DETAILED ACTION
Applicants' arguments, filed 12/11/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Priority
The instant action claims domestic priority to PRO 63/151,091 filed on 2/19/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 12/16/2025 and 02/10/2026 both comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112 New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 10-13, 15-28, 31-32, 36 and 38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation of the previous claim 1 was less than 0.0006% which is 6ppm. The Applicant specification recites “While not wishing to being bound by theory, it is believed that abrasives that include high amounts of soluble metal ions are less compatible with peroxide due to reactivity between peroxide and metal ions. Thus, suitable sources of abrasives, such as calcium pyrophosphate, can comprise less than about 0.001%, less than about 0.00075%, less than about 0.0006%, less than about 0.0005%, or less than about 0.0001%, by weight of the abrasive. Additionally, the abrasive can be free of, substantially free of, or essentially free of soluble metal ions. Examples of trace metal ions that might be present in abrasives and have been previously reported to induce peroxide degradation include Cr, Mn, Fe, Co, Ni, Cu, Mo, and/or combinations thereof.” (Instant specification at page 8). Less than about 0.001%, less than about 0.00075%, less than about 0.0006%, less than about 0.0005%, or less than about 0.0001% are equivalent to less than 10ppm, less than 7.5ppm, less than 6ppm, less than 5 ppm, or less than 1ppm. There is no support to the best of the Examiner’s understanding in the specification or the claims for about 135 ppm to about 508ppm as in amended claim 1 or about 315ppm to about 240ppm as in claim 36. There is no support based on the original claim set and the instant specification for a range of 135ppm to 508ppm of the soluble metals which would produce peroxide degradation. Nor would there be any reason to provide a greater amount of a degradation agent. Table 1 provided Examples that were outside the range claimed in the instant claims and instant specification. The Examples of Table 1 with amounts of total soluble metal that are outside of the specified range of soluble metal recited in the specification does not provide a teaching that would overcome the direct limitation of the original claims or the instant specifications recitation of the limitation and its reasoning. As such claims 1 and 36 are presently new matter, as such the dependent claims 2-8, 10-13, 15-28, 31-33 and 38 are also new matter.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues that the examples of Table 1 overcome the teaching of the instant specification and the instant claims and provide sufficient support for a range of about 315 ppm to about 508 and a range of about 315ppm to about 240ppm.
The Examiner does not agree. The limitation of the previous claim 1 was less than 0.0006% which is 6ppm. The Applicant specification recites “While not wishing to being bound by theory, it is believed that abrasives that include high amounts of soluble metal ions are less compatible with peroxide due to reactivity between peroxide and metal ions. Thus, suitable sources of abrasives, such as calcium pyrophosphate, can comprise less than about 0.001%, less than about 0.00075%, less than about 0.0006%, less than about 0.0005%, or less than about 0.0001%, by weight of the abrasive. Additionally, the abrasive can be free of, substantially free of, or essentially free of soluble metal ions. Examples of trace metal ions that might be present in abrasives and have been previously reported to induce peroxide degradation include Cr, Mn, Fe, Co, Ni, Cu, Mo, and/or combinations thereof.” (Instant specification at page 8). Less than about 0.001%, less than about 0.00075%, less than about 0.0006%, less than about 0.0005%, or less than about 0.0001% are equivalent to less than 10ppm, less than 7.5ppm, less than 6ppm, less than 5 ppm, or less than 1ppm. There is no support to the best of the Examiner’s understanding in the specification or the claims for about 135 ppm to about 508ppm as in amended claim 1 or about 315ppm to about 240ppm as in claim 36. There is no support based on the original claim set and the instant specification for a range of 135ppm to 508ppm of the soluble metals which would produce peroxide degradation. Nor would there be any reason to provide a greater amount of a degradation agent. Table 1 provided Examples that were outside the range claimed in the instant claims and instant specification. The Examples of Table 1 with amounts of total soluble metal that are outside of the specified range of soluble metal recited in the specification does not provide a teaching that would overcome the direct limitation of the original claims or the instant specifications recitation of the limitation and its reasoning. As such the Applicant’s arguments are not persuasive and the rejection is maintained.
Claim Rejections - 35 USC § 103
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 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.
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.
