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 .
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71-72, 74, 77, 79, 83, 85-86, 94 are pending.
Election/Restrictions
Applicant’s election of Invention Group I (Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71) and the following species:
SEQ ID NOs 12 and 13 (Claim 28),
SEQ ID NO 27 (Claim 29),
a targeting oligont (Claim 67), and
HPV-induced cancer (Claim 86)
in the reply filed on 10 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 72, 74, 77, 79, 83, 85-86, 94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 10 August 2026.
Since the species for Claim 67 were found searchable, the requirement for election of species for Claim 67 is withdrawn. All other species requirements are maintained.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are examined.
Information Disclosure Statement
The Spec. cites references.
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.
The IDS(es) has been considered.
Drawings
The drawings are objected to because of the following informalities:
Fig. 2: Details of the inset are not visible. Also, the inset is not described in the Spec. Adding a description to the Spec. would be New Matter. For examination purposes, please disclose a description of Fig. 2 in Applicant’s reply.
Figs. 4-9, 11, 14-20, 23-27, 33-34, 37, 43: the grayscale and quality/resolution of the Figs. is not good enough to discern details of the figs.
Fig. 16: please either place the entire figure on a single sheet or number the lines so each line of the heatmap can be matched to its GO_label.
Fig. 41: the cartoon looks like some parts are missing or there is overlap.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See the footer for Table 1 (p. 55), ¶179. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because of the following informalities:
¶76 should say the term “non-targeting oligonucleotide” refers to an….
Appropriate correction is required.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29 recites …GP100 (167-189), Melan-A/Mart-1(102-111) (SEQ ID NO 34)…. That recites no SEQ ID NO for GP100 (167-168) but it looks like there should be a SEQ ID NO there.
Appropriate correction is required.
Claim Interpretation
The claims recite alternative or optional limitations; all alternative or optional limitations are interpreted as completely optional.
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 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 recites an SNA comprising… a shell of oligonucleotides [oligont] … comprising one or more immunostimulatory oligont… a first antigen that is either a[n] MHC-I [MHC1] antigen or a[n] MHC-II [MHC2] antigen….
Claims 2-3 and 8 also recite antigens that can be any MHC1 or any MHC2 antigens, and/or any oligont and/or any immunostimulatory oligont.
Those broad claims encompass the large genera of: oligont in the shell of oligont attached to the external surface of the NP core, immunostimulatory oligont, MHC1 antigens, and MHC2 antigens. Any kind of oligont, immunostimulatory oligont, MHC1 antigens, and MHC1 antigens would be encompassed by the claims as instantly presented.
There is a WD problem because Applicant’s Spec. does not disclose the structure of oligont in the shell of oligont attached to the external surface of the NP core that is suitable or unsuitable to use in their invention. Furthermore, the claims encompass immunostimulatory oligont and MHC1/MHC2 antigens whose structure cannot be envisioned because the claims encompass:
generic oligont defined solely by their function of being immunostimulatory and
generic MHC1 antigens and generic MHC2 antigens defined solely by their function of being MHC1/MHC2 antigens.
Claim 30 recites that at least one of the one or more immunostimulatory oligont is a TLR agonist.
That broad claim encompasses the large genus of immunostimulatory oligont that are TLR agonists. Any kind of immunostimulatory oligont that agonizes TLR would be encompassed by the claims as instantly presented.
There is a WD problem because the claims encompass immunostimulatory oligont that are TLR agonists but whose structure cannot be envisioned because the claims encompass generic immunostimulatory oligont defined solely by their function of agonizing TLR.
Claim 51 recites that the shell of oligont comprises DNA oligont, RNA oligont, or a combination thereof.
That broad claim encompasses the large genera of DNA or RNA oligont. Any kind of oligont would be encompassed by the claims as instantly presented.
There is a WD problem because an artisan would not know what structure or size of oligont is or is not suitable to use in the invention.
Claim 67 recites that the shell of oligont comprises a targeting oligont, an inhibitory oligont, a non-targeting oligont, or a combination thereof.
That broad claim encompasses the large genera of targeting oligont, an inhibitory oligont, a non-targeting oligont. Any kind of targeting oligont, an inhibitory oligont, a non-targeting oligont would be encompassed by the claims as instantly presented.
There is a WD problem because the claims encompass targeting oligont, inhibitory oligont, non-targeting oligont whose structure cannot be envisioned because the claims encompass generic targeting oligont, an inhibitory oligont, a non-targeting oligont defined solely by their function of targeting, inhibiting, or being non-targeting (see §112b).
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163.
Regarding the oligont in the oligont shell of Claims 1 and 51: The Spec. discusses (¶8, ¶76) some embodiments of oligont in the shell of oligont, including possible sequences and possible lengths. However, the claims are extremely broad, and those disclosures do not provide any guidance on what the structure of the oligont in the shell may be. Therefore, an artisan wouldn’t know what sequences or lengths of oligont are appropriate or are not appropriate to use as oligont in the oligont shell of the invention.
Regarding the MHC1 and MHC2 antigens of Claims 1-3 and 8: The Spec. defines (¶77) an antigenic composition as any composition of matter that is capable of eliciting a specific immune response, and the terms “MHC1 antigen” and “MHC2 antigen” are self-explanatory: an antigen that stimulates MHC1 or MHC2. However, what structure is encompassed by those broad terms is not disclosed. The Spec. discloses (¶91) numerous exemplary MHC1 and MHC2 antigens, but a glance at the amino acid (AA) sequences of those antigens reveals that the members of each genus possess no requisite structure. The classes of molecules that are represented by the terms “MHC1 antigens” and “MHC2 antigens” are ginormous to the point of being practically infinite since Evolution continues to act on, for example, viruses and bacteria. Nothing in the Spec. discloses the structure(s) that imparts the function of being an MHC1 or MHC2 antigen.
Regarding the immunostimulatory oligont of Claims 1 and 30: The Spec. defines (¶74) immunostimulatory oligont and provides (e.g., ¶8) examples of certain species. Those § mention TLR agonists. However, none of those § describes the structure that imparts the function of stimulating the immune system or agonizing TLR. Furthermore, a person of ordinary skill understands that TLR is itself a broad group of receptors and the structure of an oligont that agonizes one TLR may not agonize another, or any, or every, TLR. The numbers of oligont that are immunostimulatory or TLR agonists are huge because Evolution continues to act on living beings and continues to diversify what oligont stimulate any immune system or any TLR agonist. Furthermore, a glance at the nt sequences of those oligont disclosed in the Spec. reveals that members of the genera immunostimulatory oligont and TLR agonizing oligont possess no requisite structure.
Regarding Claim 67: The Spec. defines (¶73) targeting oligont, (¶75) inhibitory oligont, and (¶76) non-targeting oligont and provides examples. But none of those § describes any requisite structure that imparts the function of targeting/inhibiting/nontargeting.
Regarding what structure is encompassed by the oligont in the shell of oligont, the DNA or RNA oligont in the oligont shell, the targeting/inhibitory/nontargeting oligont, the immunostimulatory oligont, the immunostimulatory oligont that is a TLR agonist, the MHC1 antigen, and the MHC2 antigen, the Spec. does not provide information describing its features. The Spec. does not disclose what physical structure(s) is responsible for the claimed functions.
Applicant’s examples discuss (starting at ¶146) limited species of CpG oligont and antigens. However, those examples are not sufficient to provide written description support for the broad genera of oligont in the shell of oligont, DNA or RNA oligont in the oligont shell, targeting/inhibitory/nontargeting oligont, immunostimulatory oligont, TLR agonizing immunostimulatory oligont, MHC1 antigen, and MHC2 antigen claimed. Although the claims claim the functional characteristics (i.e., stimulating the immune system or agonizing TLR, being an antigen for MHC1 or MHC2, targeting/inhibiting/nontargeting), none of the functional characteristics is coupled with any known structure.
