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
Summary
This is the Final Office action based on the 18/146038 in response to response dated on 10/30/2025.
Claims 1, 3-5, 7-16 are pending.
Claims 1, 3-5, 7-14, & 16 have been fully considered.
Claim 15 is withdrawn.
Claim 16 is newly added.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-5, 7-14, & 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to Claim 4, the “potentially,” and clauses makes the claims unclear if they are being further limited or not. Further, it is not clear in Claim 4 whether X-AAD protein is required or not since it’s only found in parentheses. This also applies to Claim 16 where X-AAD- protein is also found in parentheses.
With respect to Claim 7, it is not clear whether MI-protein is required or not since it’s only found in parentheses.
With respect to Claim 13, it has two step a’s and two step b’s which is confusing. Further in step, “b),” “the detection region,” fails to have proper antecedent basis, as detection region was not mentioned prior to this in the claim. Correction is required.
Further with respect to Claims 1,13, & 16 it is claimed, “detection of a first protein released during and even leading to an acute aortic dissection (1-AAD-protein).” This is confusing, since what is in parentheses is not an abbreviation for what is right before it, “acute aortic dissection.” Though it is understood that 1-AAD-protein is the protein, how it is claimed brings confusion to the claim and this needs correction for the claims to be cleared up. It is noted that when fixing this, applicant should take care to with respect to when 1-AAD-protein in introduced to the claim to ensure there is proper antecedent basis.
All other dependent on the rejected claims are rejected by virtue of being dependent on the unclear base claims. For all the above reasons, the claims require correction.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 10-12, & 14 are rejected under U.S.C. 103 as being obvious by NICOSIA in US 20130217015 in view of RUIVO in Colorimetric detection of D-dimer in paper-based immunodetection device (as cited on IDS dated 03/28/2024).
With respect to Claim 1, NICOSIA teaches of method of detecting HMGA2 as a diagnostic biomarker (abstract). NICOSIA further teaches of doing this by using a immunochromatographic lateral flow assay device (paragraph 0019, 0077-0091).
Specifically, NICOSIA teaches of the lateral flow device having features including a strip (paragraph 0078-0081) —which enables capillary flow as claimed (paragraph 0102);
a sample pad/application zone—located at a proximal end of a strip which received the sample as claimed (paragraph 0083, 0088, 0019);
a labeling zone containing antibody labels which binds to HMGA2 (protein antibody binding to said 1-AAD protein) - reads on the instant conjugate pad, which is operation through capillary action the sample flows through it and mobilizes the antibody labels (paragraph 008, 0057-0058, 0069-0071), and of a detection agent being conjugated thereto (paragraph 0089, 0106);
and a detection zone which reads on the instantly claimed detection band, wherein the HMGA2 bound binding agent is retained to give a signal (paragraph 0019, 0083, 0082, 0088-0102); wherein the detection zone can be a line/band wherein things are caught and show a line (which is perpendicular to the strip) are compared to a control line (paragraphs 0082-0083), and show a color change when binding occurs (paragraph 0089, 0110).
The instant claim requires that the 1-AAD protein is HMGI-C, which is otherwise known as HMGA2, which is taught as shown above by NICOSIA. SEQ ID NO 1, which is claimed in the dependent claims also corresponds to the protein sequence of HMGA2/HMGI-C.
NICOSIA teaches of the method of detection of an AAD-protein (HMGA2) (abstract) for detection in a mammal (paragraph 0048).
Though NICOSIA teaches that lines can be shown, used, in case the “substantially,” perpendicular band to the direction of flow is not clear, RUIVO is used to remedy this.
RUIVO teaches of a microfluidic paper-based analytical device (mPADs) (“strip formed of a material enabling capillary flow”) immunoassay and of a method detection of the blood native biomarker D-dimer. The mPAD is created by wax printing on a single piece of chromatographic paper and combined with an anti-D-dimer capture antibody and conjugates of anti-D-dimer antibody with 40 nm gold nanoparticles (abstract).
RUIVO further teaches that the device is as shown in Figure 1 below where the sample is applied at S (sample pad located proximal to one end of strip for receiving the sample), and wherein the test reaction occurs at T and the control reaction at C.
