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 .
Election/Restrictions
Applicant’s election of group I, claims, species of SEQ ID NO: 5 in the reply filed on May 28, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is noted that, in the response, new claims 11-21 are added. Claims 14-18 are depended on the elected group I,
However, Because some of these new claims are beyond the scope of the elected claims , and they are restriction as a group IV, Claim 13 is directed to a Turkeys herpesvirus vector TLV and a heterologous sequence encoding NDV, and group V, Claims 19-20 are directed to a computer program for analyzing the nucleic acid sequence, classified as C12N 15/00. They are directed to related inventions, which are distinct from the elected group I as the inventions as claimed are designed with different design, mode of operation, function, or effect; and there is nothing of record to show them to be obvious variants. Therefore, they are restriction from the elected group I. During a telephone conversation with Attorney Ms. Judy Jarecki Black regarding further restriction of groups IV & V on June 23. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13 and 19-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Hence, Claims 1-5 and 14-18 with elected species are considered.
Claims 7-13 and 19-21 are withdrawn from consideration.
Sequence requirement
This application contains sequence that are encompassed by the definitions for nucleotide and/or amino acid sequences , page 26, [0105] set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
Full compliance with the sequence rules is required in response to this Office Action. A complete response to this office action should include both compliance with the sequence rules and a response to the Office Action set forth below. Failure to fully comply with both these requirements in the time period set forth in this office action will be held non-responsive.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is ejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In the instant case, now all viruses listed in claim 2 contains UL5, UL30, UL44 , UL37 or UL45. Such viruses include reovirus, NDV, Duff Hepatitis (DHV), Avian influenza virus and avian adenovirus and Hemorrhaged enteritis virus etc. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In the instant case, Applicants do not have possession for making a deoptimized modification for any or all avian pathogen at the any or all viral genome selected from the group consisting of US 5, IL30, UL37, UL44 and UL47 of any pathogenic viruses. wherein the recombinant viral composition has an reduced virulence but retained its immunogenicity.
The first paragraph of 35 U.S.C. requires that the specification shall contain a written description of the invention. This requirement has several objectives: 1). To clearly convey the information that an applicant has invented the subject matter which is claimed; 2). To put the public in possession of what the applicant claims as the invention; and 3). To promoter the progress of the useful arts by ensuring that patentee adequately describe their inventions in their patent specification in exchange for the right to exclude others from participating the invention for the duration of the patent term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably concluded that the inventor had possession of the claimed invention. The possession of claimed invention can be shown by describing the claimed invention with disclosed specification including drawing or description of an actual reduction to practice. The written description may arise in the following situations:
a). The claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention;
b). The claimed invention as a whole may not adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art; and
c). The invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function etc.
However, in the instant case, the claimed invention is directed to a n avian vaccine for inducing an immune response against an avian subject against an avian pathogen caused by infectious Laryngotracheitis Virus (ILTV) or NDV carried by the recombinant infectious Laryngotracheitis Virus (ILTV) vector, wherein the nucleic acid sequence of the infectious Laryngotracheitis Virus (ILTV) comprising a nucleic acid sequence comprising a deoptimized nucleic acid sequence encoding envelope protein of US5 set forth in SEQ ID NO;5; UL30 with a deoptimized modification with nucleic acid sequence set forth in SEQ ID NO: 3, or UL44 with a deoptimized nucleic acid set forth in SEQ ID NO: 7 or UL47 with a deoptimized modification nucleic acids set forth in SEQ ID NO: 9 or UL37 with a deoptimized modification nucleic acid sequence set forth in SEQ ID NO: 11.
However, the scope of the claims read on making a deoptimized modification for any or all nucleic acids of any or all avian pathogen at the any or all viral genome selected from the group consisting of US5, IL30, UL37, UL44 and UL47 wherein the recombinant viral composition has an reduced virulence but retained its immunogenicity.
Moreover, the current Application does not provided sufficient evidence to support that broad scope of claims that Applicants cited in the rejected independent claims. The specification has not provided adequate guidance to so many viral polynucleotide deoptimized such that one skilled in the art would recognize that the applicant had possession of the claimed invention.
It is well known in the art that Infectious laryngotracheitis virus (ILTV), officially classified as Gallid alphaherpesvirus 1, which differs genetically from other members of the Herpesviridae primarily through its unique gene arrangement in its individual distinct set of virus-specific genes, and a unique evolutionary lineage. Moreover, ILTV contains a cluster of unique, virus-specific ORFs (notably ORFs A through E) located near the large inversion. However, These genes are completely absent from other alpha, beta, and gamma herpesviruses, suggesting they were acquired through independent evolutionary adaptation in the avian lineage as evidenced by Spatz et al. (Virus Gene 2012, April. 2012 Apr;44(2):273-85).
Still further, although ILTV is an alphaherpesvirus, phylogenetic analyses show it is only distantly related to better-characterized mammalian viruses (like HSV-1) and avian Marek’s disease virus (MDV). Even if within the same claimed US5 as evidenced by Lee et al. (PLOS. One 2013 Feb 1;8(2):e55121. doi: 10.1371/journal.pone.0055121). Lee et al. teach that The ICP4, UL27, UL36, US5 and US8 genes showed the most variability within the six strains of ILTV and the six strains could be distinguished using the nucleotide and/or amino acid sequences of these genes.