Although the Specification teaches the examples discussed above, it does not identify a core structure necessary for performing the claimed function(s) of stimulating the immune system or agonizing TLR, being an antigen for MHC1 or MHC2, targeting/inhibiting/nontargeting or being acceptable oligont for the oligont shell. The Spec. does not disclose any core structure, partial structure, physical or chemical property, or functional characteristic coupled with a known or disclosed structure/function relationship responsible for each claimed function in such a way to demonstrate possession of the full invention as claimed at time of filing. The exemplary antigens and immunostimulatory oligont do not share any core structure.
The specification teaches only some exemplary species within some claimed genera but those are only a paltry number compared with the breadth of what is claimed. Altogether, the number of species disclosed by complete structure is not sufficient to provide the written description support for the huge genera that are encompassed by the claims.
While none of these elements is specifically required to demonstrate possession, in combination their absence means that one skilled in the art at the time of filing would conclude that the inventors lacked possession of the full breadth of the invention claimed. Claims 1-3, 8, 30, 51, and 67 are rejected for failing to demonstrate possession of the claimed invention. Claims 2-3, 8, 28-30, 40-41, 44, 51, 67, 69, and 71 are rejected because they depend from Claim(s) 1-3, 8, 30, 51, and/or 67 and do not remedy the issues.
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 3, 8, 28-29, and 67 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 3 and 8 recite the limitation "the linker" in L3 (Claim 3) and L3 and L5 (Claim 8). Because Claims 3 and 8 depend from Claim 1 which doesn’t recite any linker and because each instance of “the linker” is an alternative (i.e., wherein the second antigen is attached to one or more… through a linker, or the second antigen is attached through the linker… [Claim 3] and wherein the first antigen is attached to one or more… through a linker, or the first antigen is attached through the linker…, or the first antigen is attached through the linker…), there is insufficient antecedent basis for this limitation in the claim.
In the interest of compact prosecution, the claim is interpreted as if it replaces “the” with “a” in each instance. Amending the claim to the following will obviate this rejection:
Claim 3: The SNA of claim 1, wherein the second antigen is attached to one or more oligonucleotides in the shell of oligonucleotides through a linker, or the second antigen is attached through a linker to an oligonucleotide that is hybridized to an oligonucleotide in the shell of oligonucleotides that is attached to the nanoparticle core, or the second antigen is attached to the external surface of the nanoparticle core through a linker, or the second antigen is encapsulated in the nanoparticle core.
Claim 8: The SNA of claim 1, wherein the first antigen is attached to one or more oligonucleotides in the shell of oligonucleotides through a linker, or the first antigen is attached through a linker to an oligonucleotide in the shell of oligonucleotides that is attached to the nanoparticle core, or the first antigen is attached through a linker to an oligonucleotide that is hybridized to an oligonucleotide in the shell of oligonucleotides that is attached to the nanoparticle core, or the first antigen is attached to the external surface of the nanoparticle core through a linker.
Claims 28-29 recite the limitation "wherein the MHC-I antigen is… " in L1-2 (Claim 28) and "wherein the MHC-II antigen is… " in L1-2 (Claim 29).
Claims 28 and 29 depend from Claim 1 which recites that the SNA can comprise either an MHC1 or MHC2 antigen (i.e., …a first antigen that is either a MHC1 antigen or a MHC2 antigen… and a second antigen… and that is either a MHC1 antigen or a MHC2 antigen [emphasis added]). That means that either an MHC1 or MHC2 antigen can be optional because Claim 1 requires (c) a first antigen that can be an MHC1 antigen or an MHC2 antigen and (d) a second antigen that can be an MHC1 or MHC2 antigen. The only limitations are that the antigens are MHC1 and/or MHC2 antigens and that the “second antigen” isn’t the same as the “first antigen”.
The claim allows an artisan to choose either two different MHC1 antigens for Claim 1 or two different MHC2 antigens for Claim 1. In the first case, there is no antecedent basis for the MHC2 antigen in Claim 29 and in the second case, there is no antecedent basis for the MHC1 antigen in Claim 28.
In the interest of compact prosecution, the claims are interpreted as follows and amending them (as appropriate to Applicant’s intention) will obviate the rejection:
Claim 28: The SNA of claim 1, wherein the first or second antigen is an MHC1 antigen and the MHC1 antigen is…
Claim 29: The SNA of claim 1, wherein the first or second antigen is an MHC2 antigen and the MHC2 antigen is…
A claim may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173. In the present instance, Claim 67 recites … a non-targeting oligonucleotide [oligont] …. The claim(s) are considered indefinite because there is a question or doubt as to what are the metes and bounds of the claim. An artisan would not know what is encompassed by the term a non-targeting oligont. The Spec. provides a sort of definition for the term a non-targeting oligonucleotide (oligont) at ¶76:
The term "non-targeting oligonucleotide" refers an oligonucleotide included, in some embodiments, in the shell of oligonucleotides of a SNA that is not associated with a particular activity (e.g., an immunostimulatory activity) but instead is used to achieve a certain density of oligonucleotides on the external surface of a SNA.
However, that “definition” does not clarify what the term means (i.e., in a practical, structural application) because an artisan would not know what is or is not considered to be encompassed by the phrase associated with a particular activity.
Claim 67 is rejected for those reasons. In the interest of compact prosecution, the term non-targeting oligonucleotide is interpreted as encompassing any oligont that is not an inhibitory oligont.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Publication No. WO 2019/118883 (published 20 June 2019, “WO883”, of record on IDS) as evidenced by Wikipedia (“T helper cell”. page archived 28 February 2021. Available at Wikipedia.org. Accessed on 28 August 2026, “Wikipedia”).
WO883 discloses compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents. Their SNA comprises a NP, an antigen, and an adjuvant.
Regarding Claim 1: WO883 teaches (¶9, ¶37, ¶39, ¶42, ¶73) SNAs comprise a polynt shell surrounding a NP core, and their SNA comprises an immunostimulatory oligont that is attached to a NP core and can comprise two or more antigens. WO883 teaches (¶14, ¶53) various antigens including several antigens that are MHC1 antigens or encompass genera of MHC1 antigens: OVA1, GP100, HPV related antigens including E6 and E7, among others. WO883 teaches (same §) some antigens that are MHC2 antigens or encompass genera of MHC2 antigens: GP100, PAP, Tyrosinase, HPV related antigens including E6, among others.
Regarding Claims 1 and 30: WO883 teaches (¶97) they designed SNA comprising TLR-agonizing oligont and three antigens that are MHC1 antigens (OVA1, GP100, and the HPV E6 antigen consisting of WO883 SEQ ID NO 3).
Since WO883 teaches (¶97) an SNA (which ¶37, ¶39, and ¶42 indicate by definition comprise a polynt shell surrounding a NP core) comprising an immunostimulatory oligont and three different antigens that are MHC1 antigens, WO883 anticipates Claim 1. Since WO883 teaches (¶97) the immunostimulatory oligont is a TLR9-agoning oligont, WO883 anticipates Claim 30.
Regarding Claims 2-3, 8, 40-41, and 44: WO883 teaches (¶98-104, Fig. 1) three different SNA architectures: wherein an antigen is encapsulated within a liposome core, wherein an antigen is chemically conjugated to oligont adsorbed to the SNA surface, and wherein an antigen is chemically conjugated to an oligont hybridized to the immunostimulatory CpG oligont adsorbed to the SNA surface. WO883 also teaches (¶9, ¶74) the antigen can be attached directly to the SNA surface through a linker (or via an oligont attached to the SNA surface or encapsulated within the SNA).