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RUIVO further teaches that capture antibodies(“conjugate comprised in the conjugate pad”) are applied at T & C pads/zones of the immunodetection device, and then further that the test solution is prepared by mixing antibody conjugated gold nanoparticles (AuNPs)( “detection reagent”) with the sample, and then the sample is dispensed to flow through the sample pad and the capture antibodies therein(“in operation the sample flows under capillary action through the strip from the sample pad to the conjugate pad and mobilizes a conjugate comprised in the conjugate page—the conjugate comprising a protein antibody”) and washed (See Figure 2 below).
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Finally, RUIVO further teaches that signals are obtained (“interrogating the detection region”) from the color that forms in the test zones (color that forms in the “first conjugate pad”) of the uPAds and that the intensity visually appears to increase with the protein concentration that is detected (Page 8, column 2, last paragraph). This can read on the claimed “first detection band,” through broadest reasonable interpretation,” as a filled circle contains many “bands” and also is “substantially perpendicular,” to the direction of flow through broadest reasonable interpretation.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a “substantially,” perpendicular to the direction of flow detection band as is done in RUIVO and one would have had reasonable expectation of success in combination with NICOSIA due to the advantage this offers in clear visual detection without ambiguity of the protein (RUIVO, Figure 4 description, Page 9, column 1, paragraph 2).
Further for Claim 1- it is noted that it is drawn towards a device, and the claimed intended use of the device, “for the detection of a first protein released during an event leading to an acute aortic dissection,” is not limiting for device claims.
With respect to Claim 3, NICOSIA teaches of antibody labels which binds to HMGA2 (protein antibody binding to said 1-AAD protein) (paragraph 008, 0057-0058, 0069-0071). The instant claim requires that the 1-AAD protein is HMGI-C, which is otherwise known as HMGA2, which is taught as shown above by NICOSIA. SEQ ID NO 1, which is claimed in the dependent claims also corresponds to the protein sequence of HMGA2/HMGI-C. The antibody taught by NICOSIA would/does bind to the antigen of amino acid SEQ ID NO 1 (paragraph 0063, 0109). For Claim 3 as claimed, “binds,” seems like somewhat of a method step. It is noted that method steps are not limiting in device claims.
With respect to Claim 4, NICOSIA teach of the lateral flow device as shown above for Claim 1. NICOSIA does not teach of the lateral flow device also having one or more further proteins wherein the protein is an X-AAD protein.
RUIVO is used to remedy this and further teaches of a microfluidic paper-based analytical device (mPADs) (“strip formed of a material enabling capillary flow”) immunoassay and of a method detection of the blood native biomarker D-dimer (which is an X-AAD protein). The mPAD is created by wax printing on a single piece of chromatographic paper and combined with an anti-D-dimer capture antibody and conjugates of anti-D-dimer antibody with 40 nm gold nanoparticles (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use D-Dimer antibody as an additional antibody in the lateral flow assay device and one would have had reasonable expectation of success in combination with NICOSIA due to the advantage adding the biomarker antibody of D-Dimer offers for measuring the normality or abnormality of the body’s coagulation system (RUIVO, Page 6, column 1, paragraph 2, lines 4-7).
With respect to Claim 5, NICOSIA teach of the lateral flow device as shown above for Claim 1. NICOSIA does not teach of the lateral flow device also having one or more further proteins wherein the protein is an X-AAD protein.
RUIVO is used to remedy this and further teaches of a microfluidic paper-based analytical device (mPADs) (“strip formed of a material enabling capillary flow”) immunoassay and of a method detection of the blood native biomarker D-dimer (which is an X-AAD protein). The mPAD is created by wax printing on a single piece of chromatographic paper and combined with an anti-D-dimer capture antibody and conjugates of anti-D-dimer antibody with 40 nm gold nanoparticles (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use D-Dimer antibody as an additional antibody in the lateral flow assay device and one would have had reasonable expectation of success in combination with NICOSIA due to the advantage adding the biomarker antibody of D-Dimer offers for measuring the normality or abnormality of the body’s coagulation system (RUIVO, Page 6, column 1, paragraph 2, lines 4-7).
