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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/2026 has been entered.
Priority
The present application is filed as a divisional of application serial number 14/725,894, filed 05/29/2015, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/067,702, filed 10/23/2014.
Status of the Claims
Claims 1-2, 4-10, 12-21 and 23-28 are pending; claims 1-2, 4, 7, 9, 12-13, 15-16, 19-21, 23 and 26 are amended; claims 27-28 are newly recited; claims 3, 11 and 22 are canceled. No claims are withdrawn. Claims 1-2, 4-10, 12-21 and 23-28 are examined below.
Withdrawn Objections/Rejections
The previous rejection of claim 9 under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendments to the claims.
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 1-10, 12-21 and 23-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 recites “A method for detection of hemoglobinopathies”, the method comprising providing a lateral flow immunoassay device for the capture and detection of human hemoglobin A, S and C, the claim reciting “wherein a hemoglobinopathy present in the sample is detected and differentiated by simultaneous detection and simultaneous visualization of a presence and level of each of HbC, HbS, and HbA”. As such, the method is detecting for (i.e., diagnosing/correlating with a diagnosis of) hemoglobinopathies based on the presence/detection of HbA, HbS and/or HbC.
The natural relationship to which the claims are directed (i.e., the relation between HbA, HbS and HbC and hemoglobinopathies) is a law of nature. Similar concepts have been held by the courts to constitute law of nature/ natural phenomena, as in the identification of a correlation between the presence of in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017). In Mayo, the Supreme Court found that a claim was directed to a natural law, where the claim required administering a drug and determining the levels of a metabolite following administration, where the level of metabolite was indicative of a need to increase or decrease the dosage of the drug. See Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66, 74 (2012).
The instant claims are similar to those in Mayo as they involve a "relation itself [which] exists in principle apart from any human action" (id. at 77), namely the relationship between the naturally occurring variant(s) of hemoglobin, HbA, HbS and HbC in blood and the presence of hemoglobinopathies.
The correlation between these hemoglobin variants and disease is a judicial exception as it exists in principle apart from any human action; the correlation itself therefore cannot form the basis for eligibility.
Step 2A, Prong 2
In addition to the above indicated judicial exception, the independent claim recites active method steps of providing a blood sample, mixing the blood sample with a buffer, and loading the blood sample. Such steps of obtaining, mixing and loading as indicated above are insufficient to integrate the judicial exception because the purpose is merely to obtain the data. These steps do not go beyond insignificant pre-solution activity, i.e., mere data gathering steps necessary in order to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).
The claims do recite limitations specific to a lateral flow immunoassay device comprising a lateral flow test strip comprising a chromatography matrix, a capture antibodies immobilized on the test strip, wherein the capture antibodies have binding affinity to HbA, HbS or HbC (elected species HbA, HbS and HbC), each specifically with N-terminal binding affinity. However, in the present case, the lateral flow device is merely an object on which the method operates and does not integrate the exception into a practical application. In the present case, the lateral flow immunoassay device that is claimed, is merely a tool to perform existing methods of detecting Hb variants in blood (as such the lateral flow device does not amount to an integration into a practical application). The lateral flow device as claimed is involved in the pre-solution activity, the detecting of the variants in a blood sample, and as such is involved in the data gathering. See MPEP 2106.05(b).
There are no further steps/elements recited at the independent claim which apply, rely on or use the judicial exception in a way that would amount to integration of the judicial exception into a practical application.
This is similarly the case regarding dependent claim limitations, none of the dependent claims further apply on, rely on or use the judicial exception (for example dependent claims are further directed to the data gathering steps/elements (e.g., claims 2, 3, 7-10, 23-28), or further narrow the judicial exception itself (4-6).
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additionally recited claim steps/elements fail to add significantly more to the judicial exception. For example, regarding the lateral flow immunoassay device, in the present case, the device merely operates as an object on which the method is performed and fails to provide significantly more. It is an object used to gather the data to be used in the correlation.
Furthermore, lateral flow immunoassay devices to detect hemoglobin in a blood sample are well known, routine and conventional in the assay art. See for example, JPH0954086A (English Machine Translation via Google Patents), teaching a test strip for measuring HbA1c and HbA (e.g., claim 1); JPH1183856A, para [0009] teaching a lateral flow test membrane device for detection of hemoglobin (see also claims 1-3); further Bagaria, US PG Pub No. 2003/027222A1, a test strip device for capture and detecting hemoglobin (claims 1-16).
Even more specific, see Rutter et al. US PG Pub No. 2011/0070658A1 (IDS entered 05/06/2025). Rutter et al. teach an easy to use, portable, handheld, point-of-care immunoassay testing device that is an immunochromatographic test strip device intended for the purpose of quantitatively analyzing hemoglobin, glycated hemoglobin and other variants (paras [0007] and [0011], see also para [0005] regarding point of care testing devices). See paras [0014] and [0015], Rutter et al. teach the test strip device comprises a chromatographic strip to which sample is added (see para [0027], sample such as blood), the strip comprises capture antibodies immobilized on the strip. See also Rutter et al. at para [0041], Rutter teach capture agents such as antibodies the recognize and bind hemoglobin, Rutter also teach capture agent may comprise antibodies specific for variants (such as HbA, HbA2, F, C, D, E and S). Rutter describes embodiments with labeled reagent provided in an on device conjugate pad (e.g., para [0058]).
