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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-5, 7, 11, 13, 14 and 17 and the species of influenza or influenza-associated antigen, in the reply filed on 3/6/26 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Claims 19, 21-23, 27-30 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/6/26.
Claim Status
Claims 6, 8-10, 12, 15-16, 18, 20, 24-26, 31 and 33-35 are cancelled.
Claims 1-5, 7, 11, 13, 14, 17, 19, 21-23, 27-30 and 32 are pending.
Claims 19, 21-23, 27-30 and 32 are withdrawn.
Claims 1-4, 7, 11, 13, 14 and 17 are presented for examination on the merits as they read on the elected subject matter.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/6/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner. References without a publication date have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. On page 35, the specification recites: “(https://www.ema.europa.eu/en/documents/scientific-discussion/aldara-epar-scientificdiscussion_en.pdf)”. 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.
Claim Objections
Claim 4 is objected to because of the following informalities: there is an inappropriate space that separates the term here:
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Claim 5 is objected to because of the following informalities: there is an inappropriate space that separates the term here:
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. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4, 5, 7, 14 and 17 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.
Regarding claims 5, 7 and 17, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same 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 § 2173.05(c). In the present instance, claim 5 recites the broad recitation of a plurality of cyclodextrins, and the claim also recites “advantageously, wherein the cyclodextrin is or includes 2-hdryoxypropyl-β-cyclodextrin” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 7 recites the broad recitation of “at least about 6.5”, and the claim also recites “preferably at least pH 7” and “suitably between about pH 6.5- 9 or between about pH 6.5 - 8.5 or between about pH 6.5- 8 or between about pH 7 - 9 or between about pH 7 - 8.5 or between about pH 7 - 8 or between about pH 7.5 - 9” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 17 recites the broad recitation of “at least about 6.5”, and the claim also recites “preferably at least pH 7” and “suitably between about pH 6.5- 9 or between about pH 6.5 - 8.5 or between about pH 6.5- 8 or between about pH 7 - 9 or between about pH 7 - 8.5 or between about pH 7 - 8 or between about pH 7.5 - 9” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 4, 14 and 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Please note that claim 17 has three instances of “such as”.
Correction is required.
Claim 17 is further 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. Claim 17 recites: “a Herpes simplex (HSV-1 or HSV-2)” twice. Parenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). These claims contain parentheses which raises the question as to which term is required by the claim because the subject matter in the parentheses is not identical in scope. Essentially, the claims use both narrow species “(HSV-1 or HSV-2)” and broad “a Herpes simplex” genus. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Similarly, the claim recites the narrow species of “Streptococcus pneumoniae” and the broad genus of “(Streptococcus)” twice.
Correction is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 7, 11, 13, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fahmy et al. (EP3520780 of record).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims for example a vaccine adjuvant as described in claim 1 (in part presented below):
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a vaccine adjuvant research scientist, as is the case here, then one can assume comfortably that such an educated artisan will possess specialized knowledge in immunology, formulation chemistry, and molecular biology to enhance vaccine efficacy. They understand how to activate innate immune cells—such as Toll-like receptors (TLRs)—to boost immune responses. They also specialize in developing delivery systems (e.g., emulsions, nanoparticles) to optimize the strength, durability, and safety of vaccines. Such an artisan will draw conventional ideas from vaccine adjuvant formulation components and delivery strategies— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-4 and 13, Fahmy et al. teach a nanolipogel, which is a nanoparticle [0031, 0093], delivery vehicle comprising a lipid layer surrounding a hydrogel core containing a cyclodextrin host molecule reversibly associated with a first active agent (Abstract; [0013, 0021, 0033]; claims 1-2 and 4) in a water swellable polymeric matrix core formed of, for example, one or more block copolymers and/or one or more tri-block copolymers each containing: one or more poly{alkylene oxide) segments and one or more aliphatic polyester segments, wherein the poly{alkylene oxide) segments are polyethylene glycol, polypropylene 1,2-glycol, poly{propylene oxide), and/or polypropylene 1,3-glycol segments and the aliphatic polyester segments are polylactic acid (PLA), polyglycolic acid (PGA), and/or polylactide-coglycolide (PLGA) segments (Claim 9). Thus, it is an inner aqueous hydrogel core. Fahmy et al. teach that the active agent can be an immunotherapeutic or oligonucleotide drug comprising DNA or RNA (Claim 5; [0075]) and immunological adjuvants TLR7 ligands such as imiquimod and resiquimod (Claim 6; [0074]). Fahmy et al. teach: “the host is a molecule that forms an inclusion complex with an active agent. Inclusion complexes are formed when an active agent (i.e., the guest) or portion of an active agent inserts into a cavity of another molecule, group of molecules, or material (i.e., the host).” [0019] Thus, the imidazoquinoline imiquimod and resiquimod active agents in the core matrix with the host cyclodextrin that is capable of reversibly forming a complex with the imidazoquinoline/complexes the imidazoquinoline. Fahmy et al. teach: “the nanolipogel is loaded with a molecule that serves as an adjuvant and the nanolipogel thereafter incorporates one or more target antigens after formation, for the controlled release of adjuvant together with the antigens.” [0011] And: “one of the agents is an antigen and a second agent is an immunoadjuvant, resulting in sustained release of the antigen together with the adjuvant to optimize an immune response.” [0014]. Thus, Fahmy et al. reasonably teach an adjuvant composition where the antigen is capable of inducing an immune response. Also note that optional components of instant claim 4 are not required.
