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 Status
Claims 1-9 and 12-14 are pending.
Claims 10-11 have been canceled.
Claims 14 is withdrawn.
Claims 1, 5-7 and 12 are currently amended.
Claims 1-9 and 12-13 are currently under consideration.
Claims 1-9 and 12-13 are rejected.
Acknowledgement of Receipt
This Office Action is in response to the Applicants’ amendments and remarks filed 09/17/2025.
Withdrawn Objections
The objections to claims 5-7 and 12 are withdrawn.
Withdrawn Rejections
In light of the new amendments and/or upon further consideration, the rejection of claim 12 under 35 U.S.C. § 112(b) as having insufficient antecedent basis is withdrawn.
Maintained Objections
The use of the terms “PLUS” and “EMS” (see Spec., pg. 8, line 12), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™ SM or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Maintained Rejections
The following rejections are maintained from the previous Office Action dated 06/16/2025 since the art that was previously cited continues to read on the newly amended limitations.
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.
Claim 1 is rejected under 35 U.S.C. 102 (a)(1) or (a)(2) as being anticipated by Cassels (US 5,071,977 A, pub. 12/10/1991).
Cassels discloses a purified oligosaccharide consisting of a hexasaccharide that blocks the interaction between the human oral plaque bacteria thereby inhibiting interactions between plaque bacteria to prevent, inhibit, and reverse dental plaque deposits (abstract, col. 2, lines 47-53). Cassels teaches that the hexasaccharide consists of rhamnose, galactose; glucose (col. 2, line 15). Cassels teaches that the polysaccharide yield the oligomer, which is present as repeating units of hexasaccharide, consisting of three hexoses, rhamnose, galactose and glucose, in the ratio of 2:3:1, respectively (col. 3, lines 29-34; col. 11, lines 10-13). Cassels discloses that the polysaccharide is lyophilized (i.e., powder) (col. 6, line 45)
Cassels discloses that the oligosaccharide is present in an amount of 0.001 to 5% by weight, preferably 0.05 to 1% by weight in compositions that include conventional carriers or diluents, e.g. tooth powder (bridging col. 2-3). Cassel is analogous art as the powder is taught as appearing to have excellent dental plaque prophylactic activities (col. 2, line 62-63). See Results, column 11, lines 20-55.
The recitation of “wherein the powder is configured for use in a powder jet device for cleaning tooth surfaces by powder spraying” does not give patentable weight to the claim. The claim limitations of powder comprising rhamnose recite the structural limitations of the claimed invention. The recitation of “configured for” indicates a purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. This is not considered a limitation, and is of no significance to claim construction. See MPEP § 2111.02(II.).
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 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 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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.
Claim(s) 1-9 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donnet (US 2013/0337413, cited on IDS, EP 2228175 B1) in view of Oba (JP 3985976), evidence by Von Maltzahn (US 2018/0235987) and Lee (US 2017/0189464). Citations from Oba are taken from the machine translated document provided.
Donnet discloses a powder containing at least one alditol as an agent of cleaning tooth surfaces and powder blasting a tooth surface with said agent for a powder-jet cleaning (title, abstract, [0017], claim 1). Donnet discloses the at least one powder consists essentially of two powders, said two powders being a mannitol and an erythritol (claims 1-3). Donnet teaches that alditols are also called sugar alcohols, and especially preferred are mannitol, erythritol, xylitol, sorbitol or threitol ([0018]).
Donnet does not disclose rhamnose.
Oba discloses an oligosaccharide comprising α-L-rhamnose that is demonstrated as being useful as an active ingredient of a plaque formation preventing agent and a plaque degrading agent ([0040]). Oligosaccharide is taught as one of the carbohydrates produced by lactic acid bacteria for foods and is a safe substance, it can also be used by being blended in products such toothpaste, mouth washes, and breath fresheners ([0031]).
