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 with traverse of Group III in the reply filed on June 30, 2026 is acknowledged. The traversal is on the grounds that Group IV, claim 63, drawn to a method of use, is dependent on claim 34 of elected Group III and should be rejoined.
Applicant’s traversal has been fully considered. MPEP § 608.01(n) (III) states:
The fact that a dependent claim, which is otherwise proper might relate to a separate invention that would require a separate search or be separately classified from the claim on which it depends would not render it an improper dependent claim.
MPEP § 806 recites the general principles relating to independence and distinctness and does not require independent claims as indicia. Therefore, applicant’s traversal is not persuasive. However, in the interest of compact prosecution, applicant’s request for rejoinder is reasonable and claim 63 (Group IV) is rejoined with elected Group III.
Regarding further rejoinder of method claims, applicant’s attention is directed to the following recitation of MPEP § 821.04:
Where product and process claims drawn to independent and distinct inventions are presented in the same application, applicant may be called upon under 35 U.S.C. 121 to elect claims to either the product or process. See MPEP § 806.05(f) and § 806.05(h). The claims to the nonelected invention will be withdrawn from further consideration under 37 CFR 1.142. See MPEP § 809.02© and § 821 through § 821.03. However, if applicant elects claims directed to the product, and a product claim is subsequently found allowable, withdrawn process claims which depend from or otherwise include all the limitations of the allowable product claim will be rejoined.
Where product and process claims are presented in a single application and that application qualifies under the transitional restriction practice pursuant to 37 CFR 1.129(b), applicant may either (1) elect the invention to be searched and examined and pay the fee set forth in 37 CFR 1.17(s) and have the additional inventions searched and examined under 37 CFR 1.129(b)(2), or (2) elect the invention to be searched and examined and not pay the additional fee (37 CFR 1.129(b)(3)). Where no additional fee is paid, if the elected invention is directed to the product and the claims directed to the product are subsequently found patentable, process claims which either depend from or include all the limitations of the allowable product will be rejoined . If applicant chooses to pay the fees to have the additional inventions searched and examined pursuant to 37 CFR 1.129(b)(2), even if the product is found allowable, applicant would not be entitled to a refund of the fees paid under 37 CFR 1.129(b) by arguing that the process claims could have been rejoined. 37 CFR 1.26 states that "[m]oney paid by actual mistake or in excess will be refunded, but a mere change of purpose after the payment of money...will not entitle a party to demand such a return..." The fees paid under 37 CFR 1.129(b) were not paid by actual mistake nor paid in excess, therefore, applicant would not be entitled to a refund.
In the event of rejoinder, the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104 - 1.106. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. If the application containing the rejoined claims is not in condition for allowance, the subsequent Office action may be made final, or, if the application was already under final rejection, the next Office action may be an advisory action.
The following is a recitation from paragraph five, “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. §103(b)” (1184 TMOG 86(March 26, 1996)):
“However, in the case of an elected product claim, rejoinder will be permitted when a product claim is found allowable and the withdrawn process claim depends from or otherwise includes all the limitations of an allowed product claim. Withdrawn process claims not commensurate in scope with an allowed product claim will not be rejoined.” (emphasis added)
In accordance with M.P.E.P. §821.04 and In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995), rejoinder of product claims with process claims commensurate in scope with the allowed product claims will occur following a finding that the product claims are allowable. Until such time, a restriction between product claims and process claims is deemed proper. Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution to maintain either dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder.
In conclusion, claims 18, 34, 37, 41, 48-50, 56, 63, and 76-86 are pending; claim 18 is withdrawn due to a non-elected invention; and claims 34, 37, 41, 48-50, 56, 63, and 76-86 are under consideration.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 7/23/2023; 10/14/2023; 12/21/2023; 2/13/2024; 4/1/2024; 7/8/2024; 9/24/2024; 11/12/2024; 2/14/2025; 4/24/2025; 7/29/2025; 10/15/2025; and 11/25/2025 have been considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraphs [0004, 0053, and 0055] of the instant published disclosure, USPgPub 2023/0346911. 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 specification is objected to for failing to adhere to the requirements of the sequence rules, see Figures 11 and 12 of the instant published disclosure. Applicant must append SEQ ID NOs. to all mentions of specific sequences comprising four or more amino acids and ten or more nucleic acids in the specification. When a sequence is presented in a drawing, the sequence must still be included in the sequence listing if the sequence falls within the definition set forth in 37 CFR 1.821(a), and the sequence identifier ("SEQ ID NO:X") must be used, either on the drawing itself or in the Brief Description of the Drawings. Applicant is required to append a SEQ ID NO. to any sequence applicable to the rule. See 37 CFR § 1.821 (a)-(d) and MPEP § 2422. Appropriate correction is required.
The use of the terms BLAST and TRITON X100, which are trade names or marks used in commerce, have been noted in this application in paragraphs [0054 and 0059], respectively. Any trademark term or mark should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears 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.
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.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color, as evidenced by color descriptions in paragraphs [0025-0028, 0034, 0038, 0102, and 0103] of the instant published application, USPgPub 20230346911. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 81 is objected to because of the following informalities: “position” in line 1 should be plural. Appropriate correction is required.
