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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered.
Status of Claims
Amendment filed on 01/08/2026 is acknowledged.
Claims 1-9 and 16-17 remain cancelled. Claims 10-15 remain withdrawn due to Election/Restriction.
Claim 18 is amended. Claim 19 is new.
Claims 18-19 are pending and being examined on merits herein.
Priority
This instant application 18001343, filed on 12/09/2022, is a 371 of PCT/AU2021/050590, filed on 06/10/2021, claims foreign priority of Australia 2020901910, filed on 06/10/2020.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 01/08/2026, is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
Examiner.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (CN1203864, 06/01/2005, IDS of 12/09/2022), in view of Meiji Seika Kaisha Ltd (JP2004352642, 12/16/2004, IDS of 12/09/2022; machine translation in record of 05/05/2025; hereafter, “Meiji”), Matsuda et al. (JP04173726, 06/22/1992, IDS of 12/09/2022; machine translation in record of 05/05/2025), and Li (CN102550601, 07/11/2012, machine translation relied upon below; copy attached, PTO-892).
Ma teaches a spray pharmaceutical composition comprising povidone-iodine (PVP-I), mainly for oral anti-inflammatory and antibacterial throat treatment (Technical background). The PVP-I spray contains PVP-I 2-10% (Claim 1) (corresponding to instant claims 18-19 (a), potassium iodate and/or potassium iodide 0.05-2.5% (e.g., Claim 1) with preferred potassium iodate 1g/1000 ml (=0.1%) and potassium iodide 1.5g/1000 ml (=0.15%) (e.g., English, Pg. 1, bottom) (corresponding to iodate salt and iodide salt in instant claims 18-19 (b) and 18-19 (d)), glycerin and/or propylene glycol 5-60% (Claim 1)( overlapping with about 5.0% of glycerol in instant claims 18-19 (e)), flavoring agent 0.1-3% (Claim 1) and the preferred flavoring agent is menthol (Claim 3)(corresponding to instant claims 18-19 (c)), and water (Claim 1)(corresponding to instant claims 18-19 (i)), and the composition pH is from 4.87 to 5.58 as shown in Table 1 and 2 (overlapping with pH of about 3 to about 6 in instant claims 18-19), implying pH adjusting agents are included in the formulation.
Ma does not teach the spray is virucidal spray formulation, and it does not comprise ethanol, sodium dihydrogen phosphate dihydrate, and sodium hydroxide as recited in instant claims 18-19 (f), 18-19 (g), 18-19 (h) respectively.
Meiji teaches that povidone-iodine can inactivate a virus as a means for preventing viral infection with a disinfectant [0008]. Meiji discloses a composition as preventive agent for viral infection comprising povidone-iodine (PVP-I) as an active ingredient [0013], in a dosage form including spray with a solvent such as water or alcohol [0016] in a pump container [0017] to be applied through nasal mucosa, oral cavity, human skin or the like which is an invasion route [0020]. Meiji specifies that PVP-I concentration is preferably 0.01 to 10%, more preferably 0.1 to 5%, and still more preferably 0.1 to 1%, with preferable pH 2 to 6, more preferably pH 3 to 5.5 [0018] (overlapping with pH range and PVP-I range in instant claims 18-19 (a)). Meiji shows test results of MHV being killed after 5 seconds using solutions containing 0.1% and 1% of PVP-I (overlapping with the range in instant claims 18-19(a), corresponding to virucidal formulation in instant claims 18-19) (Tables 1-2; [0024]-[0025]).