Oba discloses that the dry powder obtained by freeze-drying the eluate contains 60% to 70% by weight of the novel oligosaccharide of the present invention ([0014]). The dry powder obtained by freeze-drying the eluate contains the novel oligosaccharide with a purity of 95% or more ([0015]). Oba teaches that these doses vary depending on the form of the product but usually the dose used is in the range of about 0.5 mg-100 mg ([0031]). Oba discloses that the dosage is not particularly critical and is used in an amount that is effective and does not detract from the flavor or other qualities of the product ([0031]). Oba provides a toothpaste in which the crude oligosaccharide is blended in an amount of 0.05% by weight ([0038], Examples 1, 3).
The recitation of “wherein the powder is configured for use in a powder jet device for cleaning tooth surfaces by powder spraying” does not give patentable weight to the claim. The claim limitations of powder comprising rhamnose recite the structural limitations of the claimed invention. The recitation of “configured for” indicates a purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. This is not considered a limitation, and is of no significance to claim construction. Since the prior art meets the structure limitations then the prior art structure is considered capable of performing the intended use as recited. See MPEP § 2111.02(II.) and 2112.02.
Donnet discloses that the powder mixture additionally contains at least two of the abrasive powders disclosed, e.g., mannitol, erythritol, xylitol, sorbitol, with a particle fraction (i.e. amount of substance) of no less than 5%, preferably no less than 10%, much preferred no less than 20%, based on the total number of particles (i.e., overall amount of substance) of the powders according to the aforesaid preferred embodiments ([0031]). A much preferred powder mixture contains mannitol with a mass fraction (percentage) of about 30% and erythritol with a mass fraction (percentage) of about 70% ([0031], claims 3, 4). This corresponds to an amount-of-substance ratio (i.e., particle ratio) of about 1:6. ([0031],[0042], Tables 1, 2).
Regarding claims 1-3 and 12-13, it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to substitute the alditol (i.e., mannitol/ erythritol) taught by Donnet with the rhamnose taught by Oba with expected results. One would be motivated to do so with a high expectation of success because Oba provides results that show the oligosaccharide comprising rhamnose is useful as an active ingredient of a plaque formation preventing agent and a plaque degrading agent ([0040], Figs. 1 and 2) absent a clear showing of evidence to the contrary. The powder taught by Donnet has desirable properties in the art, e.g., less dust for an evenness of the tooth treatment ([0021]), molar mass no less than 120 g/mol for improved swirl ([0024]); particle size < 20 µm ([0025]), and gentle to dentine ([0026]). The rhamnose of Oba, would provide an advantageous alternative by providing a less intense sweet taste and by avoiding the potential less desirable laxative effect of alditols of which are noted by Donnet in paragraph [0018]. Evidenced by Von Maltzahn, rhamnose and arabinose can be in the form of a concentrate or a powder ([0009], [0057]) and can modulate (e.g. decrease) the abundance of oral disease-associated bacteria, pathobionts or pathogens when administered to the non-gut body site containing mucosal tissue of a human subject in the oral cavity ([0330], claim 3). Evidenced by Lee, arabinose as an extract from ginseng polysaccharide in powder form, can reinforce immunity (abstract, [0016], [0039], [0045], claims 6, 11) to suggest additional benefits that would positively contribute to overall oral health.
Regarding claim 4 (i.e., 0.5-2 wt.-% amorphous silicon dioxide), Donnet teaches pyrogenic silica (i.e., fumed silica, amorphous SiO2) to avoid agglutination inside the powder chamber ([0012]) and that it is material added for the increase of pourability ([0025]). Donnet states that their disclosure also relates to a powder mixture for powder blasting with a powder-jet device, wherein the powder mixture contains at least two of the aforementioned powders, wherein each of the powders is present in a mass fraction (percentage) of no less than 2%, preferably no less than 10% ([0029]) to read on the claimed range. MPEP 2144.05 states that where 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 this case, no evidence of the criticality of the claimed ranges is provided.
Regarding the particle size limitations of claims 5-7 and 12, Donnet teaches that when treating sensitive tooth surfaces, like root dentine or others less strongly mineralized tooth surfaces, with a powder-jet device, it is recommended using powders with a density of no more than 2.0 g/cm3 and a mean grain size of no more than 45 µm ([0008], [0023], claim 7).
