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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 01/09/2026, wherein the Amendment amended claims 22, 24, 25, 27-30, 32-33, and 35, cancelled claim 23, and added claims 36-40.
Claims 22 and 24-40 are pending.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Specification Objections
The newly filed Substitute Specification that deleted the hyperlinks on pgs. 97 and 100, is sufficient to overcome this objection.
Claim Objections
Applicant’s amendments to the claims is sufficient to overcome these objections.
35 U.S.C. § 112(b)
Applicant’s deletion of claim 23 and amendments to claims 24, 27-29, and 35 are sufficient to overcome these rejections.
REJECTIONS—MAINTAINED, MODIFIED, & NEW
In view of the amendments to the claims and the addition of new claims, the below prior art rejections have been modified or are new. The same prior art references relied upon the previous Office Action, continue to be relied upon.
Claim Interpretation
The terms “strong” and “severe,” as recited in claim 24, are interpreted as defined on pgs. 6-7 of the specification:
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Claim Objections
(New) Claim 22 is objected to because of the following informalities: in line 2, “SARS-CoV2” is spelled incorrectly. The term “SARS-VCoV2” should be replaced with - -SARS-CoV2- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(Maintained) Claims 22, 24, 26-31, 34-35, 37 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT04377308 (Fluoxetine to Reduce Intubation and Death After COVID19 Infection, published 05/04/2020, PTO-892).
NCT04377308 teaches fluoxetine to reduce intubation and death after COVID-19 infection (title).
Patients who have tested positive or are presumptively positive for COVID-19 are entered into the study and given the option to start the medication fluoxetine, wherein participants are monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine (pg. 5, “Brief Summary”).
Fluoxetine is administered at 20mg initially, and increased as tolerated to a maximum of 60mg until symptoms abate (pg. 7, “Arms and Interventions”).
As evidenced by pg. 1 of the specification, SARS-CoV-2 is the causative agent of COVID-19.
Regarding claim 24, NCT04377308 teaches the inclusion criteria of patients as those with a positive test or with presumptive positive COVID-19 with fever, cough and shortness of breath (pg. 8, “Criteria”), meeting the limitation of symptomatic COVID-19 disease. See the Claim Interpretation section above in reference to “strong symptomatic COVID-19 diseases.”
Regarding claims 26-30, while NCT04377308 does not explicitly teach the properties of claims 26-30, it is reasonable to assume that the method of NCT04377308, a method of treating COVID-19 by administering 20-60mg fluoxetine, would have the same properties since the fluoxetine is administered for the same purpose, in the same dosage amount, to the same patient population as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties. See MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 31, and 34, NCT04377308 teaches fluvoxamine.
Regarding claim 35, 37 and 40 NCT04377308 teaches Fluoxetine as administered at 20mg initially, and increased as tolerated to a maximum of 60mg until symptoms abate.
Response to Arguments
On pg. 8, Remarks, Applicant argues that NCT04377308 did not show any actual treatment, that no patient had been recruited, and that the study had just started.
This argument has been fully considered, but is not found persuasive. 35 USC 102(a)(1) states a person shall be entitled to a patent unless 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.
NCT04377308 describes the claimed invention in a printed publication. As such, it applies as prior art under 35 USC 102(a)(1). Moreover, Applicant has provided no evidence that the teachings of NCT04377308 were not publicly disclosed prior to the effective filing date of the instantly claimed invention.
It is further pointed out that the instant specification does not provide examples of a method of preventing or treating a viral infection due to a SARS-CoV-2 betacoronavirus by administering a FIASMA antidepressant. The instant specification states on pg. 76, “In this multicenter retrospective observational study involving a relatively large sample of patients hospitalized for severe COVID-19, we found that FIASMA medication use at study baseline was significantly and substantially associated with reduced risk of intubation or death, independently of sociodemographic characteristics and medical comorbidity;” on pg. 95, “In this multicenter retrospective observational study involving a large sample of patients admitted to the hospital with COVID-19, it was found that hydroxyzine use, at a median daily dose of 25mg was significantly and substantially associated with reduced risk of death, independently of patients’’ characteristics, clinical and biological markers of disease’s severity at hospital admission, and use of the psychotropic medications.”
