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 .
Response to Amendment/Disposition of Claims
Applicant’s Amendment filed on 01 July 2026 has been received and entered. Claims 1-14, 16, 19, and 21 were pending and examined on their merits. Claims 13, 16, 19, and 21 have been amended. Claims 15, 17-18, and 20 have been cancelled. No new claims have been added.
Accordingly, Claims 1-14, 16, 19, and 21 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0174996 A1, Published 08 June 2023. Applicant’s amended Specifications as presented on 01 July 2026, 12 February 2026, 10 October 2025, 12 January 2023, and 14 June 2022 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 01 July 2026 regarding the previous Office action dated 02 April 2026 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statements (IDSes) submitted on 12 January 2023, 01 October 2024, 03 June 2025, and 01 July 2026 have been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
(New Objection) – Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure and the CRF of the “Sequence Listing” is defective. The amended Sequence Listing filed on 01 July 2026 was deemed defective by the Office on 13 July 2026, so it is not a part of the current disclosure.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3)
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, Applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 37 CFR 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specification; Sequence Disclosure Requirements
(Objection Maintained) – The objection to the disclosure for improper incorporation by reference of a GenBank Accession Number is maintained.
Response to Arguments
Applicant's arguments filed with respect to the objection to the disclosure for improper incorporation by reference of a GenBank Accession Number have been fully considered but they are not persuasive.
In the Response, Applicant argues that they “have amended the specification and respectfully submit a Sequence Listing Paragraph and a statement that incorporates the sequence listing by reference” (see Page 1 of Remarks, Paragraph 4).
Examiner does not find these arguments persuasive. As noted above, the amended Sequence Listing filed on 01 July 2026 was deemed defective by the Office on 13 July 2026. Therefore, it is not a part of the current disclosure, and the GenBank Accession Number is still an issue as the sequence in question still does not have a SEQ ID NO.
For at least these reasons, the objection to the disclosure for improper incorporation by reference of a GenBank Accession Number is maintained.
Claim Objections
(New Objection) – Claims 16 and 19 are objected to because of the following informalities: it is suggested that they say “…with the genome segment 6 corresponding to SEQ ID NO: 34” instead of “…with the genome segment 6 of SEQ ID NO: 34”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reciting a broad range or limitation with a narrow range or limitation that falls within the broad range or limitation in the same claim is withdrawn in light of the amendments to the claim is withdrawn in light of the amendments to the claim.
(Rejection Withdrawn) – The rejection of Claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, due to the lack of clarity surrounding the source of the cell line is withdrawn in light of Applicant’s arguments.
Response to Arguments
Applicant’s arguments filed with respect to rejection of Claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been fully considered and are persuasive.
In their Response, Applicant argues that “a cursory Google search does not constitute the type of substantive, reliable evidence necessary to sustain a prima facie rejection” (see Page 3 of Remarks, First Paragraph) and that “it is well established that claim terms are evaluated from the perspective of a POSITA as of the effective filing date, not at some later point in time” (see Page 3, Paragraph 2). Applicant also argues that “at the time of Applicant’s filing, ‘CHSE-214’ was a well-recognized and widely used designation in the art for the Chinook salmon embryo cell line, catalogues by the American Type Culture Collection (“ATCC”) under accession number CRL-1681” (see Page 3, Last Paragraph) and that “Applicant’s use of “CHSE-214” was not only permissible, but was also the standard term of art at the time of filing” (see Page 4, Paragraph 3”.
Examiner finds these arguments persuasive only because, by admitting what Applicant has on the record, Applicant is referring to a very specific cell line. As such, it can be determined which cell line Applicant is referring to in the claim, based on the arguments presented. Additionally, Examiner independently verified that this cell line still exists through both a Google search and searching the ATCC website. Therefore, the rejection of Claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn. It should be noted for the record, however, that during the verification searches performed by the Examiner, it was discovered that the ATCC website states that “CHSE-214 cells (ATCC CRL-1681) are no longer available for domestic or international distribution due to being listed as a threatened species on the endangered species list”. This statement can be found under the “Characteristics” section under “Detailed product information” for both Sphaerothecum destruens (50615) and Sphaerothecum destruens (50644). In light of such information, a biological deposit rejection might be necessitated in the next Office Action.
