DETAILED ACTION
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 . 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.
Priority
The instant application is a 371 of PCT/US2022/078467 filed on 10/20/2022 and claims domestic benefit to US provisional application no. 63/275,647 filed on 11/04/2021 and US provisional application no. 63/257,649 filed on 10/20/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/19/2024, 03/19/2025, and 07/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 06/24/2024 is acknowledged. Claims 6 and 17 are amended. Claims 2 is cancelled.
Accordingly, claims 1 and 3-25 are pending and being examined on the merits herein.
Drawings
The drawings are objected to because the text and data in FIG. 1-6 have poor legibility and resolution.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code.
Embedded hyperlinks are found on line 24 page 1, line 27 page 1, line 30 page 1 through line 1 page 2, line 8 page 2, line 5 page 63, lines 12-13 page 75, lines 20-21 page 90, and line 32 page 90 in the instant specification.
For example, line 24 page 1 of the specification recites https://www.who.int/csr/sars/country/2003_07_04/en/. The bolded portions of the website link should be removed.
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claim 24 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites “wherein the at least one risk factor is chosen from age … and diabetes mellitus”.
Claim 24 depends from claims 22-23. Claim 22 recites a “subject determined to be at increased risk for severe illness from COVID-19”, and claim 23 recites “subject has one or more underlying medical condition associated with being at increased risk for severe illness from COVID-19”.
Claim 24 has an antecedent basis issue for “the at least one risk factor” and renders the claim indefinite because it is unclear if the recited “at least one risk factor” is referring back to a subject at increased risk or a subject that has one or more underlying medical condition.
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.
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.
Claim(s) 1, 3-12, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (Nature Microbiology, published 12/03/2020 in PTO-892) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892).
Cox discloses the efficacy of therapeutically administered MK-4482/EIDD-2801 to mitigate SARS-CoV-2 infection and block transmission in the ferret model, given that ferrets and related members of the weasel genus transmit the virus efficiently with minimal clinical signs, which resembles the spread in the human young-adult population (Abstract).
Cox discloses that MK-4482/EIDD-2801 is an orally available pro-drug of the nucleoside analogue N4-hydroxycytidine (NHC).
Cox demonstrates in Fig. 2 (page 14) their in vivo efficacy study of oral MK-4482/EIDD-2801 against SARS-CoV-2 in ferrets. Ferrets (n = 3 biologically independent animals) were infected intranasally with 1 × 105 p.f.u. 2019-nCoV/ USA-WA1/2020 and either oral gavaged with vehicle or treated b.i.d. (twice a day) with MK-4482/EIDD-2801 commencing 12 hrs (5 mg kg−1 and 15 mg kg−1) or 36 hrs (15 mg kg−1) after infection. The MK-4482/EIDD-2801 was administered for a duration of four days. Nasal lavages were collected twice a day and blood was collected every other day. Cox demonstrates in Fig. 2c that treatment with MK-4482/EIDD-2801 significantly reduced the virus titres within 12 h of dosing onset in all treatment groups. Cox also demonstrates in Fig. 3 (page 15) that therapeutic oral treatment with MK-4482/EIDD-2801 prevents contact transmission.
Cox concludes that treatment with MK-4482/EIDD-2801, in particular when initiated early after infection, has the potential to provide threefold benefits: it may mitigate the risk of progression to severe disease and accelerate recovery, ease the emotional and socio-economic toll associated with mandatory prolonged isolation and aid in rapidly silencing local outbreaks (second paragraph right column page 16).
While Cox teaches a method of mitigating SARS-CoV-2 by orally administering MK-4482/EIDD-2801 at 5 mg/kg or 15 mg/kg twice daily for four days, Cox does not explicitly teach the chemical structure of MK-4482/EIDD-2801 as recited in the instant claims.
However, ACS teaches that EIDD-2801 has the following chemical structure as shown on page 1 and below:
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The EIDD-2801 structure shown in ACS is identical to the compound name that is recited in the instant claims. ACS further discloses that this EIDD-2801 compound may work as a treatment for COVID-19 (page 2 last paragraph)
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention that the administered MK-4482/EIDD-2801 compound in Cox is identical to the recited compound name in the instant claims based on the teachings of ACS, which discloses EIDD-2801 having the same chemical structure as recited in the instant claims.
