.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 Application, Amendments and/or Claims
1. Claims 1-20 are pending and under examination in the present application.
Information Disclosure Statement
2. The information disclosure statement filed 04/15/2022 has been considered and the references therein are of record.
Priority
3. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/118,407, filed on November 25, 2020, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, the ‘407 provisional application does not provide support for the antibodies listed in instant claim 19 other than B3451M and B3449M (i.e., no support for C503, C508, C510, C516, C518, C524, C526, C527, C528, C529, C70, or C715), nor for any of the SARS-CoV-2 variants recited in present claim 20.
Accordingly, for purposes of prior art, the claims have been accorded the following effective filing dates:
Claims 1-18: November 25, 2020
Claims 19-20: November 24, 2021
Should applicant disagree with the examiner’s factual determination above, applicant should provide evidence that the claim limitation in question is described as required by 35 U.S.C. 112, first paragraph, in the relevant application. This could be accomplished, for example, by pointing out the page and line numbers where the limitations appear.
Drawings
4. The drawings filed on November 24, 2021 are objected to because they should be labeled as “FIG.” instead of “Figure”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
5. Claim 19 is objected to because of the following informalities: the claim recites that “the antibodies comprise one or more antibodies selected from the group consisting of C503…B3451M or B3449M” (emphasis added). The phrase “consisting of” is considered closed language (see MPEP 211.03 (II)), yet the listing of antibodies recites an “or” preceding the final antibody selection, which is considered open language. It is suggested that this final “or” be amended to recite “and” to be consistent with the “consisting of” phrasing. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitation in claim 13 that “the packaging is compliant with requirements for disposing biohazardous materials” renders the claim indefinite because it is unclear what the metes and bounds of such compliance would be with respect to packaging and the vague “requirements for disposing [of] biohazardous materials”. In particular, different countries may have different biohazardous disposal requirements, and even within a given country, there may be different requirements for different regions or states, or pertaining to different types of establishments (e.g., rural health center versus urban research laboratory versus home use). Accordingly, compliant packaging may differ based upon the area/region/country in which the test kit is used, and therefore such “compliance” may ultimately be subjective to the location of the end user. The metes and bounds of this limitation defining the packaging therefore cannot be readily determined.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a test kit for detecting the presence of coronavirus antigens in a bodily fluid, wherein the test kit comprises a lateral flow strip comprising one or more antibodies selected from the group consisting of C518, C524, C527, C706, C715, B3451M and B3449M, does not reasonably provide enablement for a test kit that comprises a lateral flow strip comprising one or more of the antibodies C503, C508, C510, C516, C517, C525, C526, C528 or C529. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The claims are drawn to a test kit that comprises one or more particular monoclonal antibodies selected from C503, C508, C516, C517, C518, C524, C525, C526, C527, C528, C529, C706, C715, B3451M AND B3449M, which antibodies are recited to bind to particular SARS-CoV-2 variants as in claim 20. The specification indicates at paragraph [0039] that the antibodies utilized by the claimed test kits are “commercially available from a variety of sources including but not limited to: HyTest (Turku, Finland), InvivoGen (California, USA), BioRad (California, USA), Novus Biologicals (Colorado, USA), and Meridian Life Sciences (Tennessee, USA). In certain embodiments the antibodies utilized in the LFIAs comprise one or more antibodies that bind to the N-terminal part of the nucleoprotein (for example, N47-A173 or N46-A174) selected from the group consisting of (Cat. # 3CV4, clones C503, C508, C516, C517, C518, C524, C525, C526, C527, C528, C529, C706, C715). In certain embodiments, the antibodies utilized in the LFIAs comprise one or more antibodies elected from the group consisting (Cat.# 3CV4, clones C518, C524, C527, C706, C715)(HyTest), in certain embodiments, the antibodies comprise one or more antibodies selected from the group consisting of (Cat.# 3Cv4, C706 and C715).” Thus according to the instant specification, antibody clones C503, C508, C516, C517, C518, C524, C525, C526, C527, C528, C529, C706, C715 are commercially available from HyTest as Catalog # 3CV4. It is noted that at the time of preparing this office action, antibody clones B3451M and B3449M are commercially available through Novus Biologicals (Cat. # NBP3-00513AF647 and Cat. # NBP3-00514, respectively). However, also at the time of preparing this office action, only antibody clones C518, C524, C527, C706 and C715 are found available for purchase under Cat. # 3CV4 from HyTest. See “Hytest SARS-CoV-2 antibodies and detection of variants” (7 pages), retrieved from internet August 2025. There are no listings for any of the other antibody clones (i.e., C503, C508, C510, C516, C517, C525, C526, C528, C529) within the HyTest website specifically, or from any other vendor generally. Therefore, none of antibody clones C503, C508, C510, C516, C517, C525, C526, C528 or C529 are presently commercially available, and claim 19 cannot be made or used in its full scope as currently claimed.
