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 .
Claim Status
Claims 1, 4-14, and 16-19 are pending. Claims 1, 4-14, and 16-19 are rejected.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 7-8 of the remarks, filed November 26th, 2025, with respect to claims 1, 4-14 and 16-19 have been fully considered and are persuasive. The 35 USC 103 rejection of claims 1, 4-14 and 16-19 has been withdrawn.
Election/Restrictions
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears free of the art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. Search and examination has been extended to the full scope of claims 1, 4-14, and 16-19.
Claim Rejections - 35 USC § 112(a)
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, 4, 6-14 and 16-19 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.
Claim Scope (MPEP 2163(II)(A)(1))
MPEP 2163 outlines the methodology for determining adequacy of written description. MPEP 2163(II)(A)(1) instructs “For Each Claim, Determine What the Claim as a Whole Covers”.
The instant claims are directed to a toll-like receptor 7/8 agonist-cholesterol complex wherein cholesterol is linked to an active site of a toll-like receptor (TLR) 7/8 agonist via a separable linkage. Instant claim 4 lists several genera of agonists and claim 5 recites various species of TLR 7/8 agonists; however, the instant claims broadly do not specify a toll-like receptor 7/8 agonist, any structural requirements, or any particular level of activity. As such the instant claims encompass TLR 7/8 agonist-cholesterol complexes using the full scope of TLR 7/8 agonistic compounds.
Additionally, claims 10-11 are directed to vaccine compositions comprising the claimed complex whereas claims 12-14 and 16-17 are directed to a composition with an intended use for controlling immune function or preventing/treating a cancer.
Disclosed Support (MPEP 2163(II)(A)(2))
MPEP 2163(II)(A)(2) instructs “Revise the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step”. The specification discusses the field of endeavor and states:
The present disclosure relates to a toll-like receptor 7/8 agonist-cholesterol complex, and more particularly, to a complex, in which a cholesterol is linked to an active site of a toll-like receptor 7/8 agonist by means of a chemical bond with a cleavable site, and a method of preparing the same.
The specification recites the individual species of TLR 7/8 agonists of claim 5 in paragraph [0014] and lists a number of references for toll-like receptor 7/8 agonist-based materials of various classes (paragraph [0089]). The disclosure further states (paragraph [0089]):
All available toll-like receptor 7/8 agonists that can be easily inferred by those of skill in the art are included.
As further noted in MPEP 2163(II)(A)(2), “Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art.” In this situation, TLR 7/8 agonists are demonstrated to be useful for treating a wide variety of applications. For instance, Dowling teaches (Recent Advances in the Discovery and Delivery of TLR7/8 Agonists as Vaccine Adjuvants, ImmunoHorizons, Volume 2, Issue 6, July 2018, page 187):
Small molecule agonist families have been identified which activate TLR2, TLR4, TLR7, and TLR8. In relation to TLR7 and TLR8, synthetic small molecule TLR7/8 agonist–based adjuvants include synthetic chemical agonists such as imidazoquinolines (IMQs) (33–35) and benzazepines (36). IMQs, including imiquimod and resiquimod (R848), are by far the most studied to date. IMQs are small (usually ,400 Da) compounds that bear structural homology to the purine adenosine and, like naturally derived agonists, activate mammalian leukocytes via TLR7 and/or TLR8, leading to MyD88-dependent NF-kB activation (37, 38). Whereas TLR7 agonist imiquimod activates significant antiviral and modest Th1-polarizing responses from pDCs (and monocytes), including IFN-a production, agonists with more specific TLR8 activity such as the small synthetic thiazoquinoline CL075 (also known as 3M-002) activate monocytes and myeloid DCs to induce robust cytokine production that drives adaptive immunity (39) (Fig. 1)
Dowling further reports that TLR7/8 agonists have been used in vaccines for several conditions and state (page 186):
The addition of TLR7/8 agonists to vaccines is not a new concept historically. First-generation vaccines, including those consisting of inactivated or attenuated virus, contained inherent TLR7 and/or TLR8 adjuvant activity (7). Both the inactivated polio and Japanese Encephalitis vaccines, which were introduced in 1955 and 1968, respectively, contained ssRNA TLR7/8 agonists. Additionally, the highly effective live attenuated yellow fever vaccine 17D is reported to activate multiple dendritic cell (DC) subsets via TLR2, TLR7, TLR8, and TLR9 (14), whereas TLR8 is upregulated following phagocytosis of Mycobacterium bovis (Bacille Calmette–Guérin [BCG] vaccine) by THP-1 cells (15).