In regards to instant claims 3-4, 7-11, and 19-21, even though the combined teachings of Cox and ACS described above do not explicitly disclose that the administered MK-4482/EIDD-2801 will result in reducing risk of death, hospitalization and hospitalization length, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2 as recited in these instant claims, all of these limitations would be necessarily present from within the combined references because the combined references demonstrate the oral administration of the same recited MK-4482/EIDD-2801 compound within the same dosing amounts and regimen, and demonstrates significant reduction in viral titre and contact transmission. Furthermore, as evidenced by the data in FIG. 1-6 and lines 26-27 page 78 of the instant specification, the same method of administering the MK-4482/EIDD-2801 compound to treat SARS-CoV-2 subjects necessarily resulted in the described effects.
MPEP 2112 section I states that "[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”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Claim(s) 1, 3-13, 15-17, 19-21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892).
NCT’739 proposed a phase 2a randomized, placebo-controlled, double-blinded clinical trial of EIDD-2801 in hospitalized men and women (18+) with PCR-confirmed SARS-CoV-2 infection who also have evidence of symptomatic COVID-19 (last paragraph page 8). NCT’739 planned to enroll hospitalized patients who present within seven days of symptom onset for a five-day course of twice daily dosing of EIDD-2801 or placebo (last paragraph page 8). NCT’739 discloses the dosages are 200 mg or 300 mg oral capsules (page 10 section “Arms and Interventions”).
NCT’739 discloses that the exclusion criteria for patient selection include women who are pregnant or breastfeeding and others (section “Exclusion Criteria” page 13).
Even though NCT’739 teaches a method of treating SARS-CoV-2 by orally administering 200 mg or 300 mg oral capsules of EIDD-2801 within seven days of symptom onset for a five-day course, NCT’739 does not explicitly teach the chemical structure of EIDD-2801 as recited in the instant claims.
However, the teachings of ACS are as described above.
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention that the administered EIDD-2801 compound in NCT’739 is identical to the recited compound name in the instant claims based on the teachings of ACS, which discloses EIDD-2801 having the same chemical structure as recited in the instant claims.
In regards to instant claims 3-11 and 19-21, even though the combined teachings of NCT’739 and ACS described above do not explicitly disclose that the administered EIDD-2801 will result in reducing risk of death, hospitalization and hospitalization length, time to SARS-CoV-2 clearance, SARS-CoV-2 viral load, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2 as recited in these instant claims, all of these limitations would be necessarily present from within the combined references because the combined references demonstrates the oral administration of the same recited EIDD-2801 compound within the same dosing amounts and regimen, and as evidenced by the data in FIG. 1-6 and lines 30 page 78 through lines 1-4 page 79 of the instant specification, the same method of administering the EIDD-2801 compound to treat SARS-CoV-2 subjects necessarily resulted in the described effects.
MPEP 2112 section I states that "[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”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In regards to instant claim 16, the combined teachings of NCT’739 and ACS described above disclose the same method of treating SARS-CoV-2 by administering 200 or 300 mg oral EIDD-2801 capsules over five days and within an overlapping range of within seven days of symptom onset, which renders the recited within 5 days of symptom onset in instant claim 16 obvious. See MPEP 2144.05 I.
Claim(s) 3-15 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), as applied to claims 1 and 16 above, and further in view of Abdelnabi et al. (bioRxiv, published 03/10/2021 in PTO-892) and Nair et al. (Journal of basic and clinical pharmacy, 2016 in PTO-892).
The combined teachings of NCT’739 and ACS are as described above and teach the method of instant claims 1 and 16 as discussed above.
The combined references, however, do not disclose the dosage amount of 800 mg and providing the dosage as four 200 mg capsules. Furthermore, the combined references do not explicitly teach that the administered MK-4482/EIDD-2801 will result in the results recited in instant claims 3-11 and 19-21 such as reducing risk of death, hospitalization and hospitalization length, time to SARS-CoV-2 clearance, SARS-CoV-2 viral load, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2.
