Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group III – claims 70-82 in the reply filed on 2/16/26 is acknowledged.
Claims 42-43 and 48-56 are withdrawn from consideration. Claims 1-41, 44-47, and 57-69 are cancelled.
Specification
The disclosure is objected to because of the following informalities: the status of parent application 15,882,914 should be updated on page 1 of the specification.
Appropriate correction is required.
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.
Claims 77-79 and 81 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.
Claim 77 is vague. In line 2, the recitation of “the interior volume” lacks antecedent support.
Claim 78 is vague. In line 1, the recitation of “said assay well” lacks antecedent support. In line 2, the phrase “an binding surface” should probably be –a binding surface--.
Claim 79 is vague. In line 1, the recitation of “said assay well” lacks antecedent support.
Claim 81 is vague because the recitation of “said binding surface” lacks antecedent support. Also, claim 70 does not recite any components to provide for an electrode.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 70 and 76-82 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wohlstadter et al (WO 03/001889 A2; herein referred to as Wohlstadter).
Wohlstadter discloses assay modules (preferably assay plates, more preferably multi-well assay plates), methods and apparatuses for conducting assay measurements. Assay modules of the invention may include one or more, preferably a plurality, of wells, chambers and/or assay regions for conducting one or more assay measurements. Preferably, these wells, chambers and/or assay regions comprise one or more electrodes for inducing luminescence from materials in the wells, chambers and/or assay regions. The assay modules may further comprise assay reagents (in liquid or dry form), preferably in the wells, chambers or assay regions of the assay module. Such assay reagents may be immobilized on electrodes of the module or confined on electrodes of the module (e.g., through the use of appropriately designed dielectric surfaces surrounding the electrode surfaces). Preferably, the module is configured to allow for the measurement of luminescence in portions of the assay module (preferably, more than one assay region, well or chamber at a time, but less than all). One aspect of the invention relates to novel configurations and materials for electrodes and electrical contacts in assay modules. The invention also relates to apparatuses, methods, systems and kits for conducting measurements using assay modules. The invention further relates to methods of manufacturing the assay modules and plates of the invention (Page 4).
The multi-well assay plates may include several elements, for example, a plate top, a plate bottom, wells, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, and assay reagents. The wells of the plates may be defined by holes/openings in the plate top. The plate bottom can be affixed to the plate top (either directly or in combination with other components) and can serve as the bottom of the well. Alternatively, the wells of the plates may be defined as indentations or dimples on a surface of a plate. The multi-well assay plates may have any number of wells of any size or shape, arranged in any pattern or configuration, and can be composed of a variety of different materials. Preferred embodiments of the invention use industry standard formats for the number, size, shape and configuration of the plate and wells. Examples of standard formats include 96-, 384-, 1536-, and 9600-well plates, with the wells configured in two-dimensional arrays. Other formats may include single well plates (preferably having a plurality of assay domains), 2 well plates, 6 well plates, 24 well plates, and 6144 well plates (Pages 4-5).
According to the invention, working, counter and, optionally, reference electrodes can be incorporated into the wells. The present invention describes several novel configurations and materials for electrodes in multi-well assay plates. Multi-well assay plates of the present invention may be used once or may be used multiple times and are well suited to applications where the plates are disposable. Furthermore, the assay reagents, preferably dried reagents and/or wet reagents, may be incorporated into the assay plate, preferably into one or more wells or assay domains. In some embodiments, a well of a multi-well plate may include a plurality of assay domains (Page 5).
One or more assay reagents may be included in wells, chambers and/or assay domains of an assay module (e.g., in the wells of a multi-well assay plate). These assay reagents may be immobilized or placed on one or more of the surfaces of a well and/or chamber (preferably on the surface of an electrode, most preferably a working electrode) and may be immobilized or placed in one or more distinct assay domains (e.g. in patterned arrays of reagents immobilized on one or more surfaces of a well and/or chamber, preferably on working electrodes and/or counter electrodes, most preferably on working electrodes). The assay reagents may also be contained or localized by features within the well and/or chamber. For example, patterned dielectric materials may confine or localize fluids (Page 16).