The process of producing monoclonal antibodies is unpredictable; even when a small antigen is used multiple different monoclonal antibodies can be produced. See for example Kuby (Immunology, Third Edition, 1997, pp. 131 - 134), which teaches the process by which monoclonals are produced. See also Alberts et al. (Molecular Biology of the Cell, 3rd Edition, 1994, pp. 1216 - 1220). Alberts teaches the three-dimensional structure of antibodies is complex. Note particularly the large models on pp. 1219 - 1220 which indicate that the antibody molecules are comprised of hundreds of amino acids. The structure of a large protein such as an antibody is dependent not just on the antigen-binding region, but on the totality of the interactions of the hundreds of amino acid residues.
The specification fails to disclose the complete sequence and structure of any of monoclonal antibodies C503, C508, C510, C516, C517, C525, C526, C528 or C529, which are encompassed by claims 19 and 20. The art recognizes that making monoclonals is an unpredictable process. Monoclonal antibodies are so unique that a skilled artisan cannot simply construct one; either the actual hybridoma which secretes the antibody must be present in order to make it, or the complete amino acid sequences that form the heavy and light chain pair of the antibody must be disclosed. Elements required for practicing a claimed invention must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. When biological material is required to practice an invention, and if it is not so obtainable or available, the enablement requirements of 35 USC §112, first paragraph, may be satisfied by either a deposit of the material (see 37 CFR 1.802) or by disclosure of the full and complete amino acid sequences comprising the heavy chain variable region (VH) and light chain variable region (VL) of the claimed antibody(ies).
The specification lacks structural disclosure for the monoclonal antibodies C503, C508, C510, C516, C517, C525, C526, C528 and C529, and these antibodies are no longer commercially available. Because these monoclonal antibodies are not disclosed with sufficient structural guidance, nor are they publicly available as of the date of this office action, undue experimentation would be required to use the present invention commensurate in scope with claims 19 and 20. For the reasons above, it would not be possible for the skilled artisan to make and use the test kit comprising one or more of the antibodies encompassed by claims 19-20.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claim(s) 1-11 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over JOYSBIO COVID-19 Antigen Rapid Test Kit (June 2020; listed on 04/15/2022 IDS; hereinafter “JOYSBIO”) as evidenced by JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Instructions for Use (28 Oct 2020; retrieved 11/25/2025) and JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit Brochure (Oct 2020; retrieve 11/25/2025).
JOYSBIO teaches a SAR-CoV-2 (COVID-19) antigen rapid test kit that tests for the presence of coronavirus antigens in a body fluid sample. The test kit is disclosed to be a lateral flow assay that detects the presence of nucleocapsid (N) in upper respiratory sample (nasal swabs) (see “COVID-19 Antigen Test Principle” at p. 3), which addresses: claim 1(a) a sample collection device, and claim 2 the sample collection device is a swab; claim 1(e) a dipstick test strip, and claim 14 the dipstick test strip comprises a lateral flow strip.
JOYSBIO teaches that the kit is available in 1, 2, 5 or 20 tests per box (see “Features” at p. 2). As evidenced by the JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit Brochure, the kit for 20 tests includes:
20x sterilized nasal (NS) swabs = a sample collection device (claim 1(a)); the sample collection device comprises a swab (claim 2)
20x buffer bottles (350 mL/bottle) = a vessel containing sample/running buffer (claim 1(b)); the vessel comprises an ampoule, bottle or sachet (claim 3)
20x extraction tubes and nozzle caps = a housing defining an enclosed hollow interior portion (claim 1(c)); the housing defining an enclosed hollow interior portion comprises a tube (claim 4); a removable cover that attaches to the housing for securing the content therein (claim 7); the removable cover is a cap (claim 8)
1x tube rack = a stand for the housing (claim 1(d))
20x test devices (lateral flow test devices) = a dipstick test strip (claim 1(e)), and
1x instructions for use
Regarding claims 4-6, as shown in the picture for JOYSBIO, as well as the JOYSBIO brochure, the extraction tube is constructed of a transparent, plastic material.
