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 in the application.
Claims 2, 6, 15-16, and 18-20 are withdrawn.
Claims 1, 3-5, 7-14 and 17 are the subject of this office action.
Election/Restrictions
Applicant’s election of Group I, claims 1, 3-5, 7-14 and 17 with traverse in the reply filed on 3 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
The instant application is a continuation of App 16/964,870, filed 24 July 2020; which is a 371 National Stage of PCT/US19/15309, filed 25 January 2019; which is a continuation of PCT/US19/13388, filed 11 January 2019 and which claims benefit of provisional application 62/621,761, filed 25 January 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 January 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 1, 10 are objected to because of the following informalities:
in claim 1: “wherein the height of the spacers and the geometry of the particles are configured to, in the closed configuration, there are no significant overlaps”
the phrasing of the limitation is not grammatically correct.
in claim 10: “the additional binding site is the binding site different from the binding site by the capture agent”
the phrasing of the limitation is not grammatically correct
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 1: “the capture agent binds the non-cell analyte”
this limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that function. That is, the particular physical structure than enables a capture agent to bind a non-cell analyte is not clear within the context of the claim.
In claim 4: “wherein the capture agent, or the detection agent, or both of the capture agent and the detection agent binds specifically the non-cell analyte”
this limitation is interpreted under 112(f) because it links a generic placeholder (i.e. a capture agent and/or detection agent) with a particular recited function, but does not provide sufficient structure to support that function. That is, the particular structural features of a detection agent or a capture agent which render it capable of performing the recited function are not clear within the context of the claim.
in claim 9: “a labeled competitive detection agent for competing with the analyte, if present, for binding to the capture agent for the analyte in a competitive assay”
this limitation is interpreted under 112(f) because it links a generic placeholder (i.e. a labeled competitive detection agent) with a particular recited function, but does not provide sufficient structure to support that function. That is, the structural or physical features and requirements of a labeled competitive detection agent which render it capable of performing the recited function are not defined within the context of the claim.
in claim 10: “a labeled detection agent that specifically binds to an additional binding site of the analyte in a non-competitive assay”
this limitation is interpreted under 112(f) because it links a generic placeholder (i.e. detection agent) with a particular recited function, but does not provide sufficient structure to support that function. That is, the particular structural features of a detection agent or a capture agent which render it capable of performing the recited function are not clear within the context of the claim.
in claim 17: a labeled detection agent that is capable of binding the non-cell analyte
this limitation is interpreted under 112(f) because it links a generic placeholder (i.e. detection agent) with a particular recited function, but does not provide sufficient structure to support that function. That is, the particular structural features of a detection agent or a capture agent which render it capable of performing the recited function are not clear within the context of the claim.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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 1, 3-5, 7-14, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “significant overlap” in claim 1 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear from the claims or the specification what degree of overlap is or is not considered “significant”, therefore the metes and bounds of this limitation in the claim are unclear.
Claim 10 is rejected as indefinite over the recitation of a “labeled detection agent that specifically binds to an additional binding site of the analyte in a non-competitive assay”. This is confusing because there is previous introduction of a “labeled detection agent” in claim 4 from which claim 10 depends. As such, it is unclear whether claim 10 is introducing a second, additional labeled detection agent, or whether it is further limiting the same labeled detection agent introduced in claim 4. Clarification is required.
The term “large oblique incidence angle” in claim 11 is a relative term which renders the claim indefinite. The term “large” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Because large is a relative term, one of ordinary skill in the art cannot recognize whether a particular oblique incidence angle reads on the limitation, because the metes and bounds of the limitation are unclear.
Claim 12 is rejected as indefinite over recitation of the apparatus comprising “a bright-field illumination” and a “fluorescent illumination”. These recitations are confusing because such “illuminations” are not physical structures or features, and it is unclear what actual structural features of the claimed apparatus are required by these limitations. Clarification is required.
The term “major” in claim 13 is a relative term which renders the claim indefinite. The term “major” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how much of a signal of an image must comprise signal from the labeled competitive detection agent in order for it to be considered “a major signal of the image” and thus the metes and bounds of the claim are unclear.
