Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-4, 6, 8, 10-12, 15-23 and 43-48 are pending in the application. Claims 1-4, 6, 8, 10-12, 15-23 and 44-48 are rejected. Claim 43 is withdrawn from further consideration.
Election/Restrictions
Applicant’s election of the species of compound A204 to prosecute the invention of Group I, claims 1-4, 6, 8, 10-12, 15-23 and 44-48, in the reply filed on September 16th, 2025 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)).
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable. Therefore, according to MPEP 803.02:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. […]
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. […]
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-4, 6, 8, 10-12, 15-23 and 44-48 have been examined to the extent that they are readable on the elected embodiment.
Furthermore, the search and examination was extended to include the scope where the TLR2 agonist is PAM2CSK4 or PAM3CSK4.
Any additional issues, such as under 35 USC 112(b), were discovered incidental to the examination of the elected species and are presented below in the interest of compact prosecution.
Claim 43 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 16th, 2025.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/AU2021/050506, filed May 26th, 2021, which claims priority under 35 U.S.C. 119(a-d) to AU2020901711 and AU2020902151, filed May 26th, 2020 and June 26th, 2020.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on December 30th, 2025, April 24th, 2025, December 18th, 2024, May 9th, 2024, January 23rd, 2024 and December 14th, 2022.
Claim Rejections - 35 USC § 112(b)
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, 10-12 and 15-21 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.
Claim 3 is rejected as indefinite since the variable definitions refer to “each z” and “each X” where the structure of formula A2 only requires one instance of the noted variables. It is unclear to which other instances the claim is referring.
Claim 8 is rejected as indefinite since the definition of R19 recites an option “A2” where the claim text only defines a variable “A2”. Compare claim 3 that recites both an instance of “A2” and “A2” that are each defined differently.
Claims 10-12, 15-21 are rejected as indefinite since they each refer to a “method of claim [#], or a pharmaceutically acceptable salt, solvate or prodrug thereof, wherein…”. It is unclear if Applicant is attempting to claim both methods and products in the same claim or if the claim should refer to, for instance, a “method of claim [#], wherein in the TLR2 agonist or pharmaceutically acceptable salt, solvate or prodrug thereof…”.
Claim 23 is rejected because it refers to compounds A201-A232 of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”. It is suggested that Applicant either define the compounds in the claim by name or structure.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma et al. Molecular Immunology 2020, 120, 52-60.
Sharma et al. teach in the abstract: “Avian infectious bronchitis (IB) is an acute, highly infectious and contagious viral disease of chickens caused by avian infectious bronchitis virus (IBV) belonging to the genus Coronavirus and family Coronaviridae.” The authors teach the following results on page 58: “In conclusion, the optimum dose(s) of TLR agonists (chosen on the basis of significantly reduced virus titers without causing mortality of embryos), when administered in ovo in chicken embryo can interfere with the replication of IBV. The timings of TLR ligands treatment also had significant impact on the inhibition of virus replication in a way that only LPS reduced virus titer pre- and post-IBV infection but Pam3CSK4 and CpG ODN reduced virus titer only when administered pre-IBV infection.” The prior art teaches on page 53 that Pam3CSK4 is a TLR2 ligand and where page 58 notes the compounds are agonists. Accordingly, since the prior art teaches administration of the TLR2 agonist Pam3CSK4 to subjects and reducing virus titers in said subjects, the prior art anticipates instant 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.
Claim(s) 1, 2, 44, 46 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/044839 A2 by Dickey et al., as evidenced by Kang et al. Immunity 2009, 31, 873-884.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Dickey et al. teach compositions comprising a lipoprotein where the lipoprotein can specifically be PAM2CSK4 (page 35, claims 1 and 2). Dickey et al. do not specifically teach that PAM2CSK4 is TLR2 agonist or that it is an agonist of a heterodimer of TLR2 and TLR6; however, the evidentiary reference by Kang et al. teaches that PAM2CSK4 activates TLR2 (page 875, right column) and binds to the TLR2/TLR6 heterodimer (Figure 1, page 874).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach a specific embodiment where PAM2CSK4 was administered to a subject and reducing coronavirus infection in the subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Dickey et al. teach the following methods on page 35:
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Dickey et al. teach that the compositions can be used in treating coronavirus infections including SARS-COV and MERS-COV, which are both recited in instant claim 47 and are betacoronaviruses in lineage C (MERS-COV) or lineage B (SARS-COV) as embraced by instant claim 46. At least in the interest of optimizing treatments for the individual types of viruses taught by Dickey et al., a person having ordinary skill in the art would have been motivated to test the exemplary lipoproteins including PAM2CSK4 in the conditions taught by the prior art including coronavirus as embraced by instant claims 1, 44, 46 and 47.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/044839 A2 by Dickey et al., as evidenced by Kang et al. Immunity 2009, 31, 873-88, as applied to claims 1, 2, 44, 46 and 47 above, and in further view of Cui et al. Nature Reviews 2019, 17, 181-192.
