DETAILED ACTION
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 .
Response to Amendment
Claims 4, 14, 15, 18, 22-28, 30-35, 37-38 and 41-46 have been amended as requested in the amendment filed on 27 March 2023. Following the amendment, claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are pending in the instant application, and are under examination in the instant office action.
Election/Restrictions
Applicant’s election without traverse of erythrocytes, C4d, an anti-T cell antibody, and CD19 in the reply filed on 1 May 2026 is acknowledged. Applicant states claims 1-3, 5-13, 16-17, 19-21, 29, 36, 39, and 40 read upon the elected species.
Claim Objections
Claims 1, 9 and 11 are objected to because of the following informalities: These claims contain abbreviations that are not each spelled out upon their first appearance in the claims. Appropriate correction is required.
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.
Claim 11 is 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.
Claim 11 is rejected as being indefinite wherein it recites the terms “BC4d, TC4d, EC4d, PC4d, RC4d, GC4d, MC4d”. These appear to recite the specific cell type to which the C4d has bound but the specification mere recites these abbreviations and does not clarify or define these terms. Therefore, when read in light of the specification these terms are undefined. For purposes of applying prior art “EC4d” will be interpreted as C4d bound to erythrocytes, as instantly-elected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 nonobviousness.
Claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over WO/2003/022223 A2, published 20 March 2003 (hereafter the WO ‘223 publication) taken with Wahrmann et al., Human Immunology, 66:526-534, 2005.
Regarding claim 1, the WO ‘223 publication teaches methods comprising::contacting a sample comprising erythrocytes or red blood cells (pg. 9, paragraph [41], line 10). The WO ‘223 publication teaches a flow cytometry detection array for C4d (pg. 9, paragraph [42]) comprising contacting the sample with a conjugate of a monoclonal antibody specific for complement component C4d with a fluorescent moiety (pg. 9, paragraph [43], lines 29-30; and pg. 10 paragraph 44, lines 4-5).
Regarding claims 2 and 3, state: wherein the CFB-CAP is attached to at least a fragment of erythrocytes, and wherein: the sample comprises … erythrocytes, respectively. The WO ‘223 publication explicitly teaches the cells to which the complement activation product binds are the instantly-elected erythrocytes (pg. 9, paragraph [41], line 10).
Regarding claim 5, which claims wherein the sample comprises a blood sample, the WO ‘223 publication teaches: “Samples of 1 mL of EDTA-anticoagulated peripheral blood were taken from each individual and used as a source of red blood cells” (pg. 14, paragraph [65]).
Regarding claim 6, which recites wherein the sample, after being obtained from the patient, has been left at a temperature equal to or above 4 degrees Celsius for at least a period of time before being contacted with the detection agent, the WO ‘223 publication specifically states collecting blood samples at room temperature, which teaches “above 4 degrees Celsius” and contacting the sample with monoclonal antibody is performed for 20 min at 4° C (pg. 14, paragraph [66]).
Regarding claim 7, which recites wherein at least a portion of the entity has been spontaneously lysed. The WO ‘223 publication states: The determination of C4d and CRl may be done by a number of methods including flow cytometry or using red blood cell lysates (pg. 9, paragraph [41]).
Regarding claims 9 and 10, which recites wherein the CFB-CAP comprises a cell fragment-bound C4d, and wherein the detection antibody comprises an anti-C4d antibody, respectively. The WO ‘223 publication teaches a flow cytometry detection array for C4d (pg. 9, paragraph [42]) comprising contacting the sample with a conjugate of a monoclonal antibody specific for complement component C4d with a fluorescent moiety (pg. 9, paragraph [43], lines 29-30; and pg. 10 paragraph 44, lines 4-5).
Regarding claim 11, in view of the indefiniteness rejection above, it is unclear what the abbreviations of the claim mean. However, the WO ‘223 publication teaches methods in which erythrocytes are detected for C4d on their surface (pg. 9, paragraphs [42] and [43]; and pg. 10 paragraph [44]). Thus the prior art teaches the cell fragment bound C4d is “EC4d” as interpreted above.
Regarding claim 40, the WO ‘223 prior art specifically teaches comparing the determined level of the CFB-CAP with a control level and determining whether the determined level is elevated as compared to the control level; and determining that the patient has lupus or an increased risk of developing lupus if the determined level of the CFB-CAP is elevated as compared to the control level. Specifically Table VII (pg. 22) demonstrates SLE (“lupus” of the instant claims) has elevated red blood cell-C4d (RBC-C4d) over Scleroderma, healthy controls, and other diseases. Table VIII (pg. 22) demonstrates red blood cell-C4d can detect SLE (“lupus” of the instant claims) over healthy control and other diseases with a high level of sensitivity and specificity.
