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 . Claims included in the prosecution are claims 1-11, 14, 15, 18, 19, 24, 27 and 28.
Applicants' arguments, filed 07/22/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6, 8-11, 14, 15 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 fails to further limit claim 1 since claim 6 limits the water-soluble alkali metal polyphosphate to sodium tripolyphosphate or potassium tripolyphosphate, but claim 1 requires the water-soluble alkali metal polyphosphate to comprise a pyrophosphate.
Claim 8 fails to further limit claim 1 since claim 8 recites a molar ratio of water-soluble alkali metal polyphosphate to stannous ion of 1:1 to 1.3:1, which is already recited in claim 1.
Claim 9 fails to further limit claim 1 since claim 9 recites a molar ratio of total amount of nitric acid, water-soluble nitrate salt, or a combination thereof to total amount of stannous ion source of about 1:1 to 5:1, which is broader in scope than the 0.7:1 to 3.4:1 molar ratio recited in claim 1.
Claims 10, 11 and 14 fail to further limit claim 1 since claims 10, 11 and 14 recite the transitional phrase “comprises,” which is open-ended and allows for additional ingredients, which is broader in scope than claim 1, which recites the transitional phrase “consisting of,” which is close-ended and does not allow for additional ingredients.
Claim 15 fails to further limit claim 1 since claim 15 recite wherein the basic amino acid may be an amino acid other than arginine, but claim 1 requires the basic amino acid to comprise arginine.
Claim 18 fail to further limit claim 1 since claim 18 recite the transitional phrase “further comprising,” which is open-ended and allows for additional ingredients, which is broader in scope than claim 1, which recites the transitional phrase “consisting of,” which is close-ended and does not allow for additional ingredients.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam).
Strand discloses an aqueous oral composition comprises a) from 0.2% to 3% divalent metal ions comprising: i. from 0.1% to 1.5% of zinc ions and ii. from 0.1% to 2% of tin(II) ions; b) a source of fluoride ions; c) a silica dental abrasive; d) one or more chelants having a MW of less than 1000 and capable of forming water-soluble complexes with the zinc ions; and e) an orally acceptable carrier comprising at least 20% total water. Zinc/stannous combination has antimicrobial activity (i.e., zinc is an antibacterial agent) (abstract). The tin(II) ions are provided by stannous chloride, stannous fluoride, or mixtures thereof (claim 8). The fluoride ion provides anticaries effectiveness (¶ [0023]). The composition may comprise potassium nitrate (i.e., water-soluble nitrate salt) as a dentinal desensitizing agent to control hypersensitivity (¶ [0047]). The composition may comprise 5 wt. % potassium nitrate (¶ [0054]). The chelant is capable of solubilizing at least 80% of the total zinc ions within the oral composition. Suitable chelants include amino acids, such as glycine and tripolyphosphates (¶ [0027]). The molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1 (¶ [0031]). The composition is a dentifrice and may comprise from 20% to 65% total water (¶ [0038]). The composition may also comprise from 5% to 70% of a humectant. Suitable humectants include sorbitol (i.e., polyol) (¶ [0041]). The compositions of the present invention will generally also include a surfactant (¶ [0041]). The composition further comprises a thickening agent (claim 16). The composition is preferably single phase, by which is meant that all of the ingredients of the composition are containable within a single compartment of a container and no further mixing is required before use (¶ [0038]). The composition does not compromise stannous stability (¶ [0007]). The composition may comprise teeth whitening agents (¶ [0038]).
Strand differs from the instant claims insofar as not disclosing wherein the composition comprises tetrasodium pyrophosphate.
However, Shanmugam discloses a dentifrice composition comprising a polyphosphate. The polyphosphate may help in increasing a zinc ion source-copolymer complex formation (which in turn help facilitate the solubility of the zinc ion) (¶ [0019]). Suitable polyphosphates include tetrasodium pyrophosphate. The presence of polyphosphate ostensibly increases the amount of soluble zinc ion in the dentifrice composition (¶ [0020]).
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. Strand discloses wherein the composition comprises a polyphosphate capable of solubilizing zinc ions as a chelant. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated tetrasodium pyrophosphate into the composition of Strand as a chelant since it is a known and effective polyphosphate capable of solubilizing zinc ions as taught by Shanmugam.
