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 .
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.
Claim Status
Claims 1-20 are currently pending and are examined on the merits herein.
Priority
The instant application claims foreign priority to CN202311690447.1 filed on 12/07/2023 as reflected in the filing receipt dated on 12/19/2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/09/2024 and 07/02/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Interpretation
Regarding the term “about” when referring to a number recited in claims 1-2, 5, 7, 10-11, 13-14, 16, and 20, the Examiner is interpreting the term to mean any number within a range of 10% of the number, as is consistent with the definition of the term provided in Applicant’s instant specification [0044].
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 1-4, 7-9, 11-17, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Xu et al. (US20200375859A1; published: 12/03/2020; PTO-892).
Xu, throughout the reference, teaches an oral care composition comprising a mixture of antibacterial agents including oleanic acid and eugenol in a 2:1 to 3:1 weight ratio [abstract; claims]. These compositions provide improved antibacterial efficacy for reducing plaque and gingivitis [0001-0003].
Regarding claim 1: Oleanic acid is the same chemical as the instantly claimed oleanolic acid as evidenced by Xu [0031], and eugenol reads on the same as instantly claimed. The weight ratio of oleanic acid to eugenol taught by Xu lies within and thus reads on the instantly claimed range. Regarding the instantly claimed zinc source: Xu further teaches that the composition may include one or more preservatives including at least one of sodium benzoate, methyl paraben, ethyl paraben, zinc citrate, zinc oxide, triclosan, stannum salts, and combinations thereof [0059]. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage a combination wherein the composition further comprises zinc citrate and zinc oxide, which reads on the instantly claimed zinc source as evidenced by instant claim 3. Note: MPEP 2131.02. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
Regarding claim 2: Xu further teaches that the composition includes 0.02 wt.% to 2.0 wt.% oleanic acid and 0.01 wt.% to 1.0 wt.% eugenol, each based on the total weight of the composition [0037; claim 20], which each lie within and thus read on the instantly claimed ranges.
Regarding claims 3 and 4: As discussed above in relation to claim 1, the combination of zinc citrate and zinc oxide reads on the instantly claimed zinc source and zinc system.
Regarding claim 7: Xu further discloses an embodiment wherein the composition includes a humectant that is a mixture of humectants, such as glycerin and sorbitol, and a polyhydric alcohol, such as propylene glycol, butylene glycol, hexylene glycol, polyethylene glycol, in an amount of 5 wt.% to 40 wt.%, based on the total weight of the composition [0043]. In addition to the polyhydric alcohols, glycerin and sorbitol are also polyols as evidenced by instant claim 8. One of ordinary skill in the art could at once envisage an embodiment wherein the humectant mixture of polyols is present in an amount of 40 wt.%, based on the total weight of the composition, which lies within and thus reads on the instantly claimed range.
Regarding claims 8 and 9: The humectant mixture disclosed by Xu, which comprises glycerin and sorbitol, reads on the polyol of instant claim 8 and the polyol system of instant claim 9.
Regarding claim 11: Xu further discloses an embodiment wherein the composition includes about 20 wt.% calcium pyrophosphate as a dental abrasive [0063-0065], which lies within and thus reads on the instantly claimed range.
Regarding claim 12: The calcium pyrophosphate disclosed by Xu reads on the instantly claimed insoluble phosphate as evidenced by Applicant’s instant specification, which states that pyrophosphates are examples of insoluble phosphates [0077].
Regarding claim 13: Xu further discloses an embodiment wherein the composition includes about 0.76 wt.% monofluorophosphate (MFP) as a fluoride ion source [0068], which lies within and thus reads on the instantly claimed range. Because compositions disclosed by Xu exemplify sodium monoflurophosphate [0070, Table 1], one of ordinary skill in the art could at once envisage an embodiment wherein sodium monoflurophosphate is the MFP used.
Regarding claims 14 and 15: Xu further discloses an embodiment wherein the composition includes about 2 wt.% tetrasodium pyrophosphate (TSPP) as an anticalculus agent [0066], which lies within and thus reads on the instantly claimed range.
Regarding claims 16 and 17: Xu further discloses an embodiment wherein the composition includes about 3 wt.% fumed silica as a thickening agent [0051], which lies within and thus reads on the instantly claimed range.
Regarding claim 20: As discussed above in relation to claim 1, Xu discloses an oral care composition comprising all features of the instantly claimed composition, including a zinc system comprising zinc citrate and zinc oxide.
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 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US20200375859A1; published: 12/03/2020; PTO-892), as applied to claims 1-4, 7-9, 11-17, and 20 above, and further in view of Prencipe et al. (US20200009031A1; published: 01/09/2020; PTO-892).