With respect to Claim 10, NICOSIA teaches of a detection agent being conjugated to the antibody and the detection agent can be a fluorescent tag/molecule or conjugated colloidal gold (paragraph 0089, 0106).
With respect to Claim 11, NICOSIA teaches of detection zone which reads on the instantly claimed detection band, wherein the HMGA2 bound binding agent is retained to give a signal (paragraph 0019, 0083, 0082, 0088-0102); wherein the detection zone can be a line/band wherein things are caught and show a line (which is perpendicular to the strip) are compared to a control line (also perpendicular to strip) (paragraphs 0082-0083), and show a color change when binding occurs (paragraph 0089, 0110).
Though NICOSIA teaches that lines can be shown, used, in case the “substantially,” perpendicular band to the direction of flow is not clear, RUIVO is used to remedy this.
RUIVO teaches that signals are obtained (“interrogating the detection region”) from the color that forms in the test zones (color that forms in the “first conjugate pad”) of the uPAds and that the intensity visually appears to increase with the protein and also the control zone filling up and showing visual indication of detection (Page 8, column 2, last paragraph, paragraph 5). This can read on the claimed substantially perpendicular control zone as a filled circle contains many “bands” and also is “substantially perpendicular,” to the direction of flow through broadest reasonable interpretation. See reason for combination from Claim 1.
With respect to Claim 12, NICOSIA teaches of a method of detection of an AAD-protein (HMGA2) (abstract) in a mammal (paragraph 0048), using the device of Claim 1 (see Claim 1 rejection above).
With respect to Claim 14, NICOSIA teaches of a kit (paragraph 0018, 0064), which comprises the lateral flow detection device of Claim 1 (see Claim 1 rejection), and also instructions for use (paragraph 0064, 0105). Again, as the claim is drawn towards a kit, which is a device, as all the claimed parts are taught, the intended use of the kit, “for detecting a protein released during an event leading to an acute aortic dissection,” is not limiting for the device.
Claims 7-9 are rejected under U.S.C. 103 as being obvious by NICOSIA in US 20130217015 in view of RUIVO in Colorimetric detection of D-dimer in paper-based immunodetection device (as cited on IDS dated 03/28/2024) and further in view of McPHERSON in US 20070224643.
With respect to Claim 7, NICOSIA in view of RUIVO teach of the invention as shown above for Claim 1. RUIVO further teaches of detecting D-Dimer (abstract), but does not teach of the claimed detection specifics for MI- protein.
McPHERSON is used to remedy this and teaches of a method and device for detection of diseases such as aortic dissection. McPHERSON teaches of doing this by detecting biomarkers like smooth muscle myosine heavy chain and soluble elastin (abstract, paragraph 0015, 0033, 0044). McPHERSON further teaches of performing the detection by using an assay strip and coating an antibody specific to the protein of interest or a combination of antibodies on the strip and then of applying the sample and detecting a measurable signal such as a colored spot (paragraph 0131).
More specifically, McPHERSON teaches of doing this by detecting biomarkers like myoglobin and creatine kinase (CK (term is interchangeable with creatine phosphokinase) and troponin I which are indicative or early or acute myocardial infarction (abstract, paragraphs 0078-0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to detect troponin as is done by McPHERSON in the method and device of RUIVO and NICOSIA due to the advantage this offers for prognosing and diagnosing diseases (abstract). Further though the prior art does not specifically call out and additional detection band, it would have been obvious to use another pad and detection band since is mere duplication of parts. See MPEP 2144.04 Duplication of Parts.
With respect to Claim 8, NICOSIA and RUIVO teaches of the above as shown for Claim 1, but does not teach of aortic dissection. McPHERSON is used to remedy this and teaches of aortic dissection which includes thoracic aortic dissection (paragraphs 0006-0007). McPHERSON further teach of the aortic dissection being acute, with “abrupt onset” (paragraph 0009). See reasons for combination from Claim 1.
With respect to Claim 9, NICOSIA and RUIVO teaches of the above, but does not teach of an FC-binding protein.
