CTNF 18/755,788 CTNF 100232 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims No preliminary amendment has been filed. Claims 1-18 are currently pending and are examined on the merits herein. Priority The instant application filed 06/27/2024, is a 371 filing of PCT/CN2023/102976, filed 06/28/2023. Information Disclosure Statement The information disclosure statements (IDS) submitted on 11/07/2024, 04/30/2025, and 05/11/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1-3, 5-13, 15-16, and 18 are rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by Baig, A., et al. (US 20220096341 A1, 03/31/2022, IDS dated 11/07/2024), hereinafter Baig, as evidenced by Percy E. et al. (2025). Characterization of mineralogical impurities in a carbonate-rich material using MLA, Minerals Engineering , Volume 230, 109409 (PTO-892), hereinafter Percy . Baig discloses arrays of anticavity oral care compositions with varying amounts of fluoride ([0008]). Regarding claim 1 : The examples disclose compositions 3-B, 2-C, 3-D, and 4-D, all of which comprise hops beta acid extract, silica, and sodium citrate (Tables 4-6). The compositions of 2-B and 2-D comprise hops beta acid extract, calcium carbonate, and carbomer (Tables 4 and 6). Sodium citrate and carbomer read on the instantly claimed polycarboxylate stabilization system having at least three carboxylate groups. Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities , as evidenced by Percy . Since the compositions of 3-B, 2-C, 3-D, and 4-D comprise silica (Tables 4-6) and the compositions of 2-B and 2-D comprise calcium carbonate (Tables 4 and 5), they must each therefore comprise the instantly claimed amount of residual iron . Regarding claim 2 : The sodium citrate above is an exemplary polycarboxylate iron metal ion chelate of the instant invention, as evidenced by the claims and specification (p. 13, para. 2). As such, the sodium citrate of Baig in examples 3-B, 2-C, 3-D, and 4-D inherently possesses the instantly claimed properties. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Regarding claim 3 : Since the composition anticipated by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Regarding claims 5-7 : The compositions of 3-B, 2-C, 3-D, and 4-D comprise sodium citrate and sodium gluconate (Tables 4-6). Regardless of their intended use in the compositions of Baig, "[p]roducts of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, these compounds read on the instantly claimed stabilization system. Regarding claim 8 : The compositions of 3-B, 2-C, 3-D, and 4-D comprise hydrated silica (Tables 4-6), which reads on a silica abrasive. The compositions of 2-B and 2-D comprise calcium carbonate (Tables 4 and 5), which reads on a calcium abrasive. Regarding claims 9-10 : The compositions of 2-B and 2-D comprise calcium carbonate and are free of silica (Tables 4 and 5). Regarding claim 11 : The compositions of 2-B, 2-D, 3-D and 4-D are free of fluoride (Table 4 and 6). Regarding claim 12 : The compositions of 3-B and 2-C further comprise stannous fluoride (Tables 4-5). Regarding claim 13 : The composition of 3-B comprises 0.45 wt% of stannous fluoride and 0.56 wt% of stannous chloride, totaling to 1.01 wt% of a stannous ion source (Table 4). The composition of 2-C comprises 0.11 wt% of stannous fluoride and 0.56 wt% of stannous chloride, totaling to 0.67 wt% (Table 5). The compositions of 2-B, 2-D, 3-D and 4-D comprise 1.1 wt% of stannous chloride (Tables 4 and 6). Regarding claim 15 : The hops beta acid can be essentially free of or substantially free of hydrogenated hops beta acid and/or hops acid ([0062]). The hops beta acids extract used in the examples of Baig is provided by Hopsteiner® and detailed in Table 7 ([0159]), and does not appear to comprise any hydrogenated hops acid. Furthermore, the examples of the instant specification utilize the same hops beta acids extract from Hopsteiner®. Given that such an extract is exemplary of the instant invention, the same Hopsteiner® extract taught by Baig must also read on the instantly claimed hops acid. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Regarding claim 16 : The Hopsteiner® extract comprises approximately 45%, by weight of the extract, of the hops beta acids and approximately 0.4%, by weight of the extract, of hops alpha acids (Table 7, [0159]). The compositions of 3-B, 2-C, 3-D, and 4-D comprise 0.5 wt% of the hops beta acid extract (Tables 4-6), meaning hops beta acids are actually present at an amount of 0.225 wt% based on the weight of the composition (0.5 x 0.45). Regarding claim 18 : The compositions of 3-B and 2-C comprise 1.55 wt% of sodium citrate and 1.3 wt% of sodium gluconate, totaling to 2.85 wt% of the stabilization system (Tables 4 and 5). The compositions of 3-D and 4-D comprise 1.05 wt% of sodium citrate and 1.3 wt% of sodium gluconate, totaling to 2.35 wt% of the stabilization system (Table 6). The compositions of 2-B and 2-D comprise 1 wt% of carbomer, reading on the stabilization system (Table 4 and 6) . 