each configured to attach to the one or more analytes of the multiple analytes and/or the one or more reference components (…reconstituting reconstitutable dry reagents in the wells… para. [0074], and
the detecting of the signal comprises detecting a second signal that is output by the one or more binding components and/or the one or more analytes and/or the one or more reference components attached to the one or more binding components (…employ an immobilized capture reagent and a detection reagent that can bind simultaneously to an analyte of interest so as to have the effect of sequestering the detection reagent on the binding surface. Thus, the presence of the analyte can be measured by measuring the accumulation of the detection reagent on the surface. Para. [0070]).
Regarding claim 14, Glezer discloses the claimed invention as discussed above in claim 10. Glezer discloses the detecting of the signal comprises launching first radiation toward the plane detection surface and detecting second radiation received from:
the one or more binding components attached to the one or more analytes and/or the one or more first components,
the one or more analytes and/or the one or more first components attached to the one or more binding components, and/or
a marker attached to the one or more binding components, the one or more analytes and/or the one or more first components (Detectable signals that may be measured include, but are limited to, optical absorbance, photoluminescence (e.g., fluorescence), chemiluminescence, electrical current or potential, catalytic activity, chemical activity, light scattering… para. [0074]).
Claim(s) 1, 10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vedrine (US 20170030901 A1).
Regarding claim 1, Vedrine discloses a device used in a determination of one or more analytes of multiple analytes in a liquid sample, the device (Fig. 1A) comprising:
a plane detection surface (Fig. 1B) and having thereon a plurality of elements, the plurality of elements including
a plurality of dissolvable elements which are dissolvable upon applying the liquid sample to the plane detection surface (A2, A5, A6, A4, Fig. 1B), the plurality of dissolvable elements being attached to the plane detection surface at first discrete locations (A2, A5, A6, A4, Fig. 1B) of the plane detection surface, the plurality of dissolvable elements one or more first components (A capture ligand is a compound fixed on a solid support, in particular at a spot or the surface of a bead. Para. [0098]; the compound is deposited as a dry spot or on a surface of a bead, hence it would be dissolvable with liquid), and
a plurality of immobilized binding elements (A1, A3,PVC, RVC, Fig. 1B) immobilized at second discrete locations (A1, A3, RVC, PVC, Fig. 1B) on the plane detection surface, each immobilized binding element including one or more binding components, each binding component configured to attach to one or more analytes of the multiple analytes and/or the one or more first components (Para. [0380] for PVC and RVC; para. [0095] for A1 and A3),
wherein at least one first discrete location or all of the first discrete locations is/are located closer to the centre of the plane detection surface than each/any of the second discrete locations (Fig. 1B below. By Pythagorean Theorem, the distance between A1 is and centre is greater than distance between A2 and centre/SDC.
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Regarding claim 10, Vedrine discloses the claimed invention as discussed above in claim 1. Vedrine discloses a method for determining one or more analytes of multiple analytes in a liquid sample using the device according to claim 1 (See the rejection of claim 1 above), the method comprising:
Applying the liquid sample to or at the centre of the plane detection surface (placing a sample to be analyzed in the presence of the spot(s) of said compartment or of said set of beads, Secure Multiplex Analysis Method para. [0288]; for purpose of examination, the liquid sample needs to flow through the center at minimum and doesn’t necessarily have to be injected at the center),
performing a first guiding step of guiding the liquid sample to the plurality of dissolvable elements to at least partly dissolve the plurality of dissolvable elements to release the one or more first components into the liquid sample (placing the liquid sample of step c in para. [0288] and dissolving/activating A2, A4, A5, and A6 would be considered as first guiding step; as discussed in para. [0304], the steps can be carried out simultaneously)
performing a second guiding step of guiding the liquid sample with the one or more first components to the plurality of immobilized binding elements to have the one or more binding components attach to the one or more analytes of the multiple analytes and/or one or more first components (placing the liquid sample of step c in para. [0288] and dissolving/activating A1, A3, PVC, and RVC would be considered as second guiding step; as discussed in para. [0304], the steps can be carried out simultaneously),
detecting a signal, wherein the signal is output by at least one of,
the one or more binding components attached to the one or more analytes of the multiple analytes and or the one or more first components, and/or
the one or more analytes and/or the one or more first components attached to the one or more binding components (Para. [0357]); and
determining, based on the signal, a presence or amount of at least one analyte of the multiple analytes in the liquid sample (para. [0396]).
Regarding claim 12, Vedrine discloses the claimed invention as discussed above in claim 10. Vedrine discloses a plurality of non-overlapping first areas exist on the plane detection surface, each first area being delimited at least partly by two straight lines through the centre, where each first area has a same amount of dissolvable elements and immobilized elements (See Fig. 1B below), and
the first guiding step and the second guiding step each include guiding the liquid sample at least substantially simultaneously over the plurality of non- overlapping first areas (as discussed in para. [0304], the steps can be carried out simultaneously).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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