Regarding claim 9, the JOYSBIO test kit Instructions for Use indicates at Step 4 of the “[TEST PROCEDURE]” (p. 1) to “[p]lace the extraction tube(s) in a rack in the designated area of the workspace.” While not pictured in the instructions or brochure, a tube rack is generally understood by one of ordinary skill in the art to be a stand that is configured to hold sample tubes in a secure position (i.e., such that they remain in an upright position).
Regarding claims 10-11, the JOYSBIO test kit Instructions for Use provide instructions for using the kit and for interpreting the results. In particular, page 1 of the instructions provide details concerning: specimen collection and handling (the collection of a bodily fluid); test procedure, see Step 2 “[a]fter collection of nasal (NS) swab specimen, insert the swab into the tube and plunge the swab up and down in the fluid for a minimum of 20 seconds, then hold the swab against the bottom of the tube and roll 5 turns, taking care not to splash contents of the tube” (the introduction of the bodily fluid to the test kit); Test procedure, Steps 3-6 “Gently squeeze the ridged body of the tube, dispensing three (3) drops of the processed specimen in the sample well” (the application of the bodily fluid to the lateral flow assay); test principle (operation of the test kit); interpretation of test results (interpretation of results); and warning #4 at p. 2 “Dispose of all specimens and materials used to perform the test a biohazardous waste” (effective disposal of the device).
Regarding claims 14-15, JOYSBIO teaches that the lateral flow test device comprises a nitrocellulose membrane (see under “[COMPONENT] Materials provided” at p. 1) (the lateral flow strip comprises a nitrocellulose membrane).
And with respect to claims 16-18, JOYSBIO teaches at p. 3 that:
The lateral flow assay is designed with the sandwich immunoassay format. When the specimen is added onto the sample pad of a test cassette, a coronavirus N protein binds with colloidal gold-labeled SARS-CoV-2 N protein antibody to form an antibody-antigen (Ab-Ag) complex. The Ab-Ag complex is captured by SARS-CoV-2 N protein antibody (Rabbit monoclonal antibody) when migrating to the test line under capillary action. A red-colored band will appear on the test line, which indicates the specimen is COVID-19 nucleocapsid protein positive. No color band will appear on the test line if the specimen does not contain any coronavirus antigen (N protein), or the antigen level is below detection limit.
These teachings thus provide for a visual readout to indicate the state of a disease in a bodily fluid (claim 16), wherein the visual readout is enabled antibodies (claim 17), and wherein the antibodies are colored (claim 18).
JOYSBIO thus provides for elements (a)-(e) of the test kit of claim 1, as well as the limitations for present claims 2-8, 10-11 and 14-18. However, while the Instructions teach that the extraction tubes (containing the biological specimens) and test devices should be labeled for each specimen or control to be tested (see Step 5 of the “[TEST PROCEDURE]”), the prior art reference does not explicitly teach that the kit also comprises sample labels (as in claim 1(f)).
Nevertheless, it would have been obvious to one of ordinary skill in the art at the time of filing to have included sample labels within the test kit of JOYSBIO and thereby arrive at the presently claimed invention. The skilled artisan would have been motivated by the express teachings of the JOYSBIO kit instructions, which indicate that sample specimens and the lateral flow test devices should be labeled. Particularly given that the JOYSBIO test kits are available with up to 20 tests per box, the skilled artisan would have recognized that proper labeling is necessary to keep track of different samples and their corresponding lateral flow test devices should multiple COVID-19 tests be performed concurrently. The inclusion of sample labels would thus make the task of labeling the specimens and test devices easier and more convenient, and therefore is obvious.
9. Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over JOYSBIO COVID-19 Antigen Rapid Test Kit (June 2020; listed on 04/15/2022 IDS; hereinafter “JOYSBIO”) as evidenced by JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Instructions for Use (10/28/2020; retrieved 11/25/2025) and JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit Brochure (Oct 2020; retrieved 11/25/2025) in view of LuciraTM COVID-19 All-In-One Test Kit Instructions for Use (11/18/2020; retrieved from internet 11/28/2025; hereinafter “Lucira”).