Although not specific to a lateral flow immunoassay device, see also Blomberg et al., WO2005/029092A1 which also supports the routine and conventional nature of screening for variants of hemoglobin by immunoassay (namely capture antibody specific to a variant, and a labeled detector antibody). Blomberg et al. teach methods (see abstract, and also page 1, lines 4-7), comprising providing a blood sample (blood sample obtained from a newborn, see page 5, lines 6-17, page 10, lines 3-14), mixing the blood sample with a buffer (see for example page 13, Example 5, page 14, Example 6, sample eluate combined with casein buffer) and performing an immunoassay to detect a combination of hemoglobin variants (see e.g., abstract, page 10, lines 9-14, and in particular page 12-13, Example 4, describing the immunoassay concept, see also Examples 5 and claims 1-11). Although the initial immunoassay format described by Blomberg et al. comprises immobilized capture antibody with affinity to the hemoglobin variants (see for example, page 7, lines 14-28, capture antibody comprising antibody against a particular globin chain, such as alpha chain), and labeled detector antibody specific for the hemoglobin variant targets (e.g., Blomberg teach 5 possible variants including HbA, HbS and HbC as claimed, see teaching at least one pair detecting a variant), see also at page 7, lines 34-46, Blomberg does teach the variant specific antibodies as capture antibodies, and the label is on the alpha chain antibody (consistent with format as presently claimed, variant specific for capture antibody, detector antibody binding alpha-chain). As such, Blomberg et al. address a first, second and third capture antibody as presently claimed, a conjugated detector (detectable moiety) antibody to the alpha-chain. See as cited above, Blomberg does teach the capture antibodies immobilized upon a substrate (see also page 7, lines 18-19).
Even further, regarding binding affinity of capture and detection antibody (referring to N-terminus and C-terminus binding affinity), it is also well known in the antibody assay art that the terminal regions of proteins are exposed and ideal targets for antibody reagents (Harlow, E. and Lane, D., Antibodies: A Laboratory Manual (1988) Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, Pages 72-76).
In view of the above evidence, the claimed steps/elements recited in addition to the judicial exception itself do not add any feature that is more than well-understood, conventional or routine in the immunoassay/lateral flow device methodologies.
This is similarly the case regarding the dependent claim limitations, see as indicated above (for example dependent claims are further directed to the data gathering steps/elements (e.g., claims 2, 3, 7-26), or further narrow the judicial exception itself (4-6)). The claim elements, when considered both individually and as an ordered combination, fail to go beyond more than what was considered routine and conventional in the assay art.
For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
Claim(s) 1-2, 4-7, 10, 12, 15-21 and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg et al., WO2005/029092A1 in view of Rutter et al., US PG Pub No. 2011/0070658A1 (IDS entered 05/06/2025), Eisinger et al., US Patent No. 4,943,522 (IDS entered 05/06/2025) and Harlow & Lane (Harlow, E. and Lane, D., Antibodies: A Laboratory Manual (1988) Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, Pages 72-76) (IDS entered 05/06/2025).
Blomberg et al. teach a method for screening/detecting hemoglobinopathies (neonatal screening of hemoglobinopathies, see abstract, and also page 1, lines 4-7), Blomberg teaching a method comprising providing a blood sample (blood sample obtained from a newborn, see page 5, lines 6-17, page 10, lines 3-14), mixing the blood sample with a buffer (see for example page 13, Example 5, page 14, Example 6, sample eluate combined with casein buffer) and performing an immunoassay to detect a combination of hemoglobin variants (see e.g., abstract, page 10, lines 9-14, and in particular page 12-13, Example 4, describing the immunoassay concept, see also Examples 5 and claims 1-11). Although the initial immunoassay format described by Blomberg et al. comprises immobilized capture antibody with affinity to the hemoglobin variants (see for example, page 7, lines 14-28, capture antibody comprising antibody against a particular globin chain, such as alpha chain), and labeled detector antibody specific for the hemoglobin variant targets (e.g., Blomberg teach 5 possible variants including HbA, HbS and HbC as claimed, see teaching at least one pair detecting a variant), see also at page 7, lines 34-36, Blomberg does teach the variant specific antibodies as capture antibodies, and the label is on the alpha chain antibody (consistent with format as presently claimed, variant specific for capture antibody, detector antibody binding alpha-chain). As such, Blomberg et al. address a first, second and third capture antibody as presently claimed, a conjugated detector (detectable moiety) antibody to the alpha-chain. See as cited above, Blomberg does teach the capture antibodies immobilized upon a substrate (see also page 7, lines 18-19).
The method of Blomberg et al. differs from that presently claimed in that Blomberg et al. fails to teach providing and loading the blood sample onto (as the solid support/assay device) a lateral flow immunoassay device comprising a lateral flow test strip comprising a chromatography matrix, and three capture antibodies, to HbA, HbS and HbC, immobilized on the test strip.
Further, although at page 7, lines 34-36, Blomberg does teach the variant specific antibodies as capture antibodies, and the label is on the alpha chain antibody (consistent with format as presently claimed, variant specific for capture antibody, detector antibody binding alpha-chain), Blomberg fails to teach the detector antibody has a binding affinity to the C-terminus of the alpha chain, and each capture antibody having binding affinity to the N-terminus of each variant.
Rutter et al. teach an easy to use, portable, handheld, point-of-care immunoassay testing device intended for the purpose of quantitatively analyzing hemoglobin, glycated hemoglobin and other a variants (paras [0007] and [0011], see also para [0005] regarding point of care testing devices). See paras [0014] and [0015], Rutter et al. teach the test strip device comprises a chromatographic strip to which sample is added (see para [0027], sample such as blood), the strip comprises capture antibodies immobilized on the strip. See also Rutter et al. at para [0041], Rutter teach capture agents such as antibodies that recognize and bind hemoglobin, see specifically like Blomberg, Rutter also teach capture agent may comprise antibodies specific for variants (such as HbA, HbA2, F, C, D, E and S). Rutter does teach (paras [0055]-[0057]), the test strip may comprise more than one capture zone (for example, paras [0055]-[0057], describing more than one capture zone to capture different forms of hemoglobin).
