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 the Claims
The amendment dated 10/03/2023 is acknowledged. Claims 1-20 are pending and under examination.
Information Disclosure Statement
There was no information disclosure statement (IDS) submitted at the time of this office action.
Drawings
The drawing filed on 10/03/2023 are acknowledged and accepted by the Examiner.
Claim Objections
Claims 19 and 20 are objected to for the following informalities:
Claims 19 and 20 recite “The method according to any one of claim 18”. The claims should recite “The method according to claim 18”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the use, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101.
The claims are directed to a use of a flavivirus protein microarray for distinguishing dengue patients with mild case from hospitalized case, wherein the hospitalized case comprises hospitalized non-severe case and hospitalized severe case; the flavivirus protein microarray comprises: a substrate including a plurality of protein array blocks on a surface of the substrate; and at least one protein immobilized on each of the plurality of protein array blocks, wherein the at least one protein comprises an amino acid sequence of SEQ ID NO: 1, an amino acid sequence of SEQ ID NO: 3, and an amino acid sequence of SEQ ID NO: 13, and wherein a serum IgM of the dengue patients against the amino acid sequence of SEQ ID NO: 1 is used to distinguish the dengue patients with mild case from the hospitalized non-severe case, a serum IgG of the dengue patients against the amino acid sequence of SEQ ID NO: 3 is used to distinguish the dengue patients with mild case from the hospitalized severe case, and the serum IgG of the dengue patients against the amino acid sequence of SEQ ID NO: 13 is used to distinguish the dengue patients with mild case from the hospitalized case.
Section 2173.05(q) of the MPEP states “Other decisions suggest that a more appropriate basis for this type of rejection is 35 U.S.C. 101. In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."; and “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
MPEP 2106.03: 35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these "four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful." In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). Id. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Supreme Court has described the second part of the test as the "search for an 'inventive concept'". Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
STEP 1: Claims 18-20 are drawn to a method for distinguishing dengue patients with mild case from hospitalized non-severe case and hospitalized severe case, which is one of the four statutory categories of invention (MPEP § 2106, subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? (Step 1: YES).
STEP 2A: MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
Regarding claims 18-20, (MPEP § 2106, subsection III, Step 2A Prong One of the eligibility analysis asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Step 2A, Prong One: YES).
Regarding claims 18-20, (MPEP § 2106, subsection III, Step 2A Prong Two of the eligibility analysis asks: Does the claim recite additional elements that integrate the judicial exception into a practical application? (Step 2A, Prong Two: NO). The claims are limited to the appreciation of the natural correlation between the detection of amino acid substrates and a subject' s serum immunoglobulin levels and data gathering steps required in order to apply the natural correlation; and do not recite any specific treatment or prophylaxis.
Claim 18 is directed to a method for distinguishing dengue patients with mild case from hospitalized non-severe case and hospitalized severe case, comprising the steps of: providing a flavivirus protein microarray of claim 1; providing a serum from one of the dengue patients with mild case, hospitalized non-severe case or hospitalized severe case and adding the serum to the flavivirus protein microarray for reaction; providing a fluorescently labeled anti-human immunoglobulin antibody and adding the fluorescently labeled anti-human immunoglobulin antibody to the flavivirus protein microarray for reaction; and reading an optical signal generated from the flavivirus protein microarray by a signal reader to quantify the fluorescently labeled anti-human immunoglobulin antibody; and distinguishing the dengue patients with mild case from the hospitalized non-severe case based upon the optical signal generated from the amino acid sequence of SEQ ID NO: 1, distinguishing the dengue patients with mild case from the hospitalized severe case based upon the optical signal generated from the amino acid sequence of SEQ ID NO: 3, and distinguishing the dengue patients with mild case from the hospitalized case based upon the optical signal generated from the amino acid sequence of SEQ ID NO: 13.
