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 .
Claim Interpretation
With respect to instant claims 3 and 4, claim 1 (from which claims 3 and 4 depend) requires the pH induced thickener of claim 1 to comprise one or more hydrophobically-modified alkali-soluble emulsion (HASE) polymers that are not crosslinked. Thus, it is the Examiner’s interpretation that instant limitations of claims 3 and 4 are further describing the HASE polymer(s) of claim 1 (see also pg.6, lines 6-7 of present specification, which states “[f]urthermore, many of the HASE polymers such as the acrylic and cellulosic based ones described hereinafter . . .”).
Instant claim 5 recites “wherein optionally the different monomer residues are randomly distributed along the polymer chain.” The Examiner interprets such limitation to mean that optionally the monomer residues denoted by x, y and z are distributed or arranged in random order in the polymer chain (if such interpretation is not correct, applicant need to clarify and/or amend the claim).
Claim 8 recites that the pH adjusting agent (an optional component of claim 1) “comprises” or “consists of” the pH induced thickener. On pg.8 (lines 22-31) of present specification, applicant state that “[i]n another embodiment, the pH adjusting agent is not present in the system at all. In some cases the pH induced thickener is intrinsically acidic as with the aforementioned polymers having acidic groups. In other words, the pH adjusting agent comprises or consists of the pH induced thickener. . . . Thus, the second pH may be already in the desired range due to the acidic nature and amount of the pH induced thickener in the second quantity of second component. Also the pH induced thickener amount and mixing ratio of quantities to be combined may be chosen such that a required composition pH is readily achieved without the need for the pH adjusting agent.” Based on such reading of present specification, it is the Examiner’s interpretation that (i) if the pH adjusting agent “consists of” the pH induced thickener, this means that a separate pH adjusting agent is not present at all in the multi-component system, and (ii) if the pH adjusting agent “comprises” the pH induced thickener, this means that there can be a separate pH adjusting agent present in the multi-component system in addition to the pH induced thickener (since “comprises” is an open-ended transitional phrase language).
The phrase “standard conditions” that appears in claims 10 and 19 is interpreted to mean ambient pressure of 1 atmosphere and room temperature as defined by applicant on pg.16, lines 6-8 of present specification.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-11, 13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Andina et al (US 10,881,737 B2) in view of Hloucha et al (WO 2007/093315 A1 and its English translation) and ACUSOL Rheology Modifiers (a product information sheet by Rohm & Haas – May 2008).
Andina teaches (see claims 1, 7 and 8; Table 2) a two-component system for the preparation of a hydrogel having a viscosity of more than 40,000 mPa.s at 20oC and a pH range of 6.0-9.5 for preventing and/or treating a periodontal disease, wherein the two-component system comprises (a) a first component which is an aqueous suspension having a pH value of less than 7 comprising at least one pH-sensitive gelling agent and (b) a second component, which is an aqueous (see Table 2) sodium hypochlorite solution at a pH range of 10-13, wherein the first and second components are physically separated, and wherein the hydrogel is obtained by mixing the two components when necessary. Such two-component system allows in situ preparation of stable hydrogel comprising sodium hypochlorite (col.2, lines 29-40), and the resulting hydrogel prevents unwanted distribution of the sodium hypochlorite solution in the mouth (col.2, liens 46-49) and provides a precise application of the sodium hypochlorite at the infected location (col.2, lines 55-57). In addition, the adherence of the hydrogel results in a longer presence of the sodium hypochlorite at the site of infection (col.2, lines 57-60). Also, the two-component system provides a long shelf stability since the separation of the two components allows to store the sodium hypochlorite solution at high concentration and a pH between 10 and 13, which are optimal conditions for storing a sodium hypochlorite solution (col.2, lines 49-54 and col.3, lines 54-65).
Andina’s aqueous sodium hypochlorite solution renders obvious instant first component comprising hypochlorite and water and having a pH in the range of 11 to 13.5 because Andina’s pH range 10-13 (for the aqueous sodium hypochlorite solution) overlaps with instant range 11-13.5. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Andina’s pH-sensitive gelling agent, which is crosslinked polyacrylic acid (such as Carbopol 974, Carbopol 980 and Carbopol ETD 2020) (see claim 4, col.5, lines 7-18, col.13, lines 55-60), does not teach instant HASE polymers that are not crosslinked.
