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
The instant application claims priority as follows:
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Claims 1-11 are currently pending.
Response to Election
Applicant’s election with traverse of species of inflammasome inhibitor
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and species of antiviral agent favipiravir, in the reply filed on August 14, 2026 is acknowledged. Applicant stated that claims 1-11 read on the elected species
The traversal is on the grounds that the claimed combination defines a contribution over the prior art since the application has an example where TDCA salt was combined with four antivirals and the result is not disclosed or suggested by the prior art. Applicant states that the special technical feature resides in the demonstrated clinical effect of the combination rather than in the identity of any single antiviral compound.
Applicant’s arguments were considered but were found unpersuasive. TDCA is not a technical feature required by claims 1 and 5-11, and clinical effects are not features of the claims.
MPEP 1893.03(d) states, “The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art.” The technical feature common to all the claims is the method with a combination of an inflammasome inhibitor and an antiviral agent. The shared technical feature common to all the claims, which is the method with a combination of an inflammasome inhibitor and an antiviral agent, is not a “special technical feature” since it was known in the prior art. See the 102 rejections below.
Where no “special technical feature” exists for subject matter that is common to all the claims, in this case combinations are common to the method claims, then unity is not present for said set of claims. See PCT International Search and Preliminary Examination Guidelines, as in force from March 25, 2004, chapter 10, page 80 section 10.21, Example 1 which deals exactly with this situation, stating “However, if substance X is known in the art, unity would be lacking because there would not be a special technical feature common to all the claims.” Note also that PCT International Search and Preliminary Examination Guidelines, as in force from March 25, 2004, chapter 10, page 75 section 10.02 states: “Whether or not any particular technical feature makes a “contribution” over the prior art, and therefore constitutes a “special technical feature,” is considered with respect to novelty and inventive step” (emphasis added).
The requirement is still deemed proper and is therefore made FINAL.
Examination
Examination will begin with the elected species. In accordance with MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and applicable art was identified. Therefore, examination stopped and art has been applied against the claims. For the purpose of a compact prosecution, prior art has been applied for other relevant species in the treatment of coronavirus infection (see 102 rejections below).
The entire scope of claims 1-11 has not yet been examined in accordance with Markush search practice. See MPEP 803.02. Not every piece of prior art found in the search has been applied against the instant claims. See MPEP 904.03.
Subject matter outside of the examined scope are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Claims 1-11 are the subject of this Office Action.
Claim Rejections - 35 USC § 112
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 7 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 7 recites a list for “antiviral agent selected from”, however, the list includes agents that are not antiviral, such as atovaquone, cromolyn and cortisone. Applicant is required to remove all compounds that are not antiviral agents.
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.
Claim(s) 1 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by NIH clinical trial -published online on May 8, 2020 and evidence by Zhao et al. (Cytokine and Growth Factor Reviews 61 (2021) 2-15; published online 18 June 2021).
The NIH Clinical trial testing disclosed a trial testing of a combination of remdesivir plus baricitinib for the treatment of COVID-19. Baricitinib is administered as a 4-mg oral dose, which for the average patient weighing 70kg, this would be a dosage of 0.06 mg/kg/day. A ratio of baricitinib to remdesivir was 4 mg to 200 mg (0.02 : 1), or 4 mg to 100 mg (0.04 :1). Participants in the trial must have laboratory-confirmed SARS-CoV-2 (COVID-19) infection and evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation.
The Zhao reference is evidence that baricitinib is a NLRP3 inflammasome inhibitor. See Table 1 of Zhao et al.
Claim(s) 1 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Nas et al. (Rheumatol Int. 41, 811-817 (2021)) and evidence by Zhao et al. (Cytokine and Growth Factor Reviews 61 (2021) 2-15; published online 18 June 2021).