Assay reagents (e.g., binding reagents, coreactants, ECL labels) may be immobilized on the bottom surface of the well. These reagents may be covalently or non-covalently immobilized on the bottom surface. Advantageously, reagents are immobilized on the working electrode. In preferred embodiments, assay reagents are immobilized in assay domains on working electrode. These assay domains may be distinct or contiguous. In some embodiments, multiple distinct assay domains containing assay reagents are present on the working electrode (Page 32).
According to one embodiment, the plate further comprises a cover or lid or plate seal ("cover") adapted to cover the wells and thereby reduce or prevent evaporation and/or prevent contamination. The cover may be, for example, a hard plastic cover or an adhesive flexible tape. The cover may be disposable and/or reusable (Page 32).
Preferred assay formats employ solid-phase supports so as to couple the measurement of an analyte or activity to the separation of labeled reagents into solution-phase and solid phase supported portions. Examples include solid-phase binding assays that measure the formation of a complex of a material and its specific binding partner (one of the pair being immobilized, or capable of being immobilized, on the solid phase support), the formation of sandwich complexes (including a capture reagent that is immobilized, or capable of being immobilized, on the solid phase support), the competition of two competitors for a binding partner (the binding partner or one of the competitors being immobilized, or capable of being immobilized, on the solid phase support), the enzymatic or chemical cleavage of a label (or labeled material) from a reagent that is immobilized, or capable of being immobilized on a solid phase support and the enzymatic or chemical attachment of a label (or labeled material) to a reagent that is immobilized or capable of being immobilized on a solid-phase support. The term "capable of being immobilized" is used herein to refer to reagents that may participate in reactions in solution and subsequently be captured on a solid phase during or prior to the detection step. For example, the reagent may be captured using a specific binding partner of the reagent that is immobilized on the solid phase. Alternatively, the reagent is linked to a capture moiety and a specific binding partner of the capture moiety is immobilized on the solid phase. Examples of useful capture moiety-binding partner pairs include biotin-streptavidin (or avidin), antibody-hapten, receptor-ligand, nucleic acid--complementary nucleic acid, etc (Page 160).
In one embodiment of the invention, a reagent labeled with a luminescent, chemiluminescent and/or redox-active label (preferably an ECL label) is measured by a method comprising the steps of i) introducing the sample to an assay plate or one or more wells of an assay plate of the invention; ii) contacting the labeled reagent with a binding reagent; ii) forming a binding complex comprising the binding reagent and the labeled reagent; iii) inducing the labeled reagent to produce an electrochemical or luminescent signal (preferably, electrochemiluminescence) and iv) measuring the signal so as to measure the labeled reagent. Preferably, the binding reagent is immobilized or capable of being immobilized on a solid phase support, the solid phase support, most preferably being a working electrode in an assay plate or a well of an assay plate of the invention. The method may also comprise the step of immobilizing the binding reagent on the solid phase support and/or working electrode (Page 161).
The present invention also relates to methods of measuring an analyte in a sample comprising the steps of i) contacting the sample with a labeled detection reagent and optionally a capture reagent, the detection and binding reagents having specific binding affinity for the analyte; ii) forming a binding complex comprising the binding reagent, the analyte and, optionally, the capture reagent; iii) inducing the labeled detection reagent to produce an electrochemical or luminescent signal (preferably, electrochemiluminescence) and iv) measuring the signal so as to measure the analyte in the sample. Preferably, the capture reagent is immobilized or capable of being immobilized on a solid phase support, the solid phase support, most preferably, being a working electrode in an assay plate or a well of an assay plate of the invention. The method may also comprise the step of immobilizing the capture reagent on the solid phase support and/or working electrode (Pages 161-162).
