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 1-4, 6-14, 18 and 22-27.
Applicants' arguments, filed 07/08/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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(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.
Claim 14 is 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 14 recites the limitation "one or more humectants" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the one or more humectants further limits the one or more polyol recited in claim 1 or is a component in addition to the polyol. Paragraph [0062] of the instant specification discloses wherein humectants include polyols.
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 11-14 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. Claims 11-14 and 18 fail to further limit the subject matter of claim 1 since claim 1 recites the transitional phrase “consisting of” and claims 11-14 and 18 broadens that scope by reciting wherein the composition “comprises.”
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. Claims 1-4, 7-14, 18 and 22-24 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 Xu et al. (US 2006/0140881, Jun. 29. 2006) (hereinafter Xu).
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 (abstract). Tin(II) (stannous) ions have long been valued for the multiple benefits that they can afford, including control of breath malodor, control of dental plaque growth and metabolism, reduced gingivitis, and reduction in dentinal hypersensitivity (¶ [0002]). Suitable stannous sources include stannous chloride, stannous fluoride, or mixtures thereof (¶ [0022]). 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 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 may also comprise from 5% to 70% of a humectant, such as sorbitol (i.e., polyol) (¶ [0041]). The composition does not compromise stannous stability (¶ [0007]). The composition will generally also include a surfactant (¶ [0041]). The composition may further comprise a thickening agent (claim 16).
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.
The combined teachings of Strand and Shanmugam do not teach wherein the composition comprises stannous pyrophosphate.
However, Xu discloses an oral composition comprising one or more stannous ion sources, which are helpful for reducing gingivitis, plaque, calculus, caries and/or sensitivity. Suitable stannous ion sources include stannous fluoride, stannous chloride dihydrate, and stannous pyrophosphate (¶ [0079]).
Accordingly, since the composition of Strand may comprise a mixture of tin(II) ions, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated stannous pyrophosphate into the composition of Strand since it is a known and effective tin(II) ions source as taught by Xu.
In regards to instant claims 1 and 8 reciting a molar ratio of the water-soluble alkali metal polyphosphate to the stannous pyrophosphate of 1:1 to 10:1 and 1:1 to 4:1, respectively, 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 claims 1 and 9 reciting a molar ratio of the total amount of water-soluble nitrate salt to stannous pyrophosphate of 1:1 to 5:1 and 1:1 to 3:1, 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.
In regards to instant claim 10 reciting 0.1 to 5 wt. % water-soluble alkali metal polyphosphate salt, 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 23 reciting a method of stabilizing stannous ion comprising (1) providing an aqueous vehicle, (2) adding to the aqueous vehicle a stannous ion source, (3) adding to the aqueous vehicle a nitrate ion source, and (4) adding to the aqueous vehicle a polyphosphate ion source, wherein the final composition is a single-component oral care composition, as discussed above, Strand discloses an aqueous composition comprising a stannous ion source (e.g., stannous chloride), a nitrate ion source (e.g., potassium nitrate), a polyphosphate ion source (e.g., tripolyphosphate), and up to 65% water. Therefore, since Strand teaches substantially the same method step as claimed, Strand necessarily teaches stabilizing stannous ion. Furthermore, Strand discloses in [0007] wherein stannous stability is not compromised. Therefore, stannous ion is stabilized in the composition of Strand.
2. Claims 1-4, 6, 8-14, 18, and 22-27 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), Prencipe et al. (US 2007/0183989, Aug. 9, 2007) (hereinafter Prencipe), and Xu et al. (US 2006/0140881, Jun. 29. 2006) (hereinafter Xu).
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 (abstract). Tin(II) (stannous) ions have long been valued for the multiple benefits that they can afford, including control of breath malodor, control of dental plaque growth and metabolism, reduced gingivitis, and reduction in dentinal hypersensitivity (¶ [0002]). Suitable stannous sources include stannous chloride, stannous fluoride, or mixtures thereof (¶ [0022]). 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 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 may also comprise from 5% to 70% of a humectant (¶ [0041]). The composition does not compromise stannous stability (¶ [0007]).
Strand differs from the instant claims insofar as not disclosing wherein the composition comprises sodium pyrophosphate, a water-soluble alkali metal hexametaphosphate, or a water-soluble alkali metal tripolyphosphate.
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]). The presence of polyphosphate ostensibly increases the amount of soluble zinc ion in the dentifrice composition (¶ [0020]).
Prencipe discloses an oral composition comprising a zinc salt for reducing one or more of plaque, tartar, caries, dentinal sensitivity, malodor, and/or inflammation (abstract). The astringency of fully or partially soluble zinc salts is believed to be reduced by the formation of a complex of a polyphosphate compound with zinc ions. A linear molecularly dehydrated polyphosphate compound useful in the composition generally comprises two or more condensed phosphate molecules. The number of phosphorus atoms in the condensed phosphate molecules can range from two (generally referred to as a pyrophosphate) to infinity (i.e., polyphosphate). Polyphosphate salts are generally employed in the form of their wholly or partially neutralized water-soluble alkali metal (e.g., potassium, sodium, or ammonium salts, and any mixtures thereof). Examples of suitable polyphosphate compounds include sodium tripolyphosphate and sodium hexametaphosphate (¶ [0035]).
