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 1-20 were previously pending.
A non-final rejection office action was mailed 11 March 2026.
In response to the 11 March 2026 office action, Applicant filed an amendment/request for reconsideration received 09 June 2026, whereby claims 1, 7, 12, and 19 were amended and claims 8, 9, 18, and 20 were cancelled. No claims were added.
Therefore, claims 1-7, 10-17, and 19 are now pending and under examination.
Priority
Acknowledgment is made for the following:
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Withdrawn Claim Rejections
Applicant has incorporated the limitations of dependent claim 20 into independent claim 1 to now require phenolic compounds present in an amount of 0.008% to about 0.025% based on the total weight of the oral care composition. Additionally, Applicant has cancelled claims 8, 9, 18, and 20 and amended claims 1, 7, 12, and 19 and therefore, the following previous claim rejections are withdrawn:
The previous rejection of claims 7-9, 12, 14-15, and 18-20 under 35 U.S.C. 112(a) is withdrawn.
The previous rejection of claims 1-8, 10-11, and 18-19 under 35 U.S.C. 102(a)(1) as being anticipated by Rege (cited in Applicant’s 27 June 2024 IDS as: US PGPub No. 2018/0280263; published 04 October 2018) is withdrawn.
The previous rejection of claims 1-4, 7-11, and 18-19 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colgate (cited in Applicant’s 27 June 2024 IDS as: WO 2020/242499; published 03 December 2020) is withdrawn.
The previous rejection of claims 1-4, 7-11, and 18-19 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu (cited in Applicant’s 27 June 2024 IDS as: WO 2019/108215; published 06 June 2019) is withdrawn.
The previous rejection of claims 1-4 and 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of US Patent 10,959,936 is withdrawn.
The previous rejection of claims 1 and 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of US Patent 10,518,113 is withdrawn.
Maintained Claim Rejections
The following previously held rejections are maintained and has only been modified to reflect Applicant’s claim cancellations and amendments.
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 1-3, 5, 7, and 10-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Scott (cited in Applicant’s 27 June 2024 IDS as: US PGPub No: 2012/0014883; published: 19 January 2012).
Scott discloses compositions containing one or more derivatives of essential oil compounds for use in personal care compositions such as oral compositions (abstract).
Regarding instant claims 1-3, 5, 7, and 10-11–
Scott provides working examples of producing dentifrice ([0121]) and mouthrinse ([0122]) compositions including:
Mouthrinse composition IIId contains 0.02 wt% methyl isoeugenol and 0.05 wt% Na Saccharin ([0122], Example III).
Though Scott is silent regarding the antioxidative properties of eugenol and derivatives as recited in instant claims 1 and 7, this is an inherent property as the claimed composition is identical to the formulation disclosed by Scott, including Scott’s disclosed amount of eugenol and derivatives falling within the claimed range of therapeutically effective amount (claims 7-9 and 18-20). See MPEP 2112(I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
For the reasons stated above, Scott anticipates that which is currently claimed in instant claims 1-3, 5, 7, and 10-11.
Response to Applicant’s Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive.
Applicant states, “[t]he Office acknowledges that Scott fails to exemplify an oral care composition comprising one or more phenolic compounds in an amount of from greater than or equal to about 0.008% to about 0.025%.” This statement is false as nowhere in the rejection under Scott does the Examiner contend or imply that Scott fails to exemplify this limitation. On the contrary, and as previous stated in the prior office action, Scott provides a working example of a mouthrinse composition containing 0.02 wt% methyl isoeugenol and 0.05 wt% Na Saccharin ([0122], Example IIId). MPEP 2131.03(I) expressly states that a specific example in the prior art which is within a claimed range anticipates the range. See UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023) (“If the prior art discloses a point within the claimed range, the prior art anticipates the claim.”).
