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 .
Status of the Claims
Claims 1-9, 11, 13-15, 24-25, 32-33, 36 are pending in this Application. No amendments to the claims were submitted in the response filed on 10/13/2025. Claims 24-25, 32-33, 36 were previously withdrawn.
Claims 1-9, 11, 13-15 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 10/13/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(previous rejection, maintained as to claims 1-9, 11, 13-15) Claims 1-9, 11, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Skraba et al., in view of Sino Biological (prior art of record).
See claims 1-9, 11, 13-15 as submitted on 10/13/2025.
Regarding claim 1 as submitted on 10/13/2025, it is noted that no amendments were introduced to claim 1 in the response filed on 10/13/2025. As previously explained, Skraba et al. teach a lateral flow assay (LFA) using commercially available antibodies for the detection of SARS-CoV-2 nucleocapsid protein from a human sample (Abstract; ¶¶ [0008], [0092], [0191]; Figs. 24A-D), (for detecting whether SARS-CoV-2 nucleocapsid protein is present in a sample, as recited on claim 1.) The LFA in Skraba et al.’s teachings further comprises:
a cartridge comprising a sample inlet for depositing a sample and a sample pad onto which the sample is absorbed prior to elution (a sample receiving region, as recited in claim 1)
a conjugate pad downstream from the sample inlet containing a plurality of antibodies complexed with a detectable marker, including specific antibodies against the nucleocapsid protein of SARS-CoV-2 (¶¶ [0008], [0092], [0060], [0061], [0191]; Figs. 24A-D below), (a conjugate region downstream from the sample receiving region and comprising test particulate labels comprising label particles conjugated to first and second specific binding members that specifically bind to the SARS-CoV-2 nucleocapsid protein, as recited in claim 1)
a detection pad located downstream from the conjugate pad, along which the sample will run and come into contact with zones of corresponding antibodies bound to the detection pad for each antigen of interest. The antibodies in the detection pad are immobilized on a solid support (¶¶ [0008], [0092], [0060], [0061], [0191], [0167]; Figs. 24A-D below) (a detection region downstream from the conjugate region and comprising an immobilized capture specific binding member that specifically binds to the SARS-CoV-2 nucleocapsid protein, as recited in claim 1)
Skraba et al. further teach a conjugate pad downstream from the sample inlet containing a plurality of antibodies complexed with a detectable marker, including specific antibodies against the nucleocapsid protein of SARS-CoV-2 (¶¶ [0008], [0092], [0060], [0061], [0191]; Figs. 24A-D). Skraba et al. further teach the use of any first and second antibody for detection of a desired antigen including the nucleocapsid protein of SARS-CoV-2, wherein the antibodies or any portion of them are present in the assay. (¶¶ [0008], [0022], [0191]). Skraba et al. further teach an assay wherein the assay is either quantitative or qualitative based on the amount of the second/detecting antibody bound (¶ [0163]).
Skraba et al. do not explicitly teach a leporine and a murine antibodies, wherein the leporine and murine antibodies bind specifically to nucleocapsid protein of SARS-CoV-2, wherein the herein the leporine antibody is present in an amount that exceeds the murine antibody amount.
However, as previously explained Sino Biological teaches the leporine antibody R004 and the murine antibody MM05 both of which bind specifically to the nucleocapsid protein of SARS-CoV-2 (pages 1, 3).
With respect to the amounts of antibody, it is noted that Skraba et al. already teach antibodies any portion of antibodies are present in the assay (¶ [0191]). Therefore, the teachings of Skraba et al. clearly encompass the amounts of antibody recited in claim 1. Further, the ranges of the amounts of antibodies recited in claim 1 of “wherein the herein the leporine antibody is present in an amount that exceeds the murine antibody amount” are considered to be those determined by routine optimization according to one of skill in the art in view of the teachings of Skraba et al.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to have included the teachings of Sino Biological into the LFA taught by Skraba et al., for the benefit of including one or more monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2, which are capable of detecting specific binding to the nucleocapsid protein and were known in the art at the time of filing.