While the WO ‘223 publication teaches flow cytometry, which is detection in a “fluid path” as claimed, it does not specifically teach immobilizing the at least one of the one or more analytes in a fluid path (as recited in instant claim 1); wherein the at least one of the one or more analytes is immobilized in the fluid path by a capture antibody (claim 12); wherein the capture antibody binds to a different epitope on the CFB-CAP from one to which the detection antibody binds or binds to the detection antibody (claim 13); wherein the one or more analytes further comprise an anti-T cell antibody, a freely circulating complement activation product (FC-CAP), or a combination thereof (claim 17). The Wahrmann et al. prior art, however, remedies this deficiency by disclosing a high-throughput ([C4d]FlowPRA), which is based on selective flow-cytometric detection of C4d on HLA-coated FlowPRA beads (Abstract).
Regarding claim 12, wherein the at least one of the one or more analytes is immobilized in the fluid path by a capture antibody. The Wahrmann prior art teaches immobilization on beads (Abstract).
Regarding claim 13, the Wahrmann prior art teaches the capture antibody binds to a different epitope on the CFB-CAP from one to which the detection antibody binds or binds to the detection antibody, wherein it recites binding of C4d on HLA-coated beads and then detecting this conjugate with an anti-C4d antibody. Specifically, the FlowPRA assay used consists of a pool of 30 different microbead preparations coated with purified HLA class I or class II antigens (pg. 528, second paragraph).
Regarding claim 16, the Wahrmann reference teaches methods further comprising assessing an anti-T cell antibody. Namely, the Wahrmann prior art discloses assessing CD8 expression on T-cells (T-CDC-PRA) isolated from whole blood using anti-CD8 antibody-coated magnetic beads (pg. 528, first paragraph).
Regarding Claims 17, 19-20, 29 and 36, the Wahrmann prior art determines C4d and the T cell antigen CD8 comprising antibodies: namely, a conjugate of a monoclonal antibody specific for complement component C4d with a fluorescent moiety (pg. 9, paragraph [43], lines 29-30) and anti-CD8 antibody-coated magnetic beads (pg. 528, first paragraph). The prior art teaches both of these are assessed in serum samples using standard Flow-PRA (HLA class I vs II), and then [C4d]FlowPRA (HLA class I vs II) methodology (pg. 528, Results, first paragraph). Thus, the prior art teaches an assay configure to assess C4d and CD8 (recited in instant claim 36) via two or more separate locations in the fluid path or in a single fluid path.
Regarding claim 21, Wahrmann et al. teach CDC-PRA screening results may compose a considerable proportion of false-positives caused by immunoglobulin (Ig)M or (dithiothreitol [DTT]-insensitive) IgG lymphocytotoxic autoantibodies reacting with non-HLA lymphocyte surface antigens. Thus, the method of Wahrmann teaches detection of autoantibodies.
Regarding claim 39, the Wahrmann et al. prior art immobilized the antibodies to the beads before the step of contacting the sample (pg. 528, sections titled FlowPRA and [C4d]FlowPRA).
It would have been obvious to a person having ordinary skill in the art to use the [C4d]FlowPRA beads, and the additional elements as disclosed in Wahrmann, in the method of the WO ‘223 publication. Explicit motivation to do so comes from the Wahrmann et al. prior art wherein it states Complement product deposition to FlowPRA beads ([C4d]FlowPRA test) was assessed according to a modification of a previously described protocol (pg. 528, last paragraph of first column) and has a high specificity for C4d (pg. 529, second column). In KSR International Co. v. Teleflex, Inc., the Supreme Court has stated that combining prior art elements according to known method to yield predictable results is prima facie obvious if the following rationale can be applied:
(1) the prior art includes each element claimed though not necessarily in the same reference.
(2) it was within the technical grasp of one of ordinary skill in the art to combine the elements as claimed by known methods, and that in combination, each element merely would have performed the same function as it did separately.
(3) one of ordinary skill in the art would have recognized that the results of such combination were predictable.
(KSR International Co. v. Teleflex, Inc. 127 S. Ct. 1727, 82 USPQ2d 1385, Supreme Court, April 30, 2007). One of ordinary skill in the art would recognize the use of the C4dFlowPRA beads, and the additional elements of assessing CD8 etc. as taught by Wahrmann et al, in combination with C4d flow cytometry methods for the diagnosis of SLE/lupus, as taught by the the WO ‘223 publication. Based on the guidance and direction within the prior art, such combination would have been well within the technical grasp of a skilled artisan since each of the elements in combination are merely performing the same function as they did separately. One of ordinary skill in the art would have been able to predictably combine the elements with a reasonable expectation of successfully determining a level of a complement activation product in a patient since successful determination of C4d is taught by both references.