The claims read on methods comprising a product of a viral protein consisting of a naturally occurring virus (i.e. Dengue virus) in a subject being contacted by a ligand (e.g. antibody) specific to the viral protein. Further, the recitation of "reading an optical signal generated from the flavivirus protein microarray by a signal reader to quantify" the antibody is a natural principle. The method steps do not impose meaningful limits on the claim scope. The steps are drawn to performing an immunoassay of a Dengue virus sample and are not considered meaningful limits because it does not narrow the claim so that others are not substantially foreclosed from using the judicial exception. The instant claims are reciting this natural process accompanied by no more than an instruction to apply the natural process using well known and routine techniques (e.g., immunoassay) to carry out the natural process. The steps of making a correlation between the detection of amino acid substrates and a subject' s serum immunoglobulin levels are at a high level of generality, and are necessary data gathering steps required in order to apply the natural correlation. While it takes a human action to trigger a manifestation of the natural process, the natural process exists in principle apart from any human action. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 10, 132 S.Ct. 1289, 101 USPQ2d 1961 (2012). Specifically, the steps of performing immunoassay reading for a dengue virus protein does not add a feature that is more than well-understood, purely conventional or routine in the relevant field.
STEP 2B: MPEP § 2106, subsection III, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)).
Regarding claims 18-20, (MPEP § 2106, subsection III, Step 2B of the eligibility analysis asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? (Step 2B: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims recite methods that are making use of a natural correlation. Claims 18-20 are a recital of a natural correlation accompanied by additional steps that must be taken to apply the natural correlation (e.g., the step of taking a sample to test for a naturally occurring correlation). Adding steps to a natural biological process/natural correlation that only recite well-understood, routine, conventional activity previously engaged in by researchers in the field are not sufficient to render the claims patentable.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1-17 recites a use without any active, positive steps delineating how this use is actually practiced. A skilled artisan would not be apprised to the metes and bounds of the claims. Thus, the claim is rendered indefinite. Section 2173.05(q) of the MPEP states “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112, second paragraph. For example, a claim which read: "A process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon." was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986)”.
Claims 1-20 are rejected as being unclear as to what the use and method of the invention is ascertaining in the subjects. The preamble recites a use or a method for “distinguishing dengue patients with mild case from hospitalized non-sever case and hospitalized severe case” whereby a serum is provided from “one of the dengue patients with mild case, hospitalized non-sever case or hospitalized sever case” and adding the serum to the microarray. It is unclear as to what is to be determined since the object of the invention is to distinguish the different dengue cases but it appears that the claims recite the serums from the patients are known prior to the microarray (i.e. the serums from the subjects are known prior to the microarray that is to be used to distinguish the dengue types from the patients). Therefore, the claims are rendered indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1 and 2 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tangy et al. “Tangy” (WO2004076619) in view of Ciaramella et al. “Ciaramella” (WO2017/015463) and further in view of Beall et al. “Beall” (US PGPUB 2005/0053923). It is noted that the claims are “use” claims, thus, the office is applying BRI of the use of the SEQ ID NOs in the claims.
The claims are directed to a use of a flavivirus protein microarray for distinguishing dengue patients with mild case from hospitalized case, wherein the hospitalized case comprises hospitalized non-severe case and hospitalized severe case; the flavivirus protein microarray comprises: a substrate including a plurality of protein array blocks on a surface of the substrate; and at least one protein immobilized on each of the plurality of protein array blocks, wherein the at least one protein comprises an amino acid sequence of SEQ ID NO: 1, an amino acid sequence of SEQ ID NO: 3, and an amino acid sequence of SEQ ID NO: 13, and wherein a serum IgM of the dengue patients against the amino acid sequence of SEQ ID NO: 1 is used to distinguish the dengue patients with mild case from the hospitalized
non-severe case, a serum IgG of the dengue patients against the amino acid sequence of SEQ ID NO: 3 is used to distinguish the dengue patients with mild case from the hospitalized severe case, and the serum IgG of the dengue patients against the amino acid sequence of SEQ ID NO: 13 is used to distinguish the dengue patients with mild case from the hospitalized case.