Regarding the NP core, the previous ¶ explained that WO883 teaches a liposome core (see also ¶15). Regarding the linker, WO883 teaches (¶11-13) various linkers including a carbamate alkylene disulfide linker, an amide alkylene disulfide linker, and an amide alkylene thio-succinimidyl linker).
Since WO883 teaches all of the structures of antigen attachment or encapsulation recited in Claims 2-3, 8, 40-41, and 44, and since any of the three antigens can be considered the “first” or “second” antigen, WO883 anticipates Claims 2-3, 8, 40-41, and 44.
Regarding Claim 28: As discussed above, WO883 discloses the HPV E6 antigen sequence WO883 SEQ ID NO 3. That sequence is 100% identical to claimed SEQ ID NO 12, as shown by the following alignment:
BGL42975
ID BGL42975 standard; peptide; 10 AA.
XX
AC BGL42975;
XX
DT 08-AUG-2019 (first entry)
XX
DE HPV-16 oncoprotein E6 antigen protein fragment, SEQ ID 3.
XX
KW E6 transcriptional transactivator; antigen; bladder cancer; breast tumor;
KW cancer; colon tumor; cytostatic; endometrioid carcinoma; gene regulation;
KW glioblastoma; immune stimulation; leukemia; liver tumor; lung tumor;
KW melanoma; non-hodgkin lymphoma; ovary tumor; pancreas tumor;
KW prostate tumor; rectal tumor; renal tumor; thyroid tumor;
KW vaccine, anticancer.
XX
OS Human papillomavirus type 16.
XX
CC PN WO2019118883-A1.
XX
CC PD 20-JUN-2019.
XX
CC PF 14-DEC-2018; 2018WO-US065765.
XX
PR 15-DEC-2017; 2017US-0599395P.
XX
CC PA (NOUN ) UNIV NORTHWESTERN.
XX
CC PI Mirkin CA, Wang S, Zhang B, Skakuj K;
XX
DR WPI; 2019-517900/50.
XX
CC PT Selecting a spherical nucleic acid (SNA) for increased ability to
CC PT activate antigen presenting cells involves treating a population of
CC PT antigen presenting cells with a spherical nucleic acid (SNA) comprising a
CC PT nanoparticle, an antigen.
XX
CC PS Disclosure; SEQ ID NO 3; 66pp; English.
XX
CC The present invention relates to a method for selecting a spherical
CC nucleic acid (SNA) having increased ability to activate antigen
CC presenting cells, useful for preparing an anti-cancer vaccine. The
CC invention further refers to: (1) a SNA which comprises a nanoparticle, an
CC adjuvant, and an antigen; (2) a composition which comprises obtained SNA
CC in a pharmaceutically acceptable carrier; (3) a vaccine which comprises
CC the composition and an adjuvant; (4) a method for producing an immune
CC response to cancer in an individual by administering to the individual an
CC effective amount of the composition, or the vaccine producing an immune
CC response to cancer in the individual; (5) a method for inhibiting the
CC expression of a gene; (6) a method for up-regulating the activity of a
CC toll-like receptor (TLR) by contacting a cell having the TLR with a SNA;
CC and (7) a method for immunizing an individual against cancer by
CC administering to the individual an effective amount of the composition
CC for immunizing the individual against cancer. The method of the invention
CC can be used for preparing a vaccine against cancer, bladder cancer,
CC breast cancer, colon and rectal cancer, endometrial cancer, glioblastoma,
CC kidney cancer, leukemia, liver cancer, lung cancer, melanoma, non-hodgkin
CC lymphoma, osteocarcinoma, ovarian cancer, pancreatic cancer, prostate
CC cancer, thyroid cancer, and human papilloma virus-induced cancer.
XX
SQ Sequence 10 AA;
Query Match 100.0%; Score 57; Length 10;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VYDFAFRDLC 10 SEQ ID NO 12
||||||||||
Db 1 VYDFAFRDLC 10 WO883 SEQ ID NO 3
Therefore, WO883 anticipates Claim 28.
Regarding Claims 51 and 67: WO883 teaches (¶17) the adjuvant—previously (¶9-10) disclosed to be an oligont within (¶37, ¶42) the shell of oligont—can comprise DNA or RNA. WO883 teaches (¶18) the SNA can further comprise additional oligont that can be inhibitory oligont including RNAi or antisense DNA. WO883 teaches (¶68-69, ¶74) the surface density of oligont affects NP stability.
Therefore, WO883 anticipates Claims 51 and 67.
Regarding Claims 69 and 71: WO883 teaches (¶52) producing a plurality of SNAs. WO883 teaches (¶6, ¶89) their SNAs are intended to be used to raise immune responses that kill cancer cells or reduce/eliminate tumor growth and (¶90) antigenic compositions for treating children and adults. WO883 teaches (¶21-22) pharmaceutical compositions comprising a pharmaceutically acceptable carrier or (¶85) diluent.
WO883 teaches (¶36) structure of vaccine ingredients affects activation of antigen-presenting cells and priming of antigen-specific cytotoxic Tcells. WO883 teaches (same §) timing of activation and intracellular processing of vaccine components is crucial for creating the most active vaccines and importance of adjusting dose has been shown. Furthermore, WO883 teaches (¶40) exposure to an antigen elicits immune response. WO883 teaches (¶112, Fig. 5I) Tcells raised by SNAs killed target cells in a dose-dependent fashion.
Together, those teachings indicate that it was routine in the art to adjust the dose of the active ingredient in a pharmaceutical composition. In this case, the active ingredient is the SNAs that expose the immune system to the antigen(s). Since WO883 teaches (Fig. 5I) dose-dependent responses to their vaccine, the reference inherently teaches a composition comprising a plurality of SNA. Even if the lowest dose is one single SNA per dose—which a person of ordinary skill would recognize is utterly implausible—the dose-dependency data indicate that the WO883 cells or mice (who exhibited dose-dependent response) were administered a composition with a plurality of SNA.
Therefore, WO883 anticipates Claims 69 and 71.
Regarding the MHC2 antigen recited in the claims (i.e., an alternative embodiment of Claim 1): WO883 teaches (¶89) immune responses including CD8+ and CD4+ Tcell responses. A person of ordinary skill in the art knows (see evidence of Wikipedia, §main text ¶2) CD4+ Tcells respond to MHC2 antigens. Therefore, the teachings of WO883 encompass the alternative embodiment (i.e., the MHC2 antigen) of Claim 1.
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.
Claim(s) 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication No. WO 2019/118883 (published 20 June 2019, “WO883”, of record on IDS) as applied to Claims 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 in the 102 rejection above, and further in view of Manuri (et al. 2007. Intranasal immunization with synthetic peptides corresponding to the E6 and E7 oncoproteins of human papillomavirus type 16 induces systemic and mucosal cellular immune responses and tumor protection. Vaccine 25:3302, “Manuri”) and US Patent Application Publication No. 2008/0131455 (published 05 June 2008, “App455”).
The teachings of WO883 as applicable to Claim(s) 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 have been described in the 102 rejections above. Those same rejections also would have made obvious those claims.
WO883 teaches (¶42) an SNA comprising a NP core, a shell of oligont including (¶9) immunostimulatory oligont, and (¶9, ¶73) multiple antigens that can be (¶53, ¶95) various MHC1 antigens, including HPV antigens.
As discussed in the 102 rejection above, WO883 teaches (¶52) producing a plurality of SNAs, (¶40, ¶112, Fig. 5I) that exposure to antigen elicits immune response and immune response to SNA is dose dependent, and (¶36) structure of vaccine ingredients affects activation of antigen-presenting cells and priming of antigen-specific cytotoxic Tcells.