A) Claims 1-8, 10-13, 15-17, 20-28, 31-32, 35-36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Midha et al. (US Patent Application Publication 2017/0027849) in view of Broge et al (US Patent 2,876,168A).
Midha teaches an oral care composition comprising peroxide (Midha at [0077]), water (Midha at [0072]), calcium pyrophosphate (Midha at [0095]), sodium lauryl sulfate (Midha at [0062]), 2-acrylamido-2-methylpropane sulfonic acid polymer, stannous fluoride (Midha at [0066]), stearyl alcohol (Midha at [0059]), zinc citrate (Midha at [0067]). Midha recites the use of sodium monofluorophosphate (Midha at claim 1).
The teachings of Midha differ from instant claim 1 insofar as they do not teach the ratio between gamma and beta phases of calcium pyrophosphate. The teachings of Borge cure this deficit.
Borge recites a dentifrice comprising a sudsing agent and an abrasive, said abrasive comprising particles of calcium pyrophosphate, from 10% to 50% of said calcium pyrophosphate being in the beta phase and the balance being substantially in the gamma phase (Borge at claim 5). Borge teaches that this composition of calcium pyrophosphate has a better cleaning ability than other forms of calcium pyrophosphate (Borge whole document).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Midha et al. disclose wherein the dentifrice composition comprises calcium pyrophosphate, but does not disclose a ratio between gamma and beta phase within the calcium pyrophosphate. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the calcium pyrophosphate of Midha et al. to have abrasive comprising particles of calcium pyrophosphate, from 10% to 50% of said calcium pyrophosphate being in the beta phase and the balance being substantially in the gamma phase used in dentifrice compositions for the benefit of cleaning as taught by Borge.
Regarding instant claim 1, Midha teaches an oral care composition comprising peroxide, water, and calcium pyrophosphate. Midha teaches the use of calcium pyrophosphate, which would have the inherent properties of calcium pyrophosphate including pH. When the prior art reference teaches the identical structure or acts but is silent about performing the claimed function, a reasonable presumption is that the prior art structure inherently performs the same function. See MPEP 2112.Therefore if the identical calcium pyrophosphate of Midha was used in the slurry pH procedure it would inherently have the same end result pH. Borge recites a dentifrice comprising a sudsing agent and an abrasive, said abrasive comprising particles of calcium pyrophosphate, from 10% to 50% of said calcium pyrophosphate being in the beta phase and the balance being substantially in the gamma phase (Borge at claim 5), which overlaps with the instantly claimed range for the ratio of gamma to beta phase calcium pyrophosphate of at least 1.04. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Borge teaches that this composition of calcium pyrophosphate has a better cleaning ability than other forms of calcium pyrophosphate (Borge whole document). One would be motivated to use this ratio for the benefit of improved cleaning. Midha recites an oral care composition comprising an abrasive which may be calcium pyrophosphate (Midha at [0095]), calcium pyrophosphate (Ca2P2O7) would have the same amount of Cr, Mn, Fe, Co, Ni, or Cu as the calcium pyrophosphate of the instant claimed invention. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP2112.01(I). Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(II). Midha teaches the use of zinc peroxide, urea peroxide, calcium peroxide, hydrogen peroxide, and sodium peroxide (Midha at [0077]). Midha teaches about the Peroxide Stability Test and provides examples which retain the majority of their peroxide after long periods of time at high temperatures (Midha at [0048-0053]). Midha further teaches the addition of polymers to improve the stability of the peroxide (Midha at [0048]). It would have been prima facie obvious to one of ordinary skill in the art to optimize the components of the composition for the desired stability at intended storage conditions. While the prior art tested peroxide stability at lower temperatures and for a longer period of time, there would have been a reasonable expectation that the claimed composition would have remained stable under the recited conditions. See MPEP 2144.05(II).
Regarding instant claim 2, Midha teaches the use of zinc peroxide, urea peroxide, calcium peroxide, hydrogen peroxide, and sodium peroxide (Midha at [0077]).