The fact that the cited reference may not expressly recognize or discuss the antioxidant property does not negate anticipation. Claims 1 and 7 are directed to a composition, not a method requiring a demonstrated amount of antioxidant activity or an affirmative step of measuring antioxidant efficacy. The limitation, “wherein the phenolic compounds are configured to provide or improve antioxidant efficacy of the oral care composition…” recites the function or property attributed to the phenolic compounds. See MPEP 2112: where the reference discloses the same oral-care composition – including the same phenolic compound at the same concentration – the composition cannot magically become structurally different merely because applicant now characterizes the phenolic compound according to an antioxidant function. Chemical compositions and their properties are inseparable and identical compositions cannot possess mutually exclusive properties.
Accordingly, the reference discloses:
A species of phenolic compound identical to what is currently claimed;
At a concentration within the currently claimed range; and
In an orally acceptable vehicle.
Applicant has not identified any additional structural ingredient, processing condition, activation step, or threshold antioxidant measurement that differentiates the claimed composition from the reference composition. See Examples at [0059] where the oral care composition contains nothing more than a carrier and pure eugenol. Applicant further attributes the antioxidant effect to the phenolic compound itself at the claimed ranges. See [0062]. Therefore, absent persuasive evidence to the contrary, the same phenolic compound in the same type of composition and within the claimed concentration range would possess the same antioxidant capability as what is instantly claimed. Once the Office provides a reasonable basis for concluding that the substantially identical prior art composition possesses the claimed property, the burden shifts to the Applicant to establish the prior art composition does not possess that property. See MPEP 2112 and 2112.01. Applicant should provide evidence or a technically persuasive explanation showing, for example, that the particular reference formulation prevents the phenolic compound from providing any antioxidant efficacy.
Accordingly, the amendment to claim 1 and Applicant’s accompanying arguments do not overcome the previous rejection under 35 U.S.C. 102 as being anticipated by Scott.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Co-pending application no. 18/973,959
Claims 1-4, 7, 10, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/973,959 (‘959 reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because each application is drawn to an oral care composition comprising eugenol and another component that is an orally acceptable vehicle. Furthermore, the currently claimed application is a genus of ‘959 and therefore, the claims of ‘959 anticipate that which is currently claimed in instant claims 1-4, 7, 10, and 19 as outlined below:
Instant claim
Anticipatory ‘959 claim
Claims 1-4 and 10: an oral care composition comprising eugenol and an orally acceptable vehicle
Claim 1: an oral care composition comprising eugenol and oleanolic acid (known antioxidant, preservative, and antimicrobial agent)
Claim 2: eugenol is present in an amount from about 0.01 to about 1.5 wt%.
Claims 7-9 and 18-20: various claimed ranges of eugenol present in the composition
Claim 2: eugenol is present in an amount from about 0.01 to about 1.5 wt%.
Therefore, claims 1 and 2 of ‘959 anticipate that which is currently claimed in instant claims 1-4, 7, 10, and 19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/973,959 (‘959 reference application) and further in view of Xu (cited previously in this Office Action).
Although the claims at issue are not identical, they are not patentably distinct from each other because each application is drawn to an oral care composition comprising eugenol and another component that is an orally acceptable vehicle. While ‘959 claims this composition, ‘959 does not explicitly claim a method for preparing the composition as required by instant claim 11.
Regarding instant claim 11, Xu discloses an oral care composition made by mixing eugenol with oleanolic acid ([0070], Table 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the composition in ‘959 in a method to make as disclosed by Xu. One would have been motivated to do so because Xu teaches a composition comprised of oleanolic acid and eugenol, which is identical to the composition claimed in ‘959, can be formulated by mixing the components. Doing so would have yielded predictable results. Therefore, ‘959 in view of Xu makes obvious instant claim 11.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant contends that the ‘959 application does not teach or suggest an oral care composition comprising one or more phenolic compounds in an amount of from greater than or equal to about 0.008 wt% to about 0.025 wt% (Remarks, p. 11). Furthermore, Applicant asserts the present application demonstrates surprising and unexpected results obtained within the claimed range (Remarks, p. 11). Applicant’s argument has been considered, but is not found to be persuasive for the following reasons:
The range claimed in ‘959 overlaps with the instantly claimed range;
The unexpected results of the instantly claimed range would therefore also apply to ‘959.