Abdelnabi discloses the effect of EIDD-2801 in a well-established Syrian hamster SARS-CoV2 infection model (Abstract).
Abdelnabi discloses and demonstrates that treatment of SARS-CoV-2-infected hamsters with 200 mg/kg BID of EIDD-2801 for four consecutive days, starting from the day of infection, significantly reduced infectious virus titers and viral RNA loads in the lungs and markedly improved lung histopathology (Abstract and Fig. 1 page 5)
Abdelnabi discloses that 75 mg/kg BID (twice a day) EIDD-2801 resulted in 1.2 log10 reduction in the viral RNA copies per mg of lung tissue compared to controls, whereas 200 mg/kg BID EIDD-2801 resulted in a 3 log10 reduction in the viral RNA copies/mg of lung tissue (last paragraph page 4 and Fig. 1B). Abdelnabi discloses a similar trend was observed for infectious virus load in the lungs (last paragraph page 4 and Fig. 1C).
The 75 mg/kg BID hamster dosage and 200 mg/kg BID hamster dosage convert to ~10.1 mg/kg human dosage and ~27 mg/kg human dosage based on guidance from Nair, which discloses a conversion factor of 7.4 to convert hamster dosages to human equivalent dosages in mg/kg (see Table 1 page 29). Furthermore, the 10.1 mg/kg and 27 mg/kg human dosage would equal 626.2 mg and 1674 mg given an average human bodyweight of 62 kg.
An ordinary skilled artisan would have performed routine optimization to increase the dosage disclosed in the combined teachings of NCT’739 and ACS described above by increasing the number of 200 mg oral EIDD-2801 capsules to arrive at the claimed 800 mg dosage and/or four 200 mg capsules based on guidance from Abdelnabi, which demonstrates that increasing dosages of EIDD-2801 from 75 mg/kg twice a day to 200 mg/kg twice a day (~626 mg to 1674 mg human equivalent dosage given an average human bodyweight of 62 kg based on guidance from Nair) was a result-effective variable to increase therapeutic efficacy against COVID-19. See MPEP 2144.05 II
Lastly, even though the combined teachings of NCT’739, ACS, Abdelnabi, and Nair do not explicitly disclose that the administered EIDD-2801 will result in reducing risk of death, hospitalization and hospitalization length, time to SARS-CoV-2 clearance, SARS-CoV-2 viral load, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2 as recited, all of these limitations would flow naturally from following the combined teachings because the combined teachings described above disclose the same oral administration of the same recited EIDD-2801 compound in the same dosing amounts and regimen (800 mg twice daily for 5 days), and as evidenced by the data in FIG. 1-6 and lines 6-10 on page 81 of the instant specification, the same treatment method of administering the EIDD-2801 at this dosage amount and regimen resulted in the described effects.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Claim(s) 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), as applied to claim 1 above, and further in view of Kwok et al. (Clinical Obesity, published 08/28/2020 in PTO-892).
The combined teachings of NCT’739 and ACS are as described above and teach the method of instant claim 1 as discussed above. Furthermore, NCT’739 discloses that there is a desperate need for safe and effective antivirals to mitigate the natural course of COVID-19, especially those who are at high risk for severe disease (page 8 second paragraph).
The combined references, however, do not disclose wherein the subject has one or more underlying medical conditions associated with increased risk for severe illness from COVID-19 such as obesity.
Kwok discloses that obesity is an emerging independent risk factor for susceptibility to and severity of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (Abstract). Kwok discloses that previous viral pandemics have shown that obesity, particularly severe obesity (BMI > 40 kg/m2), is associated with increased risk of hospitalization, critical care admission and fatalities (Abstract). Kwok concludes that people with severe obesity should be deemed as a vulnerable group for COVID-19 and that clinical trials of pharmacotherapeutics, immunotherapies, and vaccination should prioritize inclusion of people with obesity (Abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combined teachings of NCT’739 and ACS described above to administer to obesity patients who have increased risk for severe illness from COVID-19 as disclosed in Kwok to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to obesity patients because Kwok discloses that obesity patients have increased risk factor for susceptibility to and severity of COVID-19 with previous viral pandemics showing that obesity is associated with increased risk of hospitalization, critical care admission, and fatalities.