Chi et al. discuss anti-tumor activity of toll-like receptor agonists and list various tumor types such as ovarian, breast, bladder, prostate cancers, etc. for which TLR 7/8 agonists have been studied ((2017) Anti-tumor Activity of Toll-Like Receptor 7 Agonists. Front. Pharmacol. 8:304, pages 2-3, Table 1). Along with having varied biological applications, the chemical structure of TLR 7/8 agonists has high diversity. Chi et al. report several toll-like receptor 7/8 agonists including: imidazoquinoline-structured imiquimod, resiquimod, gardiquimod, and 852A, Loxoribine (7-
allyl-8-oxoguanosine), Bropirimine (2-amin-5-bromo-6-phenyl-4(3)-pyrimidinone), GS-9620 [8-(3-(pyrrolidin-1-ylmethyl) benzyl)-4-amino-2-butoxy-7,8-dihydropteridin-6(5H)-one], etc. (pages 4-5). As such, broad structural variability exists among TLR 7/8 agonists as evidenced by Chi et al.
Determination of Sufficient Support (MPEP 2163(II)(A)(3))
MPEP 2163(II)(A)(3) instructs “Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed”. This section of the MPEP further provides the following guidance:
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
In this situation and as discussed above, Applicant has specifically disclosed the following TLR 7/8 agonists, for the instant claimed complex:
imiquimod, resiquimod, dactolisib, gardiquimod, sumanirole, motolimod, vesatolimod, loxoribine, SM360320, CL264, 3M-003, IMDQ, and Compound 54.
MPEP 2163 (II)(A)(3)(a)(ii) discusses support for a generic claim as follows:
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 (see i)(A) above), reduction to drawings (see i)(B) above), 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 inventor was in possession of the claimed genus (see i)(C) above).
The same section notes the following:
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014)
In this situation, the many compounds embraced by the genus of toll-like receptor 7/8 agonists is beyond the scope of compounds that Applicant has sufficiently disclosed. The instant claims broadly are generic to any and all of these possible permutations as they require no specific structural features. Applicant has failed to provide “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 inventor was in possession of the claimed genus.” As such, the instant disclosure does not inform a person of ordinary skill on the various ways in which one may seek to prepare a TLR 7/8 agonist-cholesterol complex.
Dependent claims 4, 6-14 and 16-19 are rejected as lacking written description for the same reasons since they also encompass the unsupported scope of TLR agonists of instant claim 1.
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, 4-6, 9-14, and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 18/040,323 in view of Irby et al. Mol. Pharmaceutics 2017, 14, 1325−1338. and Chi et al. (2017) Anti-tumor Activity of Toll-Like Receptor 7 Agonists. Front. Pharmacol. 8:304.
Regarding instant claim 1, co-pending claim 1 discloses a toll-like receptor (TLR) 7/8 agonist drug complex wherein the drug is connected to the active site of the TLR 7/8 against via a cleavable linker and copending claim 4 recites that the linker may comprise bonds including a carbamate, disulfide, etc. Copending claim 8 teaches that the drug may be a lipid.