Together, those teachings indicate that it was routine in the art to adjust the dose of the active ingredient in a pharmaceutical composition. In this case, the active ingredient is the SNAs that expose the immune system to the antigen(s). Since WO883 teaches (Fig. 5I) dose-dependent responses to their vaccine, the reference inherently teaches a composition comprising a plurality of SNA. Even if the lowest dose is one single SNA per dose—which a person of ordinary skill would recognize is utterly implausible—the dose-dependency data indicate that the WO883 cells or mice (who exhibited dose-dependent response) were administered a composition with a plurality of SNA.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition comprising SNA of WO883 with the teachings regarding active ingredients and dose-dependency of WO883 for the benefit of optimizing the composition to elicit the optimal immune response. One would have been motivated to do so with a reasonable expectation of success because WO883 teaches the importance of dose, that antigen is responsible for eliciting immune response, and that immune response to SNA is dose dependent. That would have indicated to an artisan that the antigen part of the vaccine—the SNA bearing antigen—is the active ingredient and would have led an artisan to produce a pharmaceutical composition comprising a plurality of SNA.
Therefore, the limitations of Claims 69 and 71 would have been obvious in view of WO883.
As discussed in the 102 rejection, WO883 teaches a vaccine that comprises SNA bearing multiple antigens, the HPV antigens E6 and E7, and the specific AA sequence of the E649-58 antigen which is identical to claimed SEQ ID NO 12.
WO883 does not teach incorporating to their SNA the specific antigen E643-57 (which is an MHC2 antigen) or that the E643-57 antigen has claimed SEQ ID NO 27 (i.e., Claim 29). WO883 does not teach incorporating to their SNA the specific antigen E749-57 (which is a second MHC1 HPV antigen) or that the E749-57 antigen has claimed SEQ ID NO 13 (i.e., an alternative limitation of Claim 28).
However, Manuri, drawn to immunization of mice with synthetic E6 and E7 HPV 16 peptides, teaches (§Abstract) administering E643-57 peptides in an HPV vaccine. Manuri immunized mice with (§Abstract) a mixture of peptides E744-62 and E643-57 and found (§3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1) cells from the immunized mice showed strong CTL activity against both peptides.
Manuri further teaches (§3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2) both CD8+ and CD4+ Tcells exhibited immune responses to the Q15L peptide (i.e., E643-57).
Those teachings indicate that vaccines against the E643-57 peptide were of interest in the art. Those teachings indicate that a vaccine against both E6 and E7 antigens was of interest in the art.
Regarding Claim 29: Furthermore, Manuri teaches (§2. Materials and methods-2.3. Peptides) the AA sequence of the E643-57 peptide they used. That sequence is 100% identical to claimed SEQ ID NO 27, as shown by the following alignment:
AASEQ2_08272026_120137
Query Match 100.0%; Score 76; DB 1; Length 15;
Best Local Similarity 100.0%;
Matches 15; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QLLRREVYDFAFRDL 15 SEQ ID NO 27
|||||||||||||||
Db 1 QLLRREVYDFAFRDL 15 Manuri TC-1 E643-57 SEQ
Therefore, Manuri teaches formulating their HPV vaccine with the MHC2 antigen recited in Claim 29 (i.e., SEQ ID NO 27).
Regarding the alternative embodiment of Claim 28: Manuri further teaches (§2. Materials and methods-2.3. Peptides and §3. Results-3.1, Fig. 1) they used the E649-58 and E749-57 peptides to test the breadth of immune response. That indicates both of those peptides were of interest to artisans formulating an HPV vaccine. The E649-58 peptide was discussed in the 102 rejection above.
Therefore, Manuri teaches the MHC1 antigen E749-57recited in Claim 28 (i.e., SEQ ID NO 13) was of interest to artisans formulating an HPV vaccine.
Manuri discloses (§2. Materials and methods-2.3. Peptides) the E749-57 peptide is called R9F, indicating it has 9 AA, and discloses a 10-mer AA sequence for it. That AA sequence is nearly identical to claimed SEQ ID NO 13 but differs by one single AA.
A person of ordinary skill would have quickly realized that Manuri’s sequence for the E749-57 peptide comprises a typographical error. They would have known that because the peptide’s name is R9F which indicates it is a 9-mer and because AA 49-57 comprise 9 AA. That would have motivated an artisan formulating an HPV vaccine to seek out the correct sequence for the E749-57 peptide.
In doing so, they would have identified the reference App455 which (§Abstract) discloses antigen delivery compositions, including for the (¶54) HPV 16 E7 antigen. App455 teaches (¶94) E749-57 is an MHC1 protein possessing the sequence of App455 SEQ ID NO 5. That sequence is 100% identical to claimed SEQ ID NO 13 as shown by the following alignment:
ARW94010
ID ARW94010 standard; peptide; 9 AA.
XX
AC ARW94010;
XX
DT 21-AUG-2008 (first entry)
XX
DE HPV type 16 E7 oncogene MHC class I restricted peptide, SEQ ID 5.
XX
KW therapeutic; prophylactic to disease; drug delivery; strain improvement;
KW genetic engineering; vaccine, general; immune stimulation;
KW uterine cervix tumor; cytostatic; infection; antimicrobial-gen.; tumor;
KW E7 protein.
XX
OS Human papillomavirus type 16.
OS Synthetic.
XX
CC PN US2008131455-A1.
XX
CC PD 05-JUN-2008.
XX
CC PF 26-NOV-2007; 2007US-00944912.
XX
PR 30-APR-2004; 2004US-0567291P.
PR 02-MAY-2005; 2005US-00121840.
XX
CC PA (PDSB-) PDS BIOTECHNOLOGY CORP.
XX
CC PI Huang L, Cui Z, Dileo J, Han S, Vangasseri DP;
XX
DR WPI; 2008-J02281/51.
XX
CC PT Antigen or lipid complex useful for inducing and stimulating an immune
CC PT response and inhibiting the growth of a tumor cell, comprises an antigen
CC PT and non-steroidal cationic lipid.
XX
CC PS Example 2; SEQ ID NO 5; 37pp; English.
XX
CC The present invention relates to a novel antigen or lipid complex useful
CC for inducing and stimulating an immune response and inhibiting the growth
CC of a tumor cell. It further provides a lipid-protamine-DNA (LPD) vaccine
CC delivery system/adjuvant and methods of using such LPD vaccine delivery
CC system/adjuvant for the prevention and treatment of cancer and other
CC infectious diseases. It comprises an antigen and a non-steroidal cationic
CC lipid. The antigen is tumor-associated antigen; tumor-associated antigen
CC such as human papilloma virus antigen such as human papillomavirus (HPV)
CC 16 E7 protein modified to retain its antigenic activity but to eliminate
CC its tumorigenic activity; viral antigen; or microbial antigen. The
CC antigen is derived from pathogens associated with cancer risk. The lipid-
CC antigen complexes are stable, capable of being produced at relatively
CC high concentrations, and retain biological activity of the antigen
CC component over time in storage. The cationic lipid having shortly acyl
CC chain and cis-unsaturated double bond have increased immunostimulatory
CC effect. The lipid-protamine-DNA vaccine can induced strong cellular
CC immunity to cause complete regression of established tumor and prevent
CC the formation of new tumor. The present sequence is a HPV 16 E7 oncogene
CC tumor-associated antigen MHC class I restricted peptide.
XX
SQ Sequence 9 AA;
Query Match 100.0%; Score 49; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RAHYNIVTF 9 SEQ ID NO 13
|||||||||
Db 1 RAHYNIVTF 9 App455 SEQ ID NO 5
Altogether, Manuri indicated that all of the HPV 16 antigens E649-58, E749-57, and E643-57 were of interest to artisans formulating an HPV vaccine, and provided the AA sequence for E643-57.