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 chelant that is capable of solubilizing zinc. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium pyrophosphate, sodium tripolyphosphate, or sodium hexametaphosphate into the composition of Strand since polyphosphates help facilitate the solubility of zinc ions as taught by Shanmugam and sodium pyrophosphate, sodium tripolyphosphate, and sodium hexametaphosphate are known polyphosphates that may complex with zinc ions in oral care as taught by Prencipe.
The combined teachings of Strand, Shanmugam, and Prencipe do not teach wherein the composition comprises stannous pyrophosphate.
However, Xu discloses an oral composition comprising one or more stannous ion sources, which are helpful for reducing gingivitis, plaque, calculus, caries and/or sensitivity. Suitable stannous ion sources include stannous fluoride, stannous chloride dihydrate, and stannous pyrophosphate (¶ [0079]).
Accordingly, since the composition of Strand may comprise a mixture of tin(II) ions, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated stannous pyrophosphate into the composition of Strand since it is a known and effective tin(II) ions source as taught by Xu.
In regards to instant claims 1, 8, 25 and 26 reciting a molar ratio of the water-soluble alkali metal polyphosphate to the stannous pyrophosphate of 1:1 to 10:1 and 1:1 to 4:1, respectively, 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 claims 1, 9, 25 and 26 reciting a molar ratio of the total amount of water-soluble nitrate salt to stannous pyrophosphate of 1:1 to 5:1 and 1:1 to 3:1, 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.
In regards to instant claims 10 and 27 reciting 0.1 to 5 wt. % water-soluble alkali metal polyphosphate salt, 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 23 reciting a method of stabilizing stannous ion comprising (1) providing an aqueous vehicle, (2) adding to the aqueous vehicle a stannous ion source, (3) adding to the aqueous vehicle a nitrate ion source, and (4) adding to the aqueous vehicle a polyphosphate ion source, wherein the final composition is a single-component oral care composition, as discussed above, Strand discloses an aqueous composition comprising a stannous ion source (e.g., stannous chloride), a nitrate ion source (e.g., potassium nitrate), a polyphosphate ion source (e.g., tripolyphosphate), and up to 65% water. Therefore, since Strand teaches substantially the same method step as claimed, Strand necessarily teaches stabilizing stannous ion. Furthermore, Strand discloses in [0007] wherein stannous stability is not compromised. Therefore, stannous ion is stabilized in the composition of Strand.
Response to Arguments
Applicant argues that the claimed inventive oral care compositions do not include a zinc salt, zinc compound, or other zinc sources. In fact, as instantly amended, the claimed preclude the inclusion of zinc sources. Accordingly, one of ordinary skill would not have found it obvious to select a polyphosphate from Shanmugam to help in increasing a zinc ion source-copolymer complex formation. Similarly, one of one of ordinary skill would have had no reasonable rationale for relying on Prencipe.
The Examiner does not find Applicant’s argument to be persuasive. The instant claims as amended do not preclude the inclusion of zinc sources. The instant claims recite wherein the composition optionally comprises an anti-bacterial agent. Strand discloses in paragraph [0003] wherein combining zinc ions with stannous ions can give a broader spectrum of anti-microbial activity. Thus, zinc sources are anti-bacterial agents. As such, Applicant’s argument is unpersuasive.
Applicant argues that the two molar ratios are not taught.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, in regards to instant claim 1 reciting a molar ratio of the water-soluble alkali metal polyphosphate to the stannous pyrophosphate of 1:1 to 10:1, 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 reciting a molar ratio of the total amount of water-soluble nitrate salt to stannous pyrophosphate of 1:1 to 5:1, 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. As such, the two molar ratios are taught and Applicant’s argument is unpersuasive.
Applicant argues that the applied art does not disclose or provide any guidance teaching the use or benefits of employing the claimed molar ratio of the nitric acid or water-soluble nitrate salt to the stannous pyrophosphate.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown with objective evidence wherein the claimed ratio is unexpected. Therefore, it is not necessary for the prior art to teach a benefit of the claimed ratio. Also, as discussed above, the claimed ratio would have been obvious from converting the amounts disclosed by Strand and arriving at a ratio that overlaps with the claimed ratio. An overlap between the claimed ratio and the prior art ratio is obvious. See MPEP 2144.05. As such, Applicant’s argument is unpersuasive.
Applicant argues that Strand does not provide any teaching that would suggest that certain molar ratios of anti-sensitivity to stannous pyrophosphate enhance the oral care composition.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown with objective evidence wherein the claimed molar ratio is unexpected. Therefore, it is not necessary for the prior art to teach wherein the claimed ratio is beneficial. As such, Applicant’s argument is unpersuasive.
Applicant argues that it is improper to base the present rejection on routine optimization as the cited art does not show that the claimed molar ratio of the nitric acid or water-soluble salt to the stannous pyrophosphate is a result-effective variable.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state wherein claimed ratio would have been obvious through optimization. The rejection states wherein the claimed ratio would have been obvious since it overlaps with the prior art’s teachings. As such, Applicant’s argument is unpersuasive.
