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
Claims 1-19 are considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
03/26/2021 was used as the effective filing date for examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s duty to disclose all information known to be material to patentability.
Specification
The disclosure is objected to because of the following informalities: Change “chimpane” to “chimpanzee”.
Appropriate correction is required.
Claim Objections
Claims 1, 4-6, 9-10, 16 are objected to because of the following informalities:
Claim 1: Change a) and b) to (a) and (b) for consistency with other claims.
Claim 1b): HPV is an acronym. Clarify the acronym in the first instance by writing out human papillomavirus (HPV).
Claims 4 & 5: Add a colon after “consisting of” for consistency with other claims such as 6, 7, and 13.
Claim 6(a): Change “and amino acid” to “an amino acid”.
Claim 9: Insert a comma after “claim 8” for consistency with other claims.
Claim 10: Remove the extraneous “of” between composition and comprising.
Claim 16: Change “associate” to “associated”.
Appropriate correction is required.
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.
Claims 16-19 are 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 administering the composition, does not reasonably provide enablement for protecting or treating a subject, beyond “mice” in need thereof from a disease or disorder associated with HPV 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 commensurate in scope with these claims.
Claims 16 and 18 as submitted 9/26/2023.
In making a determination as to whether an application has met the requirements for enablement under 35 U.S.C. 112 P1, the courts have put forth a series of factors. See, In re Wands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Id. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered. In the present case, the factors deemed relevant are those of: the breadth of the claims, the state of the art, the absence of working examples, and the quantity of experimentation necessary.
Nature of the invention and breadth of the claims:
Claim 16 is drawn to a method of protecting a subject in need thereof from a disease or disorder associated with HPV infection, the method comprising administering a nucleic acid molecule to the subject.
Claim 18 is drawn to a method of treating a subject in need thereof for an HPV infection, the method comprising administering a nucleic acid molecule of claim 1 to the subject.
Within the claims themselves, the diseases or disorders are not specified nor is the subject. However, within the specification, the diseases or disorders include cervical cancer or a carcinoma of the lung, tonsil, or larynx. The subject can mean a mammal which can be a human, chimpanzee, dog, cat, horse, cow, mouse, or rat. The in vivo experiments demonstrating both protection and treatment with the composition in mice does not specify the mouse strain(s) used nor does it include sex or age.
The relative skill of those in the art:
The level of skill in the art is high and would include, e.g., Ph.D. level scientists, medical doctors (MDs), and veterinarians (DVM/VMD).
State of the art and the unpredictability of the art:
With respect to experimental mice, Li et al (2010) demonstrated that HPV16 full-length E6 and E7 protein vaccination can induce protective immunity in mice against TC-1 tumor growth (p. 1323, Abstract). The mice used in this study included female C57BL/6 mice aged 6-8 weeks and TC-1 mouse models (p. 1323).
With respect to humans, Meites et al., as part of the 2019 Advisory Committee on Immunization Practices, reported that “Three prophylactic HPV vaccines are licensed for use in the United States: 9-valent (9vHPV, Gardasil 9, Merck), quadrivalent (4vHPV, Gardasil, Merck), and bivalent (2vHPV, Cervarix, GlaxoSmithKline)...As of late 2016, only 9vHPV is distributed in the United States. The majority of HPV-associated cancers are caused by oncogenic HPV 16 or 18, types targeted by all three vaccines. In addition, 4vHPV and 9vHPV target HPV 6 and 11, types that cause anogenital warts. 9vHPV also protects against five additional high-risk types: HPV 31, 33, 45, 52, and 58”(p. 698). Meites et al. also reminded the public that “HPV vaccines are prophylactic (i.e., they prevent new HPV infections). They do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease.