The first paragraph of 35 U.S.C. requires that the specification shall contain a written description of the invention. This requirement has several objectives: 1). To clearly convey the information that an applicant has invented the subject matter which is claimed; 2). To put the public in possession of what the applicant claims as the invention; and 3). To promoter the progress of the useful arts by ensuring that patentee adequately describe their inventions in their patent specification in exchange for the right to exclude others from participating the invention for the duration of the patent term.
Therefore, to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably concluded that the inventor had possession of the claimed invention. The possession of claimed invention can be shown by describing the claimed invention with all of its limitation in the specification including drawing or description of an actual reduction to practice. The written description may arise in the following situations: a). The claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention; b). The claimed invention as a whole may not adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art; and c). The invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function etc.
Hence, Applicants do not have possession for making a deoptimized modification for any or all avian pathogen at the any or all viral genome selected from the group consisting of US 5, IL30, UL37, UL44 and UL47 of any pathogenic viruses. wherein the recombinant viral composition has an reduced virulence but retained its immunogenicity.
Claims 1-2 and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making a recombinant Infectious Laryngotracheitis Virus (ILTV) with a deoptimized modification in the viral genome of US5, UL30, UL44, UL47 and UL37 as shown in the corresponding nucleic acid sequence set forth in SEQ IDNO: 5, 3, 7, 9, and 11 respectively, does not reasonably provide enablement for ,making a deoptimized modification for any or all pathogenic viruses of US5, UL30, UL44, UL47 and UL37. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The test of an enablement or scope of enablement is whether one skilled in the art could make and use the claimed invention from the disclosure in the application coupled with information known in the art would render undue experimentation (See United States v. Theketronic Inc., 8USPQ2d 1217 (fed Cir. 1988). Whether undue experimentation is required is not based upon a single factor but rather a conclusion reached by weighting many factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in re Wands, 8USPQ2d 1400 (Fed. Cir. 1988), which are set forth below:
1). Nature of invention; 2). Scope of claims; 3). State of art; 4). Unpredictability; 5). Level of skill in the art; 6). Number of working examples and 7). Amount of guidance presented in the specification.
As described supra, which are related to the Nature of invention; the Scope of claims; the State of art and Number of working examples as well as Amount of guidance presented in the specification, it is also very important to note herein that the field is very unpredictable. First of all, it is only viruses in the family of Herpesviridae contains the genes encode unique shorts (US) and unique long (UL) open reading frames (ORF), i.e. to say not all avian viruses contain US and UL ORF, e.g. the NDV does not contain US or UL ORF. Therefore, the scope of the claims read on unpredictable and unenabled. Secondly, not all herpesviruses have same US and UL ORFs. Moreover, even if there are US5 or UL47 present, the molecular sequences are not same , how you can know when modification(s) is necessarily as it is cited in claim (See claim 1 for instance).
It is well known in the art that Infectious laryngotracheitis virus (ILTV) differs genetically from other members of the Herpesviridae primarily or even within the same group through its unique gene arrangement and a unique evolutionary lineage. For example, ILTV contains a cluster of unique, virus-specific ORFs (notably ORFs A through E), which are located near the large inversion. However, these genes are completely absent from other alpha, beta, and gamma herpesviruses as evidenced by Spatz et al. (Virus Gene 2012, April. 2012 Apr;44(2):273-85) .
In addition, despite sharing some conserved core genes with the Varicella-Zoster virus (VZV) and HSV-1 for vital functions, ILTV’s homology scores are significantly lower. This indicates a long period of independent genetic drift. Even if within the same claimed US5 as evidenced by Lee et al. (PLOS. One 2013 Feb 1;8(2):e55121. doi: 10.1371/journal.pone.0055121). Lee et al. teach that he ICP4, UL27, UL36, US5 and US8 genes showed the most variability within the six strains of ILTV and the six strains could be distinguished using the nucleotide and/or amino acid sequences of these genes.
Because the scope of the claims has broadly covered many avian viruses, it is so unpredictable and also require an artisan with Ph.D level mastering in science and technology related to virology and immunology to have undo experiments for fulfilling the broad scope of claims but still end up unpredictable results as there is no adequate teaching and guidance provided as the Application was originally filed.
Given the above analysis of the factors, which the courts have determined, are critical in asserting whether a claimed invention is enabled, it must be considered that the skilled artisan would have to conduct undue and excessive experimentation in order to practice the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 16-18 are rejected under 35 U.S.C. 102a) )1) as being anticipated by Eschke et al. (PLOS, Pathogens, Vol. 14 (1) published on Jan 18, 2018, pages 1-24).
Eschke et al. describe mutant Marek’s disease virus (MDV), which is attenuation with a partial or complete Codon pair bias deoptimization (CPBD) in UL30 genes, which encodes virus DNA polymerase enzyme gene. They also teach using either partial or complete CPBD MDV virus and test it in chickees (See Materials and Methods at pages 18-20), wherein the mutations were made ranging from 54% to more the 89% and they concluded that a recombinant herpesvirus with CPBD mutation in at least UL30 .i.e. the UL-30-DDDD mutant produced significantly less IL30 RNA that the parental virus (Fig. 4A), hereby in its inherently can causes attenuation of the virus infectivity or pathogenicity, which is demonstrated by the MDV with codon-paid deoptimized UL30 are attenuated in vivo test in chickens. (see Figs. 5& 6 in pages 10-15). Hence, herpesvirus with CPBD may be an applicable strategy for attenuation of other large DNA viruses.in their applications (See Abstract and results).
Therefore, claims 1-2 and 16-18 are taught explitely or implicitly by the cited reference.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/ Primary Examiner, Art Unit 1671
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