Another aspect of the invention relates to kits for use in conducting assays, preferably luminescence assays, more preferably electrode induced luminescence assays, and most preferably electrochemiluminescence assays, comprising an assay module, preferably an assay plate, more preferably a multi-well assay plate, and at least one assay component selected from the group consisting of binding reagents, enzymes, enzyme substrates and other reagents useful in carrying out an assay. Examples include, but are not limited to, whole cells, cell surface antigens, subcellular particles (e.g., organelles or membrane fragments), viruses, prions, dust mites or fragments thereof, viroids, antibodies, antigens, haptens, fatty acids, nucleic acids (and synthetic analogs), proteins (and synthetic analogs), lipoproteins, polysaccharides, lipopolysaccharides, glycoproteins, peptides, polypeptides, enzymes (e.g., phosphorylases, phosphatases, esterases, trans-glutaminases, transferases, oxidases, reductases, dehydrogenases, glycosidases, protein processing enzymes (e.g., proteases, kinases, protein phophatases, ubiquitin-protein ligases, etc.), nucleic acid processing enzymes (e.g., polymerases, nucleases, integrases, ligases, helicases, telomerases, etc.)), enzyme substrates (e.g., substrates of the enzymes listed above), second messengers, cellular metabolites, hormones, pharmacological agents, tranquilizers, barbiturates, alkaloids, steroids, vitamins, amino acids, sugars, lectins, recombinant or derived proteins, biotin, avidin, streptavidin, luminescent labels (preferably electrochemiluminescent labels), electrochemiluminescence coreactants, pH buffers, blocking agents, preservatives, stabilizing agents, detergents, dessicants, hygroscopic agents, etc. Such assay reagents may be unlabeled or labeled (preferably with a luminescent label, most preferably with an electrochemiluminescent label). One embodiment of the invention includes a kit for use in conducting assays, preferably luminescence assays, more preferably electrode induced luminescence assays, and most preferably electrochemiluminescence assays, comprising an assay module, preferably an assay plate, more preferably a multi-well assay plate, and at least one assay component selected from the group consisting of: (a) at least one luminescent label (preferably electrochemiluminescent label); (b) at least one electrochemiluminescence coreactant); (c) one or more binding reagents; (d) a pH buffer; (e) one or more blocking reagents; (f) preservatives; (g) stabilizing agents; (h) enzymes; (i) detergents; (j) desiccants and (k) hygroscopic agents (Pages 170-171).
Claim(s) 70-71, 78, and 82 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Takeda et al (CA 2,270,068 A1 (aka WO 98/22823); herein referred to as Takeda).
Takeda discloses a 96 well plate that contains dried immunoassay reagents in each well. Each well is sealed with desiccant containing film at the top of each well (Page 2). The dried reagents in each well can be colored beads or erythrocytes sensitized with antigen or antibody or labeled antigens/antibodies (Page 3). The dried antigen or antibody can be immobilized in each well and the labeled antigen/antibody are also dried in each well to reduce the frequency of reagent application steps into each well (Page 4).
Claim(s) 70 and 76-82 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by over Glezer et al (US 2005/0142033; herein referred to as Glezer).
Glezer discloses assay modules (preferably assay plates, more preferably multi-well assay plates), methods and apparatuses for conducting assay measurements. Assay modules of the invention may include one or more, preferably a plurality, of wells, chambers and/or assay regions for conducting one or more assay measurements. Preferably, these wells, chambers and/or assay regions comprise one or more electrodes for inducing luminescence from materials in the wells, chambers and/or assay regions. The assay modules may further comprise assay reagents (in liquid or dry form), preferably in the wells, chambers or assay regions of the assay module. Such assay reagents may be immobilized on electrodes of the module or confined on electrodes of the module (e.g., through the use of appropriately designed dielectric surfaces surrounding the electrode surfaces). Preferably, the module is configured to allow for the measurement of luminescence in portions of the assay module (preferably, more than one assay region, well or chamber at a time, but less than all). One aspect of the invention relates to novel configurations and materials for electrodes and electrical contacts in assay modules. The invention also relates to apparatuses, methods, systems and kits for conducting measurements using assay modules. The invention further relates to methods of manufacturing the assay modules and plates of the invention ([0012]).
