DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 21-37 are pending and have been examined.
Priority
This application, Serial No. 18/331,697 (PGPub: US2023/0324375) was filed 06/08/2023. This application is a CONTINUATION of 16/806,463 filed 03/02/2020 (now US Patent 11,709,161) which is a DIVISIONAL of 15/158,901 filed 05/19/2016 (now US Patent 10,620,196), which is a CONTINUATION of 12/971,968 filed 12/17/2010 (now abandoned), which claims benefit of Provisional Patent Application 61/287,637 filed 12/17/2009.
Information Disclosure Statements
The Information Disclosure Statement filed 08/09/2023 has been considered by the Examiner.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32 at line 2 recites “…wherein the said analyte…” and the claim should be corrected to remove either “the” or “said”.
Appropriate correction is required.
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 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.
Claim(s) 21-24, 27, 31-33 and 35-37 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Frengen (US 5,723,346).
Regarding claim 21, Frengen teaches throughout the publication a mixture, comprising: an analyte, a population of first particles, and a population of second particles capable of forming a multi-particle complex comprising a first particle of the population of first particles, a second particle of the population of second particles, and the analyte (column 3,
lines 56-67), wherein the mixture comprises analyte in free and bound form, and wherein the bound analyte is attached to or coating the first particles (see column 7, lines 5-40, labeled particle is equivalent to the first particle and the solid phase particle is equivalent to the second particle).
Regarding claim 22, Frengen teaches the mixture wherein the ratio of the average diameter of second particles to the average diameter of first particles is about 5:1 to about 50:1 (see col. 7, lines 10-20; first particle has a diameter of 0.10 microns and col. 8, lines 53-56
wherein the second particle has a diameter of 6.5 um).
Regarding claim 23, Frengen teaches the mixture wherein the first particles are colloidal nanoparticles that comprise gold and (ii) the bound analyte (Frengen, second solid support having affinity for said labeled ligand that has affinity for the analyte - column 8, lines 24-28; column 7, lines 6-20, colloidal gold label).
Regarding claim 24, Frengen teaches the mixture wherein the second particles (interpreted as the first solid support) comprise an antibody, antigen or polynucleotide (column 8, lines 1-8 and 21-23).
Regarding claim 27, Frengen teaches the mixture wherein the first particles comprise a first monoclonal antibody or a first polyclonal antibody recognizing a first epitope on the analyte, wherein the second particles comprise a second monoclonal antibody or a second polyclonal antibody recognizing a second epitope on the analyte, and wherein the first epitope does not overlap with the second epitope (see col. 8, line 47 – col. 9, line 64).
Regarding claim 31, Frengen teaches the mixture wherein free analyte disrupts formation of the multi- particle complex (column 7, lines 21-40).
Regarding claim 32, Frengen teaches the mixture wherein the first particle and the second particle each bind to the same analyte and wherein the analyte links the first particle to the second particle (column 4, lines 20-34).
Regarding claim 33, Frengen teaches the mixture wherein each of the first particle and second particle comprise a fluorescent label (column 7, lines 6-20).
Regarding claim 35, Frengen teaches the mixture wherein the first particle and the second particle are capable of forming the multi-particle complex by means of a direct binding interaction (column 3, lines 56-67).
Regarding claim 36, Frengen teaches the mixture wherein the first particle and the second particle are capable of forming the multi-particle complex by means of an indirect binding interaction (column 8, lines 9-13).
Regarding claim 37, Frengen teaches the mixture wherein the mixture is contained within a tube (column 9, lines 10-12).
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 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frengen (US 5,723,346), as applied to claim 21 above, and further in view of Bell (US 6,551,788).
Regarding claim 25, Frengen teaches the mixture as described above wherein the
second particles (interpreted as first solid support system with binding partner for the analyte)
comprise an antibody capable of recognizing an epitope of the analyte (Frengen, column 8,
lines 1-9) but fails to specifically teach that the second particles are latex, polystyrene,
polycarbonate, polyvinylidene fluoride (PVDF), or silica.
Bell teaches throughout the publication assaying a sample by incubating the sample
with two or more independently determinable classes of particles coated with an analyte-
specific binding partner (abstract). More specifically, Bell teaches that suitable materials for the
particles can include polymers and latex (column 7, lines 43-54).
It would have been prima facie obvious to one having ordinary skill in the art at the time
the invention was filed to modify particles of the first solid support system of Frengen
(interpreted as the claimed second particles) to include a particle such as latex as taught by Bell
because Frengen is generic with respect to the type of particles that can be incorporated into
the mixture and bound in the complex and one skilled in the art would be motivated to use the
appropriate particles type for detection of the desired analytes.
Claim 26 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frengen, as applied to claim 21 above, and further in view of Song et al. (2004/0043507).
Frengen has been discussed above but the reference fails to teach the analyte is canine heartworm, feline leukemia virus, canine parvovirus, C-reactive protein, Giardia lamblia, Ehrlichia antigen or antibody, Borrelia antigen or antibody, and cardiac marker antigens.
Song et al. teaches a sandwich assay detecting analytes such as a C-reactive protein (see paragraphs 0039 and 0137).
It would have been obvious to one of ordinary skill in the art to modify the method of
Frengen to detect analytes such as C-reactive proteins as taught by Song
et al. for the advantage that the assay can be used to detect different kinds of analytes.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frengen (US 5,723,346), as applied to claims 21 and 23 above, and further in view of Ryang (US 2004/0167257, Pub Date: 08/26/2004).
Regarding claim 28, Frengen teaches the mixture as described above wherein the labels can include fluorescent substances or metal based systems (column 7, lines 6-15). However, Frengen fails to teach that the first particles comprise a composite of any of: gold, silver, platinum, or copper.
