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 .
The Response of 10 Dec. 2025 has been entered.
Claims 1-3, 5-7 and 9-19 are currently pending. Claims 1, 2, 6 and 9-17 are withdrawn as being drawn to a nonelected invention (claims 1, 2 and 9-17) and species (claim 6).
Claims 3, 5, 7, 18 and 19 are considered here with respect to the elected species.
Any rejection not reiterated herein has been withdrawn.
Allowable Subject Matter
Claims 18 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 10 Dec. 2025 have been fully considered but they are not persuasive.
Regarding the 101 rejection, Applicant argues that the claims do not recite the judicial exception under prong 2A, prong one, but rather “involve the natural product (the peptides) as foundational components in a specific, non-naturally occurring combination” that is “an intentional, specific selection of four antigens”. In particular, Applicant argues that pool 5 of Crooke et al. comprising peptides of SEQ IDs 4, 5 and 6 stimulates an enhanced IFN-gamma recall response (Fig. 3C) compared to the additive effect of the single peptides administered separately (Fig. 3D), and that this is evidence that the combination has a synergistic/enhances immunogenicity that establishes markedly different characteristics from the natural counterparts (the individual peptides). This is not persuasive because the evidence cited by Applicant is not sufficient to establish markedly different characteristics. Crooke states that the tested peptide pools, including pool 5, resulted from random sorting (p. 6, last ¶), and pool 5 comprises five additional peptides that are not part of the elected combination of species (peptides 25-27, 31 and 32 in Table 1, of which 25-26 are not present within claimed SEQ IDs 1-17). It is thus not possible to attribute any effects of pool 5 to the claimed invention. Moreover, Crooke states that “Responses were highly variable between individual subjects (Fig 3C). Due to this variability, none of the ELISpot responses to the peptide pools met statistical significance compared to background” (p. 7, 1st ¶). Furthermore, it is not clear in comparing the results of the individual peptides in Fig. 3D to the results of pool 5 in Fig. 3C that the pooled peptides provide any synergistic or enhanced response compared to what would be expected based on the combination of individual peptides (e.g., several of individual peptides 27-32 in Table 1 show responses of similar magnitude in Fig. 3D as the pooled peptides in Fig. 3C). Thus, the evidence provided in Crooke does not establish markedly different characteristics for the claimed combination of peptides.
Regarding the indefiniteness rejection, Applicant argues that the trademark terms MF59, AS03 and AS04 are art-recognized terms with a fixed and un-ambiguous meaning. This is not persuasive because a trademark or trade name is used to identify a source of goods, and not the goods themselves, and thus cannot be used properly to identify any particular material or product (see MPEP 2173.05(u)). For example, a product associated with a trademark can change over time or in different locations. The rejection can be overcome by amending the claims to recite the equivalent products without using the trademarks/trade names.
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 3 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product which is a judicial exception to patentability without significantly more. The claims (as limited by the species election) recite a composition comprising four polypeptides consisting of the sequences of SEQ IDs 1, 4, 5 and 6. The instant specification evidences that the claimed peptides are naturally occurring antigen peptides that are presented on the surface of HLA molecules of B-cells infected with Zika virus (Spec., Example 1; see also, Crooke et al., PLoS One 16.6 (2021): e0252198, p. 3, 1st full ¶ and Table 1). The closest naturally occurring counterpart to the claimed composition would thus be a biological fluid, such as blood, comprising a population of B-cells presenting one or more of the claimed peptides. There is no evidence in the instant specification that the claimed combination of peptides has markedly different characteristics than the naturally occurring counterparts, such as a change in the structure, function or other properties of the component peptides. The claimed collection of peptides is analogous to the collection of bacteria in Funk Bros., which were held to be ineligible subject matter because each of the component natural products exerted its same effect separately as within the mixture (see Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”)). Claims 3 and 5 do not recite any additional elements other than the peptides that would integrate the recited judicial exception into a practical application of that exception. The claims are also not directed to any particular type of composition, such as a vaccine composition that would imply suitability for administration to a subject, amounts sufficient to induce an immune response or the like. The claims are thus directed to a natural product which is a judicial exception. Claims 3 and 5 do not recite any additional elements other than the natural product peptides, and thus do not recite any elements that would amount to significantly more than the judicial exception. The claims as a whole add nothing significantly more to the “product of nature” itself and are thus unpatentable subject matter.
Claim Rejections - 35 USC § 112(b) (indefiniteness)
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.
Claim 7 is rejected under 35 U.S.C. 112(b) 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 7 contains the trademarks/trade names MF59, AS03 and AS04. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the adjuvant and, accordingly, the identification/description is indefinite.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657