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 without traverse of required species in the reply filed on 2/8/2023 is acknowledged.
Claims 1-5, 17-19, 59-63 and 66-70 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(Prior Rejection Maintained) Claims 1-5, 17-19, 59-63 and 66-70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
Claims 1-5, 17-19, 59-63 and 66-70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature that is not patent- eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013) (hereafter “Myriad”).
Based upon an analysis with respect to the claims as a whole, claim(s) 1-5, 17-19, 59-63 and 66-70 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (1.e., abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See www.usped.eoy for further guidance).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps found at www aspto.gov, the claims are directed to an ineligible process as further detailed below.
In this case, claim(s) 1-5, 17-19, 59-63 and 66-70 recite or are directed to a process (Step 1) and recite steps that are directed to judicial exceptions (in this case, abstract ideas)(Step 2A-Prong One). The claimed methods involve steps of comparing amino acid sequences of antigens from H1, H2 OR H5 influenza viruses. The comparison involves generating a phylogenetic tree based on full-length antigen sequences of the influenza viruses, identifying clusters of sequences with at least 95% identity and substitution rates within this cluster, generating a primary sequence from the cluster and further carrying out additional phylogenetic trees based on the first cluster. These sequence comparisons are repeated. The present claims only recite mental and computational method steps and generic methods of producing and isolating a generic antigen of a generic pathogen and with an intended use of administration of the antigen. While claims 1 and 59 contains the amendment of “synthesizing a vaccine comprising the synthetic, non-naturally occurring, pan-epitopic immunogen, which, when administered to a subject, causes an immune response in the subject to the pathogen or pathogenic strain resulting from antigenic drift and sequence variability in antigenic proteins of the pathogen or pathogenic strain, wherein the synthetic vaccine is produced by” steps a-h; and claim 3 contains “synthesizing a vaccine comprising the non-naturally occurring, pan-epitopic immunogen, which, when administered to a subject, causes an immune response in the subject to the present and future influenza virus strains resulting from antigenic drift and sequence variability in antigenic proteins of the influenza virus strains, wherein the synthetic vaccine is produced by:” steps a-h. The present claims only recite mental and computational method steps and generic methods of producing and isolating a generic antigen of an influenza HA or NA protein and with an intended use of administration of the antigen.
The claims nor the specification require a specific synthesizing approach or technique. Therefore, the synthesizing step is interpreted as a step involving a computer program operating a machine which generates the amino acid sequences following the mental and computational method steps of sequence comparison. In addition, while the claim states that a synthetic, non-naturally occuring, pan-epitopic immunogen or immunogen is produced and applicants argue that this immunogen would possess broadly reactive immunogenic properties, no structure (i.e., amino acid sequence) is provided by the claims. Therefore, without an exemplary sequence in the claims the status of the sequence not being naturally occurring cannot be confirmed. Further, the steps of the method are recited at a high level of generality. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well- understood, routine and conventional activity engaged in by scientists prior to applicant’s invention. Therefore, the synthesizing step does not integrate the claim as a whole into a practical application.
Furthermore, the steps are interpreted to be mental steps, since the sequence comparison can be done by hand on a piece of paper or using a computer. Thus the claims are directed to a method in which mental steps/abstract ideas are claimed.
The claims also require administering the resulting immunogen to a host, however, this additional step does not amount to significantly more as administering such immunogens would be routine and these steps are recited at a high level of generality. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well-understood, routine and conventional activity engaged in by scientists prior to applicant’s invention. Related to routine and conventional, Giles et al. (Vaccine, 2011, p. 3042-3054) teaches computationally optimizing broadly reactive antigen (COBRA) of influenza virus by reverse translating influenza
virus amino acid sequences and optimizing the amino acids for expression in mammalian cells and generation of broadly reactive antibodies in mice due to immunization with COBRA HA H5N1 antigen (see Materials and Methods and Results). Giles et al. discloses active method steps, such as in vitro expression of the HA antigen upon expression in human embryonic kidney cells, vaccine preparation and mouse immunization and challenge, that are not recited in the present claims.
When considering step 2A-Prong Two, the claim method does not recite any additional elements that integrate it into a practical application.
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. The claims do not invoke any of the considerations that courts have identified as providing significantly more than the exceptions. Even when viewed as a combination, the additional elements fail to transform the exceptions into a patent eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception.
It is asserted that the claims are directed to judicial exceptions by reciting abstract ideas associated with comparing amino acid sequences and arriving at consensus sequences through multiple rounds of sequence comparison, which is routine and conventional steps known in the art, without reciting more or additional elements that amount to significantly more than the judicial exception. Therefore, claim(s) 1-5, 17-19, 59-63 and 66-70 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Applicants argue that the amendments to claims 1, 3 and 59 integrates the claimed methods into a practical application and recite additional elements that amount to significantly more than the alleged judicial exception. Therefore, the claimed invention does not include a judicial
exception and is patent eligible.
In response, claims 1, 3 and 59 contain the amendment of synthesizing a vaccine comprising a synthetic, non-naturally occurring, pan-epitopic immunogen, which, if administered to a subject, causes an immune response in the subject to the pathogen or pathogenic strain, such as influenza. The immunogen can be from influenza HA or NA.
The claims nor the specification require a specific synthesizing approach or technique.
Therefore, the synthesizing step is interpreted as a step involving a computer program operating
a machine which generates the amino acid sequences following the mental and computational
method steps of sequence comparison. In addition, while the claim states that a synthetic, non-naturally occurring, pan-epitopic immunogen is produced and applicants argue that this immunogen would possess broadly reactive immunogenic properties, no structure (i.e., amino acid sequence) is provided by the claims. Therefore, without an exemplary sequence in the claims the status of the sequence not being naturally occurring cannot be confirmed.
Further, the steps of the method are recited at a high level of generality, including the producing and isolating steps. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well- understood, routine and conventional activity engaged in by scientists prior to applicant's invention. Therefore, the synthesizing, producing and isolating steps do not intregrate the claim as a whole into a practical application.
No claims are allowed.
Conclusion
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 BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671