McPHERSON teaches that the term antibody includes antigen-binding portions, i.e., "antigen binding sites," (e.g., fragments, subsequences, complementarity determining regions (CDRs)) that retain capacity to bind antigen, including (i) a Fab fragment, a monovalent fragment consisting of the VL, VH, CL and CH1 domains; (ii) a F(ab')2 fragment, a bivalent fragment comprising two Fab fragments linked by a disulfide bridge at the hinge region; (iii) a Fd fragment consisting of the VH and CHI domains; (iv) a Fv fragment consisting of the VL and VH domains of a single arm of an antibody, (v) a dAb fragment (Ward et al., (1989) Nature 341:544-546), which consists of a VH domain; and (vi) an isolated complementarity determining region (CDR). Single chain antibodies are also included by reference in the term "antibody.” (paragraph 0065).
McPHERSON further teaches of detection of protein A (paragraph 0034, 0125, table 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to detect Protein A as is done in McPHERSON in the methods of NICOSIA and RUIVO due to the advantage it offers in being a preferred marker/complement (paragraph 0124, table 3).
Claim 13 is rejected under U.S.C. 103 as being obvious by NICOSIA in US 20130217015 in view of RUIVO in Colorimetric detection of D-dimer in paper-based immunodetection device (as cited on IDS dated 03/28/2024) in further view of YANG in MiR-26b Suppresses the development of Stanford Type A Aortic Dissection by Regulating HMGA2 and TGF-B/Smad3 Signaling Pathway.
With respect to Claim 16, NICOSIA teaches of method of detecting HMGA2 as a diagnostic biomarker (abstract). NICOSIA further teaches of doing this by using an immunochromatographic lateral flow assay (paragraph 0019, 0077-0091).
Specifically, NICOSIA teaches of the lateral flow device having features including a strip (paragraph 0078-0081) —which enables capillary flow as claimed (paragraph 0102);
a sample pad/application zone—located at a proximal end of a strip which received the sample as claimed (paragraph 0083, 0088, 0019);
a labeling zone containing antibody labels which binds to HMGA2 (protein antibody binding to said 1-AAD protein) - reads on the instant conjugate pad, which is operation through capillary action the sample flows through it and mobilizes the antibody labels (paragraph 008, 0057-0058, 0069-0071), and of a detection agent being conjugated thereto (paragraph 0089, 0106);
and a detection zone which reads on the instantly claimed detection band, wherein the HMGA2 bound binding agent is retained to give a signal (paragraph 0019, 0083, 0082, 0088-0102); wherein the detection zone can be a line/band wherein things are caught and show a line (which is perpendicular to the strip) are compared to a control line (paragraphs 0082-0083), and show a color change when binding occurs (paragraph 0089, 0110).
The instant claim requires that the 1-AAD protein is HMGI-C, which is otherwise known as HMGA2, which is taught as shown above by NICOSIA. SEQ ID NO 1, which is claimed in the dependent claims also corresponds to the protein sequence of HMGA2/HMGI-C.
NICOSIA teaches of the method of detection of an AAD-protein (HMGA2) (abstract) for detection in a mammal (paragraph 0048). Though NICOSIA teaches that lines can be shown, used, in case the “substantially,” perpendicular band to the direction of flow is not clear, RUIVO is used to remedy this.
RUIVO teaches of a microfluidic paper-based analytical device (mPADs) (“strip formed of a material enabling capillary flow”) immunoassay and of a method detection of the blood native biomarker D-dimer. The mPAD is created by wax printing on a single piece of chromatographic paper and combined with an anti-D-dimer capture antibody and conjugates of anti-D-dimer antibody with 40 nm gold nanoparticles (abstract).
RUIVO further teaches that the device is as shown in Figure 1 where the sample is applied at S (sample pad located proximal to one end of strip for receiving the sample), and wherein the test reaction occurs at T and the control reaction at C.
