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, 6, 8, 10-12, 15-23 and 43-48 are pending in the application. Claims 1, 6, 8, 10-12 and 15-23 are rejected. Claims 44-48 are objected to. Claim 43 is withdrawn from further consideration.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on May 12th, 2026.
Response to Amendment / Argument
On page 21 of the response filed May 12th, 2026, Applicant begins traversing the rejection of claims under 35 USC 103 over WO 2020/257870 A1 by Demaison et al. in view of Sharma et al. Molecular Immunology 2020, 120, 52-60. Applicant asserts on page 22 that “there is no teaching or suggestion in Demaison that these compounds (or other TLR2/6 heterodimer agonists) could also be effective against coronaviruses, and much less SARS-CoV-2…”. The rejection is not made over treating SARS-CoV-2. Furthermore, the prior art is presumed to be operable and enabled. See MPEP 2121. Demaison teaches that the compounds are useful in treating respiratory infections and conditions associated with viral infections.
On page 22 of the response, Applicant refers to alleged surprising results of the instant compounds being useful in treating coronaviruses. Applicant, however, has not presented data commensurate in scope with the instant claims where instant claim 1 places no limitation on dosage amounts or the type of coronavirus. The data in the instant specification appears to be largely focused on SARS CoV-2, which is not the subject of the rejection.
On page 23 of the response, Applicant asserts that Sharma constitutes a teaching away since states “LPS appeared to be the better candidate for adjuvant against IBV.” MPEP 2123(II) notes that nonpreferred and alternative embodiments constitute prior art. Sharma et al. establish the treatment of IBV as a workable embodiment within the generic disclosure of Demaison et al. Demaison et al. teach that the compounds are useful in treating conditions associated with viral infections and Sharma et al. teach that compounds having similar properties to those in Demaison et al. can positively affect IBV. The fact that Sharma et al. suggest that other compounds might be better suited to treat IBV does not detract from the treatment of IBV being an operable embodiment within the scope of Demaison et al. The same rationale applies to the argument regarding a TLR1/2 selective agonist versus a TLR2/6 selective agonist. It appears that Applicant is arguing that a person having ordinary skill in the art would recognize the treatment of IBV to be an inoperable embodiment within the scope of Demaison et al. (and by extension within the scope of claims cited in a double patenting rejection, i.e. in Application Serial No. 17/622,451). As noted above, the prior art is presumed to be operable and enabled.
On pages 23 and 24 of the response, Applicant traverses the double patenting rejections on the same grounds as for 103 or requests that a rejection be held in abeyance. Since the arguments for 103 are not found persuasive, the rejections below are maintained.
All other objections and rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims. Therefore, arguments pertaining to these objections and rejections will not be addressed.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 provides for the alternative formation of a “salt… thereof” whereas parent claim 1 only encompasses “a pharmaceutically acceptable salt… thereof”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 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, 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.
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, 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, 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, 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.
Allowable Subject Matter
Claims 44-48 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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