Irby et al. discuss various conjugation strategies for lipid-drug conjugates. Figure 1 discloses four general classes of conjugation where the conjugate drugs with fatty acids (A) possess a long chain (page 1326). Option B of Figure 1 corresponds to the instant claimed approach where the drug is conjugated with a steroid. Irby et al. teach the following about conjugate drugs with cholesterol and their utility in cancer therapeutics (page 1325):
Cholesterol and cholic acid derivatives are steroids that have
been conjugated to drug molecules. The hydroxyl group attached to the ring of steroids is the primary location of conjugation in most studies. Conjugation of drugs with cholesterol provides the benefits of decreased side effects, targeted tumor delivery, and efficient cellular uptake.12−14 Cancerous cells overexpress low-density lipoprotein (LDL)
receptors and require large amounts of cholesterol for their rapid growth.13 As a result, cholesterol drug conjugates facilitate
the loading of anticancer agents into lipoproteins. In addition,
as endogenous carriers, lipoprotein loaded drugs efficiently
target LDL receptors on malignant cells.
Accordingly, a person of ordinary skill preparing the copending complex comprising a TLR 7/8 agonist and a lipid would have been motivated to test lipid types, such as cholesterol to improve pharmacokinetics and therapeutic outcome when administering the drug conjugates.
Regarding instant claims 4-5, copending claim 7 teaches that the TLR agonist may be imidazoquinoline-based, 8-hydroxyadenine-based, etc.; however, the copending claims do not recite any individual species of agonists. Chi et al. report several toll-like receptor 7/8 agonists including: imidazoquinoline-structured imiquimod, resiquimod, gardiquimod, and 852A and discuss their utility for various tumor types (pages 2 and 4-5). Accordingly, a person of ordinary skill seeking to treat cancer as recited in copending claim 14 would have been motivated to test known TLR 7/8 agonists such as imiquimod taught by Chi et al.
Regarding instant claim 6, copending claim 3 teaches that the linker is cleaved in response to an enzyme, pH, a temperature, etc.
Regarding instant claims 9-14 and 16-17, copending claims 10 and 14 disclose methods of controlling the immune system or preventing/treating cancer by administering a pharmaceutical composition comprising the copending complex as an active ingredient. Copending claim 8 teaches that the complex may include an antigen, glycoprotein, or anticancer agent as one of the functional drugs in accordance with instant claims 10-11 and 16. Copending claims 10-11 disclose that the composition activates cells such as natural killer (NK) cells and regulates the function of immune cells such as M2 macrophages as required by instant claims 13-14.
Copending claim 16 teaches that the copending composition inhibits cancer proliferation in accordance with instant claim 17.
Instant claims 18-19 recite a product-by-process of the toll-like receptor 7/8 agonist-cholesterol complex. Regarding product-by-process claims, MPEP 2113(I) states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Therefore, complex of instant claims 18-19 are not distinguished by the method disclosed in the claim.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-12 and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of co-pending Application No. 18/040,318 in view of Chi et al. (2017) Anti-tumor Activity of Toll-Like Receptor 7 Agonists. Front. Pharmacol. 8:304.
Regarding instant claims 1 and 9-12, co-pending claim 1 discloses a composition comprising an mRNA antigen and an immune modulator wherein the immune modulator is in a complex in which a cleavable linker is linked to the active site of the immune modulator. Copending claim 4 recites that the linker may comprise bonds including a carbamate, disulfide, etc. and copending claim 7 teaches that the end of the cleavable linker is bound to cholesterol. Copending claim 9 teaches that the immune modulator may be a toll-like receptor 7/8 agonist; however, the copending claims do not recite any individual species of agonists. Regarding instant claims 4-5, Chi et al. report several toll-like receptor 7/8 agonists including: imidazoquinoline-structured imiquimod, resiquimod, gardiquimod, and 852A and discuss their utility for various tumor types (pages 2 and 4-5). Accordingly, a person of ordinary skill seeking to prepare an mRNA vaccine to prevent or treat cancer as recited in copending claim 13 would have been motivated to test known TLR 7/8 agonists such as imiquimod taught by Chi et al.
Regarding instant claim 6, copending claim 6 teaches that the linker is cleaved in response to an enzyme, pH, a temperature, etc.