07-15 AIA Claim s 1-4, 8, 12, 14, 16, and 18 are rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by Trivedi, H., et al. (US 20060134024 A1, 06/22/2006, IDS dated IDS dated 11/07/2024), hereinafter Trivedi . Trivedi discloses antibacterial and anti-inflammatory oral compositions having an active ingredient combination comprising one or more active compounds from an extract of magnolia and an extract of hops (abstract). Regarding claim 1 : The dentifrice formulation of Example 1 is prepared with 0.3% of a hops extract containing a mixture of HHBAs (i.e., hexahydrobeta acids), which read on hops beta acid , as well as tetrasodium pyrophosphate (TSPP) and sodium tripolyphosphate (STPP), which read on a polydentate polyphosphate stabilization system . The formulation further comprises silica abrasives and silica thickeners (i.e., Sylodent and Zeodent) ([0045], Table 1). The instant specification describes residual iron it as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. Since the formulation of Example 1 comprises silica, it must therefore comprise the instantly claimed amount of residual iron . Regarding claim 2 : The pyrophosphate and tripolyphosphate above are suitable polyphosphate iron metal ion chelates, as evidenced by the instant claims and specification (p. 13, para. 2). As such, the pyrophosphate and tripolyphosphate of Trivedi inherently possess the instantly claimed properties. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Regarding claim 3 : Since the composition anticipated by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Regarding claim 4 : The tetrasodium pyrophosphate of example 1 reads on a polydentate polyphosphate comprising pyrophosphate (Table 1). Regarding claim 8 : The formulation of example 1 comprises a silica abrasive (i.e., Sylodent and Zeodent) ([0045], Table 1). Regarding claim 12 : The formulation of example 1 further comprises sodium fluoride (Table 1). Regarding claim 14 : The formulation of example 1 is free of a stannous ion source (Table 1). Regarding claim 16 : The formulation of example 1 incorporates 0.3 wt% of the hop acids extract, which comprises 35% by weight of hexahydrolupulone and 65% by weight of hexahydrocolupulone (Table 1; [0044]), both of which are beta acids. Thus, the composition comprises 0.3 wt% of hops beta acid which falls within the instantly claimed range (i.e., 0.05-10%). Regarding claim 18 : The formulation of example 1 comprises 1 wt% of TSPP and 7 wt% of STPP, totaling to 8 wt% of the stabilization system (Table 1), which falls within the instantly claimed range (i.e., 0.1-10%) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 1-3, 5-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Baig, A., et al. (US 20220096341 A1, 03/31/2022, IDS dated 11/07/2024), hereinafter Baig, as evidenced by Percy E. et al. (2025). Characterization of mineralogical impurities in a carbonate-rich material using MLA, Minerals Engineering , Volume 230, 109409 (PTO-892), hereinafter Percy . The teachings of Baig are discussed above as are the rejections of claims 1-3, 5-13, 15-16, and 18. The Hopsteiner® extract used in the examples of Baig comprises approximately 45%, by weight of the extract, of the hops beta acids and approximately 0.4%, by weight of the extract, of hops alpha acids (Table 7, [0159]). The compositions of 3-B, 2-C, 3-D, and 4-D comprise 0.5 wt% of the hops beta acid extract (Tables 4-6), meaning hops alpha acids are actually present at an amount of 0.002 wt% based on the weight of the composition (0.5 x 0.004). Baig broadly teaches that the hops extract can comprise less than about 10%, by weight of the extract, of hops alpha acids ([0041]). Within the broader teaching of 10% hops alpha acids in the hops extract, a composition comprising 0.5% of hops extract would comprise 0.05% by weight of hops alpha acids, thereby falling within the instantly claimed range of claim 17 . The teachings of Baig differ from that of the instant invention in that Baig does not teach a specific embodiment comprising a concentration of hops alpha acid that falls within the instantly claimed range of claim 17 . Given that Baig broadly teaches that the hops alpha acid can be incorporated at about 0.05% by weight based on the entire composition, it would have been prima facie obvious to incorporate the hops alpha acids at such an amount since this is a known and effective amount to use in the formulations of Baig. One of ordinary skill in the art could have incorporated this amount of alpha acids into the oral care compositions of Baig according to know techniques (i.e., selecting an extract with a higher proportion of alpha acid or increasing the overall amount of the Hopsteiner extract), to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in changing the amount of hops alpha acid since extracts containing different proportions of alpha and beta acids are known as discussed by Baig . 