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 Jun. 16, 2023. Claims 1-5, 7-9, 12 and 14-15 are pending and currently examined.
Claim Objection
Claim 1 is objected to for the following minor abnormality: claim 1 recites “said rHVT also expresses a glycoprotein D and a glycoprotein I (gD and gI) gene off infectious laryngotracheitis virus (ILTV)”. Here, the word “off” appears to be a typo of “of”. Applicant is required to make proper corrections.
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.
Claims 1-5, 7-9, 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 11,229,698 B2, patented on Jan. 25, 2022; PCT publication date Apr. 18, 2019) and Fujisawa et al. (US 2015/0118250 A1, published on Apr. 30, 2015).
These claims are directed to a recombinant herpesvirus of turkeys (rHVT) expressing an infectious bursal disease virus (IBDV) viral protein 2 (VP2) gene and a Newcastle disease virus (NDV) fusion (F) protein gene from a first expression cassette which is inserted in the unique short (Us) region of the genome of the rHVT, characterized in that said rHVT also expresses a glycoprotein D and a glycoprotein I (gD and gI) gene of infectious laryngotracheitis virus (ILTV) from a second expression cassette which is inserted in the unique long (UL) region of the genome of said rHVT, either between the UL44 and UL45 genes or between the UL45 and UL46 genes.
Briefly, the claimed rHVT contains a first expression cassette expressing an IBDV VP2 protein and an NDV F protein inserted in the Us (unique short) region, and a second expression cassette expressing an ILTV gD-gI gene inserted either between UL44 and UL45 or between UL45 and UL46.
Cook teaches an invention relating to recombinant multivalent non-pathogenic Marek’s Disease virus (MDV) constructs that encode and express foreign antigens from three or more avian viruses, along with methods of the use of the multivalent poultry virus vaccines. See Abstract. MDVs include herpesvirus of turkeys (HVT, also called MDV-3). Figures 1-5 of Cook present constructs based on HVT expressing antigens from three heterologous avian viruses, i.e., IBDV VP2, NDV F and ILTV gD-gI, in two expression cassettes which can be inserted in two different sites on the HVT genome – UL54.5 and Us2.
Figure 4 of Cook presents an rHVT construct that closely resembles the rHVT as instantly claimed, i.e., an rHVT containing a first expression cassette expressing an IBDV VP2 protein and an NDV F protein inserted in the Us (unique short) region, and a second expression cassette expressing an ILTV gD-gI gene inserted either between UL44 and UL45 or between UL45 and UL46, except that the cassette expressing an ILTV gD-gI gene is inserted in UL54.5. On the other hand, Cook teaches that the three heterologous antigen sequences can be arranged in rHVT constructs in two expression cassettes in different combinations, and that the two expression cassettes can be inserted in different non-essential sites, including the US2 site, the UL54.5 site, the UL7/8 site, the UL40 site, the UL43 site, the UL45/46 site, the UL55 site, the US10 site, the region between US10 and SORF3, the region between US2 and SORF3, the IG1 site, the IG2 site, and the IG3 site, etc. See column 6, lines 17-21.
Fujisawa teaches an invention relating to a recombinant avian herpes virus, such as HVT, which comprises at least two recombinant nucleotide sequences, each recombinant nucleotide sequence encoding a distinct antigenic peptide, wherein said at least two recombinant nucleotide sequences are inserted into distinct non-coding region 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, the region located between SORF3 and US2. See Abstract and Figures 1 and 2.
Fujisawa teaches that, according to the invention, the foreign genes can be chosen among the F protein of Newcastle disease virus (NDV), the VP2 protein of the Infectious bursal disease virus (IBDV), the gB protein of ILTV, an antigenic peptide of Mycoplasma galisepticum, and an antigenic peptide of the avian influenza virus. See [0015].
Accordingly, both Cook and Fujisawa teach various recombinant HVT constructs as potential avian vaccines comprising two expression cassettes expressing heterologous antigens, including viral antigens IBDV VP2, NDV F and ILTV gD-gI, as instantly claimed. Cook specifically teaches an rHVT construct, the one shown in Figure 4, that is indistinguishable from that as claimed, except that the cassette expressing an ILTV gD-gI gene is inserted in UL54.5 (instead of inserting either between UL44 and UL45 or between UL45 and UL46, as instantly claimed), while Fujisawa teaches an rHVT construct wherein the two heterologous expression cassettes are inserted into a Us site and between UL44 and UL45 or UL45 and UL46, the two non-essential sites as instantly claimed.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to combine the teachings of Cook and Fujisawa to arrive at the invention as claimed. One would have been motivated to do so to evaluate experimental result for inserting the expression cassette expressing an ILTV gD-gI in the known insertion site of between UL44 and UL45 or UL45 and UL46, taught in both Cook and Fujisawa. Additionally, such a combination, or a substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See e.g., KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. Here, the insertion sites between UL44 and UL45, between UL45 and UL46, and the insertion site of UL54.5 are known in the art to have the same function of accommodating heterologous expression cassettes. Therefore, the instant invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claims 2 and 4, Cook teaches that the promoters, such as the murine cytomegalovirus immediate early (mCMV IE) promoter, the human cytomegalovirus immediate early (hCMV IE) promoter, the guinea pig cytomegalovirus immediate early promoter, the chicken b-actin promoter, the pseudorabies virus (PRY) gpX promoter, etc, can be used. See columns 10 and 11. Cook also teaches that the insertions of nucleotide sequences encoding the ILTV gD protein, the ILTV gI protein, and the IBDV VP2 protein may include one or more exogenous transcription terminator sequences, and that the terminator sequence (e.g. SV40 polyadenylation sequence (polyA) can be placed downstream of related genes whose transcription needs to be terminated. See columns 11 and 12.