The multi-well assay plates may include several elements, for example, a plate top, a plate bottom, wells, working electrodes, counter electrodes, reference electrodes, dielectric materials, electrical connections, and assay reagents. The wells of the plates may be defined by holes/openings in the plate top. The plate bottom can be affixed to the plate top (either directly or in combination with other components) and can serve as the bottom of the well. Alternatively, the wells of the plates may be defined as indentations or dimples on a surface of a plate. The multi-well assay plates may have any number of wells of any size or shape, arranged in any pattern or configuration, and can be composed of a variety of different materials. Preferred embodiments of the invention use industry standard formats for the number, size, shape and configuration of the plate and wells. Examples of standard formats include 96-, 384-, 1536-, and 9600-well plates, with the wells configured in two-dimensional arrays. Other formats may include single well plates (preferably having a plurality of assay domains), 2 well plates, 6 well plates, 24 well plates, and 6144 well plates ([0013]).
According to the invention, working, counter and, optionally, reference electrodes can be incorporated into the wells. The present invention describes several novel configurations and materials for electrodes in multi-well assay plates. Multi-well assay plates of the present invention may be used once or may be used multiple times and are well suited to applications where the plates are disposable. Furthermore, the assay reagents, preferably dried reagents and/or wet reagents, may be incorporated into the assay plate, preferably into one or more wells or assay domains. In some embodiments, a well of a multi-well plate may include a plurality of assay domains ([0014]).
One or more assay reagents may be included in wells, chambers and/or assay domains of an assay module (e.g., in the wells of a multi-well assay plate). These assay reagents may be immobilized or placed on one or more of the surfaces of a well and/or chamber (preferably on the surface of an electrode, most preferably a working electrode) and may be immobilized or placed in one or more distinct assay domains (e.g. in patterned arrays of reagents immobilized on one or more surfaces of a well and/or chamber, preferably on working electrodes and/or counter electrodes, most preferably on working electrodes). The assay reagents may also be contained or localized by features within the well and/or chamber. For example, patterned dielectric materials may confine or localize fluids ([0091]).
Assay reagents (e.g., binding reagents, coreactants, ECL labels) may be immobilized on the bottom surface of the well. These reagents may be covalently or non-covalently immobilized on the bottom surface. Advantageously, reagents are immobilized on the working electrode. In preferred embodiments, assay reagents are immobilized in assay domains on working electrode. These assay domains may be distinct or contiguous. In some embodiments, multiple distinct assay domains containing assay reagents are present on the working electrode ([0146]).
According to one embodiment, the plate further comprises a cover or lid or plate seal ("cover") adapted to cover the wells and thereby reduce or prevent evaporation and/or prevent contamination. The cover may be, for example, a hard plastic cover or an adhesive flexible tape. The cover may be disposable and/or reusable ([0147]).
Preferred assay formats employ solid-phase supports so as to couple the measurement of an analyte or activity to the separation of labeled reagents into solution-phase and solid phase supported portions. Examples include solid-phase binding assays that measure the formation of a complex of a material and its specific binding partner (one of the pair being immobilized, or capable of being immobilized, on the solid phase support), the formation of sandwich complexes (including a capture reagent that is immobilized, or capable of being immobilized, on the solid phase support), the competition of two competitors for a binding partner (the binding partner or one of the competitors being immobilized, or capable of being immobilized, on the solid phase support), the enzymatic or chemical cleavage of a label (or labeled material) from a reagent that is immobilized, or capable of being immobilized on a solid phase support and the enzymatic or chemical attachment of a label (or labeled material) to a reagent that is immobilized or capable of being immobilized on a solid-phase support. The term "capable of being immobilized" is used herein to refer to reagents that may participate in reactions in solution and subsequently be captured on a solid phase during or prior to the detection step. For example, the reagent may be captured using a specific binding partner of the reagent that is immobilized on the solid phase. Alternatively, the reagent is linked to a capture moiety and a specific binding partner of the capture moiety is immobilized on the solid phase. Examples of useful capture moiety-binding partner pairs include biotin-streptavidin (or avidin), antibody-hapten, receptor-ligand, nucleic acid--complementary nucleic acid, etc ([0681]).