Regarding instant claim 3, Midha teaches that the oral care composition can comprise about 1% to about 10% peroxide (Midha at [0077]) which overlaps with the instantly claimed range of at least about 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 4, Midha teaches that the oral care composition can comprise about 1% to about 10% peroxide (Midha at [0077]) which overlaps with the instantly claimed range of at least about 3%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 5, Midha teaches that the oral care composition can comprise about 1% to about 10% peroxide (Midha at [0077]) which overlaps with the instantly claimed range of at least about 3.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 6, Midha teaches that the oral care composition can comprise about 5% to about 80% water (Midha at [0072]) which overlaps with the instantly claimed range of 1% to 30%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 7, Midha teaches that the oral care composition can comprise about 6% to about 70% calcium pyrophosphate (Midha at [0095]) which overlaps with the instantly claimed range of 1% to 30%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 8, Midha teaches that the oral care composition can comprise about 6% to about 70% calcium pyrophosphate (Midha at [0095]) which overlaps with the instantly claimed range of 1% to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 10, Midha teaches that the oral care composition may be a dentifrice ([0009]).
Regarding instant claim 11, Midha teaches the use of stannous fluoride (Midha at [0066]).
Regarding instant claim 12, Midha teaches the use of stannous chloride and sodium monofluorophosphate (Midha at [0007], [0064]).
Regarding instant claim 13, Midha teaches the use of.
Regarding instant claim 14, Midha teaches the use of zinc lactate, zinc phosphate, and zinc citrate (Midha at [0067]).
Regarding instant claim 15, Midha teaches the use of zinc lactate, zinc phosphate, and zinc citrate (Midha at [0067]).
Regarding instant claim 16, Midha teaches the use of stannous chloride and stannous fluoride (Midha at [0066]).
Regarding instant claim 17, Midha teaches the use of zinc lactate, zinc phosphate, and zinc citrate (Midha at [0067]).
Regarding instant claim 20, Midha teaches the use of sodium lauryl sulfate (Midha at [0062]).
Regarding instant claim 21, Midha teaches the use of sodium lauryl sulfate at 1.5 weight percent in examples 9 and 10 (Midha at [0112-0113]). This 1.5 wt% overlaps with the instantly claimed about 1.5%.
Regarding instant claim 22, Midha teaches the use of sodium lauryl sulfate at 1.56 weight percent in examples 6 (Midha at [0112-0113]) due to the fact that Lanette® is 10% sodium lauryl sulfate (Midha at [0046]). This 1.56 wt% overlaps with the instantly claimed greater than about 1.5%.
Regarding instant claim 23, Midha teaches the use of sodium lauryl sulfate (Midha at [0062]).
Regarding instant claim 24, Midha teaches the use of sodium lauryl sulfate (Midha at [0062]).
Regarding instant claim 25, Midha teaches the use of 2-acrylamido-2-methylpropane sulfonic acid polymers, copolymers, or cross polymers (Midha whole document).
Regarding instant claim 26, Midha teaches the use of 2-acrylamido-2-methylpropane sulfonic acid polymers, copolymers, or cross polymers (Midha whole document).
Regarding instant claim 27, Midha teaches the use of 2-acrylamido-2-methylpropane sulfonic acid polymers, copolymers, or cross polymers (Midha whole document).
Regarding instant claim 28, Midha teaches the use of 2-acrylamido-2-methylpropane sulfonic acid polymers, copolymers, or cross polymers (Midha whole document).
Regarding instant claim 31, Midha teaches the use of stearyl alcohol and cetyl alcohol (Midha at [0059]).
Regarding instant claim 32, Midha teaches the use of stearyl alcohol and cetyl alcohol (Midha at [0059]).