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One of ordinary skill in the art would have had a reasonable expectation of success for including and optimizing the amounts of the monoclonal antibody clones taught by Sino Biological, which were known in the art at the time of filing to specifically bind to the nucleocapsid protein of SARS-CoV-2, to the LFA taught by Skraba et al. given that the methods of LFA assembly are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, it is noted that no amendments were introduced to claim 2 in the response filed on 10/13/2025. As previously explained, Skraba et al. further teach the LFA device described above further comprising a control region downstream from the detection region (¶¶ [0024], [0196]; claim 40; Figs. 24A-D).
Regarding claims 3 and 4, it is noted that no amendments were introduced to claims 3 and 4 in the response filed on 10/13/2025. As previously explained, Skraba et al. further teach the control region includes an immobilized binding agent (secondary antibody) that binds to one or more of the soluble antigen binding agents (primary antibodies) in the assay. The control region in Skraba et al.’s teachings includes antibodies complexed with a detector molecule (control particulate labels comprising label particles conjugated to a control specific binding member that specifically binds to the control antigen, as recited in claim 3), (¶¶ [0024], [0092], [0196], [0176]; claim 40; Figs. 24A-D above).
Regarding claim 5, it is noted that no amendments were introduced to claim 5 in the response filed on 10/13/2025. As previously explained, Skraba et al. further teach an absorbent pad downstream of the control region (wicking region, as recited in claim 5), (¶¶ [0020], [0024]; claim 40; Figs. 24A-D above).
Regarding claims 6-8, it is noted that no amendments were introduced to claims 6-8 in the response filed on 10/13/2025. As previously explained, Skraba et al. further teach a detector molecule is a visualizable marker such as a colloidal gold or a visible marker such as colored latex beads (reflective nanoparticles comprise a metal, wherein the metal comprises gold as recited in claims 6-8) (¶¶ [0019], [0176], [0179]).
Regarding claim 9, it is noted that no amendments were introduced to claim 9 in the response filed on 10/13/2025. As previously explained, Skraba et al. further teach monoclonal or polyclonal antibodies, or antibody fragments, including specific antibodies against the nucleocapsid protein of SARS-CoV-2 (the first, second and capture specific binding members are antibodies or binding fragments thereof, as recited in claim 9), (¶¶ [0008], [0022], [0191]; Figs. 24A-D above).
Regarding claims 11, 14, and 15 it is noted that no amendments were introduced to claims 11, 14 and 15 in the response filed on 10/13/2025. As previously explained, Sino Biological teaches the leporine antibody R004 and the murine antibody MM05, both of which specifically bind to the nucleocapsid protein of SARS-CoV-2 (pages 1, 3).
Regarding claim 13, it is noted that no amendments were introduced to claim 13 in the response filed on 10/13/2025. As previously explained, Skraba et al. already teach the use of any first and second antibody for detection of a desired antigen including the nucleocapsid protein of SARS-CoV-2, wherein the antibodies or any portion of them are present in the assay (¶ [0191]). Therefore, the teachings of Skraba et al. clearly encompass the amounts of antibody recited in claim 13. Further, it is noted that the range of the amount of antibody recited in amended claim 13 is considered to be one determined by routine optimization according to one of skill in the art in view of the teachings of Skraba et al.
Accordingly, claims 1-9, 11, 13-15 were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
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).
(previous rejection, maintained as to claims 1-9, 11, 13-15) Claims 1-9, 11, 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 15-17 of copending Application No. 17123995 in view of Skraba et al. and Sino Biological (both references of record). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a lateral flow assay for detecting the presence of viral antigens in a human sample.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See claims 1-9, 11, 13-15 as submitted on 10/13/2025.