In one embodiment of the invention, a reagent labeled with a luminescent, chemiluminescent and/or redox-active label (preferably an ECL label) is measured by a method comprising the steps of i) introducing the sample to an assay plate or one or more wells of an assay plate of the invention; ii) contacting the labeled reagent with a binding reagent; ii) forming a binding complex comprising the binding reagent and the labeled reagent; iii) inducing the labeled reagent to produce an electrochemical or luminescent signal (preferably, electrochemiluminescence) and iv) measuring the signal so as to measure the labeled reagent. Preferably, the binding reagent is immobilized or capable of being immobilized on a solid phase support, the solid phase support, most preferably being a working electrode in an assay plate or a well of an assay plate of the invention. The method may also comprise the step of immobilizing the binding reagent on the solid phase support and/or working electrode ([0684]).
The present invention also relates to methods of measuring an analyte in a sample comprising the steps of i) contacting the sample with a labeled detection reagent and optionally a capture reagent, the detection and binding reagents having specific binding affinity for the analyte; ii) forming a binding complex comprising the binding reagent, the analyte and, optionally, the capture reagent; iii) inducing the labeled detection reagent to produce an electrochemical or luminescent signal (preferably, electrochemiluminescence) and iv) measuring the signal so as to measure the analyte in the sample. Preferably, the capture reagent is immobilized or capable of being immobilized on a solid phase support, the solid phase support, most preferably, being a working electrode in an assay plate or a well of an assay plate of the invention. The method may also comprise the step of immobilizing the capture reagent on the solid phase support and/or working electrode ([0685]).
Another aspect of the invention relates to kits for use in conducting assays, preferably luminescence assays, more preferably electrode induced luminescence assays, and most preferably electrochemiluminescence assays, comprising an assay module, preferably an assay plate, more preferably a multi-well assay plate, and at least one assay component selected from the group consisting of binding reagents, enzymes, enzyme substrates and other reagents useful in carrying out an assay. Examples include, but are not limited to, whole cells, cell surface antigens, subcellular particles (e.g., organelles or membrane fragments), viruses, prions, dust mites or fragments thereof, viroids, antibodies, antigens, haptens, fatty acids, nucleic acids (and synthetic analogs), proteins (and synthetic analogs), lipoproteins, polysaccharides, lipopolysaccharides, glycoproteins, peptides, polypeptides, enzymes (e.g., phosphorylases, phosphatases, esterases, trans-glutaminases, transferases, oxidases, reductases, dehydrogenases, glycosidases, protein processing enzymes (e.g., proteases, kinases, protein phophatases, ubiquitin-protein ligases, etc.), nucleic acid processing enzymes (e.g., polymerases, nucleases, integrases, ligases, helicases, telomerases, etc.)), enzyme substrates (e.g., substrates of the enzymes listed above), second messengers, cellular metabolites, hormones, pharmacological agents, tranquilizers, barbiturates, alkaloids, steroids, vitamins, amino acids, sugars, lectins, recombinant or derived proteins, biotin, avidin, streptavidin, luminescent labels (preferably electrochemiluminescent labels), electrochemiluminescence coreactants, pH buffers, blocking agents, preservatives, stabilizing agents, detergents, dessicants, hygroscopic agents, etc. Such assay reagents may be unlabeled or labeled (preferably with a luminescent label, most preferably with an electrochemiluminescent label). One embodiment of the invention includes a kit for use in conducting assays, preferably luminescence assays, more preferably electrode induced luminescence assays, and most preferably electrochemiluminescence assays, comprising an assay module, preferably an assay plate, more preferably a multi-well assay plate, and at least one assay component selected from the group consisting of: (a) at least one luminescent label (preferably electrochemiluminescent label); (b) at least one electrochemiluminescence coreactant); (c) one or more binding reagents; (d) a pH buffer; (e) one or more blocking reagents; (f) preservatives; (g) stabilizing agents; (h) enzymes; (i) detergents; (j) desiccants and (k) hygroscopic agents ([0740]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 70, 76, and 82 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu (US Patent 5,766,554) in view Glezer et al (US 2005/0142033; herein referred to as Glezer).
