FINAL 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 .
Priority
This application is a CIP of PCT/US2021/023574 filed 03/23/2021.
PCT/US2021/023574 has PRO of 63026122 filed 05/17/2020 and PRO of 62993085 filed 03/23/2020.
However, the subject matters of claims 1-21 of this application are not supported or present in the provisional (PRO) applications of 63026122 and 62993085. Thus, claims 1-21 of this application will not receive filing date benefit of provisional (PRO) applications of 63026122 and 62993085.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in ISRAEL on 07/07/2020. It is noted, however, that applicant has not filed a certified copy of the ISRAEL IL275909 application as required by 37 CFR 1.55. Furthermore, should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Thus, this application will not receive foreign priority filing date benefit of ISRAEL IL275909.
Accordingly, claims 1-21 are afforded the effective filing date of 03/23/2021.
Response to Arguments:
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicant argues:
“a certified copy of IL 275909 is provided herewith. Applicants note that IL 275909 was filed in English; thus, the requirement for a certified English translation is not relevant.” (Remarks, bottom of page 5).
In response, the Examiner disagrees. In Applicant’s response filed on 03/02/2036, Applicant has not provided the certified copy of the ISRAEL IL275909 application.
Accordingly, this instant application remain to not receive foreign priority filing date benefit of ISRAEL IL275909.
Status of the Claims
This action is in response to papers filed 03/02/2026 in which claim 1 was canceled; claims 3 and 5-16 were withdrawn; claims 2, 5, and 17 were amended; and claim 22 was newly added. All the amendments have been thoroughly reviewed and entered.
Claims 2, 4, and 17-22 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Objection
Claim Objections
Claim 22 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 2. Claim 22 is the same as claim 2. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
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 2, 4, and 17-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2 and 22 introduce new matter as the claims recite the limitation: “aqueous solution comprising an iodine-releasing ionic compound and elemental iodine in a total iodine concentration of 0.5-5 ppm” There is no support in the specification for total iodine concentration range of 0.5-5 ppm, particularly to the maximum point of 5 ppm, as it pertain to the iodine-releasing ionic compound and elemental iodine in a total iodine concentration.
Applicant asserted support for the amendments to claim 2 can be found “throughout the specification as originally filed, for example in the last full paragraph of p. 5, the second full paragraph of p. 8, the second full paragraph of p. 17, the second full paragraph of p. 25, the paragraph bridging pp. 25-26, the first full paragraph of p. 26, and the paragraph bridging pp. 26- 27.” (Remarks filed 03/02/2026, page 5, 4th paragraph).
However, after a thorough review of said “the last full paragraph of p. 5, the second full paragraph of p. 8, the second full paragraph of p. 17, the second full paragraph of p. 25, the paragraph bridging pp. 25-26, the first full paragraph of p. 26, and the paragraph bridging pp. 26- 27,” as well as, throughout the specification, there appeared to be no support or disclosure for total iodine concentration range of 0.5-5 ppm, particularly to the maximum point of 5 ppm, as it pertain to the iodine-releasing ionic compound and elemental iodine in a total iodine concentration.
While page 18, paragraph 3 of the specification discloses a concentration of 5-10 ppm, said concentration pertains to the concentration of “molecular iodine,” and thus, is not support for the maximum point of 5 ppm, as it pertain to the iodine-releasing ionic compound and elemental iodine in a total iodine concentration. As such, Applicant does not have possession of the maximum point concentration of 5 ppm, as it pertain to the iodine-releasing ionic compound and elemental iodine in a total iodine concentration.
Claims 4 and 17-21 are also rejected as they depend directly or indirectly from claim 2, thereby also containing the new matter material.
Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendments at the time of filing of the instant application.
Maintained-Modified Rejection
Modification Necessitated by Applicant’s Claim Amendments
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) 2, 4, and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al (US 2015/0107588 A1) in view of Wada et al (Biocontrol Science, 2016, 21(1): 21-27), Vats et al (EC Pulmonology and Respiratory Medicine, 13 November 2020, 9(12): 26-29), and Kawana et al (1999 May; 73(5): 429-36. Japanese. doi: 10.11150/kansenshogakuzasshi1970.73.429. PMID: 10386022).
Regarding claims 2, 4 and 22, Cheung teaches a respiratory humidifier system comprising a ventilator, a heating element, and nebulizer containing a drug substance, wherein the nebulizer delivers the drug substance to a breathing circuit in the form of a vaporized mist ([0005]-[0095]). Cheung teaches the heating element heats the nebulizer to generate the vaporized mist and the ventilator delivers the vapor such that the vapor reaches the respiratory tract of the patient ([0013], [0016], [0024], [0054]-[0056], [0078]m [0088]-[0089], [0091], [0093], [0095], and [0098]). Cheung teaches the heating element generates vapor at a temperature of 37 degrees Celsius ([0013] and [0053]). Cheung teaches the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the respiratory of the patient ([0050]).