See further discussion below regarding Applicant’s unexpected results.
New/Amended Claim Rejections
Applicant’s claim amendments have prompted the following new or amended claim rejections:
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 1-7, 10-17, and 19 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.
Claim 1 recites the range of phenolic compound as, “wherein the one or more phenolic compounds are present in an amount of from greater than or equal to about 0.008% to about 0.025%...”
Claim 19 also recites the range of phenolic compound as, “wherein the one or more phenolic compounds are present in an amount of from greater than or equal to about 0.008% to about 0.01%...”
This limitation in claims 1 and 19 does not use conventional or grammatically complete range construction. “Greater than or equal to 0.008%” ordinarily establishes an open-ended lower limit with no upper limit – that is, 0.008% or more. Adding an upper limit to a range clarified by ‘greater than or equal to’ adds ambiguity to the claims as to whether Applicant intends:
An amount greater than or equal to 0.008%; or
A range from 0.08% to the recited upper limit.
If the upper limit was intended to be included in the range, ordinary claim construction would read as: “greater than or equal to about 0.008% and less than or equal to about 0.025%” or “from about 0.008% to about 0.025%.” For purposes of examination, the claims will be read as “greater than or equal to about 0.008% and less than or equal to about 0.025%” (claim 1) and “greater than or equal to 0.008% and less than or equal to 0.01%” (claim 19).
Claims 2-7, 10-17, and 19 are included in this rejection for their dependency on, and requiring every limitation of rejected claim 1 and failing to cure the defect.
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.
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.
Claims 1-6, 10-11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Colgate (cited in Applicant’s 27 June 2024 IDS as: WO 2020/242499; published 03 December 2020).
Of note: Colgate shares the same applicant/inventor as the current application. However, Colgate was published more than 1 year prior to the effective filing date of the current application.
Colgate discloses an oral care composition comprising a mixture of oleanic acid and eugenol (abstract).
Regarding claims 1-4 and 19, Colgate discloses embodiments of the invention with eugenol present between 0.01 wt% to 1.0 wt% ([0037]). This range overlaps with the instantly claimed range. See MPEP 2144.05. Colgate further discloses the presence of additional ingredients common to oral care compositions such as carriers ([0040]), which corresponds to Applicant’s definition of ‘orally acceptable vehicle’ (Specification, [0034]).
Regarding claims 5-6, Colgate discloses embodiments of the invention with eugenol or eugenol derivatives such as isoeugenol ([0006]).
Regarding claim 10, Colgate discloses embodiments of the invention with thickening agents ([0050]).
Regarding claim 11, Colgate discloses producing the composition of the invention by contacting eugenol with a carrier ([0070], Example 1).
The difference between the applied reference and the claimed invention is that the applied reference may not teach the instantly claimed method with particularity so as to amount to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
While Colgate does not expressly disclose the instantly claimed range of phenolic compounds in the working examples, Colgate does provide express disclosure that the invention includes eugenol or eugenol derivatives in a range which overlaps with the instantly claimed range. A person of ordinary skill in the art would have reasonable expectation of success in selecting the claimed phenolic components at an amount within the claimed range because Colgate expressly discloses success within these variable parameters. Both Colgate and the instantly claimed invention are drawn to oral care compositions comprising overlapping ingredients at overlapping ranges, so it would be reasonable for a skilled artisan to rely upon Colgate’s teachings to arrive at the instantly claimed invention. The applied reference discloses the elements of the claimed composition with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date. Therefore, Colgate makes obvious that which is currently claimed in instant claims 1-6, 10-11, and 19.
Claims 7 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Colgate (cited above) as applied to claims 1-6, 10-11, and 19 above, and as evidenced by Belous (cited in Applicant’s 27 June 2024 IDS as: WO 2021/020994; published 04 February 2021; international filing date: 17 July 2020; enclosed machine translation relied upon).
