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 .
DETAILED ACTION
1. Claims 1-13 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 12/24/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Claims 2-13 are objected to because of the following informalities: Claims 2-13 recite the term "Claim". For improved language, the term does not need to be capitalized and should be in lower case (reciting "claim").
Further as to claims 4, 6, 10, for improved language and consistency among the claims, the claim should recite “ … , further comprising …”.
Appropriate correction is required.
Specification
4. The disclosure is objected to because of the following informalities:
The use of trademarked term has been noted in this application on page 18. The term 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.
Appropriate correction is required.
Nucleotide and/or Amino Acid Sequence Disclosures
5. 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:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification on page 14 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
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 sequence identifiers, 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
6. Claims 1-4, 7-9, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lilja et al. (US20140271829)(cited in applicant’s IDS submitted 12/24/2024) in view of David et al.
(WO2013138776)(cited in applicant’s IDS submitted 12/24/2024).
See claims 1-4, 7-9, 13 as submitted 4/23/2024.
Lilja et al. teaches: composition [0016]; alphavirus RNA replicon [0014] (as recited in
claim 1); rabies virus antigen [0177](as recited in claim 1); wherein alphavirus includes
Venezuelan equine encephalitis virus (VEE)[0034](as recited in claim 1); generation of
broad and potent immune responses (abstract); VRPs (alphavirus replicon particle)[0014]; wherein adjuvant is optional (interpreted to also read upon a non-adjuvanted vaccine)[0194](as recited in claim 7); administration [0197](as recited in claim 8); including combinations of VRPs [0123]; including multiple VRPs [0197]; nucleotides encoding protein of interest (abstract); heterologous sequences [0036]; suitable nucleic acid vectors have the capacity to carry and drive expression of more than one protein gene [0029]; including use of proteins from different viral strains [0033, 0147, 0208]; vaccine (abstract); induction of humoral immune response [0195]; induction of protective immune response [0197].
Lilja et al. does not teach: wherein the rabies virus antigen is a glycoprotein (G) or an antigenic fragment thereof (as recited in claim 1); one shot (as recited in claim 1); canine (as recited in claims 3, 9); further comprises at least one non-rabies virus antigen (as recited in claim 4); wherein the rabies virus glycoprotein (G) comprises an amino acid sequence comprising at least 95% identity with the amino acid sequence of SEQ ID NO: 2 (as recited in claim 13).
David et al. teaches: anti-rabies vaccine (abstract); rabies glycoprotein polynucleotide
(pages 13, 14); rabies G protein (p. 4)(as recited in claim 1); including SEQ ID NO: 12, which
has 99.9% identity with instant SEQ ID NO: 2 (See Result 4 of STIC Sequence Search Result
20200602_181626_us-18-643-377-2.rag in Supplemental Content Tab)(as recited in claim 13); for dogs (abstract)(as recited in claims 2, 3, 9); including multivalent vaccines including antigens from the same species or from different genera (p. 8)(as recited in claim 4); as well as wherein vaccine compositions can be administered in dosages and by techniques well known to those skilled, taking into consideration factors as age (p. 9); wherein one skilled in the art can determine the effective dose to be used from disclosure and knowledge in the art (p. 20); wherein a single dose protected dogs against challenge (Examples 4, 5)(as recited in claim 1).
One of ordinary skill in the art would have been motivated to use rabies and non-rabies
virus antigens as taught or suggested by David et al. in the composition as taught by Lilja et al.
Lilja et al. teaches or suggests generation of broad and potent immune responses, including usage of rabies antigens, combinations of VRPs, including multiple VRPs, and use of proteins from different viral strains and different genera, and David et al. teaches such antigens (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to claim 2, Lilja et al. teaches: induction of humoral immune response [0195], and additionally such a result is also considered to flow from the composition as recited in claim 1 (see also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin V. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"); In Hoffer V. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "whereby' clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited." Id. (quoting Minton V. Nat'l Ass'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
One of ordinary skill in the art would have had a reasonable expectation of success for
using rabies and non-rabies virus antigens as taught or suggested by David et al. in the
composition as taught by Lilja et al. There would have been a reasonable expectation of success given the underlying materials (antigens as taught by Lilja et al. and David et al.) and methods (eliciting immune response as taught by Lilja et al. and David et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
7. Claims 5, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lilja et al. in view of David et al. as applied to claims 1-4, 7-9, 13 above, and further in view of Murphy et al. (U.S. Patent No. 7208161)(cited in applicant’s IDS submitted 12/24/2024).
See claims 5, 6 as submitted 4/23/2024.
See the teachings of Lilja et al. in view of David et al. above. It is noted Lilja et al. teaches: suitable nucleic acid vectors have the capacity to carry and drive expression of more than one protein gene [0029]; including combinations of VRPs [0123]; including multiple VRPs [0197]. David et al. also teaches multivalent vaccine and use of antigens, such as rabies and parainfluenza antigens (p. 8).
Lilja et al. in view of David et al. does not teach wherein the non-rabies virus pathogen is a killed non-rabies virus pathogen or a live attenuated non-rabies virus pathogen; that further comprises an alphavirus RNA replicon particle comprising a nucleotide sequence encoding at least one protein antigen or antigenic fragment thereof that originates from a non-rabies virus pathogen.
