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 .
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/KR2019/008465, filed 07/10/2019. Acknowledgement is also made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. KR10-2018-0172576, filed on 12/28/2018 in Korea.
Status of the Claims
Claims 1, 3, 6-7, and 10 are pending. Claim 1 is amended. Claims 2, 4-5, and 8-9 are cancelled. Claims 1, 3, 6-7, and 10 are examined below.
Withdrawn Rejections
The rejection of claims 1, 3, and 6-7 under 35 U.S.C. 112(a) for new matter is withdrawn due to the amendment of the claims.
The rejection of claims 1, 3, and 6-7 under 35 U.S.C. 112(b) is withdrawn due to the amendment of the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. KR20160108695A, in view of Chang et al., US7332350B2, Ward et al., WO2018140719, and Nerenz et al. Screening method to evaluate point-of-care human chorionic gonadotropin (hCG) devices for susceptibility to the hook effect by hCG β core fragment: evaluation of 11 devices. Clinical chemistry. 2014 Apr 1;60(4):667-74, as evidenced by MedixMab Hormones, Technical Note, 2020 and Bioventix, Technical Note, 2020.
Regarding claim 1, Jin teaches immunochromatographic strips comprising a detection pad and a conjugate pad (Jin, page 4, ‘E. Preparation of immunochromatographic strips’, line 1). Jin further teaches that the conjugate pad comprises colloidal gold particles and polyclonal anti-hCG as the first anti-chorionic gonadotropin antibody (Jin, page 4, ‘B. Conjugate Making a pad’, lines 1-2). Still further, Jin teaches a detection pad comprising with three analytical lines, using monoclonal anti-human chorionic gonadotropin antibody in one test line and human chorionic gonadotropin second test line (Jin, ‘A. Inspection line, Heterogeneous Inspection line and the formed detection pad making’, lines 2-5). Jin further teaches that the test lines are separated (Jin, page 10, see Figure 4), number 6 is human chorionic gonadotropin antibody immobilized test line and number 7 is human chorionic gonadotropin-immobilized heterogeneous test line (Jin, page 4, last line – page 5, line 8). Jin further teaches that the test strip is provided with a heterogeneous test line (test line comprising human chorionic gonadotropin) to overcome the problem of false negativity due to the hook phenomenon (Jin, page 1, ‘Abstract’, lines 5-7). Jin teaches that in case of the heterogeneous test line, the signal intensity gradually decreases as the concentration in the specimen increases. When the concentration of gonadotropic hormone is low, since the hook phenomenon does not occur in the test line, the concentration of the gonadotropic hormone can be analyzed through the signal intensity of the test line. When the concentration of gonadotropin stimulates further, the intensity of the signal is irregular due to the occurrence of the hook phenomenon in the test line, but it is possible to measure the concentration due to the heterogeneous test line (Jin, page 6, see entire 4th paragraph and table 1).
Jin fails to teach that the first antibody recognizes a β-core fragment site of human chorionic gonadotropin and the second antibody recognizes a different site of hCG, which is not the β-core fragment site of hCG. Jin further fails to teach that hCG or a variant thereof comprises a human chorionic gonadotropin β-core fragment and that the false negative is caused by a variant of hCG comprising a β-core fragment.
Chang teaches a one-step diagnostic device for detecting normal pregnancy and distinguishing it from ectopic pregnancy (Chang, ‘Abstract’, lines 1-3). Chang further teaches the use of an immune-chromatographic method (Chang, column 5, lines 20-21). Chang further teaches antibodies reactive to I-hCG, modified hCG, α-hCG, and β-hCG (Chang, column 5, lines 40-45). Chang further teaches that “modified” hCGs include free β-core fragment (Chang, column 2, lines 37-39). Chang further teaches a test strip comprising an anti-β-hCG monoclonal antibody has been immobilized (Figure 1b, reference numeral 9) and a pad comprising colored particulates having an anti-modified hCG monoclonal antibody bound thereon (Figure 1b, reference numeral 10; Chang, column 4, lines 25-32). Chang further teaches that an ectopic pregnancy can be determined through comparison between the concentrations of normal hCG and modified hCG (Chang, column 3, lines 54-56).