Regarding claims 1-2, Tangy discloses “The present invention relates to West-Nile virus and/or Dengue virus derived polypeptides. More specifically, one object of the invention concerns a purified polypeptide wherein it derives from a West-Nile virus antigen or a Dengue virus antigen. Another object of the invention concerns a purified polyclonal or monoclonal antibody capable of specifically binding to a polypeptide of the invention. Another object of the invention concerns a purified polynucleotide sequence coding for the polypeptide of the invention and its use for detecting the presence or absence of a West-Nile virus antigen or a Dengue virus antigen in a biological sample” (page 3 lines 7-17, page 29 ELISA assay), claims 8 and 14 of Tangy). Tangy discloses SEQ ID NO:8 (100% sequence identity to SEQ ID NO: 1). Ciaramella discloses the use of dengue virus polypeptides and the detection of said polypeptides using human serum in detecting the presence or absence of said polypeptides (Example 21); and discloses SEQ ID NO: 162 (100% sequence identity to SEQ ID NO: 3) as well as ELISA assays for detection from serum (Figures 45-48 and 50-52). Beall discloses “a method and device for determining whether an animal is infected with West Nile Virus (WNV), or is either not infected or vaccinated with a WNV vaccine. The method includes contacting a biological sample from the subject with a first WNV polypeptide that is not an element of the WNV vaccine, and detecting whether antibodies in the sample bind to the WNV polypeptide. If the antibodies in the sample bind to the WNV polypeptide, it can be determined that the animal is naturally infected with WNV and if the antibodies do not bind to the polypeptide, it can be determined that the animal is either vaccinated or not infected” (Abstract); and discloses SEQ ID NO: 3 (Example 1), (100% sequence identity to SEQ ID NO: 13).
It would have been obvious to one of ordinary skill in the art to generate a flavivirus protein microarray for distinguishing dengue patients whereby a substrate including a plurality of protein array blocks on a surface of the substrate comprising at least one immobilized protein comprising SEQ ID NO: 1 as disclosed by Tangy, SEQ ID NO: 3 as disclosed by Ciaramella, and SEQ ID NO: 13 as disclosed by Beall as the proteins were already known in the prior art for the detection of dengue virus. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the advantage of optimizing the detection of dengue virus for having rapid identification as well as accurate, reliable determination of the presence and/or severity of dengue virus infection in a subject given the fact that Tangy, Ciaramella and Beall disclose the known proteins of the instant application’s claimed protein amino acid sequences SEQ ID NOs: 1, 3 and 13 and demonstrate the detection of said proteins using human serum in microarray assays comprising protein array blocks of a substrate and immobilized protein. Moreover, MPEP §2144.06(I) states “The courts have said: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.) See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)” (See MPEP §2144.06(I) – Combining Equivalents Known For The Same Purpose). In this case, applicants are combining flavivirus polypeptides, each individually known in the art for use as detection/differentiation of flaviviruses in an immunoassay. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 3, 6 and 7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tangy et al. “Tangy” (WO2004076619) in view of Ciaramella et al. “Ciaramella” (WO2017/015463), Beall et al. “Beall” (US PGPUB 2005/0053923) as applied to claim 1 above, and further in view of Hirao et al. “Hirao” (WO2020256639). The teachings of Tangy et al., Ciaramella et al. and Beall et al. are outlined above and incorporated herein.
Regarding claims 3, 6 and 7, Tangy, Ciaramella or Beall do not disclose SEQ ID NOs: 4 and 8.
Hirao, however, discloses protein aptamers that may be used to identify a dengue infection in a subject (Abstract) utilizing an ELISA (page 21 lines 12-15, page 25 lines 1-23). Hirao discloses SEQ ID NO: 8 (Table 8) (100% sequence identity to SEQ ID NO: 4); and SEQ ID NO: 10 (100% sequence identity to SEQ ID NO: 8).
