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
Status of Claims
Claims 1-3 and 7-14 are pending and under examination in the instant office action.
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 1-3 and 7-14 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 pre-AIA the applicant regards as the invention. All the dependent claims are included.
The following phrases and limitations in parentheses render the claims indefinite because it is unclear whether the limitations following the phrases and the limitations in the parentheses are part of the claimed invention:
in claim 1, “(preferably SARS-CoV-2)” in line 5, preferably” in lines 6, 7, 11, 12, 13, 14, 15, 16, and 21, “such as” in line 7; and “more preferably” in line 23;
in claim 3, “(preferably SARS-CoV-2)” in line 4, preferably” in lines 8, 9, 13, 14, 15, 17, 18, 20, 22, and 24, “such as” in line 9, and “specifically” in 25;
in claim 7, “(preferably SARS-CoV-2)” in line 4 and (e.g., mammalian cell) in lines 2 and 3; “preferably” in line 9 and “more preferably” in line 11;
in claim 9, “(preferably SARS-CoV-2)” in line 4 and (e.g., mammalian cell) in lines 2 and 3; “preferably” in line 9, 11, and 13;
in claim 10, “such as” in line 2;
in claim 11, “such as” in line 2;
in claim 12, “(preferably SARS-CoV-2)” in line 3, preferably” in lines 7, 8, 12, 13, 14, 16, 17, 19, 21, and 23, “such as” in line 8, and “specifically” in line 24;
in claim 13, “(preferably SARS-CoV-2)”, in line 2 and (e.g., mammalian cell) in lines 2 and 3; “preferably” in lines, 7, 9, and 11; and “specifically” in line 12; and
in claim 14, “such as” in line 2.
The phrases "preferably”, “specifically” and “such as” and the limitations in parentheses raise a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See MPEP § 2173.05(d).
For the examination purpose, the features introduced by the above phrases and the limitations in parentheses are considered as not required.
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.
Claims 1-3 and 7-14 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by WO2021/211923 (MACARTHUR) as evidenced by Basco et al. (Antimicrob Agents Chemother, 1998 Sep;42(9):2347–2351).
MACARTHUR teaches a pharmaceutical composition and a method for the treatment or prevention of disease, including viral infections, particularly infections resulting from SARS-CoV-2, wherein the pharmaceutical composition comprises a compound selected from the group consisting of hydroxychloroquine, primaquine, mepacrine, mefloquine, pamaquine, pentaquine, tafenoquine, lumefantrine, pyronaridine, and salts thereof; and a carrier (abstract, p5, lines 10-14, and claims 1, 69 and 71). Lumefantrine (benflumetol) is the compound of Formula I (
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) as evidenced by Basco et al. (p2348, Fig. 1).
MACARTHUR further teaches that the composition is for use in treating the viral infection in a subject wherein the subject is a human or a non-human animal (p8, lines 27-28).
MACARTHUR states that SARS-CoV-2 infects individuals through the respiratory tract and COVID-19 manifests initially as a respiratory disease (p14, line 34-p15, line 1).
MACARTHUR further teaches that the composition is delivered via inhalation using a nebulizer (e.g., jet, mesh, or ultrasonic), atomizer, vaporizer, or electrospray (claims 53-55).
MACARTHUR further teaches that the composition is a solution, microemulsion, suspension, or co-suspension or the compound is present in the form of a microparticle, nanoparticle, cyclodextrin complex, liposome, or noisome (p6, lines 18-21).
As to claims 7-11 and 13, when the compound is administered to a subject as taught by MACARTHUR, the compound necessarily spreads throughout the body and contacts cells as claimed, thus the teachings of the prior art read on the claimed method step. As to “inhibiting the replication or proliferation of a coronavirus (preferably SARS-CoV-2) in a cell”, those are intended results of the active method step and as such are non-limiting since the language does not result in manipulative difference in steps of claims. The reference teaches the same method step as instantly claimed (i.e., administering the same compound or a composition comprising the same compound), thus the method inherently performs the functions as recited in claims when the compound or the composition is administered to a subject as taught by the prior art. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims are anticipated by MACARTHUR.
Claims 1-3 and 7-14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Cao et al. (American Chemical society, https://dx.doi.org/10.1021/acsinfecdis.0c00522; July 31, 2020; cited in the IDS filed on 5/4/2023) as evidenced by WO2021/211923 (MACARTHUR).
Cao et al. discloses in vitro anti-SARS-CoV-2 activities of nine artemisinin-related compounds, which include lumefantrine (
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), arteether, artemether, artemisinin, artemisone, dihydroartemisinin, artesunate, arteannuin B, and artemisic acid, and carried out a time-of-drug-addition assay to explore their antiviral mode of action (abstract and Fig. 1).
Cao et al. further disclose that lumefantrine showed does-dependent cytotoxicity against Vero E6 cells infected with SARS-CoV-2 (infection caused by a coronavirus) (Fig. 2). The vero E6 cells are derived from kidney epithelial cells isolated from an African green monkey (mammal cells) as evidenced by MACARTHUR (p1, lines 30-33).
Cao et al. further teach that the compound is dissolved in DMSO (solution) (p2530, col 1, para 3). Thus, the compound is in a pharmaceutical composition comprising a pharmaceutically acceptable carrier such as DMSO.
Cao et al. states that lumefantrine showed therapeutic promise due to high plasma and lung drug concentrations after multiple dosing, suggesting the potential of lumefantrine as a potential anti-SARS-CoV-2 agent (p2526, col 2, para 1-p2527, col 1, para 1). Further mode of action analysis revealed that arteannuin B and lumefantrine acted at the post-entry step of SARS-CoV-2 infection (abstract).
As such, the instant claims are anticipated by Cao et al.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a) -(d), a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Double Patenting Rejections
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 1-3 and 7-14 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 7, and 9-22 of copending application 18/017471 in view of Peele et al. (Informatics in Medicine unlocked, 19, 2020, 100345, Elsevier; cited in the IDS filed on 5/4/2023).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘471 application are also drawn to a method of treating a disease or infection caused by SARS-CoV-2 or a method of inhibiting the replication or proliferation of SARS-CoV-2 by administering artemisinin, artemether, artemisone, dihydroartemisinin, artesunate, arteannuin B, and artemisinic acid.
The claims of the ‘471 application do not recite the claimed compound (Lumefantrine/benflumetol). However, the claimed compound was known to be an anti-malarial drug and was tested for anti-viral activities against SARS-CoV-2 along with the other anti-malarial drugs such as artemether and artesunate as evidenced by Peele et al. (abstract and Table 3). Also, lumefantrine showed better docking score, which indicates the binding affinity of a potential drug molecule to the active site of COVID-19 main protease than artemether and artesunate (Table 3). Thus, one of ordinary skill in the art would have been motivated to use lumefantrine in place of the other anti-malarial drugs recited in the ‘471 application for treating a disease or infection caused by SARS-CoV-2 or a method of inhibiting the replication or proliferation of SARS-CoV-2 on the reasonable expectation that lumefantrine would be similarly effective as the other malarial drugs.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611