Chang does not teach an antibody recognizing the β-core fragment of hCG or a second antibody that recognizes a different site of hCG.
Ward teaches a method comprising a magnetic particle and a capture moiety configured to bind an analyte of interest, a reporter conjugate comprising a reporter and a reporter binding moiety configured to bind the analyte of interest and detecting the presence, absence, or level of analyte by detecting the reporter (Ward, see entire ‘Abstract’). Ward further teaches that the capture moiety and the reporter binding moiety is an antibody (Ward, page 3, lines 3 and 9-10). Ward further teaches that the terms ‘reporter’ and ‘label’ may be used interchangeably and that the label includes gold particles (Ward, page 38, paragraph [0156], lines 1 and 16-18). Ward further teaches a labeled antibody and a capture antibody bound to a substrate (Ward, page 1/35, Figure 1A) and an exemplary analyte of interest that is hCG (Ward, page 9, line 3). Ward further teaches a labeled first antibody (see Ward, Figure 1A, antibody (b)) that is anti-hCG clone 4F9 and a substrate bound second antibody (see Ward, Figure 1A, antibody (c)) that is anti-hCG clone 5011, which are able to simultaneously bind the analyte (Ward, page 9, paragraph [0032], lines 3-6), which is an important factor for choosing antibodies and a prerequisite for the antibodies to work successfully (Ward, page 18, paragraph [0070], lines 1-2). According to Bioventix Technical Note, clone 4F9 binds intact hCG as well as the β-core fragment (Bioventix Technical Note, ‘ELISA DATA: Epitope Recognition’, see column 3) and according to Medix Technical Note, clone 5011 binds intact hCG, but not the β-core fragment (Medix Technical Note, page 7, ‘Epitopes and specificity, see line 7).
Nerenz teaches that the predominant hCG variant in urine, hCG β core fragment has been demonstrated to cause false-negative results in qualitative point of care hCG devices (immunochromatographic test strips; Nerenz, page 667, ‘Background’, lines 1-4). Nerenz further teaches that hCG immunoreactivity results from intact hCG as well as chemically modified variants, including the core fragment of hCGβ (Nerenz, page 667, 2nd column, lines 1-6). Nerenz further teaches that one-step sandwich assays, including point of care hCG devices may generate weakly positive or negative signal in the presence of high analyte concentration due to excess antigen, known as the hook effect. Nerenz further teaches the phenomenon of a variant hook effect occurs when in addition to intact hCG, one of the antibodies used in the assay recognizes an hCG variant (such as hCG β-core fragment) and the other antibody does not recognize it at all. When the variant is present in high enough concentrations, a false-negative result can occur (Nerenz, page 667-668, 2nd column, see entire 3rd paragraph). Nerenz further teaches that false-negative results because of the presence of high concentrations of hCG β-core fragment, in women with hCG concentrations regularly observed during healthy pregnancy are a clinically significant concern for the healthcare profession (Nerenz, page 672, ‘Discussion’, lines 1-5). Nerenz further teaches that unlike the variant hook effect, the hook effect due to hCG occurs primarily in the presence of pathologically increased hCG such as gestational trophoblastic disease (Nerenz, page 667, 2nd column, 2nd paragraph, lines 11-13).
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 test strip of Jin to comprise antibodies to intact and modified hCG (comprising β-core fragment) as taught by Chang and specifically to have applied the antibody clones 4F9 and 5011 of Ward to the invention of Jin, because of the teaching of Ward that they can simultaneously bind hCG and that this is a prerequisite in choosing antibody pairs.
One of ordinary skill in the art would have been further motivated to do so because Jin teaches that the immunoassay comprising one test line with anti-hCG antibody and one heterogenous test line comprising hCG allows for the determination of pregnancy even in cases where the hook effect results in a negative first test line due to excess hormone in the sample and the teaching of Nerenz that the hook effect in normal pregnancy can be caused by high, but physiologically normal, levels of hCG β-core fragment whereas very high concentrations of hCG occurs primarily in the presence of pathologically increased hCG. Nerenz teaching that the variant hook effect especially occurs using a test strip where in addition to intact hCG, one of the antibodies used in the assay recognizes an hCG variant and the other antibody does not recognize it at all. Put another way, using an anti-hCG β-core fragment antibody as taught by Ward in the assay of Jin would allow to confirm pregnancy despite a hook effect caused by high, but physiologically normal levels of hCG β-core fragment but not potentially pathologically increased hCG levels.