In their review, Huber et al. (2021) reported that the three aforementioned licensed vaccines are recombinant vaccines consisting of purified virus-like particles of the major capsid (L1) protein of different HPV types (p. 1, Abstract) and that a HPV16/18 L1 VLP vaccine, Cecolin, was also approved in China (p. 3). With respect to L2-based broad-spectrum vaccine candidates, Huber et al. stated that “different scaffolds have been investigated for the improved and more immunogenic presentation of promising HPV16 L2 cross-neutralization epitopes which include presentation by HPV L1-VLP, non-HPV VLP, or the generation of nanoparticles of concatemeric peptides, filterable aggregates, or fusions to immunostimulatory agents” as evidenced in their Table 1. Several candidates combine L2 with E6 or E7 and have either initiated Phase 1 trials (CRTE6E7L2) or completed Phase II (TA-CIN) or completed Phase I-IIb (TA-GW)(p. 7).
To summarize, mouse models to investigate both prophylactic and treatment potential for compositions exist. The specification of the instant application does provide examples for use of the composition in an unspecified strain of mice with success. The specification does not, however, address the methods in the other vastly different potential subjects identified, to include humans. There are four human vaccines that appear to provide protection (as recited in the instant claim 16 “protecting”) against select HPV strains. However, they do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease (as recited in instant claim 18 “treating”). Additionally, other vaccine candidates are being explored that include HPV L2, with some in combination with E6 or E7, in humans and these vaccine candidates are in various stages of experimentation.
The amount of direction and the working examples provided:
The disclosure does provide some examples of in vivo experiments with the composition in mice, identified as an example of a subject, to support the claims as written. However, key details like the strain/sex/age of mice used, a detailed description of the mouse model used, and experiments addressing other disease conditions cause by HPV are lacking. Models for the other potential subjects listed in the specification are also lacking.
Human clinical trials are not featured in the specification nor are efficacy and safety data nor are sufficient descriptions of experimental oversight such as through Institutional Review Boards (IRBs) or data and safety monitoring boards (DSMBs).
Thus, the instant disclosure offers reasonable guidance or direction to use the claimed method in mice with an emphasis on a lung disease but no other subjects or other diseases/conditions mentioned within the disclosure.
Quantity of experimentation necessary:
As discussed above undue experimentation would be required to practice the claimed invention commensurate with the scope of the claims if one skilled in the art were to use the invention with subjects other than mice. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in specification, it would take undue trials and errors to practice the claimed invention.
In view of the foregoing, 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 this claim beyond a mouse subject and lung condition.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claims 1-19 as submitted 09/26/2023.
Claim 1: The meaning of the term “subunit” in the preamble phrase “self-assembling nanoparticle subunit polypeptide” is unclear.
Claim 1a): The language “a scaffold domain for nanoparticle aggregation” is unclear. It is difficult to decipher if the referred to scaffold domain is a description of a resulting structural feature where HPV antigen presentation occurs or if it is a sequence motif that facilitates self-assembly or if it is a scaffold protein with domain(s) for protein-protein interactions, to include signaling. The language “aggregation” is also unclear. It is difficult to decipher if “aggregation” is referring to a domain that causes the nanoparticles (or VLPs, if considered equivalent) to clump or stay in close proximity to one another or if it is vital to or dictates the structure (e.g., assembly state or “cage” or “assembly of fragments to cages”) formed by the nanoparticle or some other meaning (Azuma et al,. 2018).
The specification states that in one embodiment, the nanoparticle functions as a scaffold for presentation of the HPV antigen. Therefore, the invention relates to polypeptide subunits for self-assembly into a spherical nanoparticle, comprising an aggregation or scaffold domain and an HPV antigen domain and in one embodiment the aggregation or scaffold domain comprises lumazine synthase or a fragment or variant thereof. In another embodiment, the aggregation or scaffold domain comprises lumazine synthase or GT60.
However, the specification also discloses that in another embodiment, the invention relates to a nucleic acid molecule encoding a subunit of a self-assembling nanoparticle comprising an oligomerization domain and further comprising a HPV antigen, a fragment thereof, a variant thereof, or a combination thereof. In some embodiments, the nucleic acid molecule encoding the oligomerization domain can comprise a nucleotide sequence that encodes the amino acid sequences with variable identity to SEQ ID NO: 3 and SEQ ID NO: 4 (as recited in claims 6 and 7 which are dependent on claim 1). Protein oligomerization domains are well known in the art, especially the coiled coil folding motif (Raman et al., 2006).
