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 .
Applicant’s arguments, filed 23 January 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Status of Claims
Applicant’s elected without traverse Group II, claims 13-17, in the reply filed on 24 September 2025. Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim, and have been cancelled by the Applicant. Applicant cancelled claims 14-18 in the reply filed on 23 January 2026.
Claims 13 and 19-25 are pending and examined.
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, 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.
Claims 13, 19-21 and 23-25 stand rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (JP 2011246465 A, 12/08/2011, IDS reference) (hereinafter Yoshida) in view of Trivedi et al. (US 2012/0020896 A1, 01/26/2012) as evidenced by Wu et al. (“Further characterization of the binding properties of a GalNAc specific lectin from Codium fragile subspecies tomentosoides”, 1997) (hereinafter Wu).
Regarding claims 13, 19, and 25, Yoshida discloses a method of preventing tooth decay with a composition comprising an anticaries agent including Codium algae extract that contains a lectin protein (abs, [0024]), in amounts sufficient to suppress or inhibit the binding of the biopolymer of saliva ([0041]), which oral bacteria in the oral cavity attach to and cause dental caries ([0002]). Exemplary amounts of the algae extract include 0.05% ([0066]), 0.04% ([0068]), and 0.1% ([0069]). The composition may also comprise an antiseptic in conventional amounts ([0033]). The composition shows inhibitory effect on Streptococcus mutans ([0042]).
Yoshida differs from the instant claim insofar as not explicitly disclosing wherein the antiseptic includes a claimed antibacterial ingredient.
However, Trivedi discloses oral care compositions and methods for inhibiting growth and formation of oral biofilms (abs), formation of which is associated with attachment of a variety of bacteria ([0002]). The oral care composition includes anti-microbial agents including chlorhexidine and pyridinium salts such as cetyl pyridinium chloride ([0050]).
Accordingly, Yoshida’s disclosure corresponds to a method of suppressing adhesion of bacteria in an oral cavity as instantly claimed. It would have been obvious to one of ordinary skill in the art to have included chlorhexidine in the composition of Yoshida since it is a known and effective antibacterial agent suitable for oral care compositions as taught by Trivedi.
Regarding the claim reciting a molecular weight of the protein, the instant Specification discloses in paragraph [0022] that the active ingredient (i.e. the claimed protein) is obtained from the Codium algae extract as is, by purification, or by concentration of the extract. Such active ingredient is claimed in claim 1. The instant Specification discloses how to obtain Codium extract in para. [0036], and that lectin is a protein candidate for the active ingredient ([0024] and [0025]). None of these paragraphs disclose wherein the protein is added. Therefore, it reasonably appears that the protein of such molecular weight of claim 1 is inherent to Codium algae extract. Yoshida reasonably appears to disclose substantially the same Codium algae extract as the claimed invention. The method of obtaining the protein disclosed by Yoshida, as discussed in para. [0045] of Yoshida, is substantially similar to the method disclosed in the instant Specification in paragraph [0035]. Thus, one of ordinary skill in the art would reasonably expect the Codium algae extract of Yoshida to contain substantially the same protein of claim 1, having substantially the same molecular weight range, as the claimed invention.
Alternatively, as evidenced by Wu, lectin from Codium algae extract is known to have a molecular mass of 60,000 Da, composed of four subunits of 15,000 Da each ([p.1061, left col., bottom ¶). Accordingly, the lectin of Yoshida meets the limitation of a protein having molecular weight of 5000 or more as instantly claimed.
Regarding claims 13, 23 and 24 reciting amounts of the Codium algae extract, the claimed ranges (i.e. 0.001-5 mass %, 0.01-5 mass %, or 0.1-5 mass%, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the amounts of the prior art (i.e. 0.05% and 0.1%, respectively). 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). Moreover, in any case, the selection of appropriate mass percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in mass percentages. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 13, 20, and 21 reciting amounts of the antibacterial ingredient, although Yoshida does not explicitly disclose an amount of the antiseptics, Yoshida discloses wherein antiseptics may be included in conventional amounts. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ranges (i.e. 0.001-0.5% mass, or 0.01-0.05% mass, respectively) through routine experimentation based on the level of antibacterial activity desired. "[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." See MPEP § 2144.05(II)(A).
Response to Arguments
Applicant mainly asserts None of Yoshida, Trivedi, or Wu teaches or suggests the claimed method of amended claim 15. Yoshida is silent as to the presence, let alone the specific amount, of any antibacterial ingredient, and does not disclose or suggest that an antibacterial ingredient is present "in an amount of 0.001 mass% to 0.5 mass% relative to the total amount of the composition," as expressly required by Claim 13. Trivedi contains no disclosure linking its antibacterial ingredients with the anti- adhesion effect described in Yoshida, therefore a person of ordinary skill in the art would have no motivation to modify Yoshida's Codium-extract composition by adding Trivedi's antibacterial agent such as chlorhexidine. Furthermore, the Specification demonstrates that the specific combination and concentration ranges recited in Claim 13 yield unexpected results as shown in FIGS. 1-4 and Tables 1-4, when Codium algae extract is combined with an antibacterial ingredient within the recited ranges, bacterial adhesion to tooth surfaces and plaque formation are significantly suppressed, even though the antibacterial ingredient is present at a markedly reduced concentration compared to conventional mouthwash formulations (see paragraphs [0030], [0046]-[0056] in the Specification as originally filed). The Specification further explains that conventional mouthwashes employing higher amounts of antibacterial ingredients are associated with well- recognized problems, including adverse effects and disruption of the oral microbiome (see paragraphs [0009]-[0010] in the Specification as originally filed), providing additional support that the claimed concentration ranges are both critical and non-obvious.
