DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-8 are pending and under examination.
Priority
This application is a continuation of 15/548,468 filed on 8/3/2017, which is a national stage entry of PCT/CN2016/086995 filed on 6/24/2016, which claims priority from US provisional application 62/187,801 filed on 7/1/2015.
Objections/Rejections Withdrawn
The objection over claims 1, 6 and 8 is withdrawn as applicant has amended the claims.
The objection over claim 6 is withdrawn per applicant’s amendments.
The objection over claim 7 is withdrawn per applicant’s amendment.
The rejection under USC 112(b) over claim 1 and claims 2-5, 7 and 8 is withdrawn per applicant’s amendment to claim 1 to add “and”.
The rejection under USC 112(b) over claim 7 is withdrawn per applicant’s amendment to the claim.
The rejections under USC 112(b) over claim 8 are withdrawn per applicant’s amendment to the claim.
The rejection over double patenting over application 17/675,409 is withdrawn as this copending application is now abandoned.
As these rejections are withdrawn, applicant’s arguments toward these noted rejections are now moot.
Maintained Rejections – Modified As Necessitated by Amendment
It is noted that applicant has amended claim 1 to remove the fluoride source from this claim. The examiner considered the claim with this change in scope.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson US20130224270, Porter US20130017240 and Gaffar US4138477.
Robinson teaches an oral care composition with basic amino acid or salt thereof that may also include zinc salts including zinc citrate in embodiments (abstract and compositions 1.0.51 and 1.0.58). Robinson teaches an effective amount of a fluoride source (claim 4 of Robinson). Robinson teaches arginine bicarbonate as a salt of arginine (claim 5 of Robinson). Robinson teaches 1% to 15% of total composition weight of basic amino acid or salt thereof (claim 6 of Robinson). Robinson teaches fluoride source amounts of 0.1 to 2 wt% (composition 1.0.27). Robinson teaches sodium fluoride (composition 1.0.24 and paragraphs 136 and 138). Robinson teaches glycerin as humectant (composition 1.0.44 and paragraph 169). Robinson teaches 30% to 65% by weight of humectant (paragraph 168). Robinson teaches L-arginine (composition 1.0.5). Robinson teaches toothpaste (composition 1.0.69 or 1.0.70, paragraph 110). Paragraph 111 provides for 20-35 wt% humectants and 0.3-2 wt% of soluble fluoride salt. Paragraphs 111-126 provide for the functions of the compositions to improve oral health when administered to the oral cavity including reducing or inhibiting formation of dental caries, repairing or inhibiting pre-carious lesions, reducing or inhibiting demineralization, reducing or inhibiting gingivitis, whitening teeth, reducing plaque, and immunizing or protecting teeth against cariogenic bacteria among others. Other forms of the composition are provided such as gels, mouth rinses, sprays and chewing gum (paragraph 181).
Robinson teaches metal ion salts including zinc salts including zinc citrate, but does not include zinc oxide as an option. Robinson does not teach an amount of zinc citrate, but Robinson allows for zinc citrate as a zinc salt in embodiments.
Porter teaches an oral care composition with acceptable vehicle that includes a metal oxide including zinc oxide (claims 1 and 4 of Porter). Porter teaches up to 5% by weight of metal oxide and also a range of 0.5 to 2% (claims 6 and 7 of Porter, also paragraphs of 14-17 and 104 with 1 wt% zinc oxide). Porter teaches L-arginine (claims 9-11 of Porter). Porter teaches a formulation with sodium fluoride, L-arginine and zinc oxide (paragraph 105). Porter teaches arginine bicarbonate (paragraph 33). Paragraph 4 of Porter provides that zinc salts are a known approach to treat or ameliorate tooth sensitivity. Porter teaches zinc ion agent as another agent to use in the formulation (paragraph 102). Porter also teaches toothpastes and gel (claim 22 of Porter). Paragraph 95 teaches humectant including glycerin. Porter recognizes that zinc oxide is an antiplaque and anti-calculus agent with dual functions of occlusion of dentin tubules and providing an antiplaque/anticalculus effect (paragraph 53).
