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 .
DETAILED ACTION
Status of Claims
Claims 91-97, 99-103, 105, 107-108, 127, 172, 197-198 and 200 are pending. Claims 93, 95, 172, 197-198 and 200 have been withdrawn as drawn to non-elected inventions. Claims 91-92, 94, 96-97, 99-103, 105, 107-108 and 127 have been examined.
Election/Restriction
Applicant’s election without traverse of Group I, claims 91-92, 94, 96-97, 99-103, 105, 107-108 and 127 in the reply filed on 03/02/2026 is acknowledged.
Priority
This application, Serial No. 17/965,199 (PGPub: US2023/0109130) was filed 10/13/2022. This application is a CONTINUATION of PCT/US2021/027347 filed 04/14/2021, which claims benefit of Provisional Patent Applications 63/010,625 filed 04/15/2020 and 63/010,613 filed 04/15/2020.
Information Disclosure Statements
The Information Disclosure Statements filed 12/23/2022, 01/26/2023, 11/22/2024, 02/18/2025, 08/05/2025, 08/26/2025 and 03/02/2026 have been considered by the Examiner.
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 103 is 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 103 is indefinite because it recites “the number of separate locations” and it is unclear what locations are being referenced as no locations/separate locations have been recited in any of the claims from which claim 103 depends.
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 91 and 108 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 8 of U.S. Patent No. 12,235,267.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 91, Patent 267 recites a method for determining a measure of the concentration of analyte molecules or particles in a fluid sample, comprising: (a) providing capture objects, wherein at least some of the capture objects are associated with at least one type of analyte molecule or particle from the fluid sample and at least some of the capture objects are not associated with the at least one type of analyte molecule or particle; (b) passing at least some of the capture objects by a detection system; (c) individually interrogating with the detection system the at least some of the capture objects during the passing; (d) determining, based at least in part on step (c), a measure indicative of the number or fraction of the capture objects passed by the detection system that are associated with the at least one type of analyte molecule or particle; and (e) determining a measure of the concentration of the at least one type of analyte molecule or particle in the fluid sample based at least in part on the measure indicative of the number or fraction of the capture objects passed by the detection system that are associated with the at least one type of analyte molecule or particle (patent claim 1), wherein at least some of capture objects have a binding surface having affinity for the at least one type of analyte molecule or particle (patent claim 2), wherein a statistically significant fraction of the capture objects provided are associated with the at least one type of analyte molecule or particle and a statistically significant fraction of the capture objects provided are not associated with the at least one type of analyte molecule or particle (patent claim 4), and wherein: step (d) comprises determining a measure indicative of the number of the capture objects passed by the detection system that are associated with the at least one type of analyte molecule or particle from the fluid sample, and step (e) comprises determining a measure of the concentration of the at least one type of analyte molecule or particle in the fluid sample based at least in part on the measure indicative of the number of the capture objects passed by the detection system that are associated with the at least one type of analyte molecule or particle (patent claim 8).
Additionally, patent claim 3 reads on instant claim 108.
Claims 91 and 127 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,725,032.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claims 91 and 127, Patent 032 recites a method for determining a measure of the concentration of a plurality of types of analyte molecules or particles, said plurality including at least a first type of analyte molecules or particles and a second type of analyte molecules or particles in a fluid sample, comprising: providing a plurality of a first type of capture objects and a plurality of a second type of capture objects, wherein the first type of capture objects are each associated with either at least one first type of analyte molecule or particle of the fluid sample or are free of any analyte molecules or particles of the fluid sample, and the second type of capture objects are each associated with either at least one second type of analyte molecule or particle of the fluid sample or are free of any analyte molecules or particles of the fluid sample; individually addressing at least a portion of the capture objects and determining the fraction of said first type of capture objects associated with at least first type of one analyte molecule or particle of the fluid sample and the fraction of said second type of capture objects associated with at least one second type of analyte molecule or particle of the fluid sample; determining a measure of the concentration of first type of analyte molecules or particles in the fluid sample based at least in part on the fraction of first type of capture objects subjected to the addressing step determined to be associated with at least one first type of analyte molecule or particle of the fluid sample; and
determining a measure of the concentration of second type of analyte molecules or particles in the fluid sample based at least in part on the fraction of second type of capture objects subjected to the addressing step determined to be associated with at least one second type of analyte molecule or particle of the fluid sample, wherein the first type of capture objects and/or the second type of capture objects comprise or are each contained within a liquid droplet that is immiscible within a fluid in which the droplet is suspended during at least the addressing step, and wherein the step of individually addressing at least a portion of the capture objects comprises flowing at least a portion of the first type of capture objects and/or second type of capture objects comprising or contained within liquid droplets through a flow channel such that the at least a portion of the first type of capture objects and/or second type of capture objects pass by a detection system (see patent claim 14).