It would have been obvious to one of ordinary skill in the art to generate a flavivirus protein microarray for distinguishing dengue patients whereby a substrate including a plurality of protein array blocks on a surface of the substrate comprising at least one immobilized protein comprising SEQ ID NO: 1 as disclosed by Tangy, SEQ ID NO: 3 as disclosed by Ciaramella, SEQ ID NO: 13 as disclosed by Beall, and SEQ ID NOs: 4 and 8 as disclosed by Hirao as the proteins were already known in the prior art for the detection of dengue virus. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the advantage of optimizing the detection of dengue virus for having rapid identification as well as accurate, reliable determination of the presence and/or severity of dengue virus infection in a subject given the fact that Tangy, Ciaramella, Beall and Hirao disclose the known proteins of the instant application’s claimed protein amino acid sequences SEQ ID NOs: 1, 3, 13, 4 and 8; and demonstrate the detection of said proteins using human serum in microarray assays comprising protein array blocks of a substrate and immobilized protein. Moreover, MPEP §2144.06(I) states “The courts have said: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.) See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)” (See MPEP §2144.06(I) – Combining Equivalents Known For The Same Purpose). In this case, applicants are combining flavivirus polypeptides, each individually known in the art for use as detection/differentiation of flaviviruses in an immunoassay. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 103(a) as being unpatentable over Tangy et al. “Tangy” (WO2004076619) in view of Ciaramella et al. “Ciaramella” (WO2017/015463), Beall et al. “Beall” (US PGPUB 2005/0053923) as applied to claim 1 above, and further in view of Faatz et al. “Faatz” (WO2018/197408). The teachings of Tangy et al., Ciaramella et al. and Beall et al. are outlined above and incorporated herein.
Regarding claim 4, Tangy, Ciaramella or Beall do not disclose SEQ ID NO: 16.
Faatz, however, discloses flavivirus ns1 polypeptides as it relates to zika virus (Abstract), whereby polypeptides are utilized in detection and differentiation of zika virus as well as dengue virus (Claim 7 of Faatz, SEQ ID NO: 6) (100% sequence identity to SEQ ID NO: 16). Faatz also discloses “Human serum samples negative for both Zika and Dengue IgG antibodies, human serum samples positive for Zika IgG antibodies and human serum samples positive for Dengue IgG antibodies were tested with both of the Zika NS1 recombinant antigens” (page 28 lines 11-17).
It would have been obvious to one of ordinary skill in the art to generate a flavivirus protein microarray for distinguishing dengue patients whereby a substrate including a plurality of protein array blocks on a surface of the substrate comprising at least one immobilized protein comprising SEQ ID NO: 1 as disclosed by Tangy, SEQ ID NO: 3 as disclosed by Ciaramella, SEQ ID NO: 13 as disclosed by Beall, and SEQ ID NO: 16 as disclosed by Faatz as the proteins were already known in the prior art for the detection of flaviviruses. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the advantage of optimizing the detection of dengue virus for having rapid identification as well as accurate, reliable determination of the presence and/or severity of dengue virus infection in a subject given the fact that Tangy, Ciaramella, Beall and Faatz disclose the known proteins of the instant application’s claimed protein amino acid sequences SEQ ID NOs: 1, 3, 13 and 16 and demonstrate the detection of said proteins using human serum in microarray assays comprising protein array blocks of a substrate and immobilized protein. Moreover, MPEP §2144.06(I) states “The courts have said: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.) See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)” (See MPEP §2144.06(I) – Combining Equivalents Known For The Same Purpose). In this case, applicants are combining flavivirus polypeptides, each individually known in the art for use as detection/differentiation of flaviviruses in an immunoassay. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 5 and 8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tangy et al. “Tangy” (WO2004076619) in view of Ciaramella et al. “Ciaramella” (WO2017/015463), Beall et al. “Beall” (US PGPUB 2005/0053923) as applied to claim 1 above, and further in view of Song et al. “Song” (WO2008/020293). The teachings of Tangy et al., Ciaramella et al. and Beall et al. are outlined above and incorporated herein.