Ryang teaches throughout the publication nanocomposite particles (abstract) and more specifically teaches composite particles of host meal sols and guest metals (paragraph 0006), wherein the guest metals can include gold, silver, platinum to name a few (paragraph 0047).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the mixture of Frengen, composite metal particles as taught by Ryang since Frengen is generic regarding the types of metal sol particles that can be used within the assay and one skilled in the art would be motivated to choose the appropriate particle based on the desired signals to analyze.
Claim 29 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frengen (US 5,723,346), as applied to claim 21 above, and further in view of Hargreaves (US 4,868,130).
Regarding claim 29, Frengen teaches the second particles are larger than the first
particle (see col. 7, lines 10-12; col. 8, lines 53-60). However, Frengen fails to teach the
second particles have a greater density than the first particles. Hargreaves teaches
unbound labels are separated from the bound label-analyte-magnetio particle complex
via a primary and secondary layer. The primary layer is a substance which is not
miscible with water and serves to separate bound from unbound label by allowing the
penetration of binding components without allowing the penetration of unbound label
(see col. 9, lines 18-26). Hargreaves also teaches the primary layer is DMP which has a
density of 1.013 (see col. 11, lines 25-28). Hargreaves teaches the magnetic particles
(equivalent to the second particle of the present invention ) which serve as the solid phase particles of 1 micron and having a density of 1.5 to 3.5 gm/mL (see col. 19, lines
14-20). Thus, for the unbound label (equivalent to the first particle of the present
invention) to stay on top of the primary layer and be separated from the bound label, the
density of the unbound label must be less than the density of the primary layer which is
less than 1.013. Therefore, Hargreaves teaches the density of the second particle is
greater than that of the first particle. Hargreaves teaches the labels can be particles
(see col. 20, line 59-col. 21, line 2).
It would also have been obvious to one of ordinary skill in the art to modify the
method of Frengen to use the second particle /solid phase particle having a greater
density than the first particle/label particle as taught by Hargreaves for the advantage
that solid phase particles having a greater density aid in the unbound/bound separation
because denser particles settle to the bottom faster than the unbound/less dense
particles and thus increase separation time. A skilled artisan would have had a
reasonable expectation of success in measuring either the bound or unbound fractions
or both to allow the calculation of the percentage of the analyte as taught by
Hargreaves.
Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frengen (US 5,723,346), as applied to claim 21 above.
Regarding claim 30, while Frengen does not explicitly teach that the first particles have an average diameter of about 5 nm to about 40 nm and wherein the second particles have an average diameter of about 400 nm to about 2000 nm, 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 30 are for any particular purpose or solve any stated problem, and the prior art teaches that particle type and size is important based on the desired assay and detectors to be used, 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 particle assay art.
Claim 34 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frengen (US 5,723,346), as applied to claim 21 above, and further in view of Yang et al. (US 2009/0156421, Pub Date: 06/18/2009).
Frengen teaches the method as described above but fails to specifically teach that the first particle comprises a donor chromophore and the second particle comprise an acceptor chromophore.
Yang et al. teaches throughout the publication assays for identifying and evaluating analytes (abstract). More specifically, Yang et al. teaches that fluorescent molecules such as donor and acceptor molecules can be used (paragraph 0025) such that at least two binding members contain a suitable combination of FRET acceptor and donor (paragraph 0027).
It would have been prima facie obvious to incorporate as the first and second particles in the mixture of Frengen, donor chromophore and acceptor chromophore as taught by Yang et al. because Frengen is generic regarding the fluorescent substances that can be used as labels (column 7, lines 6-13) and one skilled in the art would have been motivated to choose the appropriate label based on the desired reaction and detection signals.
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 21-26 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 1, 12 and 15 of U.S. Patent No. 11,709,161.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 21, Patent 161 recites a method for detecting the presence of an analyte in a sample, wherein the analyte in the sample is free analyte, comprising: mixing the sample with a population of first particles and a population of second particles to form a suspension, wherein the first particles comprise the analyte in bound form; and wherein the first particles and second particles are capable of forming multi-particle complexes, removing multi-particle complexes from the suspension, and detecting the presence of free first particles in the suspension after removal of the multi-particle complexes; wherein an increase in the amount of free first particles in the suspension relative to the amount of free first particles present in a negative control suspension is indicative of the presence of the analyte in the sample (see patent claim 1 and claim 3).
Additionally, patent claim 3 reads on instant claim 23, patent claim 4 reads on instant claim 25, patent claim 5 reads on instant claim 24, patent claim 10 reads on instant claim 30, patent claim 12 reads on instant claim 26, and patent claim 15 reads on instant claim 22.
Claims 21-27 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 9, 11 and 14 of U.S. Patent No. 10,620,196.
Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 21, Patent 196 recites a method of detecting an analyte in a sample comprising mixing a sample with a population of first particles and a population of second particles to form a suspension, wherein the first and second particles are different and capable of forming a multi-particle complex comprising the first particle, second particle, and the analyte, removing the multi-particle complexes from the suspension, and detecting the presence of free first particles in the suspension after removal of the multi-particle complexes, wherein a decrease of the free first particles in the suspension is indicative of the presence of the analyte in the sample (see patent claim 1).
Additionally, patent claim 2 reads on instant claim 24, patent claim 3 reads on instant claim 27, patent claim 4 reads on instant claim 23, patent claim 7 reads on instant claims 23 and 25, patent claim 9 reads on instant claim 30, patent claim 11 reads on instant claim 26, and patent claim 14 reads on instant claim 22.
Conclusion
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677