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.
Claims 34, 37, 41, 48-50, 56, 63, and 76-86 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.
Claim 34, 37, 41, 50, and 76-85 recite numerous mutations relative to a parent virus, but fixed residues of a parent virus are indeterminate because there is no parental virus sequence provided for comparison. This rejection affects all dependent claims.
Claim 37 depends on claim 34, reciting that the HA has one or more deletions at positions 163 and/or 164. Are the deletions of claim 37 referring to residue 163 and/or 164 deletions of claim 34, or are the deletions of claim 37 in addition to 163 and/or 164 of claim 34?
Instant claim 56 recites that “the virus does not bind to sera specific for one of SEQ ID NOs: 1-3”. Reciting what is not invented does not point out and distinctly claim what is claimed. Claim 56 is indefinite.
Claims 41, 76, and 78 recite, “a majority of the substitutions in the mutant hemagglutinin are”, followed by a list, “or a combination thereof”. It cannot be determined which mutations listed would be considered “a majority” or a combination of a majority. It cannot be determined which substitutions are included and/or excluded. The metes and bounds of the substitutions are unclear.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 34, 37, 41, 48-50, 56, and 76-86 are rejected under 35 U.S.C. 101 because the invention is directed to a natural product without significantly more. The claims recite a composition comprising an influenza virus B (IBV) encoding a hemagglutinin (HA) comprising a plurality of mutations and/or substitutions relative to a parent virus.
While claim 34 recites that the IBV comprising the mutations/or substitutions is “recombinant”, implying deliberate manipulation of IBV HA by the hand of man, the instant mutations to IBV HA encompassed by the claims, is indistinguishable from naturally-occurring IBV isolates that possess mutations/ substitutions in the HA protein. Rota et al. (Journal of General Virology. 1992; 73: 2737-2742) teach HA sequence alignments of amino acid substitutions present in circulating Yamagata and Victoria IBV lineage viruses from 1987-1991, see Figure 1. The following positions and corresponding substitutions are presented in Figure 1: 73T; 76T; 129K; 137I; 229G; 298E; - recited in instant claim 41, 50, 76, 78, which corresponds to any combination thereof, recited in instant claims 77 and 79. The sequence alignments of Victoria and Yamagata lineages depicted in Figure 1 of Rota et al. possess the following amino acids at the requisite positions recited in instant claims 84 and 85: 40H; 71K; 73V; 76T; 80K; 116H;
H; 117I; 122Q; 129K; 133G; 136R; 137I; 163D; 164K; 197K; 202K; 229D; 232N; 251V; 254P; 266V; and 298E, satisfying the at least five or more substitutions recited in instant claims 34, 37, and 80-83. The IBV isolated viruses of Rota et al. additionally comprise one or more antigens, as required by instant claim 48.
Regarding deletions at residues 163 or 164, recited in alternatives to the substitutions in instant claims 34, 37, 41, 50, 78-80, 82, and 84, Hellferscee et al. (Health Science Reports) 2021 Sep; 4 (3): e367), state Victoria sub-clade V1A.1 viruses contain the 162-163 deletions and subclades V1A.2 and V1A.3 comprise three amino acid deletions at residues 162-164, see the second paragraph under section 6.
Therefore, the influenza viruses claimed possessing these naturally-occurring HA mutations are indistinguishable from naturally-occurring influenza viruses according to the teachings of Rota et al. and Hellferscee et al.
Instant claim 49 requires that the influenza virus B composition additionally comprises one or more influenza A viruses. Falchi et al. (Journal of Clinical Virology. 2008; 41: 148-151) teach dual infections with influenza A and B viruses, see the title. Therefore, a combination of influenza A and B viruses is a nature-based combination, indistinguishable from combined natural infections discussed by Falchi et al.
Therefore, the instant claims recite a natural phenomenon according to Step 2A, Prong One of MPEP § 2106.04(II). The comparison between the material claimed and the material of Rota et al., Hellferscee et al., and Falchi et al. indicates that there are no differences in structure, other characteristics and none of the naturally occurring viruses would bind sera specific to any one of SEQ ID NOs: 1-3, recited in instant claim 56 because structure is inseparable from function.
Therefore, the claimed influenza virus possessing a mutated HA protein, is a product of nature exception. See Association for Molecular Pathology V. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are "products of nature" which cannot be patented). Accordingly, the instant claims recite a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two requires eligibility analysis to evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Instant claim 86 requires that the composition is pharmaceutical. Paragraph [0070] of the instant published disclosure lists water as a pharmaceutically-acceptable carrier. However, the addition of water does not change the nature or properties of the combination of naturally-occurring materials claimed and does not render the instant composition different or distinguishable from the natural products. Recitation of “pharmaceutical” fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, recitation of a “pharmaceutical” does not integrate the recited judicial exception into a practical application that is patent eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. -U.S.— (June 13, 2013).
(Please note, added ingredients to the claimed composition that do change the nature or properties of the instant IBV HA, such as an adjuvant, discussed in instant paragraphs [0022, 0070, 0071 (for example)], would distinguish the natural product claimed. The combination of the IBV HA with one or more substances that transform the natural products or properties amounts to significantly more than the recited judicial exception and would render the subject matter patent eligible under § 101.)
