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 .
Status of the Claims
Claims 9-10, 12, 17, 20-33, and 36-37 are pending in this application. Claims 1-8, 11, 13-16, 18-19, 34-35, and 38-56 have been cancelled by applicant.
Claim Objections
Claims 20-21, 24-31, 33, and 36 are objected to because of the following informalities:
Claims 20-21 read: “wherein about 100 mg to about 600 mg is administered . . . “ Claims should read “Wherein about 100 mg to about 600 mg of tafenoquine are administered . . . “ Or something to that effect.
Claims 24-31 and 33 read: “dose(s) is administered . . . “ Claims should read: “dose(s) is/are administered . . .”
Claims 24-25 read: “wherein the subsequence dose . . .” Claims should read: “wherein the subsequent dose . . . “
Claim 33 reads: “wherein the initial doses is . . .” Claim should read “wherein the initial dose is . . .”
Claim 36 reads: “wherein the condition being treated are . . .” Claim should read: “Wherein the conditions being treated are . . .” OR “wherein the condition being treated is . . . “
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In the instant case, claim 37 recites the limitation “a means for testing for G6PD deficiency” followed by functional language that does not recite sufficient structure, material, or acts for performing the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of a disease or infections caused by at least SARS-CoV-2 and/or influenza, does not reasonably provide enablement for prevention of the same, or for prevention of many of the conditions listed in claim 36 (such as triple negative breast cancer, Alzheimer’s, diabetes, Parkinson’s disease, etc.). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use of the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), where the court set forth eight factors to considers when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the examples; and (8) the quantity of experimentation necessary.
Breadth of Claims
Claim 9 encompasses a method of treating or preventing a viral infection of the human lung caused by any virus comprising administration of tafenoquine, pharmaceutically acceptable salts, or compositions thereof. Claim 36 broadens this scope by including treatment or prevention of any condition that is associated with MCP-1, beyond viral infections of the lung.
The term “prevention” is defined in the specification as encompassing completely avoiding a disease or infection with MCP-1 involvement (page 21, lines 3-5).
The term “treatment” also comprises prevention and prophylaxis (page 20, lines 12-13).
Nature of the invention/ State of the Prior Art/ Predictability in the Art
The art discloses methods of preventing triple-negative breast cancer include: (i) staying physically active and maintaining healthy weight; (ii) avoiding or limiting alcohol intake; (iii) consistent screening; (iv) genetic testing to understand personal risks; (v) and certain prophylactics for those with high risk, which include tamoxifen, raloxifene, and aromatase inhibitors (all of which are selective estrogen receptor modulators – SERMs). Obtained from halthline.com [retrieved on 12/04/2025] <URL: https://www.healthline.com/health/breast-cancer/what-causes-triple-negative-breast-cancer#prevention>) (By Pietrangelo; Pub. Date: Dec. 2, 2022).
NHS discloses there is no certain way to prevent Alzheimer’s, but a healthy lifestyle can help reduce risk by reducing the risk of cardiovascular disease, which is a risk factor. NHS teaches other risk factors include: (i) smoking; (ii) alcohol consumption; (iii) diabetes; (iv) hearing loss; (v) depression; etc. No single prophylactic is disclosed to prevent or even reduce the risk of Alzheimer’s. Obtained from nhs.uk [retrieved on 12/04/2025] <URL: https://www.nhs.uk/conditions/alzheimers-disease/prevention/>). (Pub. Date: July 4th, 2024)
The Mayo Clinic teaches ways for diabetes prevention include: (i) weight loss; (ii) physical activity; (iii) and a healthy diet. No prophylactic medication is disclosed for lowering risks or prevention. Obtained from mayoclinic.org [retrieved on 12/04/2025] <URL: https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/in-depth/diabetes-prevention/art-20047639>). (Pub. Date: March 12th, 2025).
Finally, the medical arts are also generally considered to be unpredictable making the goal of achieving prevention in this case even less likely. See Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involve.”).
Level of One of Ordinary Skill
The level of one of ordinary skill in the art would be high, likely an M.D. or Ph.D. in the medical arts (e.g., studying treatment of cancers and viral infections). See Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at 1381–82 (Fed. Cir. 1983) (Factors that may be considered in determining level of ordinary skill in the art include: … type of problems encountered in the art …”).
Guidance/Working Examples
Example 1 of the specification states tafenoquine is more potent and has broader spectrum of activity against malaria parasites and Pneumocystis in vivo.
