NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/JP2021/044426, filed Dec. 3, 2021, which claims benefit of foreign priority to Japanese application 2021-052802, filed Mar. 26, 2021.
Claims 1-10, 12, and 13, as amended, are pending.
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 .
Priority
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Nov. 14, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (USPN 9,351,949, cited on PTO-892), as evidenced by Sakai et al. (J. Virology 88 (10), 5608-5616, cited on the IDS dated 11/14/2023).
Tanaka et al. claim methods for ameliorating symptoms in a subject having an influenza viral infection, comprising administering to the subject a therapeutic agent for influenza viral infection comprising a compound represented by formula (I) or a salt thereof:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
,
wherein R1 and R2 are each a hydrogen atom, i.e., 5-aminolevulinic acid (5-ALA); and wherein the therapeutic agent for influenza viral infection further comprises an iron compound, specifically sodium ferrous citrate (claims 1-8).
Thus, Tanaka et al. claim a therapeutic agent comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate, which reads on the pharmaceutical compositions recited by claims 1-8, and the kit recited by claim 13.
Tanaka et al. do not explicitly disclose that the therapeutic agent comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate is "for suppressing the expression of type II transmembrane serine protease (TMPRSS2)," as recited by claims 1 and 13, or "for suppressing the expression of angiotensin converting enzyme 2 (ACE2)", as recited by claim 2.
However, as recognized by MPEP § 2111.02 (II), a recitation of the intended use (for suppressing the expression of TMPRSS2 and/or ACE2) of the claimed kit and compositions must result in a structural difference between the claimed composition and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art composition is capable of performing the intended use, then it meets the claim.
Further, as evidenced by Sakai et al., proteolytic cleavage of the hemagglutinin (HA) protein is essential for influenza A virus (IAV) to acquire infectivity. Sakai et al. show that the host cell type II transmembrane serine protease (TMPRSS2), expressed in the respiratory tract, is the key host protease that activates IAVs in vivo through proteolytic cleavage of their HA proteins. Thus, TMPRSS2 expression is essential for IAV replication in vivo (abstract). Sakai et al. also teach that various respiratory viruses, including the SARS coronavirus and MERS coronavirus, also use TMPRSS2 for their activation. Drugs that inhibit TMPRSS2 are therefore expected to be effective against a wide spectrum of respiratory viruses (p. 5615, left col.).
Thus, by administering 5-ALA and sodium ferrous citrate to a subject with influenza viral infection, it is intrinsic in the methods of Tanaka et al. that:
a disease related to expression of TMPRSS2 in a cell or tissue in a subject will be treated, as recited by claim 9;
the disease related to expression of TMPRSS2 is an infection by a virus that infects by utilizing TMPRSS2, as recited by claim 10; and
the expression of type II transmembrane serine protease (TMPRSS2) will be suppressed, as recited by claim 12.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of Tanaka et al., and occur each time 5-ALA and sodium ferrous citrate are administered to a subject with influenza viral infection, regardless of whether those mechanisms were recognized or appreciated.
A novel use of a known compound can be patentable. However, the claims do not recite a novel use of a known compound, but rather a previously unknown property of compounds which were known to treat the same conditions in the same patient population. When the claim recites the use of a known compound in a known method – administration of 5-ALA and sodium ferrous citrate to patients with influenza viral infection – and the “use” is directed to a result or property of that compound, then the claim is anticipated.
Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kita et al. (US Pub. 2023/0190690, cited on PTO-892).
Kita et al. claim a method for therapeutic and/or preventive treatment of coronavirus disease 2019 (COVID-19), comprising administering to a subject a therapeutic agent comprising a compound of formula (I) or a salt thereof:
PNG
media_image2.png
200
400
media_image2.png
Greyscale
wherein R1 and R2 are each a hydrogen atom, i.e., 5-aminolevulinic acid (5-ALA), wherein the therapeutic agent for COVID-19 further comprises an iron compound (claims 1-6 and 11), specifically sodium ferrous citrate (paras. [0013], [0051], [0091]).
Thus, Kita et al. disclose and claim a therapeutic agent comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate, which reads on the pharmaceutical compositions recited by claims 1-8, and the kit recited by claim 13.
Kita et al. do not explicitly disclose that the therapeutic agent comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate is "for suppressing the expression of type II transmembrane serine protease (TMPRSS2)," as recited by claims 1 and 13, or "for suppressing the expression of angiotensin converting enzyme 2 (ACE2)", as recited by claim 2.
However, as recognized by MPEP § 2111.02 (II), a recitation of the intended use (for suppressing the expression of TMPRSS2 and/or ACE2) of the claimed kit and compositions must result in a structural difference between the claimed composition and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art composition is capable of performing the intended use, then it meets the claim.
Further, as evidenced by, e.g., the instant specification, TMPRSS2 is one of the major proteases that activate respiratory viruses in the respiratory tract. Specific viruses that utilize TMPRSS2 in the infection route to humans or animals include influenza virus and coronaviruses, e.g., SARS-COV, SARS-COV-2, and Human Coronavirus-NL63 (para. [0048]).
Thus, by administering 5-ALA and sodium ferrous citrate to a subject with coronavirus disease 2019 (COVID-19), it is intrinsic in the methods of Kita et al. that:
a disease related to expression of TMPRSS2 in a cell or tissue in a subject will be treated, as recited by claim 9;
the disease related to expression of TMPRSS2 is an infection by a virus that infects by utilizing TMPRSS2, as recited by claim 10; and
the expression of type II transmembrane serine protease (TMPRSS2) will be suppressed, as recited by claim 12.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of Kita et al., and occur each time 5-ALA and sodium ferrous citrate are administered to a subject with coronavirus disease 2019 (COVID-19), regardless of whether those mechanisms were recognized or appreciated.
