DETAILED ACTION
Responsive to communication entered 10/09/2025.
Priority
This application, filed 05/07/2021, Pub. No. US 2021/0349105 A1, published 11/11/2021, claims priority to US provisional application No. 63/021,628, filed 05/07/2020; US provisional application No. 63/032,541, filed 05/30/2020; and US provisional application No. 63/114,675, filed 11/17/2020.
Status of Claims
Claims 1-9 and 12-30 are currently pending. Claims 1-28 have been originally pending and subject to restriction/election requirement mailed 02/16/2024. Claims 1-7, 13 and 16-28 have been withdrawn from further consideration. Claims 8 and 14 have been amended; Claims 29 and 30 have been added; and Claims 10 and 11 have been cancelled, as set forth in in Applicant’s Amendment filed 09/25/2024. Claims 8 and 12 have been amended, as set forth in Applicant’s Amendment filed 01/24/2025 and entered 03/21/2025. Claims 12, 14 and 29 have been amended, as set forth in Applicant’s Amendment filed 10/09/2025. Claims 1-7, 13, 16-28 and 30 are withdrawn from further consideration. Claims 8, 9, 12, 14, 15 and 29 are examined.
Withdrawn Objections/Rejections
Any objection or rejection not reiterated herein has been withdrawn.
I. The rejection of Claims 12, 14 and 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s amendment of the claims.
II. The provisional rejection of Claims 8, 9, 12, 14, 15 and 29 on the ground of
nonstatutory double patenting as being unpatentable over Claims 1-21 of copending Application No. 17/715,988, Pub. No. US 2022/0326240 A1, published 10/13/2022, is moot in view of abandonment of Application No. 17/715,988 (a Notice of Abandonment mailed 10/16/2025).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8, 9, 12, 14, 15 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al., “Ultra-Sensitive High-Resolution Profiling of Anti-SARS-CoV-2 Antibodies for Detecting Early Seroconversion in COVID-19 Patients,” medRxiv, May 2, 2020, pp. 1-20 (IDS submitted 05/16/2024), in view of Ellis, Application 16/848,397, filed 04/14/2020, US 2021/0316002 A1, published 10/14/2021 (PTO-892 mailed 10/24/2024); and Manuguerra et al., US 2017/0336412 A1, published 11/23/2017 (IDS submitted 10/26/2021).
This rejection is maintained from the previous Office Action.
The claims, as recited in independent Claim 8, are drawn to:
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Regarding Claims 8, 12, the elected species (c)-(d), Norman et al., throughout the publication and, for example, at page 4, last paragraph and Figure 1, teach:
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Emphasis added.
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Although Norman et al. do not expressly teach the S1 sequence, Applicant is reminded that the identification and characterization of a prior art material also does not make it novel. See MPEP 2112:
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Emphasis added.
At pages 10-11, bridging paragraph, Norman et al. teach:
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Emphasis added.
Regarding Claim 29, Ellis, throughout the publication and, for example, at Table 1, teaches the spike protein of SEQ ID NO: 1, which is identical to the instantly claimed SEQ ID NO: 2:
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It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used the full‐length SARS‐CoV‐2 spike protein, which is 1273 amino acid long, as taught by Ellis, instead of spike protein fragment of 1208 amino acid long, taught by Norman et al., because the full‐length SARS‐CoV‐2 spike protein comprises all epitopes for detecting anti-SARS‐CoV‐2 spike protein antibodies.
As evidenced by a printout retrieved from https://www.uniprot.org/uniprotkb/ P0DTC9/entry on 06/19/2024 (PTO-892 mailed 06/27/2024), one of skill in the art would have known that nucleocapsid protein is the alternative name for nucleoprotein or Protein N.
Norman et al. fail to disclose:
(1) the substrate, which is glass, plastic, polystyrene or nitrocellulose, as recited in Claim 9, and
(2) the elected species (e) a fluorescent dye as a specific detectable parameter of the bead, recited in Claims 14 and 15.
Manuguerra et al., throughout the publication and, for example, in Abstract, teach:
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Emphasis added.
In paragraphs [0267-0270] and [0275]-[0280], Manuguerra et al. further teach:
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Emphasis added.
It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used the fluorescent beads, taught by Manuguerra et al., as substituting equivalent of dye-encoded beads in the method, taught by Norman et al., because Manuguerra et al. expressly teach the use of both the fluorescent beads and color coded beads as an identifiable solid support comprising a viral antigen in an immunoassay leading to the rapid and simultaneous detection of antibodies to a wide range of infectious pathogens in biological fluids of infected patients.
Noteworthy, Applicant’s admission regarding commercial availability of the beads suitable for use in the present invention:
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Specification as filed, page 18; Emphasis added.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8, 9, 12, 14, 15 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-21 of US Patent 11,740,240 B2, issued 08/29/2023 (PTO-892 mailed 06/27/2024).
This rejection is maintained from the previous Office Action.
Although the claims at issue are not identical, they are not patentably distinct from
each other because US Patent 11,740,240 B2 claims a substrate and a method of using the substrate:
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Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
Claim Rejection - 35 USC § 103
At pages 10-11 of the Remarks, Applicant argues that:
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Emphasis added.
The Examiner respectfully disagrees for the following reasons.
First, in response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have made and used the full‐length SARS‐CoV‐2 spike protein, which is 1273 amino acid long, as taught by Ellis, instead of spike protein fragment of 1208 amino acid long, taught by Norman et al., because the full‐length SARS‐CoV‐2 spike protein comprises all epitopes for detecting anti-SARS‐CoV‐2 spike protein antibodies.
Second, Norman et al., as shown at Figure 1 reproduced at page 5 of the instant Office Action, do teach the S1 protein.
Third, although Norman et al. do not expressly teach the S1 sequence, Applicant is reminded that the identification and characterization of a prior art material also does not make it novel. See MPEP 2112:
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Emphasis added.
Fourth, according to MPEP 2123 “Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments,” disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments:
“A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.”
Fifth, Applicant is reminded that, that, according to MPEP 716.01(c), attorney arguments cannot take the place of evidence:
“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). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.” Emphasis added.
Double Patenting
At pages 11-12 of the Remarks, Applicant argues that:
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Emphasis added.
The Examiner respectfully disagrees because, contrary to Applicant’s allegation, the instant claims do not require to "at least one additional SARS-CoV-2 protein or fragment that is not a SARS-CoV-2 spike protein variant or fragment thereof." See Claim 8:
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Emphasis added.
Accordingly, the rejections of the claims are maintained.
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 extension fee 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 GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678