Gaffar teaches novel compositions to prevent and control mouth odor, which is also effective in preventing calculus, plaque, caries and periodontal disease that would include zinc compound (abstract). Gaffar teaches zinc citrate and zinc oxide in a table of zinc compounds (column 4). Gaffar teaches 0.01 to 5% or 0.025 to 1% by weight of zinc compound in the oral composition (column 4, lines 39-41). Column 1 of Gaffar provides that zinc salts like zinc citrate are used for anti-calculus and anti-plaque effects. Gaffar also teaches fluorine containing compounds like sodium fluoride (column 10). Gaffar teaches that opaque vehicles typically contain 15-35% of glycerine (column 8, lines 29-31). Example 2 of Gaffar provides a zinc oxide paste.
One of ordinary skill in the art before the time of filing would have including zinc oxide from oral care/dental formulations of Porter into formulations and methods taught by Robinson as the zinc oxide particles are seen as Porter sees the dental treatment effects of zinc oxides such as antiplaque and anti-calculus activity. Each of Robinson, Porter and Gaffar are also to dental formulations such as toothpastes for treatment of teeth and gums that can included fluoride and arginine, which allows one of ordinary skill in the art to use such ingredients known for such formulations and methods (seem MPEP 2144.06). Thus, there was a reasonable expectation of success in adding zinc oxide into formulations of Robinson to obtain a dental formulation that has the added dental benefits of zinc oxide. Robinson, Gaffar and Porter provide for overlapping amounts of ingredients with the instantly claimed ranges allowing one of ordinary skill in the art to work within such ranges of zinc citrate, zinc oxide, fluoride source like NaF, arginine or salt thereof, and glycerin humectant to formulate other compositions for dental use (see MPEP 2144.05).
Claims 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575) and Porter US20130017240.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98).
Robinson ‘575 does not indicate whether the arginine is L-arginine and does not provide for amounts of the arginine as in the claim.
Porter teaches an oral care composition with acceptable vehicle that includes a metal oxide including zinc oxide (claims 1 and 4 of Porter). Porter teaches up to 5% by weight of metal oxide and also a range of 0.5 to 2% (claims 6 and 7 of Porter, also paragraphs of 14-17 and 104 with 1 wt% zinc oxide). Porter teaches L-arginine (claims 9-11 of Porter). Porter teaches a formulation with sodium fluoride, L-arginine and zinc oxide (paragraph 105). Porter teaches arginine bicarbonate (paragraph 33). Paragraph 4 of Porter provides that zinc salts are a known approach to treat or ameliorate tooth sensitivity. Porter teaches zinc ion agent as another agent to use in the formulation (paragraph 102). Porter also teaches toothpastes and gel (claim 22 of Porter). Paragraph 95 teaches humectant including glycerin. Porter recognizes that zinc oxide is an antiplaque and anti-calculus agent with dual functions of occlusion of dentin tubules and providing an antiplaque/anticalculus effect (paragraph 53). Porter teaches 0.5 to 5% by weight of the amino acid (paragraphs 19-22).
One of ordinary skill in the art before the time of filing would have included arginine like L-arginine or salts thereof in concentrations taught by Porter as these were acceptable amounts for oral care compositions that also had zinc oxide into oral care compositions of Robinson ‘575, which is noted to have zinc oxide as well as arginine or a salt thereof. There would be a reasonable expectation of success in combining the teachings of Robinson ‘575 and Porter to produce an effective oral care composition that will effectively take care of ones teeth and gums. As the prior art provides for ranges and amounts within or overlapping with applicant’s claimed ranges, it allows one of ordinary skill in the art to use such amounts and ranges of the listed ingredients in optimizing dental formulations (see MPEP 2144.05).
Response to Applicant’s Arguments over the Rejections under USC 103
The first response is toward the rejection over Robinson (‘270), Porter and Gaffar.
Applicant argues that the prior art does not provide for glycerin alone, but instead with other humectants. Robinson ‘270 allows for glycerin as an option of humectant, and thus, one of ordinary skill in the art would choose glycerin as the humectant as being an option of the prior art.
Applicant argues that there is no articulation of why glycerin would be chosen as the sole humectant. The reason is that it is an alternative embodiment of humectant presented by the prior art (see MPEP 2123). Additionally, when Robinson ‘270 provides for teachings of humectants and amounts thereof, it provides them with the genus of humectant, which allows one of ordinary skill in the art to select a species as taught by the reference.