The Examiner does not find Applicant’s assertions to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments and working examples. See MPEP § 2123. As discussed in the rejection above, Yoshida explicitly teaches or at least suggests in para. [0033] the inclusion of an antiseptic/antimicrobial in conventional amounts. Thus it would have been obvious to one of ordinary skill in the art to have included antimicrobial agents such as chlorhexidine or cetyl pyridinium chloride as taught by Trivedi, and it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts of antibacterial based on antibacterial effects desired. See MPEP § 2144.05(II)(A).
Furthermore, Applicant agrees that accordingly para. [0030] of the instant Specification, it appears that conventional amounts of antibacterial ingredients have been established depending on the indications. For example, para. [0030] of the instant Specification discloses that by March 2015, the Pharmaceutical and Food Safety Bureau established that chlorhexidine as an antibacterial ingredient usable for prevention of periodontitis is from 0.001-0.05% mass, while amounts of 0.01-0.05% mass is usable for prevention of gingivitis; benzalkonium concentrations of 0.01% mass is usable for the same. Therefore, in any case, it appears to have been well within the capabilities of one of ordinary skill in the art to have included known antibacterials suitable for oral cavity as taught by Trivedi, in known conventional quantities for its known purposes, to form a third composition usable for the same purpose. See MPEP § 2144.06(I).
Additionally, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Thus it is not necessary for Trivedi to disclose antibacterial ingredients and the effects of Codium extracts disclosed in Yoshida. In this instant case, Yoshida discloses oral care compositions comprising Codium extracts and known antiseptics/antibacterials in conventional amounts, and Trivedi discloses known antibacterials in known amounts suitable for oral care compositions. As such, Applicant’s assertion is unpersuasive. See MPEP 2141(III).
Regarding allegations of unexpected result, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. See MPEP § 716.02(b)(II). Applicant has explained that various statements referenced in the specification support their position, but these cannot take the place of evidence in the record. See MPEP § 716.01(c)(II).
Moreover, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. In this instant case, although Applicant has discussed Tables 1-4 generically regarding various combinations of amounts of Codium extracts with amounts of antibacterial agents resulting in significant suppression of bacterial adhesion and plaque formation, Applicant does not appear to have discussed the objective data in detail regarding the assertion of the criticality of concentration ranges, for example, establishing that values above and/or below the claimed ranges do not result in similar increase in suppression of bacterial adhesion and plaque formation. Moreover, Applicant refers to para. [0030] of the instant Specification, which establishes known usable concentrations of chlorhexidine as an antibacterial ingredient for oral care at concentrations of 0.001-0.05% mass or 0.01-0.05% mass, and benzalkonium concentrations of 0.01% mass. Thus it is unclear to the Examiner how Tables 1-4 employ antibacterial ingredients at a markedly reduced concentration compared to conventional formulations as asserted by Applicant.
Claim 13 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida et al. (JP 2011246465 A, 12/08/2011, IDS reference) (hereinafter Yoshida) in view of Pompejus (US 2013/0344010 A1, 12/26/2013) as evidenced by Wu et al. (“Further characterization of the binding properties of a GalNAc specific lectin from Codium fragile subspecies tomentosoides”, 1997) (hereinafter Wu).
The disclosures of Yoshida has been discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing an instantly claimed antimicrobial agent.
However, Pompejus discloses oral care compositions able to reduce Streptococci mutans for dental caries prophylaxis (abs), comprising antimicrobial agents including benzalkonium chloride, chlorhexidine, and cetyl pyridinium chloride, capable of providing anti-plaque benefits, and may be included at a level of about 0.01% to about 5.0% by weight of the composition ([0167]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included antimicrobial agents such as cetyl pyridinium chloride (claim 20), chlorhexidine (claim 21), or benzalkonium chloride (claim 22), in amounts of about 0.01-5% wt. of the composition, since it is a known and effective antimicrobial agent and known and effective amounts capable of providing anti-plaque benefits in conventional amounts as taught by Pompejus.
Citation of Pertinent Technological Background and Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Takeuchi et al. (WO 2012/133127 A1, 03/27/2014), showing a lectin fraction derived from a green alga has a molecular weight of from 10,000 to 15,000 Da.
Takashiba et al. (WO 2010/050369 A1, 05/06/2010), directed to a prophylactic agent for dental caries comprising lectin.
Scholz (US 2009/0169647 A1, 07/02/2009), directed to a liquid antiseptic composition comprising algae extract and chlorhexidine.
Kim et al. (KR 2020/0027663 A, 03/13/2020), directed to a composition for preventing, treating or alleviating oral diseases with antibacterial effects, comprising a seaweed extract.
Bockmühl et al. (WO 2005/120229 A1, 12/22/2005) (hereinafter Bockmühl), directed to compositions for oral, tooth and/or denture care (p. 31, ¶ 10), containing active substance against plaque bacteria including cetylpyridinium chloride and chlorhexidine in concentrations between 0.05 and 0.3% by weight (p. 32, ¶ 6).
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612