Further, the WO ‘223 teach samples being left for a period of 60 minutes at a temperature equal to or above 4 degrees, as recited by instant claim 8, however, the Court has stated that, generally, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed amount. In the instant case, the specification as filed provides no evidence that the particular amount of time is critical, since the specification states: “the period of time is at least about 60 minutes” (paragraph [0007]), which allows for time periods other than 60 minutes.
Therefore, the method of the invention is obvious in view of what was disclosed in the prior art references before the effective filing date of the application, and the claims are rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9495517 in view of Wahrmann et al., Human Immunology, 66:526-534, 2005 (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to methods comprising: receiving a blood sample for a patient who is determined to meet less than four classification criteria for Lupus; performing cell-bound complement activation product (CB-CAP) assays on the blood sample to generate a set of blood sampling data for the patient, wherein: the CB-CAP assays comprise a panel of assays using monoclonal antibodies specifically reactive with at least eight of the following including the elected species of the instant claims: T-C4d, B-C4d, M-C4d, G-C4d, and P-C4d, and the set of blood sampling data comprises a plurality of CB-CAP levels for the patient; and by a processing device: accessing a control data set, the control data set comprising a control level for each of the CB-CAPs, comparing the CB-CAP levels for the patient with the control levels to determine a number of the CB-CAPs for which the patient's levels are elevated as compared to the control levels, if the determined number exceeds a threshold, classifying the patient who was determined to meet less than four classification criteria for Lupus as exhibiting an increased risk of developing Lupus, and generating a report comprising an indication of whether the patient is classified as exhibiting the increased risk of developing Lupus. These claims anticipate the method of the instant claims which require detecting one or more CB-CAP in blood. The only element that appears to be missing from the Patented claims is the step of immobilizing the at least one of the one or more analytes in a fluid path, however, the Wahrmann prior art remedies this deficiency by teaching a bead assay for the specific detection of C4d. It would have been obvious to a person having ordinary skill, before the effective filing date of the application, to use the conjugated beads as taught by Wahrmann in the method of the ‘517 Patent. A person having ordinary skill would have been motivated to do so because immobilization on beads allows for high-throughput processing, according to known methods described in Wahrmann. A skilled artisan would have been able to combine the elements according to known methods with predictable success because both the Patent and Wahrmann successfully detect C4d, and the ‘517 Patent does so in the context of Lupus diagnosis.
Claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9709564 in view of Wahrmann et al., 2005 (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to methods comprising: obtaining a blood sample from the individual; incubating the blood sample in vitro, wherein incubation results in autoantibodies in the sample being in stable association with a surface of a T lymphocyte in the sample, wherein C4d is bound to a surface of the T lymphocyte; quantitating a level of the individual's autoantibodies deposited on or in contact with a surface of a TC4d lymphocyte in the sample; comparing the level of autoantibodies in the blood sample from the individual with a level of autoantibodies deposited on or in contact with a surface of a control T lymphocyte; quantitating a level of a diagnostic biomarker of systemic lupus erythematosus deposited on or in contact with a surface of a T lymphocyte in the sample, wherein the diagnostic biomarker is C4d; and comparing the level of TC4d diagnostic biomarker in the blood sample from the individual with a level of the diagnostic biomarker deposited on or in contact with a surface of a control T lymphocyte; wherein an increased level of autoantibodies deposited on or in contact with the surface of a TC4d lymphocyte and an increased level of the TC4d diagnostic biomarker in the blood sample from the individual as compared to the levels for the control T lymphocyte identifies systemic lupus erythematosus in the individual. The only element that appears to be missing from the Patented claims is the step of immobilizing the at least one of the one or more analytes in a fluid path, however, the Wahrmann prior art remedies this deficiency by teaching a bead assay for the specific detection of C4d. It would have been obvious to a person having ordinary skill, before the effective filing date of the application, to use the conjugated beads as taught by Wahrmann in the method of the ‘564 Patent. A person having ordinary skill would have been motivated to do so because immobilization on beads allows for high-throughput processing, according to known methods described in Wahrmann. A skilled artisan would have been able to combine the elements according to known methods with predictable success because both the Patent and Wahrmann successfully detect C4d, and the ‘564 Patent does so in the context of Lupus diagnosis.
Claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9863946 in view of Wahrmann et al., 2005 (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to methods comprising: receiving a blood sample for a patient who is determined to meet fewer than four classification criteria for Lupus; performing cell-bound complement activation product (CB-CAP) assays on the blood sample to generate a set of blood sampling data for the patient, wherein the CB-CAP assays comprise a panel of assays using monoclonal antibodies specifically reactive with at least two CB-CAPs, including the elected C4d, namely, E-C4d, R-C4d, P-C4d, T-C4d, B-C4d, M-C4d, and G-C4d; comparing the CB-CAP levels for the patient with a set of normal control levels to determine the CB-CAPs for which the patient's CB-CAP levels are elevated as compared to the control levels; generating a score for the patient based upon a number of CB-CAPs for which the patient's CB-CAP levels exceed the control levels by at least a threshold amount; determining whether the patient's score is greater than an average score for other subjects, exhibiting immune and/or inflammatory diseases that are not Lupus or pre-Lupus; and if the patient's score is determined to be greater than the average score for the other subjects, classifying the patient as exhibiting an increased risk of developing Lupus. The only element that appears to be missing from the Patented claims is the step of immobilizing the at least one of the one or more analytes in a fluid path, however, the Wahrmann prior art remedies this deficiency by teaching a bead assay for the specific detection of C4d. It would have been obvious to a person having ordinary skill, before the effective filing date of the application, to use the conjugated beads as taught by Wahrmann in the method of the ‘946 Patent. A person having ordinary skill would have been motivated to do so because immobilization on beads allows for high-throughput processing, according to known methods described in Wahrmann. A skilled artisan would have been able to combine the elements according to known methods with predictable success because both the Patent and Wahrmann successfully detect C4d, and the ‘946 Patent does so in the context of Lupus diagnosis.
Claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10067128 in view of Wahrmann et al., 2005 (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to methods comprising: obtaining a blood sample containing white blood cells from the subject: quantitating a level of presence of at least one biomarker on a surface of a B lymphocyte in the sample, wherein the biomarker is selected from the group consisting of C4d, C3d, C4b, iC4b, C3b, iC3b, and C3dg; and comparing the level of presence of the biomarker for the subject with the level of presence of the biomarker on a surface of a B lymphocyte of a control sample to determine whether the subject's level of presence of the biomarker is elevated as compared to the level of presence in the control sample, correlating an increased level of presence of the biomarker in the blood sample from the subject as compared to the level of presence for the control sample with a decreased binding of the potential therapeutic antibody directed against the B lymphocyte antigen on the B lymphocytes of the subject, wherein the increased level of presence of the biomarker is detected before the administration of the potential therapeutic antibody treatment to the subject and without reference to the expression of the B lymphocyte antigen targeted by the potential therapeutic antibody.
The instant claims recites the CFB-CAP can be associated with erythrocytes, lymphocytes, reticulocytes, platelets, granulocytes, monocytes, eosinophils, or basophils. Thus, teaching the Lymphocytes of the Patented claims. The only element that appears to be missing from the Patented claims is the step of immobilizing the at least one of the one or more analytes in a fluid path, however, the Wahrmann prior art remedies this deficiency by teaching a bead assay for the specific detection of C4d. It would have been obvious to a person having ordinary skill, before the effective filing date of the application, to use the conjugated beads as taught by Wahrmann in the method of the ‘128 Patent. A person having ordinary skill would have been motivated to do so because immobilization on beads allows for high-throughput processing, according to known methods described in Wahrmann. A skilled artisan would have been able to combine the elements according to known methods with predictable success because both the Patent and Wahrmann successfully detect C4d, and the ‘128 Patent does so in the context of Lupus diagnosis (see reference claim 7).
Claims 1-3, 5-13,16-17,19-21, 29, 36, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12130288 in view of Wahrmann et al., 2005 (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to methods comprising: performing one or more cell-bound complement activation product (CB-CAP) assays on a blood sample from the patient to generate blood sampling data for the patient, wherein the one or more CB-CAP assays comprise a panel of assays using monoclonal antibodies specifically reactive with at least one of the following CB-CAPs: E-C4d, R-C4d, T-C4d, B-C4d, M-C4d, G-C4d, P-C4d, Eos-C4d, and Baso-C4d. In view of the current claims that read upon erythrocytes, lymphocytes, reticulocytes, platelets, granulocytes, monocytes, eosinophils, or basophils, then the patented claims teach the method of the instant claims. The method of the Patent comprising obtaining blood sampling data for one or more CB-CAP levels for one or more CB-CAPs in the patient; detecting that the one or more CB-CAP levels for the patient are not elevated as compared to a control; and multiplying one or more of the one or more CB-CAP levels for the patient by a correction factor to obtain one or more corrected CB-CAP levels for the patient.
The only element that appears to be missing from the Patented claims is the step of immobilizing the at least one of the one or more analytes in a fluid path, however, the Wahrmann prior art remedies this deficiency by teaching a bead assay for the specific detection of C4d. It would have been obvious to a person having ordinary skill, before the effective filing date of the application, to use the conjugated beads as taught by Wahrmann in the method of the ‘288 Patent. A person having ordinary skill would have been motivated to do so because immobilization on beads allows for high-throughput processing, according to known methods described in Wahrmann. A skilled artisan would have been able to combine the elements according to known methods with predictable success because both the Patent and Wahrmann successfully detect C4d, and the ‘288 Patent does so in the context of Lupus diagnosis (see claim 2).
Conclusion
No claim is allowed.
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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