Regarding instant claim 35, Midha teaches an oral care composition comprising peroxide, water, and calcium pyrophosphate. Midha recites the use of sodium monofluorophosphate (Midha at claim 1). Midha teaches the use of calcium pyrophosphate, which would have the inherent properties of calcium pyrophosphate including pH. When the prior art reference teaches the identical structure or acts but is silent about performing the claimed function, a reasonable presumption is that the prior art structure inherently performs the same function. See MPEP 2112.Therefore if the identical calcium pyrophosphate of Midha was used in the slurry pH procedure it would inherently have the same end result pH. Borge recites a dentifrice comprising a sudsing agent and an abrasive, said abrasive comprising particles of calcium pyrophosphate, from 10% to 50% of said calcium pyrophosphate being in the beta phase and the balance being substantially in the gamma phase (Borge at claim 5), which overlaps with the instantly claimed range for the ratio of gamma to beta phase calcium pyrophosphate of at least about 1.06. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Borge teaches that this composition of calcium pyrophosphate has a better cleaning ability than other forms of calcium pyrophosphate (Borge whole document). One would be motivated to use this ratio for the benefit of improved cleaning. Midha teaches the use of zinc peroxide, urea peroxide, calcium peroxide, hydrogen peroxide, and sodium peroxide (Midha at [0077]). Midha teaches about the Peroxide Stability Test and provides examples which retain the majority of their peroxide after long periods of time at high temperatures (Midha at [0048-0053]). Midha further teaches the addition of polymers to improve the stability of the peroxide (Midha at [0048]). It would have been prima facie obvious to one of ordinary skill in the art to optimize the components of the composition for the desired stability at intended storage conditions. While the prior art tested peroxide stability at lower temperatures and for a longer period of time, there would have been a reasonable expectation that the claimed composition would have remained stable under the recited conditions. See MPEP 2144.05(II).
Regarding instant claim 36, Midha recites an oral care composition comprising an abrasive which may be calcium pyrophosphate (Midha at [0095]), calcium pyrophosphate (Ca2P2O7) would have the same amount of Cr, Mn, Fe, Co, Ni, or Cu as the calcium pyrophosphate of the instant claimed invention. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP2112.01(I). Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(II).
Regarding instant claim 38, Midha et al. disclose wherein the dentifrice composition comprises calcium pyrophosphate, but does not disclose a ratio between gamma and beta phase within the calcium pyrophosphate. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the calcium pyrophosphate of Midha et al. to have abrasive comprising particles of calcium pyrophosphate, from 10% to 50% of said calcium pyrophosphate being in the beta phase and the balance being substantially in the gamma phase used in dentifrice compositions for the benefit of cleaning as taught by Borge. This ratio would overlap the instantly claimed range of 1.06 to 1.31. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
B) Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Midha et al. (US Patent Application Publication 2017/0027849) and Broge et al (US Patent 2,876,168A) as applied to claims 1-8, 10-13, 15-17, 20-28, 31-32, 35-36 and 38 above, and further in view of Deckner et al. (US Patent Application Publication 2012/0219606).
The teachings of Midha and Borge are discussed above.
The combined teachings of Midha and Borge differ from instant claim 18 insofar as they do not specifically disclose the use of an amino acid. The teachings of deckner cure this deficit.
Deckner teaches an oral care composition comprising arginine (Deckner at [0085], [0120]), peroxide (Deckner at [0108-0109]), water (Deckner at [0033]), calcium pyrophosphate (Deckner at [0083], [0091], [0094]), stannous fluoride (Deckner at [0102]), zinc (Deckner at [0190]), stearyl alcohol (Deckner at [0165]), and sodium lauryl sulfate (Deckner at [0171]). Deckner further teaches the use of arginine as an anti-sensitivity agent (Deckner at [0085]) and an antibacterial agent (Deckner at [0120]).
One would have been motivated to have added arginine to the composition of Midha for the benefit of the anti-sensitivity and antibacterial properties of arginine.
It would have been prima facie obvious to have combined the arginine of Deckner with zinc salts of Midha for the predictable result of an oral care composition with antibacterial and anti-sensitivity properties. Midha teaches that metal salts have a wide range of functions from antimicrobial agents to sensitivity agents (Midha at [0064]). Deckner further teaches the use of arginine as an anti-sensitivity agent (Deckner at [0085]) and an antibacterial agent (Deckner at [0120]). See MPEP §2144.05(I). There would be have been a reasonable expectation of success because both compositions teach compositions comprised of similar reagents.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues that the limitation with regards to the soluble metal present in calcium pyrophosphate are not met therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. See the 112a New Matter rejection above. Further, Midha recites an oral care composition comprising an abrasive which may be calcium pyrophosphate (Midha at [0095]), calcium pyrophosphate (Ca2P2O7) would have the same amount of Cr, Mn, Fe, Co, Ni, or Cu as the calcium pyrophosphate of the instant claimed invention. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP2112.01(I). Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(II). As such the Applicant’s arguments are not persuasive and the rejection stands.
Applicant argues that Table 1 provides unexpected results that overcome the obviousness rejection. Therefore, the obviousness rejection should be withdrawn.
