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
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. This application is a 371 of
PCT/US2021/023762 filed 03/23/2021 which claims benefit of Application No. 62/993,610 filed
03/23/2020. Based on the filing receipt, the effective filing date of this application is March 23,
2020 which is the filing date of Application No. 62/993,610 from which the benefit of priority is
claimed.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, and 12-21, in the reply filed
08/04/2025 is acknowledged. In the amended claims filed 08/04/2025, claim 22 has been amended to depend on claim 1, which directs the claim to Group I.
Applicant’s election without traverse of the following species:
Human respiratory syncytial virus as the species of respiratory viruses;
SEQ ID NO: 1 as the species of peptide or polypeptide antigens or epitopes or antigen fragments; and
Serum sample as the species of fluids;
in the reply filed 08/04/2025 is acknowledged.
Claims 12, 14-17, 26, and 27 are withdrawn from further consideration due to being drawn to non-elected species of respiratory viruses pursuant to 37 CFR 1.142(b), there being
no allowable generic or linking claim.
Claims 3-11, 21, and 23-24 have been cancelled.
Claims 1, 2, 13, 18-20, 22, and 25 are under examination.
Withdrawn Rejections
The rejections of claims 21 and 22 on the grounds of 35 U.S.C. 112(b) have been withdrawn, necessitated by amendments filed 10/20/2025.
The rejection of claims 1, 2, 13, 18, 20-22, and 25 on the grounds of 35 U.S.C. 102(a)(1) has been withdrawn, necessitated by amendments filed 10/20/2025.
The rejection of claim 19 on the grounds of 35 U.S.C. 103 has been withdrawn, necessitated by amendments filed 10/20/2025.
The rejection of claim 1 as provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 17/999,417 has been withdrawn due to the copending application being abandoned.
New grounds of rejection, necessitated by amendments filed 10/20/2025, are disclosed below.
Claim Interpretation
With respect to claim 1, 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 structure of the product of manufacture recited in claim 1 is a surface with a plurality of antigenic viral peptides, viral polypeptide epitopes, or viral antigens derived from a plurality of viruses affixed or attached onto that surface. The preamble of claim 1 recites intended use and does not impart structure to the product of manufacture, therefore, the statements of intended use do not limit the claim. See MPEP 2111.02 II.
Claim 15 is interpreted to be directed away from the elected species of respiratory virus, respiratory syncytial virus (RSV). Claim 15 recites, “The product of manufacture of claim 1, wherein at least one of the plurality of viruses is a virus of the subfamily Orthocoronavirinae, or the family Coronaviridae, or the order Nidovirales”. RSV is not in the subfamily Orthocoronavirinae. RSV is not in the family Coronaviridae. RSV is not in the order Nidovirales. RSV is in the order Mononegavirales as evidenced by Liang (“Structures of the Mononegavirales Polymerases”, published 2020-10-27, cited in PTO-892 dated 2025-08-27), which discloses, “Within the order, some Mononegavirales circulate within the human population causing respiratory diseases, such as the human respiratory syncytial virus (HRSV)”.
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.
Claims 1, 2, 13, 18, 20, 22, and 25 are rejected under 35 U.S.C. 103 over Kazakova, et al. (“Serological Array-in-Well Multiplex Assay Reveals a High Rate of Respiratory Virus Infections and Reinfections in Young Children”, published 2019-09-11, cited in PTO-892 dated 2025-08-27) as evidenced by a product preview from Photonics Spectra on the Clara CCD camera with Sony's ICX285 (https://www.photonics.com/Products/CCD_Camera/pr38008, published 2009-06, cited in PTO-892 dated 2025-08-27) and Pei, et al ("Nuclear-localized human respiratory syncytial virus NS1 protein modulates host gene transcription", published 2021-10-12, cited in PTO-892 dated 2025-08-27) and further in view of Pilavaki, et al. (“CMOS Image Sensor for Lateral Flow Immunoassay Readers”, published 2018-10).
Kazakova teaches a product of manufacture comprising viral antigens derived from a plurality of viruses affixed or attached onto a surface of the product of manufacture, as in claim 1 (see, e.g., product of manufacture – p. 12, under “MATERIALS AND METHODS”, under “Array-in-well fabrication.”, para. 1-2; viral antigens derived from a plurality of viruses affixed or attached onto a surface of the product of manufacture – p. 1, under “ABSTRACT”, and p. 3, “FIG 1”, panel “A” and “B”).
