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 . Claims 13 and 21-31 are pending and examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 May 2026 has been entered.
Applicant’s arguments, filed 10 May 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 13, 21, and 23-28 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 Carneiro et al. (“New lectins from Codium isthmocladum Vickers show unique amino acid sequence and antibiofilm effect on pathogenic bacteria”, 07/21/2020, hereinafter Carneiro), further 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).
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 lectin comprises a molecular weight of 5000 or more and less than 30000.
However, Carneiro discloses lectins isolated from a Codium algae that is able to inhibit biofilm formation, wherein the lectin comprises a monomeric protein of 12 kDa (abs).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a lectin protein of 12 kDa since it is a known and effective lectin capable of inhibiting biofilm as taught by Carneiro.
Yoshida and Carneiro 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]) and extracts and fractions thereof isolated from plants including algae ([0066]).
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 or cetyl pyridinium chloride in the composition of Yoshida since each is a known and effective antibacterial agent suitable for oral care compositions as taught by Trivedi.
Moreover, regarding claim 21 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, 24, 26 and 27 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). Moreover, in any case, as noted by para [0030] on p. 12, line 14 to p. 13, line 3 of the instant Specification, Pharmaceutical and Food Safety Bureau established standard concentrations: for chlorhexidine as antibacterial ingredient usable for prevention of periodontitis, the concentrations are from 0.001 mass% to 0.05 mass%; concentrations for cetylpyridinium chloride is 0.01 mass% to 0.05 mass%; and concentrations for benzalkonium chloride is 0.01 mass%. Accordingly, it reasonably appears that 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 antibacterials in formulating the composition of Yoshida.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
Claim 13 and 21-31 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 in view of Carneiro et al. (“New lectins from Codium isthmocladum Vickers show unique amino acid sequence and antibiofilm effect on pathogenic bacteria”, 07/21/2020), further 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, Carneiro, and Wu have been discussed above. While Yoshida, as discussed above, is believed to support a finding of obviousness, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Yoshida will be interpreted as though it does not explicitly disclose 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 13), 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 benefits in oral compositions as taught by Pompejus.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made.
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
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
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