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 .
Election/Restrictions
Applicant’s election without traverse of the following species:
a recombinant viral antigen (claims 15 and 32), specifically a human respiratory syncytial virus antigen (claims 17 and 33), for the recombinant gene insert; and
inducing an immune response to an antigen for the single goal of the method of administration recited in claim 43,
in the reply filed on May 15, 2026, without prejudice and without disclaimer, 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)).
Claims 1-3, 7-9, 11, 13, 15, 17, 22-24, 29, 30, 32, 33, 40, 41, 43, 47, 52, and 54 are pending and under consideration, commensurate with the elected species.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see paragraphs [0052, 0058, 0089+] of the instant published application, USPgPub 2024/0199705. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of at least term: “GenBank” and “DTU Bioinformatics” in paragraph [0052] and “BLAST” in paragraph [0086], are trade names or marks used in commerce. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is required to properly annotate all trade names and/or marks present in the instant specification, if any additional trade names and/or marks are discovered.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. The following are examples in the instant published disclosure that improperly incorporate references:
“U.S. Provisional Application No. 63/302,434, filed Jan. 24, 2022, and U.S. Provisional Application No. 63/179,994, filed Apr. 26, 2021”, in paragraph [0001];
“Such an algorithm is incorporated into the NBLAST and XBLAST programs of Altschul et al., 1990, J. Mol. Biol. 215:403”, in paragraph [0086];
“OIE Terrestrial Manual 2012, Chapter 2.3.14, entitled “Newcastle Disease (Infection With Newcastle Disease Virus) for a description of this assay, which is found at the following website www.oie.int/fileadmin/Home/eng/Health_standards/tahm/2.03.14_NEWCASTLE_DIS.pdf”, in paragraph [0152];
“European Patent Publication EP 0702085A1, published Feb. 20, 1996; in U.S. patent application Ser. No. 09/152,845; in International Patent Publications PCT WO97/12032 published Apr. 3, 1997; WO96/34625 published Nov. 7, 1996; in European Patent Publication EP A780475; WO 99/02657 published Jan. 21, 1999; WO 98/53078 published Nov. 26, 1998; WO 98/02530 published Jan. 22, 1998; WO 99/15672 published Apr. 1, 1999; WO 98/13501 published Apr. 2, 1998; WO 97/06270 published Feb. 20, 1997; and EPO 780 475A1 published Jun. 25, 1997”, in paragraph [0172]; and
“International Publication No. WO 01/04333; U.S. Pat. Nos. 7,442,379, 6,146,642, 6,649,372, 6,544,785 and 7,384,774; Swayne et al. (2003). Avian Dis. 47:1047-1050; and Swayne et al. (2001). J. Virol. 11868-11873”, in paragraph [0173].
Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 41 is 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.
Claim 41 is incomplete because it depends from cancelled claim 31. In the interest of compact prosecution, claim 41 is treated as if it depends from claim 32. However, this courtesy does not preempt the requirement for a clarifying amendment.
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 3 and 24 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that all of the specific NDV strains listed in claims 3 and 24 are required to practice the claimed invention because they are a necessary limitation for the success of the invention as stated in the claims. As required elements, each of the strains must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the specific NDV strains listed in claims 3 and 24. See 37 CFR 1.802. One cannot practice the claimed invention without the strains recited. Therefore, access to the specific NDV strains listed in claims 3 and 24 are required to practice the invention. The specification does not provide a repeatable method for readily identifying the specific NDV strains listed in claims 3 and 24 without access to the viruses and they do not appear to be readily available material.
Deposit of the specific NDV strains listed in claims 3 and 24 in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112, because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements. Applicant is reminded that 37 CFR 1.809(d) states:
(d) For each deposit made pursuant to these regulations, the specification shall contain:
(1) The accession number for the deposit;
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(2) The date of the deposit;
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(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
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(4) The name and address of the depository.
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37 CFR 1.809(e) further states:
Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of this section must be filed before or with the payment of the issue fee (see § 1.312).
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[Added, 54 FR 34882, Aug. 22, 1989, effective Jan. 1, 1990; paras. (b) and (c) revised and para. (e) added, 66 FR 21092, Apr. 27, 2001, effective May 29, 2001]
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 1-3, 7, 22-24, 30, 32, 40, 41, 43, 52, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Steglich et al. (PLoS One. 2013; 8 (9): :e72530) and Zhao et al. (Journal of General Virology. 2003; 84: 781-788)
Steglich et al. teach a chimeric Newcastle Disease Virus (NDV) backbone with fusion (F) and hemagglutinin-neuraminidase (HN) proteins exchanged for immunologically distinct avian paramyxovirus type 8 (APMV-8) F and HN proteins, also expressing a heterologous avian influenza virus H5 protein inserted between F and HN genes. See the abstract, “Construction, transfection and recovery of chimeric NDV”, “Generation of a chimeric NDV expressing F and HN of APMV-8 and H5 of AIV”, and Figure 1. The F and HN protein replacements of Steglich et al. meet the NDV backbone-APMV F-HN genome chimera of instant claims 1, 2, 22, and 23. The NDV backbone-APMV F-HN genome chimera of Steglich et al. comprises NDV-NP-P-M-(APMV8 F) - avian influenza transgene H5 – (APMV8-HN)- NDV-L, required by instant claims 7, 30, and 32. Steglich et al. teach the F and HN genes are derived from strain APMV-8/goose/Delaware/1053/76, recited in claims 3 and 24. Under “Animal Experiments”, “chNDVFHN PMV8H5 protects MDA- chickens against lethal HPAIV infection”, and “chNDVFHN PMV8H5 protects MDA+ chickens against lethal HPAIV infection”, Steglich et al. teach the NDV backbone-APMV F-HN genome chimera is immunogenic against influenza, as required by instant claims 40 and 41 (treated as if dependent on claim 32, discussed above) upon administration, as required by instant claim 43. Figure 4 of Steglich et al. depicts replication rate of the NDV backbone-APMV F-HN genome chimera in embryonated chicken eggs (ECE), as required by instant claims 52 and 54.