Regarding claims 5 and 8, Ciaramella discloses SEQ ID NO: 19 (100% sequence identity to SEQ ID NO: 5) but Tangy, Ciaramella or Beall do not disclose SEQ ID NO: 12.
Song, however, discloses polypeptides comprising a fragment of the West Nile Virus E protein and polynucleotides encoding this protein and host cells transformed genetically to express the protein; and assays and diagnostic kits for the detection of West Nile Virus E protein antibody (Abstract). Song discloses SEQ ID NO: 1 (100% sequence identity to SEQ ID NO: 12) (claim 4 of Song).
It would have been obvious to one of ordinary skill in the art to generate a flavivirus protein microarray for distinguishing dengue patients whereby a substrate including a plurality of protein array blocks on a surface of the substrate comprising at least one immobilized protein comprising SEQ ID NO: 1 as disclosed by Tangy, SEQ ID NOs: 3 and 5 as disclosed by Ciaramella, SEQ ID NO: 13 as disclosed by Beall, and SEQ ID NO: 12 as disclosed by Song as the proteins were already known in the prior art for the detection of flaviviruses. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the advantage of optimizing the detection of dengue virus for having rapid identification as well as accurate, reliable determination of the presence and/or severity of dengue virus infection in a subject given the fact that Tangy, Ciaramella, Beall and Song disclose the known proteins of the instant application’s claimed protein amino acid sequences SEQ ID NOs: 1, 3, 5, 13 and 12 and demonstrate the detection of said proteins using human serum in microarray assays comprising protein array blocks of a substrate and immobilized protein. Moreover, MPEP §2144.06(I) states “The courts have said: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.) See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)” (See MPEP §2144.06(I) – Combining Equivalents Known For The Same Purpose). In this case, applicants are combining flavivirus polypeptides, each individually known in the art for use as detection/differentiation of flaviviruses in an immunoassay. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 9-11 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tangy et al. “Tangy” (WO2004076619) in view of Ciaramella et al. “Ciaramella” (WO2017/015463), Beall et al. “Beall” (US PGPUB 2005/0053923) and Song et al. “Song” (WO2008/020293) as applied to claims 1 and 8 above, and further in view of Hirao et al. “Hirao” (WO2020256639). The teachings of Tangy et al., Ciaramella et al., Beall et al. and Song et al. are outlined above and incorporated herein.
Regarding claims 9-11 and 16, Tangy discloses SEQ ID NO:8 (100% sequence identity to SEQ ID NO: 1), Ciaramella discloses SEQ ID NO: 162 (100% sequence identity to SEQ ID NO: 3); SEQ ID NO: 19 (100% sequence identity to SEQ ID NO: 5); Beall discloses SEQ ID NO: 3 (Example 1), (100% sequence identity to SEQ ID NO: 13); and Song discloses SEQ ID NO: 1 (100% sequence identity to SEQ ID NO: 12); and Hirao discloses SEQ ID NO: 8 (Table 8) (100% sequence identity to SEQ ID NO: 4), SEQ ID NO: 9 (100% sequence identity to SEQ ID NO: 6) as well as SEQ ID NO: 10 (100% sequence identity to SEQ ID NO: 8).