Thus, Applicant’s own examples do not show any actual treatment.
(Maintained) Claims 22, 24, 26-30, 32, and 34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0181537 to Rogers (effectively filed 05/07/2020, PTO-892).
Regarding claims 22, Rogers teaches a method of treating SARS-CoV-2, i.e. COVID-19, by administering paroxetine (pg. 9, claims 12-13).
Regarding claim 24, Rogers teaches its methods for the treatment of subjects who have or who have been diagnosed with infection with SARS-CoV-2, wherein this patient population incudes symptomatic COVID-19 subjects ([0037]). Moreover, the recitation “A method of reducing the severity of infection with coronavirus. .. for treating a subject who has an infection with a coronavirus,” in claim 12, Rogers, implies treating a patient population that includes patients with symptomatic COVID-19 disease. Since Rogers teaches that its methods reduce the severity of infection or treats a subject with coronavirus infection, it is reasonable to assume, that such symptoms include those of at least “strong COVID-19 disease,” such as fever, dry cough, aches and pains, nasal congestion, strong headache, conjunctivitis, or sore throat, as described in the claim interpretation section above.
Regarding claims 26-30, while Rogers does not teach these properties, these properties express the desired result of the positive step of administering a therapeutically effective amount of paroxetine, to a subject infected with SARS-CoV-2, to treat the disease, and thereby meets these limitations. See MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 32 and 34, Rogers teaches paroxetine.
Response to Arguments
On pg. 8, Remarks, Applicant argues that US provisional application 63/021,194, which Rogers claims benefit to, does not mention that paroxetine could be useful to treat SARS-CoV-2 and that it is only mentioned once in Fig. 5 without any link to SARS-CoV-2. Applicant argues that Rogers therefore does not apply as prior art.
This argument has been fully considered, but is not found persuasive. Pgs. 1-3 of ‘194 states that “Our existing RNA directed drugs appear to be excellent candidates for repurposing from their current drug indications as neurodegenerative disease specific blockers of APP, PrP translation of their inhibition of their 5’UTRs. We propose that they have the ability to act as translation inhibitors of the COVID RNA replicase. . .Our goal is to develop the clear medicinal lead inhibitors that can bind and intercalate into related RNA sequences in the viral replicase mRNA of the COVID-19 RNA genome. . .The high throughput screened small molecules, consistent with our bioinformatic comparisons, showed a clear potential to bind RNA sequences in key positions in the respective viral RNA replicase gene and that of the poly protein derived from the viral spikey S protein. The complete severe acute respiratory syndrome coronavirus was sequenced by the Wuhan-group. . .Our arrays of compounds are RNA targeting small molecules that have been screened. . .with a clear potential to block translation of the alpha-synuclein transcript via its 5’UTR, encoding a CAGUGU Iron Response Element (IRE) motive at its’ apex. These same agents, many of which are FDA approved for other indications instead will be tested to bind equivalent, though distinct, viral sequences to slow down COVID-19 growth, assembly and infectivity. . .Our lab has well experienced personnel who have screened and characterized lead agents. . .Upon bioinformatic examination, we noted that several of our lead molecules also blocked viral replication. Many of these leads are repurposed FDA pre-approved compounds,” wherein Fig. 5 is referenced. Paroxetine, a compound of Fig. 5, is clearly being referenced as a lead compound that is proposed as being repurposed for the treatment of COVID-19 for its targeting of alpha-synuclein or APP.
As such, the teachings of Rogers apply as prior art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(New) Claims 22, 24-31, 34-37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0181537 to NCT04377308 (Fluoxetine to Reduce Intubation and Death After COVID19 Infection, published 05/04/2020, PTO-892)in view of Gibson (Covid-19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre-COVID-19 ARDS, The Med Jn of Australia, published 06/22/2020, PTO-892).