RUIVO further teaches that capture antibodies(“conjugate comprised in the conjugate pad”) are applied at T & C pads/zones of the immunodetection device, and then further that the test solution is prepared by mixing antibody conjugated gold nanoparticles (AuNPs)( “detection reagent”) with the sample, and then the sample is dispensed to flow through the sample pad and the capture antibodies therein(“in operation the sample flows under capillary action through the strip from the sample pad to the conjugate pad and mobilizes a conjugate comprised in the conjugate page—the conjugate comprising a protein antibody”) and washed (See Figure 2).
Finally, RUIVO further teaches that signals are obtained (“interrogating the detection region”) from the color that forms in the test zones (color that forms in the “first conjugate pad”) of the uPAds and that the intensity visually appears to increase with the protein concentration that is detected (Page 8, column 2, last paragraph). This can read on the claimed “first detection band,” through broadest reasonable interpretation,” as a filled circle contains many “bands” and also is “substantially perpendicular,” to the direction of flow through broadest reasonable interpretation (See Figure 5 and Claim 1 rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a “substantially,” perpendicular to the direction of flow detection band as is done in RUIVO and one would have had reasonable expectation of success in combination with NICOSIA due to the advantage this offers in clear visual detection without ambiguity of the protein (RUIVO, Figure 4 description, Page 9, column 1, paragraph 2).
NICOSIA and RUIVO does not teach of use of the device for detection of aortic dissection or the association of HMGA2 with aortic dissection.
YANG is used to remedy this, and teaches of measuring or detecting aortic dissection (Page 140, abstract, purpose). YANG further teaches of detection of HMGA2 and that regulating it helps with aortic dissection treatment (Page 140, abstract, purpose and conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect HMGA2 for aortic dissection and one would have had reasonable expectation of success due to the advantage this has in being a biomarker for TAAD (aortic dissection) treatment (YANG, Page 140, abstract, purpose and conclusion).
Claim 16 is rejected under U.S.C. 103 as being obvious by NICOSIA in US 20130217015 in view of RUIVO in Colorimetric detection of D-dimer in paper-based immunodetection device (as cited on IDS dated 03/28/2024) in further view of McPHERSON in US 20070224643, and even further in view of YANG in MiR-26b Suppresses the development of Stanford Type A Aortic Dissection by Regulating HMGA2 and TGF-B/Smad3 Signaling Pathway.
With respect to Claim 16, NICOSIA teaches of method of detecting HMGA2 as a diagnostic biomarker (abstract). NICOSIA further teaches of doing this by using an immunochromatographic lateral flow assay (paragraph 0019, 0077-0091).
Specifically, NICOSIA teaches of the lateral flow device having features including a strip (paragraph 0078-0081) —which enables capillary flow as claimed (paragraph 0102);
a sample pad/application zone—located at a proximal end of a strip which received the sample as claimed (paragraph 0083, 0088, 0019);
a labeling zone containing antibody labels which binds to HMGA2 (protein antibody binding to said 1-AAD protein) - reads on the instant conjugate pad, which is operation through capillary action the sample flows through it and mobilizes the antibody labels (paragraph 008, 0057-0058, 0069-0071), and of a detection agent being conjugated thereto (paragraph 0089, 0106);
and a detection zone which reads on the instantly claimed detection band, wherein the HMGA2 bound binding agent is retained to give a signal (paragraph 0019, 0083, 0082, 0088-0102); wherein the detection zone can be a line/band wherein things are caught and show a line (which is perpendicular to the strip) are compared to a control line (paragraphs 0082-0083), and show a color change when binding occurs (paragraph 0089, 0110).
The instant claim requires that the 1-AAD protein is HMGI-C, which is otherwise known as HMGA2, which is taught as shown above by NICOSIA. SEQ ID NO 1, which is claimed in the dependent claims also corresponds to the protein sequence of HMGA2/HMGI-C.
NICOSIA teaches of the method of detection of an AAD-protein (HMGA2) (abstract) for detection in a mammal (paragraph 0048). Though NICOSIA teaches that lines can be shown, used, in case the “substantially,” perpendicular band to the direction of flow is not clear, RUIVO is used to remedy this.
