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 Claims
Claims 1 and 41 have been amended. Claims 1-48 are pending and have been examined.
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 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.
Claims 1-4, 8-9, 14-21, 41-44 and 46-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geddes (US 2010/0062545).
Regarding claims 1, 41 and 46-48, Geddes teaches throughout the publication a method of detecting a target analyte in a sample and analyte detection device (abstract) comprising:
(a) mixing the sample with a first detection conjugate and a second detection conjugate, wherein the first and second detection conjugates comprise composite metallic nanostructures (paragraphs 0010 and 0076) coupled to binding partners that are capable of specifically binding to the target analyte if present in the sample to form a complex between the first detection conjugate, the analyte, and the second detection conjugate (paragraphs 0023-0025);
(b) exposing the complex to a light source at a wavelength range within the ultraviolet-visible-infrared spectrum (paragraphs 0026 and 0127); and
(c) measuring an optical signal from the complex, wherein a change in the optical signal indicates the presence of the target analyte in the sample (paragraphs 0113 and 0120).
While Geddes does not specifically teach the preamble limitation of “localized surface plasmon resonance”, as stated in MPEP 2111.02: if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction and further, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention. Consequently, preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant. In the instance case, the preamble recites “localized surface plasmon resonance” but the body of the method and device claims do not put the localized surface plasmon resonance into any active structure or process step of the inventions.
Regarding claim 2, Geddes teaches the method wherein the optical signal is reflectance, an absorbance spectrum, scattering spectrum, or an emission spectrum (paragraphs 0009 and 0125).
Regarding claim 3, Geddes teaches the method wherein the change in the optical signal comprises a spectral peak wavelength shift and/or a total spectral wavelength shift (paragraphs 0102-0103).
Regarding claim 4, Geddes teaches the method wherein the total spectral wavelength shift is a difference spectrum (paragraph 0113, optical data from ligand/analyte compared to control system).
Regarding claims 8 and 42, Geddes teaches the method wherein step (a) is performed in a spectrophotometric cuvette (paragraph 0125).
Regarding claim 9, Geddes teaches the method wherein the composite metallic nanostructures comprise at least two metals selected from gold, platinum, copper, silver or silica (paragraphs 0020, 0076 and 0079).
Regarding claim 14, Geddes teaches the method wherein the composite metallic nanostructures have a geometry selected from spherical, rod-like triangular, elliptical, islands or colloidal nanoparticles (paragraphs 0020 and 0075).
Regarding claims 15-18, Geddes teaches the method wherein the binding partner is a biological macromolecule (paragraph 0081), wherein the biological macromolecule is selected from an antibody, amino acid, carbohydrate, protein, peptides, nucleic acids, etc. (paragraph 0074).
Regarding claims 19-20, Geddes teaches the method wherein the first detection conjugate and the second detection conjugate comprise binding partners that are antibodies (paragraph 0120), wherein the antibodies bind different epitopes on the target analyte (paragraph 0112).
Regarding claim 21, Geddes teaches the method wherein the target analyte is selected from a protein (paragraph 0114), amino acid or nucleotide sequence (see claim 2).
Regarding claims 43-44, Geddes teaches the device wherein the analyte detection device in an analytical rotor and contains one or more reaction chambers in which the first detection conjugate and the second detection conjugate is located (paragraph 0123, centrifuge tube within microcentrifuge).
Claim Rejections - 35 USC § 103
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 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 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.
Claims 5-7 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Geddes (US 2010/0062545), as applied to claims 1 and 7 above.
Regarding claims 5-7, although Geddes fails to specifically teach the method wherein the presence of nanogram, picogram or fentogram quantities of the target analyte is detected, 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 5-7 are for any particular purpose or solve any stated problem, and the prior art teaches that the use of metallic nanostructures increases the efficiency of detection and improves detection capabilities and absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the detectable analyte concentration disclosed by the prior art by normal optimization procedures known in the plasmonic detection art.
Regarding claims 10-13, although Geddes fails to specifically teach that each of the composite particles comprise a gold coating and a silver core or vice versa and that each of the nanostructures is an alloy of a first metal and a second metal, the reference teaches that the metallic material may include composite particles (paragraph 0076) and further that the homogeneity of the particles can be determined by the extensive publications on the optical properties of metallic particles and the effects of interface chemistry on the optical properties of colloids (paragraph 0079). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the composite metal particles of Geddes to include the claimed composite composition as it would have been no more than a matter of design choice determined by routine experimentation based on the optical properties of the metals.
Claims 22-25, 30-40 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Geddes (US 2010/0062545), as applied to claims 1 and 41 above, and further in view of Bohannon (US 2006/0246513).
