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 .
Disposition of Claims
Claims 1-18 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2024/0316180 A1, Published 26 September 2024.
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statement (IDS) submitted on 21 November 2023 has been considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. Specifically, the file size should be given in bytes, not kilobytes (KB). See MPEP § 2413.04.
Required response - Applicant must:
• 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.
Specification
The use of the terms TrueBlue, gentleMACS, MABTECH, RPMI, PowerChek, and LUNA, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include proper symbols indicating use in commerce such as ™, SM , or ® following the respective 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 disclosure is objected to because of the following informalities: in Paragraph 0003, it should say “CASE” instead of “CSSE”.
In Paragraph 0057, it should say “IFN-γ” instead of “IFN-7”.
Appropriate correction is required.
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 Objections
Claims 1, 3, 6, and 12 are objected to because of the following informalities: In Claim 1, “hemagglutinin” is spelled incorrectly. The claim currently recites “hematogglutin”.
In Claim 3, it is suggested that it say “wherein the virus is deposited” instead of “wherein the virus is as deposited”.
In Claim 6, it is suggested that it say “wherein the attenuated virus is a Vero cell subcultured attenuated virus”.
The first word of Claim 12 should say “The” instead of “Tha”.
Appropriate correction is required.
Applicant is advised that should claims 2 and 3 be found allowable, claims 17 and 18, respectively, will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1, and dependent claims 2-16 thereof, 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 1 is rejected for claiming the limitation of amino acid positions within protein sequences without providing appropriate frames of reference for said sequences. Said frame of reference can be provided by referencing a sequence disclosed within the application (i.e., a sequence with a SEQ ID NO: identifier) or by referencing a start position for said sequence (i.e., “…wherein said amino acid is at position X from the starting methionine of the protein…”). The lack of reference sequences renders the claim indefinite.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 1 is rejected on the grounds of being indefinite. Claims 2-16 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
Claim 7 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.
Regarding Claim 7, it recites the limitation “wherein the virus is subcultured in Vero cells more than 30 passages”. It is unclear if the claim language is meant to encompass embodiments where the virus is subcultured in Vero cells for 30 passages. As it is currently written, the claim language actually excludes embodiments where the virus is subcultured in Vero cells for exactly passages. It is unclear if this was Applicant’s intention. If not, it is suggested that the claim be amended to instead recite “wherein the virus is subcultured in Vero cells for 30 passages”, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 7 is rejected on the grounds of being indefinite.
Claim 9 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.
Regarding Claim 9, it recites the limitation “wherein the vaccine composition is suitable as a stand-alone vaccine or a booster vaccine”. It is unclear what is encompassed by the phrase “stand-alone vaccine”. For instance, it could be interpreted such that only one dose of said vaccine composition needs to be given in the entire lifespan of a subject. It can also be interpreted such that multiple doses can be given to a subject, as long as no other doses of a different vaccine are administered to the same subject. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite."). There is also no definition of the phrase “stand-alone vaccine” provided in the instant Specification. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended by clarifying the term or by removing it altogether, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 9 is rejected on the grounds of being indefinite.
Claim 12 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.
Regarding Claim 12, it recites the limitation “The vaccine composition of claim 8, wherein the vaccine composition can be used for MMR (measles, mumps, and rubella) combination vaccine”. The use of the phrase “can be used for” renders the claim indefinite because the phrase “be used for” implies it is capable of also being effective against Measles and Rubella as well as Mumps, which is unlikely to have been Applicant’s intention. It is suggested that the phrase “can be used for MMR (measles, mumps, and rubella) combination vaccine” be replaced with “can be used in an MMR (measles, mumps, and rubella) combination vaccine” or “can be used as part of an MMR (measles, mumps, and rubella) combination vaccine”, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 12 is rejected on the grounds of being indefinite.
Claims 13, and dependent claim 14 thereof, 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 Claim 13, it recites the limitation "the antigen-antibody complex" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Neither Claim 13 nor Claim 1, upon which Claim 13 depends, introduces the limitation of “an antigen-antibody complex”. The lack of antecedence renders the claim indefinite as it is unclear which complex the claim is referring to. It is suggested that Claim 13 be amended by properly introducing “an antigen-antibody complex”, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 13 is rejected on the grounds of being indefinite. Claim 14 is also rejected, since it depends upon Claim 13 but does not remedy the deficiencies of Claim 14.
Claims 13, and dependent claim 14 thereof, 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 Claim 13, it recites the limitation “A diagnostic kit for mumps virus comprising the mumps virus of claim 1 or its antigen and reagents for detecting the antigen-antibody complex”. Based on how the claim is currently written, it is unclear exactly what Applicant is claiming. The claim can be interpreted as a kit for detecting mumps virus in a sample. Another reasonable interpretation is that the kit can be used for detecting signs of exposure to mumps virus, either past exposure or an active infection, in a subject. This lack of clarity renders the claim indefinite. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite."). There is also no definition of the phrase “stand-alone vaccine” provided in the instant Specification. It is suggested that the claim be amended to clarify exactly what Applicant is attempting to claim, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 13 is rejected on the grounds of being indefinite. Claim 14 is also rejected, since it depends upon Claim 13 but does not remedy the deficiencies of Claim 13.
