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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/17/2026 has been entered.
Applicants’ arguments, filed 02/17/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 21 objected to because of the following informalities:
The new claim 21 appears to recite two claims; claim 21 which depends on claim 1 and another independent claim, from which claim 22 depends. Examiner suggests deleting “The medicament of claim 1, further comprising ethylhexyl sulfonate” from line 1 of claim 21 and adding a new claim 23 which recites --- The medicament of claim 1, further comprising ethylhexyl sulfonate ---.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
Claims 1-7, 9-14, 16, 18, 19, 21 and 22 are 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.
Regarding claims 1, 4, 11, 12, 14, 18 and 22, the phrase "(w/w)" renders the claim indefinite because it is unclear whether the limitation(s) in the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112 – Improper Dependent Form
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10, 13 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites the pH of 7-10 after mixing the first and second components.
Claim 10 recites “wherein the medicament is for use as the sole irrigant performing an endodontic procedure”. Claim 10 does not limit the composition of medicament recited in claim 1. Rather claim 10 addresses how the composition of medicament may be used. Such a limitation does not further limit claim 1 because it does not set forth any additional requirements for the composition disclosed therein.
Claim 13 recites the medicament has a ratio of hypochlorous acid to hypochlorite ions from 1:20 to 1:100,000. According to claim 1 the medicament refers to the mixture of component one and component two (see penultimate line in claim 1). The ratio of acid to conjugate base (hypochlorous acid to sodium hypochlorite) depends on pH and pKa of the acid. Thus in the present case where pKa is 7.5 the ratio only depends on pH of solution. In the pH range of 7-10, as recited in instant claim 1, the ratio of hypochlorous acid to hypochlorite would have to be from 1:0.3 when pH is 7 to about 1:316 when the pH is 10.
Equation 1. Henderson-Hasselbach solved for acid:ion ratio.
p
H
=
p
K
a
+
log
(
A
-
H
A
)
A
-
=
H
A
10
p
H
-
7.5
A
-
=
H
A
10
p
H
-
7.5
: [HA], written another way the weight ratio can be understood as hypochlorous acid to sodium hypochlorite [HA]:
10
p
H
-
7.5
[
H
A
]
.
Claim 13 fails to further limit the scope of claim 1 because it recites a range that implies a pH outside the range recited in claim 1.
Claim 19 recites “wherein the medicament additionally provides disinfectant properties. This is not further limiting because sodium hypochlorite, which is required by claim 14, inherently provides disinfectant properties.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44).
Nassar relates to phytic acid (IP6) as an endodontic chelator and possible replacement for ethylenediaminetetraacetic acid [title & abstract]. Nassar discloses that “mixing 5% NaOCl with 1% IP6 did not result in perceivable effervescence; the final pH of the mixture was 8.0” [p. 5, second full para., lines 6-7].
The prior art anticipates instant claims 1, 2, 9, 10, 11 because it discloses sodium hypochlorite is mixed with phytic acid to form a composition with a pH of 8 and an amount of sodium hypochlorite greater than or equal to 2% w/w. Since the prior art composition contains substantially the same components, i.e., sodium hypochlorite and phytic acid, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as retaining greater than or equal to 2% w/w sodium hypochlorite for at least one hour after mixing, and is capable of being used as the sole endodontic irrigant.
Furthermore the composition of the prior art anticipates instant claim 12. The dissociation constant, pKa, of hypochlorous acid is 7.51 and the relationship between hypochlorous acid and hypochlorite ions in solution can be described by the Henderson-Hasselbach equation. Therefore, in a solution of 5% sodium hypochlorite at pH of 8, as described above, one would have been expected hypochlorous acid to be present at about 1.6%.
Equation 2. Henderson-Hasselbach solved for % hypochlorous acid.
p
H
=
p
K
a
+
log
(
A
-
H
A
)
%
H
y
p
o
c
h
l
o
r
o
u
s
a
c
i
d
=
5
%
10
(
p
H
-
7.5
)
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.
1) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44) as applied to claims 1, 2, and 9-12 above.
Nassar, which is taught above, differs from instant 4 claims insofar as it does not disclose the claimed concentration of complexing agent.
Nassar discloses that “IP6 reversed the adverse effects of NaOCl on resin-dentin adhesion without the chlorine-depleting effect of EDTA” (see the conclusion section of the abstract). Nassar also discloses that sodium hypochlorite is unable “to fully remove the smear layer; as a result, the alternate application of NaOCl and a chelating agent is recommended to ensure effective removal of both the organic and inorganic components of the smear layer” [p. 2, para. 1, lines 16-18] and that “IP6 was shown to effectively remove the smear layer” [p. 2, para. 2, lines 5-6].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising the complexing agent (phytic acid; IP6) within the instantly claimed amounts through routine optimization. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the composition disclosed by Nassar because Nassar discloses phytic acid both reverses the adverse effects of NaOCl on resin-dentin adhesion and removes the smear layer. One would have had an expectation of success because a skilled artisan would have understood that the amount of complexing agents changes the capacity of the composition to complex, and remove, the calcium of the smear layer.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition disclosed by Nassar to comprise phytic acid within the instantly claimed amounts.
2) Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44) as applied to claims 1, 2, and 9-12 above, and in further view of Sener et al. (WO 2005/123007 A1, publication date 12/29/2005; cited in previous Office Action).
Nassar, which is taught above, differs from instant claims 5 and 6 insofar as it does not disclose any additional components. Nassar discloses the compositions are for root canal therapy [p. 5, para. 1]. Nassar also discloses “an ideal irrigant should be able to … permeate into inaccessible areas with a low surface tension” [p. 1, last para.].
Sener discloses a pharmaceutical preparation for use in a mechanical treatment of dental hard tissue (i.e., endodontic or root canal therapy) comprising an oxidizing agent (i.e, first component), such as sodium hypochlorite [p. 3, line 29], and a calcium complexing agent (i.e., second component) [abstract]. Sener discloses that citric acid has been “considered useful additives to alleviate stress on rotary nickel-titanium instruments used for mechanical debridement of infected dental hard tissue” (p. 7, lines 7-10). Sener also discloses the pharmaceutical preparation may also contain wetting agents such as polyoxymethylene derivatives of sorbitol esters (i.e., alcohol ethoxylates) [p. 4, line 8-11].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the citric acid and sorbitan esters (alcohol ethoxylate) of Sener with the compositions discloses by Nassar. One would have been motivated to combine the citric acid for benefits disclosed by Sener, i.e., alleviate stress on nickel-titanium instruments. One would have been motivated to combine the sorbitan esters (alcohol ethoxylates) for the concomitant reduction in surface tension, as desired by Nassar. A skilled artisan would have had an expectation of success because Sener discloses both citric acid and sorbitan esters (alcohol ethoxylates) for use in sodium hypochlorite based endodontic solutions. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a medicament according to Nassar to further comprise citric acid and sorbitan esters (alcohol ethoxylates).
3) Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44) in view of Sener et al. (WO 2005/123007 A1, publication date 12/29/2005; cited in previous Office Action) as applied to claims 1, 2, 5, 6 and 9-12 above, and in further view of William et al. (US 2011/0059882, publication date 10/11/2011; cited in previous Office Action).
Nassar and Sener, which are taught above, differ from in the instant claims because they do not teach sodium xylene, sodium lauryl sulfate, ethylhexyl sulfonate or sodium cumene sulfonate.