Regarding grain size, Donnet teaches a mean grain size no larger than 45 µm for a powder that consists essentially of a mannitol or erythritol (claim 7), along with mean grain size no larger than 35 microns (claim 8), between 10 and 30 microns (claim 9), and for a powder that consists essentially of erythritol having a mean grain size between 10 and 30 microns (claim 10). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Donnet teaches that it is evident that powders with a smaller mean grain size obtain similarly good cleaning effects as do powders with larger mean grain sizes ([0009], see cited U.S. Pat. No. 6,126,444). Donnet teaches and suggests that neither grain size nor density alone, give information about the powder, in the case of an almost similarly good cleaning efficiency, having a stronger or weaker abrasive effect on the tooth surface ([0009]). A person of ordinary skill in the art would optimize the particle size to achieve an improved effect on the tooth treatment.
Regarding claim 8, Donnet teaches glycine and sodium bicarbonate ([0037-0040], Tables 1, 2) and erythritol ([0031], claims 3, 4). Importantly Donnet teaches that powders made of erythritol appear to have an advantage over glycine with respect to being able to sufficiently enrich an airstream with blasting material ([0025]).
Regarding claim 9 (i.e., bactericide ELECTED), Donnet discloses a powder that further comprises the step of mixing said powder together with at least one finely particle component selected from the group consisting of silica gel, bleaching agents, analgesics, bacteriocides and flavor additives, for the preparation of said agent ([0029], claims 2, 5).
Regarding claim 12 (i.e., maximum particle size), Donnet does not mention the largest value a sample of the particle sizes. Given that Donnet recommends using powders with a mean grain size of no more than 45 µm ([0008]) and aims to keep the mean size no larger than 35 µm ([0023]), it would be obvious to one skilled in the art to obtain a maximum particle size below the claimed < 120 pm [sic]. See MPEP 2144.05.
Response to Arguments
Applicants’ arguments have been fully considered but they are not persuasive.
35 U.S.C. § 102
Applicants argue that the “configured for” language in newly amended claim 1, imposes structural limitations which are not taught or suggested by Cassels. Applicants argue the particles must be discrete, free-flowing, have a median and maximum particle sizes within a specific operational envelope, have flowability and hardness that is compatible with air-polishing nozzles (Remarks, pg. 4, para. 4).
The Examiner respectfully asserts that the anticipatory rejection is over claim 1. The structural limitation anticipated by Cassels is a powder comprising rhamnose. The limitations that Applicants list on page 5 of the remarks are limitations that are recited in claims that depend from claim 1. The newly revised claim 1 which now recites, “configured for,” indicates a purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. Thus, this is not considered a limitation and has no patentable weight. See MPEP § 2111.02(II.). Cassels discloses a purified polysaccharide that consists of rhamnose, galactose; glucose (col. 2, line 15). As Applicants mention in their remarks (see Remarks, pg. 5, para. 3), Cassels does disclose that the polysaccharide is lyophilized (i.e., powder) (col. 6, line 45). The powder is taught as having dental plaque prophylactic benefits (col. 2, line 62-63).
35 U.S.C. § 103
Applicants argue that Donnet does not mention rhamnose as a powder component, nor does it suggest or teach the use of rhamnose in any powder for dental air-polishing (see Remarks, pg. 9, para. 5). Applicants argue that Donnet teaches away from rhamnose, focusing exclusively on alditols and their mixtures for dental cleaning powders. (see Remarks, pg. 9, para. 6).
The powder taught by Donnet discloses a powder comprising at least two powders in the art of dental care (claims 1-3), that provides improved handleability and safety ([0021], [0024-0026]). Rhamnose, mannitol and erythritol are all well-known naturally occurring carbohydrates or carbohydrate derivatives that are used as sweeteners; low-calorie alternatives to sugar. The rhamnose taught by Oba provides a less intense sweet taste and avoids the potential less desirable laxative effect of alditols which is also highlighted by Donnet in paragraph [0018].
Regarding Applicants’ argument that Donnet teaches away, MPEP §2123(II) states, “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” And, MPEP § 2144.06(II) states, “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)."
