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 1-28 are pending and examined on merits in this office action.
Claim Rejections - 35 USC § 102
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 1-18 and 23-26 are rejected under 35 U.S.C. 102(a1) as being anticipated by McQuiston et al. (US 20210389334A1).
In regard to claims 1-3, 9, and 11, McQuiston discloses method for detecting ubiquitin carboxyterminal hydrolase L 1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in a biological sample (blood, serum, plasma, cerebrospinal fluid) using a lateral flow assay. McQuiston discloses method for detecting ubiquitin carboxyterminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in a sample using a lateral flow assay (claims 62-64). McQuiston does not teach utilizing a device to read to read the amount of UCH-L1 or GFAP.
In regard to claims 4-5, and 12, McQuiston discloses that the method utilizes at least one GFAP-capture antibody, at least one labeled GFAP-detection antibody, at least one UCH-L 1-capture antibody and at least one UCH-L 1-detection antibody which also comprises a detectable label (claim 68).
In regard to claim 6-8 and 12-17, McQuiston teaches that the present disclosure provides methods for aiding in the diagnosis and evaluation of a subject to determine whether the subject has sustained a traumatic brain injury (TBI) by detecting or measuring a combination of the levels of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in samples taken at various time points within 48 hours after the subject has sustained or may have sustained an injury to the head (Abstract). McQuiston teaches that the disclosure relates to a method of aiding in the diagnosis of or determining whether a subject that has sustained or may have sustained an injury to the head has suffered a moderate, severe, or moderate to severe traumatic brain injury (TBI). The method comprises the steps of: (para [0007]) performing an assay on a sample obtained from a subject within about 48 hours after the actual or suspected injury to measure or detect a combination of a level of glial fibrillary acidic protein (GFAP) and a level of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) in the sample; and (para [0008]) (a) determining that the subject has not sustained a moderate, severe, or a moderate to severe TBI when the level of GFAP in the sample is less than a reference level of GFAP of about 105 pg/mL, and the level of UCH-L1 in the sample is less than a reference level of UCH-L1 of about 110 pg/mL; or (para [0009]) (b) determining that the subject has not sustained a moderate, severe, or a moderate to severe TBI when the level of GFAP in the sample is equal to a reference level of GFAP of from about 105 pg/mL to about 890 pg/mL and the level of UCH-L1 in the sample is equal to a reference level of UCH-L1 of from about 110 pg/mL to about 2000 pg/mL; or (para [0010]) (c) determining that the subject more likely than not has sustained a moderate, severe, or a moderate to severe TBI when the level of GFAP in the sample is greater than a reference level of GFAP of about 890 pg/mL, and the level of UCH-L1 in the sample is greater than a reference level of about 2000 pg/mL.
In regard to claims 10 and 18, McQuiston teaches that the method also include aiding in the determination of whether a human subject that has or may have sustained an injury to the head would benefit from and thus receive an imaging procedure, such as magnetic resonance imaging (MRI) or head computerized tomography (CT) scan, based on assessment of a combination of the levels of GFAP and UCH-L1 (para [0263]). McQuiston teaches method of aiding in the determination of or determining whether to perform a head magnetic resonance imaging (MRI) procedure on a human subject that has sustained or may have sustained an injury to the head. The method comprises the steps of: performing an assay on a sample obtained from the subject within about 48 hours after the actual or suspected injury to measure or detect a combination of a level of glial fibrillary acidic protein (GFAP) and a level of ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) in the sample; and (a) determining that the subject does not need an MRI procedure when the level of GFAP in the sample is less than a reference level of GFAP of about 15 pg/mL, and the level of UCH-L1 in the sample is less than a reference level of UCH-L1 of about 50 pg/mL; or (b) determining that the subject more likely than not does need an MRI procedure when the level of GFAP in the sample is equal to a reference level of GFAP of from about 15 pg/mL to about 1000 pg/mL, and the level of UCH-L1 in the sample is equal to a reference level of UCH-L1 of from about 50 pg/mL to about 2000 pg/mL; or (c) determining that the subject more likely than not does need an MRI procedure when the level of GFAP in the sample is greater than a reference level of GFAP of about 1000 pg/mL, and the level of UCH-L1 in the sample is greater than a reference level of UCH-L1 of about 2000 pg/mL (para [0090-0093]).