Regarding claim 5, Fahmy et al. teach that the cyclodextrin is a cyclodextrin selected from α-cyclodextrins, βcyclodextrins, and y-cyclodextrins functionalized with one or more pendant acrylate or methacrylate groups (Claim 10). Fahmy et al. teach numerous species of cyclodextrin [0061-0063] including 2-hydroxypropyl β-cyclodextrin [0062].
Regarding claim 7, Fahmy et al. teach administration in aqueous solutions in the form of suspensions or emulsions that include buffered saline ([0103, 0114]; claims 12-13).
Regarding claims 1 and 11, Fahmy et al. teach: vaccine delivery (Example 12) and that antigen and vaccine formulations as the agent complexed to the host molecules, dispersed within the polymeric matrix, dispersed in or bound to the lipid shell or combinations thereof (Claims 3 and 7). Thus, Fahmy et al. teach and suggest a vaccine adjuvant composition and a vaccine composition. Fahmy et al. teach that liposomes and polyesters are two of the most ubiquitous platforms in vaccine delivery studies [0005].
Regarding claims 11, 13 and 14, Fahmy et al. teach: “bioactive fragments thereof (including humanized, single chain, and chimeric antibodies), antigen and vaccine formulations (including adjuvants), peptide drugs, anti-inflammatories, immunomodulators (including ligands that bind to Toll-Like Receptors (including but not limited to CpG oligonucleotides) to activate the innate immune system, molecules that mobilize and optimize the adaptive immune system” [0071]. Fahmy et al. teach: “Peptide, protein, and DNA based vaccines may be used to induce immunity to various diseases or conditions.” Fahmy et al. teach: “the nanolipogel is part of a vaccine strategy. For example, the nanolipogel can be used to deliver an antigen, an immunostimulant, an adjuvant, or a combination thereof. In some embodiments, the nanolipogel includes a target moiety that directs the delivery vehicle to specific immune cells, for example, antigen presenting cells such as dendritic cells. In some embodiments, the nanolipogel includes one or more antigen presenting cell targeting moieties displayed on the outer shell, and TLR ligands inside or outside the nanolipogel, alone or in combination with an antigen. The antigen can be any known antigen, for example, an antigen derived from a bacteria, a virus, a fungi, a parasite, or another microbe, or tumor antigens or environmental antigens.” [0138] Thus, the antigen is at least associated with the outer lipid shell of the nanoparticles. Cancer vaccine strategy is taught including delivery of one or more tumor associated antigens [0142].
Regarding claim 17, Fahmy et al. teach that the diseases to be treated include a therapeutic or prophylactic strategy [0133] using influenza fusion peptide [0134], which is an influenza antigen/associated antigen. Fahmy et al. teach treating viral infectious diseases [0150].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Fahmy et al. is that Fahmy et al. do not expressly teach a vaccine adjuvant that is buffered to a pH of at least about 6.5 with influenza or influenza associated antigen. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the nanolipogel of Fahmy et al. as a vaccine adjuvant buffered to a pH of at least about 6.5 with influenza or influenza associated antigen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Fahmy et al. expressly teach employing influenza fusion peptide, which is an influenza antigen/associated antigen [0134]. It is merely judicious selection of the antigens taught by Fahmy et al., such as influenza antigen/associated antigen, for use in the nanolipogel vaccine strategy with a reasonable expectation of success. Regarding the pH, Fahmy et al. teach buffered aqueous solutions/suspension for parenteral administration [0098, 0103]. Accordingly, the ordinary artisan would buffer the parenteral composition to be suitable for injection which would include physiological pH values of at least about 6.5 with a reasonable expectation of success.