Steglich et al. do not mention La Sota strain of NDV, recited in instant claims 7 and 30 or the intergenic regions, required in instant claim 1.
Zhao et al. teach a recombinant lentogenic Newcastle Disease Virus La Sota strain comprising the insertion of a foreign transgene cassette inserted between the NP and P genes, comprising the following native junction sequences: gene-end (GE), intergenic (IG), and gene- start (GS) sequences (GE-IG-GS) separating each of the 3' -NP-P-M-F-HN-L-5' NDV genes, as required by instant claims 1, 7, and 30. See the paragraph bridging the columns on page 781; "Construction of full-length recombinant cDNAs..." on page 782; and Figure 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used the La Sota strain of Zhao et al. as the backbone for the APMV chimera of Steglich et al. because it is lentogenic, see the first paragraph under the “Introduction” of Zhao et al. One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have retained the native junction sequences, GE-IG-GS, separating each of the 3' -NP-P-M-F-HN-L-5' NDV genes in the APMV chimera of Steglich et al. because Zhao et al. teach sustained expression of foreign inserts at different positions within the NDV genome without severely affecting replication efficiency and virus yield, see Figures 2-5 of Zhao et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success have used the La Sota strain of Zhao et al. retaining GE-IG-GS, separating each of the 3' -NP-P-M-F-HN-L-5' NDV genes in the APMV chimera of Steglich et al. because both chimeric backbones of Steglich et al. and Zhao et al. are NDV.
Claims 8, 9, 15, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Steglich et al. and Zhao e al. as applied to claims 1-3, 7, 22-24, 30, 32, 40, 41, 43, 52, and 54 above, and further in view of SEQ 1 alignment with Geneseq db access no AZF56158 in WO2011022656 by Bublot et al. 2011.
See the teachings of Steglich et al. and Zhao e al. above. Neither suggest a nucleotide sequence that is at least 85% identical to SEQ ID NO: 1, as recited in claims 8 and 29.
Geneseq db access no AZF56158 shares 89% sequence identity to instant SEQ ID NO: 1, see the alignment provided.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used Geneseq db access no AZF56158 as an APMV F and HN protein donor in the NDV-APMV chimera of Steglich et al. and Zhao et al. because the Geneseq db access no AZF56158 sequence is derived from an APMV-4 used to express heterologous antigens to induce an immune response. Therefore, the APMV-4 sequence of Geneseq db access no AZF56158 is an art-recognized equivalent used for the same purpose described by Steglich et al. and Zhao et al.
Claims 17, 33, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Steglich et al., Zhao et al., and Geneseq db access no AZF56158 as applied to claims 1-3, 7-9, 15, 22-24, 29, 30, 32, 40, 41, 43, 52, and 54 above, and further in view of Martinez-Sobrido et al. (Journal of Virology. 2006; 80 (3): 1130-1139).
See the teachings of Steglich et al., Zhao et al., and Geneseq db access no AZF56158 above. None of the references teach the heterologous gene as human RSV F, as required.
Martinez-Sobrido et al. teach a recombinant Newcastle Disease Virus (NDV) genome comprising a transgene encoding a human RSV F protein, see "Construction, rescue, and growth of recombinant NDVs expressing the RSV F glycoprotein", and Figure 1, as required by instant claims 17, 33, and 47. Under “Immunization and challenge”, Martinez-Sobrido et al. teach administering the NDV-human RSV F intranasally, as required by claim 47.
While Martinez-Sobrido et al. do not teach administering the NDV-human RSV F intranasally to humans, as required by instant claim 47, Martinez-Sobrido et al. expressly suggest it in the first full paragraph of the second column on page 1137 due to NDV adjuvanting properties and safety profiles in humans during clinical trials.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed human RSV F of Martinez-Sobrido et al. in the NDV-APMV chimera of Steglich et al., Zhao et al., and Geneseq db access no AZF56158 to prime CD8+ T cells and induce robust IFN-α/β/γ response against RSV, see Figures 3 and 6-9 of Martinez-Sobrido et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have expressed human RSV F of Martinez-Sobrido et al. in the NDV-APMV chimera of Steglich et al., Zhao et al., and Geneseq db access no AZF56158 because the chimeric backbones of Martinez-Sobrido et al. and Steglich et al., Zhao et al., and Geneseq db access no AZF56158 are NDV.
Allowable Subject Matter
Claims 11 and 13 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. The prior art does not teach or suggest a nucleotide sequence that is at least 85% identical to SEQ ID NOs: 44 or 45.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Cheng et al. (USPgPub 2016/020822) claim an attenuated NDV where F and HN genes are replaced with canine parainfluenza 5 or pigeon parainfluenza 1, see claim 17.
Zimmer et al. (Journal of Virology. Aug. 2005; 79 (16): 10467–10477) “A Chimeric Respiratory Syncytial Virus Fusion Protein Functionally Replaces the F and HN Glycoproteins in Recombinant Sendai Virus”.
Hu et al. (Vaccines. 2020 May 14; 8 (2): 222) review two decades on the development of NDV as a vaccine vector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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