In regards to claims 23-36, McQuiston teaches the components in a kit for performing the method and the kit components are fully disclosed in paragraphs [0577]-[0589] of McQuiston.
Claims 1-9 and 11-17 are rejected under 35 U.S.C. 102(a1) as being anticipated by Kang et al. (EP 3916387A1).
In regard to claims 1-3, 9, 11 and 17, Kang discloses method for detecting traumatic brain injury marker GFAP in blood sample using lateral flow device comprising adsorption pad including a probe which is mixed to the marker when the traumatic brain injury marker moves from the sample pad to form a traumatic brain injury marker complex, and a porous film which fluid-communicates with the adsorption pad and capillary-migrates the traumatic brain injury marker complex from the adsorption pad to a detection line, in which the probe includes a capture antibody consisting of an antibody labeled with a specific binding material specifically binding to the traumatic brain injury marker and a detector antibody consisting of an antibody labeled with a fluorescent material having a relatively long emission lifetime of 1 microsecond or more, and a mixture of at least two different kinds-origin antibodies is used as the antibody labeled with the specific binding material or the fluorescent material (Abstract).
Regarding claims 4-5 and 12-13, the claim is dependent on claim 1 wherein claim 1 encompasses alternative detection (detection of either UCH-L1 or GFAP and claim 4 only describes what antibodies require for lateral flow detection of either of CHH-L1 or GFAP. The claim thus does not limit detection of both. Therefore, claim 4 is rejected based on the rejection of claim 1.
Regarding claims 6-8 and 14-16, Kang teaches method for diagnosing traumatic brain injury using lateral flow assay device (claim 9) and diagnosing patients with mild traumatic brain injury (description and background).
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 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over McQuiston et al. (US 20210389334A1) as described for claims 1-18 and 23-26 above and further in view of Anfossi et al (Biosensors 2019).
McQuiston has been described above disclosing lateral flow immunoassay for detection ubiquitin carboxyterminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in a biological sample (blood, serum, plasma, cerebrospinal fluid). McQuiston teaches detection antibody which also comprises a detectable label. McQuiston teaches detectable label include among others, fluorescent compounds and chemiluminescent compounds (para [0313] and [0314]). McQuiston however, does not disclose colloidal metal particles, as for example, gold or silver colloidal particles as detectable label for the lateral flow immunoassays as claimed in claims 19-22.
Anfossi teaches multiplexing utilizing lateral flow immunoassay (LFIA) for high-thoroughput point-of-need testing and lateral flow device (LED). Anfossi teaches that the use of various labels (e.g., enzymes, fluorophores, and nanoparticles) can be regarded as a viable alternative for xLFIA multiplexing. Indeed, the exploitation of labels providing distinguishable signals allows differentiating between various complexes that are formed at the same site (i.e., at a single test line). The by far most popular strategy for multiplexing LFIAs is the design of several test lines or dots on an immunochromatographic strip using gold nanoparticles (GNP), quantum dots, colored/fluorescence microspheres as labels (page 5).
Therefore, given the fact that nanoparticles including colloidal particles such a gold particles are viable alternative to other fluorescent compounds as label for lateral flow immunoassays, it would be obvious to one of ordinary skilled in the art to easily envisage considering colloidal gold particles for the lateral flow immunoassay of McQuiston for expanding the arsenal of detectable label in the LFIA method of McQuiston with a reasonable expectation of success.
Regarding detection time as claimed in claims 27 and 28, Anfossi teaches that precise results are obtained in a reasonable time (conclusion) and also teaches detection within minutes (page 9, 2nd para).
