DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 5/27/2025 is acknowledged. Applicant traverses the Restriction Requirement between Group I (claims 1-4, drawn to a feedback loop method) and Group II (claims 5-9, drawn to a method of treatment) on the grounds that “the invention of Invention I is basically the same as that of Invention II and any prior art searched for one group is applicable to the other group” (Applicant Arguments, Page 1).
The invention of Group I is broadly directed to a method of treating, preventing worsening of symptoms, and/or ameliorating symptoms of a coronavirus infection in a patient in need thereof, comprising determining/observing one or more variable(s) in said patient, choosing an appropriate treatment based on said variable(s), and administering said treatment to said patient to improve said variable(s), wherein “the method continuously repeats [said] steps… in order in a loop”. Notably, however, the invention of Group I more specifically embraces said method wherein the chosen/administered treatment comprises nitric oxide followed by oxygen.
Group II is similarly directed to a method of treating, preventing worsening of symptoms, and/or ameliorating symptoms of a coronavirus infection in a patient in need thereof, comprising administering nitric oxide followed by oxygen to a patient in need thereof.
The inventions of Group I and Group II, however, differ in that:
(a) in the invention of Group I, the method can broadly comprise administering any undefined treatment and is not limited to nitric oxide followed by oxygen;
(b) in the invention of Group I, “the method continuously repeats [said] steps… in order in a loop” whereas, in the invention of Group II, the “steps… [can be] performed as one cycle”; and
(c) in the invention of Group I, the method requires each of steps (a), (b) and (c) in order, whereas, in the invention of Group II, steps (a) and (b) are not broadly required by the method and can optionally take place in a different order as recited by the dependent claims (e.g., step (a) can occur after administering NO treatment, etc.).
Nevertheless, in view of Applicant’s argument that “the invention of Invention I is basically the same as that of Invention II” (Applicant Arguments, Page 1), the above differences are understood as not being patentably distinct from one another and/or as being obvious variants of one another. Accordingly, administering any treatment (e.g., ibuprofen for reduction of fever as embraced by the invention of Group I) is considered to not be patentably distinct and/or an obvious variant of administering nitric oxide followed by oxygen (as required by the invention of Group II), etc.
As such, the Requirement for Restriction between Group I and Group II is WITHDRAWN.
Should Applicant traverse this conclusion, Applicant is REQUIRED to elect a single method of treating, preventing worsening of symptoms, and/or ameliorating symptoms of a coronavirus infection in a patient in need thereof by defining EACH of the following with specificity:
(A) Elect a single appropriate treatment (e.g., nitric oxide, nitric oxide for a period time followed by oxygen after the completion of nitric oxide treatment, etc.);
(B) Elect whether the method comprises the step of determining an observed state of a set of variables for choosing said appropriate treatment and, IF the method DOES comprise said step:
(i) elect with specificity a single (or single combination) of variables that are determined (e.g., SpO2 level, heart rate, respiration rate, SpO2 level + heart rate, etc.); and
(ii) elect with specificity at which point in the method said determining step takes place (e.g., step (a) as recited by claim 1 (i.e., before step (a) in claim 5), after step (a) but before step (b) in claim 5, after step (a) and after step (b) in claim 5, etc.); and
(C) Elect whether the method comprises a single cycle of steps, multiple cycles of steps, or as many cycles as needed to achieve a desired outcome.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is drawn to “[a] feedback loop method” of treating, preventing worsening of symptoms, and/or ameliorating symptoms of a coronavirus infection in a patient in need thereof, comprising (a) determining/observing one or more variable(s) in said patient, (b) choosing an appropriate treatment based on said variable(s), and (c) administering said treatment to said patient to improve said variable(s), “wherein the method continuously repeats steps (a), (b), and (c) in order in a loop”.
The claim is indefinite because the recitation that “the method continuously repeats steps (a), (b), and (c) in order in a loop” necessitates that the method continue forever. That is, the method requires that each of steps (a), (b), and (c) be carried out, over and over again, without interruption, and without end.
