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
1. Claims 1-30 are pending.
Priority
2. This application is a 371 of PCT/US2021/061863 12/03/2021; PCT/US2021/061863 has PRO 63/121,120 12/03/2020. Applicant’s claim for the benefit of a prior-filed application PRO 63/121,120 is acknowledged, however applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, provisional Application No. of PRO 63/121,120 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ’120 application presents a genus that is different from that of the instant claims and has different species and no doubly charged naked ammonium cations. The provisional 63/121,120 has only the phenyl compounds with a linker X joining a propyl group:
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The genus of claim 10 has pyridine compounds and a large number of other R2 definitions besides the propyl type groups with A, where A is a saturated ring. Claim 10 has a subgenus with the elected species of Formula II-a, and claim 18 has some species of the instant claim 19, the furans and spirocycles for example are not present. Accordingly there is no support for the claims as presented in the provisional Application No. PRO 63/121,120. The claims are afforded the date of December 3, 2021.
Restriction/Election Maintained
3. Applicant’s election of group II and the species, UMB18,
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in the reply filed on December 8, 2025 was previously 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 § 818.03(a)). According to applicants’ representative claims 10-12, 14, 16-17, 19 read on the elected species. The elected species was a compound where in Formula II, R3a/R3b is H and/or the 2-fluoro-phenethyl group, X is CR1d where R1d is H, R1a is H, R1b is -OMe, R1c is H, R2 is the propan-2-ol-(3-piperazine group where Xb is -N-(C1-C5-alkyl)- where the alkyl is methyl. These structures were canceled from claim 1 and the proviso in claim 10 excludes these compounds. After the amendments no claims read on the elected species. The examination was extended to the next species chosen by the examiner, the second compound 2002 on page 17 of claim 19. This species is a compound where in Formula II, R3a/R3b are joined together to from the first group with a terminal tetrahydrofuran, X is CR1d where R1d is H, R1a is H, R1b is H, R1c is H, R2 is ethyl. As detailed in the following rejections, this species and the generic claim encompassing the species was not found patentable. The search and examination was continued until prior art was found that anticipated or rendered obvious the species that falls within the scope of the generic Markush claim reading on the elected species. As per MPEP 803.02 II. C. “[T]he examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art.” The examiner “need not continue to search the claim if the claim is rejected over prior art”. [ibid. D.] Therefore, the provisional election of species is given effect, the examination is restricted to the next species chosen by the examiner, the compound 2002 and claims not reading on the elected species are held withdrawn. Accordingly, claims 13, 15, 18, which do not read on the elected species are withdrawn. Claims 1-9, 20-30 are withdrawn as being drawn to a non-elected invention.
Claim Rejections/Objections Withdrawn
4. The rejection of claim 19 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 is withdrawn in view of the amendments. The rejection of claim 19 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, is withdrawn based on the amendments. The rejection of claims 10-12, 14, 16-17, 19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for prodrugs or cocrystals is withdrawn based on the amendments. The rejection of claim(s) 10-12, 14, 16-17, under 35 U.S.C. 102(a)(1) as being anticipated by a publication and based upon a public use or sale of the invention over the STN-Chemical database registry # RN 1070763-39-1 entry for α-[[2-[[[2-(2-fluorophenyl)ethyl]amino]methyl]-5-methoxyphenoxy]methyl]-4-methyl-1-Piperazineethanol, SR Chemical Library Supplier: ChemBridge Corporation ED Entered STN: 04 Nov 2008 is withdrawn based on the amendments. The rejection of claim(s) 10-12, 14, 16-17, under 35 U.S.C. 102(a)(1) as being anticipated by Billich US 5,538,997 is withdrawn based on the amendments. The rejection of claims 10-12, 14, 16-17, under 35 U.S.C. 102(a)(1) as being anticipated by a publication and based upon a public use or sale of the invention over the STN-Chemical database registry # RN 1292541-70-1 entry for 2-[[[2-(2-Fluorophenyl)ethyl]amino]methyl]-5-methoxyphenol, SR Chemical Catalog Supplier: Ryan Scientific, Inc. ED Entered STN: 10 May Nov 2011 is withdrawn based on the amendments. The rejection of claim(s) 19 under 35 U.S.C. 102(a)(1) as being anticipated by a publication and based upon a public use or sale of the invention over the STN-Chemical database registry # RN 1070689-57-4 entry for 1-(2-methoxyethyl)-N-[[2-(2-propen-1-yloxy)phenyl]methyl]-N-[(tetrahydro-2-furanyl)methyl]-4-Piperidinemethanamine, SR Chemical Library Supplier: ChemBridge Corporation ED Entered STN: 04 Nov 2008 is withdrawn based upon the amendments. The rejection of claims 10-12, 14, 16-17, under 35 U.S.C. 102(a)(1) as being anticipated by Weston, Stuart et. al. “The “SKI complex is a broad-spectrum, host-directed antiviral drug target for coronaviruses, influenza, and filoviruses.” Proceedings of the National Academy of Sciences of the United States of America, 2020, 117(48), 30687-30698 (with SI) published online November 12, 2020 is withdrawn based on the amendments. The rejection of claim(s) 19 under 35 U.S.C. 103 as being unpatentable over Weston as applied to claims 10-12, 14, 16-17, above, and further in view of Pandit AND Stahl AND Paulekuhn is withdrawn based on the amendments.
