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 .
In view of applicant’s amendment, previous 112(b) rejection on claims 5, 6, 9, 10 and 11 is hereby withdrawn.
Upon reconsideration in view of applicant’s argument, previous 112(b) rejection on claim 4 is hereby withdrawn.
Upon reconsideration in view of pg.8, lines 22-25 of present specification, previous 112(b) rejection on claim 8 is hereby withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: (i) on lines 6-7, applicant need to change “the second quantity” to --- the second quantity of the second component --- (because it is the second component (not the second quantity) that is comprising an amount of pH induced thickener); (ii) “on the 3rd line from the bottom, applicant need to change “first composition” to --- first component --- (see pg.3, lines 26-28 of present specification). Appropriate correction is required.
Claim 2 is objected to because of the following informalities: (i) on line 2, applicant need to insert --- the --- in front of “one or more”; and (ii) on the last line, applicant need to insert --- that are not crosslinked --- between “polymers” and the period (so as to make it clearer that applicant is referring to the same one or more HASE polymers mentioned in claim 1). Appropriate correction is required.
Claim 3 is objected to because of the following informalities: on lines 2-3, applicant need to delete “the” as in “the acidic groups” (so as to avoid lack of antecedent basis problem); and on line 3, applicant need to delete “at least” (so as to avoid the confusion in meaning of the claim). Appropriate correction is required.
Claim 5 is objected to because of the following informalities: applicant need to make the chemical formula be shown after “wherein the one or more HASE polymers satisfies Formula 2:”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: on the last two lines, applicant need to change “as H” to --- to be H atoms --- (or alternatively, change “have R4 and R6 respectively as H” to --- have H atoms as R4 and R6 respectively). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: on line 2, applicant need to either delete “of the second quantity” or change “of the second quantity” to --- of the second quantity of the second component --- (see pg.7, lines 6-7 of present specification). Appropriate correction is required.
Claim 11 is objected to because of the following informalities: (i) on line 2, applicant need to change “a second” to --- an ---; and (ii) on line 3, applicant need to delete “second” (because in claim 1, from which claim 11 depends, applicant recite “a second quantity of a second component . . ., the second quantity comprising an amount of pH induced thickener”. It does not state that the second quantity of the second component comprises “a second amount” of pH induced thickener). Appropriate correction is required.
Claim 12 is objected to because of the following informalities: on line 4, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: (i) on lines 3 and 6, applicant need to change “the first quantity;” to --- the first quantity of the first component; ---; and (ii) on lines 4 and 6-7, applicant need to change “the second quantity;” to --- the second quantity of the second component; --- (so as to make the claim more definite). Appropriate correction is required.
Claim 14 is objected to because of the following informalities: (i) on line 4, applicant need to insert --- the first and second --- between “combining” and “quantities”; and (ii) on the 5th line from the bottom, applicant need to change “and” to --- or ---; Appropriate correction is required.
Claim 15 is objected to because of the following informalities: on line 2, applicant need to change “for providing” to --- for preparing --- (claim 1, from which claim 15 depends, recites “[a] multi-component system for preparing a hypochlorite composition . . .” (not “providing”). Appropriate correction is required.
Claim 16 is objected to because of the following informalities: (i) on line 3, applicant need to change “the first quantity, the second quantity” to --- the first quantity of the first component, the second quantity of the second component ---; and (ii) on the last line, applicant need to change “pH adjusting agent” to --- the pH adjusting agent --- (so as to make the claim more definite). Appropriate correction is required.
Claim 18 is objected to because of the following informalities: (i) on line 8, applicant need to insert --- the --- between “the amount of” and “pH induced thickener”; (ii) on the last line, applicant need to insert “7” after “a second pH lower than” and before the period (see pg.3, lines 10-13 of present specification). Appropriate correction is required.
Claim 19 is objected to because of the following informalities: on line 2, applicant need to change “mPa.s, s” to --- mPa.s ---. Appropriate correction is required.
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.
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.
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).
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. Hloucha further 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. Since 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, 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 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, it 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 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 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 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 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 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 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), as applied to claim 1 above, and further in view of Kroon (WO 00/26291).
As discussed above, Andina in view of Hloucha 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 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), as applied to claim 1 above, and further in view of Fischer et al (US 2003/0156980 A1).
Andina in view of Hloucha 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 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), as applied to claim 1 above, and further in view of Campos et al (US 2021/0290491 A1).
Andina in view of Hloucha 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 further in view of Campos renders obvious instant claim 14.
Response to Arguments
Applicant’s argument with respect to the previous 112(b) rejections on claims 4, 5, 6, 9, 10 and 11 is now moot in view of the withdrawal of those rejections (see Paragraphs 2 and 3 above).
With respect to pending 103 rejections over Andina in view of Hloucha, applicant argue that all claims are patentable over the art as applied because Hloucha does not qualify as a reference in pending rejections.