Claims 91 and 127 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 9,482,662.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claims 91 and 127, Patent 662 recites a method for determining a measure of the concentration of a plurality of types of analyte molecules or particles, said plurality including at least a first type of analyte molecules or particles and a second type of analyte molecules and particles in a fluid sample, comprising: immobilizing a plurality of the first type of analyte molecules or particles and a plurality of a second type of analyte molecules and particles with respect to a plurality of first type of capture objects and a plurality of a second type of capture objects, respectively; spatially segregating at least a portion of the plurality of first type of capture objects and the plurality of second type of capture objects into a plurality of separate locations; addressing at least some of the plurality of locations and determining the number of locations containing a first type of capture object and the number of locations containing a second type of capture object; further determining the number of said locations containing a first type of capture object and a first type of analyte molecule or particle and the number of said locations containing a second type of capture object and a second type of analyte molecule or particle; determining a measure of the concentration of the first type of analyte molecules or particles in the fluid sample based at least in part on the ratio of the number of locations containing a first type of capture object and a first type of analyte molecule and particle, to the number of locations containing a first type of capture object; and determining a measure of the concentration of the second type of analyte molecules or particles in the fluid sample based at least in part on the ratio of the number of locations containing a second type of capture object and a second type of analyte molecule and particle, to the number of locations containing a second type of capture object (see patent claim 3).
Claims 91, 96 and 108 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 11 of U.S. Patent No. 8,415,171.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding claims 91 and 96, Patent 171 recites a method for determining a measure of the concentration of analyte molecules or particles in a fluid sample, comprising: exposing a plurality of capture objects, each including a binding surface having affinity for at least one type of analyte molecule or particle, to a solution containing or suspected of containing the at least one type of analyte molecules or particles, wherein at least some of the capture objects become associated with at least one analyte molecule or particle; spatially segregating at least a portion of the capture objects subjected to the exposing step into a plurality of locations; addressing at least some of the plurality of locations and determining a measure indicative of the percentage of said locations containing a capture object associated with at least one analyte molecule or particle, wherein the locations addressed are locations which contain at least one capture object; and based upon the percentage, either determining a measure of the concentration of analyte molecules or particles in the fluid sample based at least in part on the number of locations containing a capture object associated with at least one analyte molecule or particle, or determining a measure of the concentration of analyte molecules or particles in the fluid sample based at least in part on a measured intensity level of a signal of that is indicative of the presence of a plurality of analyte molecules or particles (see patent claim 1).
Additionally, patent claims 2 and 11 read on instant claim 108.
Claims 91, 96 and 108 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5 and 9 of U.S. Patent No. 8,236,574.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 91 and 96, Patent 574 recites a method for determining a measure of the concentration of analyte molecules or particles in a fluid sample, comprising: exposing a plurality of capture objects that each include a binding surface having affinity for at least one type of analyte molecule or particle, to a solution containing or suspected of containing the at least one type of analyte molecules or particles; immobilizing analyte molecules or particles with respect to the plurality of capture objects such that at least some of the capture objects associate with at least one analyte molecule or particle and a statistically significant fraction of the capture objects do not associate with any analyte molecule or particle; spatially segregating at least a portion of the capture objects subjected to the immobilizing step into a plurality of separate locations; addressing at least a portion of the plurality of locations subjected to the spatially segregating step and determining the number of said locations containing at least one analyte molecule or particle; and determining a measure of the concentration of analyte molecules or particles in the fluid sample based at least in part on the number of locations determined to contain at least one analyte molecule or particle (patent claim 1), wherein the percentage of capture objects which do not associated with any analyte molecules is at least about 20% of the total number of capture objects (patent claim 3), wherein in the addressing step, the number of said locations containing a capture object that includes a binding surface having affinity for at least one type of analyte molecule or particle not containing an analyte molecule or particle is determined (patent claim 4), and wherein the measure of the concentration of analyte molecule or particles in the fluid sample is based at least in part on the ratio of the number of locations addressed in the addressing step determined to contain a capture object that includes a binding surface having affinity for at least one type of analyte molecule or particle containing at least one analyte molecule or particle, to the total number of locations addressed in the addressing step determined to contain a capture object that includes a binding surface having affinity for at least one type of analyte molecule or particle (patent claim 5).
