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 02 April 2026 has been received and entered. Claims 12-13 and 26-28 were pending. Claims 12-13 and 26-28 have been amended. Claims 1-11 and 14-25 have been cancelled. No new claims have been added.
Accordingly, Claims 12-13 and 26-28 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 2022/0347284 A1, Published 03 November 2022. Applicant’s amended Specifications as presented on 02 April 2026, 18 August 2025, 21 June 2022, and 24 August 2021 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 02 April 2026 regarding the previous Office action dated 02 October 2025 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 If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn.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arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Specification; Sequence Disclosure Requirements
(Objection Withdrawn) – The objection to the Specification for failing to comply with Sequence Disclosure Requirements is withdrawn in light of the filing of an amended Sequence Listing, which was approved by the Office, and the amendments to the Specification.
Specification
(Objection Withdrawn) - The objection to the Abstract of the disclosure is withdrawn in light of the amendments to the Abstract.
Claim Objections
Withdrawn Objections
(Objection Withdrawn) – The objection to Claims 12 and 26 for containing minor informalities is withdrawn in light of the amendments to the claims.
Maintained Objections
(Objection Maintained) – The objection to Claims 12-13 and 27-28 for containing minor informalities is maintained.
Response to Arguments
Applicant's arguments filed with respect to the objection to Claims 12-13 and 27-28 for containing minor informalities have been fully considered but they are not persuasive.
In their Response, Applicant argues “that the technical amendments to the claims overcome claim objections” (see Page 2 of Remarks, First Paragraph).
Examiner does not find this argument persuasive. While the amendments to Claim 12 addressed the specific objection raised in this case, the same objection was raised for Claims 27 and 28 but was not addressed. The objection in question was to amend the claims so they recited “…ORF-4, or ORF-5…”. Additionally, the objection to Claim 13 was only partially addressed by the claim amendments. There is still no space after the colon between “NOs:” and “7”. As such, the objection to Claims 12-13 and 27-28 for containing minor informalities is withdrawn as it relates to Claim 12, but is maintained as it relates to Claims 13 and 27-28.
New Objections
(New Objection) – Claims 12-13 and 26 are objected to because of the following informalities: In Claims 12 and 13, it is suggested that the phrase “a virus that infects and is capable of killing fish” be replaced with the specific name of the virus in question.
In Claim 12, all instances of “conservatively substitute variant thereof” should be replaced with “conservatively substituted variant thereof”. There should be a “d” added to the end of “substitute”.
Also in Claim 12, there is no period at the end of the claim.
In Claim 13, it is suggested that it say “…extracted from the biological sample of the fish…” instead of “…extracted from the biological virus of the fish…”.
In Claim 26, it is suggested that it say “…a sequence which is at least 80% identical to
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 12, and dependent claim 27 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s Arguments.
(Rejection Withdrawn) – The rejection of Claims 13, and dependent claim 28 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
Maintained Rejections
(Rejection Maintained) – The rejection of Claims 13, and dependent claim 28 thereof, 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 02 April 2026 and 18 August 2025, with respect to the rejection of Claims 12, and dependent claim 27 thereof, 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 the technical amendments to the claims overcome claim objections and rejections under section 112, second paragraph (clarity)”. In their previous Response, filed on 18 August 2025, Applicant argued that “it is respectfully submitted that the limitation should be read not in a vacuum but in view of the specification and in the surrounding context, which is amplification reaction” (see Page 2 of Remarks, Last Paragraph). Examiner now finds these arguments persuasive. Therefore, the rejection of Claims 12, and dependent claim 27 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn.
Applicant's arguments filed with respect to the rejection of Claims 13, and dependent claim 28 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 technical amendments to the claims overcome claim objections and rejections under section 112, second paragraph (clarity)” (see Page 2 of Remarks, First Paragraph). Examiner does not find this argument persuasive. As currently written, the phrase “wherein said nucleic acid sequence encodes a protein” still renders the claim indefinite because it is still unclear which nucleic acid sequence is being referenced by the phrase “said nucleic acid sequence”, the one extracted from the biological sample or the reference sequence. As such, the rejection of Claims 13, and dependent claim 28 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained.
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.
For the purposes of examining the claims on their merits, the limitation “wherein the at least one oligonucleotide primer is at least 15 nucleotides long and is complementary to a nucleic acid sequence which is comprised within the genome of the virus” in Claim 12 will be interpreted such that the primer must be at least 15 nucleotides long and is 100% complementary to the sequence within the genome of the virus.