Claims 4-7, 13 contain the language “at least about…” which is an unclear threshold. To remedy, remove the word “about” so that the claims read “at least 90%”.
Claim 13: The claim formatting and attribution is unclear with the usage of two “from the group consisting of” phrases in the preamble and in claim 13(a). Also, claim 13(a) recites “a peptide comprising an amino acid sequence having at least about 90% identity over an entire length of an amino acid sequence selected from the group consisting of SEQ ID NO: 4. It is unclear if “from the group consisting of” is a stray remark. It is also unclear, as written, if the peptide is a fragment of SEQ ID NO: 4 or actually the entire length of the amino acid sequence of SEQ ID NO: 4 as a whole.
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis parameters.
The instant claim is drawn to a peptide comprising an amino acid sequence selected from the group consisting of: (a) a peptide comprising an amino acid sequence having at least about 90% identity over an entire length of an amino acid sequence selected from the group consisting of SEQ ID NO: 4; and (b) a peptide comprising an amino acid sequence of SEQ ID NO: 4, i.e., composition of matter, which is a statutory category of invention (Step 1: YES).
The amino acid sequence in claim 13 refers to a human papillomavirus E7 (envelope) antigen domain (aa 49-57) – lumazine synthase fusion protein. The claim, as written, can be interpreted as reading on the fragment of the human papillomavirus E7 antigen which occurs in nature. As such, the instant claim recites a judicial exception (JE) in the form of law of nature (Step 2A, Prong One: YES).
The crux of the claimed method is the peptide comprising a sequence selected from the group consisting of a peptide with at least 90% identity or 100% identity to SEQ ID NO: 4. As such the instant claim does not recite additional elements that integrate the JE into a practical application (Step 2A, Prong Two: NO).
According to Pal et al. (2020), “HPV E6 and E7 viral oncoproteins play the pivotal role in driving the cells toward oncogenesis. In their process of replicating the viral genome, they can induce all the hallmarks of a cancer cell, i.e., uncontrolled cellular proliferation, angiogenesis, invasion, metastasis, and unrestricted telomerase activity along with the evasion of apoptosis and growth suppressors’ activity. Several in vitro and xenograft studies have also shown cancer cells to senesce or undergo apoptosis in the absence of E6 and E7 activity…, thus proving the absolute requirement of E6 and E7 for persistence of HPV-mediated cancer (p. 4). With the natural role of E7 in mind, beyond the JE, the instant claim only recite a peptide amino acid identity, known in nature. As such, the instant claims do not recite significantly more than that of the JE (Step 2B: NO).
Accordingly, the instant claim 13 does not constitute patent eligible subject matter under 35 U.S.C. § 101. To overcome this rejection, the claim should be amended to recite “a peptide comprising an amino acid sequence selected from the group consisting of: (a) a peptide comprising an amino acid sequence having at least about 90% identity over an entire length of the amino acid sequence selected from the group consisting of SEQ ID NO: 4; and (b) a peptide comprising the amino acid sequence of SEQ ID NO: 4.
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 –
Claim 13 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ziyang et al. (Ziyang)(WO2020132699-A1)(See PTO-892 Notice of Reference Cited).
Claim 13 recites: A peptide comprising an amino acid sequence selected from the group consisting of: (a) a peptide comprising an amino acid sequence having at least about 90% identity over an entire length of an amino acid sequence selected from the group consisting of SEQ ID NO: 4; and (b) a peptide comprising an amino acid sequence of SEQ ID NO: 4.
Ziyang teaches SEQ ID NO: 10 (expressible nucleic acid encoding antigen) with a 94.4% match to SEQ ID NO: 4 (See Result #21, BHY29680, us-18-552-635-4.align150.rag, in Supplemental Content Tab, dated 1/21/2026). Ziyang surpasses the 90% identity as recited in claim 13(a) with a sequence having a 94.4% match. Claim 13(b), as written, could read on a fragment of SEQ ID NO: 4 as well. Therefore, claim 13(b) is also anticipated by the teachings of Ziyang.
Therefore, Ziyang anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8, 10-12, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cid-Arregui et al. (Cid-Arregui)(WO2011072875)(See PTO-892 Notice of Reference Cited).