Applicant argues that there are unexpected results in regards to using glycerin rather than humectant combinations for improving foam generation. Applicants argue “Formulas C (Glycerin 26% by wt.) and D (Glycerin 35% by wt.) as having increased foam volume compared to Formula B (not Formula E or Formula A). Formula B contains the same amount of humectant (i.e., 20%-35% by wt.) as disclosed in all of exemplary formulations listed in paragraphs 110-111 of Robinson ‘270 in view of glycerin as one of two options in 1.0.44 of paragraph 69 of ‘270. However, applicant argues the Examiner has not demonstrated a specific reason or motivation from Robinson ‘270 to use the amount of glycerin with glyercin being the sole humectant, while reducing or removing the sorbitol — much less that doing so would yield surprising and unexpected technical benefits in terms of foam volume and density that are demonstrated in the Applicant’s specification. Accordingly, as the Examiner has not demonstrated a reason or motivation to modify Robinson ‘270 —i.e., to use glycerin in an amount of 35% as sole humectant, as required by the claimed invention — the amended claims are novel and inventive.
Examiner disagrees. Applicants point to Formulas C and D as having higher foam volumes than Example B, but provide no explanation or nexus to the pending claims. The amounts listed in the description of the composition do not add up to 100% (Formula A-51%, Formula B- 43%, Formula C-42%, Formula D-38%), and it is not clear if/which additional ingredients are present. Since fluoride is not listed as a component in any of the compositions, it appears none of the formulations tested fall within the scope of the pending claims. Further, it is noted that only Formula D has glycerin as the sole humectant. Applicants have the burden of explaining the unexpected results and Applicants have not explained how disclosing only 38% of a single composition could be considered to provide an unexpected result over the cited prior art, particularly when the test does not include the prior art composition. See MPEP 716.02(b). Since Applicants have not met the burden placed upon them for overcoming a prima facie case of obviousness, their argument for unexpected results is found unpersuasive.
Applicants argue that a trend is established by using the “net humectant” in formulas A-D. The amount of “net humectant” is tightly controlled for, and merely ranges from 34-35.1 on the high end. Given the small differences in new humectant percentage, Applicants data should be sufficient to show a trend to increased foam volume and density as the amount of glycerin is adjusted.
Examiner disagrees. Robinson ‘270 allows for the option of glycerin alone to allow it to be the sole humectant. Note that Porter and Gaffar are motivating zinc oxide and amounts of zinc compounds, but the argument is toward the type of humectant used. Based on Applicants argument, it is not clear whether the alleged trend is based on the amount of glycerin or the “net humectant”. Regardless, Examiner is unable to find any trend in the data. Where only 38-51% of the components in the compositions tested are reported, no conclusions can be drawn. For example, a skilled artisan would expect more foaming where a foaming agent is present in the unreported 49-62% of the tested compositions. It is also noted that Applicants have not compared the test data to the closest prior art as set forth in 716.02(b)(III). As such, Applicants have not met their burden to demonstrating unexpected results. Applicants argument is found unpersuasive.
Applicants allege that Examiner has not indicated why Applicants results with respect to improved foaming observed would have been expected or predicted with the inclusion of glycerin at the amount instantly recited, so the rejection should be withdrawn.
Examiner disagrees. Examiner burden is to demonstrate a prima facie case of obviousness. As discussed above, a skilled artisan would have found it prima facie obvious to pick from among the components and amounts set forth in Robinson ‘270 with teachings of Porter and Gaffar to predictably formulate an oral care composition. See MPEP 2143(I)(A). Thus a prima facie case of obviousness is established. Applicants have the burden of establishing an unexpected result using objective evidence. MPEP 716.01(a). Applicants counsel has declared that foaming is “improved” in the tested compositions. However, Applicants have not compared these compositions to the prior art compositions, so it is not clear what the tested compositions are improved relative to. Attorney arguments cannot take the place of evidence. See MPEP 716.01(c). Further, Applicants have only reported a fraction of what is contained in these tested compositions (Table 1). Thus, Applicants have not met the burden placed on them by MPEP 716.02(b), so their argument for unexpected results is unpersuasive.
The first response is toward the rejection over Robinson (‘575) and Porter.