Although Manuri doesn’t use the terms “MHC1 antigen” and “MHC2 antigen”, using those exact terms, they teach that the antigen E649-58, the antigen E749-57, both MHC1 antigens, and the antigen E64357, an MHC2 antigen, were of interest to artisans formulating an HPV vaccine. Manuri’s teachings indicate that formulating a vaccine comprising an MHC1 antigen and an MHC2 antigen was of interest in the art and that various MHC1 antigens were of interest. Their teachings indicate that they formulated a vaccine that comprises an MHC1 antigen and an MHC2 antigen.
WO883 teaches an SNA comprising multiple antigens.
App455 teaches the sequence of the antigen E749-57.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA of WO883 with the specific antigen peptides of Manuri and the antigen E749-57 having the sequence of App455 SEQ ID NO 5 for the benefit of formulating an HPV vaccine comprising multiple HPV antigens that were of known interest in the art of HPV vaccine formulation. One would have been motivated to do so with a reasonable expectation of success because WO883 teaches their SNA can comprise multiple antigens and specifically teaches including HPV antigens, and because Manuri teaches that all of the HPV antigens E649-58, E749-57, and E64357were of interest in the art of HPV vaccine formulation. Since the AA sequences of all of those antigens were known, it would have been a simple matter to include all the peptides in a single SNA for an HPV vaccine. Furthermore, a person of ordinary skill in the art would have been motivated to use all of Manuri and App455’s antigens in WO883’s SNA because WO883 indicates (as discussed above) that antigens are the active ingredient that stimulates immune response, incorporating multiple antigens in their SNA, and (e.g., ¶111, Fig 5) that SNA vaccine formulations are superior to vaccine formulations that don’t comprise the SNA architecture.
Therefore, all the limitations of Claims 28-29 (and Claims 1-3, 8, 30, 40-41, 51, 67, 69, and 71) would have been obvious in view of WO883, Manuri, and App455.
Claim(s) 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication No. WO 2019/118883 (published 20 June 2019, “WO883”, of record on IDS) as applied to Claims 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 in the 102 rejection above, and further in view of Zhu (and Chen. 2018. Aptamer-based targeted therapy. Adv. Drug Deliv. Rev. 134:65–78, “Zhu”).
The teachings of WO883 as applicable to Claim(s) 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 have been described in the 102 rejections above. Those same rejections also would have made obvious those claims.
WO883 teaches (¶42) an SNA comprising a NP core, a shell of oligont including (¶9) immunostimulatory oligont, and (¶9, ¶73) multiple antigens that can be (¶53, ¶95) various MHC1 antigens, including HPV antigens.
As discussed in the 102 rejection above, WO883 teaches (¶36) activation of antigen-presenting cells and priming of antigen-specific cytotoxic Tcells are important for vaccine efficacy.
WO883 does not teach incorporating to the SNA shell a targeting oligont (i.e., an alternative embodiment of Claim 67).
However, Zhu, drawn to aptamer-based targeted therapy, teaches (§Abstract) aptamers are oligonts with unique 3-D conformations and that aptamer–drug conjugates (ApDCs) represent an opportunity for improving drug delivery to a target cell. Zhu teaches (§1. Introduction, entire §) aptamers are easy to make and can be developed for a variety of cellular targets. Zhu teaches (§3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) it is routine and conventional in the art of drug delivery to use ApDCs to deliver immunotherapeutic agents, drugs, nucleic acid therapeutics, and other kinds of therapeutics (including peptides) to target various immune cell types.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA for vaccines of WO883 with the cell-targeting aptamer of Zhu for the benefit of targeting the SNA to cells where immune response is desired. One would have been motivated to do so with a reasonable expectation of success because WO883 teaches (¶36) it’s important to deliver a vaccine to immune cells and because Zhu teaches using immune cell-targeting aptamers to improve delivery to those cell types, including for vaccination purposes.
Therefore, the alternative limitation (i.e., the targeting oligont) of Claim 67 (and Claims 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71) would have been obvious in view of WO883 and Zhu.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following patents (see table) in view of International Publication No. WO 2019/118883 (published 20 June 2019, “WO883”, of record on IDS) as applied to Claims 1-3, 8, 28, 30, 40-41, 44, 51, 67, 69, and 71 in the 102 rejection above, and further in view of Manuri (et al. 2007. Intranasal immunization with synthetic peptides corresponding to the E6 and E7 oncoproteins of human papillomavirus type 16 induces systemic and mucosal cellular immune responses and tumor protection. Vaccine 25:3302, “Manuri”), US Patent Application Publication No. 2008/0131455 (published 05 June 2008, “App455”), and Zhu (and Chen. 2018. Aptamer-based targeted therapy. Adv. Drug Deliv. Rev. 134:65–78, “Zhu”).
App. #
Document #
Claims
Notes
16/328025
US 11364304
All
SNA that can comprise noncoding RNA or inhibitory DNA/RNA
16/906619
US 12378280
All
Generic SNA
Although the claims at issue are not identical they are directed to overlapping subject matter because the instant claims recite an SNA comprising a NP core (that can be a micelle/liposome/polymer/LNP/combination thereof), a shell of oligont (that can be DNA/RNA/combination thereof or can comprise a targeting/inhibitory/nontargeting oligont) comprising one or more immunostimulatory oligont (that can be a TLR agonist), a first antigen that is either an MHC1 or MHC2 antigen, and a second antigen, different from the first antigen, that is either an MHC1 or MHC2 antigen; wherein the antigens can be attached via a linker to one or more oligont in the shell or to an oligont in the shell, attached via a linker to an oligont that is hybridized to an oligont that is attached to the NP core, attached to the external surface of the NP via a linker, or encapsulated in the NP, wherein the linker can be one of several recited species; wherein one of the antigens is an MHC1 antigen and is either SEQ ID NO 12 or 13 or wherein one of the antigens is an MHC2 antigen and is SEQ ID NO 27; a composition comprising a plurality of the SNA, and a pharmaceutical composition comprising the SNA and a pharmaceutically acceptable carrier or diluent.
The patented claims are broadly drawn to SNA.
All claim sets are directed to SNA.
The patented claims don’t recite every limitation of the instant claims, but those limitations would have been obvious in view of the prior art:
WO883 discloses (¶9, ¶37, ¶39, ¶42, ¶73, ¶14, ¶53, ¶97, WO883 SEQ ID NO 3, ¶97, ¶98-104, Fig. 1, ¶74, ¶15, ¶11-13, ¶17, ¶9-10, ¶18, ¶68-69, ¶52, ¶6, ¶89, ¶90, ¶21-22, ¶85, ¶36, ¶40, ¶112, Fig. 5I, ¶95, ¶111) compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents and most of the limitations of the instant claims.
Manuri teaches (§Abstract; §3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1; §3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2; §2. Materials and methods-2.3. Peptides) HPV E6 and E7 antigen peptide sequences (that are MHC1 and MHC2 antigens) that were of interest to artisans developing an HPV vaccine.
App455 teaches (¶54, ¶94, App455 SEQ ID NO 5) the correct AA sequence for an of-interest HPV antigen.
Zhu teaches (§Abstract, §1. Introduction, entire §; §3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) aptamers that target immune cells and can be used in vaccine formulation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA or oligont of the patented claims with the teachings about SNA of WO883, the teachings about HPV antigens of Manuri and App455, and the teachings about immune cell-targeting aptamers of Zhu for the benefits of producing an SNA that could be used in an HPV vaccine and optimizing the vaccine. One would have been motivated to do so with a reasonable expectation of success because the patented claims are broadly drawn to SNAs and because WO883 teaches (§Abstract, ¶6) SNAs are good for use in vaccines because they can carry all of the necessary components of a vaccine, including both antigen and adjuvant and (¶14) teaches including HPV antigens.