The Examiner does not agree. See 112a New Matter rejection supra. The limitation of the previous claim 1 was less than 0.0006% which is 6ppm. The Applicant specification recites “While not wishing to being bound by theory, it is believed that abrasives that include high amounts of soluble metal ions are less compatible with peroxide due to reactivity between peroxide and metal ions. Thus, suitable sources of abrasives, such as calcium pyrophosphate, can comprise less than about 0.001%, less than about 0.00075%, less than about 0.0006%, less than about 0.0005%, or less than about 0.0001%, by weight of the abrasive. Additionally, the abrasive can be free of, substantially free of, or essentially free of soluble metal ions. Examples of trace metal ions that might be present in abrasives and have been previously reported to induce peroxide degradation include Cr, Mn, Fe, Co, Ni, Cu, Mo, and/or combinations thereof.” (Instant specification at page 8). Less than about 0.001%, less than about 0.00075%, less than about 0.0006%, less than about 0.0005%, or less than about 0.0001% are equivalent to less than 10ppm, less than 7.5ppm, less than 6ppm, less than 5 ppm, or less than 1ppm. The Examples of Table 1 do not fall within the instantly claimed specification or claim limitations and therefore do not have a nexus with the instant claims. As such, the Applicant’s arguments are not persuasive and the obviousness rejections are maintained.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
B1) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8,551,457 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A), and Deckner et al. (US Patent Application Publication 2012/0219606).
US Patent 8,551,457 recites an oral care composition (8,551,457 at claim 1) wherein the abrasive is a fused silica (8,551,457 at claim1). US Patent 8,551,457 further recites that composition further comprises peroxide sources, fluoride ion sources, other abrasive materials, and water (8,551,457 at claim15). US Patent 8,551,457 further recites that composition further comprises stannous ions (8,551,457 at claim 1). Fused silica does not include Cr, Mn, Fe, Co, Ni, or Cu.
The teachings of US Patent 8,551,457 differ from that of claim 1 insofar as they do not recite the specific additional abrasive, nor do they disclose the gamma to beta ratio of said abrasive material. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Broge, and Deckner with the abrasive composition of US Patent 8,551,457 for the predictable result of an oral care composition comprising abrasives, water and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the additional abrasive of US Patent 8,551,457 for the benefit of the superior cleaning. One would be motivated to combine the composition of US Patent 8,551,457 for the benefit of the high pellicle cleaning ratio provided by the fused silica which would increase the cleaning capability of the composition.
B2) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,114,095 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
U.S. Patent No. 9,114,095 recites a dentifrice (9,114,095 at claim 1) comprising a peroxide (9,114,095 at claim 3), calcium pyrophosphate (9,114,095 at claim 10), and water (9,114,095 at claim 9). U.S. Patent No. 9,114,095 further recites a polymethylsilsesquioxane abrasive (9,114,095 at claim 1). U.S. Patent No. 9,114,095 recites the use of hydrogen peroxide (9,114,095 at claim 3), a pH of about 3.5 to about 7.5(9,114,095 at claim 5), stannous fluoride (9,114,095 at claim 12), and zinc fluoride (9,114,095 at claim 12). (9,114,095 at claim 16)
The teachings of US Patent 9,114,095 differ from that of claim 1 insofar as they do not recite the specific gamma to beta ratio of calcium pyrophosphate. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra. It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Borge, and Deckner with the abrasive composition of US Patent 9,114,095 for the predictable result of an oral care composition comprising calcium pyrophosphate abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Broge, and Deckner as the additional abrasive of US Patent 9,114,095 for the benefit of the superior cleaning.
B3) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,192,563 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
U.S. Patent No. 9,192,563 recites a dentifrice (9,192,563 at claim1) comprising a polymethylsilsesquioxane abrasive (9,192,563 at claim 1), water (9,192,563 at claim 1), and hydrogen peroxide (9,192,563 at claim 9). U.S. Patent No. 9,192,563 further recites the use of calcium pyrophosphate (9,192,563 at claim 10), stannous fluoride (9,192,563 at claim 9), and monofluorophosphate (9,192,563 at claim 9).