A novel use of a known compound can be patentable. However, the claims do not recite a novel use of a known compound, but rather a previously unknown property of compounds which were known to treat the same conditions in the same patient population. When the claim recites the use of a known compound in a known method – administration of 5-ALA and sodium ferrous citrate to patients with coronavirus disease 2019 (COVID-19) – and the “use” is directed to a result or property of that compound, then the claim is anticipated.
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 1-10, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,351,949, as evidenced by Sakai et al. (J. Virology 88 (10), 5608-5616, cited on the IDS dated 11/14/2023)
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed compositions, methods, and kit are intrinsic in the methods recited by the reference claims.
Reference claims 1-8 are drawn to methods for ameliorating symptoms in a subject having an influenza viral infection, comprising administering to the subject a therapeutic agent for influenza viral infection comprising a compound represented by formula (I) or a salt thereof:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
,
wherein R1 represents a hydrogen atom or an acyl group, and R2 represents a hydrogen atom, a linear or branched alkyl group, a cycloalkyl group, an aryl group or an aralkyl group), specifically wherein R1 and R2 represent a hydrogen atom, i.e., 5-aminolevulinic acid (5-ALA); wherein the therapeutic agent for influenza viral infection further comprises an iron compound, specifically sodium ferrous citrate.
Thus, the reference claims are drawn to methods of administering a therapeutic agent comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate, which reads on the pharmaceutical compositions recited by examined claims 1-8, and the kit recited by examined claim 13.
The reference claims do not explicitly recite that the therapeutic agent comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate is "for suppressing the expression of type II transmembrane serine protease (TMPRSS2)," as recited by examined claims 1 and 13, or "for suppressing the expression of angiotensin converting enzyme 2 (ACE2)", as recited by examined claim 2.
However, as evidenced by Sakai et al., proteolytic cleavage of the hemagglutinin (HA) protein is essential for influenza A virus (IAV) to acquire infectivity. Sakai et al. show that the host cell type II transmembrane serine protease (TMPRSS2), expressed in the respiratory tract, is the key host protease that activates IAVs in vivo through proteolytic cleavage of their HA proteins. Thus, TMPRSS2 expression is essential for IAV replication in vivo (abstract). Sakai et al. also teach that various respiratory viruses, including the SARS coronavirus and MERS coronavirus, also use TMPRSS2 for their activation. Drugs that inhibit TMPRSS2 are therefore expected to be effective against a wide spectrum of respiratory viruses (p. 5615, left col.).
Thus, by administering 5-ALA and sodium ferrous citrate to a subject with influenza viral infection, it is intrinsic in the methods recited by the reference claims that:
a disease related to expression of TMPRSS2 in a cell or tissue in a subject will be treated, as recited by examined claim 9;
the disease related to expression of TMPRSS2 is an infection by a virus that infects by utilizing TMPRSS2, as recited by examined claim 10; and
the expression of type II transmembrane serine protease (TMPRSS2) will be suppressed, as recited by examined claim 12.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of the reference claims, and occur each time 5-ALA and sodium ferrous citrate are administered to a subject with influenza viral infection, regardless of whether those mechanisms were recognized or appreciated.
A novel use of a known compound can be patentable. However, the examined claims do not recite a novel use of a known compound, but rather a previously unknown property of compounds which were known to treat the same conditions in the same patient population. When the claim recites the use of a known compound in a known method – administration of 5-ALA and sodium ferrous citrate to patients with influenza viral infection – and the “use” is directed to a result or property of that compound, then the claim is anticipated.
Claims 1-8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,675,242. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to formulations which read on the examined claims.
The reference claims are drawn to aqueous formulations comprising a compound of formula (I) or a salt thereof:
PNG
media_image3.png
200
400
media_image3.png
Greyscale
wherein R1 is a hydrogen atom or an acyl group, and R2 is a hydrogen atom, a linear or branched alkyl group, a cycloalkyl group, an aryl group, or an aralkyl group; and an iron compound, wherein the composition further comprises 2.5-30% by weight of sodium salts or potassium salts, and the pH of said aqueous formulation is 5-7 (reference claims 1-2 and 7-9).
In particular, the compound of formula (I) is 5-aminolevulinic acid, wherein R1 and R2 are hydrogen atoms; and the iron compound is sodium ferrous citrate (reference claims 3-6).
Thus, the reference claims read on the pharmaceutical compositions of examined claims 1-8, and the kit of examined claim 13.
The reference claims do not explicitly recite that the formulations comprising 5-aminolevulinic acid (5-ALA) and sodium ferrous citrate are "for suppressing the expression of type II transmembrane serine protease (TMPRSS2)," as recited by examined claims 1 and 13, or "for suppressing the expression of angiotensin converting enzyme 2 (ACE2)", as recited by examined claim 2.
However, as recognized by MPEP § 2111.02 (II), a recitation of the intended use (for suppressing the expression of TMPRSS2 and/or ACE2) of the claimed kit and compositions must result in a structural difference between the claimed composition and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art composition is capable of performing the intended use, then it meets the claim.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
US Pub. 2018/0125805; WO 2014/010206; and WO 2016/163082.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629