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
Election/Restrictions
Claims 1, 3, 7-15, and 19-26 were pending.
Claims 15, 19, and 20 have been amended.
Applicant’s election without traverse of invention Group II, claims 15, 19, 20, 21 and 24 in the reply filed on 08/11/2026 is acknowledged.
Claims 1, 3, 7-14, 20, 22, 23, 25, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/11/2026.
Applicant’s election without traverse of species in the reply filed on 08/11/2026 is acknowledged.
For species, Applicant elected the residues of SEQ ID NO: 265 without traverse.
Claims 15, 19, 20, 21, and 24 are under consideration.
Priority
This application is a national stage filing under U.S.C. 371 of international application number PCT/IB2022/051504, filed on 02/21/2022 which claims priority from U.S. provisional patent application 63/306,669, filed on 02/04/2022, and from US provisional patent application 63/153,164 filed on 02/24/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/26/2024, 10/21/2025, 01/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the term RIBIlTM, DETOXTM, STIMULONTM (p. 72) which are trade names or a mark used in commerce, has been noted in this application. 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.
NOTE: Specific examples of tradenames in the specification are provided above but may not reflect all present in the specification.
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.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing an immune response, does not reasonably provide enablement for treating or preventing a disease associated with HCMV infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention – for treating or preventing a disease associated with HCMV infection.
See claim 24 as submitted 08/11/2026.
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.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, instant claim 24 is broadly drawn to a kit for treating or preventing a disease or disorder associated with HCMV infection, comprising a pharmaceutical composition.
The level of skill in the art is high and would include, e.g., Ph.D. level scientists and physicians.
With respect to the state of the art, Gugliesi et al. (Gugliesi)(See PTO-892: Notice of References Cited) evidences that “Following primary infection, HCMV establishes a state of latency primarily in myeloid cells, from which it can be reactivated by various inflammatory stimuli. Several studies have shown that HCMV, despite being a DNA virus, is highly prone to genetic variability that strongly influences its replication and dissemination rates as well as cellular tropism. In this scenario, the few currently available drugs for the treatment of HCMV infections are characterized by high toxicity, poor oral bioavailability, and emerging resistance” (p. 1 Abstract).
Gugliesi further evidences “Despite these increasing efforts, an effective vaccine against HCMV is currently missing, de facto leaving high-risk populations, chiefly immunocompromised patients and immunocompetent seronegative pregnant mothers, exposed to primary infection…Given that one of the main obstacles to the development of an efficient vaccine against HCMV is the lack of protection against HCMV re-infection and/or reactivation, the first
objective of a newly designed HCMV vaccine should be that of shielding vulnerable populations
from primary infection. The long-range goal would then be to grant permanent protection against new infections with other HCMV strains and reactivated infections, which can occur repeatedly throughout life. To reach these goals, the ideal HCMV vaccine should be able to trigger a strong humoral response, in the form of binding and neutralizing antibodies, and an HCMV-specific CD8+ and CD4+ T-cell response. With this in mind, the experimental and clinical results achieved so far predict that the ideal HCMV vaccine should include: (i) gB, promoting both humoral—primarily antibody-binding—and T-cell-mediated response…(ii) pp65, triggering a potent T-cell response; and (iii) the pentameric complex (PC), which prompts a quite strong neutralizing antibody (NAb) response (p. 13). Gugliesi provides a list of live HCMV vaccines and non-living HCMV vaccines (p. 13-14, Table 2).
Gugliesi states the “high incidence and clinical manifestations of HCMV infection underscore the need for efficient antiviral therapies in treating disease in immunocompromised patients and congenitally infected infants. Gugliesi also provides details on the antiviral agents approved for treatment or prophylaxis of HCMV infections: ganciclovir (GCV) and its oral prodrug valganciclovir (VGCV), cidofovir (CDV), foscarnet (FOS), and, more recently, letermovir (LTV),
With respect to working examples and required experimentation, the Specification only provides examples of immunogenicity studies in mice, e.g., FIG. 11 depicts the dose-dependent IgG responses in both gB1666 and wild type gB (Towne) immunized mice. Additional data, from animal model experiments or human clinical trials, on treating or preventing a disease or disorder associated with HCMV infection is not provided. As a result, an undue amount of experimentation, including extensive animal and clinical trials, would be required to use the invention based on the content of the disclosure.
Taken together, the Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claims.
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 15, 19, 20, 21, 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 15, 19, 20, 21, and 24 as submitted 08/11/2026.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claims 15, 19, and 20 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf )
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 cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an ineligible product as further detailed below.