Liu discloses a multi-well plate comprising a plate body with a plurality of wells. The plate body has a plate top with a plurality of through holes and plate bottom that is sealed against the plate top. A desiccant material (200) is situated on the plate body in well (See Fig. 2a and Cols. 2-4).
Liu differs from the instant invention in failing to teach a plate seal that isolates the plurality of wells from the external environment.
Glezer teaches plate seal ("cover") adapted to cover the wells of a multi-well plate and thereby reduce or prevent evaporation and/or prevent contamination. The cover may be, for example, a hard plastic cover or an adhesive flexible tape. The cover may be disposable and/or reusable ([0147]).
It would have been obvious to one of ordinary skill in the art to add the plate seal of Glezer to the multi-well plate of Liu because the plate seal provides the advantage of reducing or preventing evaporation or contamination of reagents in the wells. A person of ordinary skill in the art reasonably would have expected success because both Liu and Glezer are directed to multi-well plates.
Claim 71 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wohlstadter et al (WO 03/001889 A2; herein referred to as Wohlstadter) or Glezer et al (US 2005/0142033; herein referred to as Glezer) in view of Takeda et al (CA 2,270,068 A1 (aka WO 98/22823); herein referred to as Takeda).
See above for the teachings of Wohlstadter or Glezer.
Wohlstadter and Glezer differ from the instant invention in failing to teach a plate seal that comprises a desiccant material.
See above for the teachings of Takeda.
It would have been obvious to one of ordinary skill in the art to use the desiccant containing plate seal of Takeda on the multi-well plate of Wohlstadter or Glezer because the plate seal of Takeda provides the additional advantage of mitigating problems with moisture effecting the reagents in the wells. A person of ordinary skill in the art reasonably would have expected success because Takeda, Wohlstadter, and Glezer are all directed to multi-well plates.
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 70 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 7,807,448. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of patent ‘448 anticipates instant claim 70. Patent ‘448 has the desiccant material situated in well while instant claim 70 does not recite a specific location of the desiccant material. Thus, patent ‘448 anticipates the broader scope of the instant invention.
Claims 70, 71, and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8,298,834 in view of Takeda et al (CA 2,270,068 A1 (aka WO 98/22823); herein referred to as Takeda).
Patent ‘834 claims:
1. A multi-well assay plate comprising a plate body with a plurality of wells defined therein, wherein said plurality of wells comprises:
(a) a binding surface having a capture reagent immobilized thereon and
(b) a reconstitutable dry reagent, wherein said dry reagent is located on a surface of said well that does not overlap with said binding surface.
2. The multi-well assay plate of claim 1, wherein said reconstitutable dry reagent comprises a labeled detection reagent.
3. The multi-well assay plate of claim 2, wherein said binding surface is located on a bottom surface of said well and said reconstitutable dry reagent is located on a wall of said well.
4. The multi-well assay plate of claim 3, wherein said wall of said well comprises a reagent storage shelf upon which said reconstitutable dry reagent is located.
5. The multi-well plate of claim 4, wherein said binding surface is coated with a reconstitutable protective layer.
Patent ‘834 differs from the instant invention in not teaching plate seal with a desiccant material that covers each well.
See above for the teachings of Takeda.
It would have been obvious to one of ordinary skill in the art to use the desiccant containing plate seal of Takeda on the multi-well plate of patent ‘834 because the plate seal of Takeda provides the advantage of mitigating problems with moisture effecting the reagents in the wells. A person of ordinary skill in the art reasonably would have expected success because both Takeda and patent ‘834 are directed to multi-well plates.
Claims 70, 71, and 82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,065,615 in view of Takeda et al (CA 2,270,068 A1 (aka WO 98/22823); herein referred to as Takeda).
Patent ‘615 claims:
1. A multi-well assay plate comprising a plate body with a plurality of wells defined therein comprising:
(a) a plurality of detection wells, wherein each detection well comprises a binding surface having a capture reagent immobilized thereon and
(b) a plurality of reagent reconstitution wells, wherein each reagent reconstitution well comprises a reconstitutable labeled detection reagent,
wherein at least one detection well and one reagent reconstitution well comprises matched capture and detection reagents for measuring an analyte of interest, and wherein said capture reagent and said reconstitutable labeled detection reagent are not in the same well.