Additionally, patent claim 9 reads on instant claim 108.
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.
Claim(s) 91-92, 94, 96-97, 102-103, 105, 107-108 and 127 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duffy et al. (US 2018/0017552).
Regarding claim 91, Duffy teaches throughout the publication a method for determining a measure of the concentration of analyte molecules or particles in a fluid sample (paragraph 0008), comprising:
exposing capture objects, each having affinity for a particular type of analyte molecule or particle, to a solution containing or suspected of containing at least one type of analyte molecule or particle (paragraph 0009), wherein the number of capture objects exposed to the solution containing or suspected of containing the analyte molecules or particles is less than or equal to 50,000 (paragraph 0076);
immobilizing analyte molecules or particles of the particular type of analyte molecule or particle with respect to the capture objects such that at least some of the capture objects associate with at least one of the particular type of analyte molecule or particle from the fluid sample and a statistically significant fraction of the capture objects do not associate with any of the particular type of analyte molecule or particle from the fluid sample (paragraph 0009);
determining a measure indicative of the number or fraction of capture objects associated with at least one of the particular type of analyte molecule or particle from the fluid sample (paragraph 0009); and
determining a measure of the concentration of the particular type of analyte molecule or particle in the fluid sample based at least in part on the measure indicative of the number or fraction of capture objects determined to be associated with at least one of the particular type of analyte molecule or particle (paragraph 0009).
Regarding claim 92, Duffy teaches throughout the publication a method for determining a measure of the concentration of analyte molecules or particles in a fluid sample (paragraph 0008), comprising:
exposing capture objects, each having affinity for a particular type of analyte molecule or particle, to a solution containing or suspected of containing the at least one type of analyte molecules or particle (paragraph 0009), wherein the number of capture objects exposed to the solution containing or suspected of containing the analyte molecules or particles is less than or equal to 50,000 (paragraph 0076);
immobilizing analyte molecules or particles of the particular type of analyte molecule or particle with respect to the capture objects such that at least some of the capture objects associate with at least one of the particular type of analyte molecule or particle from the fluid sample (paragraph 0009);
determining a measure indicative of the number or fraction of capture objects associated with at least one of the particular type of analyte molecule or particle from the fluid sample (paragraph 0009); and
based upon the measure indicative of the number or fraction of capture objects associated with at least one of the particular type of analyte molecule or particle from the fluid sample, either determining a measure of the concentration of the particular type of analyte molecule or particle in the fluid sample based at least in part on the measure indicative of the number or fraction of capture objects determined to be associated with at least one of the particular type of analyte molecule or particle (paragraph 0009), or determining a measure of the concentration of the particular type of analyte molecule or particle in the fluid sample based at least in part on a measured intensity level of a signal that is indicative of the presence of a plurality of the particular type of analyte molecules or particles (paragraph 0059).