In this case, claims 15, 19, 20 recite, read on, or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, glycoprotein B precursor from human cytomegalovirus (clinical strains) as taught by Chou et al. (Chou)(See PTO-892 Notice of References Cited) that is directed to a judicial exception (in this case, a natural phenomenon)(Step 2A). Chou teaches “sequence variation in the gp 116 component of cytomegalovirus envelope glycoprotein B was examined in 11 clinical strains and compared with variation in gp55” (p. 388, Abstract). Chou also teaches Q69165_HCMV with residues (651-690) that have a 100% Query Match to the instant application’s SEQ ID NO: 265 (see Result #4, Q69165_HCMV, us-18-277-425-265.rup, 09/02/2026, in supplemental contents tab).
Claim 15 recites a peptide comprising residues I653-Q692 (SEQ ID NO: 265).
Claim 19 recites a peptide consisting of residues of I653-Q692 (SEQ ID NO: 265).
Claim 20 recites a nucleic acid encoding a peptide comprising residues I653-Q692 (SEQ ID NO: 265).
Thus, the claimed products of claims 15, 19, 20 are not markedly different from its naturally occurring counterpart (See Nature-Based Products, Example 4 (“Purified Proteins”) at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf ; see also Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Claims 15, 19, 20 read on naturally occurring human cytomegalovirus glycoprotein B precursor and does not show a difference in characteristics between the claimed peptides and naturally occurring glycoprotein B precursor. Thus, the claims also read upon naturally occurring glycoprotein B precursor, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Thus, the claimed products of claims 15, 19, 20 are not markedly different from their naturally occurring counterpart (see Part I. A.3 of the Interim Eligibility Guidance, Example 2, p. 29). Thus, the claims also read upon naturally occurring human cytomegalovirus glycoprotein B precursor, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A. Claims 21 and 24 are rejected because of their dependency on claim 15, and because the claimed products in claims 21 and 24 are not markedly different from their naturally occurring counterparts and do not add further distinguishing structural features.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception.
Further as to Step 2A in view of the 2019 PEG, in view of Prong 1 of Revised Step 2A, the claims recite a natural phenomenon.
As to Prong 2 of Step 2A, the instant claims do not recite additional elements that integrate the judicial exception (natural phenomenon according to MPEP 2106.04(b)) into a practical application. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html )
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.
Therefore, claims 15, 19, 20, 21 and 24 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 20, 21, 24 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Baudoux et al. (Baudoux)(WO2012049317A2)(See PTO-892 Notice of References Cited).
See claim 15, 20, 21, 24 as submitted 08/11/2026.
Regarding claims 15, Baudoux teaches “a cytomegalovirus (CMV) gB polypeptide comprising at least a portion of a gB protein extracellular domain comprising a fusion loop 1 (FL1) domain and a fusion loop 2 (FL2) domain, wherein at least one of the FL1 and FL2 domains comprises at least one amino acid deletion or substitution” (Abstract).
Baudoux also teaches Cytomegalovirus gB-SLP12-Delta725-LVL776 (LVL776) polypeptide, SEQ ID 20 with a 100% Query Match to the instant application’s SEQ ID NO: 265 (se Result# 14, AZV29626, us-18-277-425-265.rag, 09/02/2026, in supplemental contents tab).
Regarding claim 20, Baudoux teaches CMV gB-SLP12-Delta725-LVL776 (LVL776) polypeptide coding sequence, SEQ 16, with a 100% Query Match to the instant application’s nucleic acid encoding a peptide comprising residues of SEQ ID NO: 1 (Towne Strain) I653-Q692 (SEQ ID NO: 265)(see Result #4, AZV29621, us-18-277-425-265.rng, 09/08/2026, in supplemental contents tab).
Regarding claim 21, Baudoux teaches “In a fifth aspect, there is provided an immunogenic composition comprising the CMV gB polypeptides of the invention admixed with a suitable pharmaceutical carrier” (though terminology is not precise, it reads on a pharmaceutical composition).
Regarding claim 24, The “kit” is interpreted to read upon the composition, and the instructions are not considered to distinguish the claimed product from the prior art product (See MPEP 2111.01: III. PRODUCT CLAIMS – NONFUNCTIONAL PRINTED MATTER DOES NOT DISTINGUISH CLAIMED PRODUCT FROM OTHERWISE IDENTICAL PRIOR ART PRODUCT).
Accordingly, the claimed invention was anticipated by Baudoux.
Conclusion
Regarding claim 19, A peptide consisting only of residues of I653-Q692 (SEQ ID NO: 265) is free of the prior art (see size limited 40 amino acids, sequence search, us-18-277-425-265.rag, 09/03/2026, in supplemental contents tab as well as us-18-277-425-265.rapm, us-18-277-425-265.rpr, us-18-277-425-265.rai, us-18-277-425-265.rapbn, us-18-277-425-265.rapbm, and us-18-277-425-265.rup).
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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