Dependent claims 3-5, 7-14 and 17 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
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, 3-5, 7-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, 35, 51, 55, 73, 83, 139 of U.S. Patent No. 12181472 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 7-8,The reference patent recites a device comprising:
a first plate, a second plate, a plurality of spacers, a plurality of particles, and a capture agent (claim 1), wherein:
the first and second plates are movable relative to each other into different configurations, including an open configuration and a closed configuration (claim 1);
each of the plates has, on its respective surface, a sample contact area for contacting a sample (claim 1);
an array of spacers with predetermined inter-spacer distance fixed on the first plate (claim 1-2)
the particles have a size equal to or less than the height of the spacers (claim 9) and are distributed in one of the sample contact areas (claim 1); and
a capture agent attached to the particles, wherein the capture agent binds a non-cell analyte (claim 1);
wherein in the open configuration, the two plates are separated apart, and the sample is deposited on one or both plates (claim 1);
wherein in the closed configuration, which is configured after a sample is deposited in the open configuration, a relevant sample volume is compressed by the two plates into a layer of uniform thickness regulated by the plates and the spacers (claim 1);
wherein the capture agent binds specifically to a non-cell analyte (claims 73).
Although the reference patent does not specifically recite the height of the spacers and the geometry of the particles are configured to make, in the closed configuration, no significant overlap between one or more target cells, between the particles, and between the cells and the particles, this limitation is drawn to a functional limitation of the device to eliminate overlap between components. When a functional limitation is claimed, the prior art need only be capable of performing the recited functional limitation. In the instant case, the sample, and by extension the overlap of sample components, are not claimed as part of the device. The reference patent teaches the structural components of the device required by the instant claims and is therefore considered of be capable of performing the recited function.
Regarding instant claim 3, the reference patent recites an apparatus comprising the device of claim 1; an imager that takes an image of the sample volume (claims 33 and 35) and a processor configured to process the image (claim 35).
Regarding instant claim 4, the reference patent teaches the device of claim 1 and a labeled detection agent (claim 83) wherein the detection agent binds specifically to the non-cell analyte (claim 83).
Regarding instant claim 5, the reference patent teaches the device wherein the particles have a diameter between 0.2um and 100um (claims 1, 9).
Regarding instant claim 9, the reference patent teaches a labeled competitive detection agent for competing with the analyte, if present, for binding to the capture agent for the analyte in a competitive assay (claim 55).
Regarding instant claim 10, the reference patent teaches a labeled detection agent that specifically binds to an additional binding site of the analyte in a non-competitive assay, wherein the additional binding site is the binding site different from the binding site by the capture agent (claim 54)
Regarding instant claim 11, the reference patent teaches the apparatus further comprising fluorescent illumination optics (claim 139).
Regarding instant claim 12, the reference patent teaches the apparatus further comprising a bright field illumination and fluorescent illumination (claim 139).
Regarding instant claim 17, the reference patent teaches the device further comprising a labeled detection agent that is capable of binding the non-cell analyte (claim 51).
Claims 1, 4-5, 7-9, 11, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 17, 20-24, 30 of U.S. Patent No. 11,156,606. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 7-8,The reference patent recites a device comprising:
a first plate, a second plate, a plurality of spacers, a plurality of particles, and a capture agent (claims 13, 22), wherein:
the first and second plates are movable relative to each other into different configurations, including an open configuration and a closed configuration (claim 13);
each of the plates has, on its respective surface, a sample contact area for contacting a sample (claim 13, 30);
an array of spacers with predetermined inter-spacer distance fixed on the first plate (claims 20-22)
the particles have a size equal to or less than the height of the spacers and are distributed in one of the sample contact areas (claim 22); and
a capture agent attached to the particles, wherein the capture agent binds a non-cell analyte (claim 13);
wherein in the open configuration, the two plates are separated apart, and the sample is deposited on one or both plates (claim 13);
wherein in the closed configuration, which is configured after a sample is deposited in the open configuration, a relevant sample volume is compressed by the two plates into a layer of uniform thickness regulated by the plates and the spacers (claim 13);
wherein the capture agent binds specifically to a non-cell analyte (claims 13).
wherein the height of the spacers and the geometry of the particles are configured to make, in the closed configuration, no significant overlap between the particles and analyte (particles are the same height as the spacers, therefore no overlap can exist between particles or analyte (claim 23).