It would have been a simple matter to modify the invention of the patented claims by including various elements (TLR-agonizing immunostimulatory oligont, HPV antigens) known in the cited prior art because the prior art teaches all of those elements were known and because the prior art (e.g., Manuri) indicates producing an HPV vaccine was of interest and teaches (WO883, Manuri, Zhu) benefits of including each element. Therefore, the claimed invention would have been obvious in view of the patented claims and the prior art.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following copending Applications (see table) in view of WO883, Manuri, App455, and Zhu.
App. #
Document #
Claims
Notes
18/717280
US 20250043081
Claims 29 and 43 and claims depending therefrom
Oligont dendrimer, claims require generic SNA,
19/149326
US 20260224711
All pending
Generic SNA
19/105587
Not yet pub’d
All pending
Oligont dendron, can comprise TLR-agonizing immunostimulatory oligont, antigen, inhibitory oligont; would have been obvious to use it in an SNA
19/465797
Not yet pub’d
All pending
Generic SNA
Although the claims at issue are not identical they are directed to overlapping subject matter because the instant claims recite an SNA comprising a NP core (that can be a micelle/liposome/polymer/LNP/combination thereof), a shell of oligont (that can be DNA/RNA/combination thereof or can comprise a targeting/inhibitory/nontargeting oligont) comprising one or more immunostimulatory oligont (that can be a TLR agonist), a first antigen that is either an MHC1 or MHC2 antigen, and a second antigen, different from the first antigen, that is either an MHC1 or MHC2 antigen; wherein the antigens can be attached via a linker to one or more oligont in the shell or to an oligont in the shell, attached via a linker to an oligont that is hybridized to an oligont that is attached to the NP core, attached to the external surface of the NP via a linker, or encapsulated in the NP, wherein the linker can be one of several recited species; wherein one of the antigens is an MHC1 antigen and is either SEQ ID NO 12 or 13 or wherein one of the antigens is an MHC2 antigen and is SEQ ID NO 27; a composition comprising a plurality of the SNA, and a pharmaceutical composition comprising the SNA and a pharmaceutically acceptable carrier or diluent.
The copending claims are drawn to SNA or oligont comprising immunostimulatory oligont (which an artisan would have realized could be used in an SNA).
All claim sets are directed to SNA or oligont that an artisan would have wanted to use in SNA.
The copending claims don’t recite every limitation of the instant claims but those limitations would have been obvious in view of the prior art:
WO883 discloses (¶9, ¶37, ¶39, ¶42, ¶73, ¶14, ¶53, ¶97, WO883 SEQ ID NO 3, ¶97, ¶98-104, Fig. 1, ¶74, ¶15, ¶11-13, ¶17, ¶9-10, ¶18, ¶68-69, ¶52, ¶6, ¶89, ¶90, ¶21-22, ¶85, ¶36, ¶40, ¶112, Fig. 5I, ¶95, ¶111) compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents and most of the limitations of the instant claims.
Manuri teaches (§Abstract; §3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1; §3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2; §2. Materials and methods-2.3. Peptides) HPV E6 and E7 antigen peptide sequences (that are MHC1 and MHC2 antigens) that were of interest to artisans developing an HPV vaccine.
App455 teaches (¶54, ¶94, App455 SEQ ID NO 5) the correct AA sequence for an of-interest HPV antigen.
Zhu teaches (§Abstract, §1. Introduction, entire §; §3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) aptamers that target immune cells and can be used in vaccine formulation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA or oligont of the copending claims with the teachings about SNA of WO883, the teachings about HPV antigens of Manuri and App455, and the teachings about immune cell-targeting aptamers of Zhu for the benefits of producing an SNA that could be used in an HPV vaccine and optimizing the vaccine. One would have been motivated to do so with a reasonable expectation of success because the copending claims are broadly drawn to SNAs and because WO883 teaches (§Abstract, ¶6) SNAs are good for use in vaccines because they can carry all of the necessary components of a vaccine, including both antigen and adjuvant and (¶14) teaches including HPV antigens. One would have been motivated to incorporate the oligont of the App 18/717280 and App 19/105587 claims to the SNA of WO883 because WO883 teaches (¶43) their SNA can comprise dendrimers.
It would have been a simple matter to modify the invention of the copending claims by including various elements (TLR-agonizing immunostimulatory oligont, HPV antigens) known in the cited prior art because the prior art teaches all of those elements were known and because the prior art (e.g., Manuri) indicates producing an HPV vaccine was of interest and teaches (WO883, Manuri, Zhu) benefits of including each element. Therefore, the claimed invention would have been obvious in view of the copending claims and the prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-22 of the US Patent No. 12319711 (App. # 17/025637) in view of WO883, Manuri, App455, and Zhu .
Although the claims at issue are not identical they are directed to overlapping subject matter because the instant claims recite an SNA comprising a NP core (that can be a micelle/liposome/polymer/LNP/combination thereof), a shell of oligont (that can be DNA/RNA/combination thereof or can comprise a targeting/inhibitory/nontargeting oligont) comprising one or more immunostimulatory oligont (that can be a TLR agonist), a first antigen that is either an MHC1 or MHC2 antigen, and a second antigen, different from the first antigen, that is either an MHC1 or MHC2 antigen; wherein the antigens can be attached via a linker to one or more oligont in the shell or to an oligont in the shell, attached via a linker to an oligont that is hybridized to an oligont that is attached to the NP core, attached to the external surface of the NP via a linker, or encapsulated in the NP, wherein the linker can be one of several recited species; wherein one of the antigens is an MHC1 antigen and is either SEQ ID NO 12 or 13 or wherein one of the antigens is an MHC2 antigen and is SEQ ID NO 27; a composition comprising a plurality of the SNA, and a pharmaceutical composition comprising the SNA and a pharmaceutically acceptable carrier or diluent.
The patented claims are drawn to an SNA comprising a protein corona, wherein the SNA comprises (i) an NP core and (ii) one or more oligont attached to the surface of the NP core; and wherein the protein corona comprises a plurality of at least 5 proteins, wherein each of the plurality of proteins is adsorbed on the surface of the SNA via a non-covalent interaction; wherein the SNA can comprise TLR-agonizing immunostimulatory oligont and inhibitory oligont.
All claim sets are directed to SNA that can comprise TLR-agonizing immunostimulatory oligont and inhibitory oligont.
The patented claims don’t recite every limitation of the instant claims, but those limitations would have been obvious in view of the prior art:
WO883 discloses (¶9, ¶37, ¶39, ¶42, ¶73, ¶14, ¶53, ¶97, WO883 SEQ ID NO 3, ¶97, ¶98-104, Fig. 1, ¶74, ¶15, ¶11-13, ¶17, ¶9-10, ¶18, ¶68-69, ¶52, ¶6, ¶89, ¶90, ¶21-22, ¶85, ¶36, ¶40, ¶112, Fig. 5I, ¶95, ¶111) compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents and most of the limitations of the instant claims.
Manuri teaches (§Abstract; §3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1; §3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2; §2. Materials and methods-2.3. Peptides) HPV E6 and E7 antigen peptide sequences (that are MHC1 and MHC2 antigens) that were of interest to artisans developing an HPV vaccine.
App455 teaches (¶54, ¶94, App455 SEQ ID NO 5) the correct AA sequence for an of-interest HPV antigen.
Zhu teaches (§Abstract, §1. Introduction, entire §; §3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) aptamers that target immune cells and can be used in vaccine formulation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA or oligont of the patented claims with the teachings about SNA of WO883, the teachings about HPV antigens of Manuri and App455, and the teachings about immune cell-targeting aptamers of Zhu for the benefits of producing an SNA that could be used in an HPV vaccine and optimizing the vaccine. One would have been motivated to do so with a reasonable expectation of success because the patented claims are broadly drawn to SNAs and because WO883 teaches (§Abstract, ¶6) SNAs are good for use in vaccines because they can carry all of the necessary components of a vaccine, including both antigen and adjuvant and (¶14) teaches including HPV antigens.