Maintained Rejections
(Rejection Maintained) – The rejection of Claims 1, and dependent claims 2-14, 16, 19, and 21 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained.
(Rejection Maintained) – The rejection of Claims 16 and 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 1, and dependent claims 2-14, 16, 19, and 21 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been fully considered but they are not persuasive.
In their Response, Applicant argues that the position asserted by the Examiner that the term “reassorted” is unclear “is inconsistent with the Office Action’s own reliance on the same term in the prior art” and that the “Office Action states that ‘reassorted ISAV is not new to the prior art,’ and further acknowledges that the accepted meaning of ‘reassorted in the making of new combinations of genetic materials” (see Page 2 of Remarks, First Paragraph). Applicant also argues that the “Office therefore appears to understand the term sufficiently to identify alleged prior-art reassorted ISAVs and to apply the term in formulating the obviousness rejection” (see Page 2, First Paragraph). Additionally, Applicant argues that “‘reassorted’ is used in its ordinary virological sense to refer to an ISA virus having genome segments derived from different genotypes”, that “claim 1 as currently presented provides objective boundaries for the term”, and that the “Office’s reliance on prior-art ‘reassorted ISAV’ confirms that a person of ordinary skill in the art would understand the term” (see Page 2, Paragraph 2).
Examiner does not find these arguments persuasive. As stated in the rejection in question, Page 7 of the specification teaches a genomic organization of ISA virus, labelling the protein encoded by each segment, but a reassorted variant need not have these proteins encoded by these segments. Segment 1, the first segment, may encode HE instead of PB2 in a reorganized, recombined, and, thus, reassorted virus. As a result, in every instance of the claims where a segment is referred to bey number, said segment is indefinite as it is neither clear what it encodes nor its position (e.g., first, second, etc.) in the new genome. This was the point of the rejection and the reasoning for determining the claim to be indefinite. One way to overcome this rejection is by creating an estoppel by saying that “by segment 1, we mean segment 1 in table 1”, for example.
For at least these reasons, the rejection of Claims 1, and dependent claims 2-14, 16, 19, and 21 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained.
Applicant's arguments filed with respect to the rejection of Claims 16 and 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been fully considered but they are not persuasive.
In their Response, Applicant argues that the claims have been amended “to refer to the SEQ ID NO: 34” and concurrently file an updated the Sequence listing to add the NC_006499 as SEQ ID NO: 34” (see Page 4 of Remarks, Paragraph 5).
Examiner does not find these arguments persuasive. As noted previously, the amended Sequence Listing filed on 01 July 2026 was deemed defective by the Office on 13 July 2026. Therefore, SEQ ID NO: 34 is not part of the current disclosure. As such, this renders all arguments presented with regard to this rejection by Applicant moot as they were presented on the basis that the most recent Sequence Listing was accepted by the Office, which is not the case.
For at least these reasons, the rejection of Claims 16 and 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained.
New Rejections
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.
(New Rejection – necessitated by amendment) – Claims 16 and 19 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.
Regarding Claims 16 and 19, they both recite the limitation “wherein genome segment 6 is of Genotype II when the sequence of an amplicon obtained by the forward primer of SEQ ID NO: 10 and the reverse primer SEQ ID NO: 11 has at least 98% sequence identity with the genome segment 6 of SEQ ID NO: 34”. As noted above, the amended Sequence Listing filed on 01 July 2026 was deemed defective by the Office on 13 July 2026. Therefore, SEQ ID NO: 34 is not part of the current disclosure. As such, it is unclear what the metes and bounds of “SEQ ID NO: 34” are, as no such sequence exists in the most recent version of the Sequence Listing which was actually accepted by the Office, filed on 12 January 2023, as this Sequence Listing only goes up to SEQ ID NO: 33. It is suggested that an amended Sequence Listing be submitted, and subsequently approved by the Office, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 16 and 19 are rejected on the grounds of being indefinite.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(a)
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claim 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for being enabling for vaccinating Atlantic Salmon against ISA virus but not reasonably providing enablement for vaccinating just any fish against ISA virus is withdrawn in light of Applicant’s amendments and arguments.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claim 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, have been fully considered and are persuasive.