Claims 1-4, 8, 10-12, 14-17 as submitted 09/26/2023.
Note: In light of the 35 U.S.C. 112 (b) concerns above and for compact prosecution purposes, the scaffold domain is being interpreted as either bacterial or viral protein scaffold or non-viral, natural proteins such as lumazine synthase that promote self-assembling and influence the structure of the nanoparticle and its ability to present HPV antigen on its surface(s) in order to interact with the host immune system. A VLP is an example of a self-assembled nanoparticle. The subunit is being interpreted as a polypeptide chain consisting of both the scaffold protein and a HPV protein (no defined order).
Cid-Arregui teaches nucleic acid sequences encoding fusion proteins and novel vaccine formulations based on composite fusion proteins comprising at least the following components: (i) a carrier polypeptide molecule able to self-assemble into nanoparticles, preferably virus-like particles (VLPs) , (ii) one or more tumor antigen sequences or immunologically relevant epitopes of these, (iii) one or more immunostimulatory domains, and, optionally, (iv) one or more encapsulated, conjugated or associated components, which enhance the immunogenicity of the complex (p. 4-5). The tumor antigen term comprises both tumor associated antigens and tumor specific antigens (TSA) where examples of HPV’s E6 and E7 proteins are given (p. 3) (as recited in the instant application claims 1, 2, and 3).
Cid-Arregui teaches amino acid sequence RAHYNIVTF with 100% match to the instant application’s SEQ ID NO: 2 (p. 21) (as recited in instant application claim 4).
Cid-Arregui teaches the present invention also provides nucleic acid sequences encoding such fusion polypeptides as well as vectors, preferably viral vectors, containing these nucleic acid sequences (Abstract)(as recited in the instant application claim 8).
Cid-Arregui teaches a polypeptide, nucleic acid sequence or vector of the present invention can be present in the vaccine as such or in combination with carriers. It is favorable for the carriers in the individual not to be immunogenic. Such carriers may be the individual's own proteins or foreign proteins or fragments thereof. Carriers, such as serum albumin, fibrinogen or transferrin or a fragment thereof are preferred (p. 25) (as recited in the instant application claims 10 and 11).
Cid-Arregui teaches the immunogenic polypeptide, nucleic acid sequence or vector of the present invention can additionally be combined with an immunostimulatory adjuvant, e.g., alum salt, cholesterol, an immunostimulatory oligonucleotide, a saponin, tocopherol, oil-in-water emulsion, liposome, or a lipopolysaccharide (p. 25) (as recited in the instant application claim 12).
Cid-Arregui teaches a vaccine used as a prophylactic treatment is administered to individuals who do not have cancer, and are designed to elicit an immune response to target potential cancer cells or to target an antigen derived from a virus associated with cancer (p. 26). Exemplary viral TSAs are the E6 or E7 proteins of oncogenic HPV types, such as HPV-16 and HPV-18 (p. 14) (as recited in the instant application claims 14, 16).
Cid-Arregui teaches the administration of the vaccine by injection may be made at various sites of the individual intramuscularly, subcutaneously, intradermally or in any other form of application (p. 25) (as recited in the instant application claims 15, 17).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cid-Arregui as applied to claims 1-4 in view of Rybicki et al. (Rybicki)(WO2011077371-A1)(See PTO-892 Notice of Reference Cited).
Claim 5 as submitted 09/26/2023.
Cid-Arregui teaches claims 1-4. Cid-Arregui does not teach wherein the nucleotide sequence encoding the HPV antigen domain is selected from the group consisting of (a) a nucleotide sequence having at least about 90% identity over an entire length of SEQ ID NO:1; and (b) SEQ ID NO:1.
Rybicki teaches the nucleotide sequence encoding the HPV antigen domain, SEQ ID NO: 32 with a 100% match to the instant application’s SEQ ID NO: 1(See Result #1, AZJ36638, us-18-552-635-1.align450.rng, in Supplemental Content Tab, dtd1/21/2026). SEQ ID NO: 32 is HPV16 E7 epitope peptide encoding codon optimized DNA.