Regarding claims 22-25 Geddes teaches the method wherein the target analyte detected can be any analyte or biospecies which can induce the approach of the metallic structures to cause interaction between the structures and aggregation for the sandwich assay (paragraph 0115). However, Geddes fails to explicitly teach that the target analyte is a pathogenic antigen or antibody to a pathogenic antigen.
Bohannon teaches throughout the publication an immunoassay for detecting a desired analyte through use of labeled colloidal gold particles (paragraph 0013). More specifically, Bohannon teaches that the target analyte can include proteins, peptides, antibodies, small molecules, metabolites, hormones, breakdown products, antigens, epitopes, nucleic acids, lipids, carbohydrates, sugars, cells, spores, viruses, bacteria, inorganic compounds, organic compounds, drugs, poisons, contaminants (paragraph 0042) as well as antibodies to HIV and antibodies to other infectious diseases (paragraph 0103).
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 method of Geddes, bacterial, viral and pathogenic target analytes as taught by Bohannon because Geddes is generic regarding the target analyte and one skilled in the art would have been motivated to choose the appropriate analyte based on the desired condition to be detected.
Regarding claims 30-31, while Geddes fails to teach that the mixing step occurs in the presence of a polymeric material, Bohannon teaches the method wherein the mixing step occurs in the presence of a polymeric material such as polyethylene glycol (paragraph 0225). It would have been desirable to include within the mixing step in the method of Geddes, a polymeric material as taught by Bohannon because it would have been desirable to incorporate a solution that efficiently moderates false positives and analyte specific reactivity of reagents (Bohannon, paragraph 0060).
Regarding claims 32-34, while Geddes fails to teach that the mixing step occurs in the presence of a polysaccharide, Bohannon teaches the method wherein the mixing step occurs in the presence of a polysaccharide such as maltodextrin (paragraph 0149). It would have been desirable to include within the mixing step in the method of Geddes, a polysaccharide such as maltodextrin as taught by Bohannon because it would have been desirable to incorporate a solution that provides stability of reagents since the polysaccharide solutions allow the reagents to be present in a dry state (Bohannon, paragraph 0149).
Regarding claims 35-36, although Geddes in view of Bohannon fail to teach that the final concentration of the maltodextrin in the reaction mixture is about 2% to about 20% wt/vol and more specifically 5% to about 10% wt/vol., 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 35-36 are for any particular purpose or solve any stated problem, and the prior art teaches that the use of a polysaccharide such as maltodextrin provides stability for the reagents, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the solution amount disclosed by the prior art by normal optimization procedures known in the assay art.
Regarding claims 37-39, while Geddes fails to teach that the mixing step occurs in the presence of a blocking agent such as BSA, Bohannon teaches the method wherein the mixing step occurs in the presence of a polymeric material such as polyethylene glycol (paragraphs 0213 and 0223-0225). It would have been desirable to include within the mixing step in the method of Geddes, a blocking agent as taught by Bohannon because it would have been desirable to incorporate a solution that efficiently moderates false positives by blocking excess binding sites (Bohannon, paragraph 0223).
Regarding claim 40, although Geddes in view of Bohannon fail to teach that the final concentration of bovine serum albumin in the reaction mixture is about 1% to about 5% wt/vol, 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 40 are for any particular purpose or solve any stated problem, and the prior art teaches that the use of a blocking agent such as BSA provides stability for the reagents and prevent false positives, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the solution amount disclosed by the prior art by normal optimization procedures known in the assay art.
Regarding claim 45, while Geddes does not specifically teach the device wherein the first and/or second detection conjugate is lyophilized, Bohannon teaches that the labeled agents can be freeze-dried (paragraph 0017). It would have been prima facie obvious to one having ordinary skill in the art to modify the device of Geddes to include freeze-dried conjugates as taught by Bohannon because it would have been desirable to preserve the conjugates within the device.
Claims 26-27 is rejected under 35 U.S.C. 103 as being unpatentable over Geddes (US 2010/0062545) in view of Bohannon (US 2006/0246513), as applied to claims 1, 22 and 25 above (hereinafter "Modified Geddes”), and further in view of Wu et al. (ACS Appl Mater. Interfaces 2014, 6, 16974-16981, hereinafter "Wu").
While Modified Geddes teaches the method as described above wherein the target analyte detected can be any analyte or biospecies which can induce the approach of the metallic structures to cause interaction between the structures and aggregation for the sandwich assay (Geddes, paragraph 0115). Modified Geddes fails to explicitly teach that the bacterial antigen is selected from Ehrlichia canis, Ehrlichia chafeensis, Ehrlichia ewingii, Borrelia burgdorferi, Anaplasma platys, Anaplasma phagocytophilum, Salmonella enterica, Bacillus anthracis, and Rickettsia rickettsii.