Regarding instant claims 7-8, copending claim 18 discloses that the copending composition may be loaded into a nanoliposome.
Regarding instant claim 17, the copending claims teach prevention of cancer with the vaccine which embraces inhibiting recurrence of cancer.
Instant claims 18-19 recite a product-by-process of the toll-like receptor 7/8 agonist-cholesterol complex. Regarding product-by-process claims, MPEP 2113(I) states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Therefore, complex of instant claims 18-19 are not distinguished by the method disclosed in the claim.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-12 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-19 and 21 of co-pending Application No. 17/909,066 in view of Irby et al. Mol. Pharmaceutics 2017, 14, 1325−1338. and Chi et al. (2017) Anti-tumor Activity of Toll-Like Receptor 7 Agonists. Front. Pharmacol. 8:304.
Regarding instant claims 1, 4, and 7, co-pending claim 1 discloses a nanomolecule comprising a toll-like receptor 7/8 agonist in an inactive state in which a cleavable linker binds the active site of the agonist to a lipid. Copending claim 1 further teaches that the agonist may be an imidazoquinoline-, hydroxyadenine-based, etc. however, the copending claims do not recite any individual species of agonists. Regarding instant claim 5, Chi et al. report several toll-like receptor 7/8 agonists including: imidazoquinoline-structured imiquimod, resiquimod, gardiquimod, and 852A and discuss their utility for various tumor types (pages 2 and 4-5). Accordingly, a person of ordinary skill seeking to prepare a vaccine to prevent or treat cancer as recited in copending claim 14 would have been motivated to test known TLR 7/8 agonists such as imiquimod taught by Chi et al.
Copending claim 4 recites that the linker may comprise bonds including a carbamate, disulfide, etc.
Irby et al. discuss various conjugation strategies for lipid-drug conjugates. Figure 1 discloses four general classes of conjugation where the conjugate drugs with fatty acids (A) possess a long chain (page 1326). Option B of Figure 1 corresponds to the instant claimed approach where the drug is conjugated with a steroid. Irby et al. teach the following about conjugate drugs with cholesterol and their utility in cancer therapeutics (page 1325):
Cholesterol and cholic acid derivatives are steroids that have
been conjugated to drug molecules. The hydroxyl group attached to the ring of steroids is the primary location of conjugation in most studies. Conjugation of drugs with cholesterol provides the benefits of decreased side effects, targeted tumor delivery, and efficient cellular uptake.12−14 Cancerous cells overexpress low-density lipoprotein (LDL)
receptors and require large amounts of cholesterol for their rapid growth.13 As a result, cholesterol drug conjugates facilitate
the loading of anticancer agents into lipoproteins. In addition,
as endogenous carriers, lipoprotein loaded drugs efficiently
target LDL receptors on malignant cells.
Accordingly, a person of ordinary skill preparing the copending complex comprising a TLR 7/8 agonist and a lipid would have been motivated to test lipid types, such as cholesterol to improve pharmacokinetics and therapeutic outcome when administering the drug conjugates.
Regarding instant claim 6, copending claim 6 teaches that the linker is cleaved in response to an enzyme, pH, a temperature, etc.
Regarding instant claim 8, copending claim 8 teaches that the nanomolecule may be a nanoliposome.
Regarding instant claims 9-12 and 16, copending claims 10-13 teach a vaccine composition comprising the copending nanomolecule and an antigen, wherein the antigen is a glycoprotein, and wherein the composition is for preventing or treating cancer and further comprises a chemotherapeutic agent.
Copending claim 15 teaches that the copending composition inhibits cancer proliferation in accordance with instant claim 17.
Instant claims 18-19 recite a product-by-process of the toll-like receptor 7/8 agonist-cholesterol complex. Regarding product-by-process claims, MPEP 2113(I) states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Therefore, complex of instant claims 18-19 are not distinguished by the method disclosed in the claim.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626