As indicated above, the teachings of Skraba in view of Sino Biologicals render claims 1-9, 11, 13-15 obvious. As previously explained, claims 1, 2, and 15 of copending application ’995 are directed to a LFA for detecting the presence of viral antigens in a human sample comprising: a) a first conjugate comprising a first label, an agent configured to specifically bind to the analyte of interest, and a first binding partner; a second conjugate upstream of the first conjugate along a fluid flow path of the lateral flow assay, wherein the second conjugate comprises a second label and a second binding partner configured to specifically bind to the first binding partner; b) detection zone downstream of the first conjugate and the second conjugate along the fluid flow path of the lateral flow assay, the detection zone comprising an immobilized capture agent that specifically binds the analyte of interest; c) wherein the first conjugate is present in a first conjugate zone downstream of the sample receiving zone; d) a control zone comprising immobilized capture agent that specifically binds the first conjugate; and e) metal nanoparticles comprising gold nanoparticles.
Claims 1, 2 and 15 of copending application ’995 do not explicitly teach one or more antibodies that specifically bind the SARS-CoV-2 nucleocapsid protein, wherein the one or more antibodies are the leporine antibody R004 and the murine antibodies MM05 and MM08.
However, as indicated above, Skraba et al. teach a LFA wherein one or more antibodies that specifically bind the SARS-CoV-2 nucleocapsid protein (¶¶ [0008], [0022], [0191]). Skraba et al. further teach that pairs of binding agents, including antibodies, may bind to different portions of the same antigen and may be present in any amount (¶ [0191). Further, as indicated above, Sino Biological teaches the leporine antibody R004 and the murine antibodies MM05 and MM08for both of which specifically bind to the nucleocapsid protein of SARS-CoV-2 (pages 1-3).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to have included the teachings of Skraba et al. and Sino Biological to the LFA taught by claims 1, 2 and 15 of copending application ’995, for the benefit of including one or more monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2, which are capable of detecting specific binding to the nucleocapsid protein and were known in the art at the time of filing.
One of ordinary skill in the art would have had a reasonable expectation of success for including the monoclonal antibody clones as taught by Skraba et al. and Sino Biological, which were known in the art at the time of filing to specifically bind to the nucleocapsid protein of SARS-CoV-2, to the LFA taught by claims 1, 2 and 15 of copending application ’995 given that the methods of LFA assembly are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, claims 1-9, 11, 13-15 of instant application are provisionally rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant's arguments filed on 10/13/2025 have been fully considered and found unpersuasive.
Applicant contends on page 7 of the Remarks submitted on 10/13/2025:
[A]n element of Claim 1 is a conjugate region comprising a first specific binding member that is a leporine antibody and a second specific binding member that is a murine antibody. In other words, the conjugate region of the LFA comprises two different antibodies. Turning now to Skraba, as acknowledged by the Office, Skraba fails to teach a LFA comprising any leporine and murine antibodies, much less a LFA comprising a leporine antibody and a murine antibody in the conjugate region. Nor is there any suggestion of this, as paragraph [0191] cited by the Office merely broadly recites that pairs of agents (where agents are antibodies, antibody fragments or molecules that include all or a portion of antibodies or antibody fragments) may bind to different portions of the same antigen (Skraba, paragraph [0191]). Turning now to Sino, Sino is a catalog product page listing various SARS-CoV-2 antibodies including MM05, MM08 and R004 antibodies. As such, Sino likewise fails to teach or suggest a LFA comprising a leporine antibody and a murine in the conjugate region. Further, the Applicant respectfully submits that it would not be obvious to include the antibodies of Sino in the LFA of Skraba. Skraba provides no guidance for selecting any particular antibodies for a LFA to detect a SARS-CoV-2 nucleocapsid protein. Indeed, Skraba is silent on selecting how many types of antibodies should be used in the LFA, picking what ratio of antibodies to use, or choosing which region a particular antibody should be located in. In view of Skraba, there would be no reason to select the combination of two different antibodies (i.e., a leporine antibody and a murine antibody) for use in the conjugate region.