Matsuda teaches a dentifrice composition comprising PVP-I 0.001 to 5.0% (overlapping with the range in instant claims (18-19 (a)), potassium iodide and/or sodium iodide 0.5 to 5.0% (corresponding to iodide salt in instant claims 18-19 (d)), a flavor, e.g., L-menthol 0.01-2.0% (overlapping with menthol range in instant claims 18-19 (c)), 10-50% wetting agent, e.g., glycerin (Pg. 4, top paragraphs) (corresponding to glycerol in instant claims 18-19 (e)). Matsuda also exemplifies in 1-11 formulations with PVP-I 0.30%, L-menthol 0.50%, glycerin 15%, ethanol 0.50% (overlapping with about 0.5% ethanol in instant claims 18-19 (f)) and water to 100g sum totals (e.g., Pg. 5, top paragraph) (corresponding to instant claims 18-19(i)). Matsuda indicates that the formulation has improved long lasting PVP-I activity and reduced irritating odor, and the feeling of use is excellent (Pg. 8, end paragraph, <Effect of Invention>).
Li teaches iodine disinfection liquid spray and preparation method having advantages of low skin irritation, low toxicity, action durability, safety, convenience and simpleness use as well as steady quality (e.g., Abstract; [0041]), wherein the iodine disinfection liquid comprises materials by weights: 4-65 g of povidone iodine (PVP-I), 0.05-0.15 g of potassium iodate, 4-8 g of sodium dihydrogen phosphate, 1-3 g of disodium hydrogen phosphate, suitable amount of 10% sodium hydroxide and purified water added to 1000 ml (e.g., Abstract), resulting in ingredient concentrations as 0.4-6.5% PVP-I (overlapping with instant claims 18-19 (a), 0.005-0.015% potassium iodate (overlapping with instant claims 18-19 (b), 0.4-0.8% sodium dihydrogen phosphate (corresponding to instant claims 18-19 (g), 0.1-0.3% disodium hydrogen phosphate, 10% sodium hydroxide q.s. (corresponding to instant claims 18-19 (h) to adjust pH, and water to 1000 ml (e.g., Abstract; [0008- 0013]). Li specifies that sodium dihydrogen phosphate and disodium hydrogen phosphate act as pH buffers, together with sodium hydroxide as pH adjuster maintaining the pH of povidone-iodine disinfectant between 3.0 and 6.5 (overlapping with pH in instant claims 18-19). It is known in the field that sodium dihydrogen phosphate NaH2PO4 is the anhydrous status of sodium dihydrogen phosphate dihydrate NaH2PO4.2H2O, and constitutes the same function in compositions, except having different molecular weight due to the H2O. Li emphasizes that sodium dihydrogen phosphate which is slightly toxic and is used as a pH buffer in the product at very small amount (e.g., [0045]).
It would have been prima facie obvious to incorporate the teaching of Meiji with the sprayable PVP-I composition taught by Ma to arrive at current invention as a spray aqueous virucidal formulation. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. For this instance, Meiji teaches that PVP-I is an antiviral active agent suitable for nasal spray, the property of antiviral activity is inherited and not separable from the PVP-I composition.
It would have been prima facie obvious for a person prior to filing date to incorporate Meiji, Matsuda and Li’s teaching into Ma’s composition to arrive at current composition consisting (essentially) of the claimed ingredients. Because Ma teaches the essential ingredients in the composition as active ingredients PVP-I stabilized with potassium iodate and potassium iodide, odor masking flavor agent menthol to mask odor and make the medication more acceptable, solvent water and co-solvents (dispersants) glycerol and/or propylene glycol to increase absorption rate and absorption with specific pH range (English, Pg. 2 middle), while both Meiji and Matsuda teaches ethanol as suitable agent in the composition, especially ethanol is known as one of the most common solvents comprising antimicrobial activity, and Li teaches the proper pH adjustment material for the PVP-I and potassium iodate composition providing low skin irritation, low toxicity, action durability, safety, convenience and simpleness of use as well as steady quality, artisans would have motivated to add ethanol in the composition, and use sodium dihydrogen phosphate (anhydrate or dihydrate) with sodium hydroxide to adjust pH and expect reasonable success. Therefore, the claimed invention is a simple combination of reagents known to be obvious materials that all already taught in prior art and discussed above. The idea for combining them flows logically from them having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, amount ranges of PVP-I, menthol, glycerol, potassium iodate salt and ethanol overlap with those disclosed in prior art. Ma points out that PVP-I is a soluble complex formed by iodine and polyvinylpyrro-lidone, however, compared with iodine, it has the advantage of good water solubility and low volatility; but the effective iodine of povidone iodine will gradually decompose during storage and certain stabilizer needs to be added to the preparation to stabilize the quality of the composition, and the preparation must be non-irritating or extremely (low) (note: machine translation missed this word) irritating (English, Pg. 2, top-middle). All compositions in Meiji, Matsuda and Li show effective maximum amount of PVP-I being lower than Ma’s PVP-I maximum amount, taking the effective PVP-I virucidal amount taught by Meiji, which is lower than Ma’s amount and overlaps with instantly claimed amount, would be advantageous for the composition being less irritating, and long-lasting active in combination with the stabilization components taught by Ma.