It would have been obvious to one of ordinary skill in the art to generate a flavivirus protein microarray for distinguishing dengue patients whereby a substrate including a plurality of protein array blocks on a surface of the substrate comprising at least one immobilized protein comprising SEQ ID NO: 1 as disclosed by Tangy, SEQ ID NOs: 3 and 5 as disclosed by Ciaramella, SEQ ID NO: 13 as disclosed by Beall, SEQ ID NO: 12 as disclosed by Song and SEQ ID NO: 4 as disclosed by Hirao as the proteins were already known in the prior art for the detection of flaviviruses. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the advantage of optimizing the detection of dengue virus for having rapid identification as well as accurate, reliable determination of the presence and/or severity of dengue virus infection in a subject given the fact that Tangy, Ciaramella, Beall, Song and Hirao disclose the known proteins of the instant application’s claimed protein amino acid sequences SEQ ID NOs: 1, 3-5 and 12-13; and demonstrate the detection of said proteins using human serum in microarray assays comprising protein array blocks of a substrate and immobilized protein. Moreover, MPEP §2144.06(I) states “The courts have said: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.) See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)” (See MPEP §2144.06(I) – Combining Equivalents Known For The Same Purpose). In this case, applicants are combining flavivirus polypeptides, each individually known in the art for use as detection/differentiation of flaviviruses in an immunoassay. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 12-15 and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tangy et al. “Tangy” (WO2004076619) in view of Ciaramella et al. “Ciaramella” (WO2017/015463), Beall et al. “Beall” (US PGPUB 2005/0053923), Song et al. “Song” (WO2008/020293) and Hirao et al. “Hirao” (WO2020256639) as applied to claim 1 above, and further in view of Barouch et al. “Barouch” (WO2017/214596) and Schrieber et al. “Shrieber” (EP2980099). The teachings of Tangy et al., Ciaramella et al., Beall et al., Song et al. and Hirao et al. are outlined above and incorporated herein.
Regarding claims 12-15 and 17, Tangy discloses SEQ ID NO:8 (100% sequence identity to SEQ ID NO: 1), Ciaramella discloses SEQ ID NO: 162 (100% sequence identity to SEQ ID NO: 3); SEQ ID NO: 19 (100% sequence identity to SEQ ID NO: 5); Beall discloses SEQ ID NO: 3 (Example 1), (100% sequence identity to SEQ ID NO: 13); and Song discloses SEQ ID NO: 1 (100% sequence identity to SEQ ID NO: 12); and Hirao discloses SEQ ID NO: 8 (Table 8) (100% sequence identity to SEQ ID NO: 4), SEQ ID NO: 7 (100% sequence identity to SEQ ID NO: 2) as well as and SEQ ID NO: 10 (100% sequence identity to SEQ ID NO: 8).
Tangy, Ciaramella, Beall, Song and Hirao do not disclose SEQ ID NOs: 10, 14 and 15.
Barouch, however, discloses compositions comprising zika virus proteins and polynucleotides encoding the flavivirus (Abstract). Barouch discloses SEQ ID NO: 12 (100% sequence identity to SEQ ID NO: 10); and Schrieber discloses polypeptides used for the detection of flavivirus infection in a subject comprising SEQ ID NO: 29 (100% sequence identity to SEQ ID NOs: 14 and 15).
It would have been obvious to one of ordinary skill in the art to generate a flavivirus protein microarray for distinguishing dengue patients whereby a substrate including a plurality of protein array blocks on a surface of the substrate comprising at least one immobilized protein comprising SEQ ID NO: 1 as disclosed by Tangy, SEQ ID NOs: 3 and 5 as disclosed by Ciaramella, SEQ ID NO: 13 as disclosed by Beall, SEQ ID NO: 12 as disclosed by Song, SEQ ID NOs: 2, 4 and 8 as disclosed by Hirao and SEQ ID NO: 10 as disclosed by Barouch as the proteins were already known in the prior art for the detection of flaviviruses. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success for the advantage of optimizing the detection of dengue virus for having rapid identification as well as accurate, reliable determination of the presence and/or severity of dengue virus infection in a subject given the fact that Tangy, Ciaramella, Beall, Song, Hirao, Barouch and Schrieber disclose the known proteins of the instant application’s claimed protein amino acid sequences SEQ ID NOs: 1-5, 8, 10 and 12-15; and demonstrate the detection of said proteins using human serum in microarray assays comprising protein array blocks of a substrate and immobilized protein. Moreover, MPEP §2144.06(I) states “The courts have said: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.) See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious)” (See MPEP §2144.06(I) – Combining Equivalents Known For The Same Purpose). In this case, applicants are combining flavivirus polypeptides, each individually known in the art for use as detection/differentiation of flaviviruses in an immunoassay. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672