William discloses a composition useful as an endodontic root canal disinfectant and comprising hypochlorite and a hydrotrope (para. 94 and abstract). William discloses hydrotropes are included to solubilize other components in the composition (para. 75). Such hydrotropes include sodium salts of xylene sulfonate (i.e., sodium xylene sulfonate; para. 75).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the sodium xylene sulfonate hydrotrope of William with the composition taught be Nassar and Sener to yield nothing more than predictable results. One would have been motivated to combine the prior are elements to improve the solubilizing action of the hypochlorite endodontic irrigant taught be Nassar and Sener. One would have had an expectation of success because sodium xylene sulfonate was disclosed as an additive for an endodontic irrigant comprising hypochlorite. Additionally, the combination would have yielded nothing more than predictable results because each prior art element would have performed the same function, when combined, as they did separately. See MPEP 2143 I, Rational A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a medicament according to Nassar and Sener to further comprise sodium xylene sulfonate.
4) Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44) as applied to claims 1, 2, and 9-12 above, and in further view of Wright et al. (Materials, 2017, vol. 10, article 1147; cited in previous Office Action).
Nassar, which is taught above, differs from claim 13 insofar as it does not disclose the instantly claimed ratio of hypochlorous acid to hypochlorite anion. Nassar discloses “[i]n endodontics, an ideal irrigant should be able to kill microorganisms, dissolve necrotic tissue, remove the smear layer, lubricate the canal” [p. 1, last para.].
Wright relates to alkaline sodium hypochlorite irrigants for cleaning and disinfecting root canals [title & abstract]. With respect to the pH of the irrigants Wright discloses “[a]t pH values of 9 and above, the hypochlorite ion (OCl-) predominates. At neutral pH, hypochlorous acid (HOCl) is mostly present, while below pH 4, chlorine gas starts to form [14]. The antibacterial ability is maximized at pH conditions where HOCl predominates. In contrast, at higher pH levels where OCl- is present, tissue dissolution is maximized” (p. 2, 1st paragraph).
It would have been obvious to one of ordinary skill in the art, for the effective filling date, to have formulated the composition at a pH of 9 or more (where OCl- predominates) because Wright discloses this pH range is suitable to enhance tissue dissolution. One would have been motivated formulated the composition in this pH range because Nassar discloses ideal irrigants should be able to dissolve tissue. One would have had an expectation of success because pH can be adjusted using different amounts of the acidic chelating agent and basic sodium hypochlorite. See MPEP 2143, Exemplary Rationale A.
At a pH of 9 the ratio of hypochlorous acid to hypochlorite ion would be, for example, about 1:32 (i.e., [HA]:
10
p
H
-
7.5
[
H
A
]
; see Equation 1 on page 5 of this Office Action).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed range for the ratio of hypochlorous acid to hypochlorite ions (1:20-1:100,000) overlaps with the ratio taught by the prior art (1:32) and so a prima facie case of obviousness exists.
5) Claims 14, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44) as applied to claims 1, 2, and 9-12 above, and in further view of Dioguardi et al. (Dioguardi et al., European Journal of Dentistry, 2018, 12, 3, p. 459-466; cited in previous Office Action), as evidenced by Sener et al. (WO 2005/123007 A1, publication date 12/29/2005; cited in previous Office Action).
Nassar, which is taught above, differs from instant claims insofar as it does not disclose a method of irrigating a root canal. Nassar discloses the compositions are for root canal therapy [p. 5, para. 1].
Regarding instant claim 14 and 19, Dioguardi discloses that among the most common instruments for root canal irrigation are syringes, to prevent accidental spills when administering sodium hypochlorite (p. 462, left column, last paragraph), and endodontic irrigation needles for administering the irrigant (p. 462, right column, second paragraph).
Sodium hypochlorite is a strong antimicrobial agent (i.e., provides disinfectant properties), as evidenced by Sener at page 2, lines 1-2.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the methods described in Dioguardi with the composition disclosed by Nassar with predictable results. One would have been motivated to combine these known elements to provide a method of application for the endodontic irrigant of Nassar. One would have had an expectation of success because the methods were used with a sodium hypochlorite endodontic solution. Additionally, in combining the methods and composition each component merely would have performed the same function as it did separately. See MPEP 2143 I, Rational A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have administered the composition disclosed by Nassar to a root canal with a syringe and irrigation needle. Wherein the composition provides disinfectant properties.