Xu teaches the invention(s) of claims 1-4, 7-9, 11-17, and 20 as discussed in detail above and further incorporated herein.
However, Xu does not expressly teach that the composition further comprises a basic amino acid as recited in claims 5-6 or 18-19.
Prencipe, throughout the reference, teaches an oral care composition comprising: 0.5 wt.% to 3 wt.% arginine; zinc oxide; and zinc citrate; wherein the addition of arginine to an oral care composition comprising a zinc salt improves the efficacy of the oral care composition in reducing biofilm [claims 1-2; 0025].
Regarding claims 5, 6, 18, and 19: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the oral care composition of Xu by further including 0.5 wt.% to 3 wt.% arginine as taught by Prencipe, which lies within and thus reads on the instantly claimed range. One would have been motivated and there is a reasonable expectation of success because the composition of Xu, which is designed to combat gingivitis, includes zinc oxide and zinc citrate, and Prencipe teaches that this amount of arginine in combination with a zinc salt is efficacious in reducing biofilm, which is implicated in the occurrence of gingivitis [Prencipe, 0001].
Claims 1-4, 7-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US20200375859A1; published: 12/03/2020; PTO-892), as applied to claims 1-4, 7-9, 11-17, and 20 above, and further in view of Grider et al. (Anticavity Toothpaste Design, pg. 1-53; published: 03/14/2008; PTO-892).
Xu teaches the invention(s) of claims 1-4, 7-9, 11-17, and 20 as discussed in detail above and further incorporated herein.
However, Xu is silent as to the weight ratio of glycerin to sorbitol and thus does not expressly teach the further limitations of claim 10.
Grider, throughout the reference, teaches anticavity toothpaste design [title, abstract]. Grider further teaches that sorbitol and glycerin are common humectants used in toothpastes that can also add sweetness and a cooling effect, wherein glycerol (same compound as glycerin) has a relative sweetness value of 50 and sorbitol has a relative sweetness value of 0.5 [pg. 13, second paragraph and table 3].
Regarding claim 10: It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the relative concentrations of glycerin and sorbitol in the composition of Xu within the prior art range of 5 wt.% to 40 wt.%, which encompasses weight ratios of glycerin to sorbitol that render obvious the instantly claimed range, in order to achieve a composition with a desired level of sweetness, as taught by Grider. An ordinarily skilled artisan would reasonably expect success because Grider teaches that humectants are routinely used to achieve a particular sweetness effect. It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that Applicant did not point out the criticality of the glycerin and sorbitol concentrations of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,260,004 B2 in view of Xu et al. (US20200375859A1; published: 12/03/2020; PTO-892), Prencipe et al. (US20200009031A1; published: 01/09/2020; PTO-892), and Grider et al. (Anticavity Toothpaste Design, pg. 1-53; published: 03/14/2008; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct because the claims of US ‘004 recite a method comprising adding a mixture of oleanic acid and eugenol in a 2:1 or 3:1 weight ratio to an oral care composition, wherein the oleanic acid is at 0.1 wt.% or 0.15 wt.% by weight of the composition and eugenol is at 0.05 wt.% by weight of the composition [see US ‘004, claims 1-3].
While the claims do not expressly recite that the resulting composition comprises a zinc source as recited in instant claims 1 and 20, or the further limitations of claims 3-19, these limitations are rendered obvious by Xu, Precipe, and Grider, whose teachings are as set forth above and further incorporated herein.
Regarding claims 1, 3-6, and 18-20: Xu teaches that compositions comprising the same components as that produced by the method recited in the claims of US ‘004 are useful for reducing gingivitis. Prencipe teaches that compositions comprising 0.5 wt.% to wt.% arginine in combination with zinc oxide and zinc citrate are efficacious in reducing biofilm, which is implicated in the occurrence of gingivitis. Therefore, it would have been obvious to one of ordinary skill in the art to combine the composition produced by the method recited in the claims of US ‘004 with the composition of Precipe according to known methods to yield the predictable result of an oral care composition for combatting gingivitis. Note: MPEP 2144.06(I). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claims 7-9: It would have been prima facie obvious to further include 40 wt.% of a mixture comprising glycerin, sorbitol, and a polyhydric alcohol because Xu teaches that these components are useful humectants in oral care compositions comprising the same ingredients as claimed in US ‘004.
Regarding claim 10: It would have been prima facie obvious to manipulate the relative concentrations of glycerin and sorbitol in order to achieve a composition with a desired level of sweetness, as taught by Grider.