The teachings of US Patent 9,192,563 differ from that of claim 1 insofar as they do not recite the specific gamma to beta ratio of the calcium pyrophospahte. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra. It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Broge, and Deckner with the abrasive composition of US Patent 9,192,563 for the predictable result of an oral care composition comprising calcium pyrophosphate abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the abrasive of US Patent 9,192,563 for the benefit of the superior cleaning.
B4) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,017,647 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
U.S. Patent No. 9,017,647 recites an oral care composition comprising a polyorganosilsesquioxane particle abrasive, a gel network (which include water based on the definitions within the specification), calcium pyrophosphate (9,017,647 at claim 16), and hydrogen peroxide (9,017,647 at claim 14). U.S. Patent 9,017,647 further specifies the use of water (9,017,647 at claim 15), stearyl alcohol (9,017,647 at claim 8), sodium lauryl sulfate (9,017,647 at claim 11), stannous fluoride (9,017,647 at claim 14), and zinc fluoride (9,017,647 at claim 20).
The teachings of US Patent 9,017,647 differ from that of claim 1 insofar as they do not recite the specific gamma to beta ratio of the calcium pyrophosphate. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra. It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Borge, and Deckner with the abrasive composition of US Patent 9,017,647 for the predictable result of an oral care composition comprising calcium pyrophosphate abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the abrasive of US Patent 9,017,647 for the benefit of the superior cleaning.
B5) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-23 of U.S. Patent No. 9,393,188 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
U.S. Patent. 9,393,188 recites a dentifrice (9,393,188 at claim 1) comprising peroxide (9,393,188 at claim 1), water (9,393,188 at claim 1), and an abrasive (9,393,188 at claim 1). U.S. Patent. 9,393,188 recites a dentifrice (9,393,188 at claim 1) comprising stannous fluoride (9,393,188 at claim 1), sodium monofluoride (9,393,188 at claim 1), stearyl alcohol (9,393,188 at claim 2), and sodium lauryl sulfate (9,393,188 at claim 7).
The teachings of US Patent 9,393,188 differ from that of claim 1 insofar as they do not recite a specific abrasive material. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Borge, and Deckner with the abrasive composition of US Patent 9,393,188 for the predictable result of an oral care composition comprising abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the abrasive of US Patent 9,393,188 for the benefit of the superior cleaning capacity.
B6) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,925,820 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
US Patent 10,925,820 recites an oral care composition comprising an abrasive (10,925,820 at claim 15), water (10,925,820 at claim 15), and peroxide (10,925,820 at claim 18). US Patent 10,925,820 further recites the use of sodium monofluoride (10,925,820 at claim 15), stannous fluoride (10,925,820 at claim 15), and stearyl alcohol (10,925,820 at claim 16).
The teachings of US Patent 10,925,820 differ from that of claim 1 insofar as they do not recite a specific abrasive material. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Borge, and Deckner with the abrasive composition of US Patent 10,925,820 for the predictable result of an oral care composition comprising abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the abrasive of US Patent 10,925,820 for the benefit of the superior cleaning capacity.
B7) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,765,610 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
U.S. Patent 10,765,610 recites an oral care composition comprising peroxide (10,765,610 at claim 1), an abrasive (10,765,610 at claim 1) and water (10,765,610 at claim 6). U.S. Patent 10,765,610 further recites that the abrasive may be calcium pyrophosphate (10,765,610 at claim 8). U.S. Patent 10,765,610 further recites the use of stearyl alcohol (10,765,610 at claim 1), sodium lauryl sulfate (10,765,610 at claim 1), zinc peroxide (10,765,610 at claim 1), stannous fluoride (10,765,610 at claim 1), and sodium monofluorophosphate (10,765,610 at claim 1).
The teachings of US Patent 10,765,610 differ from that of claim 1 insofar as they do not recite the specific gamma to beta ratio of the calcium pyrophosphate abrasive material. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Borge, and Deckner with the abrasive composition of US Patent 10,765,610 for the predictable result of an oral care composition comprising calcium pyrophosphate abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the abrasive of US Patent 10,765,610 for the benefit of the superior cleaning capacity.
B8) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,219,988 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
US Patent 10,219,988 recites an oral care composition comprising water (10,219,988 at claims 6 and 8), peroxide (10,219,988 at claim 8), and abrasive (10,219,988 at claims 1 and 8). U.S. Patent 10,219,988 further recites the use of stannous fluoride (10,219,988 at claim1), sodium monofluorophosphate (10,219,988 at claim 1), and stearyl alcohol (10,219,988 at claim 4).