Wu teaches throughout the publication an ELISA assay for the detection of Salmonella enterica (STM, abstract and page 16975, section 2.3). 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 method of Modified Geddes, detection of STM as taught by Wu because Modified Geddes is generic regarding the target analyte and one skilled in the art would have been motivated to choose the appropriate analyte based on the desired condition to be detected.
Claims 28-29 is rejected under 35 U.S.C. 103 as being unpatentable over Geddes (US 2010/0062545) in view of Bohannon (US 2006/0246513), as applied to claims 1 and 22 above (hereinafter "Modified Geddes”), and further in view of Mehra et al. (US2010/0120057 Pub Date: 05/13/2010, hereinafter "Mehra", IDS).
While Modified Geddes teaches the method as described above wherein the target analyte detected can be any analyte or biospecies which can induce the approach of the metallic structures to cause interaction between the structures and aggregation for the sandwich assay (Geddes, paragraph 0115). Modified Geddes fails to explicitly teach that the pathogenic antigen is a fungal antigen or parasitic antigen selected from canine heartworm, Giardia lamblia, plasmodium falciparum, African trypanosomiasis, and Trypanosoma brucei.
Mehra teaches throughout the publication assays for detection of a target in a sample (abstract), and more specifically teaches that the analytes that can be detected can include canine heartworm (paragraph 0028 and see Figure 1). 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 method of Modified Geddes, detection of canine heartworm as taught by Mehra because Modified Geddes is generic regarding the target analyte and one skilled in the art would have been motivated to choose the appropriate analyte based on the desired condition to be detected.
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 1-5, 8-9, 12-16, 19-23, 25-28, 30-31, 35 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9,835,622.
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claim 1, Patent 622 recites a method of detecting a target analyte in a sample comprising: (a) mixing the sample with a first detection conjugate and a second detection conjugate in the presence of maltodextrin and bovine serum albumin, wherein the first and second detection conjugates comprise composite metallic nanostructures coupled to binding partners that are capable of specifically binding to the target analyte if present in the sample to form a complex between the first detection conjugate, the analyte, and the second detection conjugate; (b) exposing the complex to a light source at a wavelength range within the ultraviolet-visible-infrared spectrum; and (c) measuring an optical signal from the complex, wherein a change in the optical signal indicates the presence of the target analyte in the sample (see patent claim 1).
Additionally, patent claim 2 reads on instant claim 2, patent claim 3 reads on instant claim 3, patent claim 4 reads on instant claim 4, patent claim 5 reads on instant claim 5, patent claim 6 reads on instant claim 8, patent claim 7 reads on instant claim 9, patent claim 8 reads on instant claim 12, patent claim 9 reads on instant claim 12, patent claim 9 reads on instant claim 13, patent claim 10 reads on instant claim 14, patent claim 11 reads on instant claim 15, patent claim 12 reads on instant claim 16, patent claim 13 reads on instant claim 19, patent claim 14 reads on instant claim 20, patent claim 15 reads on instant claim 21, patent claim 16 reads on instant claim 22, patent claim 17 reads on instant claim 23, patent claim 18 reads on instant claim 25, patent claim 19 reads on instant claims 26-27, patent claim 20 reads on instant claim 28, patent claim 21 reads on instant claim 30, patent claim 22 reads on instant claim 31, patent claim 23 reads on instant claim 35, patent claim 24 reads on instant claim 40.
Claims 1-3, 8-9, 11, 14, 19-20, 22-23, 25, 30-33 and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-13 of U.S. Patent No. 10,429,383.
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claims 1, 30-31, 22-23 and 25, Patent 383 recites a method of detecting a target analyte in a sample comprising: (a) mixing the sample with a first detection conjugate and a second detection conjugate in the presence of a salt and polyethylene glycol, wherein the polyethylene glycol is present at a concentration of between about 0.1 mg/mL to about 200 mg/mL, wherein the first and second detection conjugates comprise composite metallic nanostructures coupled to binding partners that are capable of specifically binding to the target analyte if present in the sample to form a complex between the first detection conjugate, the analyte, and the second detection conjugate, wherein the target analyte is a pathogenic antigen or antibody to a pathogenic antigen, wherein the pathogenic antigen is a viral or bacterial antigen; (b) exposing the complex to a light source at a wavelength range within the ultraviolet-visible-infrared spectrum; and (c) measuring an optical signal from the complex, wherein a change in the optical signal indicates the presence of the target analyte in the sample (see patent claim 1).