Examples 3-4 show that Tafenoquine reduced time to clinical recovery from fever, cough, and shortness of breath in patients suffering COVID-19, reducing the risk of persistent symptoms in already infected subjects at day 28. Example 5 discloses that Tafenoquine achieves this effect by downregulating cytokine MCP-1 in COVID-19 patients. Examples 10-11 show SARS-CoV-2 replication inhibition in vitro.
Example 7 speaks to the upregulation of MCP-1 in SARS-CoV-2, influenza infections, and by mRNA vaccinations (Example 8). Thus, Applicant states tafenoquine administration would be expected to mitigate these adverse infections/outcomes, however, specific in vitro or in vivo data is only provided for SARS-CoV-2.
Example 9 lists an extensive number of diseases in which MCP-1 is upregulated and concludes that tafenoquine is expected to provide clinical benefit in all cases. No in vitro or in vivo data is provided to support this statement.
Degree of Experimentation
To practice the invention as claimed, the skilled artisan would have to need to determine whether the tafenoquine meets the functional limitations of the claim for the treatment and prevention of the many different conditions listed in claim 36 by administering tafenoquine to a statistically significant pool of subjects suffering from each of the conditions claimed. Prevention of the aforementioned conditions would require long-term monitoring of each patient for appearance of any new cancers, viral infections, or metabolic conditions. Thus, the quantity of experimentation in this area would be large, since there are a significant number of parameters that have to be studied beyond the general notion that MCP-1 upregulation occurs in these conditions. Furthermore, the ultimate outcome of such experimentation is completely unpredictable.
In sum, taking into consideration the Wands factors outlined above, an undue amount of experimentation would be required here to make and use the full scope of the claimed invention.
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 9-10, 12, 17, 20-33, 36-37 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "said lung infection" in the last line. There is insufficient antecedent basis for this limitation in the claim. Claims 10, 12, 17, 20-33, and 36 are rejected for depending upon the limitations of claim 9.
Claim 27 is indefinite because it recites “the method according to claim
Claim 36 recites the limitation "the condition being treated" in the second to last line. There is insufficient antecedent basis for this limitation in the claims, wherein claim 9 speaks to diseases or infections with MCP-1 upregulation or symptoms thereof, not conditions.
Claim 37 limitation “a means for testing for G6PD deficiency” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
In the present case, the disclosure is devoid of any structure that performs the function in the claim. The “means for testing” is referenced in the specification, however, no detail is provided as to what the “means for testing” comprises (see page 7, lines 3-5; Embodiment 37, page 39; and Embodiment 39, page 40).
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 36 is rejected for failing to further limit claim 9, from which it depends. Claim 9 speaks to a lung infection caused by at least one virus, while claim 36 expands the diseases to comprise gastric ulcers, breast cancer, Alzheimer’s, etc., which are not encompassed by lung infection.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 10 recites “the method of claim 9, further comprising determining said subject has said disease or infection ( . . . ) or is at risk of contracting said disease or infection ( . . . )”. This judicial exception is not integrated into a practical application because, while screening a group of subjects for the disease or infection, some subjects may end up not being affected by or infected with the disease or infection, and thus would not require treatment. In this case, as it pertains to this healthy group of individuals not receiving treatment after determining the presence or absence of disease or infection, the claim fails to integrate the judicial exception into practical application.
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 36 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding claim 36, Dow discloses tafenoquine is active against the lung pathogen Pneumocystis in vitro and in vivo at pharmacologically relevant concentrations and doses (page 4, last 5 lines) – thus anticipating wherein the disease is a fungi-associated respiratory tract infection.
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.
Claims 9, 17, 20-33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding claims 9 and 36, Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of Dow’s disclosure that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding claim 17, Dow discloses known TQ formulations are administered orally (reading on buccal) (page 4, lines 6-7).
Regarding claims 20-33, Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Claims 12 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 17, 20-33, and 36; in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of Dow are disclosed above and incorporated herein.
While Dow does not specifically teach: (i) wherein the subject is G6PD-normal (claim 12); or (ii) a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Dow’s disclosure of TQ (an FDA approved anti-malarial drug) for the treatment of SARS-CoV-2 infections; further in view Dow 2019’s teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency.
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Dow and Dow 2019 both disclose TQ (structure shown below) which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
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Regarding the instructions for use, as required by the instant claim, Applicant is advised that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Dow discloses TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 17, 20-33, and 36; in view of Stracher et al. (Obtained from weillcornell.org [retrieved on 12/04/2025] <URL: https://weillcornell.org/news/to-test-or-not-to-test-answering-your-questions-about-testing-for-covid-19> - Pub Date: Jan. 12th, 2022) (“Stracher”).
The teachings of Dow are disclosed above and incorporated herein.
While Dow does not specifically teach determining whether a subject has a disease or infection prior to administering treatment; the teachings of Stracher are relied upon for these disclosures.
Stracher teaches subjects should test for COVID-19 about 5-7 days after last exposure or as soon as symptoms appear (page 1, first question). Stracher teaches testing is more critical in subjects at risk for serious complications and eligible for treatment (page 2, question 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to determine if a subject has a disease or condition, such as COVID-19, prior to administration of treatment. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Dow teaches TQ may be effective for the treatment of SARS-CoV-2 infections; further because Stracher teaches subjects should test for a COVID-19 infection 5-7 days after exposure, or as soon as symptoms appear in order to confirm infection prior to seeking treatment.
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 9, 12, 17, 20-33, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,744,828 B2 (US ‘828); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding instant claims 9, 17, 20-33, and 36, US ‘828 claims a method of preventing systematic malaria in a human subject comprising administration of 3 loading doses of TQ (about 200 mg once a day for 3 days) – reading on initial doses - and administration of a maintenance dose once a week of about 200 mg – reading on subsequent doses (US ‘828’s claim 1).
Regarding instant claim 12, US ‘828 discloses their treatment is intended for G6PD-normal subjects (abstract) since TQ may be harmful to subjects who are G6PD deficient (col. 2, lines 25-30).
Regarding instant claim 37, US ‘828 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) (col. 2, lines 45-56).
While US ‘828 does not claim treatment of a SARS-CoV-2 infection; the teachings of Dow are relied upon for these disclosures.
Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract). Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of US ‘828’s disclosure of TQ and a kit comprising TQ; further in view of Dow’s teachings that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Further regarding instant claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘828’s disclosure of TQ, and their teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency; further in view of Dow’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections.
Further regarding instant claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, US ‘828 and Dow both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, US ‘828 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) (col. 2, lines 45-56).
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘828 discloses TQ and a kit comprising TQ (see US ‘828’s claim 10); and Dow discloses TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,744,828 B2 (US ‘828); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 12, 17, 20-33, and 36-37; further in view of Stracher et al. (Obtained from weillcornell.org [retrieved on 12/04/2025] <URL: https://weillcornell.org/news/to-test-or-not-to-test-answering-your-questions-about-testing-for-covid-19> - Pub Date: Jan. 12th, 2022) (“Stracher”).
The teachings of US ‘828 and Dow are disclosed above and incorporated herein.
While US ‘828 in view of Dow does not specifically teach determining whether a subject has a disease or infection prior to administering treatment; the teachings of Stracher are relied upon for these disclosures.
Stracher teaches subjects should test for COVID-19 about 5-7 days after last exposure or as soon as symptoms appear (page 1, first question). Stracher teaches testing is more critical in subjects at risk for serious complications and eligible for treatment (page 2, question 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to determine if a subject has a disease or condition, such as COVID-19, prior to administration of treatment. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘828 in view of Dow teaches TQ may be effective for the treatment of SARS-CoV-2 infections; further because Stracher teaches subjects should test for a COVID-19 infection 5-7 days after exposure, or as soon as symptoms appear in order to confirm infection prior to seeking treatment.
Claims 9, 12, 17, 20-33, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,888,558 B2 (US ‘558); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding instant claims 9, 17, 20-33, and 36, US ‘558 claims a method of preventing malaria in a human subject comprising administration of 2 or more initial doses of TQ (about 75-299 mg once a day for 2 or more days) and administration of an exposure dose once a week of about 75-299 mg – reading on subsequent doses (US ‘558’s claim 1).
Regarding instant claim 12, US ‘588 discloses their treatment is intended for G6PD-normal subjects (US ‘588’s claim 1) since TQ may be harmful to subjects who are G6PD deficient (col. 2, lines 39-50 – in PG Pub.).
Regarding instant claim 37, US ‘588 claims a kit comprising TQ (US ‘558’s claim 33) and discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) (col. 2, last para. – in PG Pub.).
While US ‘558 does not claim treatment of a SARS-CoV-2 infection; the teachings of Dow are relied upon for these disclosures.
Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract). Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of US ‘558’s disclosure of TQ and a kit comprising TQ; further in view of Dow’s teachings that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Further regarding instant claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘558’s disclosure of TQ, and their teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency; further in view of Dow’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections.
Further regarding instant claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, US ‘558 and Dow both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, US ‘558 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) (col. 2, last para.).
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘558 discloses TQ and a kit comprising TQ (see US ‘558’s claim 33); and Dow discloses TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,888,558 B2 (US ‘558); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 12, 17, 20-33, and 36-37; further in view of Stracher et al. (Obtained from weillcornell.org [retrieved on 12/04/2025] <URL: https://weillcornell.org/news/to-test-or-not-to-test-answering-your-questions-about-testing-for-covid-19> - Pub Date: Jan. 12th, 2022) (“Stracher”).
The teachings of US ‘558 and Dow are disclosed above and incorporated herein.
While US ‘558 in view of Dow does not specifically teach determining whether a subject has a disease or infection prior to administering treatment; the teachings of Stracher are relied upon for these disclosures.
Stracher teaches subjects should test for COVID-19 about 5-7 days after last exposure or as soon as symptoms appear (page 1, first question). Stracher teaches testing is more critical in subjects at risk for serious complications and eligible for treatment (page 2, question 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to determine if a subject has a disease or condition, such as COVID-19, prior to administration of treatment. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘558 in view of Dow teaches TQ may be effective for the treatment of SARS-CoV-2 infections; further because Stracher teaches subjects should test for a COVID-19 infection 5-7 days after exposure, or as soon as symptoms appear in order to confirm infection prior to seeking treatment.
Claims 9-10, 17, 20-33, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 11,633,391 B2 (US 391). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 9-10, 17, 20-33, and 36, US ‘391 claims a method for treating viral lung infections (including SARS-CoV-2 infections) comprising administration of tafenoquine (US ‘391’s claims 1 and 26), with one or more initial doses of 100-600 mg (US ‘391’s claims 10-11, 16-18) and a subsequent dose of about 200 mg about 1 week after last initial dose (US ‘391 claims 11 and 19-24) – thus anticipating the instant method claims. US ‘391 further claims their method wherein the subject has the viral infection prior to treatment – reading on “determining said subject has said infection” (instant claim 10) (US ‘391’s claim 3).
Claims 12 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 11,633,391 B2 (US 391); as applied to claims 9-10, 17, 20-33, and 36; in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of US ‘391 are disclosed above and incorporated herein.
While US ‘391 does not specifically teach: (i) wherein the subject is G6PD-normal (claim 12); or (ii) a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘391s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections; further in view Dow 2019’s teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency.
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, US ‘391 and Dow 2019 both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘391 discloses TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
Claims 9, 12, 17, 20-33, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 47-70 of copending Application No. 18/240,049 (Copending ‘049); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding instant claims 9, 17, 20-33, and 36, Copending ‘049 claims a method of preventing malaria in a human subject comprising administration of 2 or more initial doses of TQ (about 75-299 mg once a day for 2 or more days) and administration of an exposure dose once a week of about 75-299 mg – reading on subsequent doses (Copending ‘049’s claim 47).
Regarding instant claim 12, Copending ‘049 discloses their treatment is intended for G6PD-normal subjects (Copending ‘049’s claim 47) since TQ may be harmful to subjects who are G6PD deficient ([0006]-[0007] – in PG Pub.).
Regarding instant claim 37, Copending ‘049 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) ([0007] – in PG Pub.).
While Copending ‘049 does not claim treatment of a SARS-CoV-2 infection; the teachings of Dow are relied upon for these disclosures.
Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract). Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of Copending ‘049’s disclosure of TQ; further in view of Dow’s teachings that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Further regarding instant claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘049’s disclosure of TQ, and their teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency; further in view of Dow’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections.
Further regarding instant claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Copending ‘049 and Dow both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Copending ‘049 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) (col. 2, last para.).
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘049 discloses TQ; and Dow discloses TQ as effective for the treatment of SARS-CoV-2 infections.
This is a provisional nonstatutory double patenting rejection.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 47-70 of copending Application No. 18/240,049 (Copending ‘049); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 12, 17, 20-33, and 36-37; further in view of Stracher et al. (Obtained from weillcornell.org [retrieved on 12/04/2025] <URL: https://weillcornell.org/news/to-test-or-not-to-test-answering-your-questions-about-testing-for-covid-19> - Pub Date: Jan. 12th, 2022) (“Stracher”).
The teachings of Copending ‘049 and Dow are disclosed above and incorporated herein.
While Copending ‘049 in view of Dow does not specifically teach determining whether a subject has a disease or infection prior to administering treatment; the teachings of Stracher are relied upon for these disclosures.
Stracher teaches subjects should test for COVID-19 about 5-7 days after last exposure or as soon as symptoms appear (page 1, first question). Stracher teaches testing is more critical in subjects at risk for serious complications and eligible for treatment (page 2, question 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to determine if a subject has a disease or condition, such as COVID-19, prior to administration of treatment. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘049 in view of Dow teaches TQ may be effective for the treatment of SARS-CoV-2 infections; further because Stracher teaches subjects should test for a COVID-19 infection 5-7 days after exposure, or as soon as symptoms appear in order to confirm infection prior to seeking treatment.
This is a provisional nonstatutory double patenting rejection.
Claims 9-10, 12, 17, 20-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51-73 of copending Application No. 18/300,805 (Copending ‘805). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 9-10, 17, 20-33, and 36, Copending ‘805 claims a method for treating viral lung infections (including SARS-CoV-2 infections) comprising administration of tafenoquine (Copending ‘805’s claims 51), with one or more initial doses of 100-600 mg (Copending ‘805’s claims 58-66) and a subsequent dose of about 200 mg about 1 week after last initial dose (Copending ‘805 claims 67-73) – thus anticipating the instant method claims. Copending ‘805 further claims their method wherein the subject has the viral infection prior to treatment – reading on “determining said subject has said infection” (instant claim 10) (Copending ‘805’s claims 54-55); and wherein the subject is G6PD normal (anticipating instant claim 12) (Copending ‘805’s claim 53).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 37 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51-73 of copending Application No. 18/300,805 (Copending ‘805); as applied to claims 9-10, 12, 17, 20-33, and 36; in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of Copending ‘805 are disclosed above and incorporated herein.
While Copending ‘805 does not specifically teach a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Copending ‘805 and Dow 2019 both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘805 discloses TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
This is a provisional nonstatutory double patenting rejection.
Claims 9, 17, 20-33, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 50, 53-58, 61-66, 69-75 of copending Application No. 17/683,718 (Copending ‘718). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 9, 17, 20-33, and 36, Copending ‘718 claims a method for treating a SARS-CoV-2 infection comprising administration of tafenoquine (Copending ‘718’s claims 50, 58, and 66), with one or more initial doses of 100-800 mg and a subsequent dose about 1 week after last initial dose (Copending ‘718 claims 53-57, 61-65, and 69-75) – thus anticipating the instant method claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 50, 53-58, 61-66, 69-75 of copending Application No. 17/683,718 (Copending ‘718); as applied to claims 9, 17, 20-33, and 36; in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of Copending ‘718 are disclosed above and incorporated herein.
While Copending ‘718 does not specifically teach: (i) wherein the subject is G6PD-normal (claim 12); or (ii) a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘718’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections; further in view Dow 2019’s teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency.
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Copending ‘718 and Dow 2019 both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘718 discloses TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
This is a provisional nonstatutory double patenting rejection.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 50, 53-58, 61-66, 69-75 of copending Application No. 17/683,718 (Copending ‘718); as applied to claims 9, 17, 20-33, and 36; Stracher et al. (Obtained from weillcornell.org [retrieved on 12/04/2025] <URL: https://weillcornell.org/news/to-test-or-not-to-test-answering-your-questions-about-testing-for-covid-19> - Pub Date: Jan. 12th, 2022) (“Stracher”).
The teachings of Copending ‘718 and Dow are disclosed above and incorporated herein.
While Copending ‘718 in view of Dow does not specifically teach determining whether a subject has a disease or infection prior to administering treatment; the teachings of Stracher are relied upon for these disclosures.
Stracher teaches subjects should test for COVID-19 about 5-7 days after last exposure or as soon as symptoms appear (page 1, first question). Stracher teaches testing is more critical in subjects at risk for serious complications and eligible for treatment (page 2, question 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to determine if a subject has a disease or condition, such as COVID-19, prior to administration of treatment. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘718 in view of Dow teaches TQ may be effective for the treatment of SARS-CoV-2 infections; further because Stracher teaches subjects should test for a COVID-19 infection 5-7 days after exposure, or as soon as symptoms appear in order to confirm infection prior to seeking treatment.
This is a provisional nonstatutory double patenting rejection.
Claims 9-10, 17, 20-33, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24-36 of copending Application No. 18/640,611 (Copending ‘611); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding instant claims 9-10, 17, 20-33, and 36, Copending ‘611 claims a method of treating a tick-borne disease in a human subject comprising administration of one or more first doses of TQ (about 200 mg once a day for 3 days) – reading on initial doses - and administration of a maintenance dose once a week of about 200 mg – reading on subsequent doses (Copending ‘611’s claims 25 and 29).
Regarding instant claim 10, Copending ‘611 claims their method wherein the subject is symptomatic ambulatory or hospitalized (Copending ‘611’s claims 34-35) (reading on determining that the subject has the disease or condition).
While Copending ‘611 does not claim treatment of a SARS-CoV-2 infection; the teachings of Dow are relied upon for these disclosures.
Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract). Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of Copending ‘611’s disclosure of TQ and a kit comprising TQ; further in view of Dow’s teachings that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 12 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24-36 of copending Application No. 18/640,611 (Copending ‘611); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9-10, 17, 20-33, and 36; further in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of Copending ‘611 are disclosed above and incorporated herein.
While Copending ‘611 does not specifically teach: (i) wherein the subject is G6PD-normal (claim 12); or (ii) a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘611 and Dow’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections; further in view Dow 2019’s teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency.
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Copending ‘611 and Dow 2019 both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘611 and Dow disclose TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
This is a provisional nonstatutory double patenting rejection.
Claims 9, 17, 20-33, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29-40, 62-67, 69, and 71 of copending Application No. 18/640,657 (Copending ‘657); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding instant claims 9, 17, 20-33, and 36, Copending ‘657 claims a method of treating a tick-borne disease in a human subject comprising administration of one or more first doses of TQ (about 200 mg once a day for 3 days) – reading on initial doses - and administration of a maintenance dose once a week of about 200 mg – reading on subsequent doses (Copending ‘657’s claims 29 and 35).
While Copending ‘657 does not claim treatment of a SARS-CoV-2 infection; the teachings of Dow are relied upon for these disclosures.
Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract). Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of Copending ‘657’s disclosure of TQ and a kit comprising TQ; further in view of Dow’s teachings that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 12 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24-36 of copending Application No. 18/640,657 (Copending ‘657); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 17, 20-33, and 36; further in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of Copending ‘657 are disclosed above and incorporated herein.
While Copending ‘611 does not specifically teach: (i) wherein the subject is G6PD-normal (claim 12); or (ii) a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘657 and Dow’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections; further in view Dow 2019’s teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency.
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Copending ‘657 and Dow 2019 both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘611 and Dow disclose TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
This is a provisional nonstatutory double patenting rejection.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24-36 of copending Application No. 18/640,657 (Copending ‘657); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9, 17, 20-33, and 36; further in view of Stracher et al. (Obtained from weillcornell.org [retrieved on 12/04/2025] <URL: https://weillcornell.org/news/to-test-or-not-to-test-answering-your-questions-about-testing-for-covid-19> - Pub Date: Jan. 12th, 2022) (“Stracher”).
The teachings of Copending ‘657 and Dow are disclosed above and incorporated herein.
While Copending ‘657 in view of Dow does not specifically teach determining whether a subject has a disease or infection prior to administering treatment; the teachings of Stracher are relied upon for these disclosures.
Stracher teaches subjects should test for COVID-19 about 5-7 days after last exposure or as soon as symptoms appear (page 1, first question). Stracher teaches testing is more critical in subjects at risk for serious complications and eligible for treatment (page 2, question 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to determine if a subject has a disease or condition, such as COVID-19, prior to administration of treatment. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘657 in view of Dow teaches TQ may be effective for the treatment of SARS-CoV-2 infections; further because Stracher teaches subjects should test for a COVID-19 infection 5-7 days after exposure, or as soon as symptoms appear in order to confirm infection prior to seeking treatment.
This is a provisional nonstatutory double patenting rejection.
Claims 9-10, 17, 20-33, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-24, 45-54, 81, and 83 of copending Application No. 18/640,695 (Copending ‘695); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”).
Regarding instant claims 9-10, 17, 20-33, and 36, Copending ‘695 claims a method of treating a tick-borne disease in a human subject comprising administration of one or more first doses of TQ (about 200 mg once a day for 3 days) – reading on initial doses - and administration of a maintenance dose once a week of about 200 mg – reading on subsequent doses (Copending ‘695’s claims 17 and 21).
Regarding instant claim 10, Copending ‘695 claims their method wherein the subject is has had potential exposure to the tick-borne pathogen (Copending ‘695’s claim 45) (reading on determining that the subject has the disease or condition).
While Copending ‘695 does not claim treatment of a SARS-CoV-2 infection; the teachings of Dow are relied upon for these disclosures.
Dow discloses that tafenoquine (TQ) exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and states that therapeutic potential of TQ in management of COVID-19 should be evaluated (page 3, abstract). Dow discloses TQ administration of FDA approved doses for malaria prophylaxis is 200 mg/day for three days (reading on one or more initial doses of 100-600 mg) followed by 200 mg seven days later (reading on a subsequent dose once a week and at least seven days after the last initial dose) (page 7). Dow discloses that these dosages achieved concentrations of TQ in the lung that were higher than the EC50/ 90 concentrations, thus suggesting a reasonable expectation of success in treating a SARS-CoV-2 infection with these dosage amounts (Figure 2, page 20).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective fling date of the claimed invention to administer TQ to a human subject suffering from a disease or infection caused by SARS-CoV-2. One of ordinary skill would have been motivated to do so in view of Copending ‘695’s disclosure of TQ; further in view of Dow’s teachings that TQ exhibited an EC50/ 90 of about 2.6/ 5.1 µM against SARS-CoV-2 and that its potential in the management of COVID-19 should be further evaluated. One of ordinary skill would have had a reasonable expectation of success because, as Dow discloses, TQ is already FDA approved for the treatment of malaria in humans, and is active against other lung pathogens, like Pneumocystis in vivo (page 4, lines 6-7).
Regarding the instantly claimed ranges and number of dosages, as recited in instant claims 20-33, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
This is a provisional nonstatutory double patenting rejection.
Claims 12 and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-24, 45-54, 81, and 83 of copending Application No. 18/640,695 (Copending ‘695); in view of Dow et al. (bioRxiv Preprint, doi: https://doi.org/10.1101/2020.07.12.199059 - Posted July 12th, 2020) (“Dow”); as applied to claims 9-10, 17, 20-33, and 36; further in view of Dow et al. (US 2019/0328723 A1 – Pub Date: Oct. 31st, 2019) (“Dow 2019”).
The teachings of Copending ‘695 are disclosed above and incorporated herein.
While Copending ‘695 does not specifically teach: (i) wherein the subject is G6PD-normal (claim 12); or (ii) a kit comprising a means for testing G6PD deficiency, the compounds of Formula I, and instructions of use (claim 37); the teachings of Dow 2019 are relied upon for these disclosures.
Dow 2019 discloses that many substances, including anti-malarial drugs can cause acute hemolysis in people with G6PD deficiency. Dow specifically teaches TQ may cause hemolytic anemia in G6PD individuals [0005]-[0006]. Dow 2019 discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding claim 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer TQ for the treatment of a SARS-CoV-2 infection only to subjects who are G6PD-normal. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Copending ‘695 and Dow’s teaching that TQ (an FDA approved anti-malarial drug) is effective for the treatment of SARS-CoV-2 infections; further in view Dow 2019’s teaching that anti-malarial drugs, such as TQ, can cause acute hemolysis in subjects with G6PD-deficiency.
Regarding claim 37, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
In the present case, Copending ‘695 and Dow 2019 both disclose TQ, which is encompassed by the claimed general structure of Formula I and therefore reads on the claim. Furthermore, Dow 2019 discloses there are over 30 kits available for diagnosing G6PD, and also discloses the gold standard for G6PD deficiency diagnosis is to use a direct, quantitative enzymatic assay to establish the amount of G6PD in blood (reading on a means for testing G6PD deficiency) [0006].
Regarding the instructions for use, as required by the instant claim, Applicant is reminded that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a kit comprising TQ, a means for testing G6PD, and instruction for use. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘695 and Dow disclose TQ as effective for the treatment of SARS-CoV-2 infections; further in view of Dow 2019’s teaching that TQ may lead to acute hemolysis in people with G6PD deficiency, and their teaching of a means for testing G6PD deficiency.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627