Nas et al. disclosed the treatment of SARS-CoV-2 (COVID-19) infection with favipiravir or oseltamivir, and colchicine administration. Participants had confirmed SARS-CoV-2 (COVID-19) infection. The patients had fever, or diarrhea, headache, nausea or shortness of breath. To patient 1, colchicine was administered as a 0.5 mg tablet 3 times per day, which for the average patient weighing 70kg, this would be a dosage of 0.02 mg/kg/day. A ratio of colchicine to oseltamivir was 1.5 mg/day to 150 mg/day (0.01 : 1). Patient 2 was treated with 0.5 mg three times daily of colchicine, followed by a favipiravir regimen of 1600 mg x 2 for the first day and 600 mg x2 for the following 4 days. A ratio of colchicine to favipirarivr, thus, was 0.0005 : 1, and 0.00125 : 1. Patient 3 was administered favipiravir regimen of 1600 mg x 2 for the first day and 600 mg x2 for the following 4 days, while being on a colchicine regiment of 0.5mg x2 day tablets. For the average patient weighing 70kg, this would be a dosage of 0.01 mg/kg/day. A ratio of colchicine to favipirarivr, thus, was 0.0003 : 1, and 0.0008 : 1.
The Zhao reference is additional evidence that colchicine is a NLRP3 inflammasome inhibitor. See Table 1 of Zhao et al.
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) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nas et al. (Rheumatol Int. 41, 811-817 (2021)) or Hossen et al. (SN Compr. Clin. Med. 2, 1777–1789 (2020)) and Ghaderi (US 2022/0001014).
Applicant claims a method of treating a lower respiratory tract infectious disease comprising administering taurodeoxycholic acid (inflammasome inhibitor) and the antiviral agent favipiravir.
The teachings of Nas et al. have been discussed above and are here incorporated by reference.
Favipiravir is an antiviral drug effective for the treatment of SARS-CoV-2 (COVID-19) and its symptoms as described in Nas et al. and Hossen et al. It can be administered in combination with other SARS-CoV-2 ( COVID-19) treatments, as evidenced by the references.
Ghaderi identifies taurodeoxycholic acid (TUDCA) as an inhibitor of “NLRP3, NLRC4, NLRP1, NLRP6, IFI16, Pyrin, and/or AIM2 and/or their related adaptors or effectors” for the treatment of SARS-CoV-2 infection ( COVID-19). See claim 17, paragraph [0029-0030] and others. Ghaderi also taught treatment with a combination of agents.
It is noted that claim 4 does not require that the inflammasome inhibitor is the sodium salt of taurodeoxychlolic acid. Claim 4 only requires that when the pharmaceutical salt is selected, it is the sodium salt. In the instant case, the reference above teaches the acid.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR exemplary rationale (A), it would have been prima facie obvious to administer a combination of taurodeoxychlolic acid and favipiravir to treat patients with SARS-CoV-2 infection (COVID-19). Each agent was taught in the prior art for treatment of SARS-CoV-2 infection (COVID-19) and its symptoms, which include breathing difficulty, fever, etc. A person having ordinary skill would have had a reasonable expectation that administering a combination of the two agents would effectively treat COVID-19 in a patient.
It has been held that “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).
With respect to claims 5 and 8, while Ghaderi disclosed general therapeutic amounts for the active agents at paragraph [0384], the combination of references fails to teach the particular dosage of inflammasome inhibitor taurodeoxychlolic acid and therefore, also its ratio based on the second component. However, differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the dose of taurodeoxychlolic acid administered to the patient, and its ratio based on the second component, are considered a result-effective variable that impacts the effectiveness of the treatment. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization.
The present application does not provide any evidence for a particular technical effect associated with the specific range of dosage recited in claim 5 and ratio of claim 8. It is well within the level of skill of the skilled artisan to determine optimal dosages and ratio for combination of ingredients through routine optimization.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Seong (US 2025/0262225- of effective filing date May 20, 2021) in view of Nas et al. (Rheumatol Int. 41, 811-817 (2021)) or Hossen et al. (SN Compr. Clin. Med. 2, 1777–1789 (2020)). The Seong reference contains an inventor that is not a joint inventor in the instant application.
Applicant claims a method of treating a lower respiratory tract infectious disease comprising administering taurodeoxycholic acid (inflammasome inhibitor) and the antiviral agent favipiravir.
Seong teaches the treatment of lower respiratory tract infectious diseases, such as SARS-CoV-2 infection ( COVID-19), and its symptoms, by administering taurodeoxycholic acid (TDCA) or its sodium salt. See at least page 4 and the claims. Seong disclosed that the compound inhibits activation of NLRP3 inflammasome by inhibiting a function of P2X7. Pharmaceutically effective amounts/dosages of the compounds were taught in page 5 and examples.