Although the reference patent does not specifically teach the particles distributed in the sample contact area, this limitation is drawn to a configuration in which the device must only be capable of being. The reference patent teaches particles that bind to the analyte and are in the common area of the sample area where the sample is deposited (claim 13) therefore the beads are considered capable of being distributed in the sample contact area in an open configuration. The reference patent does not specifically recite assaying a target cell and non-cell analyte in a sample. However, the sample is not claimed as part of the device. Therefore, the device of the reference patent must only be capable of assaying a target cell and non-cell analyte in a sample. The reference patent recites an analyte may be cells or non-cell analyte (claim 30) and therefore is considered capable of receiving a sample where a target cell and non-cell analyte are assayed.
Regarding instant claim 4, the reference patent teaches the device of claim 1 and a labeled detection agent (claim 13) wherein the detection agent binds specifically to the non-cell analyte (claim 13).
Regarding instant claim 5, the reference patent teaches the device wherein the particles have a diameter between 0.2um and 100um (claim 20).
Regarding instant claim 9, the reference patent teaches a labeled competitive detection agent for competing with the analyte, if present, for binding to the capture agent for the analyte in a competitive assay (claim 13).
Regarding instant claim 11, the reference patent teaches the apparatus further comprising fluorescent illumination optics (claim 17, 24).
Regarding instant claim 17, the reference patent teaches the device further comprising a labeled detection agent that is capable of binding the non-cell analyte (claim 13).
Claims 1, 5, 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims, 1-2, 14-15 21, 27-30 of U.S. Patent No. 11709162 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 7-8, the reference patent recites a device for assay comprising:
a first plate, a second plate, a plurality of spacers, a plurality of particles, and a capture agent (claims 1-2), wherein:
the first and second plates are movable relative to each other into different configurations, including an open configuration and a closed configuration (claims 1-2);
each of the plates has, on its respective surface, a sample contact area for contacting a sample (claim 1-2. 30);
an array of spacers with predetermined inter-spacer distance fixed on the first plate (claims 21, 27-29)
the particles have a size equal to or less than the height of the spacers and are distributed in one of the sample contact areas (claims 1-2, 21); and
a capture agent attached to the particles, wherein the capture agent binds a non-cell analyte (claim 1-2, 18);
wherein in the open configuration, the two plates are separated apart, and the sample is deposited on one or both plates (claim 1-2);
wherein in the closed configuration, which is configured after a sample is deposited in the open configuration, a relevant sample volume is compressed by the two plates into a layer of uniform thickness regulated by the plates and the spacers (claim 1-2);
Although the reference patent does not specifically recite the height of the spacers and the geometry of the particles are configured to make, in the closed configuration, no significant overlap between one or more target cells, between the particles, and between the cells and the particles, this limitation is drawn to a functional limitation of the device to eliminate overlap between sample components. When a functional limitation is claimed, the prior art need only be capable of performing the recited function. In the instant case, the sample, and by extension the overlap of sample components, are not claimed as part of the device. The reference patent teaches the structural components of the device required by the instant claims and is therefore considered capable of providing no overlap in a closed configuration.
Although the reference patent does not specifically teach the particles distributed in the sample contact area, this limitation is drawn to a configuration in which the device must only be capable of being. The reference patent teaches particles that bind to the analyte and are in the common area of the sample area where the sample is deposited (claim 1) therefore the beads are considered capable of being distributed in the sample contact area in an open configuration. The reference patent does not specifically recite assaying a target cell and non-cell analyte in a sample. However, the sample is not claimed as part of the device. Therefore, the device of the reference patent must only be capable of assaying a target cell and non-cell analyte in a sample.
Regarding instant claim 5, the reference patent teaches the device wherein the particles have a diameter between 0.2um and 100um (claims 14-15).
