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
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.
Status of the claims
Claims 8-27 are pending and examined on merits in this office.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 is directed to a sample comprising: element-tagged analyte comprising analyte bound to element-tagged affinity reagent, wherein the element-tagged affinity reagent comprises an affinity reagent for binding to the analyte and a metal-binding moiety bound to one or more metal elements; and a stabilizing solution having a total dissolved solids at or below approximately 0.2%, wherein the stabilizing solution contains a salt. Claims 20-22 teaches that the salt is present in concentrations of at least 5 mM. Claim 9 teaches that the salt is a non-metallic salt and claim 12 teaches that the salt includes nitrogen.
The salt as claimed, encompass an inordinately a large number of ammonium-based salt not having any metal. The sample as claimed encompasses various types of various ammonium based non-metallic salts of various concentrations (5 mM to any upper concentration without any limit) in a stabilizing solution in combination of various affinity reagent having various types of metal binding moiety bound to various types of metals. The stabilizing solution as implied from claims 11, 14-16, also includes various distinct types of metals (claim 11 only excludes some atomic mass metal which clearly implied that claim 8 includes all atomic mass metals of various types). Thus, the stabilizing solution includes various types of metal and various ammonium-based non-metallic salt. As claimed, the non-metallic salt encompasses various ammonim-based non-metallic salt of ammonium citrate, ammonium oxalate, ammonium carbonate, ammonium bifluoride, ammonium chloride, ammonium bromide, acetylcholine chloride and ephedrine hydrochloride. As claimed, and as implied from claims 9-12 and 14-17, the stabilizing solution comprises various types of metals with various mass unit (claim 11 only excludes some mass unit by the negative limitation) and the various ammonium-based non-metallic salt as described above.
Throughout the specification, the description and all the examples are very limited to non-metallic salt of ammonium nitrate in a stabilizing solution wherein the stabilizing solution is used with element-tagged affinity reagent having metal binding moiety bound to lanthanide metals. Specification merely mentioned that the salt can be ammonium-based molecule such as ammonium acetate, ammonium phosphate, ammonium formate, or other such salts (paragraph [0079]). However, throughout the specification other salts (as described above) have not been clearly described in the specification at a concentration of 5mM and above (without any limit) and in combination with various affinity reagents that represent the broad genus of various ammonium-based non-metallic salt. Even for ammonium phosphate and ammonium formate, the specification does not have any disclosure with any affinity reagent or any disclosure that provides the property of reducing signal drop and deposition of the salt on an injector. Salt so ammonium base molecules, the salts encompass a large number of non-metallic salts having various structures, functions and properties. As for example, ammonium based non-metallic salts may include salt so ammonium fluoride, ammonium bifluoride, ammonium oxalate, ammonium bicarbonate, ammonium dichromate, ammonium chloride, ephedrine hydrochloride, ammonium persulfate, ammonium thiocyanate, tetrabutyl ammonium hydroxide, tetrabutyl ammonium fluoride, tetrakis(decyl) ammonium bromide, acetylcholine chloride salt and so no. Specification does not have any clear descriptive support and representation of various stabilizing solution having the various ammonium-based salts as described above with the various types of metals as encompassed and as implied by the negative limitation of claim 11. Specification does not have any descriptive or representative support for various concentrations (5 mM and up) of the various salts with various types of metals for stabilizing solutions in combination with various element-tagged affinity reagents having metal binding moiety bound to various types of metal elements including calcium, iron, gold, silver and others.
MPEP § 2163 further states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus:
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Emphasis added.
Therefore, by disclosing salts of ammonium acetate and ammonium nitrate with few specific element-tagged affinity reagents comprising an affinity reagent and a metal binding moiety bound to only lanthanide metal element, does not provide representative disclosure for various combination of various salts, metals and affinity reagents at various concentrations as encompassed by the scope of the claims.
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 of this title, 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 8-27 are rejected under 35 U.S.C. 103 as being unpatentable over Mavropoulos et al. (Cytometry 2017; Cited in IDS filed 07/12/2024, Cite # 28).