As discussed above, Colgate makes obvious that which is claimed in instant claims 1-6, 10-11, and 19. Specifically, Colgate provides embodiments of an oral care composition containing eugenol and eugenol derivatives in an amount from 0.01 wt% to 1.0 wt%. While Colgate does not expressly disclose that what is claimed in instant claims 7 and 12-17, these claims are made obvious over Colgate as evidenced by Belous. Specifically, Belous discloses the antioxidative properties of eugenol and mechanisms behind such properties that evidence the obviousness of instant claims 7 and 12-17 over Colgate.
Belous discloses a novel complex of active ingredients used in dental and oral care
products, the preventive use of which reduces oxidative stress in the oral cavity (p. 3, ¶ 1).
Belous further discloses that oxidative stress is a factor in gingivitis and the imbalance of free
radical processes in periodontal diseases affects the oxygen stage of oxidative stress to a greater
extent and for a longer period of time (p. 6, ¶ 2-5). Thus, Belous calls for use of antioxidants to
alleviate gum inflammation and improve the course of periodontal disease (p. 6, ¶ 5). For
prevention and treatment of periodontal inflammation, Belous discloses the use of medicinal
plants and their extracts due to their less severe agitation of gum tissue, higher efficiency of
biological substances, and low frequency of side effects after use (p. 6, ¶ 6).
Belous discloses a toothpaste or mouthwash composition comprised of clove essential oil (Eugenia caryophyllus) between 0.001 to 0.1 wt% (toothpaste) and 0.001 to 0.01 wt% (mouthwash) (p. 13). Eugenol, Belous teaches, is the main biologically active ingredient of clove essential oil and has antibacterial, anti-inflammatory, antifungal, and immunomodulatory properties (p. 10, ¶ 4). In additional, Belous discloses clove essential oil has been shown to have antioxidant effects by neutralizing free radicals under oxidative stress and altering the expression of enzymes that suppress oxidative stress in cells (p. 10, ¶ 5). Finally, Belous discloses use of these compositions containing eugenol to prevent oxidative stress of the oral cavity; reduce periodontal inflammation in a subject experiencing such inflammation; and reduce bleeding gums in a subject experiencing bleeding gums (p. 26, claims 17-19).
Therefore, Belous shows one of ordinary skill could use the eugenol-containing oral care composition disclosed by Colgate in a method of treating conditions of an oral cavity resulting from oxidative damage as follows:
Belous discloses an oral care composition comprising eugenol and a humectant whereby eugenol is able to retain its antioxidative properties in an amount between 0.0001 to 0.01.
Belous discloses eugenol is an antioxidant and calls for the use of antioxidants to alleviate gum inflammation and improve the course of periodontal disease. Belous discloses clove essential oil has been shown to have antioxidant effects by neutralizing free radicals under oxidative stress and altering the expression of enzymes that suppress oxidative stress in cells. Finally, Belous discloses use of compositions containing eugenol to prevent oxidative stress of the oral cavity; reduce periodontal inflammation in a subject experiencing such inflammation; and reduce bleeding gums in a subject experiencing bleeding gums (instant claims 12 and 13). Because Belous discloses treatment with the oral care composition and reduction in periodontal disease inflammation, this implies an active step of diagnosing the presence of periodontal disease before and after treatment (instant claims 15 and 17) and measuring the decrease of free radicals post-treatment (instant claims 14 and 16).
While Colgate contemplates a method of treatment using an oral care composition containing eugenol, Colgate does so while only recognizing the antibacterial properties of eugenol. Belous provides evidence that an identical composition can be used to decrease free radicals in the oral cavity and treat conditions of an oral cavity resulting from oxidative damage because Belous teaches eugenol is an effective antioxidant in an amount as little as 0.001 wt %.