NCT04377308 is applied to claims 22, 24, 26-31, 34-35, 37 and 40 as discussed above and incorporated herein.
Regarding claims 25 and 36, while NCT04377308 teaches a method of treating COVID-19 by administering fluoxetine, it differs from that of instant claims 25 and 36, and 40 in that it does not teach treating or preventing acute respiratory distress syndrome (ARDS) associated with a viral infection due to SARS-CoV-2.
Gibson teaches that severe COVID-19 leads to acute respiratory distress syndrome (ARDS) (pg. 54, Col. 1). ARDS develops in 42% of patients presenting with COVID-19 pneumonia (pg. 54, Cols. 1-2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of NCT04377308 to prevent ARDS, to arrive at instant claims 25, 36-37, and 40. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because NCT04377308 teaches a method of treating COVID-19 and Gibson teaches ARDS as developing in patients with COVID-19 pneumonia.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of preventing ARDS by treating the COVID-19 infection.
(Modified) Claims 22, 24-30, 32, 34-36, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0181537 to Rogers (effectively filed 05/07/2020, PTO-892) in view of Gibson (Covid-19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre-COVID-19 ARDS, The Med Jn of Australia, published 06/22/2020, PTO-892).
Rogers is applied to claims 22, 24, 26-30, 32, and 34, as discussed in the above rejection, and incorporated herein.
Regarding claims 25 and 36, while Rogers teaches a method of treating COVID-19 by administering paroxetine, it differs from that of instant claims 25, 36, 38, and 40 in that it does not teach treating or preventing acute respiratory distress syndrome (ARDS).
Gibson teaches that severe COVID-19 leads to acute respiratory distress syndrome (ARDS) (pg. 54, Col. 1). ARDS develops in 42% of patients presenting with COVID-19 pneumonia (pg. 54, Cols. 1-2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of Rogers to prevent ARDS, to arrive at instant claim 25. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Rogers teaches a method of treating COVID-19 and Gibson teaches ARDS as developing in patients with COVID-19 pneumonia.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of preventing ARDS by treating the COVID-19 infection.
Regarding claim 35, while Rogers teaches a method of treating SARS-CoV-2 by administering paroxetine, it differs from that of instant claim 35, in that it does not teach administering an effective fluoxetine-equivalent dose.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select an amount of paroxetine that is an effective fluoxetine-equivalent dose, to arrive at instant claim 35. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Rogers teaches administering an amount of paroxetine effective for reducing the risk of infection, for reducing the severity of infection, or for treating a subject who has an infection with a SARS-Cov-2 coronavirus, and
- "[W]here 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," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 38 and 40, Rogers teaches paroxetine.
(Maintained) Claims 22, 24, 26-30, 32-33, 35, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over US 7,544,712 to Hsu (published 2009, PTO-892) in view of Malik (Properties of coronavirus and SARS-CoV-2,” The Malaysian Jn of Pathology, published 04/2000, PTO-892).
Hsu teaches a method for treating coronavirus severe acute respiratory syndrome (SARS) infection by administering to a subject in need of the treatment, an effective amount of nortriptyline, trimipramine, amitriptyline, or other compounds, wherein nortriptyline is taught as a preferred compound. (abstract; Col. 1, line 34-Col. 2, line 35). The compounds are taught as inhibiting at least 95%-100% of TFI-TGEV growth.
Regarding claims 22, while Hsu teaches a method of treating coronavirus by administering nortriptyline, trimipramine, or amitriptyline, it differs from that of the instantly claimed invention in that it does not teach a SARS-CoV2 coronavirus.
Hsu teaches its methods as treating severe acute respiratory syndrome (SARS) virus infection (Col. 2, lines 26-29; Col. 4, lines 19-26; Cols. 5-6, Ex. 2).