One of ordinary skill in the art would have a reasonable expectation of success because the combined teachings of NCT’739 and ACS described above disclose a treatment method against COVID-19 using EIDD-2801 to mitigate the natural course of COVID-19, especially for those who are at high risk for severe disease, and Kwok further discloses prioritizing including obesity patients in clinical trials for pharmacotherapeutics.
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.
Claim 1, 3-21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/940,253 (‘253) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892) and NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892).
The claims of ‘253 recite a method of treating SARS-CoV-2 infection in a patient in need thereof, comprising orally administering to the patient a compound with the following structure:
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or a tautomer thereof, wherein the compound is administered to the patient in an amount of 800 mg twice a day (claim 78). The claims of ‘253 recite the composition is administered to the patient for five days (claim 79), wherein each composition comprises 200 mg of the compound (claim 80), and wherein the composition are capsules (claim 93).
The claims of ‘253, however, do not recite administering the recited compound within 5 days of symptom onset.
The independent teachings of ACS and NCT’739 are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method of ‘253 by administering the tautomer form of the recited compound of ‘253 as shown in ACS within 7 days of symptom onset as disclosed in NCT’739 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the claims of ‘253, ACS, and NCT’739 disclose the same method of treating SARS-CoV-2 using the same base compound structure, and NCT’739 provides further guidance of administering the compound within an overlapping range of within seven days of symptom onset, which renders the recited within 5 days of symptom onset in instant claim 16 obvious. See MPEP 2144.05 I.
In regards to instant claims 3-11 and 19-21, even though the combination of the claims of ‘253, ACS, and NCT’739 do not explicitly recite that the administered MK-4482/EIDD-2801 will result in reducing risk of death, hospitalization and hospitalization length, time to SARS-CoV-2 clearance, SARS-CoV-2 viral load, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2 as recited, all of these limitations would flow naturally from following the combined references because the combined references described above disclose the same oral administration of the same recited MK-4482/EIDD-2801 compound in the same dosing amounts and regimen (800 mg twice daily for 5 days), and as evidenced by the data in FIG. 1-6 and lines 6-10 on page 81 of the instant specification, the same treatment method of administering the MK-4482/EIDD-2801 at this dosage amount and regimen resulted in the described effects.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 25, it would have also been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combination of the claims of ‘253, ACS, and NCT’739 described above to administer to a patient who is not pregnant as disclosed in NCT’739 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because NCT’739 provides guidance of excluding the pregnant patient population for the same treatment method of COVID-19 using the recited compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/940,253 (‘253) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892), and Kwok et al. (Clinical Obesity, published 08/28/2020 in PTO-892).
The combination of the claims of ‘253, ACS, NCT’739 are as described above and recite the method of instant claims 1 as discussed above.
The combined references, however, do not recite wherein the subject has one or more underlying medical conditions associated with increased risk for severe illness from COVID-19 such as obesity.
The teachings of Kwok are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combination of the claims of ‘253, ACS, and NCT’739 described above to administer to obesity patients as suggested in Kwok to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to obesity patients because Kwok discloses that obesity patients have increased risk factor for susceptibility to and severity of COVID-19 with previous viral pandemics showing that obesity is associated with increased risk of hospitalization, critical care admission and fatalities.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘253, ACS, and NCT’739 described above disclose a treatment method against COVID-19 using EIDD-2801, and Kwok further discloses prioritizing including obesity patients in clinical trials for pharmacotherapeutics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 3-21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/223,315 (‘315) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892), Abdelnabi et al. (bioRxiv, published 03/10/2021 in PTO-892), and Nair et al. (Journal of basic and clinical pharmacy, 2016 in PTO-892).
