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 .
Status of Claims
Amendment filed on 07/27/2026 is acknowledged.
Claims 1-9 and 16-17 remain cancelled. Claim 18 is cancelled. Claim 20 is new.
Claims 10-15 remain withdrawn due to Election/Restriction.
Claims 19-20 are pending and being examined on the 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.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 04/01/2026) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 07/27/2026.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 recites acronym “HRV-14” without full definition of the virus name.
Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites “under the assay conditions described in Example 1”. There is insufficient antecedent basis for this limitation in the claim because the assay conditions described in Example 1 are not previously mentioned in the claim. Further, it is unclear what assay conditions are supposed to be included in achieving such reduction of viral titer because the method in Example 1 in specification contains paragraphs [0054-0059] with many variables and does not indicate clearly of “assay conditions”; further, it is improper to refer the assay conditions in Example 1 which is located in specification, especially in Example 1 representing Formulation 2 does not show the ingredients in “about” concentrations as in instant claim, and therefore, such titer result becomes questionable applying to the instantly claimed formulation in broader ranges than Example 1.
Remained/Updated 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 19-20 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 in record of 04/01/2026).
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 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 claim 19 (b) and 19 (d)), glycerin and/or propylene glycol 5-60% (Claim 1)( overlapping with about 5.0% of glycerol in instant claim 19 (e)), flavoring agent 0.1-3% (Claim 1) and the preferred flavoring agent is menthol (Claim 3)(corresponding to instant claim 19 (c)), and water (Claim 1)(corresponding to instant claim 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 claim 19), implying pH adjusting agents are included in the formulation.
Ma does not teach the spray is virucidal spray formulation, and Ma formulation does not contain ethanol, sodium dihydrogen phosphate dihydrate, and sodium hydroxide as recited in instant claim 19 (f)-(h); Ma does not teach it is an intranasal spray as recited in instant claim 20.
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], corresponding to intranasal spray in instant claim 20. 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 claim 19 (a)). Meiji shows test results of MHV being killed after 5 seconds using solutions containing 0.1% and 1% of PVP-I (corresponding to instant claim 19(a)(Tables 1-2; [0024]-[0025]), corresponding to virucidal formulation that achieves viral titer reduction in instant claim 19.
Matsuda teaches a dentifrice composition comprising PVP-I 0.001 to 5.0% (overlapping with the range in instant claim 19 (a), potassium iodide and/or sodium iodide 0.5 to 5.0% (corresponding to iodide salt in instant claim 19 (d), a flavor, e.g., L-menthol 0.01-2.0% (overlapping with menthol range in instant claim 19 (c)), 10-50% wetting agent, e.g., glycerin (Pg. 4, top paragraphs) (corresponding to glycerol in instant claim 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 claim 19 (f)) and water to 100g sum totals (e.g., Pg. 5, top paragraph) (corresponding to instant claim 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 claim 19 (a), 0.005-0.015% potassium iodate (overlapping with instant claim 19 (b), 0.4-0.8% sodium dihydrogen phosphate (corresponding to instant claim 19 (g), 0.1-0.3% disodium hydrogen phosphate, 10% sodium hydroxide q.s. (corresponding to instant claim 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 claim 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 intranasal 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. Moreover, because Meiji shows that PVP-I is effective antiviral agent for nasal spray formulation, it would have motivated artisans to optimize and explore what ingredients in Ma’s formulation can be further eliminated or added in the formulation for achieving effective antiviral activity. 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 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 (propylene glycol can be optional) 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.
Regarding the phrase in instant claim 19, “wherein the formulation achieves at least a 4 log10 reduction in HRV-14 viral titer after a 5-minute exposure under the assay conditions described in Example 1” is interpreted as intended use of the formulation, because it does not contribute structurally to the subject matter of the formulation, and it is the outcome of process of using the formulation, which has been taught by prior art as discussed above, and therefore, the prior art formulation would be capable of performing HRV-14 viral titer reduction under same assay conditions.
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 07/27/2026 have been fully considered.
Applicant asserts that prior art does not teach or suggest the claimed formulation because:
Ma does not teach or evaluate the claimed virucidal formulation or the claimed HRV-14 performance, and Ma teaches additives propylene glycol and Tween-80 as functionally active excipients, while instant claim uses “consisting of “ transition;
Meiji does not provide information about its formulations and does not teach the instantly claimed excipients, while using commercial products allegedly containing PVP-I, and in Table 1 and 2 the concentrations of PVP-1 fail to overlap with that in instant claim;
Matsuda directs to dentifrice composition and fails to teach aqueous virucidal spray formulation, and Matsuda fails to teach in Examples I-11 the claimed amounts of, e.g., PVP-I, glycerol, menthol; Matsuda’s iodide concentration range which examiner relies on is at least an order of magnitude greater than that as instantly claimed;
Li does not teach the use of potassium iodide, menthol, glycerol, or ethanol, all of which are required by claim 19; and the active excipients and the pH buffer ingredients, e.g., sodium dihydrogen phosphate and disodium hydrogen phosphate , are co-components of the pH buffer system that cannot be extracted one from the other.
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). 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).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.
Regarding each reference does not teach certain elements as instantly claimed, because it is obviousness rejection, combined prior art as presented in office action teaches the current invention, each individual reference does not require to teach all elements in current claim.