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 these claims on their merits, Claim 1 is being interpreted such that, due to the lack of a reference sequence or reference sequences, it reads on any mumps virus of genotype F.
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.
Claims 13-14 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.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... reduction to drawings .... or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 13-14 are rejected as lacking adequate descriptive support for generating any antibody which has the ability to bind to the virus of instant Claim 1.
In support of the claimed genus (an antibody which binds the virus of instant Claim 1), the application discloses one example of a primary antibody, Ab9880 . No derivatives or variants or mutants thereof are disclosed that can achieve this ability to bind to the virus of instant Claim 1. While the instant Specification discusses high antibody titers and neutralizing antibody titers in the context of the immune response generated by the virus of instant Claim 1, no specific antibodies are actually disclosed or identified in this context. Additionally, the sequence (full sequence, CDRs, VH/VL) of the primary antibody used, Ab9880, is not disclosed. Furthermore, the claims are not only drawn to any anti-mumps antibody, but also any type of anti-mumps antibody (e.g., any antibody class/isotype, such as IgG, IgM, IgA, IgE, and IgD; any antibody subclass, such as IgG1, IgG2, IgG3, and IgG4; any antibody fragments/permutations/structures, such as scFv, Fab, scFv-Fc, F(ab' )2, etc.; any species type (e.g., goat, human, mouse, rat, camel, etc.), and any valency type. Thus, the application fails to provide examples of a representative number of species within the claimed genus.
Further, while the claims provide both a structure and a function, the application fails to draw any correlation between the two, i.e., there is no evidence that any antibody can still retain the ability to bind to the virus of instant Claim 1.
The teachings of the art also fail to indicate that, without such evidence, those in the art would have expected the full scope of the claimed antibodies would confer the claimed ability to bind to the virus of instant Claim 1. For example, a search of the art indicates that modifications to biological molecules such as proteins are unpredictable, and require experimentation regarding the relationships between alterations in sequence bases/side chains and the function and structure of the protein in order to determine the actual effects of the modifications as discussed by Bowie et al. (Bowie JU, Reidhaar-Olson JF, Lim WA, Sauer RT. Deciphering the message in protein sequences: tolerance to amino acid substitutions. Science. 1990 Mar16;247(4948):1306-10; See page 1306). The art also shows that single amino acid mutations in the antibodies can greatly affect the ability of said antibody to bind to its target antigen (Winkler K, Kramer A, Küttner G, Seifert M, Scholz C, Wessner H, Schneider-Mergener J, Höhne W. Changing the antigen binding specificity by single point mutations of an anti-p24 (HIV-1) antibody. J Immunol. 2000 Oct 15;165(8):4505-14.; See also Kussie PH, Parhami-Seren B, Wysocki LJ, Margolies MN. A single engineered amino acid substitution changes antibody fine specificity. J Immunol. 1994 Jan 1;152(1):146-52.) When single amino acid mutations are generated, or when the combination or order of CDRs within an antibody is altered, it affects the neutralizing capability of the resulting antibody or fragment thereof (Chen Z, Wang J, Bao L, Guo L, Zhang W, Xue Y, Zhou H, Xiao Y, Wang J, Wu F, Deng Y, Qin C, Jin Q. Human monoclonal antibodies targeting the haemagglutinin glycoprotein can neutralize H7N9 influenza virus. Nat Commun. 2015 Mar 30;6:6714.)
The art has further highlighted the importance of the order of CDRs, the interaction of non-CDR domains with respect to antigen/epitope binding, and that antigen-antibody algorithms or epitope prediction software/rational antibody design is highly inaccurate (Sela-Culang I, Kunik V, Ofran Y. The structural basis of antibody-antigen recognition. Front Immunol. 2013 Oct 8;4:302.) Computational in silico methods have traditionally struggled to predict the effect of mutations in antibody–antigen complexes on binding affinity, and generation of actual mutants in vitro of antibodies is the preferred and reliable method to determine the effect of mutations on antigen-antibody binding (Sirin S, Apgar JR, Bennett EM, Keating AE. AB-Bind: Antibody binding mutational database for computational affinity predictions. Protein Sci. 2016 Feb;25(2):393-409. Epub 2015 Nov 6.) The CDR positions are also vital, as it is shown the length and sequence of the CDR in the H3 position can affect the overall binding capability of the antibody (Tsuchiya Y, Mizuguchi K. The diversity of H3 loops determines the antigen-binding tendencies of antibody CDR loops. Protein Sci. 2016 Apr;25(4):815-25. Epub 2016 Jan 20.) The antigen itself can determine what lengths of CDRs are tolerated (Collis AV, Brouwer AP, Martin AC. Analysis of the antigen combining site: correlations between length and sequence composition of the hypervariable loops and the nature of the antigen. J Mol Biol. 2003 Jan 10;325(2):337-54.). Further, CDRs may vary depending on the numbering system utilized. The Chothia, Kabat, Martin, IMGT, Honneger, and Gelfand numbering schemes all differ, and depending on the numbering system utilized, one may end up with wildly different antibodies with functional differences distinct from the original antibody (See e.g. Dondelinger M, Filée P, Sauvage E, Quinting B, Muyldermans S, Galleni M, Vandevenne MS. Understanding the Significance and Implications of Antibody Numbering and Antigen-Binding Surface/Residue Definition. Front Immunol. 2018 Oct 16;9:2278.) These results highlight the pitfalls in attempting to describe an antibody functionally and/or with a percent identity to known structural characteristics.