The ordinary artisan would have a reasonable expectation of success, because Jin teaches an immunoassay with a free labeled antibody specific for hCG and a membrane bound antibody specific for hCG and Ward similarly teaches a free labeled antibody specific for hCG and a complimentary substrate-bound antibody for hCG.
Regarding the functional limitations recited in claims wherein the first anti-hCG monoclonal antibody binds both normal hCG and the β-core fragment of hCG and the second anti-hCG monoclonal antibody binds the normal hCG but not the β-core fragment of hCG, wherein a complex of normal hCG and first anti-hCG antibody is captured on test line 1, a complex of the β-core fragment and the first antibody is not bound on test line 1 and a bare conjugate (first antibody not bound to either normal hCG or β-core fragment) is captured on test line 2) and wherein the strip is configured to diagnose pregnancy by comparing the signal of the test line 1 and the signal of the test line 2, thereby avoiding a false negative caused by the β-core fragment.
The prior art needs only teach the structural limitations capable of performing the functions as claimed.
The combination of the prior art teaches a chromatography strip for diagnosing pregnancy comprising comparing the signal of a test line 1 (an anti-hCG antibody) and test line 2 (hCG) to avoid a false negative test result (see Jin, page 1, ‘Abstract’, lines 5-7). A conjugate pad comprising gold-labeled anti-hCG antibody (Jin, page 4, ‘B. Conjugate Making a pad’, lines 1-2). Bioventix Technical Note teaches an antibody clone 4F9 which binds intact hCG as well as the β-core fragment (Bioventix Technical Note, ‘ELISA DATA: Epitope Recognition’, see column 3) and Medix Technical Note teaches an antibody clone 5011 which binds intact hCG, but not the β-core fragment (Medix Technical Note, page 7, ‘Epitopes and specificity, see line 7). Nerenz provides motivation to eliminate the β-core fragment from detection in the assay of Jin because Nerenz teaches that the variant hook effect occurs when in addition to intact hCG, one of the antibodies used in the assay recognizes an hCG variant such as hCG β-core fragment (Nerenz, page 667-668, 2nd column, see entire 3rd paragraph).
Put another way, the combination of the prior art teaches a device, the chromatography strip as claimed, with a first, labeled, anti-hCG antibody on the conjugate pad recognizing the β-core fragment site of hCG (antibody clone 4F9), a second antibody that recognizes a different site that is not the β-core fragment (antibody clone 5011) on test line 1, and test line 2 comprising hCG. As such, the first antibody (clone 4F9) is capable of binding both normal hCG and the β-core fragment and the second antibody (clone 5011) is capable of binding the normal hCG but not the β-core fragment. Further, the combination of the art teaches a device capable of capturing a complex of normal hCG and the first antibody on test line 1 to indicate a signal but not a complex of the β-core fragment and the first antibody, and capable of capturing a bare conjugate of only the first antibody bound to neither normal hCG nor the β-core fragment is captured on test line 2. As such the combination of the prior art teaches a strip capable of diagnosing pregnancy by comparing the signal of the test line 1 and 2 thereby avoiding a false negative caused by the β-core fragment.
Regarding claim 3, Jin teaches immunochromatographic strips used to diagnose pregnancy detecting human chorionic gonadotropin comprising an antibody bound to a labeling substance such as gold particles, fixed on the conjugate pad. Jin further teaches that when the specimen is developed, it passes through the conjugate pad, a complex of chorionic gonadotropin-anti-human chorionic gonadotropin antibody-gold particles is formed and the complex is bound by the antibody against anti-choroidal gonadotropin immobilized at the test line (Jin, page 3, lines 4-13). Jin further teaches that with increasing amount of human chorionic gonadotropin in the sample the anti-hCG-antibody line increases and the hCG-line decreases (Jin, page 11, see table 1, columns 0-1600).