One of ordinary skill in the art would have been motivated to substitute the nucleotide sequence encoding the HPV antigen domain as taught by Cid-Arregui with SEQ ID NO: 32 (e.g., HPV16 E7 epitope peptide) as taught by Rybicki because it has a 100% match with SEQ ID NO: 1 (See MPEP 2144.06 II. Substituting Equivalents Known for the Same Purpose).
One of ordinary skill in the art would have had a reasonable expectation of success using SEQ ID NO: 32 as taught by Rybicki as it is a 100% match to that of the instant application’s SEQ ID NO: 1. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 6, 7, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cid-Arregui as applied to claim 1 in view of Ziyang et al. (Ziyang)(WO2020132699-A1)(See PTO-892 Notice of Reference Cited).
For Claim 6:
Claim 6 as submitted 09/26/2023.
Cid-Arregui teaches claim 1. Cid-Arregui does not teach wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding and amino acid sequence having at least about 90% identity over an entire length of SEQ ID NO:4; and (b) a nucleotide sequence encoding SEQ ID NO: 4.
Ziyang, however, teaches SEQ ID NO: 10 (expressible nucleic acid encoding antigen) with a 94.4% match to SEQ ID NO: 4 (See Result #21, BHY29680, us-18-552-635-4.align150.rag, in Supplemental Content Tab, dtd 1/21/2026, See Supplemental tab).
One of ordinary skill in the art would have been motivated to combine the nucleic acid molecule with nucleotide sequence SEQ ID NO: 10 (e.g., expressible nucleic acid encoding antigen) as taught by Ziyang because it has a 94.4% % match with SEQ ID NO: 1 and is useful in preparing nucleic acid vaccines (See MPEP 2143 Rationale A: Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success using SEQ ID NO: 10 as taught by Ziyang because it has a 94.4% % match to that of the instant application’s SEQ ID NO: 4. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
For Claim 7:
Claim 7 as submitted 09/26/2023.
Cid-Arregui teaches claim 1. Cid-Arregui does not teach wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding and amino acid sequence having at least about 90% identity over an entire length of SEQ ID NO: 3; and (b) a nucleotide sequence encoding SEQ ID NO: 3.
Ziyang, however, teaches SEQ ID NO: 5 (expressible nucleic acid encoding antigen) with a 94.2% match to SEQ ID NO: 3 (See Result #13, BHY29675, us-18-552-635-3.align45.rng, in Supplemental Content Tab, dtd 1/21/2026).
One of ordinary skill in the art would have been motivated to combine the nucleic acid molecule with nucleotide sequence SEQ ID NO: 5 (e.g., expressible nucleic acid encoding antigen) as taught by Ziyang because it has a 94.2% % match with SEQ ID NO: 3 and is useful in preparing nucleic acid vaccines (See MPEP 2143 Rationale A: Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success using SEQ ID NO: 5 as taught by Ziyang because it has a 94.2% % match to that of the instant application’s SEQ ID NO: 3. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
For Claims 18 and 19:
Claims 18 and 19 as submitted 09/26/2023.
Cid-Arregui teaches claim 1.
Ziyang, however, teaches: Disclosed are methods of inducing expression of a self-assembling vaccine in a subject comprising administering any of the disclosed pharmaceutical compositions. Also disclosed are methods of treating a subject having a viral infection or susceptible to becoming infected with a virus comprising administering to the subject a therapeutically effective amount of any of the disclosed pharmaceutical compositions… In some embodiments, the viral infection is an infection of human papillomavirus [00185](as recited in the instant application claim 18)… In some embodiments, the administering can be accomplished by… injection of the pharmaceutical compositions disclosed herein [00186] (as recited in the instant application claim 19).
One of ordinary skill in the art would have been motivated to combine the nucleic acid molecule from claim 1 (e.g., a composition) which facilitates HPV antigen presentation with the method of treating a subject with an HPV infection by administering the molecule from claim 1 via injection to induce an immune response for the treatment and/or prevention of HPV or associated cancerous conditions (See MPEP 2143, Rationale A: Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success using the method of treating a subject with an HPV infection. There would have been a reasonable expectation of success given the underlying materials and methods are known in the protein, immunology and human papillomavirus vaccinology field, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims allowed.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672