Claim 2 is further rejected under 35 U.S.C. 103 as being unpatentable over Fahmy et al. (EP3520780), as applied to claims 1-4, 7, 11, 13, 14 and 17 above, in further view of Patinote et al. (EuropeanJournalofMedicinalChemistry193(2020)112238; 37 pages).
Applicant claims:
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The reference of Fahmy et al. is discussed in detail above and that discussion is incorporated by reference.
Regarding claim 2, Patinote et al. teach TLR7/8 ligands include imidazo[4,5-c]quinolines such as resiquimod (Figure 1, page 3; Figure 20, page 13), imiquimod (Page 14, right column 3.3.3.1 Imidazo[4,5-c]quinoline series; Figure 20, page 13), gardiquimod (Figure 24, page 16), S28690 (Table 1, page 19), 852A (Table 3, page 24; Figure 23, page 15), CL075 (Page 15, left column last paragraph; Figure 23, page 15), 3M-011 (854A) (Figure 23, page 15) and CL097 (Page 15, left column; Figure 22, page 14).
The difference between the instant application and Fahmy et al. is that Fahmy et al. do not expressly teach all the TLR7/8 ligands claimed. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the nanolipogel of Fahmy et al. as a vaccine adjuvant with all the TLR7/8 ligands claimed, as suggested by Patinote et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Fahmy et al. teach one or more immunological adjuvants selected from TLR ligands (Claim 6), which would include the TLR7/8 ligands claimed as taught by Patinote et al. It is merely employing other known TLR7/8 ligands by the ordinary artisan with a reasonable expectation of success. “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
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 1-4, 7, 11, 13, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-8 and 11 of copending Application No.18700066. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application is also directed to a nanoparticle for co-delivery and sustained release of an active TLR7/8 imidazoquinoline and a protein cytokine that comprises an outer lipid shell and inner aqueous core encapsulated within the outer lipid shell (Claim 1) where the inner core comprises a cyclodextrin host molecule that is capable of reversibly forming a complex with the imidazoquinoline (Claim 2) that is imiquimod, resiquimod, gardiquimod, S28690, 852-A, 854A, CL075 or CL097 (Claim 5) and the inner core comprises a hydrogel polymer (Claim 6) with targeting agents on the outer surface of the lipid shell (Claim 7) and in the form of an aqueous solution, dispersion or suspension buffered to a pH of at least about 6.5 (Claim 8). The composition of claim 8 is used in methods of stimulating or enhancing a therapeutic or protective immune response or for treating cancer (Claim 11). Accordingly, the co-pending teaches a vaccine adjuvant composition as instantly claimed.
The co-pending does not expressly teach a viral, bacterial, fungal or disease- or cancer-associated antigen capable of inducing an immune response. However, since the co-pending expressly teaches stimulating or enhancing a therapeutic or protective immune response or for treating cancer and that the targeting agents can be an antibody, peptide, protein, aptamer or small molecule targeting agent (Claim 7), then it is obvious to employ an antigen, which is a foreign substance from bacteria, viruses or toxins, that can elicit an immune response, such an influenza antigen on the outer lipid shell of the nanoparticles to make a vaccine composition. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the co-pending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, 11, 13, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6 and 8-17 of copending Application No.19140585. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application is also directed to a nanoparticle for delivery of a TLR7/8 imidazoquinoline and one or more polynucleotides where the nanoparticle comprising an outer lipid shell and an inner aqueous core within the outer shill that comprises a cyclodextrin host molecule capable of reversibly forming a complex with the TLR7/8 agonist such as resiquimod (Claims 1, 6, 8-11 and 13). The inner aqueous core has a pH of at least about 6.5 (Claim 2) and the composition is buffered to a pH of at least about 6.5 (Claim 14). The inner core comprises a hydrogel polymer (Claim 12). The co-pending teaches a vaccine composition with an immunogenic antigen that is capable of inducing an immune response and/or an immunogenic polynucleotide that encodes an antigen capable of inducing an immune response (Claim 16) wherein the immunogenic antigen is a viral, bacterial, fungal or disease-associated or cancer associated antigen; and/or wherein the immunogenic polynucleotide encodes a viral, bacterial, fungal or disease-associated or cancer-associated antigen (Claim 17).
The co-pending does not expressly teach all the cyclodextrin derivatives [0054-0055]. However, the scope of the co-pending includes all of the cyclodextrin derivatives. MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
The co-pending does not expressly teach an influenza antigen/associated antigen. However, the scope of the co-pending includes influenza or influenza associated antigen ([0096-0097]; Example 9).
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the co-pending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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