DETAILED ACTION
Claims 1-18 are currently pending in the instant application.
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
This application was filed 11/21/2023.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 114805478, hereafter referred to as CN ‘478, pub. 07/29/2022.
CN ‘478 teaches compounds of formula
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where R1 to R 15 are each independently hydrogen or deuterium; Y1 to Y14 are each independently hydrogen or deuterium. Furthermore, at least one of R 1 to R 15 and Y 1 to Y 14 is a deuterium atom (see p. 2-3 of enclosed machine translation). CN ‘478 exemplifies compounds such as
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which reads on claims 1-2. CN ‘478 teaches the compound may be used to treat disease associated with RNA virus infection, specifically COVID-19. The compound may also be administered in combination with other related drugs, including CYP inhibitors (see p. 22 of machine translation). This reads on claims 3-4.
Claims 1, 3, 5-6, 9-10 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by OWEN (see US Pub No. 2022/0062232, pub. 03/03/02022) teaches compound
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and a method of treating a coronavirus infection wherein the infection is COVID-19 (see p. 17). This corresponds to a compound of claims 1 and 3 wherein R1-R25 are independently H. Regarding claims 5-6, OWEN further teaches the compound may be used in methods in combination with other drugs and names remdesivir (see paragraph [0382], p. 22), monoclonal antibodies such as bamlanivimab (see paragraph [0392], p. 23-24). The compound may also be administered with telmisartan (see paragraph [0386], p. 22), which reads on claims 9-10 as well as nicardipine (see paragraphs [0385]-[0386], p. 22), which reads on claims 15-16.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-4, 7-8, 11-14 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over CN ‘478 as applied to claims 3-4 above, and further in view of OWEN (see US Pub No. 2022/0062232, pub. 03/03/02022) and Dhanoa (see US Pub No. 2022/0306646, pub. 09/29/2022 and filed 03/29/2021).
The limitations of claim 3-4 are taught as discussed above in the 102(a)(1) rejection. Specifically, CN ‘478 teaches the compounds of claims 3-4 may be administered in combination with other related drugs to treat COVID-19 but does not explicitly name other drugs to be administered.
OWEN teaches compounds
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and a method of treating a coronavirus infection wherein the infection is COVID-19 (see p. 17), which reads on claim 3. Further OWEN teaches that substitution with heavier isotopes such as deuterium can afford certain therapeutic advantages resulting from greater metabolic stability, for example increased in vivo half-life or reduced dosage requirements and, hence, may be preferred in some circumstances. Isotopically labelled compounds used in the methods of this invention and prodrugs thereof can generally be prepared by carrying out the procedures for preparing the compounds disclosed in the art by substituting a readily available isotopically labelled reagent for a non-isotopically labelled reagent (see paragraph [0380]). Thus, one of ordinary skill in the art would know to substitute the hydrogen atoms on the compound with a deuterium to arrive at compounds of claim 4. Additionally, CN ‘478 teaches examples of compounds substituted with deuterium and positions that may be substituted with deuterium atoms to arrive at additional compounds of claim 4.
Regarding the limitations of claims 7-8 and 11-12, OWEN further teaches the compounds in treating a coronavirus infection wherein the infection is COVID-19 may be used in combination with other drugs and names remdesivir (see paragraph [0382], p. 22), monoclonal antibodies such as bamlanivimab (see paragraph [0392], p. 23-24) and telmisartan (see paragraph [0386], p. 22). Thus, it would be obvious to one of ordinary skill in the art to combine compounds taught by CN ‘478 to treat COVID-19 with those of OWEN to arrive at the limitations of claims 7-8 and 11-12. According to MPEP 2144.06, Section I states that it is obvious to combine equivalents known for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Regarding claims 13-14 and 17-18, Dhanoa teaches compounds such as
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(see claim 2, p. 8) as ACE-2 inhibitors and useful in treatment of Covid-19. Further Dhanoa teaches ACE inhibitors such as Enalapril, Lisinopril, Captopril, Benazepril, Fosinopril, Ramipril, Quinapril, and Perindopril (see paragraph [0019], p. 2 used in combination as useful in the treatment of the unprecedented pandemic disease Covid-19 caused by the Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2). Thus, it would be obvious to one of ordinary skill in the art to combine compounds taught by CN ‘478 with those of Dhanoa to treat Covid-19. According to MPEP 2144.06, Section I states that it is obvious to combine equivalents known for the same purpose. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623