Malik teaches that zoonotic coronaviruses were discovered in 1962 and that since then, pathogenic human coronaviruses were identified beginning with the discovery of SARS-CoV in 2002, and that with the recent detection of SARS-CoV-2, there are now seven human coronaviruses (abstract). Malik teaches that the coronaviral genome contains four major structure proteins, the spike, membrane, envelope, and the nucleocapsid protein, all of which are encoded within the 3’ end of the genome (abstract). Malik teaches that SARS-CoV-2 genome is similar to that of typical CoVs (pg. 6, Col. 2, “Genomic structure of SARS-CoV-2”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select SARS-CoV-2, a betacoronavirus, as the coronavirus of Hsu, to arrive at instant claims 22. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Hsu teaches a method of treating coronavirus and is published in 2009,
-Hsu specifically teaches treating severe acute respiratory syndrome virus infection (SARS),
-Malik teaches that there are only seven known human coronaviruses, beginning with the discovery of SARS-CoV in 2002, and
-Malik teaches the SARS-CoV-2 genome as similar to that of typical CoVs.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of treating SARS-CoV-2, one of seven known human coronaviruses that has a genome similar to that of typical CoVs.
Regarding claim 24, the combination of Hsu and Malik teaches the treatment of SARS-CoV-2 the causative agent of COVID-19, as evidenced by pg. 1 of the specification, and Hsu teaches that its methods of treatment refers to subjects with symptoms of the coronavirus infection (Col. 3, lines 11-25). Since Hsu teaches that its methods of treatment refers to subjects with symptoms, it is reasonable to assume, that such symptoms include those of at least “strong COVID-19 disease,” such as fever, dry cough, aches and pains, nasal congestion, strong headache, conjunctivitis, or sore throat, as described in the claim interpretation section above.
Regarding claims 26-30, while the combination of Hsu and Malik does not teach these properties, these properties express the desired result of the positive step of administering a therapeutically effective amount of amitriptyline, nortriptyline, or trimipramine, to a subject infected with SARS-CoV-2, to treat the disease, and thereby meets these limitations. See MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claims 32-33, Hsu teaches amitriptyline, trimipramine, and nortriptyline.
Regarding claim 35, the combination of Hsu and Malik does not teach a fluoxetine-equivalent dose of nortriptyline, trimipramine, or amitriptyline.
Hsu additionally teaches administering an effective amount of its compound to treat coronavirus infection and teaches an effective amount as referring to an amount of one or more compounds required to confer a therapeutic effect on a treated subject (Col. 3, lines 11-26).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select amounts of nortriptyline, trimipramine, or amitriptyline that are effective fluoxetine-equivalent doses, to arrive at instant claim 35. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Hsu teaches its methods for the treatment of coronavirus and the combination of Hsu and Malik teaches its methods for the treatment of SARS-CoV-2 infection,
-Hsu teaches administering an effective amount of its compound to treat coronavirus infection, wherein an effective amount is an amount of one or more compounds required to confer a therapeutic effect on a treated subject, and
- "[W]here 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," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 38, Hsu teaches amitriptyline.
Regarding claim 39, Hsu teaches nortriptyline and trimipramine.
(New) Claims 25 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over US 7,544,712 to Hsu (published 2009, PTO-892) in view of Malik (Properties of coronavirus and SARS-CoV-2,” The Malaysian Jn of Pathology, published 04/2000, PTO-892), as applied to claims 22, 24, 26-30, 32-33, 35, and 38-39 above, and further in view of Gibson (Covid-19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre-COVID-19 ARDS, The Med Jn of Australia, published 06/22/2020, PTO-892).
Hsu and Malik are applied as discussed above and incorporated herein.
While the combination of Hsu and Malik teach a method of treating COVID-19 by administering nortriptyline, trimipramine, amitriptyline, or other compounds, wherein nortriptyline is taught as a preferred compound, it differs from that of instant claims 25 and 36, in that it does not teach treating or preventing acute respiratory distress syndrome (ARDS) associated with a viral infection due to SARS-CoV-2.