Murphy et al. teaches: live attenuated parainfluenza vaccines (Examples IX, X, XI, XII)(as recited in claim 5); embodiments wherein N, P, and L proteins are each encoded on separate expression vectors (as recited in claim 6).
One of ordinary skill in the art would have been motivated to use live attenuated non-
rabies virus pathogen and nucleotide sequences as taught by Murphy et al. in view of the composition as taught by Lilja et al. in view of David et al. Lilja et al. in view of David et al. teaches or suggests generation of broad and potent immune responses, including usage of combinations of VRPs, including multiple VRPs and use of sequences and proteins from different viral strains and parainfluenza, and Murphy et al. teaches such antigens and sequences (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using live attenuated non-rabies virus pathogen and nucleotide sequences as taught by Murphy et al. in view of the composition as taught by Lilja et al. in view of David et al. There would have been a reasonable expectation of success given the underlying materials (antigens as taught by Lilja et al. in view of David et al. and Murphy et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lilja et al. in view of David et al. as applied to claims 1-4, 7-9, 13 above, and further in view of Wu et al. (U.S. Patent No. 8795681)(cited in applicant’s IDS submitted 12/24/2024).
See claims 10-12 as submitted 4/23/2024.
See the all the teachings of Lilja et al. in view of David et al. above, including as to rabies G protein, using multiple VRPs; including wherein alphavirus includes Venezuelan equine encephalitis virus (VEE)[0034]; including combinations of VRPs [0123]; including use of proteins from different viral strains [0033, 0147, 0208]. David et al. also teaches multivalent vaccine (p. 8).
Lilja et al. in view of David et al. does not teach one or more additional alphavirus RNA replicon particles which encodes a second rabies virus antigen that originates from a different strain of rabies virus than the one that said rabies virus antigen originates from.
Wu et al. teaches: nucleic acid molecules encoding rabies virus glycoprotein (title,
abstract); including genes of at least two different rabies strains (column 1, line 14).
One of ordinary skill in the art would have been motivated to use antigens from different strains as taught or suggested by Wu et al. in view of the composition as taught by Lilja et al. in view of David et al. Lilja et al. in view of David et al. teaches or suggests generation of broad and potent immune responses, including usage of combinations of VRPs, including multiple VRPs and use of proteins from different viral strains, including using rabies antigens, and Wu et al. teaches such antigens from different rabies strains (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using antigens from different strains as taught or suggested by Wu et al. in view of the
composition as taught by Lilja et al. in view of David et al. There would have been a reasonable expectation of success given the underlying materials (rabies antigens as taught by Lilja et al., David et al., and Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
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.
9. Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11992526 (16/759868).
See claims 1-13 as submitted 4/23/2024.
Claims 1-18 of U.S. Patent No. 11992526 recite a vaccine to aid in the prevention of disease due to rabies virus comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle (RP), and comprising a nucleotide sequence encoding a rabies virus antigen and a pharmaceutically acceptable carrier; wherein the nucleotide sequence encoding the rabies virus antigen comprises at least 85% sequence identity to the nucleotide sequence of SEQ ID NO: 1 or SEQ ID NO: 4; that comprises one or more additional alphavirus RNA replicon particles which encodes a second rabies virus antigen that originates from a different strain of rabies virus than the one that said rabies virus antigen originates from; wherein the second rabies virus antigen is a glycoprotein (G) or an antigenic fragment thereof; wherein the one or more additional alphavirus RNA replicon particles are VEE alphavirus RNA replicon particles; wherein the rabies virus antigen is a rabies virus glycoprotein (G) having an amino acid sequence comprising at least 95% identity with the amino acid sequence of SEQ ID NO: 2; wherein an antibody is induced in a mammal when said mammal is immunized with the vaccine; wherein the mammal is selected from the group consisting of a canine, a feline, an equine, a ferret, a sheep, and a bovine; that further comprises at least one non-rabies virus antigen for eliciting protective immunity to a non-rabies virus pathogen; that further comprises an alphavirus RNA replicon particle comprising a nucleotide sequence encoding at least one protein antigen or antigenic fragment thereof that originates from a non-rabies virus pathogen; that is a non-adjuvanted vaccine; method of immunizing a mammal against rabies virus comprising administering to the mammal an immunologically effective amount of the vaccine of claim 1; wherein the mammal is selected from the group of a canine, a feline, and an equine; that is a one dose vaccine; wherein the rabies virus antigen is a rabies virus glycoprotein (G) having an amino acid sequence of SEQ ID NO: 2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1-13 and claims 1-18 of U.S. Patent No. 11992526 recite a vaccine to aid in the prevention of disease due to rabies virus comprising a Venezuelan Equine Encephalitis (VEE) alphavirus RNA replicon particle, and comprising a nucleotide sequence encoding a rabies virus antigen and a pharmaceutically acceptable carrier; wherein the rabies virus antigen is a rabies virus glycoprotein (G) having an amino acid sequence of SEQ ID NO: 2; that is a one dose vaccine.
Conclusion
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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