However, Cheung does not teach the drug substance is a aqueous solution having a pH of 7.5-10.0 containing an iodine-releasing ionic compound and elemental iodine in a total iodine concentration of 0.5-5 ppm of claims 2 and 22.
Regarding the aqueous solution containing an iodine-releasing ionic compound and elemental iodine of claims 2 and 22, Wada teaches a buffered aqueous solution of povidone-iodine (PVP-I) having 0.01-10% concentration of PVP-I, wherein free iodine concentrations in the 0.01-10% PVP-I were 1.84, 4.88, 1.58 and 0.17 ppm, respectively, with the maximum obtained for the 0.1% solution (Abstract; Introduction; page 22 and 24-26). Wada teaches the aqueous solution of PVP-I have biocidal activity against viruses such as influenza A virus (Abstract; Introduction; page 22 and 24-26). Wada teaches the pH of the solution is 7 (Abstract; page 22). It is noted that pH 7 is close to the claimed minimum pH of 7.5 for the aqueous solution and thus, it is noted that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed pH parameter, the optimization of the pH of the aqueous solution would have been obvious at the time of applicant's invention. See MPEP §2144.05 (I)-(II).
It would have been obvious to one of ordinary skill in the art incorporate the buffered aqueous solution of povidone-iodine (PVP-I) of Wada as the drug substance to vaporized from the nebulizer in the respiratory humidifier system of Cheung, and arrive at the claimed system. One of ordinary skill in the art would have been motivated to do so because per Vats, it is recognized in the prior art that povidone-iodine solution can be administered through inhalation via a nebulizer for the treatment against bacteria, fungi, and viruses such as influenza A virus and coronavirus (Vats: pages 26-29). Vats further indicated that delivery of iodine via nebulizer provided good antiviral activity, as the aerosols is able to be delivered deep into the alveoli and interstitial (page 26, last paragraph). Furthermore, per Kawana, povidone-iodine solution can be effectively administered by inhalation via nebulizer to remove potentially pathogenic bacteria colonized in the upper airway (Kawana: Abstract). Thus, an ordinary artisan seeking to provide safe and effective treatment of respiratory infection caused by bacteria and viruses via inhalation would have looked to incorporate the buffered aqueous solution of povidone-iodine (PVP-I) of Wada as the drug substance to vaporized from the nebulizer in the respiratory humidifier system of Cheung with an expectation that the system of Cheung delivers therapeutically vaporized iodine into the respiratory tract, and achieve Applicant’s claimed invention with reasonable expectation of success.
It is noted that the recitation of “for treating a subject infected with a respiratory pathogen” as recited in the preamble of claims 2 and 22, is a recitation of intended use. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With respect to the limitation of “for administration of said vapor for 2 hours or less per day, wherein total iodine delivered to said respiratory tract does not exceed 10 mg/kg of weight/day” as recited in claims 2 and 22, it is noted that as discussed, above, the claimed ventilator that is part of the system have been taught by Cheung with the guidance that the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the patient. Thus, it would have been obvious for an ordinary artisan to utilize the ventilator having the computer function to optimize or control the therapy time and dosage so as to achieve the intended use/result “for administration of said vapor for 2 hours or less per day, wherein total iodine delivered to said respiratory tract does not exceed 10 mg/kg of weight/day” as claimed.
With respect to instruction for use of said system of claim 4, it is noted that claim 4 is structured as a kit type claim. As discussed above, an article of a system of claim of claim 2 has been taught by Cheung in view of Wada, Vats, and Kawana. Thus, “instructions for use of said system in administering a vapor to a respiratory tract of a subject infected with a respiratory pathogen” as recited in claim 4 are non-functional descriptive matter. It is noted that [w]here 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."). See MPEP §2112.01 and §2111.05.
Regarding claim 17, as discussed above, Cheung teaches the system contains a ventilator that operates with the nebulizer and the heating element to deliver the vapor of the drug substance to the respiratory tract ([0013], [0016], [0024], [0054]-[0056], [0078]m [0088]-[0089], [0091], [0093], [0095], and [0098]).
Regarding claim 18, as discussed above, Cheung teaches the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the respiratory of the patient ([0050]).