Regarding Ma formulation has additional functional excipients, both propylene glycol or tween-80 are optional ingredients, as evidenced the formulation shown in session “The content of the invention” (English, bottom of Pg. 1), indicating “glycerin and/or propylene glycol”, “it may further contain 0.1-2% Tween-80”. They are required ingredients.
Regarding the assertion that Meiji does not specifically teach formulation ingredients or PVP-I concentration as instantly claimed, Meiji explicitly teaches PVP-I concentrations as presented in office action, “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]”. The Table 1 and 2 concentration examples, and commercial products examples do not limit Meiji’s general teaching. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Regarding the assertion that Matsuda does not teach the right concentrations of the ingredients and does not teach the right format of the formulation, Matsuda is combined with Ma, Meiji, Matsuda to teach menthol and ethanol amounts, not the formulation format or iodide salt amount, because iodide salt amount has been taught by Ma based upon the total amount of iodate/iodide as 0.05-2.5%, while the preferred iodate salt as 0.1% and iodide salt preferred as 0.15%, the total range already covers the individual amount, especially since Li teaches 0.005-0.015% potassium iodate, the amount of iodide low end would be about 0.05%, taking into consideration the conventional “about” means +-%.
Regarding Li teaching ingredients for adjusting pH, as applicant points out that Li emphasizes that sodium dihydrogen phosphate is slightly toxic, which provides artisans in the field to lower the toxic ingredient amount and makes sense to lower the sodium dihydrogen phosphate in the formulation from 0.4-0.8% to the claimed 0.15% in claim 19. Moreover, adjusting pH with pH buffering agents is a common practice in the field, no matter what other ingredients are present in Li’s formulation, the ingredients used for pH adjustment, whether it is with disodium hydrogen phosphate or without it, along with the concentrations can be experimented and optimized by scientists in the field.
Applicant asserts that motivation-to-combine rationale is based on hindsight reasoning.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). For this instance, prior art combined teaches the current invention with logic reasoning, as presented above in the office action in detail (the most relevant paragraph copied below for reference):
It would have been prima facie obvious to incorporate the teaching of Meiji with the intranasal 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. Moreover, because Meiji shows that PVP-I is effective antiviral agent for nasal spray formulation, it would have motivated artisans to optimize and explore what ingredients in Ma’s formulation can be further eliminated or added in the formulation for achieving effective antiviral activity. 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 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 (propylene glycol can be optional) 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).
Applicant asserts that the inherency rationale is inapplicable, because inherency may not be established by probabilities or possibilities when no cited reference discloses a product of identical chemical composition to the formulation of claim 19.
The obviousness rejection has been established based on the combined teachings of Ma, Meiji, Matsuda and Li, as discussed above. The formulation therefore is taught by prior art. Therefore, whatever property the formulation can have, or functions it is capable of performing, such property would be present in the formulation established by prior art. It is not probably, rather it is obvious and would necessarily present the properties, functions, or intended uses of the taught formulation. MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991).
Applicant states that the claimed formulation exhibits unexpected results, such that Formulation 2, comprising 0.50% PVP-I, 0.050% potassium iodide, 0.005% potassium iodate, 5.00% glycerol, 0.15% sodium dihydrogen phosphate dihydrate, 0.75% sodium hydroxide, 0.50% ethanol, 0.010% menthol, and water to 100%, which corresponds to the closed composition of amended claim 19, has significant virucidal activity against HRV-14 relative to other PVP-I formulations tested, and has demonstrated excipients matter and to be virus specific, as shown in Fig. 1 with further demonstration in Examples 2 and 3.
The Formulation 2 in specification indicates specific values of the ingredients in the formulation, however, in claim 19 the amounts are listed with “about”, which conventionally means +-10% of the values. Therefore, the current claim amount ranges are not commensurate with the disclosed Formulation 2 amounts. The results generated from Formulation 2 cannot draw conclusion for the current claim formulation of having same results, for instance, if all ingredients (excluding water) are at 10% as much of the amount in Formulation 2, what effect would have to the viral titer reduction is not known. Further, If the selectivity is unexpected and the virus enhancement is virus-specific, instant claim 19 claims the formulation is general virucidal formulation, and it does not specify what viruses are included or excluded, and the general virucidal function of the claim scope cannot be justified by merely indicating the titer reduction of HRV-14 under specific assay conditions as in Example 1. Furthermore, since combined teachings of Ma, Meiji, Matsuda, and Li teach the instantly claimed composition for antiviral use, the results are not different in kind from those achievable by prior art, for instance, reference Meiji teaches many viruses that can be prevented by the formulation (e.g., [0022]), moreover, whatever significant functions or effect of the virucidal formulation can achieve, the prior art formulation would necessarily present.
Applicant asserts that routine optimization rationale does not apply because applicant’s specification has shown the concentration is critical to achieve the unexpectedly enhanced virucidal activity, while no reference discloses all the components of claim 19.
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 applied as a whole, 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).
As responded above regarding the unexpected enhanced virucidal activity, the data and result is not commensurate with the claim scope. The result is generated from one single point of concentration for each ingredient, while claim 19 recites “about” concentrations that are broader; the result shows virus specific, e.g., HRV-14, SARS-CoV-2, while instant claim indicates virucidal formulation in general and using HRV-14 under specific assay conditions as a working example, which apparently cannot be applied to a general virucidal function.
In summary, 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 arguments.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
