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
Applicant’s amendments and remarks filed on April 30, 2026 are acknowledged. Claims 1, 3, 7, 9, 10, 13-15, and 17 have been canceled. Claims 4 and 5 were amended. Claims 2, 4-6, 8, 11, 12, 16, 18, and 19 are pending.
Claims 2, 6, 8, 11, 12, 16, 18, and 19 are withdrawn.
Claims 4 and 5 are examined on the merits herein.
Priority
This application is a continuation in part of PCT/EP2020/051766, filed on January 24, 2020 which claims priority to EP19153535.0 filed on January 24, 2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections
In view of Applicant’s amendments and response, the objections to the abstract and specification are withdrawn.
In view of Applicant’s amendments and response, the objection to claim 1 is withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments and response, the 35 U.S.C 112(a) written description, 35 U.S.C 101, 35 U.S.C 102, and 35 U.S.C 103 rejections are withdrawn.
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.
Enablement
Claims 4 and 5 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors to be considered when determining whether there is
sufficient evidence to support a determination that a disclosure does not satisfy the
enablement requirement and whether any necessary experimentation is "undue".
These factors include, but are not limited to: (A) The breadth of the claims; (B) The
nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary
skill; (E) The level of predictability in the art; (F) The amount of direction provided by the
inventor; (G) The existence of working examples; and (H) The quantity of
experimentation needed to make or use the invention based on the content of the
disclosure. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Breadth of claims and nature of the invention:
Claim 4 is drawn to
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Claim 5 is drawn to a non-human host cell transformed or modified with an expression vector according to claim 4.
State of the prior art, level of predictability in the art, and level of one of
ordinary skill:
zur Hausen et al. (Current Topics in Microbiology and Immunology 2017) discloses that red meat and dairy products have frequently been suggested to represent risk factors for certain cancers, chronic neurodegenerative diseases, and autoimmune and cardiovascular disorders [abstract]. Further, besides cancer, several chronic neurodegenerative diseases have also repeatedly been linked to dairy product consumption or to a diet rich in red meat [page 89, third full paragraph].
A review of the prior art shows that the state of the art of vaccines comprising C2MI polynucleic acids is immature and nascent.
Pardi et al. (Nat Rev Drug Discov. 2018) discloses that mRNA vaccines represent a promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration. However, their application has until recently been restricted by the instability and inefficient in vivo delivery of mRNA [abstract]. While conventional vaccine approaches provide durable protection against a variety of diseases, there remains major hurdles to vaccine development against a variety of infectious pathogens [page 1, first paragraph].
Yang et al. (Biomaterials Research 2015) discloses that gene-based vaccines have become a favored strategy for inducing immunity. However, the lower immunogenicity of nucleic acid vaccines has hindered their progress in humans [page 7, left column, second full paragraph]. Yang et al. also discloses that challenges remain due to a lack of deep and comprehensive understanding of the in vivo behavior of delivery vectors and immunostimulative mechanism. Therefore, intensive and comprehensive understanding of the mechanism of biomaterial vector on both delivery routes and immunostimulatory are very crucial for rational design of delivery vectors for vaccines, and will accelerate the development of nucleic acid vaccine for clinical application [page 7, right column, first full paragraph].
While the state of the art of vaccines comprising C2MI polynucleic acids is immature and nascent, there is also unpredictability and challenges in nucleic acid vaccine therapeutics as evidenced by Pardi et al. and Yang et al.
Amount of direction provided by the inventor and existence of working
examples:
The specification envisions that a C2MI polynucleic acid may comprise (a) a nucleotide sequence depicted in any one of Figures 1(A) to 22(A); (b) a nucleotide sequence having at least 93% identity to a nucleotide sequence of (a); (c) a fragment of a nucleotide sequence of (a) or (b); (d) a nucleotide sequence being complementary to a nucleotide sequence of (a), (b), or (c); or (e) a nucleotide sequence which is redundant as a result of the degeneracy of the genetic code compared to any of the above-given nucleotide sequences [0039]. Further, the specification defines a “polynucleic acid” as a single-stranded or double-stranded nucleic acid sequence and may consist of deoxyribonucleotides or ribonucleotides, nucleotide analogues or modified nucleotides [0040].
The specification envisions a vaccine for immunizing a mammal against a C2MI infection comprising at least one C2MI polypeptide or C2MI polynucleic acid in a pharmaceutically acceptable carrier [0117]. A “vaccine” is defined as an immunogenic composition capable of eliciting protection against C2MI, whether partial or complete [0119].
However, the specification as filed does not disclose any working examples of the claimed invention. Specifically, there are no working examples of any C2MI polynucleic acids, such as SEQ ID NO: 604.
The specification also envisions that functional fragments of the nucleotide sequences harbor a replication gene which codes for a replication protein. An autonomous replicating nucleotide sequence may comprise a nucleotide sequence of the replication gene or a fragment thereof which is capable of inducing autonomous replication [0043].
Further, the specification envisions using standard assays to determine which nucleic acid sequences are related to a nucleotide sequence of Figures 1 to 22 or are fragments thereof and still have the same function as the full length sequences [0044].
However, the examples provided in the specification only encompass DNA extraction, rolling circle amplification, polymerase chain reaction, and in silico analyses (paragraphs [0129] through [0142]). The specification does not disclose how to use the nucleic acid sequences.
Quantity of experimentation:
In view of the breadth of the claims which embrace nucleotide sequences that must function as an immunogenic composition, the state and level of predictability in the art, the lack of working examples, and the failure to provide adequate guidance to overcome the state and level of predictability of the art, one of skill would have to perform undue experimentation in order to practice the invention commensurate in scope with the claims. This type of experimentation is not routine and would require a large amount of inventive effort.
In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Response to Arguments
Applicant's arguments filed April 30, 2026 have been fully considered but they are not persuasive.
Applicant indicates that MPEP §2164.01 states the test for enablement as “is the experimentation needed to practice the invention undue or unreasonable?”.
With respect to Applicant’s arguments, there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue". These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant asserts the following:
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These arguments are not found persuasive. The specification envisions a vaccine for immunizing a mammal against a C2MI infection comprising at least one C2MI polypeptide or C2MI polynucleic acid in a pharmaceutically acceptable carrier [0117]. The specification also envisions that functional fragments of the nucleotide sequences harbor a replication gene which codes for a replication protein. An autonomous replicating nucleotide sequence may comprise a nucleotide sequence of the replication gene or a fragment thereof which is capable of inducing autonomous replication [0043]. Further, the specification envisions using standard assays to determine which nucleic acid sequences are related to a nucleotide sequence of Figures 1 to 22 or are fragments thereof and still have the same function as the full length sequences [0044]. However, the specification as filed does not disclose any working examples of the claimed invention. Specifically, there are no working examples of any C2MI polynucleic acids, such as SEQ ID NO: 604. The examples provided in the specification only encompass DNA extraction, rolling circle amplification, polymerase chain reaction, and in silico analyses (paragraphs [0129] through [0142]). The specification does not disclose how to use the nucleic acid sequences. Thus, in view of the state and level of predictability in the art, the lack of working examples to show how to use the C2MI polynucleic acid, and the failure to provide adequate guidance to overcome the state and level of predictability of the art, one of skill would have to perform undue experimentation in order to practice the invention commensurate in scope with the claims.
Conclusion
No claims are allowed.
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 CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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