The teachings of US Patent 10,219,988 differ from that of claim 1 insofar as they do not recite a specific abrasive material. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the abrasive compositions of Midha, Borge, and Deckner with the abrasive composition of US Patent 10,219,988 for the predictable result of an oral care composition comprising abrasives, water, and peroxide. One would be motived to use the calcium pyrophosphate of Midha, Borge, and Deckner as the abrasive of US Patent 10,219,988 for the benefit of the superior cleaning.
C1) Claims 1-8, 10-13, 15-28, 31-32, 35-36 and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 11-24, 26-27, and 34-36 of copending Application No. 17/577,399 in view of Midha et al. (US Patent Application Publication 2017/0027849), Broge et al (US Patent 2,876,168A) and Deckner et al. (US Patent Application Publication 2012/0219606).
The instant application recites an oral care composition comprising: (a) peroxide; (b) abrasive; and (c) water, wherein the abrasive comprises less than about 0.0006%, by weight of the oral care composition, of soluble metal selected from the group consisting of Cr, Mn, Fe, Co, Ni, Cu, and combinations thereof. The instant application further recites wherein the ratio of gamma phase calcium pyrophosphate to beta phase calcium pyrophosphate is at least about 1.
17/577,399 recites an oral care composition comprising peroxide and more specifically at least 1%, at least 3% or at least 3.5% hydrogen peroxide (17/577,399 at claims 1-5). 17/577,399 recites an oral care composition comprising water and more specifically about 5% to about 60%, water (17/577,399 at claim 1). 17/577,399 recites the use of calcium pyrophosphate, and more specifically 1-30% or 1-15% calcium pyrophosphate wherein the calcium pyrophosphate has a ratio of gamma phase calcium pyrophosphate to beta phase calcium pyrophosphate of at least about 1 (17/577,399 at claims 6-9). 17/577,399 recited that the oral care composition is a dentifrice (17/577,399 at claim 10). 17/577,399 further recites the use of the fluoride source sodium monofluorophosphate (17/577,399 at claims 11-13), the tin source stannous chloride (17/577,399 at claims 14-16), and the zinc source zinc oxide (17/577,399 at claims 14-15 and 17). 17/577,399 further recites the use of amino acids including arginine (17/577,399 at claims 18-19), 2- acrylamido-2-methylpropane sulfonic acid polymer (17/577,399 at claims 25-28), and stearyl alcohol (17/577,399 at claim 29). 17/577,399 further recites the use of more than 1.5% sodium lauryl sulfate (17/577,399 at claims 20-24).
The teachings of US Patent application 17/577,399 differ from that of claim 1 insofar as they do not recite that the peroxide is soluble in water. The teachings of Midha, Borge, and Deckner cure these deficits.
The combined teachings of Medha, Borge and Deckner are discussed in the obviousness rejections supra.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the peroxide of Midha, Borge, and Deckner with the peroxide composition of 17/577,399 for the predictable result of an oral care composition comprising abrasives, water, and peroxide. One would be motived to use the peroxide of Midha, Borge, and Deckner as the peroxide of 17/577,399 for the benefit of the superior water solubility given that the composition of 17/57,7399 is from 5% to 60% water. This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues that the limitation of claims is not addressed by Midha, Borge, and Deckner nor is it addressed by the reference applicants and therefore the double patenting obviousness rejections should be withdrawn.
The Examiner does not agree. See the 112a New Matter rejection above. Further, Midha recites an oral care composition comprising an abrasive which may be calcium pyrophosphate (Midha at [0095]), calcium pyrophosphate (Ca2P2O7) would have the same amount of Cr, Mn, Fe, Co, Ni, or Cu as the calcium pyrophosphate of the instant claimed invention. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP2112.01(I). Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01(II). As such the Applicant’s arguments are not persuasive and the rejection stands.
Applicant states that upon indication of allowable subject matter but for the non-statutory obviousness-type double patenting rejection, Applicant will consider filing a terminal disclaimer if necessary.
Since terminal disclaimers have not yet been filed, the non-statutory double patenting rejections are maintained.
Conclusion
No claims are presently allowable.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612