Applicants argue that Oba does not teach or suggest the use of free rhamnose as a powder, and that there is no teaching of particle size, flowability, or suitability for air-polishing (see Remarks, pg. 10, para. 2-3). Applicants argue that the physical form and application of Donnet and Oba are fundamentally different (pg. 10, para. 4).
Oba provides results that show the oligosaccharide comprising rhamnose is useful as an active ingredient of a plaque formation preventing agent and a plaque degrading agent ([0040], Figs. 1 and 2) absent a clear showing of evidence to the contrary. The rhamnose of Oba, would provide an advantageous alternative by providing a less intense sweet taste and by avoiding the potential less desirable laxative effect of alditols of which are noted by Donnet in paragraph [0018]. In response to Appellant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (e.g., free rhamnose) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the argument about fundamentally different, MPEP 2144.09(I.) states that a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. A claimed compound may be obvious because it was suggested by, or structurally similar to, a prior art compound even though a particular benefit of the claimed compound asserted by patentee is not expressly disclosed in the prior art. It is the differences, in fact, in their respective properties which are determinative of nonobviousness. Thus, if the prior art compound does in fact possess a particular benefit, even if that benefit is not recognized in the prior art, Applicants’ recognition of the benefit is not in itself sufficient to distinguish the claimed compound from the prior art. Therefore, the properties possessed by the composition of the instant application, e.g., improved abrasiveness as well as an improved cleaning efficiency compared to commercially available dental cleaning powders and compared to tagatose and trehalose (see last sentence in the instant specification) would be possessed by the prior art. Where the claimed and prior art product(s) are identical or substantially identical, the burden of proof is on applicant to establish that the prior art product(s) do not necessarily or inherently possess the characteristics of the instantly claimed product(s), see In re Best, 195 USPQ 430. See MPEP 2112.01.
Applicants argue that the references of record do not provide rhamnose, configured as a powder with appropriate particle size and flowability, with superior cleaning efficiency and lower abrasiveness compared to known powders (glycine, erythritol, sodium bicarbonate) (see Remarks, pg. 10, para. 5). Applicants state that this unexpected result supports non-obviousness (see Remarks, bridging pgs. 10-11).
Importantly the claims do not recite flowability and upon a thorough review of the instant disclosure, “flowability” is not found. MPEP 2173.05 states that although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification, into the claims. As such, one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
The Examiner notes that the instant specification provides Example 1: Rhamnose dental powder and Example 2: Arabinose dental cleaning powder tested individually and compared with “PLUS” and “COMFORT” and “PERIO” in terms of efficiency and abrasiveness (Fig. 1-2). Example 1 was compared to “PLUS,” tagatose, and trehalose in terms of abrasiveness (Fig. 3). No data is shown for the physical properties (e.g., particle size) of the products/components (e.g., “PLUS”) to which Example 1 and Example 2 are being compared. Absent any data showing that the rhamnose powder is vastly different from other powders and provides an unexpected benefit over the prior art through concrete data, there is no support for the above mentioned “unexpected result.” The Examiner respectfully submits that Applicant is required to present a comparison with the closest prior art of record.
In addition, no criticality is provided. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). See MPEP § 716.02 - § 716.02(g).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (see Remarks, pg. 11, para. 1), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicants argue (see Remarks, pg. 11, last para. through pg. 13) that Von Maltzahn nor Lee discloses or suggests aspects of Applicant's amended claim 1: rhamnose as a principal component; required particle size, flowability, and physical properties; use of powder as abrasive cleaning of teeth by powder spraying.
Evidentiary references Von Maltzahn and Lee provide additional motivation by showing the benefits that would positively contribute to oral health. In Von Maltazhn, oral disease-associated bacteria can be decreased ([0330], claim 3) whilst in Lee, immunity can be reinforced (abstract, [0016], [0039], [0045], claims 6, 11).
For these reasons, Applicants’ arguments are found unpersuasive. The rejections are therefore maintained.
Conclusion
All claims under consideration remain rejected; no claims are allowed. Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614