Gibson teaches that severe COVID-19 leads to acute respiratory distress syndrome (ARDS) (pg. 54, Col. 1). ARDS develops in 42% of patients presenting with COVID-19 pneumonia (pg. 54, Cols. 1-2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the combined method of Hsu and Malik to prevent ARDS caused by COVID-19, to arrive at instant claims 25 and 36. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because the combination of Hsu and Malik teach a method of treating COVID-19, and Gibson teaches ARDS as developing in patients with COVID-19 pneumonia.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of preventing ARDS by treating the COVID-19 infection.
Response to Arguments
On pg. 9, Remarks, Applicant argues that Hsu does not teach or suggest any method of treating SARS-CoV-2, which was known to behave differently and which did not respond to the same treatments as other known viruses do, including coronaviruses infecting other animal species.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that Applicant has provided no evidence to substantiate this argument; the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c). For the reasons stated in the above rejection, there is motivation to combine Hsu and Malik to arrive at the instantly claimed invention.
On pg. 9, Remarks, Applicant argues that the skilled person did not have any reasonable expectation of success that the compounds of Hsu could be used to successfully treat SARS-CoV-2.
This argument has been fully considered, but is not found persuasive. As discussed above, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select SARS-CoV-2, a betacoronavirus, as the coronavirus of Hsu, to arrive at instant claims 22-23. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Hsu teaches a method of treating coronavirus and is published in 2009,
-Hsu specifically teaches treating severe acute respiratory syndrome virus infection (SARS),
-Malik teaches that there are only seven known human coronaviruses, beginning with the discovery of SARS-CoV in 2002, and
-Malik teaches the SARS-CoV-2 genome as similar to that of typical CoVs.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of treating SARS-CoV-2, one of seven known human coronaviruses that has a genome similar to that of typical CoVs.
Applicant is respectfully reminded that obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02. In view of the combination of Hsu and Malik, it would reasonably be expected that compounds taught to treat SARS would treat COVID-19 since Malik teaches that there are only seven known human coronaviruses and since Malik teaches that the SARS-CoV-2 genome is similar to that of typical SARS viruses.
For these reasons, Applicant’s arguments are not persuasive to overcome the prior art rejections.
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.
(Modified) Claims 22, 24, 26-30, 32, 34-35, 38, and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim claims 1 of copending Application No. 17/999,298 (claim set dated 11/18/2022, reference application) in view of Malik (Properties of coronavirus and SARS-CoV-2,” The Malaysian Jn of Pathology, published 04/2000, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘298 claims a method of treating coronavirus infection in a subject in need thereof comprising administering a therapeutically effective amount of a drug selected from citalopram, escitalopram, and sertraline (claim 1).
Regarding claim 22, while ‘298 teaches a method of treating coronavirus by administering citalopram, escitalopram, and sertraline, it differs from that of the instantly claimed invention in that it does not teach a SARS-CoV2 betacoronavirus.
Malik teaches that zoonotic coronaviruses were discovered in the 19602 and that since then, pathogenic human coronaviruses were identified beginning with the discovery of SARS-CoV in 2002, and that with the recent detection of SARS-CoV-2, there are now seven human coronaviruses (abstract). Malik teaches that the coronaviral genome contains four major structure proteins, the spike, membrane, envelope, and the nucleocapsid protein, all of which are encoded within the 3’ end of the genome (abstract). Malik additionally teaches that SARS-CoV-2 genome is similar to that of typical CoVs (pg. 6, Col. 2, “Genomic structure of SARS-CoV-2”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select SARS-CoV-2, a betacoronavirus, as the coronavirus of ‘298, to arrive at instant claim 22. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘298 teaches a method of treating coronavirus,
-Malik teaches that there are only seven known human coronaviruses, beginning with the discovery of SARS-CoV in 2002, and
-Malik teaches the SARS-CoV-2 genome as similar to that of typical CoVs.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of treating SARS-CoV-2, one of seven known human coronaviruses that has a genome similar to that of typical CoVs.