Regarding claims 8, 12-13, 25 and 27, Mavropoulos teaches detection of protein and mRNA in Jukat and KG-1a cells by mass cytometry (title). Mavropoulos teaches multiplex method for targeted RAN detection by combining mass cytometry and RNAscope platform which utilizes hybridization of RNA specific target probes followed by signal amplification achieved through a cascade of hybridization events, ending with the binding of amplifier-specific detector probes wherein the detector probes are tagged with isotopically pure metal atoms used for detection by mass cytometry (fig.4). Mavropoulos discloses various thiol terminated oligonunleotides conjugated to maleimide-functionalized metal-chelating polymer and different element-tagged antibodies (Table 1 and page 1202, 1st col.) with various metal tags (Table 1), which reads on the element-tagged reagent (affinity reagent and a metal binding moiety bound to one or more metal elements) as claimed in claim 1. Mavropoulos discloses CD45-154Sm antibody (page 1204, 2nd col.), which also reads on the element-tagged affinity reagent of claim 8. Mavropoulos teaches that prior to data acquisition, cells stained in suspension were filtered and diluted with 0.1X EQ four calibration beads in 0.01% ammonium nitrate (approximately 1.25 mM) for data normalization.
Therefore, in the method of detection of an analyte as described above by Mavropoulus, element-tagged analyte comprising analyte bound to element-tagged affinity reagent, wherein the element-tagged affinity reagent comprises an affinity reagent for binding to the analyte and a metal-binding moiety bound to one or more metal elements, and a stabilizing solution having a total dissolved solids at or below approximately 0.2% would be obvious to one of ordinary skilled in the art.
Regarding claims 9-13 and 17, as described above, Mavropoulus teaches ammonium nitrate and ammonium nitrate is considered a non-metallic salt and is devoid of carbon and ammonium nitrate possesses all the limitations as claimed in claims 9-14 absent showing otherwise by Applicant.
Regarding claims 15 and 16, Mavropoulos teaches ammonium nitrate and the property of vapor pressure of ammonium nitrate as disclosed in claims 15 and 16 would be inherently present in ammonium nitrate salt. Moreover, as discloses in Table 1 of the specification, the property would be obvious to ammonium nitrate salt.
Regarding claims 18 and 19, Mavropoulos discloses CD45-154Sm antibody and different element-tagged antibodies, which are bindable to surface of whole cells and the cells in 0.01% ammonium nitrate would be expected to induce sufficiently low osmotic pressure on membranes of whole cells as the salt is the same as that of instantly claimed in claim 8.
Regarding claim 21, Mavropoulus teaches 0.01% ammonium nitrate, which is about 1.25 mM and which is less than 25 mM.
Regarding claims 20 and 22, Mavropulus discloses cells suspended in about 1.25 mM ammonium nitrate but however, one of ordinary skilled in the art may consider various concentrated forms of ammonium nitrate for subjected to dilution before assay performance.
Regarding claims 23-24, pH of 0.1 M ammonium nitrate is 5.13 and Mavropoulos discloses ammonium nitrate of 0.01%, which is less than 0.1M and thus pH would be expected to be higher than 5 and would be expected to lie in between 5-9.
Regarding claim 26, Mavropoulos teaches detection of analyte using element tagged affinity reagent wherein the element-tagged affinity reagent comprises an affinity reagent for binding to the analyte and a metal-binding moiety bound to one or more meal element. Mavropoulos also teaches multiplex detection with two or more markers (abstract and page 1200) and thus utilizing different element-tagged affinity reagents that are distinguishable from the other would be obvious and within the purview of one of ordinary skilled in the art.
Claims 8-12, 17, 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 2017/0176422; Cited in IDS filed 07/12/2024, Cite # 13) in view of Easter et al (Analyst 2010; Cited in IDS filed 07/12/2024, Cite # 24).
In regards to claim 8, Sanders describes methods, devices, reagents and kits for detection of one or more target molecules that may be present in a test sample (Abstract). Sanders discloses a sample (a sample; abstract; paragraphs [0010], [0016]), comprising: element-tagged analyte comprising analyte bound to element-tagged affinity reagent (a tagged aptamer-target affinity complex having a tag comprises a chelated metal ion (element-tagged analyte) and a bound analyte; abstract; paragraphs [0010]-[0011], [0018], [0111], wherein the element-tagged affinity reagent (the tagged aptamer-target affinity complex; abstract; paragraphs [0010]-[0011], [0018] comprises an affinity reagent for binding to the analyte and a metal-binding moiety bound to one or more metal elements (the tagged aptamer-target affinity complex comprises an aptamer that have a specific affinity for a respective target molecule (an affinity reagent for binding to the analyte) and the tag comprising the metal ion which is coordinated with polyhistidine (a metal-binding moiety); abstract; paragraphs [0010]-[0011], [0018], [0111]; and a stabilizing solution, wherein the stabilizing solution contains a salt (a solution having a chaotropic salt (a stabilizing solution contains a salt) that disrupts aptamer/analyte interactions but supports aptamer/aptamer interactions (stabilizing) and DNA hybridization, resulting diminished background; abstract; paragraphs [0018], [0062], [0157]. Sanders teaches kit comprises, in packaged combination, at least one tagged aptamer and one or more solid supports, each including at least one capture agent. The kit may also include washing solutions such as buffered aqueous medium for sample dilution as well as array washing, sample preparation reagents, and so forth. In addition the kit may contain reagents suitable for performing the desired kinetic challenge during the analytical method. The relative amounts of the various reagents in the kits can be varied widely to provide for concentrations of the reagents that substantially optimize the reactions that need to occur during the assay and to further substantially optimize the sensitivity of the assay.
