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 .
DETAILED ACTION
Change of Examiner
The examiner assigned to the instant application has changed. The new examiner is Bong-Sook Baek. Contact information is provided at the end of this Office Action.
Status of Claims
Claims 1-23 are pending.
Election/Restrictions
Applicants’ election of Group I, in the reply filed on 7/20/2026 is acknowledged. The election was made without traverse.
Accordingly, claims 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 1-20 are under examination in the instant office action.
Claim Objections
Claims 4, 13, 15-16 and 20 are objected to because of the following informalities: typographical errors.
In claim 4, a transitional word, “and”, appears to be missing after “b) calcium hydroxy apatite in line 4.
In claims 4 and 13, “calcium hydroxy apatite” should be corrected to -- calcium hydroxyapatite--.
In claim 15, “10.000” mg/L in line 3 should be corrected to --10,000 mg/L in light of the specification.
In claim 16, “15.000” mg/L in line 3 should be corrected to --15,000 mg/L in light of the specification.
In claim 20, a transitional word, “and”, appears to be missing after the step (3) in line 7.
Claim Rejections - 35 USC § 112 (b)
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 4, 12-13 and 20 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 pre-AIA the applicant regards as the invention.
Claim 13 recites “said calcium hydroxyapatite” is present in said composition in a ratio of 0.8 to 20 for calcium/phosphate”. However, calcium hydroxyapatite has the following chemical formula: Ca5(PO4)3(OH), thus the ratio of calcium/phosphate is about 1.67 as evidenced by US 4327234 (col 2, line 21-23). It is not known that calcium hydroxyapatite can have a different range of calcium/phosphate ratio as claimed. Thus, it appears that the term of “calcium hydroxyapatite” in the claim is used contrary to its ordinary meaning in view of claim 13. However, it is unclear what applicants regard as calcium hydroxyapatite recited in claims 4 and 12-13 since the specification does not clearly redefine the term. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
Claim 20 recites “said composition is obtainable by applying the following processing: (1) Dissolving a preservative in a liquid matrix; (2) Dissolving soluble components;(3) Suspending insoluble components; (4) Inserting the hyaluronic acid under strong stirring.” in lines 2-8. Claim 1 from which claim 20 depends recites the composition comprises one or more inorganic peroxide. However, the claim 4 does not recite said inorganic peroxide for preparing the composition. Also, there is insufficient antecedent basis for “soluble components and insoluble components” in the claim. It is unclear that said soluble components and insoluble components are intended to refer to “one or more inorganic peroxide”, or the composition comprises other soluble and insoluble components. As such, the metes and bounds of the claims are unclear. Clarification is required.
For examination purpose, it is interpreted to refer to “one or more inorganic peroxide”.
Claim Rejections - 35 USC § 102
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, 4, 6-7, 10, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9603929 (hereafter, Piergallini; cited in the IDS filed on 11/7/2024).
Piergallini teaches methods of use of photo-activated compositions for oral disinfection and/or treatment of an oral disease such as gingivitis, periodontitis, or periodontal disease, which comprise at least one oxidant, at least one photoactivator capable of activating the oxidant, and at least one healing factor such as hyaluronic acid, in association with a pharmacologically acceptable carrier, wherein the one oxidant is hydrogen peroxide (inorganic peroxide) (abstract, col 1, line 59-col 2, line 3, col 3, lines 26-27, claims 1-2). The oral disease such as gingivitis, periodontitis, or periodontal disease (gum disease) is a pathological condition requiring wound healing, tissue regeneration or bone regeneration as recited in instant claim 6-7.
Piergallini discloses that hyaluronic acid appears in the early stages of healing to physically create room for white blood cells that mediate the immune response and it is used in the synthesis of biological scaffolds for wound healing applications and in wrinkle treatment (col 11, lines 20-24). Piergallini further discloses that the composition includes in the range of less than about 2% (2g/100 ml=20 mg/ml) hyaluronic acid, or from about 0.001% to about 2%, or preferable from about 0.002% to about 2%, or from about 0.002% to about 1% (1g/100 ml=10 mg/ml) hyaluronic acid (col 11, lines 24-28).