Regarding claim 6, Jin teaches colloidal gold particles (Jin, page 4, ‘B. Conjugate Making a pad (conjugate pad)’, line 3).
Regarding claim 7¸ Jin teaches three analytical lines, comprising an anti-mouse immunoglobulin antibody line as a ligand for the control (Jin, page 4, ‘A. Inspection line, heterogeneous inspection line and the formed detection pad making’, lines 7-9).
Regarding claim 10, Jin teaches an immunochromatographic strip for pregnancy test and a Kit using the same (Jin, page 1, see title). Jin further teaches a plastic case, a sample inlet for dropping the sample at the position of the sample pad on the upper part of the case and a result confirmation window for confirming the result of the inspection at the position where the binding agent of the detection pad is fixed (position corresponding to the test line or the control line; Jin, page 2, ‘Description of the drawings’, lines 12-16; see also Figure 5). Jin further teaches inserting the immunochromatographic strip for pregnancy diagnosis into the strip fixing position (guide and strip support) of the plastic lower case (Jin, page 5, ‘F: Case Assembly’, lines 1-3).
Response to Arguments
Applicant's arguments filed 08/24/2026 have been fully considered but they are not persuasive.
Applicant argues, starting on page 6 that claim 1 recites that the variant of hCG comprises an hCG β-core fragment and that the first anti-hCG monoclonal antibody binds both normal hCG and the β-core fragment, while the second anti-hCG antibody binds normal hCG but not the β-core fragment and that a complex of normal hCG and the first antibody is captured on test line 1 and a complex of β-core fragment and the first antibody is not captured on test line 1 and the bare conjugate is captured on test line 2 and that the strip is configured to diagnose pregnancy by comparing signals of test line 1 and 2 thereby avoiding a false negative caused by β-core fragment.
Applicant argues that Jin does not teach the claimed β-core fragment-specific antibody arrangement but rather employs a polyclonal anti-hCG antibody on the conjugate pad and monoclonal anti-hCG antibody on the test line and that the antibody pair is not designed to selectively discriminate normal hCG from the β-core variant which is in contrast to amended claim 1 and Jin neither teaches nor suggests the claimed epitope-specific arrangement that excludes the variant from test line 1. Applicant further recites that examiner acknowledges that Jin does not teach that hCG or a variant thereof comprises an hCG β-core fragment and that the false negative is caused by a variant of hCG comprising a β-core fragment. Applicant further argues that Chang teaches a one-step diagnostic device for detecting normal pregnancy and distinguishing it from ectopic pregnancy, and further alleges that Chang teaches antibodies reactive to modified hCG, including the β-core fragment and that Chang teaches a test strip having anti-β-hCG monoclonal antibody immobilized and colored particulates having anti-modified hCG, including β-core fragment.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant further argues that Chang is directed to a different purpose than the presently claimed chromatography strip, namely, to detecting modified hCG, in order to distinguish normal pregnancy from ectopic pregnancy rather than excluding β-core variant from a diagnostic test line which is in contrast to amended claim 1, wherein the variant-bound complex is not captured on a test line at all.
In response to applicant's argument that Chang is directed to a different purpose, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Jin is relied on to teach the test strip comprising two test lines (with an anti-hCG antibody immobilized on test line 1 and hCG immobilized on test line 2 and a gold-labeled antibody at the conjugate pad) and Chang teaches success using anti-hCG and anti-variant hCG antibodies in a lateral flow assay. Chang is not relied on to teach the test strip device as claimed.
Applicant further argues that Ward describes a magnetic-particle pulldown assay and not a lateral flow assay with a first and second test line as claimed. Applicant argues that Ward uses antibody clones 4F9 and 5011 as reporter and capture antibodies in a magnetic-particle sandwich assay in which two antibodies simultaneously bind hCG and thus employing the antibodies in a different assay format and for different functions as claimed.
This argument is not persuasive.