Regarding claims 11-12: It would have been prima facie obvious to further include 20 wt.% calcium pyrophosphate because Xu teaches it is useful as a dental abrasive in oral care compositions comprising the same ingredients as claimed in US ‘004.
Regarding claim 13: It would have been prima facie obvious to further include 0.76 wt.% sodium monofluorophosphate because Xu teaches it is useful as a fluoride source in oral care compositions comprising the same ingredients as claimed in US ‘004.
Regarding claims 14-15: It would have been prima facie obvious to further include 2 wt.% tetrasodium pyrophosphate because Xu teaches it is useful as a anticalculus agent in oral care compositions comprising the same ingredients as claimed in US ‘004.
Regarding claims 16-17: It would have been prima facie obvious to further include 3 wt.% fumed silica because Xu teaches it is useful as a thickening agent in oral care compositions comprising the same ingredients as claimed in US ‘004.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the composition produced in the method recited in the claims of US ‘004 with the prior art teachings as proposed because all ingredients and concentrations are known in the art to be useful in formulating oral care compositions.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,260,002 B2 in view of Xu et al. (US20200375859A1; published: 12/03/2020; PTO-892) and Grider et al. (Anticavity Toothpaste Design, pg. 1-53; published: 03/14/2008; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct because the claims of US ‘002 recite an oral care composition comprising about 1.5 wt.% arginine, based on the total weight of the composition, and zinc oxide and zinc citrate [see US ‘002 claim 1, for example].
While the claims do not expressly recite that the resulting composition comprises oleanolic acid and eugenol in the weight ratio recited in instant claims 1, 18, and 20, or the further limitations of claims 2 and 7-17, these limitations are rendered obvious by Xu and Grider, whose teachings are as set forth above and further incorporated herein.
Regarding claims 1-2, 18, and 20: Prencipe teaches that compositions the same components as recited in the claims of US ‘002 are efficacious in reducing biofilm, which is implicated in the occurrence of gingivitis. Xu teaches that compositions comprising 0.02 wt.% to 2.0 wt.% oleanic acid and 0.01 wt.% to 1.0 wt.% eugenol in a weight ratio of oleanic acid to eugenol of 2:1 to 3:1 are useful for reducing gingivitis. Therefore, it would have been obvious to one of ordinary skill in the art to combine the composition recited in the claims of US ‘002 with the composition of Xu according to known methods to yield the predictable result of an oral care composition for combatting gingivitis. Note: MPEP 2144.06(I). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claims 7-9: It would have been prima facie obvious to further include 40 wt.% of a mixture comprising glycerin, sorbitol, and a polyhydric alcohol because Xu teaches that these components are useful humectants in oral care compositions for combatting gingivitis.
Regarding claim 10: It would have been prima facie obvious to manipulate the relative concentrations of glycerin and sorbitol in order to achieve a composition with a desired level of sweetness, as taught by Grider.
Regarding claims 11-12: It would have been prima facie obvious to further include 20 wt.% calcium pyrophosphate because Xu teaches it is useful as a dental abrasive in oral care compositions for combatting gingivitis.
Regarding claim 13: It would have been prima facie obvious to further include 0.76 wt.% sodium monofluorophosphate because Xu teaches it is useful as a fluoride source in oral care compositions for combatting gingivitis.
Regarding claims 14-15: It would have been prima facie obvious to further include 2 wt.% tetrasodium pyrophosphate because Xu teaches it is useful as a anticalculus agent in oral care compositions for combatting gingivitis.
Regarding claims 16-17: It would have been prima facie obvious to further include 3 wt.% fumed silica because Xu teaches it is useful as a thickening agent in oral care compositions for combatting gingivitis.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the composition produced in the method recited in the claims of US ‘002 with the prior art teachings as proposed because all ingredients and concentrations are known in the art to be useful in formulating oral care compositions.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,583,074 B2 in view of Xu et al. (US20200375859A1; published: 12/03/2020; PTO-892), Prencipe et al. (US20200009031A1; published: 01/09/2020; PTO-892), and Grider et al. (Anticavity Toothpaste Design, pg. 1-53; published: 03/14/2008; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct because the claims of US ‘074 recite an oral care composition, wherein oleanic acid is at 0.05 wt.% to 0.5 wt.% by weight of the composition and eugenol is at 0.05 wt.% to 0.25 wt.% by weight of the composition [see US ‘074, claim 1, for example]. The weight ratio of 0.5 wt.% oleanic acid to 0.25 wt.% eugenol is 2:1, which reads on the instantly claimed range.
The claims of US ‘074 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-3 of U.S. Patent No. 11,260,004 B2 in view of Xu, Prencipe, and Grider, which is discussed in detail above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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