PNG
media_image1.png
672
1558
media_image1.png
Greyscale
Kazakova teaches a product of manufacture of claim 1, wherein a digital fluorescent reader, specifically the reader comprises a digital fluorescent microscope comprising a digital camera, and a transmitting element capable of transmitting data generated by the digital camera to a computer, as in claims 2 and 20 (see, e.g., a digital fluorescent reader, specifically comprising a digital fluorescent microscope comprising a digital camera – p. 13, under “MATERIALS AND METHODS”, under “Microarray immunoassay procedure.”: “The emission of UCNPs was detected through a 650-nm short-pass filter(Chroma Technology, Rockingham, VT) with a cooled charge-coupled-device (CCD) camera (Andor Clara with Sony ICX285 CCD; Andor Technology, South Windsor, CT) using 2x binning, a 2.2-s exposure time per well, and laser excitation at 976 ± 2 nm with 7 W of optical power”; transmitting element capable of transmitting data generated by the digital camera to a computer – p. 13, under “MATERIALS AND METHODS”, under “Image analysis program.”: “Image analysis was performed with ImageJ software version 1.43n. The computer program was written in Visual Basic language to aid in microarray analysis”). The CCD camera used in Kazakova is a digital fluorescent microscope comprising a digital camera as evidenced by the product preview from Photonics Spectra, which discloses, “Applications include […] wide-field fluorescence microscopy”. Kazakova’s teaching of the product of manufacture of claim 1 is discussed above. It is understood that Kazakova teaches a transmitting element due to the image analysis being performed on a computer, which necessitates a transmitting element.
Kazakova teaches the viral antigen attached to the surface of the product of manufacture comprises a viral nuclear antigen, as in claim 13 (see, e.g., p. 12, under “MATERIALS AND METHODS”, under “Antigens and controls.”: “The microarray included seven different viral antigens and three controls. The antigens were partially purified […] RSV whole viruses”). The RSV whole viruses of Kazakova include viral nuclear antigen as evidenced by Pei, which recites “RSV non-structural protein NS1 is a known cytosolic immune antagonist, but how NS1 modulates host responses remains poorly defined. Here, we observe NS1 partitioning into the nucleus of RSV-infected cells” (see p. 1, under “SUMMARY”). A viral protein in the nucleus of a host is a viral nuclear antigen by definition.
Kazakova teaches one of the viruses is a respiratory virus, such as a human respiratory syncytial virus, as in claims 18 and 25 (see, e.g., human – p. 12, under “MATERIALS AND METHODS”, under “Serum samples.”; respiratory syncytial virus - p. 1, under “ABSTRACT”).
Kazakova teaches the samples comprises a serum sample from the individual in need thereof, as in claim 22 (see, e.g., p. 12, under “MATERIALS AND METHODS”, under “Serum samples.”).
Kazakova fails to teach the product of manufacture comprises a digital fluorescence reader wherein the digital camera uses a CMOS image sensor to capture images and a microscope slide holder, as in claim 1. However, in a journal article on a CMOS image sensor for immunoassay readers, Pilavaki rectifies these deficiencies. Pilavaki teaches a CMOS image sensor to capture images, as in claim 1 (see, e.g., p. 1405, under “Abstract”: “A low power CMOS image sensor is presented that can be used in quantitative lateral flow immunoassay readers”). Also, Pilavaki teaches a microscope slide holder, as in claim 1 (see, e.g., p. 1409, col. 1, para. 1: “The system was mounted in a custom made 3D printed enclosure […] a special receptacle was developed, which accurately placed the strip above the chip”). It is understood that the strip is equivalent to a microscope slide because it is imaged by the CMOS image sensor, which acts as a microscope. It is understood that the receptacle is equivalent to a microscope slide holder because it holds the strip in place.
Kazakova and Pilavaki are analogous to the field of the claimed invention because they are both in the field of immunoassays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the CMOS image sensor of Pilavaki into the product of manufacture of Kazakova. An artisan would have been motivated to do so because Pilavaki discloses, “The proposed reader uses a CMOS image sensor (CIS) that is specifically designed to provide a low cost solution for this application” (see, p. 1405, col. 2, para. 3). The lower cost of using the CMOS image sensor would have motivated the artisan to incorporate the CMOS image sensor of Pilavaki into the product of manufacture of Kazakova. An artisan would have had a reasonable expectation of success based on the given disclosures.
One of ordinary skill in the art before the effective filing date of the application would have found it obvious to add the microscope slide holder of Pilavaki to the product of manufacture of Kazakova. An artisan would have been motivated to do so because Pilavaki discloses, “The system was mounted in a custom made 3D printed enclosure to remove any ambient light interference during the readings. Also, a special receptacle was developed, which accurately placed the strip above the chip with a 10 degree tilt to match the simulation results” (see, p. 1409, col. 1, para. 1). The enclosure and receptacle of Pilavaki provide two benefits that would have motivated the artisan to add the microscope slide holder of Pilavaki to the product of manufacture of Kazakova. The first benefit is the removal of ambient light, which interferes with the readings. The second benefit is that the strip is placed accurately at a tilt to increase predictability in imaging. An artisan would have had a reasonable expectation of success based on the given disclosures.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kazakova (cited above) as evidenced by Photonics Spectra (cited above) and Pei (cited above) in view of Pilavaki (cited above), as applied to claims 1, 2, 13, 18, 20, 22, and 25 above, and further in view of Rappuoli (US 20060257852 A1, published 2006-11-16, cited in PTO-892 dated 2025-08-27).