The teachings of Nas et al. have been discussed above and are here incorporated by reference. Favipiravir is an antiviral drug effective for the treatment of SARS-CoV-2 (COVID-19) and its symptoms as described in Nas et al. and Hossen et al. It can be administered in combination with other SARS-CoV-2 ( COVID-19) treatments, as evidenced by the references.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR exemplary rationale (A), it would have been prima facie obvious to administer a combination of taurodeoxychlolic acid and favipiravir to treat patients with SARS-CoV-2 infection (COVID-19). Each agent was taught in the prior art for treatment of SARS-CoV-2 infection (COVID-19) and its symptoms, which include breathing difficulty, fever, etc. A person having ordinary skill would have had a reasonable expectation that administering a combination of the two agents would effectively treat COVID-19 in a patient.
It has been held that “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).
With respect to claims 5 and 8, Seong disclosed effective amounts/dosages of the compounds as discussed above, thus, one of ordinary skill in the art would have been motivated to use the doses of taurodeoxychlolic acid taught by Seong to be effective for the treatment of COVID, together with the doses of antiviral taught by the secondary references, and therefore, would have been able to optimize and obtain the ratio of components claimed in claim 8.
In addition, the dose of taurodeoxychlolic acid administered to the patient, and its ratio based on the second component, are considered a result-effective variable that impacts the effectiveness of the treatment. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization. See MPEP 2144.05.
The present application does not provide any evidence for a particular technical effect associated with the specific range of dosage recited in claim 5 and ratio of claim 8. It is well within the level of skill of the skilled artisan to determine optimal dosages and ratio for combination of ingredients through routine optimization.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/561,881 (reference application) in view of Nas et al. (Rheumatol Int. 41, 811-817 (2021)) or Hossen et al. (SN Compr. Clin. Med. 2, 1777–1789 (2020))
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The reference claims teaches the treatment of lower respiratory tract infectious diseases, such as SARS-CoV-2 infection ( COVID-19), and its symptoms, by administering taurodeoxycholic acid (TDCA) or its sodium salt. The compound inhibits activation of NLRP3 inflammasome by inhibiting a function of P2X7.
The teachings of Nas et al. have been discussed above and are here incorporated by reference. Favipiravir is an antiviral drug effective for the treatment of SARS-CoV-2 (COVID-19) and its symptoms as described in Nas et al. and Hossen et al. It can be administered in combination with other SARS-CoV-2 ( COVID-19) treatments, as evidenced by the references.
Ascertainment of the difference between the conflicting application and the claims. (MPEP §2141.02)
The instant claims differ from the reference application claims in that the instant claims recite an additional ingredient, which is an antiviral agent, for the treatment of COVID-10.
Finding of prima facie obviousness--rational and motivation. (MPEP §2142-2413)
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR exemplary rationale (A), it would have been prima facie obvious to administer a combination of taurodeoxychlolic acid and favipiravir to treat patients with SARS-CoV-2 infection (COVID-19). Each agent was taught in the prior art for treatment of SARS-CoV-2 infection (COVID-19) and its symptoms, which include breathing difficulty, fever, etc. A person having ordinary skill would have had a reasonable expectation that administering a combination of the two agents would effectively treat COVID-19 in a patient.
It has been held that “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).
With respect to claims 5 and 8, the reference application disclosed effective amounts/dosages of the compounds as discussed above, thus, one of ordinary skill in the art would have been motivated to use the doses of taurodeoxychlolic acid taught by the reference application for the treatment of COVID, together with the doses of antiviral taught by the secondary references, and therefore, would have been able to optimize and obtain the ratio of components claimed in claim 8.
In addition, the dose of taurodeoxychlolic acid administered to the patient, and its ratio based on the second component, are considered a result-effective variable that impacts the effectiveness of the treatment. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization. See MPEP 2144.05.
The present application does not provide any evidence for a particular technical effect associated with the specific range of dosage recited in claim 5 and ratio of claim 8. It is well within the level of skill of the skilled artisan to determine optimal dosages and ratio for combination of ingredients through routine optimization.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-11 are rejected. No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 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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/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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