Claims 1, 3-5, 7-14, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-8, 18, 35-38, 85-87 of U.S. Patent No. 11940443 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 7-8, the reference patent teaches a device for assaying a target cell and a non-cell analyte in a liquid sample (claim 1-3) comprising:
a first plate, a second plate, a plurality of spacers, a plurality of particles, and a capture agent (claim 1-3) wherein:
the first and second plates a movable relative to each other into different configurations including an open configuration and a closed configuration (claim 1-3);
each of the plates has a sample contact area for contacting a sample (claim 1-3);
each spacer has a predetermined inter spacer distance and is fixed on the first plate (claim 1-3);
the particles are equal to or less than the height of the spacers and are distributed in one of the sample contact areas (claim 1-3);
the capture agent is attached to the particles, wherein the capture agent binds the non-cell analyte (claims 1-3);
wherein in the open configuration, the two plates are separated and the sample is deposited on one or both plate (claims 1-3);
wherein in the closed configuration, a relevant sample volume is compressed by the first and second plates into a layer having a thickness and is substantially stagnant relative to the first and second plates, and the thickness of the layer is confined by the first and second plates and is regulated by the plates and the spacers (claims 1-3);
wherein the relevant sample volume is a portion of the sample containing or suspected of containing the non-cell analyte and the target cells to be analyzed (claims 1-3);
wherein the height of the spacers and the geometry of the particles are configured to make, in the closed configuration, no significant overlaps between the one or more target cells, between the particles, and between target cells and particles (claims 1-3).
Regarding instant claim 3, the reference patent recites an apparatus comprising the device of claim 1; an imager that takes an image of the sample volume and a processor configured to process the image (claims 3, 7-8).
Regarding instant claim 4, the reference patent teaches the device of claim 1 and a labeled detection agent wherein the detection agent binds specifically to the non-cell analyte (claim 35-36).
Regarding instant claim 5, the reference patent teaches the device wherein the particles have a diameter between 0.2um and 100um (claims 1-3).
Regarding instant claim 9, the reference patent teaches a labeled competitive detection agent for competing with the analyte, if present, for binding to the capture agent for the analyte in a competitive assay (claim 2, 4, 18, 36).
Regarding instant claim 10, the reference patent teaches a labeled detection agent that specifically binds to an additional binding site of the analyte in a non-competitive assay, wherein the additional binding site is the binding site different from the binding site by the capture agent (claim 37)
Regarding instant claim 11, the reference patent teaches the apparatus further comprising fluorescent illumination optics (claim 85).
Regarding instant claim 12, the reference patent teaches the apparatus further comprising a bright field illumination and fluorescent illumination (claim 85-86).
Regarding instant claim 13, the reference patent teaches the apparatus wherein one of the images is a direct image (claim 38, 87)
Regarding instant claim 14, the reference patent teaches the device further comprising a non-transitory computer readable medium that stores a ML algorithm for analyzing the one or more images (claim 7, 88)
Regarding instant claim 17, the reference patent teaches the device further comprising a labeled detection agent that is capable of binding the non-cell analyte (claim 2, 4, 18, 36-37),
Subject Matter Free of Prior Art
Claims 1, 3-5, 7-14, and 17 are rejected as described above, but appear to be free of the prior art.
The closest prior art is Lue et al (US 2012/0108787 A1; IDS entered).
Lue teaches first and second plates movable relative to each other, each of the plates having a sample contact area; spacers comprising an array of pillars with predetermined interspacer distance and uniform height disposed on the first plate; and a capture agent attached to the first plate. Lue fails to teach the device comprising particles as claimed in the instant claim. (Figs. 1-6 and 12; Par. 23: immobilizing molecules attached to at least a portion of a surface of a substrate structure, wherein spacer structures are affixed to the substrate).
Watanabe et al (US 2006/0246508 A1) teaches a device comprising first and second plates movable relative to each other, each of the plates having a sample contact area; spacers comprising an array of pillars with predetermined interspacer distance fixed on the first plate; (Par. 37, 42; Fig. 7B). Watanabe teaches that the device may comprise a capture agent for detection of a non-cell analyte (Par. 37).
Watanabe differs from the instant claim in that it does not teach: the capture agent is attached to particles that are equal to or less than the height of the spacers and are distributed in the sample contact area; in the closed configuration, a sample volume is compressed by the first and second plates into a layer having a thickness that is regulated by the first and second plates and the spacers.
Conclusion
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