It would have been a simple matter to modify the invention of the patented claims by including various elements (TLR-agonizing immunostimulatory oligont, HPV antigens) known in the cited prior art because the prior art teaches all of those elements were known and because the prior art (e.g., Manuri) indicates producing an HPV vaccine was of interest and teaches (WO883, Manuri, Zhu) benefits of including each element. Therefore, the claimed invention would have been obvious in view of the patented claims and the prior art.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following copending Applications (see table) in view of WO883, Manuri, App455, and Zhu.
App. #
Document #
Claims
Notes
19/204026
US 20250270250
All pending
Method of improving stability of SNA; SNA comprises at least 5 proteins, can comprise TLR-agonizing immunostimulatory oligont and inhibitory oligont
17/084460
US 20210123057
All pending
SNA comprising CpG oligont; can comprise peptide and inhibitory oligont
18/949786
US 20250075219
All pending
SNA comprising CpG oligont; can comprise peptide and inhibitory oligont
17/076607
US 20210122778
All pending
Nucleic acid nanoparticle, encompasses SNA (title of application); can comprise TLR-agonizing immunostimulatory oligont, inhibitory oligont, peptide
18/271782
US 20240309367
All pending
SNA, can comprise immunostimulatory oligont, inhibitory oligont
18/279034
US 20240318204
All pending
SNA, can comprise immunostimulatory oligont, inhibitory oligont
19/073709
US 20250283095
All pending
SNA and methods of producing and using it; SNA can comprise TLR-agonizing immunostimulatory oligont
18/862866
US 20250354140
All pending
SNA, can comprise TLR-agonizing immunostimulatory oligont, targeting/inhibitory/nontargeting oligont
18/225400
US20230382941
All pending
Oligont dendron comprising immunostimulatory oligont, encompasses SNA (title of application); can comprise inhibitory oligont
Although the claims at issue are not identical they are directed to overlapping subject matter because the instant claims recite an SNA comprising a NP core (that can be a micelle/liposome/polymer/LNP/combination thereof), a shell of oligont (that can be DNA/RNA/combination thereof or can comprise a targeting/inhibitory/nontargeting oligont) comprising one or more immunostimulatory oligont (that can be a TLR agonist), a first antigen that is either an MHC1 or MHC2 antigen, and a second antigen, different from the first antigen, that is either an MHC1 or MHC2 antigen; wherein the antigens can be attached via a linker to one or more oligont in the shell or to an oligont in the shell, attached via a linker to an oligont that is hybridized to an oligont that is attached to the NP core, attached to the external surface of the NP via a linker, or encapsulated in the NP, wherein the linker can be one of several recited species; wherein one of the antigens is an MHC1 antigen and is either SEQ ID NO 12 or 13 or wherein one of the antigens is an MHC2 antigen and is SEQ ID NO 27; a composition comprising a plurality of the SNA, and a pharmaceutical composition comprising the SNA and a pharmaceutically acceptable carrier or diluent.
The copending claims are drawn to SNA comprising immunostimulatory oligont or oligont comprising immunostimulatory oligont that could be used in an SNA, or to methods of using them (which require SNA comprising immunostimulatory oligont).
All claim sets are directed to SNA comprising immunostimulatory oligont or methods of using them.
The copending claims don’t recite every limitation of the instant claims but those limitations would have been obvious in view of the prior art:
WO883 discloses (¶9, ¶37, ¶39, ¶42, ¶73, ¶14, ¶53, ¶97, WO883 SEQ ID NO 3, ¶97, ¶98-104, Fig. 1, ¶74, ¶15, ¶11-13, ¶17, ¶9-10, ¶18, ¶68-69, ¶52, ¶6, ¶89, ¶90, ¶21-22, ¶85, ¶36, ¶40, ¶112, Fig. 5I, ¶95, ¶111) compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents and most of the limitations of the instant claims.
Manuri teaches (§Abstract; §3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1; §3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2; §2. Materials and methods-2.3. Peptides) HPV E6 and E7 antigen peptide sequences (that are MHC1 and MHC2 antigens) that were of interest to artisans developing an HPV vaccine.
App455 teaches (¶54, ¶94, App455 SEQ ID NO 5) the correct AA sequence for an of-interest HPV antigen.
Zhu teaches (§Abstract, §1. Introduction, entire §; §3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) aptamers that target immune cells and can be used in vaccine formulation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA or oligont of the copending claims with the teachings about SNA of WO883, the teachings about HPV antigens of Manuri and App455, and the teachings about immune cell-targeting aptamers of Zhu for the benefits of producing an SNA that could be used in an HPV vaccine and optimizing the vaccine. One would have been motivated to do so with a reasonable expectation of success because the copending claims are broadly drawn to SNAs comprising immunostimulatory oligont and because WO883 teaches (§Abstract, ¶6) SNAs are good for use in vaccines because they can carry all of the necessary components of a vaccine, including both antigen and adjuvant and (¶14) teaches including HPV antigens.
It would have been a simple matter to modify the invention of the copending claims by including various elements (TLR-agonizing immunostimulatory oligont, HPV antigens) known in the cited prior art because the prior art teaches all of those elements were known and because the prior art (e.g., Manuri) indicates producing an HPV vaccine was of interest and teaches (WO883, Manuri, Zhu) benefits of including each element. Therefore, the claimed invention would have been obvious in view of the copending claims and the prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following patents (see table) in view of WO883, Manuri, App455, and Zhu.
App. #
Document #
Claims
Notes
16/611502
US 11433131
All
Method of treating cancer requiring an SNA that comprises immunostimulatory oligont and tumor-associated antigen (TAG) and can comprise CpG oligont, RNA or inhibitory DNA/RNA
17/684269
US 12691166
All
SNA comprising TLR-agonizing immunostimulatory oligont and coronavirus antigen
Although the claims at issue are not identical they are directed to overlapping subject matter because the instant claims recite an SNA comprising a NP core (that can be a micelle/liposome/polymer/LNP/combination thereof), a shell of oligont (that can be DNA/RNA/combination thereof or can comprise a targeting/inhibitory/nontargeting oligont) comprising one or more immunostimulatory oligont (that can be a TLR agonist), a first antigen that is either an MHC1 or MHC2 antigen, and a second antigen, different from the first antigen, that is either an MHC1 or MHC2 antigen; wherein the antigens can be attached via a linker to one or more oligont in the shell or to an oligont in the shell, attached via a linker to an oligont that is hybridized to an oligont that is attached to the NP core, attached to the external surface of the NP via a linker, or encapsulated in the NP, wherein the linker can be one of several recited species; wherein one of the antigens is an MHC1 antigen and is either SEQ ID NO 12 or 13 or wherein one of the antigens is an MHC2 antigen and is SEQ ID NO 27; a composition comprising a plurality of the SNA, and a pharmaceutical composition comprising the SNA and a pharmaceutically acceptable carrier or diluent.
The patented claims are drawn to SNA comprising immunostimulatory oligont and an antigen or methods of using them.
All claim sets are directed to SNA comprising immunostimulatory oligont and an antigen or to methods of using the SNA.
The patented claims don’t recite every limitation of the instant claims, including the specific antigens or their sequences, but those limitations would have been obvious in view of the prior art:
WO883 discloses (¶9, ¶37, ¶39, ¶42, ¶73, ¶14, ¶53, ¶97, WO883 SEQ ID NO 3, ¶97, ¶98-104, Fig. 1, ¶74, ¶15, ¶11-13, ¶17, ¶9-10, ¶18, ¶68-69, ¶52, ¶6, ¶89, ¶90, ¶21-22, ¶85, ¶36, ¶40, ¶112, Fig. 5I, ¶95, ¶111) compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents and most of the limitations of the instant claims.