Regarding immunochromatographic test devices for detecting multiple targeted analytes, see as an example, Eisinger et al. teach an immunochromatographic apparatus/system comprising a porous membrane for promoting lateral flow as an assay substrate (see abstract), the substrate comprising an affixed specific binding member for capture of an analyte described as an indicator zone, see col. 5, lines 12-18, multiple indicator zones to detect different analytes). See at col. 5, lines 12-18 Eisinger teach a membrane may contain multiple indicator zones to detect different analytes (see also col. 11, lines 45-48, col. 16, lines 60-65 and Figure 9). See also col. 18, starting at line 10, Eisinger teach detection performed relying on detectable particles (see lines 19-39), and further using non particulate labels (such as enzymes) col. 18 starting at line 61 to col. 19.
Harlow & Lane also provide extensive guidance for producing highly specific antibodies that recognize antigens by using peptides as immunogens; noting that this approach has the advantage in that particular regions of a protein can be targeted specifically for antibody production (page 73). Harlow & Lane teach that carboxy terminal sequences are often exposed and can be targeted for producing antibodies; surprisingly high percentage of the resulting antibodies will recognize the native protein (see pages 75-76), see also at page 75 Harlow teach “amino-terminal regions are exposed, and these also make good targets”. As to the size of the peptide, Harlow & Lane suggest using peptides of about 10-15 amino acids in length (page 76).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Blomberg et al. in order to provide (as the test device) a lateral flow immunoassay test device as taught by Rutter et al. (the modification resulting in a method comprising providing and loading sample onto the test strip device, wherein a hemoglobinopathy present in the sample will be revealed by the lateral flow immunoassay device), one having ordinary skill in the art motivated to provide a lateral flow immunoassay test device because they are recognized as easy to use, portable handheld devices that allow for quantitative analysis at the point of care (Rutter et al.).
Further, one having ordinary skill would have a reasonable expectation of success performing the method of Blomberg et al., for detecting the hemoglobin variants to screen for hemoglobinopathies, on the lateral flow immunoassay test device of Rutter et al. because Rutter teach their device can be used with capture antibodies to the various hemoglobin variants, as in the method of Blomberg. As a result, one would reasonably expect success when performing the method of Blomberg, namely by using the device of Rutter, as the solid support assay device.
Further, although Rutter’s device does encompass detection using a mixture of capture antibodies (for example, a mixture to different hemoglobin variants), the reference is also cited as teaching the device having more than one capture zone (referring to paras [0055]-[0057] above), it would have been further prima facie obvious to one having ordinary skill in the art to have modified the test device, such that each capture antibody (the capture antibodies to the various variants) is at a different indicator zone as an obvious matter of applying a known technique to a known device/method. In particular, Blomberg is teaching screening for hemoglobinopathies by detection binding at separately, distinguishable variant specific capture antibodies. Rutter is teaching a portable, easy to use, handheld point of care device, that allows detection of hemoglobin, including detection of binding of hemoglobin to various different variants of hemoglobin. Although Rutter teaches a mixture of capture antibodies, and does reference having more than one “capture zone”, it does not clearly/explicitly teach providing each mixture at a different position on the device in order to clearly distinguish one from another (i.e., is silent as to the arrangement of the mixture), it would have been obvious when modifying Blomberg to use the immunochromatographic device of Rutter, to have provided each variant specific capture antibody at a distinct, separate indicator (capture) zone (i.e., multiple different indicator zones as in Eisinger et al.), as an obvious matter of applying a known technique to a known method, because by providing each at a spatially distinct/discrete zone from the others one would predictably allow the user to clearly be able to indicate one variant from another, and as such one hemoglobinopathy from another, based visually on binding to the distinct variant specific capture antibody (as is consistent with Blomberg, Rutter and Eisinger).
One having ordinary skill in the art would have a reasonable expectation of success because this technique for spatially arranging the indicator zones was recognized in the immunochromatographic test device art at the time (see as taught by Eisinger) and because Rutter does teach providing more than one “capture zone” (each capture zone described as capturing a particular species of hemoglobin. As a result, one would have a reasonable expectation of success applying the art recognized, known technique, used in the prior art for detecting multiple distinct analytes on a singular immunochromatographic test device.
Regarding the amended claim, limited to “a chromatography matrix, three capture antibodies…”, Blomberg et al. teach 5 possible variants to be detected, Blomberg et al. teaching detection of at least two hemoglobin variants (e.g., page 10, lines 26-30).
It would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the combination of HbA, HbS and HbC (the combination of three), by selecting from the finite list of variants suggested by Blomberg (as well as taught by Rutter, see above, Rutter also teaching the variant species as a finite list), Blomberg teaching of these variants, selecting to screen for at least two variants. One having ordinary skill would have a reasonable expectation of success because “at least two” is open to two or more, and because it was known to be able to detect multiple targeted analytes with devices such as that of Rutter (see Eisinger et al.).
Also, regarding amended claim 1 (limitations previously recited at claim 11), it would have been prima facie obvious, and one of ordinary skill would have a reasonable expectation of success, to have arranged the capture zones in any order including in the order of HbA, HbS and HbC (such that sample first interacts with HbA, then HbS, then HbC) because regardless of their order/position, the sample will proceed through the device and make contact with each. Since each capture antibody is specific for a particular variant, it would have been further obvious that the order is insignificant because each variant (if present in a sample) will bind only at its corresponding capture antibody. It is not expected that arrangement of the capture antibodies (the arrangement of their order) would have modified the operation of the device. MPEP 2144.04.