Applicant argues that the prior art does not provide for glycerin alone, but instead with other humectants. Robinson ‘575 allows for glycerin as an option of humectant, and thus, one of ordinary skill in the art would choose glycerin as the humectant as being an option of the prior art.
Applicant argues that there is no articulation of why glycerin would be chosen as the sole humectant. The reason is that it is an alternative embodiment of humectant presented by the prior art (see MPEP 2123). Additionally, when Robinson ‘575 provides for teachings of humectants and amounts thereof, it provides them with the genus of humectant, which allows one of ordinary skill in the art to select a species as taught by the reference. Particularly as ‘575 does provide the use of glycerin as the humectant in its teachings (see paragraph 73 of ‘575 for example).
Applicant argues that there are unexpected results in regards to using glycerin rather than humectant combinations for improving foam generation. Applicants argue “Formulas C (Glycerin 26% by wt.) and D (Glycerin 35% by wt.) as having increased foam volume compared to Formula B (not Formula E or Formula A). Formula B contains the same amount of humectant (i.e., 15%-35% by wt.) as disclosed in all of exemplary formulations listed in paragraph 109 (composition with arginine bicarbonate, zinc citrate and zinc oxide) with teachings in paragraphs 70 and 73 of using glycerin as the humectant. However, applicant argues the Examiner has not demonstrated a specific reason or motivation from Robinson ‘575 to use the amount of glycerin with glyercin being the sole humectant, while reducing or removing the sorbitol — much less that doing so would yield surprising and unexpected technical benefits in terms of foam volume and density that are demonstrated in the Applicant’s specification. Accordingly, as the Examiner has not demonstrated a reason or motivation to modify Robinson ‘575 —i.e., to use glycerin in an amount of 35% as sole humectant, as required by the claimed invention — the amended claims are novel and inventive.
Examiner disagrees. Applicants point to Formulas C and D as having higher foam volumes than Example B, but provide no explanation or nexus to the pending claims. The amounts listed in the description of the composition do not add up to 100% (Formula A-51%, Formula B- 43%, Formula C-42%, Formula D-38%), and it is not clear if/which additional ingredients are present. Since fluoride is not listed as a component in any of the compositions, it appears none of the formulations tested fall within the scope of the pending claims. Further, it is noted that only Formula D has glycerin as the sole humectant. Applicants have the burden of explaining the unexpected results and Applicants have not explained how disclosing only 38% of a single composition could be considered to provide an unexpected result over the cited prior art, particularly when the test does not include the prior art composition. See MPEP 716.02(b). Since Applicants have not met the burden placed upon them for overcoming a prima facie case of obviousness, their argument for unexpected results is found unpersuasive.
Applicants argue that a trend is established by using the “net humectant” in formulas A-D. The amount of “net humectant” is tightly controlled for, and merely ranges from 34-35.1 on the high end. Given the small differences in new humectant percentage, Applicants data should be sufficient to show a trend to increased foam volume and density as the amount of glycerin is adjusted.
Examiner disagrees. Robinson ‘575 allows for the option of glycerin alone to allow it to be the sole humectant. Note that Porter is used for motivating l-arginine as type of arginine, but the applicant’s argument is toward the type of humectant used. Based on Applicants argument, it is not clear whether the alleged trend is based on the amount of glycerin or the “net humectant”. Regardless, Examiner is unable to find any trend in the data. Where only 38-51% of the components in the compositions tested are reported, no conclusions can be drawn. For example, a skilled artisan would expect more foaming where a foaming agent is present in the unreported 49-62% of the tested compositions. It is also noted that Applicants have not compared the test data to the closest prior art as set forth in 716.02(b)(III). As such, Applicants have not met their burden to demonstrating unexpected results. Applicants argument is found unpersuasive.
Applicants allege that Examiner has not indicated why Applicants results with respect to improved foaming observed would have been expected or predicted with the inclusion of glycerin at the amount instantly recited, so the rejection should be withdrawn.