While Kang et al. generally teach application in the Coronaviridae family, Cui et al. teach on page 181: “The alphacoronaviruses and betacoronaviruses infect only mammals. The gammacoronaviruses and deltacoronaviruses infect birds, but some of them can also infect mammals24. Alphacoronaviruses and betacoronaviruses usually cause respiratory illness in humans and gastroenteritis in animals.” At least since paragraph [00031] of Kang et al. refers to “the type of mammal being treated,” a person having would have been motivated to apply the compositions in types of coronavirus known to infect mammals as embraced by instant claims 45 where Cui et al. teach subgroups 1a and 1b for alphacoronaviruses on page 184.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/044839 A2 by Dickey et al., as evidenced by Kang et al. Immunity 2009, 31, 873-88, as applied to claims 1, 2, 44, 46 and 47 above, and in further view of Tang et al. PLoS Pathog 2020, 16, e1008536.
While Kang et al. was filed in 2015 and published in 2016 and generally teach application in the Coronaviridae family, Tang et al. teach SARS-CoV-2 is a type of coronavirus originating in 2019. At least in the interest of expanding the utility of the compositions taught by Kang et al., a person having ordinary skill in the art would have been motivated to apply the compositions in types of coronavirus discovered after the disclosure of Kang et al.
Claim(s) 1-4, 6, 8, 10-12 and 15-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/257870 A1 by Demaison et al. in view of Sharma et al. Molecular Immunology 2020, 120, 52-60.
The applied reference by Demaison has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Demaison et al. teach (abstract) TLR2 agonist compounds in the prevention and/or treatment of respiratory infections, or diseases or conditions with viral or bacterial infections. The prior art teaches compounds of the following general formula A-Y-B (page 2) where the corresponding pieces have the same definitions as instant claim 1. As an example of the genus, the prior art teaches the following compound on page 60:
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The structure above corresponds to Applicant’s elected species and corresponds to the instant variables as discussed in the remarks dated September 16th, 2025 (except where m is 2 instead of 1), which are embraced by instant claims 1-4, 6, 8, 10-12, 15-23. Applicant implies in the remarks that claim 18 does not correspond to the elected species; however, in the elected species since b is 0, R11 and R12 can be considered hydrogen. Similarly regarding claim 4, the definitions cited by Applicant are embraced by instant claim 4 although the remarks imply that claim 4 does not embrace the elected species where the A2 and PEG moieties are linked by a serine residue.
Regarding utilities, the prior art teaches on page 14 (line 19) through page 15 (line 19) that the compounds can be used in treating and/or preventing conditions including respiratory infections and diseases or conditions associated with the TLR2 receptor.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach application of the compounds in reducing a coronavirus infection in a subject. Additional limitations of dependent claims are addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
While Demaison et al. do not specifically teach the application of their TLR2 agonists in coronavirus infections, Sharma et al. teach in the abstract: “Avian infectious bronchitis (IB) is an acute, highly infectious and contagious viral disease of chickens caused by avian infectious bronchitis virus (IBV) belonging to the genus Coronavirus and family Coronaviridae.” Sharma et al. further teach the following results on page 58: “In conclusion, the optimum dose(s) of TLR agonists (chosen on the basis of significantly reduced virus titers without causing mortality of embryos), when administered in ovo in chicken embryo can interfere with the replication of IBV. The timings of TLR ligands treatment also had significant impact on the inhibition of virus replication in a way that only LPS reduced virus titer pre- and post-IBV infection but Pam3CSK4 and CpG ODN reduced virus titer only when administered pre-IBV infection.” The prior art teaches on page 53 that Pam3CSK4 is a TLR2 ligand and where page 58 notes the compounds are agonists. At least since Sharma et al. teach application of TLR2 agonists in IBV, a person having ordinary skill in the art seeking to develop an optimum treatment would have been motivated to test the use of known TLR2 agonists including those of Demaison et al.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 6, 8, 10-12 and 15-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,017,979 in view of WO 2020/257870 A1 by Demaison et al. and in further view of Sharma et al. Molecular Immunology 2020, 120, 52-60. The claims of the patent recite the instant elected species (claim 2 of the patent) For the same reasons as discussed under the corresponding 103 rejection, which is incorporated here by reference, a method of treating IBV would have been an obvious utility of the compound recited in the patent in view of Demaison et al. and Sharma et al.
Claims 1-4, 6, 8, 10-12 and 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-16, 19, 23-26, 29, 30, 32 and 52 of copending Application No. 17/622,451 in view of WO 2020/257870 A1 by Demaison et al. and in further view of Sharma et al. Molecular Immunology 2020, 120, 52-60. The claims of the copending case recite compounds including the instant elected species (claim 23 of the copending case) and further claims methods of treating conditions in claim 25 of the copending case. For the same reasons as discussed under the corresponding 103 rejection, which is incorporated here by reference, a method of treating IBV would have been obvious in view of Demaison et al. and Sharma et al.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 6, 8, 10-12 and 15-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14-19, 23 and 24 of copending Application No. 18/688,369 in view of WO 2020/257870 A1 by Demaison et al. and in further view of Sharma et al. Molecular Immunology 2020, 120, 52-60. The claims of the copending case recite compositions comprising the instant elected species (claim 17 of the copending case) and further claims methods of treating conditions associated with the TLR2 receptor in claim 24 of the copending case. For the same reasons as discussed under the corresponding 103 rejection, which is incorporated here by reference, a method of treating IBV would have been obvious in view of Demaison et al. and Sharma et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626