Therefore, since the basic concept of utilizing LIFA with gold particles has been found to be obvious and since Anfossi teaches detection within minutes, various detection times as claimed in claims 27 and 28 would be obvious to one of ordinary skilled in the art.
Claims 1-9, 11-17, 19-22 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (EP 3916387A1) as described for claims 1-9 and 11-17 above and further in view of Anfossi et al (Biosensors 2019).
Kang has been described above disclosing lateral flow immunoassay for detection of glial fibrillary acidic protein (GFAP) in a biological sample (blood, serum, plasma, cerebrospinal fluid). Kang teaches detection antibody which also comprises a detectable label. Kang teaches detectable label include fluorescent material (page 2. , line 15 of col.2). Kang however, does not disclose colloidal metal particles, as for example, gold or silver colloidal particles as detectable label for the lateral flow immunoassays as claimed in claims 19-22.
Anfossi teaches multiplexing utilizing lateral flow immunoassay (LFIA) for high-thoroughput point-of-need testing and lateral flow device (LED). Anfossi teaches that the use of various labels (e.g., enzymes, fluorophores, and nanoparticles) can be regarded as a viable alternative for xLFIA multiplexing. Indeed, the exploitation of labels providing distinguishable signals allows differentiating between various complexes that are formed at the same site (i.e., at a single test line). The by far most popular strategy for multiplexing LFIAs is the design of several test lines or dots on an immunochromatographic strip using gold nanoparticles (GNP), quantum dots, colored/fluorescence microspheres as labels (page 5).
Therefore, given the fact that nanoparticles including colloidal particles such a gold particles are viable alternative to other fluorescent compounds as label for lateral flow immunoassays, it would be obvious to one of ordinary skilled in the art to easily envisage considering colloidal gold particles for the lateral flow immunoassay of Kang for expanding the arsenal of detectable label in the LFIA method of McQuiston with a reasonable expectation of success.
Regarding detection time as claimed in claims 27 and 28, Anfossi teaches that precise results are obtained in a reasonable time (conclusion) and also teaches detection within minutes (page 9, 2nd para). Therefore, since the basic concept of utilizing LIFA with gold particles has been found to be obvious and since Anfossi teaches detection within minutes, various detection times as claimed in claims 27 and 28 would be obvious to one of ordinary skilled in the art.
Claims 1-18 and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Natarajan et al. (US 20210389334A1) in view of Mondello et al (Scientific report, 2016).
In regard to claims 1-3, 9, 11 and 17, Natarajan teaches time-resolved fluorescent lateral flow immunoassay (See Fig.1 disclosing lateral flow test strip) utilizing anti-GFAP antibody for quantitative detection of brain injury biomarker (Title). Natarajan teaches that glial fibrillary acidic protein (GFAP) is a blood biomarker for traumatic brain injury (TBI), which is elevated in the case of TBI (Introduction). Natarajan teaches that GFAP is a glial cell injury biomarker, and is released from glial cells upon their being damaged and then appears in the blood and so GFAP can be detected in blood samples shortly after the damage (Introduction). Natarajan teaches that in the case of mild and moderate cases of TBI, GFAP levels have been found to be increased eight hours after the trauma and in addition, the concentration of GFAP in the blood has also been suggested to predict the outcome of the injury. Natarajan teaches that fluorescence lateral flow immunoassay is an ultrasensitive method to detect GFAP in blood sample (Abstract and Introduction) and GFAP is a potential tool in the diagnosis and treatment of brain injury (introduction). Natarajan teaches that this TRF-LFIA assay was found to be rapid, sensitive, and highly discriminating between normal controls and head injury patients. Furthermore, this assay showed good sensitivity and stability and was determined to be extremely suitable for rapid detection in early diagnosis, and to have great potential in clinical applications (page 194, 1st para of left col.).
Natarajan teaches the one test that measures GFAP (and UCH-L1) has been approved by the Food and Drug Administration for evaluating mild TBI (page 193, right col.). Natarajan however, does not disclose detecting UCH-L1 in combination with GFAP.