Kazakova and Pilavaki teaches as set forth above, but fails to teach the viral polypeptide antigen is an antigenic fragment of SEQ ID NO: 1, as in claim 19.
However, in a patent application publication on the nucleic acids and proteins of the SARS coronavirus, Rappuoli rectifies this deficiency. Rappuoli recites, “These nucleic acids and proteins can be used in the preparation and manufacture of vaccine formulations, diagnostic reagents, kits, etc.” (see under “ABSTRACT”). Rappuoli teaches SEQ ID NO: 6802 in Fig. 23 (see, e.g., para. [0165]), which has 100% local similarity to this application's SEQ ID NO: 1, as evidenced by the sequence alignment provided below:
Query Match 96.4%; Score 2227; Length 428;
Best Local Similarity 100.0%;
Matches 422; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSDNGPQSNQRSAPRITFGGPTDSTDNNQNGGRNGARPKQRRPQGLPNNTASWFTALTQH 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 7 MSDNGPQSNQRSAPRITFGGPTDSTDNNQNGGRNGARPKQRRPQGLPNNTASWFTALTQH 66
Qy 61 GKEELRFPRGQGVPINTNSGPDDQIGYYRRATRRVRGGDGKMKELSPRWYFYYLGTGPEA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 67 GKEELRFPRGQGVPINTNSGPDDQIGYYRRATRRVRGGDGKMKELSPRWYFYYLGTGPEA 126
Qy 121 SLPYGANKEGIVWVATEGALNTPKDHIGTRNPNNNAATVLQLPQGTTLPKGFYAEGSRGG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 127 SLPYGANKEGIVWVATEGALNTPKDHIGTRNPNNNAATVLQLPQGTTLPKGFYAEGSRGG 186
Qy 181 SQASSRSSSRSRGNSRNSTPGSSRGNSPARMASGGGETALALLLLDRLNQLESKVSGKGQ 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 187 SQASSRSSSRSRGNSRNSTPGSSRGNSPARMASGGGETALALLLLDRLNQLESKVSGKGQ 246
Qy 241 QQQGQTVTKKSAAEASKKPRQKRTATKQYNVTQAFGRRGPEQTQGNFGDQDLIRQGTDYK 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 247 QQQGQTVTKKSAAEASKKPRQKRTATKQYNVTQAFGRRGPEQTQGNFGDQDLIRQGTDYK 306
Qy 301 HWPQIAQFAPSASAFFGMSRIGMEVTPSGTWLTYHGAIKLDDKDPQFKDNVILLNKHIDA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 307 HWPQIAQFAPSASAFFGMSRIGMEVTPSGTWLTYHGAIKLDDKDPQFKDNVILLNKHIDA 366
Qy 361 YKTFPPTEPKKDKKKKTDEAQPLPQRQKKQPTVTLLPAADMDDFSRQLQNSMSGASADST 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 367 YKTFPPTEPKKDKKKKTDEAQPLPQRQKKQPTVTLLPAADMDDFSRQLQNSMSGASADST 426
Qy 421 QA 422
||
Db 427 QA 428
Kazakova, Pilavaki, and Rappuoli are analogous to the field of the claimed invention because they are both in the field of epidemiology. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the antigenic polypeptide of Rappuoli into the product of manufacture of Kazakova and Pilavaki. The artisan would be motivated to do so because Rappuoli discloses, “The invention relates to nucleic acids and proteins from the SARS coronavirus. These nucleic acids and proteins can be used in the preparation and manufacture of vaccine formulations, diagnostic reagents, kits, etc.” (see under “ABSTRACT”). Rappuoli continues, “The invention also relates to diagnostic reagents, kits (comprising such reagents) and methods which can be used to diagnose or identify the presence or absence of a SARS virus in a biological sample. The invention further includes non-coding SARS viral polynucleotide sequences, SARS viral sequences encoding for non-immunogenic proteins, conserved and variant SARS viral polynucleotide sequences for use in such diagnostic compositions and methods” (see para. [0009]). An artisan would have a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liang discloses RSV is in the order of Mononegavirales.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL C SVEIVEN whose telephone number is (703)756-4653. The examiner can normally be reached Monday to Friday - 8AM to 5PM PST.
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 Emch can be reached at (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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678