Regarding claims 19-21, Cheung teaches that ventilator is connected to a humidity chamber that refill volume of liquid as appropriate ([0054], [0079], [0085], [0094]). Thus, it would have been reasonably obvious to use said chamber to refill the buffered aqueous solution of povidone-iodine (PVP-I) of Wada when appropriate refill is needed to continue therapy.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicant argues:
“amended claim 2 recites "... an iodine- releasing ionic compound and elemental iodine in a total iodine concentration of 0.5-5 ppm..." (emphasis added). By contrast, Wada is alleged to teach "a buffered aqueous solution of PVP-I having 0.01-10% concentration of PVP-I, wherein free iodine concentrations,,, were 1.84, 4.88, 1.58, and 0.17 ppm...". Thus, the relevant metric does not seem to be disclosed in Wada.” (Remarks, middle of page 7).
In response, the Examiner disagrees. As acknowledged by Applicant, Wada teaches a buffered aqueous solution of povidone-iodine (PVP-I) having 0.01-10% concentration of PVP-I, wherein free iodine concentrations in the 0.01-10% PVP-I were 1.84, 4.88, 1.58 and 0.17 ppm. The free iodine concentration of 1.84, 4.88 or 1.58 as taught by Wada remained to read on the claimed iodine concentration range of 0.5-5 ppm. It is noted that "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Applicant argues:
“[e]ven if the POSA would have combined Wada with Cheung (which Applicants do not admit), it is respectfully asserted that Wada cannot fairly be considered to teach towards the present invention. Wada measured biocidal activity under "[c]ontrolled conditions" (Discussion, first paragraph). The POSA would know that such artificial conditions cannot be extrapolated to in-vivo use, as presently claimed.” (Remarks, bottom of page 7).
In response, the Examiner disagrees. Wada indicated that the PVP-I formulations are commercially available, and such PVP-I formulations have been well-known in the prior art for having biocidal activity (see Wada, Abstract, Introduction, and pages 21-22). Thus, the biocidal activity of PVP-I is known to be extrapolated to in-vivo use. Nevertheless, it is noted that that claim 2 is drawn to a system and not to a method of treating a subject infected with a respiratory pathogen, much less anything to relating to an ”in-vivo” method of use. Thus, Applicant’s argument focusing on “[t]he POSA would know that such artificial conditions cannot be extrapolated to in-vivo use” is not pertinent to the claimed system.
Applicant argues:
“although the Examiner proposes incorporating Wada's iodine compositions into the humidifier system of Cheung, W teaches virus inactivation via direct liquid mixing at room temperature, thereby achieving the intended antiviral effect without heating, aerosolization, or humidification. Cheung, by contrast, is directed to humidifier-based delivery systems involving generation or dispersion of vaporized compositions. The Examiner has not articulated a technical reason why a POSA would have modified Cheung's humidifier system to incorporate Wada's iodine compositions for virus inactivation, given that Wada teaches successful inactivation via room-temperature liquid mixing. In the absence of any identified technical reason why a POSA seeking to implement Cheung would adopt Wada's room-temperature liquid-mixing approach through a humidifier, the proposed combination appears to rely on hindsight rather than a reasoned motivation to combine.” (Remarks, page 8).
In response, the Examiner disagrees. Applicant is reminded that the 103 rejection is based on the combined teachings of Cheung, Wada, Vats and Kawana. As discussed above in the standing 103 rejection, it is reiterated that it would have been obvious to one of ordinary skill in the art incorporate the buffered aqueous solution of povidone-iodine (PVP-I) of Wada as the drug substance to vaporized from the nebulizer in the respiratory humidifier system of Cheung, and arrive at the claimed system. One of ordinary skill in the art would have been motivated to do so because per Vats, it is recognized in the prior art that povidone-iodine solution can be administered through inhalation via a nebulizer for the treatment against bacteria, fungi, and viruses such as influenza A virus and coronavirus (Vats: pages 26-29). Vats further indicated that delivery of iodine via nebulizer provided good antiviral activity, as the aerosols is able to be delivered deep into the alveoli and interstitial (page 26, last paragraph). Furthermore, per Kawana, povidone-iodine solution can be effectively administered by inhalation via nebulizer to remove potentially pathogenic bacteria colonized in the upper airway (Kawana: Abstract). Thus, an ordinary artisan seeking to provide safe and effective treatment of respiratory infection caused by bacteria and viruses via inhalation would have looked to incorporate the buffered aqueous solution of povidone-iodine (PVP-I) of Wada as the drug substance to vaporized from the nebulizer in the respiratory humidifier system of Cheung with an expectation that the system of Cheung delivers therapeutically vaporized iodine into the respiratory tract, and achieve Applicant’s claimed invention with reasonable expectation of success.