Hloucha teaches ([0002] and [0119]) a multi-component system which forms a highly viscous liquid when mixed, and such multi-component system can be used as a cleaning agent, such as a sanitary agent, a sterilizing agent and/or a disinfectant. Hloucha teaches ([0003]) that although a cleaning agent with high viscosity provides an extended contact time with a surface (to be cleaned) and thereby improves the cleaning effect, highly viscous liquids are difficult to handle in practice. Hloucha teaches ([0004]) that one solution to such problem is to produce the highly viscous cleaning agent at the application site itself. Hloucha teaches ([0008], [0013] and [0119]) that when a low viscosity aqueous liquid at pH range of 3-5 containing a hydrophobically modified polymer is mixed with a low viscosity aqueous liquid at pH range of 8-12 in a suitable ratio, a highly viscous liquid is formed at the application site itself, which gives a cleaning agent with an extended contact time (while avoiding the difficult handling of the highly viscous liquid in practice). Also, In this way, increased product adhesion to surfaces and thus a longer exposure time is possible, which increases the cleaning effect (besides, Hloucha even teaches ([0136]) that sodium hypochlorite may be used in its multi-component system). Hloucha teaches ([0036]) that such hydrophobically modified polymer can be selected from Acusol 820, Acusol 801S, Aculyn 22, Aculyn 28, Pemulen TR-1, Pemulen TR-2 and Carbopol ETD 2020 (used in Andina). Thus, Hloucha teaches the equivalence of Acusol 820 and Carbopol ETD 2020 both as hydrophobically modified polymers used in a multi-component system which forms a highly viscous liquid and provides an extended contact time and increased product adhesion to surfaces, thus increasing effectiveness of a cleaning agent, such as sanitary agent a sterilizing agent or a disinfectant. Furthermore, as evidenced by ACUSOL Rheology Modifiers (see pg.13), it is known in the art that Acusol 820 is a HASE polymer with unusually high aqueous thickening and stabilizing efficiency and that when neutralized to a pH about 7, it thickens instantly to a highly viscous clear solution. Thus, based on the teachings of Hloucha and ACUSOL Rheology Modifiers, it would be obvious to one skilled in the art to use Acusol 820 (instead of Carbopol ETD 2020) as Andina’s pH sensitive gelling agent with a reasonable expectation of instantly forming a high viscosity hydrogel (when mixed with the aqueous sodium hypochlorite solution having a pH range of 10 to 13) and providing an extended contact time and increased adhesion of the hydrogel, which would result in a longer presence of the sodium hypochlorite at the site of infection, thus increasing the disinfecting effect. Acusol 820 is applicant’s preferred HASE polymer of claims 5 and 6 (see pg.27, last paragraph of present specification). Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers teaches instant HASE polymer that is not crosslinked.
As to instant “hypochlorite composition having a composition pH in the range of 7-12”, as indicated above, Andina’s hydrogel has a pH range of 6.0-9.5. Such range overlaps with instant range 7-12, thus rendering instant range prima facie obvious. In re Wertheim, supra.
Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers renders obvious instant claims 1-3, 5-8, 16, 18 and 20.
With respect to instant claim 9, in Table 5, Andina gives the concentration of the sodium hypochlorite solutions used to make its hydrogel. In Table 6, Andina gives the final concentration of the sodium hypochlorite in the hydrogel. For one example, in Table 5 (see the first solution shown in the portion of Table 5 appearing in col.12), Andina uses 0.2 g of 0.763% NaOCl solution to produce (see Sample DA054 in Table 6) a hydrogel composition with 0.09% NaOCl. This means that the weight of the hydrogel is approximately 1.7 g (0.2 g x 0.763 divided by 0.09 = 1.7 g), which means that there is 1.5 g of a pH sensitive gelling agent (1.7 g minus 0.2 g). Therefore, the weight ratio of the first quantity (NaOCl solution) to the second quantity (pH sensitive gelling agent) is 0.2 / 1.5 (= about 0.13). Using the same process, the Examiner calculated the weight ratios of the first quantity to the second quantity for the other samples shown in Tables 5 and 6, and the weight ratios range from 0.13 to 1.92. Such range falls within instant range of 0.1 to 10 as recited in claim 9. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers renders obvious instant claim 9.
With respect to instant claim 10, Andina teaches (claim 2) that the aqueous suspension comprising the pH sensitive gelling agent has a viscosity of less than 4000 mPa.s at 20oC. Such range overlaps with instant range of lower than 1000 mPa.s, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers renders obvious instant claim 10.