Since Colgate teaches administration of an oral care composition containing eugenol, instant claims 7 and 12-17 would require nothing more than recognition of eugenol’s antioxidative properties, with which Belous provides evidence of. Recognition of these properties is not so out of the grasp of a skilled artisan because Belous discloses the purpose of the components (e.g., reduce free radicals and decrease oxidative stress) and their anticipated outcome (e.g., prevents oxidative stress of the oral cavity, reduces periodontal inflammation in a subject having such inflammation, and reducing bleeding gums in a subject experiencing bleeding gums).
The applied reference Colgate, as evidenced by Belous, discloses the components of the claimed composition and a method to use with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would be prima facie obvious to one of ordinary skill in the art. Therefore, the instantly claimed invention in claims 7 and 12-17 are obvious over Colgate as evidenced by Belous.
Response to Applicant’s Arguments
Applicant argues that the rejection improperly combines Colgate and Belous to establish a prima facie case of obviousness. This argument is not persuasive with respect to the limitations for which Belous was cited merely as an inherent property or result of the composition and method expressly disclosed by Colgate.
The rejection does not rely on Belous to modify the composition or method disclosed by Colgate, nor does it relay on a selection of separate structural or process elements from the two references. Colgate discloses an oral care composition containing eugenol or eugenol derivatives in an amount from 0.01 wt% to 1.0 wt% and teaches contacting that composition with the oral cavity for the prevention and treatment of a condition or disorder of the hard or soft tissue of the oral cavity ([0062]). Belous was cited as evidence concerning the antioxidant and oxidative stress-related effects that would flow naturally and result from use of the composition disclosed by Colgate. Evidence is not being used to add a feature to Colgate, rather, Belous demonstrates a property or natural result of practicing Colgate’s existing disclosure.
In addition, Applicant argues the “surprising and unexpected results of an oral care composition comprising one or more phenolic compounds in an amount of from greater than or equal to about 0.008 wt% to 0.025 wt%” (Remarks p. 10). To support this conclusion, Applicant has provided a single working example whereby embodiments of eugenol + an unnamed carrier were prepared and tested for antioxidant efficacy:
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(Specification [0059]-[0061]).
Applicant asserts that 0.008 wt% eugenol + carrier produces unexpected results. However, the evidence presented at 0.008 wt% is not commensurate in scope with the claimed ranges of 0.008 wt% to 0.025 wt% or 0.008 wt% to 0.01 wt%. In particular, Applicant has not established that the asserted unexpected results occur throughout the claimed range, including the portion from 0.01 wt% to 0.025 wt% which expressly overlaps the prior art range. Applicant’s own disclosure contends that “a concentration of about 0.008 wt% was the lowest dosage that provided the best performance or best antioxidant activity, as increasing amounts of eugenol, as provided in oral care compositions (4)-(6) did not significantly increase the antioxidant efficacy…” ([0062]), so it is unclear if 0.008 wt% showed unexpected results or merely a lower threshold of eugenol concentration. The data does not establish that the 0.008 wt% eugenol composition provides superior antioxidant efficacy relative to the prior art disclosure of 0.01 to 0.025 wt%, nor does the data establish criticality throughout the claimed range relative to the closest prior art range.
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(Specification, [0061]).
In fact, the disclosure expressly states the opposite – that the ranges disclosed by prior art from 0.01 to 0.025 wt% is considered “statistically or significantly the same with respect to antioxidant efficacy, free radical scavenging ability, and/or antioxidant capacity” as Applicant’s 0.008 wt% eugenol composition purportedly showing surprising and unexpected results (see Specification at [0061]: “It should be appreciated that oral care compositions within the same group (i.e., A, B, and C) are considered statistically or significantly the same with respect to antioxidant efficacy, free radical scavenging ability, and/or antioxidant capacity.”). By their own disclosure, Applicants have placed 0.008 wt% eugenol in the same category as the range disclosed by prior art and the data merely supports a plateau/minimum effective concentration, not a showing that the entire claimed range in unexpectedly superior to an overlapping prior art range.
Conclusion
Claims 1-7, 10-17, and 19 are rejected. No claim is 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 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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