In regards to instant claim 27 reciting about 0.1 to about 3 wt. % tetrasodium pyrophosphate, Strand discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and up to 20:1 and wherein the composition comprises from 0.2% to 3% divalent metal ions. Accordingly, one of ordinary skill in the art would have arrived at an amount of chelants that overlaps with claimed range from these ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists.
In regards to instant claim 27 reciting a molar ratio of the total amount of stannous ion source to the total amount of the nitric acid, water-soluble nitrate salt, or the combination thereof to the total amount of tetrasodium pyrophosphate of about 1:3.4:1, one of ordinary skill in the art would have arrived at the claimed ratio from Strand disclosing 0.1% to 2% tin(II) ions, 5 wt. % potassium nitrate, and a molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists.
2. Claims 1-11, 14, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), and further in view of Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli).
The teachings of Strand and Shanmugam are discussed above. Strand and Shanmugan do not teach wherein the composition comprises arginine.
However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine is believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). The basic amino acid is present in an amount of about 0.1 to about 20% of the total composition weight (¶ [0031]).
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. Strand discloses wherein the composition comprises amino acids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 0.1 to about 20% arginine into the composition of Strand since it is a known and effective amino acid and it combats cavity formation and tooth sensitivity as taught by Kohli.
In regards to instant claims 1 and 8 reciting a molar ratio of water-soluble alkali metal polyphosphate to the stannous ion source of 1:1 to 1.3:1, Strand discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. The divalent metal ions comprises tin(II) ions. Thus, the claimed range overlaps with the range in the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. In regards to instant claim 1 and 9 reciting a molar ratio of the total amount of water-soluble nitrate salt to the total amount of stannous ions source of 0.7:1 to 3.4:1 and about 1:1 to 5:1, respectively, Strand discloses 5 wt. % potassium nitrate and 0.1% to 2% tin(II) ions. When converting the amounts of potassium nitrate and tin(II) ions to mole amounts, one of ordinary skill in the art would have arrived at a ratio between the two compounds that overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
3. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli), and further in view of Price et al. (US 2019/0269606, Sep. 5, 2019) (hereinafter Price).
The teachings of Strand, Shanmugam, and Kohil are discussed above. Strand, Shanmugan, and Kohil do not teach wherein the composition comprises charcoal.
However, Price discloses a toothpaste composition having white activated coconut husk charcoal (¶ [0013]). Activated charcoal has been used for a number of years as a dentifrice and whitening agent for the teeth (¶ [0011]). The composition may comprise 0.05-2% activated coconut white charcoal (Table 1).
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. Strand discloses wherein the composition comprises teeth whitening agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.05-2% activated coconut white charcoal into the composition of Strand since it is a known and effective whitening agent for the teeth as taught by Price.
4. Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of Shanmugam et al. (US 2017/0135936, May 18, 2017) (hereinafter Shanmugam), Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli), and further in view of Kruse et al. (US 2022/0339228, Filed Jul. 29, 2019) (hereinafter Kruse).
The teachings of Strand, Shanmugam, and Kohil are discussed above. Strand, Shanmugan, and Kohil do not teach wherein the composition is used for treating or reducing systemic blood pressure.
However, Kruse discloses a composition having a concentration-promoting and/or stimulating effect, in particular for the simultaneous lowering of arterial blood pressure, wherein said composition contains as component (a) at least one nitrate source and/or nitrate and as component (b) at least one substance having stimulating and/or stimulating effect, preferably caffeine (abstract). The reduction in blood pressure is achieved by the nitrate contained in the composition. Topical application of nitrate in the oral cavity can significantly lower blood pressure (¶ [0038]). The composition may be in the form of a toothpaste (¶ [0045]). The nitrate may be potassium nitrate (¶ [0063]).
Accordingly, since the composition of Strand comprises potassium nitrate and is a topical oral composition (e.g., dentifrice), it would have been prima facie obvious to one of ordinary skill in the art to have used the composition for lowering arterial blood pressure since nitrates in topical oral compositions reduces blood pressure as taught by Kruse.
5. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Strand et al. (US 2009/0136432, May 28, 2009) (hereinafter Strand) in view of An et al. (KR 2013061874 A, Jun. 12, 2013) (hereinafter An) and Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli).