With respect to instant claims 11 and 19, Andina teaches (claim 1) that its hydrogel formed by mixing the two components has a viscosity of greater than 40,000 mPa.s at 20oC. Such range overlaps with instant range of higher than 50000 mPa.s, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers renders obvious instant claims 11 and 19.
With respect to instant claim 13, Andina teaches (claim 6) that the two component system of claim 1 can be a dual syringe system. Andina further teaches (col.5, lines 58-67) that such dual syringe system are known to those skilled in the art where the components contained in each of the syringes are discharged together through a mixer and mixed in the process. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers renders obvious instant claim 13.
With respect to instant claims 15 and 17, Andina teaches (claim 13) a method for treating a periodontal disease (a serious gum infection – see col.3, lines 1-6) by administering its hydrogel to a site of infection in a patient suffering from the periodontal disease. Andina teaches (col.4, lines 38-42, col.6, lines 51-62) that the method involves cleaning or disinfecting the site of microbial infection by directly applying the hydrogel to the wound. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers renders obvious instant claims 15 and 17.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Andina et al (US 10,881,737 B2) in view of Hloucha et al (WO 2007/093315 A1 and its English translation) and ACUSOL Rheology Modifiers (a product information sheet by Rohm & Haas – May 2008), as applied to claim 1 above, and further in view of Kroon (WO 00/26291).
As discussed above, Andina in view of Hloucha and ACUSOL Rheology Modifiers teaches the use of Acusol 820 as Andina’s pH sensitive gelling agent. Hloucha also teaches ([0016] and [0038]) that the hydrophobically modified polymer can also be mixture of a hydrophobically modified polyacrylate (such as Acusol 820) and a hydrophobically modified cellulose derivative. Hloucha does not explicitly teaches that the hydrophobically modified cellulose has residues at least a fraction of which comprises hydroxyl groups. As evidenced by Kroon (pg.2, lines 20-25), hydrophobically modified hydroxyethyl cellulose and hydrophobically modified ethyl hydroxyethyl cellulose are well known as examples of hydrophobically modified cellulose derivatives (and both of these examples contain hydroxyl groups). It would be obvious to one skilled in the art to include either hydrophobically modified ethyl hydroxyethyl cellulose or hydrophobically modified hydroxyethyl cellulose in a mixture together with Acusol 820 and use such mixture as Andina’s pH sensitive gelling agent with a reasonable expectation of success. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers, and further in view of Kroon renders obvious instant claim 4.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Andina et al (US 10,881,737 B2) in view of Hloucha et al (WO 2007/093315 A1 and its English translation) and ACUSOL Rheology Modifiers (a product information sheet by Rohm & Haas – May 2008) as applied to claim 1 above, and further in view of Fischer et al (US 2003/0156980 A1).
Andina in view of Hloucha and ACUSOL Rheology Modifiers does not teach instant agents of claim 12. Fischer teaches ([0038]) that oral disinfecting compositions containing flavoring oils are well known in the art. Such flavoring oils are used to minimize potential agitation to the patients if the disinfection compositions come in contact with oral tissue. It would be obvious to one skilled in the art to include flavoring oil (instant flavoring agent) in Andina’s two component system (as modified by Hloucha) in order to minimize potential agitation to the patients when Andina’s hydrogel comes in contact with oral tissue. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers, and further in view of Fischer renders obvious instant claim 12.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Andina et al (US 10,881,737 B2) in view of Hloucha et al (WO 2007/093315 A1 and its English translation) and ACUSOL Rheology Modifiers (a product information sheet by Rohm & Haas – May 2008), as applied to claim 1 above, and further in view of Campos et al (US 2021/0290491 A1).
Andina in view of Hloucha and ACUSOL Rheology Modifiers teaches all the elements of claim 14 except for the user interface and the selection module. Campos teaches ([0043], [0113] and [0116]) systems and methods for dispensing and administering precise, customized doses of one or more preparation constituents. Campos teaches an embodiment where a liquid or fluid is dispensed from a dual chamber module, each separately housing a different preparation or liquid. Campos further teaches that a user interface may be used to control the dispensing device and teaches that the dispensed dose can be tailored to a specific target individual by using the user interface to enter constituent amounts and ratio information. It would be obvious to one skilled in the art to use Campos’s user interface in Andina’s two component hydrogel dispensing system (as modified by Hloucha) with a reasonable expectation of administering precise, customized doses of Andina’s hydrogel. Since Campos teaches that both the amounts and the ratio of the constituents may be selected using the user interface, it is the Examiner’s position that both the user interface and selection module limitation of claim 14 are inherently taught by Campos. Thus, Andina in view of Hloucha and ACUSOL Rheology Modifiers, and further in view of Campos renders obvious instant claim 14.