Manuri teaches (§Abstract; §3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1; §3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2; §2. Materials and methods-2.3. Peptides) HPV E6 and E7 antigen peptide sequences (that are MHC1 and MHC2 antigens) that were of interest to artisans developing an HPV vaccine.
App455 teaches (¶54, ¶94, App455 SEQ ID NO 5) the correct AA sequence for an of-interest HPV antigen.
Zhu teaches (§Abstract, §1. Introduction, entire §; §3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) aptamers that target immune cells and can be used in vaccine formulation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA or oligont of the patented claims with the teachings about SNA of WO883, the teachings about HPV antigens of Manuri and App455, and the teachings about immune cell-targeting aptamers of Zhu for the benefits of producing an SNA that could be used in an HPV vaccine and optimizing the vaccine. One would have been motivated to do so with a reasonable expectation of success because the patented claims are broadly drawn to SNAs and because WO883 teaches (§Abstract, ¶6) SNAs are good for use in vaccines because they can carry all of the necessary components of a vaccine, including both antigen and adjuvant and (¶14) teaches including HPV antigens.
It would have been a simple matter to modify the invention of the patented claims by including various elements (TLR-agonizing immunostimulatory oligont, HPV antigens) known in the cited prior art because the prior art teaches all of those elements were known and because the prior art (e.g., Manuri) indicates producing an HPV vaccine was of interest and teaches (WO883, Manuri, Zhu) benefits of including each element. Therefore, the claimed invention would have been obvious in view of the patented claims and the prior art.
Claims 1-3, 8, 28-30, 40-41, 44, 51, 67, 69, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the following copending Applications (see table) in view of WO883, Manuri, App455, and Zhu.
App. #
Document #
Claims
Notes
17/814211
US 20220387585
All pending
Composition comprising SNA comprising CpG and TAG and can comprise other oligont components
16/611548
US 20200291394
All pending
Composition comprising SNA comprising CpG and TAG and can comprise other oligont components, some MHC1 and MHC2 antigens (OVA1, HPV)
18/784244
US 20240398918
All pending
SNA can comprise antigen, immunostimulatory oligont, other oligont including nontargeting oligont; methods of stimulating CD8 Tcell (i.e., MHC1) and CD4 Tcell (i.e., MHC2) responses
17/046482
US 20220010302
All pending
Methods of assessing SNA; SNA can comprise OVA or E7 antigen and TLR-agonizing oligont
17/743422
US 20220364095
All pending
SNA that comprise TLR-agonizing immunostimulatory oligont and antigen, methods of using it
17/749977
US 20220370490
All pending
SNA that comprise TLR-agonizing immunostimulatory oligont and antigen, methods of using it
18/710942
US 20250002921
All pending
SNA, can comprise immunostimulatory oligont, inhibitory oligont, TAG
18/864318
US 20250295745
All pending
SNA, can comprise TLR-agonizing immunostimulatory oligont, targeting/inhibitory/nontargeting oligont, TAG
19/545780
US 20260248899
All pending
SNA, can comprise TLR-agonizing immunostimulatory oligont (Claims 20-21, Spec. ¶62 to determine what are those SEQ ID NOs), other oligont, any antigen
19/722059
Not yet pub’d
All pending
SNA, can comprise TLR-agonizing immunostimulatory oligont, other oligont, coronavirus antigen, targeting/inhibitory oligont
Although the claims at issue are not identical they are directed to overlapping subject matter because the instant claims recite an SNA comprising a NP core (that can be a micelle/liposome/polymer/LNP/combination thereof), a shell of oligont (that can be DNA/RNA/combination thereof or can comprise a targeting/inhibitory/nontargeting oligont) comprising one or more immunostimulatory oligont (that can be a TLR agonist), a first antigen that is either an MHC1 or MHC2 antigen, and a second antigen, different from the first antigen, that is either an MHC1 or MHC2 antigen; wherein the antigens can be attached via a linker to one or more oligont in the shell or to an oligont in the shell, attached via a linker to an oligont that is hybridized to an oligont that is attached to the NP core, attached to the external surface of the NP via a linker, or encapsulated in the NP, wherein the linker can be one of several recited species; wherein one of the antigens is an MHC1 antigen and is either SEQ ID NO 12 or 13 or wherein one of the antigens is an MHC2 antigen and is SEQ ID NO 27; a composition comprising a plurality of the SNA, and a pharmaceutical composition comprising the SNA and a pharmaceutically acceptable carrier or diluent.
The copending claims are drawn to SNA comprising immunostimulatory oligont and an antigen or to method of using them (methods that require the SNA).
All claim sets are directed to SNA comprising immunostimulatory oligont and an antigen or to methods of using them.
The copending claims don’t recite every limitation of the instant claims but those limitations would have been obvious in view of the prior art:
WO883 discloses (¶9, ¶37, ¶39, ¶42, ¶73, ¶14, ¶53, ¶97, WO883 SEQ ID NO 3, ¶97, ¶98-104, Fig. 1, ¶74, ¶15, ¶11-13, ¶17, ¶9-10, ¶18, ¶68-69, ¶52, ¶6, ¶89, ¶90, ¶21-22, ¶85, ¶36, ¶40, ¶112, Fig. 5I, ¶95, ¶111) compositions and methods comprising spherical nucleic acid (SNA) components for use as immunotherapeutic agents and most of the limitations of the instant claims.
Manuri teaches (§Abstract; §3. Results-3.1. Intranasal immunization with a combination of the E7 peptide Q19D and the E6 peptide Q15L of HPV-16 along with the mutant cholera toxin CT-2* adjuvant primes antigen-specific CTL that lyse syngeneic TC-1 tumor cells expressing the cognate proteins, Fig. 1; §3. Results-3.2. Immunization with the mixture of the Q19D and Q15L peptides induces IFN-γ production by CD4+ and CD8+ T cells from the systemic and mucosal compartments, Fig. 2; §2. Materials and methods-2.3. Peptides) HPV E6 and E7 antigen peptide sequences (that are MHC1 and MHC2 antigens) that were of interest to artisans developing an HPV vaccine.
App455 teaches (¶54, ¶94, App455 SEQ ID NO 5) the correct AA sequence for an of-interest HPV antigen.
Zhu teaches (§Abstract, §1. Introduction, entire §; §3.3. Aptamer conjugates for immunotherapy ¶3-4, ¶6) aptamers that target immune cells and can be used in vaccine formulation.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the SNA or oligont of the copending claims with the teachings about SNA of WO883, the teachings about HPV antigens of Manuri and App455, and the teachings about immune cell-targeting aptamers of Zhu for the benefits of producing an SNA that could be used in an HPV vaccine and optimizing the vaccine. One would have been motivated to do so with a reasonable expectation of success because the copending claims are broadly drawn to SNAs and because WO883 teaches (§Abstract, ¶6) SNAs are good for use in vaccines because they can carry all of the necessary components of a vaccine, including both antigen and adjuvant and (¶14) teaches including HPV antigens.
It would have been a simple matter to modify the invention of the copending claims by including various elements (TLR-agonizing immunostimulatory oligont, HPV antigens) known in the cited prior art because the prior art teaches all of those elements were known and because the prior art (e.g., Manuri) indicates producing an HPV vaccine was of interest and teaches (WO883, Manuri, Zhu) benefits of including each element. Therefore, the claimed invention would have been obvious in view of the copending claims and the prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTHIE S ARIETI whose telephone number is (571)272-1293. The examiner can normally be reached M-Th 8:30AM-4PM, alternate Fridays 8:30AM-4PM (ET).
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RUTHIE S ARIETI
Examiner
Art Unit 1635
/RUTH SOPHIA ARIETI/Examiner, Art Unit 1635
/NANCY J LEITH/Primary Examiner, Art Unit 1636
Prosecution Insights