Further, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the capture and detector antibodies, specifically to have relied on as detection antibody, a universal detection antibody with affinity to the C-terminal region of the alpha chain (i.e., a single detection antibody, thereby also addressing claim 27), by applying the known technique of Harlow & Lane when employing a universal detection antibody (as in Blomberg). One would be motivated to modify the detector antibody to target the C-terminal region because it was known in the art that the variant residues (the residues distinguishing the variants) are located in the N-terminal region; thereby a detector antibody that binds the C-terminal region would not interfere with or be affected by binding at the variant.
Regarding the capture antibodies, additionally, it would have been prima facie obvious to rely on capture antibodies that have affinity to the N-terminus of each variant because like the carboxy terminal region, it was known that the “amino-terminal regions are exposed” and as such make good targets for binding, this coupled with the knowledge that the residues distinguishing variants are located in this region, it would have been obvious (motivation being this region as suitable for distinguishing targets, and because this region also would be expected to make a good target for binding based on Harlow).
One of ordinary skill would have a reasonable expectation of success because the motivation would result in an antibody that binds all of the variants (consistent with that of Blomberg et al.), and because generally it was recognized that terminal regions of the protein are exposed and make for good binding targets.
The combination of the cited art above addresses a method of screening for and detecting hemoglobinopathies if present, where if present, hemoglobinopathy is detected and simultaneously differentiated by visualization of presence of the associated variant.
Regarding claim 2, see Blomberg et al. in view of the cited art, the combination of the cited art teach determining, simultaneously (on one immunochromatographic device) each of HbS, HbC and HbA. See Rutter et al. at para [0052], their test device allows for relative quantitation. Therefore, the combination of the cited art as set forth above addresses relative quantitation (Blomberg et al., modified to rely on Rutter’s device).
Regarding claim 4, Blomberg teach their methods can differentiate sickle cell carrier samples from other samples (See Blomberg at Example 8). See also for example, page 6, lines 13-26, the methods of Blomberg are for simultaneously distinguishing non-afflicted subjects from subject’s afflicted with a hemoglobinopathy based on the detected hemoglobin variants to be detected (see as discussed above, the combination of the cited art addresses detecting at least HbS, HbC and HbA, thereby differentiating sickle cell, HbC disease and normal hemoglobin).
Regarding claims 5 and 6, Blomberg et al. teach detection of HbS and HbC relates to sickle cell anemia (page 1, line 24 to page 2, line 2; page 8, lines 19-31), see further the methods of Blomberg provide indication of α and/or β- thalassemia (page 8, lines 19-27).
Regarding claim 7, see Blomberg teach use of dried blood spot specimens (Guthrie spots), further Rutter et al. teach samples that are blood samples which have been lysed to release Hb from the red blood cells (para [0016]). It would have been prima facie obvious to have started with a blood sample that is for example a whole blood sample, and then further to have lysed the sample thereby resulting in an isolated hemoglobin sample as in Rutter, as Rutter teach lysing the cells release the hemoglobin for detection by way of the immunochromatographic test device. As a result, the modification would have been an obvious matter of applying a known technique to a known method (namely starting with a dried blood sample, further lysing to produce and isolated hemoglobin sample, thereby addressing the claims as presented). One having ordinary skill in the art would have a reasonable expectation of success applying a known technique to a known method.
Regarding claims 10 and 17, see Rutter et al. at Figure 2, adding the lysed solution to the sample addition port of the immunochromatographic test device. As such, the combination of the cited art addresses the claim.
Regarding claim 12, see as cited in detail above, the combination of the cited art teaches each capture antibody immobilized in multiple distinct zones (i.e., discrete analyte capture zones).
Regarding claims 15 and 19, the limitations specific to the shape of the capture zones (see claim 15, rectangular shaped or circular shaped capture zones; claim 19, arranged on the strip in a linear array parallel or substantially equidistant on the chromatography matrix), see as in Rutter, capture zones are shown as equidistant parallel lines spanning the width of the membrane (rectangular, see Figure 7) and in Eisinger see Figure 9 described at col. 13, lines 53 to col. 14, showing indicator zones provided at equidistantly spaced circular spots. See Eisinger teaching (col. 13, end of column) geometry is arbitrary.
The courts have held that changes in shape would have been obvious absent persuasive evidence that the particular configuration of the claimed structure was significant (MPEP 2144.04, IV, B). It would have been obvious to have provided the capture antibodies in the distinct positions, equidistant from one another in order to distinguish one from another, in either of rectangular or circular shape because Eisinger teach regarding devices comprising multiple binding reagent, that the geometry is arbitrary. One of ordinary skill in the art would have a reasonable expectation of success providing either shape capture zones (either rectangular or circular) considering the shape was an art recognized feature considered insignificant (Eisinger).
Regarding claim 16, see as cited in detail above, the combination of the cited is teaching multiple capture zones, a capture antibody at each zone (thereby addressing simplexed as presently claimed).
Regarding claim 18, see further although Rutter demonstrate subjecting specimens to a lysis solution, see also Rutter teach lysing is optional (i.e., blood samples can be added directly to the sample receiving area (see specifically at para [0028], the cell need not be lysed).
Regarding claims 20 and 21, see Rutter further teach the test strip may comprise a conjugate pad comprising conjugated detector antibody (see Rutter et al. at paras [0058] and [0059] (detectably labeled agents… that are present in the conjugate pad, and at Rutter claim 30, see further para [0061] regarding detectably labeled agent that is an antibody), see also located between sample addition region and the capture agents (analyte capture zones). As such, the modification as set forth previously above, to rely on the test device of Rutter, addresses the claims (the combination of the cited art addresses the claims).
Regarding claim 23, the combination of Blomberg, Rutter and Eisinger address detectable moieties comprising fluorescent labels (see for example, the device of Rutter teaching fluorophores labels, para [0013], see also Rutter although focused on fluorescent labels, Rutter also teaches detectable markers are not limited and can includes luminescent labels, fluorescent labels, particles (particulate labels), metal colloids, radioactive labels etc.).