As one with ordinary skills in the art knows that the amounts of sodium dihydrogen phosphate dihydrate and sodium hydroxide for adjusting pH depend on the formulation preparation and amounts are easily adjustable. Regarding potassium iodate and potassium iodide, Ma specifies the total amount can be 0.05-2.5% (e.g., Claim 1) and exemplifies that potassium iodide salt uses more than potassium iodate salt as preferred (e.g., English, Pg. 1, bottom), Li specifically teaches using potassium iodate at 0.005-0.015%, especially Meiji’s composition shows effective virucidal activity without stabilization agents, artisans would be motivated to explore lower end iodide salt amount taught by Ma, e.g., about 0.05%, because making composition effective but less irritating with as low as required amount would be desirable both economically and user friendly, while keeping the benefit of stabilization for long time composition stability and activity. Moreover, adjustment and experimentation of ingredient amounts is a routine practice in formulation. “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant's remarks/arguments filed on 01/08/2026 have been fully considered.
Applicant points out what a prima facie case of obviousness requires the satisfaction of three requirements, and emphasizes that suggestion or motivation to modify a reference must be found in prior art. With the amendment preamble language “consisting essentially of” and “consisting of”, applicant emphasizes that all excipients matter for the virucidal formulation.
In response, the preamble language with the ingredients of the formulations in amended claims have been thoroughly examined. The prima facie case of obviousness is presented in the office action above. The teaching of combined prior art, Meiji, Matsuda and Li with Ma, provides motivation to modify the composition in Ma and teaches all the excipients as instantly claimed of the PVP-I formulation. Please refer to the entire office action as a complete response to the remarks.
Applicant states that the current claims are limited to the components of Formulation 2, which has significant virucidal activity against HRV-14 relative to other PVP-I formulations tested, and has demonstrated to be virus specific, as shown in Fig. 1, Table 3, and paragraphs [007]-[008], while prior art does not teach the specific combination of excipients as claimed.
Because combined teachings of Ma, Meiji, Matsuda, and Li teach the instantly claimed composition with the combined excipients, as presented above in this office action in detail, and therefore, whatever significant functions or effect of the virucidal formulation have demonstrated by Formulation 2, the prior art formulation would necessarily present such significant function or effect.
Applicant argued that each prior art reference does not teach all the combined excipients as instantly claimed, such as features of claim 18(g), (h) and (f) missing in Ma, and specific ingredient amounts are different, and the teaching of features from the references reflect cherry picking.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
Applicant asserts that Paul formulation contains colloidal silver solution, not PVP-I composition, and the teaching of sodium dihydrogen phosphate dihydrate with sodium hydroxide is cherry picking and not proper.
Paul reference applied in previous office action mailed on 09/08/2025 is not used in this office action as presented above. Therefore, the argument is moot.
Prior art Meiji, Matsuda, Li with Ma teaches the current invention. Please refer to the entire office action as presented above as a complete response to the remarks/arguments.
Conclusion
No claim is allowed.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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