In their Response, Applicant argues that they respectfully disagree and traverse the rejection but that “solely to expedite prosecution and move towards allowance, claim 21 is amended to clarify that the fish are salmonid”, which is supported by the original application, e.g., at [0090] of the published application” (see Page 6 of Remarks, Paragraph 4).
Examiner finds these amendments sufficient and the arguments persuasive. Paragraph 0090 of the PGPub of the instant application states, in part, that “the fish is a salmonid”, which includes “salmon, trout, chars, freshwater whitefishes, and graylings. Examiner also independently found references, such as Rimstad and Markussen (Rimstad E, Markussen T. Infectious salmon anaemia virus-molecular biology and pathogenesis of the infection. J Appl Microbiol. 2020 Jul;129(1):85-97.) (see attached), which teach that while Atlantic salmon is the only species in which the disease ISA naturally occurs, the virus can replicate in several salmonid fish species and that other species may be important as carriers of the virus (see Page 87, Left Column, First Paragraph). In light of this information, the amendment limiting the fish to a salmonid appears to be sufficient to enable the claim and overcome the rejection in question. As such, the rejection of Claim 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn.
Maintained Rejections
(Rejection Maintained) – The rejection of Claims 16 and 19 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 is maintained.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 16 and 19 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 have been fully considered but they are not persuasive.
In their Response, Applicant argues that they respectfully disagree and traverse the rejection and that “solely to expedite prosecution, claims 16 and 19 are amended to clarify at least 98% sequence identity to genome segment 6 corresponding to SEQ ID NO: 34” (see Page 5 of Remarks, Paragraph 3). No other arguments were presented.
Examiner does not find these arguments persuasive. Even with amending the claims to recite 98% instead of 90%, the claim limitations still do not require that the sequence of an amplicon with at least 98% sequence identity to genome segment 6 corresponding to SEQ ID NO: 34 possess any particular distinguishing features or conserved regions, only that it is an amplicon with at least 98% sequence identity to the reference sequence, which encompasses any and all sequences which meet this limitation. It is still the Examiner’s position that the disclosure of the instant application does not convey Applicant’s possession of the claimed genus of an amplicon with at least 98% sequence identity to genome segment 6 corresponding to SEQ ID NO: 34 and Applicant has not presented any evidence to assuage these concerns.
For at least these reasons, the rejection of Claims 16 and 19 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 is maintained.
Claim Rejections - 35 USC § 103
(Rejection Maintained) – The rejection of Claims 1-14, 16, 19, and 21 under 35 U.S.C. 103 as being unpatentable over Beltran Pavez et al. (US 2018/0030416 A1, Published 01 February 2018) (cited in a previous Office Action), Takazawa and Tokashiki (U.S. Patent No. 5,219,752 A, Issued 15 June 1993) (cited in a previous Office Action), Clouthier and Anderson (US 2004/0147467 A1, Published 29 July 2004) (cited in a previous Office Action), Rudenko et al. (US 2009/0104228 A1, Published 23 April 2009) (cited in a previous Office Action), Cottet et al. (Cottet, L et al. "Bioinformatic Analysis of the Genome of Infectious Salmon Anemia Virus Associated with Outbreaks with High Mortality in Chile." Journal of Virology 84.22 (2010): 11916-11928.) (cited in a previous Office Action), Kibenge and Kibenge (US 2003/0108901 A1, Published 12 June 2003), Devold et al. (Devold, M., Falk, K., Dale, B., Krossøy, B., Biering, E., Aspehaug, V., Nilsen, F., & Nylund, A. (2001). Strain variation, based on the hemagglutinin gene, in Norwegian ISA virus isolates collected from 1987 to 2001: indications of recombination. Diseases of aquatic organisms, 47(2), 119-128.) (cited in a previous Office Action), Godoy et al. (Godoy MG, Aedo A, Kibenge MJ, Groman DB, Yason CV, Grothusen H, Lisperguer A, Calbucura M, Avendaño F, Imilán M, Jarpa M, Kibenge FS. First detection, isolation and molecular characterization of infectious salmon anaemia virus associated with clinical disease in farmed Atlantic salmon (Salmo salar) in Chile. BMC Vet Res. 2008 Aug 4;4:28.), and Cárdenas et al. (Cárdenas C, Ojeda N, Labra Á, Marshall SH. Molecular features associated with the adaptive evolution of Infectious Salmon Anemia Virus (ISAV) in Chile. Infect Genet Evol. 2019 Mar;68:203-211.) is maintained.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 1-14, 16, 19, and 21 under 35 U.S.C. 103 as being unpatentable over the prior art have been fully considered but they are not persuasive.