Regarding claim 24, Eisinger et al. teach appropriate test strip matrix material as claimed, see for example suitable known materials such as nitrocellulose, nylon and the like (col. 6, lines 52-55, thereby addressing nitrocellulose membrane as claimed). Although Rutter et al. is silent as to their test strip material, it would have been prima facie obvious to one of ordinary skill to have used nitrocellulose as an obvious matter of use of a known material for its art recognized purpose, namely as an immunochromatographic material for lateral flow assay device. One having ordinary skill would have a reasonable expectation of success because like Rutter, Eisinger et al. is teaching an immunochromatographic test strip device that operates based on lateral flow.
Regarding claim 25, the combination of the cited art is teaching sandwich assay technique.
Regarding claims 26 and 28, see as cited above, the combination of the cited art, relies on a point of care (POC) testing devices, as taught by Rutter et al.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Blomberg et al. in view of Rutter et al., Eisinger et al. and Harlow, as applied to claim 1 above, and further in view of WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. 7, Capillary sampling. Available from: https://www.ncbi.nlm.nih.gov/books/NBK138654/.
Blomberg et al. teach obtaining neonatal blood samples for screening hemoglobinopathies, but is silent as to the technique for collection.
As such, fails to teach providing a blood sample comprising finger-stick, heel-stick or venipuncture (claim 8).
Regarding paediatric and neonatal patients, WHO Guidelines encourage selection of a site (finger stick or heel stick) for capillary sampling based on age and weight of patient, and considerations like if the child is walking (see section 7.1.1.).
It would have been prima facie obvious to one having ordinary skill to have obtained the blood sample of Blomberg et al., by way of finger or heel stick according to WHO Guidelines as an obvious matter of applying a common technique known in the prior art for paediatric/neonatal sample collection (use of a known technique for a known method). One having ordinary skill would have a reasonable expectation of success obtaining a neonatal blood sample using techniques known for paediatric and neonatal blood sample collection.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blomberg et al. in view of Rutter et al., Eisinger et al. and Harlow, as applied to claim 1 above, and further in view of Hideki et al., JP201125819A (English machine translation obtained via PE2E search).
Regarding claim 9, see regarding the combined prior art as cited above, Rutter teach performing lysis in order to release hemoglobin from red blood cells (paras [0016]-[0018]). See specifically para [0029] using a lysis buffer (4 mM phosphate buffer, pH 7.5, 1% Triton X-100, 150 mM NaCl).
Instant claim 9 recites hemolysis, dilution of the blood sample, release/mobilization of packed NP-detection antibody conjugates on the test strip, creation of an immuoreaction environment between detection antibody and hemoglobins, and enhancement of the Hb-bound detector antibody movement on the strip to the discrete capture zones of immobilized binding reagent, the claim further amended to recite wherein the buffer comprises a detergent effective to lyse red blood cells and release hemoglobin. Rutter et al. teach a lysis buffer which similarly dilutes sample and promotes release of reagents/flow through device, thereby creating immunoreaction environment between regions and target antibody, moving to the discrete regions for capture. See as cited above, Rutter teach detergent (see for example, Triton X). Embodiments of Rutter describe conjugate (detector antibody) at a conjugate pad, see paras [0058]-[0059], buffer causing detector antibody to be released/mobilize and flow through strip (see e.g., paras [0017]-[0018], and also paras [0040], [0054] labeled hemoglobin flows along).
However, the combination of the cited art fails to teach the fluorescent label as a fluorescent nanoparticle label.
Hideki et al. is another example of an immunochromatographic test strip device (see abstract and Figures), Hideki teach a fluorescent silica nanoparticle label that exhibits less aggregation, high dispersibility, less non-specific adsorption and high biomolecule reactivity resulting in high sensitivity analysis (see page 2 of translation, technical problem, page 4, advantageous effects, page 9, last paragraph, page 10, last full paragraph). See at page 5 of the translation, paragraph 3, and also page , paragraph 5, referring to silica particles containing fluorescent dye.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the lateral flow immunoassay device of the method of Blomberg and the cited art in order to have used as conjugate label the silica fluorescent substance containing nanoparticles of Hideki et al. because they result in less aggregation, high dispersibility, less non-specific adsorption and high reactivity, thereby resulting in high sensitivity. One having ordinarily skill in the art would have a reasonable expectation of success because like the method taught by the combined cited prior art, Hideki teach these nanoparticle labels as known usable for immunochromatographic assay methods (methods using such devices).
Claim(s) 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg et al. in view of Rutter et al., Eisinger et al. and Harlow, as applied to claim 12 above, and further in view of Davis et al., US PG Pub No. 2009/023059A1 (IDS entered 05/06/2025).
Regarding claim 13, see further Rutter also teach on their test strip, a control band comprising capture agent that binds a control present in the sample (para [0023]).
However, Rutter et al. and the cited prior art fails to teach the fourth capture antibody as an antibody with affinity to IgG of the host animal of the conjugate detector antibody (claim 13).
Davis is another example in the prior art of a lateral flow immunoassay device (see abstract and Figure 1) structurally similar to that as taught by the combination of the cited prior art above (a chromatographic assay device which operates on the principle of lateral flow of fluid as in Rutter and Eisinger); see at para [0008] Davis teach providing a control band (immobilized anti-IgG) at the substrate device, specifically providing excess labeled antibody, such that even if the targeted analyte is present in the sample, there is sufficient labeled species present to ensure some passes beyond the capture band. Davis teach as such, whether or not the analyte is present, some labeled antibody reaches the control band. As such, Davis is teaching a control that demonstrates proper operation of the device regardless of presence/absence of analyte.