In response:
Applicant's arguments against the references individually are not persuasive because 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). As explained above and previously, the LFA as taught by Skraba et al. can be in principle used with any antibody combination, be it leporine, murine, or any other antibody at any amounts. It is noted that the recitation of “leporine” or “murine” simply refers to the species in which the antibody was produced (rabbit or mouse). The Sino Biological antibodies MM05, MM08, and R004 were known in the art. Further LFAs are well known in routinely used in the art with any antibodies as needed (see Skraba et al.). The combination of the teachings of Skraba et al. and Sino Biological teach the exact embodiment of the claimed invention. Accordingly, it is herein maintained that the claimed invention would have been prima facie obvious to a person of ordinary skill in the art before the filing date.
Applicant contends on page 9 of the Remarks submitted on 10/13/2025:
In making the rejection, the Office asserts that the '955 application does not teach that one or more antibodies specifically bind to the SARS-CoV-2 nucleocapsid protein where the antibodies are R004, MM05 and MM08, for which the Office turns to Skraba and Sino. The Office asserts it would have been obvious to include the teachings of Skraba and Sino in the LFA as taught by the '955 application. However, as discussed above, the claims are not obvious over Skraba in view of Sino. As such, for at least the reasons described above, the claims are patentable over the '955 application in view of Skraba and Sino, and this provisional rejection may be withdrawn.
In response:
Claims 1-9, 11, 13-15 were rendered prima facie obvious by the cited prior art, as explained above in detail. Therefore, the non-statutory double patenting rejection set forth above is herein maintained.
Response to Declaration under 37 C. F. R. § 1.132
Applicant’s Rule 132 Declaration filed on 10/13/2025 has been thoroughly reviewed and fully considered.
The Declaration under 37 CFR 1.132 filed on 10/13/2025 is insufficient to overcome the rejection of instant claims as set forth in this Office Action because of the reasons explained below.
It is noted that the Declaration under 37 CFR 1.132 filed on 10/13/2025 by Huimiao Ren has a potential bias in favor of instant Application given that Mr. Ren is an inventor of instant Application. Accordingly, the statements in the Declaration under 37 CFR 1.132 filed on 10/13/2025 may not represent an unbiased assessments of the teachings of the cited prior art.
It is also noted that the Declaration under 37 CFR 1.132 filed on 10/13/2025 by Mr. Ren does not provide any evidence or data to support of the remarks in the Declaration.
Turning to the arguments provided in Applicant’s Declaration, as indicated above, instant claims recite a lateral flow assay (LFA) using commercially available antibodies for the detection of SARS-CoV-2 nucleocapsid protein from a human sample. With respect to Applicant’s remarks regarding alleged unexpected results, it is noted that Applicant has not explained why such alleged unexpected results of decreased false positive rate by the use of a combination of two antibodies are considered to be surprising. Further, Applicant has not provided any baseline or basis for comparison of expected versus unexpected results in view of the instant claim language, rather merely stating or asserting or concluding that results are unexpected. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Based on the teachings and suggestions of the cited prior art it is herein maintained that the alleged unexpected results of decreased false positive rate by the use of a combination of two antibodies are in fact expected and entirely consistent with the teachings of the prior art. For instance, Skraba et al. teach the use of two antibodies, as opposed to a single antibody, with low-cross reactivity for enhanced detection by concentrating antibodies bound to the marker (¶ [0191], Example 3). Skraba et al. further teach an assay wherein the assay is either quantitative or qualitative based on the amount of the second/detecting antibody bound (¶ [0163]). Such concentration of antibodies bound to a second/detecting antibody would result in higher sensitivity given that binding of the target by two antibodies, instead of one antibody, would occur. In other words, binding of a second specific antibody servers as an independent confirmation of the presence of the target in the sample thereby increasing test sensitivity. The higher sensitivity would account for a decrease in false positive rates. Accordingly, Applicant’s remarks in the Declaration are not persuasive.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672