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 .
Applicant’s amendment filed 4/8/2026 is acknowledged.
Claims 22-24, 26-27, and 30 are under examination on the merits.
Response to Arguments
Applicant’s argument, see pp. 1-2, filed 4/8/2026, regarding the previous rejection under 35 U.S.C. §103 have been fully considered but they are not persuasive. See response below.
A new claim objection is presented below.
A new rejection under 35 U.S.C. §101, necessitated by Applicant’s amendment, is raised below. See below.
Maintained Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous Rejection Maintained) Claims 22-24, 26-27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Glanville, et al. (PLoS Pathog. 2013;9(9):e1003669. doi: 10.1371/journal.ppat.1003669. Epub 2013 Sep 26. PMID: 24086140; hereinafter referred to as “Glanville”) in view of Lau, et al. (J Clin Microbiol. 2007 Nov;45(11):3655-64. doi: 10.1128/JCM.01254-07. Epub 2007 Sep 5. PMID: 17804649; hereinafter referred to as “Lau”).
Applicant traversed the rejection under 35 U.S.C. §103 in the reply filed 4/8/2026, but after careful consideration, the examiner has determined that Applicant’s arguments are unpersuasive.
Applicant presents the following arguments:
In response to the Final Office Action (dated October 21, 2025), Applicant submitted the Declaration of Stephen Shaw, Ph.D. under 37 C.F.R §1.132 (referred herein as the “Shaw Declaration”). The Examiner concluded that the Shaw Declaration was not persuasive because this declaration allegedly only demonstrated results when the amino acid of SEQ ID NO: 13 was administered, and the claimed genus is larger than the scope of immunogen tested. Thus, the Examiner asserted that the data provided in the Shaw Declaration is allegedly not commensurate in scope with the pending claims. Applicants disagree with the conclusion, but to expedite examination, claim 22 is amended to be directed to an immunogenic composition comprising an isolated human rhinovirus peptide, or an isolated polynucleotide encoding the peptide, wherein the peptide comprises an amino acid sequence as set out in SEQ ID NO: 13 and/or wherein the peptide is encoded by the nucleotide sequence at least 80% identical to the nucleotide sequence as set out in SEQ ID NO: 14, wherein the nucleotide sequence encodes an amino acid sequence as set out in SEQ ID NO: 13.
Furthermore, the Examiner alleged that RV-A16 VP0 peptide, which was disclosed in Glanville et al., did elicit an immune response against at least one RV-C strain, and in the Examiner’s view this confirms that Glanville’s VP0 peptide could elicit an immune response to RV-A, RV-B, and RV-C. In particular, the Examiner asserted that Fig. 3 Panel C of the specification (para. 7 of the Shaw Declaration) shows an immune response was elicited against at least RV-C07 pool of Glanville. However, a close review of Panel C shows all responses elicited by Glanville’s VP0 peptide were not statistically significant (e.g. n.s. refers to “non-significant”). One of skill in the art would not know if the responses is a background effect or whether this response is due to the presence of Glanville VP0 peptide. Thus, the Examiner’s conclusion regarding Fig. 3, Panel C is not scientifically accurate. Applicant maintains that the replication experiments demonstrated that RV-A16 immunization described in Glanville et al. did not elicit RV-C strain VP0 reactive immunity, and there is no reason one of skill in the art would reasonably expect that the claim-recited immunogenic compositions would successfully induce cross-reactive by modifying the teaching in Glanville et al. with the teaching in Lau et al. However, as stated above, Applicant has amended the claims, and the Examiner’s view is now moot.
Thus, the amended claims are not obvious in view of the cited references and rejection under 35 U.S.C. §103 should be withdrawn.
Applicant’s arguments are not persuasive:
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).
[M]ere recognition of those latent properties does not render the otherwise obvious [method] unobvious and thereby patentable.” In re Prindle, 297 F.2d 251, 254 (CCPA 1962).
The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)
Applicant has described a latent property of a prior art reagent. Whatever effects of the prior art reagent (a peptide SEQ ID NO: 13 or polynucleotide SEQ ID NO: 14, which encodes SEQ ID NO: 13), they are inherent to the compositions. The prior art possessed the entire structure of the claimed peptide (SEQ ID NO: 13), and sequence encoding it (SEQ ID NO: 14), see rejections for a description thereof.
Regarding scientific rationale, the fact that a peptide from one strain of rhinovirus elicited cross-reactivity to other strains of rhinovirus would not be surprising, considering they are related viruses.
Further, the amended claims do not require an immunogenic effect against any particular rhinovirus strain.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
New Objections
Claim Objections
Claim 22 is objected to because of the following informalities: the claim recites “an amino acid sequence as set out in SEQ ID NO: 13” on line 3, “the nucleotide sequence at least 80% identical to the nucleotide sequence as set out in SEQ ID NO: 14” on lines 5-6, and “an amino acid sequence as set out as SEQ ID NO: 13” on lines 6-7. To put the claim in better form, the examiner suggests changing the claims to recite “the amino acid sequence SEQ ID NO: 13” on line 3, “the nucleotide sequence at least 80% identical to the nucleotide sequence SEQ ID NO: 14” on lines 5-6, and “the amino acid sequence SEQ ID NO: 13” on lines 6-7. Appropriate correction is required.
New Rejections
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 22-24 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature and natural phenomenon without significantly more. The claims recite “an immunogenic composition comprising an isolated human rhinovirus peptide or isolated polynucleotide encoding the peptide”, wherein the peptide is encoded by the nucleotide sequence at least 80% identical to the nucleotide sequence as set out in SEQ ID NO: 14, wherein the nucleotide sequence encodes an amino acid sequence as set out as SEQ ID NO: 13 (claim 22). The claims also indicate that the polynucleotide comprises a nucleic acid sequence encoding the peptide (claim 23), the immunogenic composition is RNA (claim 24), or a vaccine (claim 26). This judicial exception is not integrated into a practical application because SEQ ID NO: 14 is identical to a portion of the Rhinovirus C4 RNA genome EF582385 (Genbank accession EF582385.1; 11/11/2007), which is a natural isolate from a nasopharyngeal aspirate of a patient. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the isolated polynucleotide or peptide that it encodes could naturally become isolated during the course of infection. Additionally, the immunogenic composition could be considered “administered” during the normal course of transmission during spread of infection.
This rejection is similar to the rejection under 35 U.S.C. §101 raised in the Non-final rejection filed 12/27/2024, and could be obviated by the requirement that the immunogenic composition comprises an adjuvant.
Conclusion
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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is 571-272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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