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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Feb. 03, 2026. Claims 1-3, 5-10, 16-29 are pending and are currently examined.
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.
(Previous rejection- withdrawn except claim 6) Claims 8, 10 and 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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.
This rejection is withdrawn in view of the amendment filed on Feb. 03, 2026.
(Previous rejection for claim 6-maintained) Claim 6 recites the term “preferably" that renders the claim indefinite. It is unclear whether the limitations following the phrase are parts of the claimed invention.
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(Previous rejection- withdrawn) Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Panshin et al. (Taxonomy ID: 576252, https://www.ncbi.nlm.nih.gov/nuccore/?term=txid576252[Organism:noexp], Feb. 19, 2009) as evidenced by Ross T. (J Infect Dis. 2019 Apr 8;219(Suppl_1):S57-S61).
This rejection is withdrawn in view of the amendment filed on Feb. 03, 2026.
(New Rejection-necessitated by amendment) Claims 1-3, 6-7, 9-10 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al. (US 10,251,951 B2, patented on April 09, 2019) as evidenced by Liu et al. (Virology. 2019 Mar; 529:7-15) and in view of Chen et al. (CN110128545A, published on Aug. 16, 2019).
The amended base claim 1 is directed to a recombinant Herpes Virus of Turkeys (rHVT) which comprises (i) a nucleotide sequence encoding a F protein of Newcastle Disease Virus, or an immunogenic fragment or variant thereof, inserted into a first insertion site of the viral genome; and (ii) a nucleotide sequence encoding an Hemagglutinin (HA) protein of a subtype H9 avian influenza virus, or an immunogenic fragment or variant thereof, inserted into a second insertion site of the viral genome, the first and second insertion sites being located in different non-coding regions of the viral genome selected from the non-coding region between UL45 and UL46, and the non-coding region between SORF3 and US2, wherein the nucleotide sequence encoding the HA protein comprises SEO ID NO: 8, 9, 10, 11, 12, or 13.
Fujisawa et al. teaches a recombinant avian herpes virus, which comprises at least two recombinant nucleotide sequences, each recombinant nucleotide sequence encoding a distinct antigenic peptide, wherein the at least two recombinant nucleotide sequences are inserted into distinct noncoding regions of the viral genome chosen among the region located between UL44 and UL45, the region located between UL45 and UL46, the region located between US10 and SORF3, and the region located between SORF3 and US2 (See Abstract), where the herpes virus is herpes virus of turkey (HVT) (See column 1). Fujisawa et al. also teaches that the foreign genes can be the F protein of Newcastle disease virus (NDV) and an antigenic peptide of the avian influenza virus, preferentially a surface protein hemagglutinin (HA) (See column 2, lines 45-55), which teaches the base claim (i) and (ii) because the fist antigen peptide can be inserted into the noncoding region located between UL45 and UL46, and the second antigenic peptide can be inserted between US10 and SORF3, or between SORF3 and US2 (See column 2, lines 56-63).
Accordingly, Fujisawa et al. teaches a recombinant Herpes Virus of Turkeys (rHVT) comprising F protein of Newcastle Disease Virus and Hemagglutinin (HA) protein that insert in different non-coding regions of the viral genome selected from the non-coding region between UL45 and UL46, and the non-coding region between SORF3 and US2 as claimed.
As for the HA protein of the subtype H9 avian influenza virus claimed in the instant application, Fujisawa et al. teaches that the antigen can be selected from the surface protein hemagglutinin (HA) of the avian influenza virus (See e.g., column 7, lines 1-3), where the H9 influenza is an avian influenza virus. Here Liu’s study can be evidenced to demonstrate that the recombinant HVT (rHVT-H9) contains the hemagglutinin (HA) gene from H9 influenzas virus. Liu et al. teaches that the recombinant turkey herpesvirus expressing H9 hemagglutinin providing protection against H9N2 avian influenza (See Title). Therefore, it would be obvious for one of ordinary skill in the art to use the Hemagglutinin (HA) protein of a subtype H9N2 avian influenza virus as the antigen if needed and the result would be predictable based on the teaching of Fujisawa and Liu.