Sanders does not disclose the solution having a total dissolved solids at or below approximately 0.2%.
Easter discloses a solution having a total dissolved solids at or below approximately 0.2% (a solution with either 5 mM or 10 mM ammonium acetate is present, thus a total dissolved solids at or below approximately 0.2% as the Applicant discloses in paragraph [0011] a total dissolved solids at or below approximately 0.2%, wherein the stabilizing solution contains a salt present in concentrations of at least 5 mM, and in some cases. in paragraph (0010) the salt is present in the stabilizing solution in concentrations of at or less than 25 mM; page 4, third paragraph).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the composition, as previously disclosed by Sanders, in order to have provided wherein a salt is ammonium acetate, as previously disclosed by Easter, for the benefit of using a salt that is compatible with mass spectrometry and improves sample elution to yield better resolution (Easter; page 4, third paragraph). Since Sanders discloses the assay components in a kit, compiling various assay components as shown obvious in view of Sanders and Easter would be obvious to one of ordinary skilled in the art. It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the kit, as previously disclosed by Sanders, in order to have provided wherein a salt is ammonium acetate, as previously disclosed by Easter, for the benefit of using a salt that is compatible with mass spectrometry and improves sample elution to yield better resolution (Easter; page 4, third paragraph).
In regards to claims 9, 11-12 and 17, as described above, the combination of the references teaches ammonium acetate salt, which is non-metallic and includes nitrogen.
In regards to claims 9, 10 and 11, Sanders further discloses wherein the salt is devoid of carbon or a metal having an atomic mass unit greater than 80 (the solution comprising the chaotropic salt which is selected from sodium perchlorate = NaCIO4, sodium chloride= NaCl, lithium chloride= LiCI or magnesium chloride= MgCl2 (devoid of carbon): abstract; paragraphs (0018], [0062], [0157)).
In regards to claim 19, as described above, the combination of the references teach total dissolved solids at or below approximately 0.2%, which is sufficiently low to avoid lysis of the analyte.
In regards to claims 20-23, Sanders further discloses wherein the salt is present in the stabilizing solution in concentrations of at least 5 mM (the solution comprising the chaotropic salt such as 150 mM sodium chloride = NaCl).
In regards to claims 23-24, Sanders discloses wherein the stabilizing solution has a pH of between 5-9 (the solution having the chaolropic salt is at neutral = 7 pH; abstract; paragraphs [0018], [0062], [0157].
In regards to claim 25, Sanders discloses wherein the metal-binding moiety includes a polymer linked to the affinity reagent and comprising at least one metal-binding pendant group that comprises at least one metal atom (the tag comprising a polymer having a capture element linked to the aptamer (liked to the affinity reagent) the metal ion which is coordinated with polyhistidine (at least one metal-binding pendant group); abstract; paragraphs [0010]-(0011], [0018], [0109], [0111].
In regards to claim 26, Sanders teaches multiplexed assays for detection of plurality of target molecules (para [0016] and [0034]) and thus utilizing different element-tagged affinity reagents that are distinguishable from the other would be obvious and within the purview of one of ordinary skilled in the art.
In regards to claim 27, Sanders teaches affinity reagent comprising antibody (para [0118]).
Claims 8-17 and 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 2017/0176422) in view of Easter et al (Analyst 2010) as applied to claims 8-12 and 17-27 above and further in view of Oxley et al (Pyrotechnics 2010; Cited in IDS filed 7/12/2024, Cite # 29).
As described above, Sanders and Easter, in combination, disclose the sample-making kit of claims 12 and 14, but Sanders does not disclose wherein the salt is ammonium nitrate and having a vapor pressure of at least 3 pa.