Strand discloses an aqueous oral composition comprises a) from 0.2% to 3% divalent metal ions comprising: i. from 0.1% to 1.5% of zinc ions and ii. from 0.1% to 2% of tin(II) ions; b) a source of fluoride ions; c) a silica dental abrasive; d) one or more chelants having a MW of less than 1000 and capable of forming water-soluble complexes with the zinc ions; and e) an orally acceptable carrier comprising at least 20% total water. Zinc/stannous combination has antimicrobial activity (i.e., zinc is an antibacterial agent) (abstract). The tin(II) ions are provided by stannous chloride, stannous fluoride, or mixtures thereof (claim 8). The fluoride ion provides anticaries effectiveness (¶ [0023]). The composition may comprise potassium nitrate (i.e., water-soluble nitrate salt) as a dentinal desensitizing agent to control hypersensitivity (¶ [0047]). The composition may comprise 5 wt. % potassium nitrate (¶ [0054]). The chelant is capable of solubilizing at least 80% of the total zinc ions within the oral composition. Suitable chelants include amino acids, such as glycine and tripolyphosphates (¶ [0027]). The molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1 (¶ [0031]). The composition is a dentifrice and may comprise from 20% to 65% total water (¶ [0038]). The composition may also comprise from 5% to 70% of a humectant. Suitable humectants include sorbitol (i.e., polyol) (¶ [0041]). The compositions of the present invention will generally also include a surfactant (¶ [0041]). The composition further comprises a thickening agent (claim 16). The composition is preferably single phase, by which is meant that all of the ingredients of the composition are containable within a single compartment of a container and no further mixing is required before use (¶ [0038]). The composition does not compromise stannous stability (¶ [0007]). The composition may comprise teeth whitening agents (¶ [0038]).
Strand differs from the instant claims insofar as not disclosing wherein the composition comprises sodium tripolyphosphate.
However, An discloses an oral care composition comprising a metal ion chelating agent. The metal ion chelating agent may be sodium tripolyphosphate (abstract).
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. Strand discloses wherein the chelating agent may be a tripolyphosphate. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium tripolyphosphate into the composition of Strand since it is a known and effective tripolyphosphate chelating agent as taught by An.
The combined teachings of Strand and An do not teach wherein the composition comprises arginine.
However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine is believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). The basic amino acid is present in an amount of about 0.1 to about 20% of the total composition weight (¶ [0031]).
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. Strand discloses wherein the composition comprises amino acids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 0.1 to about 20% arginine into the composition of Strand since it is a known and effective amino acid and it combats cavity formation and tooth sensitivity as taught by Kohli.
In regards to instant claim 28 reciting a molar ratio of sodium tripolyphosphate to the total amount of stannous ion source of 1:1 to 1:3, Strand discloses wherein the molar ratio of the chelants to divalent metal ions is at least 0.70:1 and can be as high as 20:1. The divalent metal ions comprises tin(II) ions. Thus, the claimed range overlaps with the range in the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. In regards to instant claim 28 reciting a molar ratio of potassium nitrate to the total amount of stannous ions source of 0.2:1 to 34:1, Strand discloses 5 wt. % potassium nitrate and 0.1% to 2% tin(II) ions. When converting the amounts of potassium nitrate and tin(II) ions to mole amounts, one of ordinary skill in the art would have arrived at a ratio between the two compounds that overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Response to Arguments
Applicant argues that in view of the teachings of Kohli, one of ordinary skill would not remove the soluble calcium salts as such a modification is contrary to the wisdom of the primary reference (Kohli). Further, one of ordinary skill would not find it obvious to modify the oral care compositions of Kohli in a manner that undermines the technical principals of Kohli.
The Examiner does not find Applicant’s argument to be persuasive. Kohli was never and still is not the primary reference. The primary reference in the rejection has been and still is Strand. Applicant has not explained why it would not have been obvious to have incorporated arginine into the composition of Strand. As such, the rejections are maintained.