It would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have provided the control reagent of Rutter as an antibody that binds residual detector antibody (antibody with affinity to IgG of the host animal of the conjugate detector antibody), as in Davis, in order to demonstrate proper operation of the device regardless of whether or not analyte is present in the sample (the motivation is in order to demonstrate proper operation of the device during its use). The modification (to have provided control reagent of Rutter as an antibody that binds residual detector antibody) would be considered an obvious matter of applying a known technique to a known immunochromatographic product, specifically the prior art contained the base product, namely immunochromatographic lateral flow devices (for example, as in Rutter and/or Eisinger). Further the prior art contained the known technique of providing on such immunochromatographic devices a control band capable of binding residual detector (labeled) antibody for the purpose of demonstrating proper operation of the device (Davis), independent of the presence of targeted analyte(s). One having ordinary skill in the art would have recognized that applying the technique of providing a control band to bind residual detector antibody would have yielded predictable results, namely the ability to confirm proper operation of the device during its use. One having ordinary skill would have a reasonable expectation of success in modifying the device to provide a control as in Davis because the device of Davis, similarly to that as taught by the combination of the cited art, operates by lateral flow of sample through conjugate (the conjugate is already present at the device, and would be available to bind at a control for showing proper operation, this modification feasible considering it was already an art recognized technique, as shown by Davis).
Response to Arguments
Applicants’ arguments filed 07/10/2026 have been fully considered but they are not persuasive for the following reasons.
Regarding remarks at pages 8-9, the previous rejection of claim 9 under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendments to the claims.
Regarding remarks at page 9, Applicant argues the rejection of claims under 35 U.S.C. 101, referring to amendments to the claims (page 9), Applicant arguing as amended, that the claims are no longer directed to a law of nature, natural phenomenon or abstract idea (page 10), but rather a new and useful implementation of an innovative antibody design strategy that provides for lateral flow immunoassay system that can be used for simultaneous detection of the claimed hemoglobin variants at the POC. Applicant argues the claimed invention is a first of its kind system that can differentiate between sickle cell disease and trait, HbC disease and trait, and normal hemoglobin, and as such applicant asserts the claimed methods are the type of method that are carried out by an artisan to achieve a new and useful end.
However, Applicant’s arguments are not persuasive, the claims still recite a judicial exception and as such, are subject to the required analyses under 35 U.S.C. 101 (the correlation between the biomarkers and the detection of hemoglobinopathies). Regarding the argument that the claimed method is directed to an innovative antibody design strategy, this argument is not persuasive, the claimed innovative antibody design strategy is not considered innovative in view of the cited prior art, particularly given that the prior art supports those of ordinary skill in the art already appreciated immunoassay differentiation of the different hemoglobin variants to distinguish normal hemoglobin from HbS and HbC, see specifically referring in particular to Blomberg et al. and Rutter et al., each cited in detail previously above.
Applicant specifically argues (remarks pages 10-11, referring to Step 2A, Prong 1) that the claims are not directed to a judicial exception, that referring to the relation between HbA, HbS and HbC and hemoglobinopathies mischaracterizes the claims, that rather the claim recites a method of physically performing a specific lateral flow immunoassay using a defined device architecture, that the “heart” of the invention is the physical construction and operation of the lateral flow device as claimed (see summarized at remarks page 11). Applicant asserts that the method requires physical steps and a specific device architecture to achieve a practical, real world result: POC differentiation of the variants for hemoglobinopathies.
This argument is not persuasive, see the rejection above which specifically refers to the specific steps of the analysis under 35 U.S.C. 101. Prong One specifically considers “does the claim recite an abstract idea, law of nature, or natural phenomenon”, and the answer to this consideration is “yes”, see referring to the arguments at page 11 by Applicant the claim is directed to “differentiation of hemoglobin variants for hemoglobinopathy detection”, hemoglobinopathy refers to a diagnostic result, namely a group of inherited blood disorders. The claim is specifically correlating the naturally occurring hemoglobin variant biomarkers with this diagnostic result(s). Because the claim recites an exception, it is necessary to proceed to Prong two of the analysis- the device itself is not considered at Prong one, rather the limitations specific to the device are additional limitations recited in addition to the judicial exception.
Applicant presents arguments specific to Prong two of the analysis at remarks page 12, arguing that the claims integrate any alleged exception into a practical application because the lateral flow device recited is not a generic tool, but rather is a structurally specific device that integrates, and as such satisfies the “improvement to another technology” consideration and is considered a “particular machine”. Applicant argues the claimed device is not generic data gathering equipment.
Regarding the “improvements” consideration, in determining whether a claim integrates a judicial exception into a practical application, it is necessary to consider whether the invention pertains to an improvement in the technology or the technical field, i.e., a technological solution to a technological problem, and in making this determination it is necessary to evaluate whether a claim “contains an improvement”, it is also important to note (MPEP 2106.05(a)) the judicial exception alone cannot provide the improvement. See specifically MPEP 2106.05(a), the courts have indicated examples of what may not be sufficient to show an improvement, for example “gathering or analyzing information using conventional techniques and displaying the results”, and “using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma”.