Mondello teaches that serum concentration of Ubiquitin C-terminal hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein after pediatric traumatic brain injury (Title). Mondella teaches that the results of the exploratory study point to a role of GFAP and UCH-L1 as candidate biomarkers for pediatric TBI. Mondello teaches that our data indicate that only UCH-L1 may function as a reliable biomarker for the detection of acute intracranial lesions as assessed by CT in pediatric TBI and furthermore, GFAP and UCH-L1 might be used to identify children at risk of poor outcome thereby providing theranostic use both in clinical care and research (page 6, 1st para).
Therefore, given the fact that UCH-L1 is also a potential biomarker for assessing brain injury (Mondello), it would be obvious to one of ordinary skilled in the art to easily envisage also including UCH-L1 biomarker in the method of Natarajan utilizing the LFIA method with the expectation of expanding the arsenal of brain injury biomarker for detection of traumatic brain injury with a reasonable expectation of success.
In regard to claims 4-5 and 12-13, Natarajan teaches LFIA utilizing anti-GFAP capturing antibody as detecting antibody (page 194, left col.) and capture antibody for binding to complex formed with GFAP antigen and also teaches detectable label, as for example, polystyrene-Eu microparticles (CM-EU) conjugated with antibody (page 194). Thus, different variations of antibody conjugates and capture antibody on the test strip would be obvious to one of ordinary skilled in the art.
In regard to claims 6-8 and 14-16, Natarajan teaches detection of GFAP biomarker in blood of patients with TBI for diagnosing severity of brain injury and Mondello teaches detection of both UCH-L1 and GFAP biomarkers for TBI and detection after TBI to assess severity. Thus, the detection of the biomarker provides aid in diagnosis of traumatic brain injury, assess severity and diagnose if the TBI is mild, moderate or severe.
In regards to claims 10 and 18, Natarajan teaches that a confirmatory report on moderate or severe TBI patient is performed with computed tomography (CT) and clinical CT often fails to detect mild TBI, which indicates for mild TBI, CT is not very useful. Natarajan teaches that detection of GFAP with LFIA can detect mild TBI and also detects moderate to severe TBI (Introduction). Thus, one of ordinary skilled in the art would readily understand the diagnosis with mild TBI by GFAP detection would not suggest CT but diagnosis of TBI of mild to severe by GFAP detection would suggest confirmatory determination by CT.
In regards to claims 23-26, Natarajan teaches development of GFAP LFIA kit (page 194, left col.) and teaches LFA for detection of GFAP can be utilized as diagnosis kit (page 196, see “Conclusion”). Therefore, since the basic concept of detection of GFAP and UCH-L1 has been found to be obvious in view of Natarajan and Mondello and since Natarajan teaches the LFA detection for diagnostic kit, it would be obvious to one of ordinary skilled in the art to easily envisage compiling the LFIA components in a kit for convenience with a reasonable expectation of success.
In regard to claims 27 and 28, Natarajan teaches that the assay test can be completed withing 25 minutes (page 196, left col.). Natarajan also teaches acquiring data after 15 minutes (Page 194, right col.) and one of ordinary skilled in the art in the field of LFIA would understand that with optimization, the completion time may be further reduced.
Claims 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over Natarajan et al. (US 20210389334A1) in view of Mondello et al (Scientific report, 2016) as described for claims 1-18 and 23-28 above and further in view of Lou et al (VIEW 2022).
Natarajan in view of Mondello has been described above making obviousness of Lateral flow immunoassay detection of UCH-L1 and GFAP as biomarkers for assesses traumatic brain injury.
Natarajan teaches utilizing europium chelate microparticle as label for time-resolved Lateral flow immunoassay. Natarajan however, does not teach Lateral flow immunoassay of the biomarkers utilizing gold nanoparticles as labels as claimed in claims 19-22.