The claims of ‘315 recite a method of treating human coronavirus, SARS coronavirus, and others comprising administering an effective amount of a compound to a patient in need thereof with the structure:
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The claims of ‘315, however, do not recite administering the compound in the recited amounts and dosing regimens as well as within 5 days of symptom onset.
The independent teachings of ACS, NCT’739, Abdelnabi, and Nair are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method of ‘315 by administering the tautomer form of the recited compound of ‘315 as shown in ACS and as 200 mg oral capsules for 5 days and within 7 days of symptom onset as disclosed in NCT’739 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the claims of ‘315, ACS, and NCT’739 disclose the same method of treating coronavirus using the same base compound structure.
Furthermore an ordinary skilled artisan would have performed routine optimization to increase the dosage as disclosed in the combination of the claims of ‘315, ACS, and NCT’739 described above by increasing the number of 200 mg oral EIDD-2801 capsules to arrive at the claimed 800 mg dosage and/or four 200 mg capsules based on guidance from Abdelnabi, which demonstrates that increasing dosages of EIDD-2801 from 75 mg/kg twice a day to 200 mg/kg twice a day (~626 mg to 1674 mg human equivalent dosage given an average human bodyweight of 62 kg based on guidance from Nair) was a result-effective variable to increase therapeutic efficacy against COVID-19. See MPEP 2144.05 II
In regards to instant claims 3-11 and 19-21, even though the combination of the claims of ‘315 and the teachings of ACS, NCT’739 , Abdelnabi, and Nair described above do not explicitly recite that the administered MK-4482/EIDD-2801 will result in reducing risk of death, hospitalization and hospitalization length, time to SARS-CoV-2 clearance, SARS-CoV-2 viral load, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2 as recited, all of these limitations would flow naturally from following the combined references because the combined references described above disclose the same oral administration of the same recited MK-4482/EIDD-2801 compound in the same dosing amounts and regimen (800 mg twice daily for 5 days), and as evidenced by the data in FIG. 1-6 and lines 6-10 on page 81 of the instant specification, the same treatment method of administering the MK-4482/EIDD-2801 at this dosage amount and regimen resulted in the described effects.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 25, it would have also been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combination of the claims of ‘315 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above to administer to a patient who is not pregnant as disclosed in NCT’739 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because NCT’739 provides guidance of excluding the pregnant patient population for the same treatment method of COVID-19 using the recited compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/223,315 (‘315) in view of in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892), Abdelnabi et al. (bioRxiv, published 03/10/2021 in PTO-892), Nair et al. (Journal of basic and clinical pharmacy, 2016 in PTO-892), and Kwok et al. (Clinical Obesity, published 08/28/2020 in PTO-892).
The combination of the claims of ‘315 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above and recite the method of instant claims 1 as discussed above.
The combined references, however, do not recite wherein the subject has one or more underlying medical conditions associated with increased risk for severe illness from COVID-19 such as obesity.
The teachings of Kwok are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combination of the claims of ‘315 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above to administer to obesity patients as suggested in Kwok to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to obesity patients because Kwok discloses that obesity patients have increased risk factor for susceptibility to and severity of COVID-19 with previous viral pandemics showing that obesity is associated with increased risk of hospitalization, critical care admission and fatalities.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘315 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above disclose a treatment method against COVID-19 using EIDD-2801, and Kwok further discloses prioritizing including obesity patients in clinical trials for pharmacotherapeutics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/541,148 (‘148) in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892), Abdelnabi et al. (bioRxiv, published 03/10/2021 in PTO-892), and Nair et al. (Journal of basic and clinical pharmacy, 2016 in PTO-892).
The claims of ‘148 recite a method of treating coronavirus infection such as SARS coronavirus comprising contacting the lungs of a patient in need thereof with an effective amount of a compound have the structure
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160
124
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(claims 1-4).
The claims of ‘148, however, do not recite administering the recited compound in the recited amounts and dosing regimens as well as within 5 days of symptom onset.