Accordingly, the obviousness analysis for how it would have been obvious to incorporate the buffered aqueous solution of povidone-iodine (PVP-I) of Wada as the drug substance to vaporized from the nebulizer in the respiratory humidifier system of Cheung, have been properly established by the combined teachings of Cheung, Wada, Vats and Kawana, as a motivation to modify/combine and a reasonable expectation of success in doing so have been articulated in the 103 rejection, thereby a prima facie case of obviousness have been adequately established by the Examiner. As such, contrary to Applicant’s allegation, the standing 103 rejection is not based on impermissible hindsight, as the obviousness analysis provided in the 103 rejection relied on knowledge gleaned only from the teachings of the cited prior arts, and such construction based on the teachings of the cited prior arts is proper for establishing obviousness of the claimed invention.
Applicant argues:
“at least the presently amended claims are fully supported in IL 275909. Since IL 275909 was filed on 07/07/2020, and the claims are fully supported in the priority document, as described supra, a valid priority date of Jul 7, 2020 is validly claimed. Vats, which published on Nov 13, 2020, is therefore disqualified as prior art.” (Remarks, page 9, 1st paragraph).
In response, the Examiner disagrees. As discussed above in the Priority section (see pages 2-3 of this office action), Applicant has not provided the certified copy of the ISRAEL IL275909 application. Thus, the instant application remain to not receive foreign priority filing date benefit of ISRAEL IL275909. As such, as discussed above in the Priority section, the claims of the instant application remained to be afforded the effective filing date of 03/23/2021, thereby Vats remained proper as prior art under 103(a).
Applicant argues:
“Kawana administers iodine using a jet nebulizer, which aerosolizes liquid formulations mechanically and does not require heating or humidifier-based vapor generation. Thus, rather than supporting modification of Cheung's humidifier system, Kawana confirms that iodine compositions were delivered under non-heated conditions. Kawana therefore does not provide a technical rationale for combining Wada's room-temperature compositions with Cheung's humidifier-based delivery system, nor does it support a reasonable expectation that heating or humidification would be beneficial or necessary. Furthermore, a POSA would have recognized that nebulization and humidification represent different delivery paradigms with different technical parameters, and that the cited art provides no reason to expect that teachings from one could be predictably applied to the other.” (Remarks, page 9, last paragraph to page 10).
In response, the Examiner disagrees. As discussed above in the standing 103 rejection, Cheung was drawn to a respiratory humidifier system that contains a nebulizer to deliver drug substance to a breathing circuit in the form of a vaporized mist. See 103 rejection, pages 7-8 of this office action. Kawana was used for establishing that povidone-iodine solution can be effectively administered by inhalation via nebulizer to remove potentially pathogenic bacteria colonized in the upper airway. See 103 rejection, page 9 of this office action. Since the system of Cheung also contains a nebulizer, Kawana is properly combined with Cheung, Wada, and Vats in the standing 103 rejection to render obvious Applicant’s claimed invention.
Applicant argues:
“[i]n sharp contradistinction to the cited art, alone or in combination, the present specification subject specification demonstrates differential toxicity of a specific range of iodine-containing compositions, under a particularly recited, specific range of conditions. The cited art, alone or in combination, does not disclose or suggest the differential toxicity observed for the claimed range of iodine-containing compositions under the recited conditions. Thus, an asserted motivation to safely treat respiratory infections does not provide the specific technical teaching required to arrive at the claimed invention.” (Remarks, page 10).
In response, the Examiner disagrees. it is noted that that claim 2 is drawn to a system and not to a method of treating a subject infected with a respiratory pathogen/infection. As discussed above in the standing 103 rejection, It is noted that the recitation of “for treating a subject infected with a respiratory pathogen” as recited in the preamble of claims 2 and 22, is a recitation of intended use. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, as discussed above in the standing 103 rejection, it is maintained that the claimed ventilator that is part of the system have been taught by Cheung supra with the guidance that the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the patient. Thus, it would have been obvious for an ordinary artisan to utilize the ventilator having the computer function to optimize or control the therapy time and dosage so as to achieve the intended use/result “for administration of said vapor for 2 hours or less per day, wherein total iodine delivered to said respiratory tract does not exceed 10 mg/kg of weight/day” as claimed.