Examiner disagrees. Examiner burden is to demonstrate a prima facie case of obviousness. As discussed above, a skilled artisan would have found it prima facie obvious to pick from among the components and amounts set forth in Robinson ‘575 with teachings of Porter to predictably formulate an oral care composition. See MPEP 2143(I)(A). Thus a prima facie case of obviousness is established. Applicants have the burden of establishing an unexpected result using objective evidence. MPEP 716.01(a). Applicants counsel has declared that foaming is “improved” in the tested compositions. However, Applicants have not compared these compositions to the prior art compositions, so it is not clear what the tested compositions are improved relative to. Attorney arguments cannot take the place of evidence. See MPEP 716.01(c). Further, Applicants have only reported a fraction of what is contained in these tested compositions (Table 1). Thus, Applicants have not met the burden placed on them by MPEP 716.02(b), so their argument for unexpected results is unpersuasive.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US Patent 10555883. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for basic amino acid in free acid or salt form where the amino acid is L-arginine, zinc oxide in an amount of about 1 wt%, zinc citrate in an amount of about 0.5 wt%, a fluoride source that is a metal fluoride and glycerin (‘883 has “about 39.2% glycerin” in claim 7). ‘883 also provides for toothpaste, dentifrice, mouthwash, mouthrinse and other forms. ‘883 also provides for sodium fluoride in claim 4. As ‘883 provides for forms of toothpastes and mouthwash, ‘883 provides for forms that are applied to the oral cavity to clean the mouth/teeth.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, 9, and 14 of U.S. Patent No. US Patent 11752075 in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for basic amino acid in free acid or salt form where the amino acid is arginine, zinc oxide in an amount of about 1 wt%, zinc citrate in an amount of about 0.5 wt%, a fluoride source that is sodium fluoride and acceptable carrier. ‘075 provides for treatment or prophylaxis of acid softened enamel by administering the composition to the oral cavity and also a treatment or prevention of erosive tooth demineralization, gingivitis, plaque and/or dental caries.
‘075 does not provide for forms of the oral care composition, a salt of arginine, or glycerin in the claimed amount.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98). The teaching of arginine obviates its different forms including L-arginine (a most common form).
One of ordinary skill in the art before the time of filing would have utilized oral care composition forms, arginine salts like arginine bicarbonate and glycerin humectant in amounts of 15 to 35 wt% of Robinson ‘575 in oral care compositions of the claims of ‘075 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘075 and producing the claimed compositions and methods.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9, 14-17 of U.S. Patent No. US Patent 11806418 in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for basic amino acid in free acid or salt form where the amino acid is arginine, zinc oxide in an amount of 0.05 to 10% by weight zinc source, zinc citrate in an amount of about 0.05 to 10 wt% zinc source, a fluoride source that is a metal fluoride (stannous fluoride) and acceptable carrier. ‘418 provides for a treatment or prevention of erosive tooth demineralization, gingivitis, plaque and/or dental caries.
‘418 does not provide for forms of the oral care composition, a salt of arginine, or glycerin in the claimed amount. ‘418 does not provide for sodium fluoride.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98). The teaching of arginine obviates its different forms including L-arginine (a most common form).
One of ordinary skill in the art before the time of filing would have utilized oral care composition forms, arginine salts like arginine bicarbonate and glycerin humectant in amounts of 15 to 35 wt% of Robinson ‘575 in oral care compositions of the claims of ‘418 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘418 and producing the claimed compositions and methods.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US Patent 10441517 in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for basic amino acid in free acid or salt form where the amino acid is arginine or a salt thereof, zinc oxide in an amount of 0.05 to 10% by weight zinc source, zinc citrate in an amount of about 0.05 to 10 wt% zinc source. ‘517 provides for reducing or inhibiting a biofilm in an oral cavity by contacting the oral cavity with the composition.
‘517 does not provide for forms of the oral care composition or glycerin in the claimed amount. Claims of ‘517 do not provide for fluoride sources.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98). The teaching of arginine obviates its different forms including L-arginine (a most common form).
One of ordinary skill in the art before the time of filing would have utilized oral care composition forms, arginine salts like arginine bicarbonate and glycerin humectant in amounts of 15 to 35 wt% of Robinson ‘575 in oral care compositions of the claims of ‘517 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. ‘575 provides for fluoride sources in oral care compositions. There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘517 and producing the claimed compositions and methods.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US Patent 11260002 in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for basic amino acid in free acid or salt form where the amino acid is arginine or a salt thereof, zinc oxide in an amount of 0.05 to 10% by weight zinc source, zinc citrate in an amount of about 0.05 to 10 wt% zinc source. ‘002 provides for reducing or inhibiting a biofilm in an oral cavity by contacting the oral cavity with the composition.