As for the amended nucleotide sequence encoding the HA protein comprises SEO ID NO: 8, 9, 10, 11, 12, or 13 in the base claim 1, Fujisawa evidenced by Liu does not teach these required SEQ ID NOs. However, the base claim 1 (ii) recites a limitation that “a nucleotide sequence encoding a Hemagglutinin (HA) protein of a subtype H9 avian influenza virus, or an immunogenic fragment or variant”, which indicates that the base claim 1 (ii) can be “…an immunogenic fragment or variant”. Fujisawa teaches a surface protein hemagglutinin (HA) of an avian influenza virus or an immunogenic fragment (See column 37, claim 3), however, it is silent on an immunogenic fragment or variant from the SEQ ID NOs: 8, 9, 10, 11, 12, or 13.
Chen teaches an application of fused antigen as vaccine development where the fusion antigen is merged using bird flu H9 hypotype HA gene, Adenovirus Type 4 fiber2 gene, specific link peptide fragment gene (See Abstract; page 2, claim 10), where the SEQ ID NO: 4 of the Bird flu H9 hypotype HA gene has a 96.1% match to the claimed SEQ ID NO: 10 (See Table A below), which can be an example that Fujisawa in view of Chen to teach an immunogenic fragment or variant of HA as claimed.
PNG
media_image1.png
467
930
media_image1.png
Greyscale
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to use known HA fragments or variants, such as the variant SEQ ID NO: 4 of Chen in Fujisawa’s invention to arrive at an invention as claimed. One of skill in the art would have been motivated to do so to use the known sequence to develop a recombinant Herpes Virus of Turkeys (rHVT) comprising a nucleotide sequence encoding an Hemagglutinin (HA) protein of a subtype H9 avian influenza virus, or an immunogenic fragment or variant (See MPEP 2144.06: Substituting equivalents known for the same purpose). There would be a reasonable expectation of success to construct such a recombinant Herpes Virus of Turkeys (rHVT) as claimed based on the teachings of Fujisawa and Chen.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 2 and 3, Fujisawa et al. teaches that the rHVT comprises at least two recombinant nucleotide sequences that are inserted into distinct non-coding regions of the viral genome chosen among the region located between UL44 and UL45, the region located between UL45 and UL46, the region located between US10 and SORF3, and the region located between SORF3 and US2 (See column 2), and discloses that preferentially, the nucleotide sequences inserted into the viral genome are chosen among the F protein of NDV, the VP2 protein of IBDV, the gB protein of ILTV, the protein of Mycoplasma galisepticum, and the surface protein hemagglutinin (HA) of the avian influenza virus (See column 6, lines 66-67 and column 7, lines 1-11). These descriptions indicate that the antigens such as F protein and HA can be inserted in the sites between UL45 and UL46 or between SORF3 and US2 based on the application needs. For example, Fujisawa et al. teaches that a nucleotide sequence encoding a F protein of NDV can insert into a non-coding region site between UL45 and UL46 and the nucleotide sequence encoding VP2 protein of IBDV can insert into a non-coding region site between SORF3 and US2 (See column 10, lines 23-31), where it is obvious that one of skilled can replace the VP2 protein of IBDV with the HA of the H9N2 avian influenza virus. Also, Fujisawa et al. teaches an embodiment that a nucleotide sequence encoding a F protein of NDV can insert into a site between a non-coding region of SORF3 and US2 (See column 10, lines 59-67), where the second antigen can insert at the sites between UL45 and UL46. Therefore, the claims of inserting the sequence encoding F protein of NDV and HA of avian influenza virus into the sites between UL45 and UL46 or between SORF3 and US2 is routine and obvious for one of ordinary skill in the art to determine which antigen can be inserted in the recited locations and the result would be predictable. Further, applicant has not demonstrated unexpected or superior results if either antigen is inserted in to a particular non-coding region.