Lastly, the Federal Circuit opinion in Amgen v. Sanofi No. 2017-1480 slip op. Fed. Cir. Oct. 5, 2017 (“Amgen”) has shown that mere possession of an antigen does not satisfy the written description requirement for possession of any antibodies that may bind to said antigen. This recent finding is the current guidance utilized by the Office, and the opinion overrides the MPEP guidance regarding “newly characterized antigens” (MPEP § 2163 II.A.3).
Thus, in view of the above, there would have been significant uncertainty as to whether any antibody would be able confer the claimed ability to bind the virus of Claim 1. In view of this uncertainty and the lack of a representative number of examples of the claimed genus and the lack of sequence information regarding the disclosed examples, the claims are rejected for lack of adequate written description support.
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 1-5 and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite an isolated mumps virus, comprising amino acid variants of Ala to Thr at amino acid position 120 in the nuclear protein (NP),Asp to Asn at amino acid position 78 and Met to Val at amino acid position 269 in the fusion protein (F), Leu to Pro at amino acid position 57 in the small hydrophobic protein (SH), Thr to Ala at amino acid position 154 and His to Asn at amino acid position 498 in the hemagglutinin-neuraminidase protein (HN), and His to Asn at amino acid position 818, Lys to Arg at amino acid position 1406, and Pro to Gin at amino acid position 1946 in the large protein (L), an isolated mumps virus comprising a polynucleotide consisting of the nucleotide sequence of SEQ ID NO: 1, and an isolated mumps virus as deposited under accession number: KCTC 15330BP. Claims 1-5 and 17-18 are ineligible because they recite nucleotide sequences and corresponding amino acid sequences that are naturally-occurring sequences which are not markedly different from their naturally-occurring counterparts because they convey the same genetic information.
This judicial exception is not integrated into a practical application because the claimed invention, as currently written, is not used to provide a particular treatment or prophylaxis for a disease or medical condition. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention, as currently written, simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. It is suggested that the claims be amended to recite sequences that are not naturally occurring by incorporating non-natural nucleotides or amino acids, heterologous sequence elements, or tags, for example. Applicant is free to amend the claims as they deem necessary, as long as said amendments do not introduce new matter, or persuasively argue that the claims are patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of AIA 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.
(a)(2)the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-12, and 15-16 are rejected under AIA 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Zhang, Y., Xie, L., Chai, B., Ruan, J., Gu, Y., Niu, B., Zhang, Y., Fu, Z., An, Q., & Tian, D. (2021). A Highly Attenuated Mumps Virus Strain of Genotype F Generated by Passaging in Vero Cells. Virologica Sinica, 36(2), 337–340.).
Zhang et al. teach a highly attenuated mumps virus strain of genotype F which was generated by passaging the virus in Vero cells 30 times as well as a method for generating said attenuated mumps virus (see Table 1; Figure 1C; Page 337, Right Column, Last Paragraph and Page 339, Left Column Paragraphs 1-2), which reads on instant Claims 1, 4-7, and 15. As noted above, due to the lack of a reference sequence for Claim 1, the claims are being interpreted as reading upon on any mumps virus of genotype F. Zhang et al. also teach a vaccine composition comprising the attenuated mumps virus in a pharmaceutically acceptable solution with a pharmaceutically acceptable carrier wherein the vaccine composition was used as a booster vaccine (see Page 339, Right Column, Last Paragraph and Page 340, Left Column, Paragraphs 1-2), which reads on instant Claims 8-9. Additionally, Zhang et al. teach that said vaccine composition had a virus concentration of 4x105 CCID50 (see Page 339, Right Column, Last Paragraph and Page 340, Left Column, Paragraphs 1-2), which reads on instant Claims 10-11. Furthermore, the vaccine developed by Zhang et al. can be used as part of an MMR (measles, mumps, and rubella) combination vaccine or serve as a standalone or booster vaccine (see Page 339, Right Column, Last Paragraph and Page 340, Left Column, Paragraphs 1-2), which reads on instant Claims 9 and 12. Finally, Zhang et al. teach a method for generating an immune response against mumps virus using their attenuated mumps virus vaccine candidate by administering said vaccine candidate to a subject (see Figure 1G; Page 339, Right Column, Last Paragraph and Page 340, Left Column, Paragraphs 1-2), which reads on instant Claim 16.
For at least these reasons, Zhang et al. teach the limitations of instant Claims 1, 4-12, and 15-16 and anticipate the invention encompassed by said claims.
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:
Harford et al. (US 2004/0120969 A1, published 24 June 2004)
Harford et al. teach an attenuated mumps virus belonging to the Jeryl-Lynn strain. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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