Detailed Office 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
Acknowledgement is hereby made of receipt and entry of the communication filed 05 December, 2025. Claims 1, 4-8, 10, 12, and 13 are pending in the instant application. Applicants’ election of Group I (claims 1, 4, and 5) with traverse for examination on the merits is noted. Applicant asserts the claimed invention contains a special technical feature by providing a set of four primers and two probes to distinguish between HBV genotypes D and the recombinant form C/D. Applicant’s arguments have been carefully considered but are not deemed to be persuasive. As set forth below, the claimed invention lacks a special technical feature. Accordingly, claims 6-8, 10, 12, and 13 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
35 U.S.C. § 119
Acknowledgment is hereby made of Applicants’ claim for foreign priority based on CN 2020/10330948.9, filed 23 April, 2021. A copy of the foreign priority document submitted under 35 U.S.C. § 119(a)-(d), has been received and placed of record in the file.
37 C.F.R. § 1.98
The information disclosure statements filed 24 October, 2022, and 26 October, 2022, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 24 October, 2022, are objected to because they are illegible. Corrected drawing sheets in compliance with 37 C.F.R. § 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 C.F.R. § 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.
Joint Inventors, Common Ownership Presumed
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
35 U.S.C. § 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.
Graham v. Deere
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 U.S.P.Q. 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 1, 4 and 5 are rejected under 35 U.S.C. § 103 as being unpatentable over CN 105256075 (published 20 January, 2016; hereinafter referred to as the “’075 publication”), in view of Tadokoro et al. (2006, Classification of hepatitis B virus genotypes by the PCR-Invader method with genotype-specific probes, J. Virol. Meth. 138:30-39), Wang et al. (2007, Distribution and characteristics of hepatitis B virus genotype C subgenotypes in China, J. Viral Hepatitis 14:426-434), and Irshad et al. (2016, Multiplex qPCR for serodetection and serotyping of hepatitis viruses: A brief review, World J. Gastroenterol. 22(20):4824-4834).
Claim 1 is directed toward an oligonucleotide composition for fluorescent PCR detection of HBV genotypes, comprising: (1) a first pair of primers and a first probe for specific detection of HBV genotype D and C/D recombinant type, the first pair of primers and the first probe being designed for the S gene region of the HBV genotype D, wherein the first pair of primers and the first probe have base sequences of SEQ ID NOS.: 13 to 15; and (2) a second pair of primers and a second probe for specific detection of the HBV C/D recombinant type, the second pair of primers and the second probe being designed for the C gene region of the HBV C/D recombinant type, wherein the second pair of primers and the second probe have base sequences of SEQ ID NOS.: 16 to 18. Claim 4 further recites oligonucleotides further comprising at least one of (3) to (6): (3) primers and a probe for detecting HBV genotype A, which have base sequences of SEQ ID NOS.: 1 to 3 respectively; (4) primers and a probe for detecting HBV genotype B, which have base sequences of SEQ ID NOS.: 4 to 6 respectively; (5) primers and a probe for detecting HBV genotype C, which have base sequences of SEQ ID NOS.: 10 to 12 respectively; and (6) primers and a probe for detecting HBV DNA, which have base sequences of SEQ ID NOS.: 7 to 9 respectively. Claim 5 references a series of internal reference primers and probes corresponding to SEQ ID NOS.: 19-21.
The ‘075 publication discloses a fluorescent PCR kit for the detection of eight different HBV genotypes (e.g., A-H) utilizing primers and probes corresponding to the C, S, and P gene regions (see claims and Example 1). The probe is typically labeled with a fluorescent reporter group such as FAM, TET, HEX, ROX, JOE, or CY3. The Geneseq database from Genbank was utilized to identify highly conservative regions amongst full-length genomic sequences of HBV A-H. Primer design software (PrimerPremier5) was employed to identify suitable primer sequences (see Embodiment 1). This teaching does not disclose the detection of HBV C/D recombinants or the precise primers/probes claimed.
Tadokoro et al. (2006) generated preS/S and core region primers/probes capable of amplifying ten different HBV genotypes and four subgenotypes (see Abstract, p. 30; Table 1, p. 31; and Materials and Methods, 2.3. Design of genotype-specific Invader probes). This teaching does not disclose the detection of HBV C/D recombinants or the precise primers/probes claimed.
Wang et al. (2007) used PCR-restriction fragment length polymorphism (RFLP) to identify four new HBV genotype C subgenotypes (see METHODS, Hepatitias B virus subgenotyping and Amplification and sequencing of the full-length genome. These were designated subgenotypes C1, C2, CD1, and CD2. The last two subgenotypes correspond to C/D recombinant forms. This teaching does not disclose the precise primers/probes claimed.
Irshad et al. (2016) describe the current status of multiplex qPCR for the detection of hepatitis viruses and HBV genotyping/subgenotyping. The authors provided a detailed explanation about experimental approaches for identifying suitable primers and probes (see pp. 4826-4827; Experimental Approach for Multiplex qPCR, Search for conserved regions and Designing of primers and probes, and Designing Tools). The authors reported that several designing tools are available to guide the design of qPCR assays and analyze resulting quantitative data. Some important tools include Primer3, Primer-BLAST, PerlPrimer, FastPCR software, IDTSciTools, and UniPrime. This teaching does not disclose the detection of HBV C/D recombinants or the precise primers/probes claimed.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to utilize the fluorescent PCR assay disclosed in the ‘075 publication, to detect various HBV genotypes and subgenotypes, including variant C/D, as disclosed by Wang et al. (2007). One of ordinary skill in the art, using routine primer selection programs, such as those disclosed by Tadokoro et al. (2006) and Irshad et al. (2016), would have been capable of identifying conserved regions in S and core and targeting them for amplification. Absent evidence to the contrary, one of ordinary skill in the art would have been capable of using these art-recognized programs to arrive at the instantly claimed primer and probe combinations. One of ordinary skill in the art would have been motivated to detect HBV C/D recombinants because they represent a new subgenus of HBV with unique genotypic/phenotypic properties.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 10 January, 2026