A skilled artisan would have found it obvious to test different promoters and terminator, as well as their proper location relative to the genes to be transcribed to find a proper arrangement, including the ones as claimed, through routine experimental optimization unless there is evidence that the claimed arrangements are critical.
Regarding claim 8, Cook teaches that an adjuvant may be used together with a vaccine of the invention. See column 30, lines 19-53. Here, adjuvants can be considered as additional immunoactive component.
Regarding claim 9, Cook teaches that a method for the preparation of the vaccine according to the invention comprises the steps of infecting host cells with a recombinant MDVnp of the present invention, harvesting the infected host cells, and then mixing the harvested infected host cells with a pharmaceutically acceptable carrier. Suitable methods for infection, culture and harvesting are well known in the art and are described and exemplified therein. See column 29, lines 46-53.
Regarding claims 14 and 15, Cook teaches that the combination vaccine of the invention can be made in a variety of ways including by combining the recombinant MDVnp of the invention with preparations of virus, or bacteria, or fungi, or parasites, or host cells, or a mixture of any and/or all of these. See column 31, lines 37-41. This teaching indicates that host cells may be included in a vaccine combination. One of skill in the art would have found it obvious to include rHVT-producing host cells in a vaccine combination to immunize subject animals, based on the teachings of Cook. One would have been motivated to do so, e.g., to reduce the purification effort of the recombinant viruses since host cells may also be included in a vaccine combination.
Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7-9, 12 and 14-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent 11,229,698 B2 in view of Fujisawa et al. (US 2015/0118250 A1, published on Apr. 30, 2015), as applied in the 103 rejection above.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both sets of claims encompass an rHVT construct comprising two expression cassettes1 each comprising one or two nucleotide sequences encoding IBDV VP2, NDV F and ILTV gD-gI antigens. The only difference between the instant claims and the patented claims is: that the instant claims specify that one of the two expression cassettes expresses the IBDV VP2 and the NDV F antigens and is inserted in an Us site, and the other expression cassette expresses the ILTV gD-gI antigens and is inserted in a site between UL44 and UL45 or UL45 and UL46 genes; while the patented claims are more generic in the arrangement of the nucleotide sequences encoding the IBDV VP2, NDV F and ILTV gD-gI antigens in the two expression cassettes (except for claims 7 and 8, which specify the same arrangement of the IBDV VP2, NDV F and ILTV gD-gI antigens in the expression cassettes as the instant claims), and the patented claims specify that the expression cassettes are inserted in the Us and UL54.5 sites.
As indicated in the 103 rejection above, Fujisawa teach the sites for heterologous nucleic acid insertions can be in the Us region, between the UL44 and UL45 genes, or between the UL45 and UL46 genes. See discussion in the 103 rejection above.
It would have been prima facie obvious for one of ordinary skill in the art to arrive at the instant claims from the patented claims based on the same rationales presented in the art rejection above.
Instant claim 9, which is directed to a process of preparation of a vaccine product, does not have a corresponding process-of-preparation claim in the patented claims set. Since the claim 9 specifies a common basic process of preparing recombinant viruses in host cells, one of skill in the art would have found it obvious over the recombinant HVT constructs of the patented claims.
Accordingly, claims 1-5, 7-9, 12 and 14-15 are unpatentable over claims 1-20 of US Patent 11,229,698 B2.
Claims 1-5, 7-9, 12 and 14-15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 and 12-15 of US Applicant 18/862,717 in view of Cook et al. (US 11, 229, 698 B2, patented on Jan. 25, 2022; PCT publication date Apr. 18, 2019) and Fujisawa et al. (US 2015/0118250 A1, published on Apr. 30, 2015), as applied in the 103 rejection above.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both sets of claims encompass an rHVT construct comprising a first and a second expression cassette, wherein the first expression cassette comprises an IBDV VP2 gene and a NDV F gene and is inserted in the Us region of the rHVT, and the second expression cassette comprises a gD-gI gene of ILTV. The only difference is that the second expression cassette of the reference claims is inserted between the UL54 and the LORF3 genes of the rHVT, as opposed to the instantly claimed insertion site of between the UL44 and UL45 genes or between the UL45 and UL46 genes.
As indicated in the 103 rejection above, both Cook and Fujisawa teach that the sites for heterologous nucleic acid insertions can be in the Us region, between the UL44 and UL45 genes, between the UL45 and UL46 genes, or the UL54.5, etc. See discussion in the 103 rejection above. The UL54.5 site is considered as being located in the region between UL54 and UL55 genes, which includes the insertion site “located between the UL54 and the LORF3 genes” specified in the reference claims.
It would have been prima facie obvious for one of ordinary skill in the art to interchange the insertion sites used for the second expression cassette of the reference and instant claims, since these two choices are considered as equivalent for accommodating the second expression cassette that expresses the gD-gI gene of ILTV.
Accordingly, claims 1-5, 7-9, 12 and 14-15 are provisionally unpatentable over claims 1-10 and 12-15 of US Applicant 18/862,717.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. 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.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671
1 The patented claims do not recite the term “expression cassette”. Instead, they recite “a first heterologous nucleic acid” and “a second heterologous nucleic acid”, which are considered as being indistinguishable from “expression cassette” in the related inventions.