Applicant argues:
“the claimed system recites both a heating element and a ventilator that are configured to operate under specific functional constraints, including defined temperature ranges, vapor generation, administration duration, and maximum iodine delivery. These limitations impose operational requirements on the claimed system and therefore go beyond a mere statement of intended therapeutic use. The claim thus defines a system structurally and functionally configured to deliver vapor under specific conditions associated with the disclosed therapeutic utility, rather than merely reciting a desired result. The rejection does not identify where Cheung teaches or suggests configuring a ventilated vapor system to maintain the claimed combination of temperature, exposure duration, and dosage limitations.” (Remarks, page 11).
In response, the Examiner disagrees. As discussed above, the ventilator has been structurally taught by Cheung. See 103 rejection, pages 7-8 of this office action. “for administration of said vapor for 2 hours or less per day, wherein total iodine delivered to said respiratory tract does not exceed 10 mg/kg of weight/day” as recited in claims 2 and 22 is a recitation of intended use/result. Applicant is noted that the instant specification defined the ventilator as tool/device that can be “be set to make a time-based calculation, so that the patient would, for example, receive 15 mg/kg or less in the course of one hour, once per day, to enable a more concentrated regimen of iodine with a higher number of ppm than would be possible if the patient received a maintenance dose steadily throughout 24 hours.” (Specification, page 7, bottom paragraph). Thus, said intended use/result would be reasonably achieved when the same structurally same ventilator is used, as the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the patient. As such, it is maintained that it would have been obvious for an ordinary artisan to utilize the ventilator having the computer function to optimize or control the therapy time and dosage so as to achieve the intended use/result “for administration of said vapor for 2 hours or less per day, wherein total iodine delivered to said respiratory tract does not exceed 10 mg/kg of weight/day” as claimed.
Applicant argues:
“[a] pH of 7.5-10.0, as recited in the amended claim, further distinguishes the present invention from the combined teaching of the cited art, exemplified by Wada, whose solution pH was 7; or exemplified by Kawana.” (Remarks, top of page 12).
In response, the Examiner disagrees. As discussed above in the standing 103 rejection, the of pH 7 as taught in Wada is close to the claimed minimum pH of 7.5 for the aqueous solution and thus, it is noted that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed pH parameter, the optimization of the pH of the aqueous solution would have been obvious at the time of applicant's invention. See MPEP §2144.05 (I)-(II).
Applicant argues:
“Kawana is allegedly directed to administration of povidone-iodine solution by inhalation via nebulizer to remove potentially pathogenic bacteria colonized in the upper airway. Accordingly, Kawana does not provide a motivation to configure pressure and cadence of a ventilator to enable administration a lower respiratory tract of a subject infected with a respiratory pathogen.” (Remarks, middle page 12).
In response, the Examiner disagrees. It is first noted that there is nothing in the system of claim 2 that is drawn to pressure or cadence of a ventilator. Thus, Applicant’s argument focusing on “configure pressure and cadence of a ventilator to enable administration a lower respiratory tract of a subject infected with a respiratory pathogen” is not pertinent to the claimed system. As discussed above, the ventilator was taught by Cheung. See 103 rejection, pages 7-8 of this office action. Furthermore, as discussed above in the standing 103 rejection, Cheung teaches the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the respiratory of the patient ([0050]). Thus, the configuration of pressure and cadence have been render obvious by Cheung, as Cheung teaches the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the respiratory of the patient.
Applicant argues that for claim 18, “Kawana is allegedly directed to administration of povidone-iodine solution by inhalation via nebulizer to remove potentially pathogenic bacteria colonized in the upper airway. Accordingly, Kawana does not provide a motivation to configure pressure and cadence of a ventilator to enable deep breaths in a subject.” (Remarks, top of page 13).
In response, the Examiner disagrees. As discussed above in standing 103 rejection, claim 18 was taught and render obvious by Cheung. As discussed above, Cheung teaches the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the respiratory of the patient ([0050]). Thus, the configuration of pressure and cadence have been render obvious by Cheung, as Cheung teaches the ventilator has an electronic or computer functions to control the timing, pressure, volume or flow rate of the vapor to be supplied to the respiratory of the patient.
Applicant argues that for claim 22, “Kawana is directed to bacterial pathogens and does not disclose or suggest treatment of viral pathogens. Accordingly, Kawana does not provide the alleged expectation of success relied upon by the Examiner with respect to the newly recited viral limitation.” (Remarks, bottom of page 13).
In response, the Examiner disagrees. Claim 22 is drawn to a system and not a method of treating a respiratory pathogen, much less a method of treating viral pathogens. Thus, Applicant’s argument focusing on treatment of viral pathogens is not pertinent to claim 22.
As a result, for at least the reasons discussed above, claims 2, 4, and 17-22 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the standing 103 rejection as set forth in this office action.
Conclusion
No claim is 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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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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