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 34, 37, 41, 48-50, 56, 63, and 76-86 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. This is a written description rejection.
Claim 34, 37, 41, 48, 50, and 76-85 recite an IBV HA comprising a plurality of mutations, or combinations thereof, relative to a parent virus. The disclosure fails to adequately describe the broad genus of IBV HA mutants claimed. The instant claims encompass IBV Victoria and Yamagata lineages that are structurally and biologically indistinguishable from naturally-occurring variants, as evidenced by Rota et al., Hellferscee et al., and Falchi et al., supra.
The instant specification is directed to generating recombinant IBV’s comprising hybrid HAs presenting residues specific to Yamagata and Victoria lineages, see paragraphs [0011 and 0092, for example]. In paragraph [0098], applicant teaches there are 38 amino acid differences between Victoria lineage, B/Florida/78/2015 (‘Florida/Vic’) and Yamagata lineage, B/Phuket/3073/2013 (‘Phuket/Yam’). A synthetic library generated from these differences encodes two-to-four different amino acids at each of the 38 positions, yielding gene libraries that theoretically encode 2-438 different amino acid combinations. In paragraph [0101], synthetic libraries were generated based on parental lineages, B/Phuket/3073/2013 and B/Washington/02/2019 HA proteins, which differ by 39 amino acids in the region targeted for mutagenesis. Figures 14 and 17 appear to indicate that four IBV mutants stimulate cross-reactive ferret sera against Victoria and Yamagata viruses, but these four are not clearly distinguished in the Figures due to absent color, critical for identification. These four species do not show possession of the broad genus claimed.
The mere contemplation of the claimed genus in the specification is not sufficient to support the present claimed invention directed to a genus of influenza B viruses. The claimed invention as a whole is not adequately described if the claims require essential or critical elements, which are not adequately described in the specification and which is not conventional in the art as of applicant's effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. The skilled artisan cannot envision the detailed structure of a genus of viruses which comprises sequences having unspecified changes that must exhibit the contemplated biological functions of resembling Victoria and Yamagata lineages. Conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the structures and/or methods disclosed in the as-filed specification.
A vague functional description and an invitation for further research by testing to determine which IBV comprising HA mutants possess the requisite characteristics does not satisfy written description requirement. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341 (Fed. Cir. 2010) (en banc). The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, there is no disclosure of sufficient characteristics of the claimed genus of IBV-Yamagata-Victoria-hybrid-HA viruses to allow persons skilled in the art to recognize that applicants were in possession of the claimed.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. A definition by function alone, i.e., cross-reactivity of IBV lineages discussed in instant paragraphs [0012, 0101] and “not binding to sera specific for one of SEQ ID NOs: 1-3”, recited in instant claim 56, is not sufficient because it is only an indication of what a thing does, rather than what it is. Eli Lily, 119 F.3 at 1568, 43 USPQ2d at 1406.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not clearly allow persons skilled in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the distinguishing, identifying characteristics of the encompassed genus of IBV-Yamagata-Victoria-hybrid-HA viruses claimed. The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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 34, 37, 41, 48, 50, 56, 63, and 76-86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rota et al. (Journal of General Virology. 1992; 73: 2737-2742).
Rota et al. teach HA sequence alignments of amino acid substitutions present in circulating Yamagata and Victoria IBV lineage viruses from 1987-1991, see Figure 1. The following positions and corresponding substitutions are presented in Figure 1: 73T; 76T; 129K; 137I; 229G; 298E; - recited in instant claim 41, 50, 76, 78, which corresponds to any combination thereof, recited in instant claims 77 and 79. The sequence alignments of Victoria and Yamagata lineages depicted in Figure 1 of Rota et al. possess the following amino acids at the requisite positions recited in instant claims 84 and 85: 40H; 71K; 73V; 76T; 80K; 116H;
H; 117I; 122Q; 129K; 133G; 136R; 137I; 163D; 164K; 197K; 202K; 229D; 232N; 251V; 254P; 266V; and 298E, satisfying the at least five or more substitutions recited in instant claims 34, 37, and 80-83. The IBV isolated viruses of Rota et al. additionally comprise one or more antigens, as required by instant claim 48. Since the HAs of the IBVs Rota et al. possess the requisite structures, the viruses of Rota et al. would not bind to sera specific for one of SEQ ID NOs: 1-3, recited in claim 56. Table 1 of Rota et al. depicts ferret neutralization antibody titer post-infection, anticipating the pharmaceutical composition of instant claim 86 and the method of administering recited in instant claim 63.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kawaoka et al. (WO 2017/143236, cited in the IDS) teach IBV Yamagata-Victoria reassortant viruses comprising a backbone of internal virus genes and selected HA and NA of circulating strains to enhance virus growth, see the “Summary” and Example 1. No residue substitutions of HA are discussed.
Suptawiwat et al. (Virology. 2017; 502: 84-96) analyze HA mutations arising in Yamagata viruses between 1993-2016 and Victoria viruses between 1995-2016, see Figure 1.
Conclusion
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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