RUIVO teaches of a microfluidic paper-based analytical device (mPADs) (“strip formed of a material enabling capillary flow”) immunoassay and of a method detection of the blood native biomarker D-dimer. The mPAD is created by wax printing on a single piece of chromatographic paper and combined with an anti-D-dimer capture antibody and conjugates of anti-D-dimer antibody with 40 nm gold nanoparticles (abstract).
RUIVO further teaches that the device is as shown in Figure 1 where the sample is applied at S (sample pad located proximal to one end of strip for receiving the sample), and wherein the test reaction occurs at T and the control reaction at C.
RUIVO further teaches that capture antibodies(“conjugate comprised in the conjugate pad”) are applied at T & C pads/zones of the immunodetection device, and then further that the test solution is prepared by mixing antibody conjugated gold nanoparticles (AuNPs)( “detection reagent”) with the sample, and then the sample is dispensed to flow through the sample pad and the capture antibodies therein(“in operation the sample flows under capillary action through the strip from the sample pad to the conjugate pad and mobilizes a conjugate comprised in the conjugate page—the conjugate comprising a protein antibody”) and washed (See Figure 2).
Finally, RUIVO further teaches that signals are obtained (“interrogating the detection region”) from the color that forms in the test zones (color that forms in the “first conjugate pad”) of the uPAds and that the intensity visually appears to increase with the protein concentration that is detected (Page 8, column 2, last paragraph). This can read on the claimed “first detection band,” through broadest reasonable interpretation,” as a filled circle contains many “bands” and also is “substantially perpendicular,” to the direction of flow through broadest reasonable interpretation (See Figure 5 and Claim 1 rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a “substantially,” perpendicular to the direction of flow detection band as is done in RUIVO and one would have had reasonable expectation of success in combination with NICOSIA due to the advantage this offers in clear visual detection without ambiguity of the protein (RUIVO, Figure 4 description, Page 9, column 1, paragraph 2).
NICOSIA and RUIVO does not teach of use of the device for detection of aortic dissection. NICOSIA and RUIVO also do not teach of using an additional protein antibody in the invention wherein the protein antibody is D-Dimer or MI-protein antibody TnT (troponin).
McPHERSON is used to remedy this and teaches of a method and device for detection of diseases such as aortic dissection. McPHERSON teaches of doing this by detecting biomarkers like smooth muscle myosine heavy chain and soluble elastin (abstract, paragraph 0015, 0033, 0044). McPHERSON further teaches of performing the detection by using an assay strip and coating an antibody specific to the protein of interest or a combination of antibodies on the strip and then of applying the sample and detecting a measurable signal such as a colored spot (paragraph 0131).
McPHERSON teaches of doing this by detecting biomarkers like myoglobin and creatine kinase (CK (term is interchangeable with creatine phosphokinase) and troponin I which are indicative or early or acute myocardial infarction (abstract, paragraphs 0078-0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to detect CK, and troponin as is done by McPHERSON in the method and device of RUIVO and NICOSIA due to the advantage this offers for prognosing and diagnosing diseases (abstract). Further though the prior art does not specifically call out and additional detection band, it would have been obvious to use another pad and detection band since is mere duplication of parts. See MPEP 2144.04 Duplication of Parts.
Also, it would have been obvious to one of ordinary skill in the art to detect aortic dissection as is done in McPHERSON on a test strip in the method of RUIVO due to the need in the art for better ways to diagnose and test for aortic dissection since most patients with undiagnosed dissection die within two weeks (McPHERSON, paragraph 0007, 0015).
NICOSIA, RUIVO and McPHERSON do not teach of the association of HMGA2 with aortic dissection.
YANG is used to remedy this, and teaches of measuring or detecting aortic dissection (Page 140, abstract, purpose). YANG further teaches of detection of HMGA2 and that regulating it helps with aortic dissection treatment (Page 140, abstract, purpose and conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect HMGA2 for aortic dissection and one would have had reasonable expectation of success due to the advantage this has in being a biomarker for TAAD (aortic dissection) treatment (Page 140, abstract, purpose and conclusion).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Some of the prior 112 issues were overcome due to amendments made 10/30/2025, however some remain as shown in the rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758