Regarding claim 94, Duffy teaches throughout the publication a method for determining a measure of the concentration of analyte molecules or particles in a fluid sample (paragraph 0008), comprising: exposing capture objects, each having affinity for a particular type of analyte molecule or particle, to a solution containing or suspected of containing at least one type of analyte molecule or particle, wherein the number of capture objects exposed to the solution containing or suspected of containing the analyte molecules or particles is less than or equal to 50,000; immobilizing analyte molecules or particles of the particular type of analyte molecule or particle with respect to the capture objects such that at least some of the capture objects associate with at least one of the particular type of analyte molecule or particle from the fluid sample, while a statistically significant fraction of the capture objects do not associate with any of the particular type of analyte molecule or particle from the fluid sample; immobilizing at least one binding ligand with respect to at least some of the particular type of analyte molecules or particles associated with a capture object; exposing the at least one immobilized binding ligand to a precursor labeling agent such that the precursor labeling agent is converted to a labeling agent that becomes immobilized with respect to the capture object to which the binding ligand is immobilized; determining a measure indicative of the number or fraction of capture objects comprising at least one immobilized labeling agent; and determining a measure of the concentration of the particular type of analyte molecule or particle in the fluid sample based at least in part on the measure indicative of the number or fraction of capture objects determined to comprise at least one immobilized labeling agent (see paragraphs 0010, 0071, 0076 and 0086-0088).
Regarding claim 96, Duffy teaches the method wherein the method further comprises: spatially segregating at least a portion of the capture objects subjected to the immobilizing step into a plurality of separate locations; addressing at least a portion of the plurality of locations subjected to the spatially segregating step to determine the measure indicative of the number or fraction of beads containing at least one of the particular type of analyte molecule or particle from the fluid sample (paragraph 0009).
Regarding claim 97, Duffy teaches the method wherein the method comprises spatially segregating at least 25% of the capture objects subjected to the immobilizing step into a plurality of separate locations (paragraph 0082).
Regarding claim 102, Duffy teaches the method wherein the number of capture objects exposed to the solution containing or suspected of containing the analyte molecules or particles greater than or equal to 100 (paragraph 0076).
Regarding claim 103, Duffy teaches the method wherein a ratio of the number of capture objects exposed to the solution containing or suspected of containing the analyte molecules or particles to the number of separate locations is less than or equal to 1:1 (paragraph 0082).
Regarding claim 105, Duffy teaches the method wherein the solution containing or suspected of containing at least one type of analyte molecule or particles has a volume of greater than or equal to 50 microliters (paragraph 0173).
Regarding claim 107, Duffy teaches the method wherein the capture objects include a binding surface having affinity for the particular type of analyte molecule or particle (paragraph 0009).
Regarding claim 108, Duffy teaches the method wherein the capture objects comprise beads (paragraph 0059).
Regarding claim 127, Duffy teaches the method wherein the capture objects are first capture objects and the particular type of analyte molecule or particle is a first type of analyte molecule or particle, and the method further comprises: exposing second capture objects, each including a binding surface having affinity for a second type of analyte molecule or particle, to the solution containing or suspected of containing at least one type of analyte molecule or particle, wherein the number of second capture objects exposed to the solution containing or suspected of containing the analyte molecules or particles is less than or equal to 50,000; immobilizing analyte molecules or particles of the second type of analyte molecule or particle with respect to the second capture objects such that at least some of the second capture objects associate with at least one of the second type of analyte molecule or particle from the fluid sample and a statistically significant fraction of the second capture objects do not associate with any of the second type of analyte molecule or particle from the fluid sample; determining a measure indicative of the number or fraction of capture objects associated with at least one of the second type of analyte molecule or particle from the fluid sample; and determining a measure of the concentration of the second type of analyte molecule or particle in the fluid sample based at least in part on the measure indicative of the number or fraction of capture objects determined to be associated at least one of the second type of analyte molecule or particle (paragraphs 0102-0103).
Claim Rejections - 35 USC § 103
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.
Claim(s) 99-101 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US 2018/0017552), as applied to claim 91 above.
Regarding claim 99, while Duffy does not specifically teach that the method is characterized by a level of detection for the particular type of analyte molecule or particle of less than or equal to 50 x 10-18 M, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 99 are for any particular purpose or solve any stated problem, and the prior art teaches that the methods and systems described allow for the detection and/or quantification of analyte molecules in a sample at a lower detection limit as compared to typical conventional technologies, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the immunoassay art.
Regarding claims 100-101, Duffy teaches that the number of capture objects can be as low as 10,000 (paragraph 0076). While Duffy does not explicitly teach that the number of capture objects can be less than or equal to 7,500, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claims 100-102 are for any particular purpose or solve any stated problem, and the prior art teaches that capture object quantity may be varied based on the desired number of analytes desired to be captured. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the immunoassay art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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