Additionally, patent claim 2 reads on instant claim 2, patent claim 3 reads on instant claim 3, patent claim 4 reads on instant claim 8, patent claim 5 reads on instant claim 9, patent claim 6 reads on instant claim 11, patent claim 7 reads on instant claim 14, patent claim 8 reads on instant claims 19-20, patent claim 10 reads on instant claim 32, patent claim 11 reads on instant claim 33, patent claim 12 reads on instant claim 37,and patent claim 13 reads on instant claim 38.
Claims 1-5, 8, 11-12, 14-16, 19-23, 25-28, 30-31 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 24 of U.S. Patent No. 11,215,614.
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claims 1 and 11-12, Patent 614 recites a method of detecting a target analyte in a sample comprising: (a) mixing said sample with a first detection conjugate and a second detection conjugate, wherein each of said first and second detection conjugates comprises a metallic nanostructure coupled to a binding partner, wherein said metallic nanostructure comprises an alloy of gold and silver, and wherein said binding partner is capable of specifically binding to said target analyte to form a complex between said first detection conjugate, said analyte, and said second detection conjugate; (b) exposing the complex to a light source at a wavelength range within the ultraviolet-visible-infrared spectrum; and (c) measuring an optical signal from the complex, wherein a change in the optical signal indicates the presence of said target analyte in said sample (see patent claim 1).
Additionally, patent claim 2 reads on instant claim 2, patent claim 3 reads on instant claim 3, patent claim 4 reads on instant claim 4, patent claim 5 reads on instant claim 5, patent claim 6 reads on instant claim 8, patent claim 7 reads on instant claim 14, patent claim 8 reads on instant claim 15, patent claim 9 reads on instant claim 16, patent claim 10 reads on instant claim 19, patent claim 11 reads on instant claim 20, patent claim 12 reads on instant claim 21, patent claim 13 reads on instant claim 22, patent claim 14 reads on instant claim 23, patent claim 15 reads on instant claim 25, patent claim 16 reads on instant claim 27, patent claim 17 reads on instant claim 28 patent claim 18 reads on instant claim 30, patent claim 19 reads on instant claim 31 and patent claim 24 reads on instant claim 41.
Claims 1-5, 8, 11-12, 14-16, 19-23, 25, 27-28, 30-31 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 24 of U.S. Patent No. 11,614,447.
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claims 1, Patent 447 recites a method of detecting a target analyte in a sample comprising: (a) mixing said sample with a first detection conjugate and a second detection conjugate, wherein each of said first and second detection conjugates comprises a metallic nanostructure coupled to a binding partner, wherein said metallic nanostructure comprises a gold nanoparticle coated with a capping agent that includes 3-((3-cholamidopropyl) dimethylammino)-1-propanesulfonate (“CHAPS”), and wherein said binding partner is capable of specifically binding to said target analyte to form a complex between said first detection conjugate, said analyte, and said second detection conjugate; (b) exposing the complex to a light source at a wavelength range within the ultraviolet-visible-infrared spectrum; and (c) measuring an optical signal from the complex, wherein a change in the optical signal indicates the presence of said target analyte in said sample (see instant claim 1).
Additionally, patent claim 2 reads on instant claim 14, patent claim 3 reads on instant claims 11-12, patent claim 4 reads on instant claim 2, patent claim 5 reads on instant claim 3, patent claim 6 reads on instant claim 4, patent claim 7 reads on instant claim 5, patent claim 8 reads on instant claim 8, patent claim 9 reads on instant claim 15, patent claim 10 reads on instant claim 16, patent claim 11 reads on instant claim 19, patent claim 12 reads on instant claim 20, patent claim 13 reads on instant claim 20, patent claim 14 reads on instant claim 22, patent claim 15 reads on instant claim 23, patent claim 16 reads on instant claim 25, patent claim 17 reads on instant claim 27, patent claim 18 reads on instant claim 28, patent claim 19 reads on instant claim 30, patent claim 20 reads on instant claim 31, patent claim 24 reads on instant claim 40.
Response to Arguments
Applicant’s arguments in the response filed 11/04/2025 have been considered but are not found to be persuasive. Applicant argues that Geddes fails to teach the use of LSPR-based detection and the measurement of LSPR optical signals. These arguments are not persuasive because as described above, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02). Neither the method or the device claims provide limitations that actively utilize the local surface plasmon resonance. For example, the method claim broadly claims measuring an optical signal while the device claims are only focused on the detection conjugates and provides no structural limitations related to LSPR. As such, the instant preamble states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations.
Applicant also briefly argues that Geddes fails to teach composite metallic nanostructures but this argument is not persuasive because Geddes specifically teaches at paragraph 0076 that the metallic material may include metal colloid particles and/or metal-silica composite particles. Therefore, Geddes clearly teaches that composite metallic nanostructures can be used in the invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677