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 included in the prosecution are claims 1, 3, 4, 10, 11 and 30-32.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/16/2026 has been entered.
Applicants' arguments, filed 08/22/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112
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, 3, 4, 10, 11 and 30-32 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation dentifrice and the claim also recites toothpaste which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
1. Claims 1, 3, 4, 10 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2006/0134020, Jun. 22, 2006) (hereinafter Robinson) in view of Silafu et al. (CN 102228479A, Nov. 2, 2011) (hereinafter Silafu) and GotMead (Tannin Galalcool?????, Oct. 2, 2006), as evidenced by Laffort (Tanin Galalcool, 2024).
Robinson discloses an oral care composition comprising a fluoride-providing agent (abstract). The composition may optionally comprise an orally acceptable zinc ion source. Suitable zinc ion sources include zinc gluconate. One or more zinc ion sources are optionally present in a total amount of about 0.05% to about 3% by weight of the composition (¶ [0068]). The composition may optionally comprise an antimicrobial (e.g. antibacterial) agent. One or more antimicrobial agents are optionally present in an antimicrobial effective total amount, typically about 0.05% to about 10% by weight of the composition (¶ [0065]). The composition may optionally comprise one or more further active material(s), which is operable for the prevention or treatment of a condition or disorder of hard or soft tissue of the oral cavity, the prevention or treatment of a physiological disorder or condition, or to provide a cosmetic benefit. In various embodiments, the active is a “systemic active” which is operable to treat or prevent a disorder which, in whole or in part, is not a disorder of the oral cavity. In various embodiments, the active is an “oral care active” operable to treat or prevent a disorder or provide a cosmetic benefit within the oral cavity (e.g., to the teeth, gingiva or other hard or soft tissue of the oral cavity) (¶ [0062]). Actives useful are present in the composition in safe and effective amounts. The specific safe and effective amount of the active will vary with such factors as the particular condition being treated, the physical condition of the subject, the nature of concurrent therapy (if any), the specific active used, the specific dosage form, the carrier employed, and the desired dosage regimen (¶ [0065]). The oral care composition may be a dentifrice, such as a toothpaste (¶ [0049]).
Robinson differs from the instant claims insofar as not disclosing wherein the composition comprises a purified extract of gallic tannin from tara (Caesalpinia spinosa) pods.
However, Silafu discloses a medicine for treating oral diseases. The medicine comprises the effective parts and the effective components extracted from gallnut. The effective parts and the effective components of gallnut have the effects of resisting inflammation, easing pain, resisting bacteria and oxidation, immunoregulating and the like, can quickly repair dental ulcer and accelerate the healing of dental ulcer, and can effectively resist oral diseases such as gingivitis, ozostomia, stinking throat, mouth and tongue sore and the like caused by common pathogenic bacteria in oral cavities (abstract). Suitable effective parts and effective components include gallotannin (claim 1). Gallotannin has strong inhibition and killing action to staphylococcus aureus, Escherichia coli, beta hemolytic streptococcus, etc. (second page).
GotMead discloses wherein TANIN GALALCOOL is a tannin derived from the gall nut of oak trees.
As evidenced by Laffort, TANIN GALALCOOLTM is a highly purified extract of gallic tannin.
As noted by the instant specification on page 2, lines 20-21, GALALCOOL® (sold by Laffort) is a highly purified extract of gallic tannins from tara pods.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Robinson discloses wherein the composition may further comprise an oral care active to treat or prevent a disorder within the oral cavity. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a tannin from gall nut into the composition of Robinson since tannins from gall nuts are effective in treating oral diseases caused by pathogenic bacteria as taught by Silafu.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated TANIN GALALCOOL (i.e., purified extract of gallic tannin from tara pods) into the composition of Robinson since it is a known and effective tannin from gall nuts as taught by GotMead.
In regards to instant claims 1, 30 and 31 reciting for inhibiting or reducing the incidence or likelihood of colds or other upper respiratory and pharyngeal infections, wherein the infection is a coronavirus infection, in particular COVID-19, respectively, this is merely a recitation of the intended use of the claimed invention. The composition of the prior art comprises substantially the same active (e.g. GALALCOOL®) as the claimed invention and thus would be useable for inhibiting or reducing the incidence or likelihood of colds or other upper respiratory and pharyngeal infections, whether the prior art discloses such use or not.
In regards to instant claim 1 reciting 0.01% to 10% purified extract of gallic tannins, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount of TANIN GALALCOOL since Robinson discloses wherein the amount of active varies with the condition to be treated, the physical condition of the subject, the specific dosage form, and etc. Furthermore, tannins from gall nuts are antibacterial as taught by Silafu. Robinson disclose wherein antimicrobial agents are present in an amount of about 0.05% to about 10%.
2. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US 2006/0134020, Jun. 22, 2006) (hereinafter Robinson) (of record) in view of Silafu (CN 102228479A, Nov. 2, 2011) (hereinafter Silafu) (of record), GotMead (Tannin Galalcool?????, Oct. 2, 2006), and further in view of Fruge (US 2012/0207686, Aug. 16, 2012) (hereinafter Fruge) (of record).
The teachings of Robinson, Silafu, and GotMead are discussed above. Robinson, Silafu, and GotMead do not disclose wherein the composition is stored in a malleable or squeezable tube.
However, Fruge discloses wherein it is desirable to provide singe phase dentifrice compositions that can be packaged in conventional laminate squeeze tubes (¶ [0008]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have stored the composition of Robinson in a squeeze tube since this is a desirable product form as taught by Fruge.
Response to Arguments
Applicant argues that the results with zinc gluconate are clearly representative of the recited salts, thereby rending the Examiner’s argument moot.
The Examiner does not find Applicant’s argument to be persuasive. In the declaration of US 16/353,802, only zinc gluconate was shown to have unexpected and synergistic beneficial properties with a specific tannin component. The instant claims are not limited to zinc gluconate and Applicant has not shown wherein the other zinc salts recited also have unexpected and synergistic beneficial properties with the tannin component. As such, the instant claims are still not commensurate in scope and Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 3, 4, 10, 11 and 30-32 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614