The reasons why the JOYSBIO COVID-19 antigen test kit teaches and renders obvious the presently claimed kit are discussed above. And while the JOYSBIO instructions teach that all specimens and materials used to perform the test should be disposed of as biohazardous waste (see #4 of “[WARNINGS]”), the JOYSBIO kit does not teach that the kit further comprises packaging for disposing of the test kit (claim 12), or that the packaging is compliant with requirements for disposing of biohazardous materials (claim 13).
Consistent with the above disclosure, Lucira also teaches a COVID-19 detection test kit for diagnostic use. The all-in-one test kit contents are noted to include a plastic disposable bag to dispose of the test kit after use (p. 6 under Test Kit contents). Step 5 of the Lucira instructions (at p. 9) also teaches that once the test is completed, the user should place the test unit and all test kit materials in the plastic disposal bag and dispose of them. The plastic disposal bag therefore meets the limitation of packaging for disposing of the test kit in claim 12, and absent evidence to the contrary, would be considered as being compliant with requirements for disposing of biohazardous materials as in claim 13.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have included a plastic disposal bag, as taught by Lucira, in the test kit of JOYSBIO and thereby arrive at the presently claimed invention. JOYSBIO teaches that the COVID-19 test kit materials need to be disposed of properly as biohazardous waste, and Lucira also recognizes this need and provides a solution: a plastic disposal bag included within the test kit. Thus, it would have been obvious to have included such a disposal bag in the JOYSBIO test kit so as to enhance the convenience for the end user as well as to promote the compliance with any requirements for the disposal of biohazardous waste. Claims 12-13 are therefore rendered obvious in view of the prior art reference teachings.
10. Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over JOYSBIO COVID-19 Antigen Rapid Test Kit (June 2020; listed on 04/15/2022 IDS; hereinafter “JOYSBIO”) as evidenced by JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Instructions for Use (10/28/2020; retrieved 11/25/2025) and JOYSBIO SARS-CoV-2 Antigen Rapid Test Kit Brochure (Oct 2020; retrieved 11/25/2025) in view of HyTest News (“Soon Available! COVID-19 Antibodies”, 01/10/2020; listed on 04/15/2022 IDS), as evidenced by Hytest “SARS-CoV-2 antibodies and detection of variants” fact sheet (retrieved 08/2025).
The reasons why the JOYSBIO COVID-19 antigen test kit teaches and renders obvious the presently claimed kit are discussed above. While JOYSBIO teaches that the antibodies employed by the disclosed lateral flow antigen test are specific for the nucleocapsid (N) protein of SARS-CoV-2, the reference does not disclose that the antibodies may comprise one or more of the antibodies as recited in claim 19, or that the antibodies bind the SARS-CoV-2 antigens or variants as recited in claim 20.
HyTest teaches Catalog # 3CV4 anti-SARS-CoV-2 nucleoprotein monoclonal antibodies (mAbs), such as NP1518 (C518) and NP1524 (C524). As noted by the instant specification at [0039], the C518 and C524 mAbs are described as being commercially available from HyTest under Cat. # 3CV4. The Hytest “SARS-CoV-2 antibodies and detection of variants” fact sheet evidences that all Hytest mAbs under Cat. # 3CV4 (including C524 and C518) recognize the Alpha (B.1.1.7) variant (see Table spanning pp. 1-2). Thus, absent evidence to the contrary, the antibodies taught by HyTest are the same as those of present claim 19, and thus would necessarily bind coronavirus antigens associated with SARS-CoV-2, or variants thereof, as in present claim 20.
It would have been obvious to one of ordinary skill in the art at the time of filing to have substituted the HyTest mAbs for the antibodies of the JOYSBIO test kit and thereby arrive at the presently claimed invention. This is because the skilled artisan has good reason for pursuing the known options within his or her technical grasp in order to yield a predictable outcome. Such would amount to the simple substitution of one known functional element for another (i.e., one known anti-SARS-CoV-2 nucleoprotein antibody (or antibody pairing) for another) to obtain predictable results.
Conclusion
11. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675