07-21-aia AIA Claim s 1-4, 8, 12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Trivedi, H., et al. (US 20060134024 A1, 06/22/2006, IDS dated IDS dated 11/07/2024), hereinafter Trivedi . The teachings of Trivedi are discussed above as are the rejections of claims 1-4, 8, 12, 14, 16, and 18. Trivedi further teaches that hop acids are extracted from the hop plant by any of a variety of suitable extraction methods known to one of skill in the art. One major active compound within the hops extract is the organic acid humulone, also generally referred to as alpha acid. Alpha acids constitute about 10 to 15 percent by weight in dry hops and over 50 percent by weight of carbon dioxide hops extract. Exemplary hops acids that may be used in the compositions of Trivedi include humulone (alpha acids), lupulone, and colupulone (beta acids) ([0010]-[0011]). The teachings of Trivedi differ from that of the instant invention in that Trivedi does not teach a specific embodiment comprising a concentration of hops alpha acid that falls within the instantly claimed range of claim 17 . However, it would have been prima facie obvious to one of ordinary skill in the art to replace the hops acid extract in example 1 of Trivedi with a hops acid extract comprising > 50% by weight of alpha acids since hops extracts comprising such an amount of alpha acids are known and routine in the art as taught by Trivedi. One of ordinary skill in the art could have made this modification via simple substitution of one known element for another (i.e., hops acid extract) to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Trivedi teaches that exemplary hops acids to be used in the compositions include humulones (i.e., alpha acids). Since the formulation of example 1 incorporates 0.3 wt% of the hop acids extract, replacing it with an extract comprising > 50% by weight of alpha acids would result in a composition comprising from 0.15% to 0.3% of alpha acids by weight of the composition. Such an amount falls within the instantly claimed range (i.e., 0.05-10%) . Double Patenting 08-33 AIA 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. 1. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 18/755,808 . Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims recite an oral care composition comprising hops beta acid and one or more polydentate ligands comprising citrate (copending claim 1), which reads on the instantly claimed polycarboxylate stabilization system . The oral care composition further comprises an abrasive, the abrasive comprising a silica abrasive or a calcium abrasive (copending claim 7). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. Since the copending compositions comprises an abrasive such as silica, it must therefore comprise the instantly claimed amount of residual iron . This is a provisional nonstatutory double patenting rejection. 08-37 AIA 2 . Claim s 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 12, 15, and 23 of copending Application No. 18/755,888 in view of Baig (US 20220096341 A1) . The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Baig. The copending claims define an oral care composition comprising hops acid, wherein the hops acid comprises only non-hydrogenated hops beta acid (copending claims 1, 12, 15), reading on the hops acids of instant claim 1. The composition further comprises sodium citrate (copending claim 23), reading on the polycarboxylate stabilization system as instantly claimed. The copending claims differ from the instant claims in that they do not explicitly recite a residual amount of iron. However, the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. Baig teaches that oral care compositions can comprise a calcium abrasive and/or a non-calcium abrasive, such as bentonite, silica gel (by itself, and of any structure), precipitated silica, amorphous precipitated silica etc. Such materials can be introduced into the oral care compositions to tailor the polishing characteristics of the target dentifrice formulation. While the composition of the copending claims does not explicitly recite an abrasive, it would have been prima facie obvious to incorporate an abrasive such as silica since these are known and routine components of oral care compositions, as taught by Baig. One of ordinary skill in the art would have been motivated to incorporate an abrasive in order to tailor the polishing characteristics of the formulation as taught by Baig. The incorporation of an abrasive would simultaneously incorporate residual iron as evidenced by the instant specification. As such, instant claim 1 is obvious in view of the copending claims and Baig . This is a provisional nonstatutory double patenting rejection. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 15 of copending Application No. 18/655,468 as evidenced by Percy . The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims as evidenced by Percy. The copending claims recite a method comprising administering a dentifrice composition comprising a hops extract comprising hops beta acid and calcium abrasives such as calcium carbonate (copending claims 1 and 5-6). The dentifrice composition further comprises sodium citrate (copending claim 15), which reads on the polycarboxylate stabilization system as instantly claimed. Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . While the copending claims define a method, the composition used in said method is obvious. This is a provisional nonstatutory double patenting rejection. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, 14, and 18-20 of copending Application No. 17/485,553 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims recite an oral care composition comprising hops, wherein the hops comprises hops alpha acid or hops beta acid (copending claims 1 and 7). The composition further comprises zinc, specifically zinc citrate (copending claims 12 and 14), which reads on the instantly claimed polycarboxylate stabilization system . The oral care composition further comprises a calcium abrasive, such as calcium carbonate, or a silica abrasive (copending claims 18-20). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending composition comprises calcium carbonate and/or silica, it must therefore comprise the instantly claimed amount of residual iron . This is a provisional nonstatutory double patenting rejection. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 6-8 of copending Application No. 17/485,552 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims recite an aqueous composition comprising hops beta acid and hops alpha acid (copending claim 1). The composition further comprises zinc, specifically zinc citrate (copending claims 3-4), which reads on the instantly claimed polycarboxylate stabilization system . The oral care composition further comprises a calcium abrasive, such as calcium carbonate (copending claims 6-8). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . This is a provisional nonstatutory double patenting rejection. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-20 of copending Application No. 18/322,652 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims recite an oral care composition comprising a hops extract, wherein the hops extract comprises non- hydrogenated hops beta acid and less than 1% of hops alpha acid (copending claim 16). The composition further comprises zinc, specifically zinc citrate (copending claim 17), which reads on the instantly claimed polycarboxylate stabilization system . The oral care composition further comprises a calcium abrasive, such as calcium carbonate (copending claims 18-20). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . This is a provisional nonstatutory double patenting rejection. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of copending Application No. 17/704,023 . The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims. The copending claims recite a method comprising applying a toothpaste composition to the oral cavity wherein the toothpaste comprises abrasive and a hops extract comprising hops beta acid and less than about 1% of hops alpha extract (copending claim 1). The abrasive comprises silica abrasive, calcium abrasive, or combinations thereof (copending claim 6). The calcium abrasive may comprise calcium pyrophosphate (copending claim 7), which reads on the polydentate polyphosphate stabilization system as instantly claimed. Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. Since the copending compositions comprises an abrasive, specifically silica, it must therefore comprise the instantly claimed amount of residual iron . While the copending claims define a method, the composition used in said method is obvious. This is a provisional nonstatutory double patenting rejection. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 17, and 20-23 of copending Application No. 17/704,027 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims recite an oral care composition comprising a hops extract comprising hops beta acids (copending claim 1). The composition further comprises zinc, specifically zinc citrate (claims 15 and 17), which reads on the instantly claimed polycarboxylate stabilization system . The oral care composition further comprises a calcium abrasive, such as calcium carbonate, or a silica abrasive (copending claims 20-23). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises silica and/or calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . This is a provisional nonstatutory double patenting rejection. 08-34 AIA Claim s 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 14 and 16-18 of U.S. Patent No. 12,350,355 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because : The conflicting claims recite an oral care composition comprising hops beta acid and citrate (conflicting claim 14), which reads on the instantly claimed polycarboxylate stabilization system . The composition further comprises calcium, specifically a calcium abrasive such as calcium carbonate (conflicting claims 16-18). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . 08-34 AIA Claim s 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 17-19, 21, and 29-30 of U.S. Patent No. 11,696,881 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because : The conflicting claims recite an oral care composition comprising hops beta acid and polyphosphate (conflicting claim 17). The polyphosphate comprises a polyphosphate with two or more phosphate molecules such as pyrophosphate, tripolyphosphate, tetrapolyphosphate, hexametaphosphate, or combinations thereof (conflicting claims 18-19), all of which read on the instantly claimed polydentate polyphosphate stabilization system . The composition further comprises calcium, specifically a calcium abrasive such as calcium carbonate (claims 21 and 29-30). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises silica or calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . 08-34 AIA Claim s 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-3 and 7-8 of U.S. Patent No. 11,690,792 as evidenced by Percy . Although the claims at issue are not identical, they are not patentably distinct from each other because : The conflicting claims recite an oral care composition comprising a hops extract comprising hops beta acid and less than 5% hops alpha acid (conflicting claim 1). The composition further comprises zinc in the form of zinc citrate (conflicting claims 2-3), which reads on the instantly claimed polycarboxylate stabilization system . The oral care composition further comprises a calcium abrasive, specifically calcium carbonate (conflicting claims 7-8). Regarding the residual iron , the instant specification describes residual iron as “iron which is present only as an impurity of the other materials deliberately added (e.g., silica) or that entered the composition during the manufacturing process” (p. 12 of spec.). The specification further discusses how “during processing, silica can abrade stainless-steel production equipment thus increasing the iron content of the toothpaste” (p. 48 of spec). Thus, it appears that any composition comprising an abrasive will comprise a residual amount of iron due to abrasion during manufacturing, as evidenced by the instant specification. Furthermore, the specification discloses iron as an inherent impurity of silica, meaning regardless of the manufacturing process, any composition comprising silica will also comprise residual iron. The same can be said of calcium carbonate which is known to comprise iron oxide impurities, as evidenced by Percy . Since the copending compositions comprises calcium carbonate, it must therefore comprise the instantly claimed amount of residual iron . Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616 /SUE X LIU/Supervisory Patent Examiner, Art Unit 1616 Application/Control Number: 18/755,788 Page 2 Art Unit: 1616 Application/Control Number: 18/755,788 Page 3 Art Unit: 1616 Application/Control Number: 18/755,788 Page 4 Art Unit: 1616 Application/Control Number: 18/755,788 Page 5 Art Unit: 1616 Application/Control Number: 18/755,788 Page 6 Art Unit: 1616 Application/Control Number: 18/755,788 Page 7 Art Unit: 1616 Application/Control Number: 18/755,788 Page 8 Art Unit: 1616 Application/Control Number: 18/755,788 Page 9 Art Unit: 1616 Application/Control Number: 18/755,788 Page 10 Art Unit: 1616 Application/Control Number: 18/755,788 Page 11 Art Unit: 1616 Application/Control Number: 18/755,788 Page 12 Art Unit: 1616 Application/Control Number: 18/755,788 Page 13 Art Unit: 1616 Application/Control Number: 18/755,788 Page 14 Art Unit: 1616 Application/Control Number: 18/755,788 Page 16 Art Unit: 1616 Application/Control Number: 18/755,788 Page 17 Art Unit: 1616 Application/Control Number: 18/755,788 Page 18 Art Unit: 1616 Application/Control Number: 18/755,788 Page 19 Art Unit: 1616 Application/Control Number: 18/755,788 Page 20 Art Unit: 1616 Application/Control Number: 18/755,788 Page 21 Art Unit: 1616 Application/Control Number: 18/755,788 Page 22 Art Unit: 1616
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