2. A multi-well assay plate comprising a plate body with a plurality of wells defined therein comprising:
(a) a plurality of detection wells, wherein said detection wells
(i) having well floors and well walls, wherein said well walls have inner wall surfaces and outer wall surfaces,
(ii) are arranged in a regular two dimensional pattern, and
(iii) comprise, on an inner surface of each of said detection wells, a binding surface having capture reagent immobilized thereon an array; and
(b) a plurality of reagent reconstitution wells, wherein said reagent reconstitution wells
(i) have well floors and well walls, wherein said well walls are defined by outer wall surfaces of said detection wells and by rib elements connecting the outer wall surface of adjacent detection wells and
(ii) comprise, in each reagent reconstitution well, a reconstitutable dry labeled detection reagent; wherein at least one detection well and one reagent reconstitution well comprise matched capture and detection reagents for measuring an analyte of interest, and wherein said capture reagent and said reconstitutable dry labeled detection reagent are not in the same well.
3. The multi-well assay plate of claim 2, wherein said detection wells have well opening perimeters with no reentrant angles or curves and said reagent reconstitution wells have well opening perimeters with reentrant curves or angles.
4. The multi-well assay plate of claim 2, wherein said detection wells have well opening perimeters that are round.
5. The multi-well assay plate of any one of claims 2, wherein said detection and reagent reconstitution wells can be grouped into a plurality of assay sets consisting of one or more detection wells and one reagent reconstitution well, and said detection well(s) and reagent reconstitution well within a set comprise matched capture and detection reagents for measuring an analyte of interest.
6. The multi-well assay plate of claim 5, wherein said sets consist of one detection well and one reagent reconstitution well.
7. The multi-well assay plate of any one of claims 2, wherein said detection well(s) or said reagent reconstitution well further comprises a reconstitutable dry assay control analyte.
8. The multi-well assay plate of any one of claims 2 further comprising one or more additional immobilized capture reagents, wherein said capture reagent and additional capture reagents form a patterned array of binding domains on said binding surface, and said binding domains differ in specificity or affinity for binding partners.
9. The multi-well assay plate of claim 8, wherein said reconstitutable dry reagent further comprises one or more additional labeled detection reagents, and said detection reagent and additional detection reagents differ in specificity or affinity for binding partners.
10. The multi-well assay plate of claim 2, wherein said binding surface is an electrode for use in an electrochemiluminescence assay.
11. A multi-well plate comprising a plate body with a plurality of wells defined therein comprising:
(a) a plurality of first reagent wells holding a reconstitutable first dry reagent and
(b) a plurality of second reagent wells holding a second dry reagent, wherein said first and second reagents are matched reagents for conducting an assay, and wherein said reconstitutable first dry reagent and second dry reagent are not in the same well.
12. The multi-well assay plate of claim 11, wherein said first reagent wells are arranged in a regular two dimensional pattern and said first reagent wells have well floors and well walls, said well walls having inner wall surfaces and outer wall surfaces and said second reagent wells have well floors and well walls, said well walls being defined by outer wall surfaces of said detection wells and by rib elements connecting the outer wall surfaces of adjacent detection wells.
13. The multi-well assay plate of claim 12, wherein said detection wells are arranged in an 8×12 array.
14. The multi-well assay plate of claim 12, wherein said first reagent wells have well opening perimeters that are round.
Patent ‘615 differs from the instant invention in not teaching plate seal with a desiccant material that covers each well.
See above for the teachings of Takeda.
It would have been obvious to one of ordinary skill in the art to use the desiccant containing plate seal of Takeda on the multi-well plate of patent ‘615 because the plate seal of Takeda provides the advantage of mitigating problems with moisture effecting the reagents in the wells. A person of ordinary skill in the art reasonably would have expected success because both Takeda and patent ‘615 are directed to multi-well plates.
Allowable Subject Matter
Claims 72-75 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims because the prior art of record fails to teach placement of a desiccant material in a multi-well plate in the manner recited in claims 72-75.
Conclusion
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
6/8/2026
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