(i) Applicant first argue that Hloucha is not in the same field of endeavor as present application since Hloucha relates to the production of a high viscosity material in liquid form, which is useful in cosmetic products, or washing and/or rinsing and cleaning of the skin whereas present invention is focused on producing hypochlorite based gels for oral sanitization/disinfection applications for prevention/treatment of oral infections (such as periodontal diseases and peri-implant diseases). The Examiner agrees with applicant’s such argument.
(ii) Applicant next argue that the problems faced by applicants are not reasonably pertinent to those faced by Hloucha. Applicant argue that present application describes formulating a hypochlorite based disinfecting or drug product for the treatment and prevention of periodontal diseases and peri-implant diseases in oral health care or for sanitization applications. Applicant argue that in order to address these issues, present application notes the improved retention time of the inventive gels on the affected oral location formed by the present teachings and that such improved retention time is useful in treating oral maladies. Applicant argue that plainly the problems faced by present inventors relate to oral hygiene and oral healthcare. Applicant argue that in contrast, Hloucha relates to addressing the “need for cleaning agents with high viscosity in order to achieve an extended contact time with the surface and thus improve the cleaning effect...”. Applicant also point to Hloucha ([0003]-[0004]), which states that “one problem with highly viscous liquids is that they are difficult to handle in practice. For example, it is not possible or only with difficulty to dose highly viscous cleaning agents or to apply them using a spray device.” Applicant argue that the problem address by Hloucha, is the lack of suitable materials used as cleaning agents, particularly in cosmetic applications. For such reasons, applicant argue that present application and Hloucha do not seek solutions to the same problem and thus concludes that Hloucha reference is not only not from the same field of endeavor as the claimed invention, but also is not reasonably pertinent to the problem faced by the inventor. Applicant therefore argue that Hloucha is not analogous art and thus does not qualify as a reference in the pending 103 rejections. The Examiner disagrees. It is the Examiner’s position that the problems faced by applicants are reasonably pertinent to those faced by Hloucha. As already discussed in Paragraph 25 above, Hloucha teaches that although a cleaning agent with high viscosity provides an extended contact time with a surface and thereby improves the cleaning effect, highly viscous liquids are difficult to handle in practice. As a solution to such problem, Hloucha teaches producing the highly viscous cleaning agent at the application site itself. That is, Hloucha teaches 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, thus avoiding the difficult handling of the highly viscous liquid in practice. Also, the extended contact time provided by the highly viscous liquid (formed at the application site) and increased product adhesion to surfaces give a longer exposure time, which increases the effectiveness of a cleaning agent, such as sanitary agent a sterilizing agent or a disinfectant. Applicant, too, desire their product to have a high viscosity which provides an extended retention time of the product on the infected area (in the mouth) (see the last three lines of pg.1 and the 1st two lines of pg.2 of present specification; see also, the 3rd paragraph on pg.6 of present specification, which states, “[h]igher viscosity is sometimes desired for bodily or oral application of the system or hypochlorite composition as the environmental temperature is then almost 40° C. and viscosities are known to decrease with increasing temperature. Also mechanical action in the mouth for example by tongue must be resisted by the hypochlorite composition in order to increase resident time in the mouth.”). However, applicant also recognizes that preformed gels are difficult to prepare and handle due to the rheological properties associated with gels (see the last two lines of pg.1 and the 1st four lines of pg.2 of present specification). Thus, applicant state (pg.2, lines 5-12 of present specification) that it would be desirable to improve the rheological properties of the gel by providing a system capable of forming gels with a high viscosity that are made immediately before or after application. Present multi-component system includes a first component that comprises hypochlorite and water and has a pH in the range of 11-13.5 and a separate second component that comprises a pH induced thickener capable of thickening a composition including water upon an increase of the pH of the composition from an acidic to an alkaline value, the pH induced thickener being dissolved/dispersed at a second pH lower than 7 (see pg.2, lines 26-34 and pg.3, lines 1-3 and lines 7-13 of present specification). Such system provides improved manufacture and handling due to its low viscosity components while at the same time, mixing of the two components results in a thickened hypochlorite composition with all associated advantages (see pg.4, lines 15-17 of present specification) (besides, present specification states (pg.49, 3rd paragraph) that their method, the hypochlorite composition and the system may be formulated to be suitable for sanitization in general or for disinfection of the human body (including human body surfaces, such as the hand, foot, etc., when applicable, and not just oral cavity) when relatively long sanitizing time during which the gel-like composition is applied to surfaces is required). Thus, as explained above, although Hloucha might not be in the same field of endeavor as present application, it is the Examiner’s position that the problems faced by applicants are reasonably (if not clearly) pertinent to those faced by Hloucha, and therefore Hloucha is an analogous art and does qualify as a reference in the rejection of the pending claims.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
July 22, 2025
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