Oxley discloses wherein a salt is ammonium nitrate (a nitrite salt is selected from ammonium nitrate= AN, urea nitrate= UN and guanidine nitrate= GN in a manner that it has a vapor pressure according to equation (8) which is identical to the Applicant's equation in paragraph (0073], thus the selected nitrite salt has a vapor pressure of at least 3 Pa at 100 degrees C; page 6, first paragraph and equation 8).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the kit, as previously disclosed by Sanders, in order to have provided wherein a salt is ammonium nitrate, as previously disclosed by Oxley, for the benefit of using nitrogen comprising nitrate salt what is known to be highly soluble, and a salt that has optimal vapor pressure for ionization (Oxley; abstract).
In regards to claims 15 and 16, as described above, the combination of the references teaches ammonium nitrate salt and the property of vapor pressure of ammonium nitrate as disclosed in claims 15 and 16 would be inherently present in ammonium nitrate salt. Moreover, as disclosed in Table 1 of the specification, the property would be obvious to ammonium nitrate salt.
Claims 18-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (US 2017/0176422) in view of Easter et al (Analyst 2010) as applied to claims 8-17 and 19-27 above and further in view of Rayman et al (Journal of Bacteriology 1975; Cited in IDS filed 07/12/2024, Cite # 31).
As described above, Sanders, Easter and 8-17 and 19-27, in combination, disclose the sample of claim 8, but Sanders does not disclose wherein the affinity reagent is bindable to surfaces of whole cells.
Rayman discloses wherein the affinity reagent is bindable to surfaces of whole cells (a peptide is bound to surfaces of intact cells; abstract; page 650, column 1, first paragraph; page 657, column 1, second paragraph; page 658, column 2, figure 7 and first paragraph).
It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the kit, as previously disclosed by Sanders, in order to have provided wherein the affinity reagent is bind able to surfaces of whole cells, as previously disclosed by Rayman, for the benefit of being able to use fully viable cells (Rayman; page 651, column 2, sixth paragraph).
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 8-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,013,391. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the sample composition of claims 8-17 would be obvious from the disclosed kit composition and method of claims 1-18 or US patent ‘391.
Claim 1 of US patent ‘391 discloses a sample-making kit, comprising element-tagged affinity reagent comprising an affinity reagent capable of specifically binding to an analyte and a metal-binding moiety bound to one or more metal elements; and a stabilizing solution having a total dissolved solids at or below approximately 0.2%, wherein the stabilizing solution has a pH of between 5-9 and comprises a salt, wherein: the salt is present in concentrations of 5 mM to 25 mM, the salt is ammonium nitrate, and the stabilizing solution prevents or reduces signal drop and deposition of the salt on an injector configured to convey a sample solution comprising the analyte, the element-tagged affinity reagent, and the stabilizing solution to an inductively coupled plasma. Claim 5 of the US patent discloses a method, comprising providing an element-tagged analyte, wherein the element-tagged analyte comprises a sample containing whole cells each bound to an element-tagged affinity reagent, wherein each of the element-tagged affinity reagents comprises an affinity reagent and a metal-binding moiety wherein the affinity reagent is bound to the whole cell and the metal binding moiety is bound to one or more metal elements; and mixing the element-tagged analyte with a stabilizing solution having a pH of between 5-9 and having a total dissolved solids at or below approximately 0.2%, wherein: the stabilizing solution comprises a salt, the salt is present in concentrations of 5 mM to 25 mM, the salt is ammonium nitrate, and the stabilizing solution prevents or reduces signal drop and deposition of the salt on an injector configured to convey a sample solution comprising the analyte, the element-tagged affinity reagent, and the stabilizing solution to an inductively coupled plasma.
Therefore, from the above disclosure, the element-tagged analyte bound to element-tagged affinity reagents and a stabilizing solution containing salt as claimed in claims 8-13, 18-19, 23-25 and 27 would be obvious to one of ordinary skilled in the art.
In regards to claims 14-16, claim 1 teaches ammonium nitrate and ammonium nitrate would be expected to have the property of vapor pressure as claimed. Moreover, claim 6 of US patent teaches passing the stabilizing solution through the injector heated to a temperature of at least 100C and at this temperature the salt would be expected to exhibit the claimed vapor pressure absent showing otherwise by applicant.
In regards to claim 17, claim 12 of the US patent teaches various salts including ammonium acetate salt.
In regards to claims 20-22, claim 10 of the US patent teaches salt at a concentration of 25 mM.
In regards to claim 26, the claims of US patent do not teach multiplexing, but however, teaches various metal elements (claim 13) and one of ordinary skilled in the art can easily envisage multiplexing for detection of multiple analytes utilizing different element tags specific for different analyte distinguishable form the other having different metals and different affinity molecules.
It is noted that in the parent application (Application # 16/383,241), the sample composition as claimed in claim 8, was not restricted out and thus are subjected to double patenting rejection.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