In the interest of compact prosecution, the method is understood as requiring said steps be carried out in order for at least one cycle and any additional cycles as necessary until the target state of the set of variables is achieved and/or treating, preventing worsening symptoms of, and/or ameliorating symptoms of the coronavirus infection is achieved.
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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (Clinical Infectious Diseases 39:1531-1535, 2004).
Claim 1 is drawn to a feedback loop method of treating, preventing worsening of symptoms, and/or ameliorating symptoms of a coronavirus infection in a patient in need thereof, said method comprising:
(a) determining an observed state of a set of variables in the patient, wherein the set of variables comprises, for example, an oxygen saturation level (SpO2) in the patient;
(b) choosing an appropriate treatment to administer to said patient based on said oxygen saturation level (SpO2) determined in step (a) in order to achieve a target state of said oxygen saturation level (SpO2); and
(c) administering said appropriate treatment chosen in step (b) to said patient in order to achieve the target state of said oxygen saturation level (SpO2);
more specifically, wherein (as recited by claims 2-4) said appropriate treatment chosen in step (b) and administered in step (c) comprises a dose of nitric oxide (NO) for a period of time and, subsequently, after completion of said NO treatment, a dose of oxygen that is essentially free of NO for a period of time.
wherein the method continuously repeats steps (a), (b), and (c) in order in a loop.
Chen et al teach treatment of “six patients” with a “diagnosis of SARS” as determined by “fever… infiltrates on a chest radiograph… low or normal WBC counts… and a value of <300 mm Hg for the arterial oxygen tension divided by inspired oxygen fraction (FIO2), an oxygen saturation of <93%, or an FIO2 of 0.5” (Page 1531, Column 1) comprising administration of “[m]edicinal NO (INOmax; INO Therapeutics”… delivered with INOvert delivery systems” wherein said “[i]nhaled NO therapy was given for >3 days (30 ppm on the first day, followed by 20 and 10 ppm on the second and third days, respectively)” after which, “[o]n day 3, the NO concentration was reduced stepwise to 0 ppm” unless “arterial oxygenation deteriorated during weaning” – further noting that “[a]rterial oxygen saturation (SpO2) was continuously monitored by pulse oximetry” (see also Page 1533, Figure 1, SpO2) – in which case “[i]nhaled NO treatment (10 ppm) was resumed… [and subsequent] attempts to wean patients from NO treatment were done daily until such therapy was successfully discontinued” (Page 1532, Column 1). As further taught by Chen et al, “[i]n 3 patients, inhaled NO treatment was discontinued after 3 days without any worsening of the arterial oxygenation” whereas “[i]n the other 3 patients, inhaled NO treatment lasted for 4, 6, and 7 days before weaning trials were successful” (Page 1532, Column 2).
As such, Chen et al teach a method of treating, preventing worsening of symptoms, and/or ameliorating symptoms of a coronavirus infection in a patient in need thereof comprising:
(a) determining an oxygen saturation level (SpO2) in the patient; and
(b)/(c) choosing and administering to said patient an appropriate treatment based on said oxygen saturation level in order to achieve a target state of said oxygen saturation level, wherein said appropriate treatment comprises a dose of nitric oxide (NO) for a period of time and, subsequently, after completion of said NO treatment, a dose of oxygen that is essentially free of NO for a period of time (i.e., the step of reducing the NO concentration to 0 ppm taught by Chen et al entails the step of providing a dose of oxygen that is essentially free of NO for a period of time after completion of said NO treatment);
wherein, in some patients, “[i]nhaled NO treatment (10 ppm) was resumed… [and subsequent] attempts to wean patients from NO treatment were done daily”, which entails repeating steps (a), (b), and (c) in order in a loop.
Accordingly, claims 1-4 are anticipated.
Claim 5 (drafted independently) and claims 6-9 do not introduce any additional limitations not already considered in the rejection of claims 1-4 above.
Accordingly, claims 5-9 are also anticipated.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611