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.
Information Disclosure Statement
The information disclosure statement filed on 3/4/2024 has been considered by the examiner.
Claim Objections
Claims 1, 6 and 8 utilize periods after a, b, c…. and i, ii, iii…where applicant could resort to a parentheses such as a), b), c)…. and i), ii), iii)….. Normally, there is only one period allowed in the claim at the end of the claim unless there is no other option.
Claim 6 is objected to for not have the “wt” before “%” in each recitation of %.
Claim 7 presents a Markush group that contains recitation of “or”. As the Markush group is already a group of options, these recitations of “or” are not necessary. Instead, the claim may read “The oral composition of claim 1, wherein the oral composition may be any of the following oral compositions selected from the group consisting of: a toothpaste, a dentifrice, a mouthwash, a mouth rinse, a topical oral gel, and a denture cleanser.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite as there is no “and”, “or” or “and/or” to connect the items a.-d. Thus, it is unclear if all of a-d should be present or if different options or combinations thereof are allowed. If applicant means for all the items to be present, then applicant should use the word “and” between items c. and d. in the claim. It cannot be presumed what applicant means to claim even if it appears that applicant has embodied using a composition with all of a-d. For the purpose of compact prosecution, the examiner will read the claim as with “and” to include all of items a-d. However, as the prior art used below in the action covers each of the limitations of the claim, the references would also teach a composition with the items in an optional reading such as with “or” or “and/or”.
Claims 2-5, 7 and 8 are rejected as being dependent on an indefinite claim.
Claim 7 is indefinite for the recitation of “oral composition may be any of the following…” as the use of “may be” makes it unclear if the items appearing after “may be” will be part of the claim or do not have to be part of the invention as “may be” suggests they do not have to be present. For the purpose of compact prosecution, the examiner will point out in the prior art where these forms are taught. Applicant may replace the “may be” to “is” in the claim.
Regarding claim 8 (item ii), the phrase "for example" (“e.g.” is short for “for example”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 (item xvi) is indefinite for the phrase “immunize (or protect)” as it is unclear if the “or protect” in the parenthetical is a needed option in the limitation or if applicant is using it to indicate that “immunize” means to “protect”. For the purpose of compact prosecution if the prior art provides for immunization or protection against cariogenic bacteria then it will read on the limitation.
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).
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, 8, 12-14, 16-18, and 33 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, 11-14, 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.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 24, 25, 27, 29, 35-36, 39-41 of copending Application No. 17/675,409 (reference application) in view of WO2014088575 (Published June 12, 2014, referred to as Robinson ‘575) and Porter US20130017240. 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), zinc oxide (0.75 to 1.25 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.
‘409 does not provide for forms of the oral care composition or glycerin in the claimed amount. ‘409 does not provide for a fluoride source like sodium fluoride, but it does provide for applying to teeth for treatment.
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).
Porter teaches in Paragraph 95 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 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 ‘409 as these are acceptable forms and ingredients for oral care compositions of arginine and zinc salts to treat the oral cavity. ‘575 provides for the addition of fluoride sources to its compositions for oral benefit and Porter provides for an amount of arginine that overlaps with applicant’s claimed amounts (see MPEP 2144.05). There was a reasonable expectation of success of utilizing ingredients and forms of ‘575 to apply to claims of ‘409 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.
Pertinent Cited Art Not Used For These Rejections
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yin et al (Journal of Dentistry, Aug 2013, volume 41, pages S22-S28) --
Yin teaches dentifrice with 1.5% arginine and 1450 ppm of fluoride as sodium monofluorophosphate in addition to a positive control with 1450 ppm of fluoride as sodium fluoride (objective and study design of abstract). Yin provides that 438 participants completed the study (by using the dentifrice) (Results of abstract). The methods of Yin provide for the administration of the dentifrice compositions brushing using a toothbrush (2. Methods). Yin provides for anti-caries efficacy (4. Discussion).
Acevedo et al (The Journal of Clinical Dentristry, volume XVI, 2005, pages 63-70) -
Acevedo teaches comparison of an arginine bicarbonate/calcium carbonate (Cavistat)-containing dentifrice on caries development in children (objective, abstract). Acevedo tests this formulation against a 1100 ppm fluoride toothpaste (methodology, abstract). On page 66, Acevedo teaches toothpaste treatment by brushing teeth. Acevedo teaches significantly less caries development with treatment (discussion).
Conclusion
No claim is allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613