Applicant argues that the oral care compositions having the recited components in the specifically claimed molar ratios unexpectedly achieved multiple benefits that would not be readily expected by one of ordinary skill. As shown in Example 2, the inventors discovered that multiple benefits, such as stannous stability and compositional clarity (or a lack of turbidity), are affected by the molar ratios of the stannous ion source, the nitric acid, a water-soluble nitrate salt, or a combination thereof, and the water-soluble alkali metal polyphosphate relative to each other.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein the claimed molar ratio ranges are unexpected. With regards to turbidity, Example 2 of the instant specification shows wherein turbidity is reduced with an increased amount of tetrasodium pyrophosphate. As evidenced by Prencipe et al. (US 5,578,293, Nov.26, 1996) (hereinafter Prencipe), a composition containing stannous compounds is stabilized with the combination of a water-soluble pyrophosphate salt and an organic acid compound (col. 1, lines 12-15). Stannous ion is unstable and tends to react with other ingredients of an oral care composition to form insoluble inactive tin compounds (col. 1, lines 65-67). Suitable water-soluble pyrophosphate salts include tetrasodium pyrophosphate (col. 3, line 54). Thus, one of ordinary skill in the art would have reasonably expected the turbidity result in Example 2 since it was known in the art that tetrasodium pyrophosphate stabilized stannous compounds, which then leads to fewer insoluble inactive tin compounds, and which then reduces turbidity since insoluble compounds increases turbidity. As such, Applicant’s showing with regards to turbidity is unpersuasive.
With regards to % stannous on day 14, instant claim 1 recites a molar ratio of water-soluble nitrate salt to stannous ion source of 0.7:1 to 3.4:1 and a molar ratio of water-soluble alkali metal polyphosphate to stannous ion source of 1:1 to 1.3:1. Claim 28 recites a molar ratio of water-soluble nitrate salt to stannous ion source of 0.2:1 to 34:1 and a molar ratio of water-soluble alkali metal polyphosphate to stannous ion source of 1:1 to 1:3. All the embodiments in the showing meeting this limitation have a % Stannous on Day 14 of at least 86%. An embodiment, which does not meet the claims, having a KNO3 to SnF2 molar ratio of 7:1 and a TSPP to SnF2 molar ratio of 1:1 has a % Stannous on Day 14 of 85%. It is unclear why a molar ratio producing 86% stannous on Day 14 would be considered unexpected and not a molar ratio producing 85% stannous on Day 14. The evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b). It is unclear how a 1% difference is significant enough that a user would noticeable a difference when using the claimed composition. Therefore, it is unclear how Applicant’s claimed molar ratios are unexpected.
Also, the claimed KNO3 to SnF2 molar ratio do not appear to be unexpected since as discussed previously it was known in the art that nitrates stabilize stannous ions. Thus, increasing the amount KNO3 to stannous ions would be expected to increase the % Stannous.
Additionally, claim 28 recites a molar ratio of the amount of sodium tripolyphosphate to the total amount of stannous ion source of 1:1 to 1:3. Even if Applicant’s showing is probative of unexpected results, the claim is not be commensurate in scope since there is no showing that a ratio of 1:3 is effective. In fact, the showing appears to show wherein a ratio of 1:3 would lead to turbidity. Example 3 shows composition having a molar ratio of potassium nitrate to stannous fluoride of 1:1 and a molar ratio of sodium tripolyphosphate to stannous fluoride of 1:0.3 being turbid.
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 1-11, 14, 15, 18, 19, 24, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 7, 9-14, 27, 33 and 34 of copending Application No. 17/826,961 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional ingredients) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-11, 14, 15, 18, 19, 24, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/894,098, 17/950,735, 18/258,248, 18/258,251, 18/366,067, and 18/517,201 in view of Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli).
The pending claims differ from the copending claims insofar as reciting wherein the composition comprises a basic amino acid. However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine and other basic amino acids are believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). Accordingly, it would have been obvious to have incorporated a basic amino acid into the pending claims since basic amino acids combat cavity formation and tooth sensitivity as taught by Kohli.
This is a provisional nonstatutory double patenting rejection.
Claims 1-11, 14, 15, 18, 19, 24, 27 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over the of U.S. Patent Nos. 10,918,580 and 11,723,846 in view of Kohli et al. (US 2011/0014136, Jan. 20, 2011) (hereinafter Kohli).
The pending claims differ from the patented claims insofar as reciting wherein the composition comprises a basic amino acid. However, Kohli discloses an oral care composition comprising an effective amount of a basic amino acid in free or salt form (abstract). The basic amino acid may be arginine (¶ [0009]). Arginine and other basic amino acids are believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0003]). Accordingly, it would have been obvious to have incorporated a basic amino acid into the pending claims since basic amino acids combat cavity formation and tooth sensitivity as taught by Kohli.
Response to Arguments
Applicant has not addressed the double patenting rejections. Therefore, the double patenting rejections are maintained.
Conclusion
Claims 1-11, 14, 15, 18, 19, 24, 27 and 28 are rejected.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights