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 .1
Reassignment of Application
This application has been reassigned from Examiner Kamal Saeed to Examiner William Lee, in Art Unit 1623. In order to expedite accurate processing of the application papers, all future correspondence with the office should reflect this change.
Status
Claims 5-7, 10, 15, 17 and 22-35 are pending.
Election/Restrictions
Applicant's election with traverse of Group I (claims 5-7, 10, 15, 17,
22, 23, 34, and 35), in the reply filed on June 12, 2026 is acknowledged. The traversal is on the ground(s) that the Invention of Group I is the same as Group II. This is not found persuasive because of the reasons set forth by Examiner Saeed in the Restriction Requirement.
The requirement is still deemed proper and is therefore made FINAL.
It was noted by the Examiner that the June 12, 2026 species election by Applicant was not limited to a single elected species, but rather a genus of compounds where R2 is alkyl. On September 29, 2026, the Examiner called Applicant’s representatives to confirm a single elected species of quinacrine derivative.
Patent Agent Karla Fry identified the below species,
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where R1 is F and R2 is an alkyl, specifically, methyl (CH3). The Examiner and Ms. Fry identified support for this compound at Fig. 16 of the specification, where the following formula
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(last genus structure on right side of Figure 16) where
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.
The Examiner and Ms. Fry reviewed the claims and agreed claims 5-7, 10, 15 and 17 read upon the elected species, where R1 is F and R2 is CH3. The election of this species necessitates the withdrawal of claims 22-35.
An initial compound search for the examined species has been expanded to now include the compound quinacrine per se.
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2
As quinacrine has been added to the examined species, claims 34-35 have been rejoined, as they are directed a method of treatment comprising administering a composition comprising quinacrine to a subject in need. Therefore, claims 5-7,10,15,17, and 34-35 are under examination.
Claims 22-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species of compounds and non-elected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 12, 2026.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 5/21/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 57, the last sentence does not end with a period punctuation. It states “observed” not “observed.”
Paragraphs 68, 70-74 and 76-77, the last sentence of each does not end with a period punctuation mark after the last chemical structure listed.
Paragraph 97 the last sentence does not end with a period punctuation. It states “reported” not “reported.”
Appropriate correction is required.
Claim Objections
Claims 10 and 34-35 are objected to because of the following informalities:
Claim 10 simply recites “or derivative” with reference to quinacrine, when it should recite “or the derivative. . . . “ Claim 10 depends from claim 5, where claim 5 establishes antecedent basis for “a derivative” of quinacrine.
Method claims 34-35 depend from withdrawn claim 24. Claim 24 is directed to a composition comprising a derivative of quinacrine or quinacrine per se,
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. Amendment of claims 34-35 to recite the composition limitations of claim 24, to make them independent, will overcome this objection.
Appropriate correction is required.
Claim Interpretation
For purposes of examination, while claims 34-35 are objected to as dependent upon withdrawn claim 24, the claim 24 limitations of a composition comprising quinacrine will be imported into claims 34-35.
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 5, 7, 10, 15 and 17 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 preventing or treating a viral respiratory infection (such as COVID-19 or influenza) in a subject in need with the species quinacrine, does not reasonably provide enablement for the preventing or treating of ANY respiratory viral infection as claimed with any species of quinacrine derivative, including the elected species
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, where R1 is F and R2 is methyl. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims, such as the elected species of quinacrine derivative.
Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set eight forth factors to consider 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 amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The predictability or unpredictability of the art: The instant claimed invention is highly unpredictable since a person having ordinary skill in the art (PHOSITA) recognizes the unpredictability in treating or preventing respiratory viral diseases such as COVID-19, with quinacrine derivatives beyond the scope of quinacrine.
As evidence of this, a SciFinder compound and reference search of the elected species of quinacrine derivative, a compound of formula
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, where R1 is F and R2 is methyl, did not result in any references pre- or post-filing date of the examined application. This lack of references demonstrates the unpredictability of the elected species to treat or prevent respiratory viral infections such as COVID-19 or influenza. See attached SciFinder search report.
In fact, the only compound noted by the examination of the claims that predictably treats a respiratory viral infection is quinacrine per se. See anticipation rejection below citing to Pineda3 enabling the treatment of COVID-19 with quinacrine.
Accordingly, the unpredictability in the art is Wands factor against enablement of the claims.
The breadth of the claims: The instant claims are deemed broad since these claims read on treatment or prevention of any respiratory viral infections (e.g., COVID-19 and influenza) with any quinacrine derivative. The limitation of quinacrine derivative is noted to have broad but nonetheless adequate enabling description in the specification at Figures 11-19 and the generic structural formulas at paragraphs 68-77 of the specification. The broad scope of claims is a Wands factors weighing against enablement of the claims.
The amount of direction or guidance presented, and the presence or absence of working examples: It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970).
It is pointed out that there is no working example, in vitro or in vivo, beyond the species of quinacrine, to enable the preventing or treating of respiratory viral infections in a subject with quinacrine derivatives as claimed, including the non-enabled elected species
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where R1 is fluoro and R2 is methyl.
In fact the working examples only provide enablement for the species quinacrine and treatment and prevention of COVID-19 and influenza.
Starting at paragraph 79, Examples 1, 1.1, 1.2, 1.3, 1.4, and 1.5, are solely directed to quinacrine, with relation to antiviral activity against COVID-19 thru the interaction with G-4 RNA. Examples 2-3 note treatment strategies of COVID-19 via intravenous and oral administration of quinacrine.
Examples 4, 4.1 and 4.2, detail the RNA G4 structure of influenza and use of orally administered quinacrine to treat influenza alone, or a combination of influenza virus and SARS-CoV2 co-infection. Example 5 discloses the prevention of COVID-19 in a male subject over a winter season with orally administering 300 mg of quinacrine twice daily for a month. See paragraphs 96-97.
The lack of working examples is a Wands factor against the enablement of the claimed invention.
In summary, per the Wands factors detailed above, the claims are not enabled for the full scope as claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 5-7, 10, 15 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pineda B., Quinacrine, an Old Drug with Potentially usefull (sic) in the Treatment for COVID-19. Arch Med Res. 2021 Nov;52(8):858-859. Pineda is cited on the PTO-892 form.
Note this novelty rejection applies to the species quinacrine.
Regarding claims 5-7 and 34, a method of treating or preventing a viral respiratory infection in a subject in need of such, the method comprising administering to the subject a therapeutic amount of quinacrine,
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,
where claims 7 and 34 specifically claim SARS-CoV2, the coronavirus responsible for COVID-19, Pineda teaches quinacrine (identified therein as Qx) as an oral composition (oral dosage of 100 mg/ml) is useful in the treatment of the respiratory viral infection COVID-19, in subjects. See title and page 1 column 1. Regarding the claim limitation of therapeutic amount of quinacrine, Pineda teaches “Considering its pharmacokinetics and set up a record of wellbeing, the safest dose reported, even in children is 100 mg/day for 7 d (13, 14 ), which would allow reaching Qx [quinacrine] levels in lung tissue above the anti-SARS-CoV-2 EC 50 reported.” See page 1, top of column 2. Note that claim 34 depends from claim 24, which is directed solely to a composition comprising quinacrine.
Regarding claim 10 and oral quinacrine administration, Pineda teaches the therapeutic amount of quinacrine has been identified 100 mg/day by an oral route. See page 1, column 1.
Regarding claim 15 and a compound of formula 1, where R1-R4 are defined therein, Pineda teaches quinacrine
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. See page 1 and title. Pineda’s teaching of quinacrine anticipates formula 1 of claim 15, where quinacrine is equivalent to a species of formula I as follows:
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, when R1 is Cl, R2 is alkyl (methyl), R3 is alkyl (methyl), and R4 is an aliphatic amine comprises nitrogen and carbon atoms, such as where R4 is -N(ethyl)2.
As detailed above, Pineda anticipates claim 34.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5-7, 10, 15 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pineda B., Quinacrine, an Old Drug with Potentially usefull (sic) in the Treatment for COVID-19. Arch Med Res. 2021 Nov;52(8):858-859 in view of Liu et al. (2022), Disease of influenza virus and SARS-CoV-2 coinfection: Flurona or Flucovid?. J Med Virol, 94: 4056-4057. Both Pineda and Liu et al. are cited on the PTO-892 form.
Regarding claims 5-7, 10, 15, and 34, while Pineda teaches a method of treating the respiratory viral infection, COVID-19, in a subject, see page 1, columns 1-2, it is pointed out that Pineda does not necessarily teach a species of respiratory viral infection that includes not only COVID-19 but also a secondary respiratory viral infection. See pending claims 7 and 35 noting a combination of viral co-infection of COVID-19 and influenza in a subject.
Pineda teaches the treatment of COVID-19 with quinacrine, where it notes a proposed mechanism of action where quinacrine is taught to inhibit proinflammatory cytokines that cause a cytokine storm produced in severe COVID-19 patients. See page 1, column 1. Pineda teaches quinacrine therapeutic levels achieved in the lungs of COVID-19 patients. See page 1, column 2. There is no mention of a co-infection in Pineda.
Liu teaches the co-infection of a patient (identified as Flucovid), where a subject has both flu and COVID-19 symptoms such as fever, cough, fatigue, headache, shortness of breath and loss of taste and smell. See page 1, column 1. Liu teaches that co-infection by influenza A and SARS-CoV2 results in more severe inflammatory lung damage, as well as increased tissue cytokine/chemokine expression of the co-infection compared to infection by either virus alone. See page 1, column 2.
Prior to the filing of the instant application a PHOSITA following the teachings of Pineda to treat COVID-19 with quinacrine, where quinacrine is a potent inhibitor of proinflammatory cytokines and achieves therapeutic amounts in the lung, would have found it prima facie obvious to treat a COVID-19 and influenza co-infection in light of the teachings of Liu, noting the similarities of symptoms between the two, the association of both infections on the lungs of a subject and where both infections are associated with cytokine expression, where quinacrine is taught to inhibit cytokines.
The rationale to support a finding of obviousness are the prior art teachings combined according to known methods to yield predictable results. Pineda teaches quinacrine to treat SARS-CoV2, associated with targeting the lungs for therapeutic amounts and associated cytokine inhibition, where Liu teaches common symptoms between COVID-19 and influenza, in particular increased inflammatory cytokine expression and severe inflammatory lung damage.
Conclusion and Correspondence
In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a 371 of PCT/US2022/075222 08/19/2022
PCT/US2022/075222 has PRO 63/234,903 08/19/2021
2 CAS Reg. No. 83-89-6
(RS)-N′-(6-Chloro-2-methoxy-acridin-9-yl)-N,N-diethylpentane-1,4-diamine
Mepacrine
Atabrine or Atrebin
3 Pineda B., Quinacrine, an Old Drug with Potentially usefull (sic) in the Treatment for COVID-19. Arch Med Res. 2021 Nov;52(8):858-859.
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