The independent teachings of ACS, NCT’739, Abdelnabi, and Nair are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method of ‘148 by substituting the recited compound of ‘148 with the EIDD-2801 as disclosed in ACS, NCT’739, and Abdelnabi and further administering the recited compound as 200 mg oral capsules for 5 days and within 7 days of symptom onset as disclosed in NCT’739 to arrive at the claimed invention.
One of ordinary skill in the art would have substituted one known element (compound of ‘148) for another (EIDD-2801) to obtain predictable results and would have a reasonable expectation of success in doing so because both ‘148 and the teachings of ACS, NCT’739 and Abdelnabi disclose a similar method of treating a coronavirus infection using the same base nucleoside compound structure.
One of ordinary skill in the art would have combined prior art elements according to known methods to administer this compound according to NCT’739 to yield predictable results and would have a reasonable expectation of success in doing so because the claims of ‘148 and NCT’739 disclose the same method of treating coronavirus using the same base nucleoside compound structure.
Furthermore an ordinary skilled artisan would have performed routine optimization to increase the dosage as disclosed in the combination of the claims of ‘148, ACS, and NCT’739 described above by increasing the number of 200 mg oral EIDD-2801 capsules to arrive at the claimed 800 mg dosage and/or four 200 mg capsules based on guidance from Abdelnabi, which demonstrates that increasing dosages of EIDD-2801 from 75 mg/kg twice a day to 200 mg/kg twice a day (~626 mg to 1674 mg human equivalent dosage given an average human bodyweight of 62 kg based on guidance from Nair) was a result-effective variable to increase therapeutic efficacy against COVID-19. See MPEP 2144.05 II
In regards to instant claims 3-11 and 19-21, even though the combination of the claims of ‘148 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above do not explicitly recite that the administered MK-4482/EIDD-2801 will result in reducing risk of death, hospitalization and hospitalization length, time to SARS-CoV-2 clearance, SARS-CoV-2 viral load, normalization of high-sensitivity C-reactive protein in a subject with SARS-CoV-2, normalization of oxygen saturation in a subject with SARS-CoV-2, and reducing need for respiratory interventions in a subject with SARS-CoV-2 as recited, all of these limitations would flow naturally from following the combined references because the combined references described above disclose the same oral administration of the same recited MK-4482/EIDD-2801 compound in the same dosing amounts and regimen (800 mg twice daily for 5 days), and as evidenced by the data in FIG. 1-6 and lines 6-10 on page 81 of the instant specification, the same treatment method of administering the MK-4482/EIDD-2801 at this dosage amount and regimen resulted in the described effects.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 25, it would have also been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combination of the claims of ‘148 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above to administer to a patient who is not pregnant as disclosed in NCT’739 to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because NCT’739 provides guidance of excluding the pregnant patient population for the same treatment method of COVID-19 using the recited compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/541,148 (‘148) in view of in view of ACS (EIDD-2801 article from ACS website published online on 06/01/2020 in PTO-892), NCT04405739 (referred to as NCT’739, publication version posted 05/26/2020, in PTO-892) and Abdelnabi et al. (bioRxiv, published 03/10/2021 in PTO-892), Nair et al. (Journal of basic and clinical pharmacy, 2016 in PTO-892), and Kwok et al. (Clinical Obesity, published 08/28/2020 in PTO-892).
The combination of the claims of ‘148 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above and recite the method of instant claims 1 as discussed above.
The combined references, however, do not recite wherein the subject has one or more underlying medical conditions associated with increased risk for severe illness from COVID-19 such as obesity.
The teachings of Kwok are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the treatment method as disclosed by the combination of the claims of ‘148 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above to administer to obesity patients as suggested in Kwok to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to obesity patients because Kwok discloses that obesity patients have increased risk factor for susceptibility to and severity of COVID-19 with previous viral pandemics showing that obesity is associated with increased risk of hospitalization, critical care admission and fatalities.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘148 and the teachings of ACS, NCT’739, Abdelnabi, and Nair described above disclose a treatment method against COVID-19 using EIDD-2801, and Kwok further discloses prioritizing including obesity patients in clinical trials for pharmacotherapeutics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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