Both the magnetic pull-down assay and the lateral flow assay involve immobilizing the capture antibody on a surface (the surface comprising either the magnetic particle or the lateral flow assay substrate) and detecting the target (hCG) with a labeled reporter antibody. The target (hCG) can be detected by the labeled reporter antibody while bound to the capture antibody either on the magnetic particle or the test line. As such the function of the capture and the reporter antibodies fulfill the same functions in both assays.
Applicant further argues that Ward selects the hCG antibody pair on the express prerequisite that the two antibodies simultaneously bind the same hCG molecule and although the two antibodies differ in its recognition of the β-core fragment, Ward itself does not teach or rely on this differential β-core fragment recognition. Applicant argues that amended claim 1 requires a first antibody that binds both normal hCG and the β-core fragment and a second antibody that binds normal hCG but not the β-core fragment and that Ward provides no reason to select the antibody pair based on their differential β-core fragment recognition or to apply that pair to Jin’s chromatographic strip for the purpose of providing the claimed variant-excluding antibody arrangement.
In response to applicant's argument that Ward itself does not teach or rely on the differential β-core fragment recognition in order to specifically select an antibody pair in which a first antibody binds both normal hCG and the β-core fragment and a second antibody binds normal hCG but not the β-core fragment, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The antibody pair of Ward is capable of differential β-core fragment recognition even though the motivation to select the pair is because it is capable of simultaneously binding hCG. As such the antibody pair of Ward is capable of performing the intended use.
Applicant further argues that Nerenz does not remedy the deficiencies of Jin, Chang, Ward, Bioventix, or MedixMab. Applicant argues that Nerenz teaches that the asymmetric antibody-recognition relationship, in which one antibody recognizes the β-core fragment and the other does not, can itself cause the variant hook effect and a false negative result, whereas claim 1 uses this differential antibody-recognition relationship as part of the claimed two-line arrangement to avoid a false-negative result caused by high levels of β-core fragment. Applicant argues that Nerenz does not teach the claimed approach for addressing that problem nor deliberately exploiting the selective non-binding of the variant to leave the variant-antibody complex uncaptured as claimed.
This argument is not persuasive.
As discussed previously in detail above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Nerenz is relied on to teach that high β-core fragment is the cause of false negative pregnancy tests due to the hook effect, it is not relied on to teach the device as claimed. Further, the lateral flow assays reviewed by Nerenz screens traditional pregnancy tests for false negatives dues to β-core fragment induced hook effect. The assays evaluated do not incorporate methods designed to negate the hook effect caused by excess hCG variant as taught by Jin.
Applicant further argues that the proposed combination relies on impermissible hindsight because the cited references provide no teaching, suggestion, or rational underpinning for selecting and using the antibody pair in Jin’s strip in the claimed asymmetric arrangement based on the differential β-core fragment binding characteristics rather than Ward’s disclosed use of the pair for simultaneous binding of hCG rather than Ward’s disclosed use of the pair for simultaneous binding of hCG.
This argument 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).
However, as discussed previously above, the argument that the antibody pair is selected for the differential β-core fragment binding characteristics rather than for simultaneous binding of hCG, is directed to the intended use of the device and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Whether the antibodies are selected because of the differential β-core fragment binding characteristics or for simultaneous binding of hCG does not result in a structural difference of the claimed device and therefore does not result in a patentable difference over the prior art. Ward provides motivation to one of ordinary skill in the art to have modified the device of Jin with an antibody pair where one antibody binds normal hCG and the β-core fragment and a second antibody binds normal hCG but not the β-core fragment.
Applicant further argues that without impermissible hindsight the skilled artisan would not have incorporated that specific antibody pair into Jin’s strip despite Nerenz’s teaching that such differential recognition of the β-core fragment can result in a false-negative result.
This argument is not persuasive.
Nerenz identifies a problem with conventional lateral flow assays for determining pregnancy. Nerenz does not address lateral flow assays such as the assay as taught by Jin that include a mechanism to eliminate the hook effect in determining pregnancy and as such the argument is not persuasive.
For all the reasons above the arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFANIE J KIRWIN whose telephone number is (571)272-6574. The examiner can normally be reached Monday - Friday 7.30 - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEFANIE J. KIRWIN/Examiner, Art Unit 1677
/Soren Harward/Primary Examiner, TC 1600