Claim Rejections - 35 USC § 112(a); First Paragraph
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.
(Rejection Maintained) – The rejection of Claims 12-13 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.
(Rejection Maintained) – The rejection of Claims 26-28 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.
(Rejection Maintained) – The rejection of Claims 12-13 and 26-28 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 12-13 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 states that they “respectfully disagree” with the rejection “and maintain their previous argument” (see Page 2 of Remarks, Paragraph 2). Applicant also argues that “amendments to claim 12 and 13 now specify that sequences at least 80% identical to ORFs 1-5 have to encode proteins that are at least 95% identical to SEQ ID Nos 7-11, respectively” and that similarity “this high on the protein level suggests continuous identity”. Additionally, Applicant argues that “the claims provide for conservative substitutions”, “that the structure-function (i.e., the structure of the DNA and its function) correlation is reflected in the claims”, and “that the high similarity (95%) to the references SEQ ID NOs 7-11 implies high functional similarity”. Furthermore, Applicant argues that “it is respectfully submitted that a virus that comprises proteins that are 95% identical to SEQ ID NOs 7-11 and is a conservative substitute thereof is likely to have properties similar to those of the reference virus, without missing critical bases (see Page 2, Paragraph 2).
Examiner does not find these arguments persuasive. As stated in the previous Office Action, while Examiner agrees with the arguments presented regarding the 95% cutoff, Examiner still holds that Applicant has again failed to disclose which residues or bases are essential and are therefore required to be present and unchanged, as noted previously. As also noted in previous Office Actions, Applicant has stated in the instant Specification that the claimed percent identities can be over either a continuous or a non-continuous sequence (see Paragraphs 0064 and 0067-0069), meaning that any sequence which meets the percent identity threshold is encompassed by the claimed invention, regardless of which or how many critical residues or bases are missing, which is particularly important in the context of any and all non-continuous sequences encompassed by the claimed invention. If Applicant perhaps cited a conserved domain or domains, this argument might be persuasive. As it stands, however, the “continuous identity” argument presented by Applicant is not persuasive because Applicant has not disclosed a conserved core/structure for the claimed sequences and there is unpredictability present when mutations are introduced. Additionally, Applicant has also still failed to demonstrate that any variants possessing any sequence identity less than 100% relative to the claimed sequences were disclosed. Applicant’s assertion that “a virus that comprises proteins that are 95% identical to SEQ ID NOs 7-11 and is a conservative substitute thereof is likely to have properties similar to those of the reference virus, without missing critical bases” fails to address the obvious question of what those critical bases (or residues) are. If the 5% variation being claimed resides in a critical region, even conservative substitutions can change the structure and/or function of the proteins corresponding to instant SEQ ID NOs: 7-11 as the 5% variability could encompass critical bases or residues which constitute the essential characteristics of the genus Applicant is claiming. The same logic applies to the 20% variation being claimed for the nucleic acids corresponding to instant SEQ ID NOs: 1-5. Thus, simply amending the claims to recite “a conservatively substituted variant thereof” is insufficient to overcome the lack of written description support for the instant claims as currently written. As such, a person having ordinary skill in the art would still not know which nucleotides or residues can be changed and which ones cannot be changed and it would still be unclear what the essential characteristics of the claimed sequences are. Furthermore, Applicant cannot simply assert functionality or anything scientific without evidence. When statements like those of Applicant are made which are contrary to science, evidence must be provided. Applicant has essentially put their opinion on the record in place of facts. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). As such, the rejection of Claims 12-13 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.
Applicant's arguments filed with respect to the rejection of Claims 26-28 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 presents the same arguments above with regard to Claims 26-28, which depend upon independent Claims 12-13 (see Page 2, Paragraph 2). Examiner counters with the same arguments presented above as well. As such, the rejection of Claims 26-28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained.
Applicant's arguments filed with respect to the rejection of Claims 12-13 and 26-28 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 presents the same arguments above with regard to the previous written description rejections (see Page 2, Paragraph 2). Examiner counters with the same arguments presented above as well. As such, the rejection of Claims 12-13 and 26-28 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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:
Nylund et al. (U.S. Patent No. 12,606,875 B2) (formerly copending Application # 17/433,416)
Nylund et al. disclose a Totivirus, which causes mortality in fish, and methods of detecting said virus in fish.
THIS ACTION IS MADE FINAL. 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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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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