Applicant argues that application of overlapping ranges does not properly apply where the cited art does not disclose an overlapping range or the underlying claimed molar amount for the alleged overlapping range.
The Examiner disagrees and does not find Applicant’s argument to be persuasive. Just because the prior art does not disclose a molar ratio specifically does not mean that a molar ratio is not taught from the teachings. When an amount by weight is disclosed, it can be converted into a molar amount. When amounts of two ingredients are disclosed, the amounts of those two ingredients may be presented as a ratio. All of this is within the skills of one of ordinary skill in the art. As discussed above, from the ranges disclosed by Strand, one of ordinary skill in the art would have arrived at molar ratios. The molar ratios taught from the ranges of Strand overlaps with the claimed molar ratio. Thus, making the claimed molar ratio obvious. Although the Board has never applied the presumption of obviousness for overlapping ranges in a case in which the prior art does not contain an express disclosure of a range, this does not apply here since Strand does teach ranges that would lead to the claimed molar ratio. As such, Applicant’s argument is unpersuasive.
Applicant argues that the combination of stannous pyrophosphate, nitric acid or a soluble nitrate salt, and alkali metal polyphosphates in particular ratios yields surprising improvements in stannous stability. See ¶¶ [0009], [0218], and [0219].
The Examiner does not find Applicant’s argument to be persuasive. Mere conclusory statements in the specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield, 571 F.2d 1185, 197 U.S.P.Q. 227, 229 (C.C.P.A. 1978). Applicant has not shown comparative examples comparing the claimed molar ratio with molar ratios outside of the claimed range to show that the claimed molar ratio is unexpected. As such, Applicant’s argument is unpersuasive.
Applicant argues that there is no requirement that an Applicant provide an explanation as to whether a claim limitation has some particular effect or benefit as to not be considered arbitrary.
The Examiner does not find Applicant’s argument to be persuasive and submits that it is Applicant’s burden to show that the claimed invention is unexpected. See MPEP 716.02(b).
Applicant argues that one of ordinary skill would not replace the stannous ion source of Strand with stannous pyrophosphate. Strand expressly teaches that while phytate is a preferred chelant because it provides stain removal benefits, the fact that it is insoluble makes it undesirable as the sole chelant. As stannous pyrophosphate is also insoluble, one of ordinary skill would have readily concluded that such insolubility is an undesirable property.
The Examiner does not find Applicant’s argument to be persuasive. Strand discloses in paragraph [0029] wherein because stannous phytate is not soluble it is preferably not used as the sole chelant. The instant claims as currently recited do not limit the composition to comprise only one chelant. The instant claims as currently recited only limits the water-soluble alkali metal polyphosphate in the composition to a pyrophosphate, tripolyphosphate, or hexametaphosphate. Thus, incorporating an additional chelant, such as citric acid, with stannous pyrophosphate so that stannous pyrophosphate is not the sole chelant would not teach away from the instant claims. Incorporation of citric acid would not teach away from the instant claims since as noted in paragraph [0041] of the instant specification, citric acid is a buffering agent and the instant claims recite wherein the composition may optionally have a buffer. As such, Applicant’s argument is unpersuasive.
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 1-4, 6-14, 18 and 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent Nos. 10,918,580 and 11,723,846 in view of Xu et al. (US 2006/0140881, Jun. 29. 2006) (hereinafter Xu).
The pending claims differ from the patented claims insofar as reciting stannous pyrophosphate. However, Xu discloses an oral composition comprising one or more stannous ion sources, which are helpful for reducing gingivitis, plaque, calculus, caries and/or sensitivity. Suitable stannous ion sources include stannous fluoride, stannous chloride dihydrate, and stannous pyrophosphate (¶ [0079]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated stannous pyrophosphate into the pending claims since it is a known and effective alternative stannous ion source from stannous fluoride and stannous chloride as taught by Xu.
Claims 1-4, 6-14, 18 and 22-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 18/366,067, 17/894,098, and 18/517,201 in view of Xu et al. (US 2006/0140881, Jun. 29. 2006) (hereinafter Xu).
The pending claims differ from the copending claims insofar as reciting stannous pyrophosphate. However, Xu discloses an oral composition comprising one or more stannous ion sources, which are helpful for reducing gingivitis, plaque, calculus, caries and/or sensitivity. Suitable stannous ion sources include stannous fluoride, stannous chloride dihydrate, and stannous pyrophosphate (¶ [0079]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated stannous pyrophosphate into the pending claims since it is a known and effective alternative stannous ion source from stannous fluoride and stannous chloride as taught by Xu.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 6-14, 18 and 22-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application Nos. 17/826,961, 17/950,735, 18/258,267, and 18/258,248 (reference applications). 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 ingredient) 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.
Response to Arguments
Applicant has not addressed any of the double patenting rejections. Therefore, the rejections are maintained.
Conclusion
Claims 1-4, 6-14, 18 and 22-27 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.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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