Claim Rejections/Objections Maintained/ New Grounds of Rejection
5. The rejection of claims 10-12, 14, 16-17, 19 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8-18 of copending Application No. 17/616,586 is maintained. Applicant's arguments filed May 1, 2026 have been fully considered but they are not persuasive.
The rejection of claim(s) 10-12, 14, 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by a publication and based upon a public use or sale of the invention over the STN-Chemical database registry # RN 1070689-57-4 entry for 1-(2-methoxyethyl)-N-[[2-(2-propen-1-yloxy)phenyl]methyl]-N-[(tetrahydro-2-furanyl)methyl]-4-Piperidinemethanamine, SR Chemical Library Supplier: ChemBridge Corporation ED Entered STN: 04 Nov 2008 is maintained. Applicant's arguments filed May 1, 2026 have been fully considered but they are not persuasive.
Various new grounds of rejection are set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 10-12, 14, 16-17 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 10, with the amendment of May 1, 2026, adds 3 new provisos which deal with each of the subject compounds of the 102 rejections in the previous office action in part. While species in claim 19 are disclosed for at least the Chembridge compound and the compound of Weston, the proviso is not so limited to these compounds since not all the variables of the species are in the proviso. This is new matter. The 2nd proviso directed to the compound of Billich and the compound from Ryan scientific cited in the previous action and is wholly unsupported since the compound defined, or at least the subgenus sans R1, is not disclosed in the specification. This is also new matter.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 10-12, 14, 16-17, 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8-18 of copending Application No. 17/616,586. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending generic claims while somewhat narrower are also the subject of the instant claims where in Formula (II) claim 10 R2 is the propan-2-ol-(3-piperazine/3-piperidine/3-pyrrolidine) group where Xb is CH2, -NH- or -N-(C1-C5-alkyl)-. The copending claimed genus embraces the compound in claim 19 at least where there is a propyl-2-hydroxy-( 3-piperidine/3-pyrrolidine) group as in compounds 2011. The species in copending claim 18 of Formula II-a and II-b fall under the claimed genus 10, as discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
8. Claim(s) 10-12, 14, 16-17, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN-Chemical database registry # 1379252-14-8 for 2-(Aminomethyl)-5-methoxy-4-methylphenol SR Chemical Catalog Supplier: FCH Group ED Entered STN: 17 Jun 2012. This is a compound of claim 10 where in Formula II, R3a/R3b is H, X is CR1d where R1d is H, R1a is H, R1b is -OMe, R1c is methyl, R2 is H. This compound is listed as being commercially available by the company FCH Group.
9. Claim(s) 10-12, 16, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a publication and based upon a public use or sale of the invention over the STN-Chemical database registry # RN 551922-78-2 entry for CN 4-Piperidinecarboxamide, 1-[(2-ethoxyphenyl)methyl]-N-[(tetrahydro-2-furanyl)methyl]- (CA INDEX NAME), SR Chemical Catalog Supplier: Ambinter ED Entered STN: 21 July 2003. This compound reads on claim 10 where in Formula II, R3a and R3b are joined together to form the 1st selection the piperidine with a terminal tetrahydrofuran, X is CR1d where R1d is H, R1a is H, R1b is -H, R1c is H, R2 is ethyl. This is the compound 2002 in claim 19. This compound is listed as being commercially available by the company Ambinter.
10. Claim(s) 10-12, 14, 16-17, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a publication and based upon a public use or sale of the invention over the STN-Chemical database registry # RN 1070689-57-4 entry for 1-(2-methoxyethyl)-N-[[2-(2-propen-1-yloxy)phenyl]methyl]-N-[(tetrahydro-2-furanyl)methyl]-4-Piperidinemethanamine, SR Chemical Library Supplier: ChemBridge Corporation ED Entered STN: 04 Nov 2008. This compound reads on claim 10 where in Formula II, R3b is the methyl-THF selection 4th, R3a is the piperidine group selection 5th, where R5 is the last selection, R1d is H, R1a is H, R1b is H, R1c is H, R2 is C3 alkenyl (allyl). This compound was entered on November 4, 2008 and is listed as being commercially available by the company ChemBridge. The on sale bar is met since the documentation shown previously is evidence that this material was subject to an offer for sale.
Conclusion
11. 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 DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621
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