Response to Arguments
Citing Villa & Russo (“Hydrogels in Hand Sanitizers”, Materials 2021, 14*7), pg.1577), “Biologically Inspired: Fighting Germs Using HClO Hydrogels with Smectites”, SOFW Journal 12/22, Vol.148, pg.2-7 (BYK article) and WO 2016/202907 (Straumann), applicant argue that these references teach away from the Examiner’s proposed modifications and applicant’s claimed use of non-crosslinked HASE polymers in hypochlorite systems to form high-viscosity gels with the claimed pH and rheological characteristics. Applicant argue that these references show that one skilled in the art would not substitute Acusol 820 for Andina’s Carbopol ETD 2020 because:
(1) Villa & Russo explicitly state that NaOCI is incompatible with "polymers used as gelling
agents", particularly organic ones, and that only a few inorganic thickeners can be used- and even then, stability issues drive practice back to simple solutions. This directly contradicts the premise that one would reasonably expect success by combining NaOCl with an organic gelling polymer such as Acusol 820.
(2) SOFW expressly states that, for hypochlorous systems, "no organic polymer thickeners can be used" because they weaken the active effect of HCIO, and thus are "not suitable." In other words, using organic HASE/carbomer-type polymers with hypochlorite/hypochlorous disinfectant systems would render the systems unsatisfactory for their intended purpose of providing effective, stable disinfection.
(3) Straumann experimentally demonstrates that increasing NaOCl concentration in a Carbopol gel decreases viscosity ("the more liquid is the sample"). This further discourages a skilled person from expecting that substitution with other organic polymers (such as HASE) would yield the stable, high-viscosity NaOCl gel envisioned in the rejection.
Applicant argue that the Examiner’s proposed modification is not a routine substitution of an art-recognized equivalent gelling agent for another, but instead is contrary to the clear direction and experimental evidence in the art as such modification will destabilize and liquefy hypochlorite gels and reduce their antimicrobial efficacy. Applicant thus argue that the modification (substitution) would render Andina’s system unsatisfactory for its intended purpose of delivering a stable, high-viscosity NaOCl hydrogel with good shelf stability and potent antimicrobial activity. The Examiner disagrees. Applicant’s such argument would have been persuasive if the modification was to substitute an organic polymer for something that is not an organic polymer (e.g., inorganic/synthetic smectite clays). Applicant’s argument is unpersuasive because Andina’s two-component system is already using Carbopol ETD 2020, which is an organic polymer, as a pH-sensitive gelling agent. Thus, the modification is substituting one organic polymer (Acusol 820) for another organic polymer. Besides, the stability issues discussed above by both Villa & Russo and SOFW arise because the NaOCl or HClO is mixed and kept together with organic polymers for long term storage. Such stability issues will not arise in Andina or Hloucha since the hypochlorite and the polymer are kept separately (in two or multi-component system) until the time of use.
Applicant next argue the non-obvious, surprising nature of the claimed HASE-based system by pointing to pg.5 lines 24-28 of present specification, which states “. . . the inclusion of one or more HASE polymers that are not crosslinked in the present system surprisingly allows for rapid gel formation, which can be substantially instantaneous and/or the formation of gels with desired rheological properties (e.g., high viscosity).” However, first of all, arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Applicant have not presented any experimental data that show “unexpected” superior results of using instant HASE polymers that are not crosslinked (such as Acusol 820) as opposed to using Andina’s Carbopol ETD 2020. Besides, as already discussed above, the product information sheet (“Acusol Rheology Modifiers”) proves that it is already known in the art that Acusol 820 is a HASE polymer with unusually high aqueous thickening and stabilizing efficiency and that when neutralized to a pH about 7, it thickens instantly to a highly viscous clear solution. Thus, the unexpected results (instantaneous gel formation and high viscosity) argued by applicant are nothing unexpected.
For the reasons stated above, instant 103 rejections over Andina in view of Hloucha still stand.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
August 8, 2026
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