Piergallini further teaches that the oxidant comprises about 1% to about 12% hydrogen peroxide.
Piergallini also teaches that the composition further comprises saffron red powder, annatto extract (plant extract) and brown algae extract (col 3, lines 63-65).
Piergallini discloses that the compositions may be solutions, suspensions or any appropriate formulation suitable for administration, and are typically sterile and free of undesirable particulate matter (col 4, lines 49-52). Piergallini also discloses that the composition is applied in a patient’s mouth (pharmaceutical composition for topical administration) (col 2, lines 52-62). In addition, Piergallini discloses that the antibacterial periodontal composition may further comprise at least one hydrophilic gelling agent (col 3, lines 28-29), which implicitly discloses a gel composition.
As to claim 20, the claim further recites how the composition is prepared. There is no indication that there is any structural difference resulted from the claimed process. Also, Piergallini teaches the use of a preservative solution as a “pharmacologically acceptable carrier” (col 4, lines 42-49). Thus, Piergallini discloses the same composition comprising the same components (i.e., hyaluronic acid, inorganic peroxide such as hydrogen peroxide, and a preservative solution) as claimed. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP §2113.
As such, the instant claims are anticipated by Piergallini.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 4, 6-11, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 9603929 (hereafter, Piergallini) in view of US 5000942 (hereafter, Libin; cited in the IDS filed on 11/7/2024).
US 9603929 as applied supra is herein applied for the same teachings in their entirety.
US 9603929 does not specifically disclose inorganic peroxide such as magnesium peroxide and calcium peroxide.
Libin teaches that the use of hydrogen peroxide as an oxidizing agent to fight plaque and to remove stains presents problems because hydrogen peroxide is not only unstable and can quickly lose efficacy, but it is also not free from toxicity and therefore may have adverse side effects if the dosage is excessive or its use is unduly prolonged. Libin further teaches that on the other hand, magnesium peroxide and calcium peroxide are relatively slow oxidizing agents (col 2, lines 15-24).
Libin teaches a synergistic blend of magnesium peroxide and calcium peroxide which together release active oxygen at a relatively slow rate was used as an oxidizing germicidal agent to destroy anerobic bacteria associated with dental plaque and periodontal disease (col 2, lines 50-58). Libin further teaches that while magnesium peroxide is virtually insoluble in water, when slurred in water, partial hydrolysis takes place with a very slow release of active oxygen and this very slow release allows for a sustained and long lasting effect of oxidation on the enamel surface of the teeth and on the adjacent gingival tissue (col 3, lines 53-58). Libin further teaches that calcium peroxide, on the other hand, is slightly soluble in water and therefore releases active oxygen at a more rapid rate than magnesium peroxide, thus if used as the sole source of active oxygen, it may be unduly reactive and not completely safe (col 3, line 65-col4, line 1). Libin further teaches that by blending calcium peroxide with the virtually insoluble magnesium peroxide in proper proportions, one can produce an oxidative reaction at the tooth and gingival tissue surfaces which is relatively rapid but not unduly so, and is therefore efficacious, yet altogether safe (col 4, lines 1-7).
Libin discloses that the composition comprises from 0.5% (5000 mg/L) to 5% (50000 mg/L) by weight magnesium peroxide (bleaching, oxidizing and germicidal agent), from 0.5% (5000 mg/L) to 5% (50000 mg/L) by weight calcium peroxide (bleaching, oxidizing and germicidal agent), a preservative such as from 0.5% to 5% by weight sodium benzoate and from 01% to 1.0% by weight methyl paraben, and from 0.01% to 1% by weight peppermint oil (plant extract) (col 3, lines 3-43).