In a review of lateral flow immunoassay for point-of-care testing, Lou teaches that gold nanomaterials are not only mature in color-based LFIA platform, but also have promising prospects in new devices. Gold nanomaterials can generate visible, SERS, and even photothermal signals (page 7). Lou teaches that gold nanoparticles (GNPs) are the most used nanomaterial for color-based LFIA. Lou teaches that GNPs have characteristic plasmonic absorption peaks in the visible region that shows slightly red shift with the increase of the size. Lou teaches that generally, GNPs with sizes between 20 and 40 nm are preferred since they easily generate clear rose red color after accumulating on the test zone, which can be observed with naked eyes or recorded by image readers for qualitative and quantitative detection, respectively.
Therefore, given the fact the gold particles are widely used and very useful in LFIA and given the fact that the test result can be observed with naked eyes without requiring device to read, it would be obvious to one of ordinary skilled in the art to easily envisage adopting LFIA with the use of gold nanoparticles as alternative detection process for the biomarkers with a reasonable expectation of success.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,849,548, claims 1-16 of U.S. Patent No. 10,877, 038, claims 1-22 of U.S. Patent No. 10,877,048, claims 1-19 of U.S. Patent No. 11,016,092, claims 1-36 of U.S. Patent No. 11,016,105 and claims 1-26 of U.S. Patent 11, 022,617, in view of Anfossi et al (Biosensors 2019).
The claims of the above patents disclose performing assays of at least one biomarker UCH-L1 and detecting and/or determining the amount of the biomarker in a sample which includes blood sample. The claims of the US patents do not teach that the assay is lateral flow immunoassay.
Anfossi teaches that although immunoanalytical techniques have well-established and prevailing advantages over alternative screening analytical platforms, one of the incoming challenges for immunoassay is exact multiplexing and Lateral flow immunoassay (LFIA) is a leading immunoanalytical technique for onsite analysis. Anfossi teaches that moreover, LFIA architecture is adaptable to multiplexing, and is therefore a possible answer to the pressing demand of multiplexing point-of-need analysis. Anfossi teaches multiplexing utilizing lateral flow immunoassay (LFIA) for high-thoroughput point-of-need testing and lateral flow device (LED). Anfossi teaches that the use of various labels (e.g., enzymes, fluorophores, and nanoparticles) can be regarded as a viable alternative for xLFIA multiplexing. Indeed, the exploitation of labels providing distinguishable signals allows differentiating between various complexes that are formed at the same site (i.e., at a single test line). The by far most popular strategy for multiplexing LFIAs is the design of several test lines or dots on an immunochromatographic strip using gold nanoparticles (GNP), quantum dots, colored/fluorescence microspheres as labels (page 5).
Therefore, given the fact that LFIA is leading immunoanalytical technique for onsite analysis and LFIA architecture is adaptable to multiplexing, and is therefore a possible answer to the pressing demand of multiplexing point-of-need analysis, it would be obvious to one of ordinary skilled in the art to easily envisage Lateral flow immunoassays for detection of the biomarker with a reasonable expectation of success. Moreover, given the fact that nanoparticles including colloidal particles such a gold particles are viable alternative to other fluorescent compounds as label for lateral flow immunoassays, it would be obvious to one of ordinary skilled in the art to easily envisage considering colloidal gold particles for the lateral flow immunoassay with a reasonable expectation of success.
In regards to dependent claim 2-28, the limitations are either disclosed in the claims or are obvious from the disclosure of the claims of the US patents.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12163958, and claims 1-38 of U.S.patent 12105100. Although the claims at issue are not identical, they are not patentably distinct from each other because present claims of the above mentioned patent encompass identical methods, which recite the same steps, use the same materials and accomplish identical results. The claim of the US patents are directed to detecting biomarkers of UCH-L1 and GFAP for diagnosing TBI utilizing lateral flow immunoassays and the subject matters of the dependent claims 2-28 are either disclosed in the claims of the US patents or are obvious from the disclosure. The claims, when compared against each other and by broadest reasonable interpretation, encompass essentially the same subject matter.
Conclusion
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