Regarding the assertions by Applicant that the lateral flow device is not a generic tool, this argument is not persuasive, the structure of the claimed device is not considered to go beyond well-known structural embodiments typically implemented for these types of devices, the method is using a conventional technology (lateral flow/immunochromatographic test device) to gather and analyze the information obtained, specifically, as noted in the rejections above, it was standard in the assay art to use immunoassay techniques to distinguish different hemoglobin variants, including variants HbS and HbC from HbA (Blomberg et al.), further it was standard to rely on immunochromatographic test device for this type of detection (referring specifically to Rutter, and the additionally cited evidence as noted above under 35 U.S.C. 101). Regarding the claimed details specific to the claimed assay device and its elements (e.g., antibody affinity to C or N terminal regions, discrete capture zones, single detection antibody, nanoparticle label, etc.), Applicant is combining standard, art recognized assay device structures/techniques well established in the immunochromatographic assay art. For example, using the terminal regions of proteins (the exposed regions) for antibody design is well recognized given that these regions are considered good targets (see Harlow and Lane cited in detail above), having discrete/distinct capture zones for multiplex detection is also recognized in the art, thereby allowing differentiation in multi-plex format where more than one targeted analyte is detected. Generally, implementing an exception on a physical structure/machine, is not a patentable application. In the present case, the claimed device does not appear to amount to a particular machine because it is merely relying on conventional lateral flow/immunochromatographic structure/design.
However, even if the lateral flow device structure was considered to be a particular machine, referring to MPEP 2106.05(b), its involvement is considered to be extra solution activity in that, when considering the extent to which or how it imposes meaningful limits on the claim, it contributes only insignificantly to the execution of the claimed method in that it is merely being used to obtain the data (the structure, which implements standard immunochromatographic strategy for design of a lateral flow device for hemoglobin detection, is being used to detect those variants present in the sample, which the correlation is those variants correlate with hemoglobinopathies). There are no limitations which then apply, rely on or use the correlation (the exception) to amount to a practical application thereof.
Regarding step 2B, Applicant further refers to the specific binding of the capture and detector antibodies (remarks page 12), however, see these limitations discussed in detail above, targeting these regions is not activity that goes beyond that which was well-known-routine and conventional in the assay art (referring to the text book, Harlow & Lane, discussed previously above).
Regarding the asserted improvement, Applicant argues the presently claimed subject matter is the integrated diagnostic device itself, particularly the combination of 3 capture antibodies as claimed and a single universal C-terminus alpha-chain detector antibody, which together enables simultaneous, visually readable, POC differentiation, Applicant arguing this was not previously achievable with prior art methods, such as Blomberg’s DELFIA. However, this argument is not persuasive, particularly because it would be expected to be achieved with an immunochromatographic device such as that of Rutter, which is also specifically for detecting and visualizing hemoglobin species.
See specifically, Rutter et al. teach an easy to use, portable, handheld, point-of-care immunoassay testing device that is an immunochromatographic test strip device intended for the purpose of quantitatively analyzing hemoglobin, glycated hemoglobin and other variants (paras [0007] and [0011], see also para [0005] regarding point of care testing devices). See also Rutter et al. at para [0041], Rutter teach capture agents such as antibodies the recognize and bind hemoglobin, Rutter also teach capture agent may comprise antibodies specific for variants (such as HbA, HbA2, F, C, D, E and S). Based on the cited art of record, one having ordinary skill, contrary to Applicant’s remarks, would expect such detection as achievable with immunochromatographic test device methods.
Applicant refers to the Declaration under Rule 37 CFR 1.132 by co-inventor Dr. Frank Wang (hereinafter referred to as the Wang Declaration). The Wang Declaration asserts (paragraph 5) that the Sickle SCAN™ device is a commercial embodiment of the claimed invention, further that this is a lateral flow immunoassay device consistent with the embodiments of the present claims. Applicant argues that prior to the subject application, methods and devices for POC detection of hemoglobinopathies like Sickle cell disease represented a long-felt need in the art and medical communities worldwide (paragraph 6), asserting this is evidenced by the true and accurate copy of the RFI: Challenges and Opportunities for the Development of a Point of Care Device for the Diagnosis of Sickle Cell Disease, issued by the National Heart, Lung and Blood Institute of the US NIH on April 6, 2012, attached presently as Exhibit A.
However, regarding remarks at page 13 referring to the Wang Declaration, it is noted that long felt need is not a consideration under 35 U.S.C. 101, rather long-felt need is a secondary consideration evaluated under 35 U.S.C. 103. This argument is addressed in more detail below in response to remarks to the rejection under 35 U.S.C. 103.
Arguments specific to the rejection of claims under 35 U.S.C. 103 begin at remarks page 16, however, first in response to remarks asserting long-felt need in relation to the rejection of claims under 35 U.S.C. 103 (referring to the Wang Declaration referenced at remarks page 13, paragraphs 5 and 6 of the Wang Declaration, although presented under arguments specific to rejection under 35 U.S.C. 101, the argument is addressed in relation to the cited prior art under 35 U.S.C. 103 in the interest of compact prosecution), establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. See MPEP § 716.04. Notably, Exhibit A was published in 2012, and the device of Rutter was published in 2011. There is no showing that others of ordinary skill in the art were working on the problem, and if so, for how long. In addition, there is no evidence that if persons skilled in the art who were presumably working on the problem knew of the cited prior art of record, they would still be unable to solve the problem. See MPEP § 716.04. In addition, the long-felt need must not have been satisfied by another before the invention by Applicant.
The Wang Declaration at paragraph 7 asserts Williams et al., (referred to at remarks as Exhibit B) is evidence the Applicant’s Sickle SCAN™ is s solution to the long felt need. However, consistent with response to arguments above, this evidence is not evidence that if persons skilled in the art who were presumably working on the problem knew of the cited prior art of record, they would still be unable to solve the problem. It is not disputed that Applicant’s invention is a rapid, POC screening tool that allows rapid detection of the hemoglobin variants that distinguish hemoglobinopathies, however, Applicant’s remarks and evidence are not persuasive that the claimed invention is unobvious over the cited prior art of record. This is similarly the case regarding Applicant’s cited Exhibits C, D and E (Kanter et al., which is cited as stating the Sickle SCAN has “an unprecedented capacity to differentiate SCD…”, Nguyen-Khoa et al., cited as stating this commercial scan “fulfills analytical conditions for neonatal screening of sickle cell disease”, and Nwegbu et al., which references the scans high sensitivity of detection).