Libin also discloses that it is important to note that the prepared composition is non-acidic or alkaline; that is, it has a pH of 8 or higher wherein in this state, the composition is inactive and may be stored in a squeeze tube or other suitable sealed container and when, however, the composition is applied orally, it is rendered acidic by the saliva in the mouth, and it then proceeds to release active oxygen (col 4, lines 42-48).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the synergistic blend of magnesium peroxide and calcium peroxide which together release active oxygen taught by Libin as oxidant in place of hydrogen peroxide for the composition in use for oral disinfection or treating an oral disease such as gingivitis, periodontitis, or periodontal disease because Libin teaches while hydrogen peroxide as an oxidizing agent is unstable and can quickly lose efficacy as well as having toxicity, magnesium peroxide and calcium peroxide as relatively slow oxidizing agents together release active oxygen at a relatively slow rate and can be safely used as an oxidizing germicidal agent to destroy anerobic bacteria associated with dental plaque and periodontal disease. Thus, one of ordinary skill in the art would have been motivated to do so on the reasonable expectation that such substitution would allow for a sustained and long-lasting effect of oxidation on the enamel surface of the teeth and on the adjacent gingival tissue as taught by Libin, thereby useful for oral disinfection or treating an oral disease such as gingivitis, periodontitis, or periodontal disease.
As to the concentrations of hyaluronic acid and inorganic peroxide, Piergallini and Libin disclose the ranges of hyaluronic acid and inorganic peroxide such as magnesium peroxide and calcium peroxide which overlap those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Also, a rejection under 35 USC §103 is proper for that portion of the range that overlaps as it would have been prima facie obvious to have selected the overlapping portion of the range. See MPEP 2144.05 Obviousness of Ranges.
As to pH of the composition, Libin already teaches and suggest that the composition comprising inorganic peroxide such as magnesium peroxide and calcium peroxide should be prepared as non-acidic or alkaline composition having a pH of 8 or higher for maintaining them in inactive state as stated above. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the pH of the composition so that the inorganic peroxide in the composition remain inactive during storage based on the pH range disclosed in Libin.
In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 9603929 (hereafter, Piergallini) in view of US 5000942 (hereafter, Libin) in further view of EP 2745877.
US 9603929 and US 5000942 as applied supra is herein applied for the same teachings in their entirety.
They do not specifically teach zinc peroxide recited in claim 3.
However, it was well known in the art that peroxide compounds suitable for use in oral care product include zinc peroxide as well as calcium peroxide and magnesium peroxide as evidenced by EP 2745877 (title, abstract, p3, and [0032]). EP 2745877 further teaches that the peroxide compounds are present at a concentration of about 0.25 to about 5% by weight and preferably about 0.5 (5000 mg/L) to about 2.0% (20000 mg/L) by weight ([0032]).
According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, it would have been obvious to use zinc peroxide in combination with magnesium peroxide and calcium peroxide based on their independent activities as peroxide oxidants in oral product. One would have a reasonable expectation that they would provide combined effects as peroxide oxidants. As to claim 15, EP 2745877 teaches and suggest the concentration range of zinc peroxide in the oral care composition which overlaps the range recited in claim 15. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Also, a rejection under 35 USC §103 is proper for that portion of the range that overlaps as it would have been prima facie obvious to have selected the overlapping portion of the range. See MPEP 2144.05 Obviousness of Ranges.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 9603929 (hereafter, Piergallini) in view of US 5000942 (hereafter, Libin) in further view of Kumar et al. (Recent Patents on Drug Delivery & Formulation 2009, 3, 221-228).
US 9603929 and US 5000942 as applied supra is herein applied for the same teachings in their entirety.
They do not specifically teach plant extracts obtained from eucalyptus, rhubarb root, clove oil, aloe vera and/or cumin recited in claim 5.