Regarding claim 6, Fujisawa et al. teaches that the recombinant nucleotide sequences are advantageously under the control of particular promoters. The promoters are preferentially chosen among the chicken beta-actin (Bae) promoter, the Pee promoter, the Murine Cytomegalovirus (mCMV) immediate-early (IE)l promoter, Human Cytomegalovirus (Hcmv) promoter, the Simian virus (SV)40 promoter, and the Raus Sarcoma virus (RSV) promoter, or any fragments thereof which retain a promoter activity. Preferentially, each recombinant nucleotide sequence is under the control of a distinct promoter. (See column 2, lines 35-55). Here the teaching indicates that the sequence encoding the F-protein of HA protein can be under control of one of the listed promoters such as the CMV promoter as claimed. Nevertheless, Liu et al. teaches that the HA gene of H9N2 virus was inserted, integrating with the human cytomegalovirus immediate-early promoter (CMV) or pec promoter into HVT-BAC (See page 629, left column, paragraph 2). It is obvious that one of skilled clone the HA gene under the control of the CMV promoter based on the needs.
PNG
media_image2.png
850
902
media_image2.png
Greyscale
Regarding claim 7, Fujisawa et al. teaches a Pec promoter shown in SEQ ID NO: 2 (See column 7, lines 33-39), which is identical to the claimed SEQ ID NO: 15 (See Table 1 below).
Regarding claims 9-10 and 28-29, Fujisawa et al. teaches that according to the invention, foreign DNA sequences are inserted in particular insertion sites within the rHVT genome, providing stable and efficient constructs suitable for use in vaccine compositions or methods (See column 5, paragraph 1), and their invention relates generally to the field of vaccine preparations that specifically relates to multivalent recombinant herpes viruses in which at least two foreign genes have been inserted, and their uses for simultaneously inducing a protective immunity against a plurality of avian diseases (See column 1, lines 12-17). Based on the descriptions above, Fujisawa et al. teaches the rHVT virus, a nucleotide sequence encoding the F protein of NDV and a nucleotide sequence encoding the HA protein of H9N2. Therefore, Fujisawa evidenced by Liu teaches a vaccine that comprises a rHVT as claimed in claim 1 (teach claim 9). Fujisawa also teaches that their invention further relates to a method of immunizing an avian comprising administering to said avian an effective immunizing amount of the vaccine according to the invention (See column 3, lines 22-24) (teach claim 10). Fujisawa further teaches that the term "avian species" is intended to encompass all kinds of avians such as birds of the class of Aves, i.e., vertebrate animals which are feathered, winged, bipedal, endothermic and egg-laying. In the context of the invention, avians or avian species refer more particularly to birds with economical and/or agronomical interests, such as poultry (such as chickens and turkeys), waterfowl poultry (such as ducks and geese) and ornamental birds (such as swans and psittacines) (See column 5, lines 47-55) (teach claims 28-29).
Allowable Subject Matter
The nucleic acid sequence SEQ ID Nos: 8-14 are free of prior art.
Accordingly, claims 5, 8 and 16-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Responses to Applicant’s Remarks
Applicant’s arguments filed on Feb. 03, 2026 has been received and fully considered.
Applicant’s amendment on the rejection under 35 U.S.C. § l 12(b) is considered except the claim 6. The rejection is withdrawn except maintaining the claim 6.
Applicant’s amendment and argument on the rejection under 35 U.S.C. § 103 is not found persuasive.
1). Applicant argued that the claimed invention is not obvious over the cited references; however, the amendment made to the claims has rendered this rejection moot (See Remarks, page 6).
Applicant’s argument is not persuasive.
Although the amendments recite limitations on the SEQ ID NOs: SEO ID NO: 8, 9, 10, 11, 12, or 13 for the nucleotide sequence encoding the HA protein, however, the limitation does not overcome the 103 rejections because Fujisawa teaches an immunogenic fragment as claimed in the base claim 1 (ii) (See column 37, claim 3).
2). Applicant’s amendment on the rejection for claims 11 and 15 under 35 U.S.C. § 103 is considered. The rejection is withdrawn.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) 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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am-5:00 pm, EST.
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, Thomas J. Visone can be reached on (571) 270-0684. 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.
/RUIXUE WANG/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672
Prosecution Insights