In their Response, Applicant argues that they respectfully disagree and traverse the rejection (see Page 7, First Paragraph). No other arguments were presented.
Examiner does not find these arguments persuasive. Applicant’s traversal is acknowledged, but no substantive arguments were presented, so the rejection must stand. Additionally, the claims were not amended in an attempt to overcome this rejection.
For at least these reasons, the rejection of Claims 1-14, 16, 19, and 21 under 35 U.S.C. 103 as being unpatentable over the prior art is maintained.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Rejection Maintained) – The provisional rejection of Claims 1-4, 7, and 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 10, 12, 18-20, 24, and 26 of copending Application No. 19/465,533 (reference application) is maintained.
Response to Arguments
Applicant's arguments filed with respect to the provisional rejection of Claims 1-4, 7, and 21 on the ground of nonstatutory double patenting as being unpatentable over the reference claims have been fully considered but they are not persuasive.
In their Response, Applicant argues that independent “claim 1 of the present application is directed toa specific reassorted Infectious salmon anemia (ISA) virus” (see Page 7 of Remarks, Paragraph 3), while “currently pending claims in reference application 19/465,533 are broadly directed to a vaccine composition comprising an antigen from an intracellular pathogen, including ISAV, without any structural or genomic limitations” (see Page 7, Last Paragraph). Applicant also argues that “the reference claims do not recite reassorted viruses; genotype mixing; or segment-specific requirements” and that the “reference claims are further limited by formulation parameters such as serum and albumin content (e.g., <5% serum), whereas the present claims impose no such formulation constraints” (see Page 8, Paragraphs 2-3). Additionally, Applicant argues that the pending claims do not “read on or render obvious the reference claims” and that the “pending claims require a reassorted ISA virus having a defined genomic architecture, while the reference claims encompass generic antigens, including materials lacking any such reassorted genome structure” (see Page 8, Last Paragraph). Furthermore, Applicant argues that a “composition that does not include the claimed reassorted virus cannot fall within the scope of the present claims”, that “Claim 21 likewise remains distinct because it requires administration of the specific reassorted ISA virus, whereas the reference methods use different compositions defined by formulation parameters rather than genomic structure”, and that “there is no basis to conclude that the pending claims are an obvious variants of the reference claims” (see Page 8, Last Paragraph).
Examiner does not find these arguments persuasive. As stated in the previous Office Action, while the reference claims do not recite a reassorted ISA virus, the extremely wide breadth of the instant claims coupled with the lack of a definition for the phrase “reassorted virus” means that the instant claims read on every combination of virus, including the reference virus. The lack of a clear definition for “reassorted virus” was not resolved by Applicant’s amendments or arguments (see indefiniteness rejection section), so this problem is still present in the instant claims. As such, it is still reasonable to interpret the instant claims in the same manner as before, which means that they still read on every combination of virus, including the reference virus. As such, while the instant claims recite a method of vaccinating a fish against an ISA virus, this method still comprises using the reference vaccine composition, which recites additional elements which make it more specific than any composition comprising the instant ISA virus. Thus, it would still be obvious to use the reference vaccine composition in the instant method.
For at least these reasons, the provisional rejection of Claims 1-4, 7, and 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 10, 12, 18-20, 24, and 26 of the reference application is maintained.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Snow et al. (2001a)
Snow et al. teach that detectable levels of virus can be found in Arctic char, rainbow trout, and brown trout via RT-PCR when infected with a Scottish isolate of ISAV.
Snow et al. (2001b)
Snow et al. teach that rainbow trout can be infected with ISAV via cohabitation with infected salmon.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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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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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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