However, it was well known in the art that plant extracts obtained from eucalyptus, aloe vera, clove oil and rhubarb root have been used for oral products in the treatment of periodontal diseases such as gingivitis as evidenced by Kumar et al. (abstract and p226, Table 2). Kumar et al. further teach that aloe vera gel has been reported to sooth gum tissue and relieve pain and discomfort when applied on gums and clove oil reduces infection and relives pain (p221, col 2, para 2-p222, col 1 para 1). Kumar et al. further teach the topical application of a natural plant herb, herbal extract or essential oils like eucalyptus oil and clove oil either alone or in combination with an anti-microbial compound in the form of a liquid or a gel in the treatment of periodontal disease. (p225, col 1, para 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use plant extracts obtained from eucalyptus, aloe vera, clove oil or rhubarb root in combination with the composition of Piergallini because those plant extracts are useful for treatment of periodontal diseases such as gingivitis and can be used with other active ingredients in the form of a liquid or a gel for topical administration as evidenced by Kumar et al. The skilled artisan would have been motivated to do so on a reasonable expectation that they would provide additional known beneficial effects in the treatment of periodontal disease. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 4 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 9603929 (hereafter, Piergallini) in view of US 5000942 (hereafter, Libin) in further view of US 2021/0315809 (hereafter Estey) as evidenced by US 4327234.
US 9603929 and US 5000942 as applied supra is herein applied for the same teachings in their entirety.
They do not specifically teach calcium hydroxyapatite and its concentration recited in the claims.
However, it was well known in the art that the hydroxyapatite (also known as calcium hydroxyapatite) could be incorporated into oral care composition as a remineralization compound for strengthening teeth in people with gingivitis and periodontitis as evidenced by Estey ([0002], [0037], and [0140]). The hydroxyapatite (Ca5(PO4)3(OH)) has claimed ratio of calcium/phosphate (5:3=1.67) as evidenced by US 4327234 (col 2, line 21-23). Estey further teaches the hydroxyapatite can be used with other active ingredients and the hydroxyapatite is present at a concentration of about 1% to about 10% by weight (Table 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use calcium hydroxyapatite in combination with the composition of Piergallini because incorporation of calcium hydroxyapatite as a remineralization compound into oral care composition is taught to be useful for strengthening teeth in people with gingivitis and periodontitis as evidenced by Estey. The skilled artisan would have been motivated to do so on the reasonable expectation that calcium hydroxyapatite would work as a remineralization compound, thereby providing additional beneficial effects in the treatment of periodontal disease such as gingivitis and periodontitis. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As to the concentration of calcium hydroxyapatite, the range disclosed in Estey falls within or overlap the range recited in claim 12. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 9603929 (hereafter, Piergallini) in view of US 5000942 (hereafter, Libin) in further view of US 2009/0274627 (hereafter, Yamada).
US 9603929 and US 5000942 as applied supra is herein applied for the same teachings in their entirety.
They do not specifically teach collagen and its concentration recited in claims 4 and 14.
However, it was well known in the art that collagen could be used with hyaluronic acid as a matrix material in a composition for regeneration of periodontal soft tissue as evidenced by Yamada (abstract and [0055]). Yamada further teaches that the matrix material solution used for the present composition can have a hyaluronic acid concentration of 3 mg/mL to 15 mg/mL and preferably 10 mg/mL and can have a collagen concentration of 0.5 to 5 weight % and preferably 1 to 3 weight % ([0081]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use collagen in combination with the composition comprising hyaluronic acid taught by Piergallini because collagen was taught to be used in combination with hyaluronic acid as matrix material in a composition for regeneration of periodontal soft tissue as evidenced by Yamada. The skilled artisan would have been motivated to do so on a reasonable expectation that collagen would work as additional matrix material useful for regeneration of periodontal soft tissue in the treatment of periodontal disease such as gingivitis and periodontitis. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As to the concentration of collagen, the range disclosed in Yamada falls within or overlap the range recited in claim 14. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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