In regard to instant claim 16, Nassar discloses “the present study proved IP6 to be an effective chelating agent with a comparable ability to that of EDTA to reverse the deleterious effects of NaOCl on resin bond strength in dentin. Compared to 17% EDTA, 1% IP6 resulted in less chlorine depletion of NaOCl. Considering our previous findings of better biocompatibility and better tubule patency, in addition to the abovementioned results of the present study, IP6 might be considered as a suitable alternative to EDTA for use as an endodontic chelating agent” [p. 6, last paragraph]. Furthermore, Nassar does not disclose the sodium hexametaphosphate and sodium hypochlorite solution must be used in combination with another irrigant.
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have administered the disclosed endodontic irrigant as the sole endodontic irrigant. One would have been motivated to administer it as the sole irrigant to maintain the advantages of reduced interaction with the sodium hypochlorite, as disclosed by Nassar. One would have had an expectation of success because the irrigant was proposed to replace traditional EDTA based irrigants.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have administered the endodontic irrigant of Nassar as the sole irrigant.
6) Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nassar et al. (Restorative Dentistry & Endodontics, 09/24/2020, 45(4): e44) in view of Sener et al. (WO 2005/123007 A1, publication date 12/29/2005; cited in previous Office Action) and William et al. (US 2011/0059882, publication date 10/11/2011; cited in previous Office Action), as applied to claims 1, 2, 5-7 and 9-12 above, and in further view of BASF (Texapon EHS Technical Information, BASF, 01/16/2015), as evidenced by NCBI (PubChem Compound Summary for CID 24181097, Sodium 2-ethylhexyl sulfate. Retrieved April 2, 2026 from https://pubchem.ncbi.nlm.nih.gov/compound/Sodium-2-ethylhexyl-sulfate).
Nassar, Sener and William, which are taught above, differ from the instant claims insofar as they do not teach ethylhexyl sulfonate. William discloses “[t]he hydrotrope solubilizing materials, when used, include, but are not limited to, water soluble salts of low molecular weight organic acids such as the alkali metal (sodium and/or potassium) salts of aromatic sulfonic acids, aliphatic sulfates, aliphatic sulfonates, and aliphatic carboxylates” [0075].
BASF discloses “Texapon® EHS possesses very good solubilizing (hydrotropic) properties and improves the spreadability of liquid cleaners particularly on hard surfaces. In addition, it exhibits an excellent solubility in electrolyte containing systems. Owing to the properties described, Texapon® EHS can be used as a raw material for wetting agents in alkaline media” [p. 1, “Example of use”]. Texapon EHS is sodium ethylhexyl sulfate, CAS no. 126-92-1 [p. 1, ingredient].
Ethylhexyl sulfate, CAS no. 126-92-1 as a sulfonate structure, as evidenced by NCBI at page 3 and 5.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the ethylhexyl sulfate of BASF for the aliphatic sulfonate hydrotrope desired by Williams in the composition taught by Nassar, Sener and Williams because BASF discloses sodium ethylhexyl sulfate is a very good hydrotrope in cleaning solutions. One would have had an expectation of success because BASF discloses it is suitable for use in alkaline solitons.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition taught by Nassar, Sener and Williams to further comprise ethylhexyl sulfonate.
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 9-14, 16, 18, 19, 21 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 3, 18 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure. Slaughter, R. J., Watts, M., Vale, J. A., Grieve, J. R., & Schep, L. J., The clinical toxicology of sodium hypochlorite, 2019, Clinical Toxicology, 57(5), 303–311; cited in previous Office Action. Slaughter is pertinent for teaching the pKa of hypochlorous acid to be 7.5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
1 Slaughter et al., Clinical Toxicology, 2019, v. 57, no. 5, p. 303-311