Regarding claim 24, the combination of ‘298 and Malik teaches the treatment of SARS-CoV-2 the causative agent of COVID-19, as evidenced by pg. 1 of the specification, and ‘298 teaches that its methods as treating coronavirus infection by administering an effective amount of citalopram, escitalopram, and sertraline, and pg. 6 of the ‘298 specification states that “By a ‘therapeutically effective amount’ is meant a sufficient amount of the active ingredient for treating or reducing the symptoms of the coronavirus infection.” Since ‘298 teaches that its treatment reduces the symptoms of coronavirus infection, it is reasonable to assume, that such symptoms include at least those of “strong COVID-19 disease,” such as fever, dry cough, aches and pains, nasal congestion, strong headache, conjunctivitis, or sore throat, as described in the claim interpretation section above.
Regarding claims 26-30, while ‘298 does not teach these properties, these properties express the desired result of the positive step of administering a therapeutically effective amount of citalopram, escitalopram, and sertraline, to a subject infected with SARS-CoV-2, to treat the disease, and thereby meets these limitations. See MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 35, the combination of ‘298 and Malik does not teach a fluoxetine-equivalent dose of citalopram, escitalopram, and sertraline.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select amounts of citalopram, escitalopram, and sertraline that are effective fluoxetine-equivalent doses, to arrive at instant claim 35. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘298 claims a method of treating coronavirus infection by administering a therapeutically effective amount of citalopram, escitalopram, and sertraline, and pg. 6 of the ‘298 specification states that “By a ‘therapeutically effective amount’ is meant a sufficient amount of the active ingredient for treating or reducing the symptoms of the coronavirus infection,” and
- "[W]here 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," MPEP 2144.05(II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(New) Claims 25 and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim claims 1 of copending Application No. 17/999,298 (claim set dated 11/18/2022, reference application) in view of Malik (Properties of coronavirus and SARS-CoV-2,” The Malaysian Jn of Pathology, published 04/2000, PTO-892), as applied to claims 22, 24, 26-30, 32, 34-35, 38, and 40, above, and further in view of Gibson (Covid-19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre-COVID-19 ARDS, The Med Jn of Australia, published 06/22/2020, PTO-892).
‘298 and Malik are applied as discussed above and incorporated herein.
While the combination of ‘298 and Malik teach a method of treating a SARS-CoV2 betacoronavirus by administering citalopram, escitalopram, and sertraline, it differs from that of instant claims 25, 36, 38, and 40 in that it does not teach treating or preventing acute respiratory distress syndrome.
Gibson is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the combined method of ‘298 and Malik to prevent ARDS caused by COVID-19, to arrive at instant claims 25, 36, 38 and 40. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because the combination of ‘298 and Malik teach a method of treating COVID-19, and Gibson teaches ARDS as developing in patients with COVID-19 pneumonia.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of preventing ARDS by treating the COVID-19 infection.
Response to Arguments
On pg. 9, Remarks, Applicant argues that at the effective date of the present application, the skilled artisan did not have any reasonable expectation of success that a compound useful to treat a coronavirus would treat SARS-CoV-2.
This argument has been fully considered, but is not found persuasive.
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select SARS-CoV-2, a betacoronavirus, as the coronavirus of ‘298, to arrive at instant claim 22. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘298 teaches a method of treating coronavirus,
-Malik teaches that there are only seven known human coronaviruses, beginning with the discovery of SARS-CoV in 2002, and
-Malik teaches the SARS-CoV-2 genome as similar to that of typical CoVs.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a method of treating SARS-CoV-2, one of seven known human coronaviruses that has a genome similar to that of typical CoVs.
Applicant is respectfully reminded that obviousness does not require absolute predictability, but a reasonable expectation of success. See MPEP 2143.02. In view of the combination of ‘298 and Malik, it would reasonably be expected that compounds taught to treat SARS would treat a SARS-CoV-2 infection since Malik teaches a) that there are only seven known human coronaviruses and b) that the SARS-CoV-2 genome is similar to that of typical SARS viruses.
Moreover, it is respectfully pointed out that the effective filing date of ‘298 is only one month earlier than the effective filing date of the instant application.
For these reasons, the rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAUREN WELLS/Examiner, Art Unit 1622