‘002 does not provide for forms of the oral care composition or glycerin in the claimed amount. Claims of ‘002 do not provide for fluoride sources.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98). The teaching of arginine obviates its different forms including L-arginine (a most common form).
One of ordinary skill in the art before the time of filing would have utilized oral care composition forms, arginine salts like arginine bicarbonate and glycerin humectant in amounts of 15 to 35 wt% of Robinson ‘575 in oral care compositions of the claims of ‘002 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. ‘575 provides for fluoride sources in oral care compositions. There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘002 and producing the claimed compositions and methods.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13-14, and 16-18 of copending Application No. 18/180,717 (reference application) in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for L-arginine (basic amino acids or salts thereof) (about 2 to about 5 wt%), zinc oxide (1%), zinc citrate (0.5%), and a fluoride source including sodium fluoride for an oral care composition.
‘717 does not provide for forms of the oral care composition or glycerin in the claimed amount.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98). The teaching of arginine obviates its different forms including L-arginine (a most common form).
One of ordinary skill in the art before the time of filing would have utilized oral care composition forms, arginine salts like arginine bicarbonate and glycerin humectant in amounts of 15 to 35 wt% of Robinson ‘575 in oral care compositions of the claims of ‘717 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘717 and producing the claimed compositions and methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 13-14, 16-17, 21, and 24 of copending Application No. 18/360,665 (reference application) in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for arginine (basic amino acids or salts thereof) (about 2 to about 5 wt%), zinc oxide (0.5 to 1.5 wt%), zinc citrate (0.25 to 0.75 wt%), and a fluoride source including sodium fluoride for an oral care composition. ‘665 provides for oral acceptable carrier and for a method to treat erosive tooth demineralization, gingivitis, plaque and/or dental caries.
‘665 does not provide for forms of the oral care composition or glycerin in the claimed amount.
Robinson ‘575 teaches zinc containing compositions (abstract). Robinson ‘575 teaches a composition with arginine bicarbonate, sorbitol (humectant), 1% zinc oxide and 0.5% zinc citrate and 1.1% sodium monofluorophosphate (fluoride source) (example 4 in table 4). Paragraph 49 provides for combinations of zinc oxide and zinc citrate with 0.25 to 0.75% zinc citrate and 0.75 to 1.25% zinc oxide in oral care compositions. Robinson ‘575 teaches oral care compositions with source of zinc ions as anti-plaque/anti-gingivitis component to reduce plaque and gingivitis (paragraphs 46-47). Robinson ‘575 provides for glycerin as an alternative to sorbitol as at least one humectant that can be 15 to 35 wt% of the composition (paragraphs 71-73). Robinson ‘575 provides a source of fluoride ions to supply 25 to 5000 ppm (25 to 5000 mg/L or 0.0025 to 0.5 wt%) of fluoride ions including sodium fluoride as an option (paragraph 64- as anti-caries agent). Sodium fluoride is another option to sodium monofluorophosphate as noted in paragraph 64. Robinson ‘575 teaches optionally the basic amino acid is in free or salt form (claim 1 of Robinson ‘575). Robinson ‘575 teaches paste or gel forms (paragraphs 18 and 77). Robinson ‘575 also teaches lozenge, spray, mouth rinse, gum and others (paragraph 81). Robinson ‘575 teaches applying the composition to the tooth or administering to oral cavity (paragraphs 93-98). The teaching of arginine obviates its different forms including L-arginine (a most common form).
One of ordinary skill in the art before the time of filing would have utilized oral care composition forms, arginine salts like arginine bicarbonate and glycerin humectant in amounts of 15 to 35 wt% of Robinson ‘575 in oral care compositions of the claims of ‘665 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘665 and producing the claimed compositions and methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant argues that each of these non-statutory double patenting rejections should be withdrawn for the reasons noted for the rejection under USC 103. As noted above, the rejections under USC 103 are being maintained. Applicant has not filed terminal disclaimers at this time. Thus, the rejections over each of these patents and copending patents are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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