At remarks pages 16-17 Applicant refers to amendments to the claims and asserts the claimed invention is distinguished over the cited combination of references in that the particular antigen targets for the capture and detector antibodies were selected so that the simultaneous detection of the presence/absence and/or relative levels of the claimed hemoglobin variants can be accomplished with one test. Applicant argues that one of ordinary skill in the art could not accomplish this objective with a reasonable expectation of success based on the cited combination of the prior art, at remarks pages 18-19 summarizing each of the cited reference individually.
At remarks page 19 Applicant argues Rutters lateral flow device was designed for a fundamentally different purpose, HbA1c quantification for diabetes, and its single capture zone, total Hb-capture architecture is incompatible with hemoglobinopathy screening and detection. However, fundamentally different suggest that prior art, at its very foundation, is distinct. However, like Blomberg, Rutter’s invention is based on immunoassay detection of hemoglobin, including glycated hemoglobin as well as other variants, and the other variants include HbA, HbA2, F, C, D, E and S (see paras [0007], [0011], [0041]). As a result, the argument that Rutter is fundamentally different is not persuasive; while the focused embodiment of the US PG Pub. is HbA1c quantification for diabetes, Rutter also acknowledges detection of “other variants” with their immunochromatographic test strip device, and further (as cited above), references the specific variant hemoglobin forms, including in that finite list those of the present claims. As a result, the argument that the Office has applied impermissible hindsight reasoning, is not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, only that which was within the level of ordinary skill at the time is what was taken into account in making the rejection (see the cited art referenced above).
Although Rutter’s example for glycated hemoglobin discloses a single capture zone, as noted above, Rutter does also suggest detection of other variants forms and does suggest the ability to provide more than one capture zone, and the use of immunochromatographic test strip devices for plural analytes in a multiplex format is also a well-known modification, see for example as cited above as an example, Eisinger et al. teach an immunochromatographic apparatus/system comprising a porous membrane for promoting lateral flow as an assay substrate (see abstract), the substrate comprising an affixed specific binding member for capture of an analyte described as an indicator zone, see col. 5, lines 12-18, multiple indicator zones to detect different analytes). See at col. 5, lines 12-18 Eisinger also more clearly (as compared to Rutter) does teach a membrane may contain multiple distinct indicator zones to detect different analytes (see also col. 11, lines 45-48, col. 16, lines 60-65 and Figure 9).
Applicant further remarks (page 20) that Eisinger’s generic multi-analyte zones do not address the specific technical challenge of distinguishing hemoglobin variants to distinguish hemoglobinopathies in lateral flow format, however this argument is not persuasive, it appears that a multi-analyte strategy, such as that taught by Eisinger’s is exactly the type of solution to a challenge of distinguishing different variants captured using different variant specific antibodies by lateral flow immunochromatographic device, and as such would be considered particularly relevant when considering Blomberg as modified by Rutter et al. See specifically col. 5, lines 13-18, Eisinger state “multiple indicator zones may be designed to detect different analytes or for quantifying the amount of analyte. Multiple indicator zones may be in any spaced relationship to the application zone, since the membrane itself does not provide a barrier to sample flow.” Specifically, Eisinger teaches “multiple analytes in a single sample can be determined with a single apparatus by providing multiple indicator zones so that each indicator binds only one analyte”. This references solution specifically addresses the application of immunochromatographic test devices to detect more than one target, and as such would be considered applicable with an expectation of success for the reasons as discussed in detail above.
Additionally, regarding remarks at apges19-20, specific to the use of N-terminal and C-terminal binding for detection, as discussed above Applicant’s remarks are not persuasive, antibodies targeting these binding regions of targeted analytes is a routine strategy considering the availability of these regions for targeted binding by antibodies.
At remarks page 21 Applicant also argues the citation of Rutter in reference to the amended claim language at claim 2, arguing Rutter’s quantitation is of HbA1c disease, not ratio of HbA/HbS/HbC ratio. This argument is not persuasive when considering the combination of the prior art, the device of Rutter is teaching relative quantitation, and the modification of Blomberg in view of Rutter and the other cited prior art results in detection/relative quantitation of these variants, and as such thereby differentiation based on the relative amounts (ratios) of each detected.
At remarks 22-24 Applicant argues the further rejected dependent claim limitations, for example regarding claim 7 that Rutter’s lysis is for Hb1Ac release, however this argument is not persuasive, one of ordinary skill would expect release of the hemoglobin variants upon red blood cell lysis as taught by Rutter.
Regarding claim 15, Applicant argues Eisinger’s teaching that geometry is arbitrary is not applicable to zone spacing and shape, however, see Eisinger as cited in detail above both in the rejection and response to remarks, this argument is not persuasive. Even further the reference does demonstrate linearly spaced indicator zones (for example see the document including claims). See further in this sample pace referenced by arguments (col. 13, last paragraph), plurality of indicator zones… provided equidistantly spaced.
Regarding claims 8 and 26, it is maintained for the reasons as indicated in the pending rejection that the combination of the cited art addresses the claimed blood collection as well as the use of the device as a point of care device. See also the pending ground of rejection, it is maintained that claims 13 and 14 are addressed.
See the amended grounds of rejection regarding claim 20, Rutter also address labeled conjugate in a conjugate pad of the device.
The Wang Declaration is further referenced at remarks pages 23-24, see response to the Wang Declaration as set forth in detail above.
Additionally, see the amended grounds of rejection addressing new claims 27 and 28.
For all of these reasons, Applicant’s remarks are not persuasive.
Correspondence
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
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