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 40-60.
Applicants' arguments, filed 02/23/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 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 40-52 and 54-58 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 2021/0093551, Apr. 1, 2021) (hereinafter Baig).
Baig discloses an oral care composition comprising hops (abstract). The oral care composition can comprise one or more surfactants (i.e., a surfactant system). Suitable surfactants are safe and effective amounts of anionic, cationic, nonionic, zwitterionic, amphoteric, and betaine surfactants (¶ [0092]). Suitable anionic surfactants include sodium methyl acyl taurate (i.e., a non-sulfate based anionic surfactant) (i.e., an acyl taurate) (¶ [0096]). Suitable betaine surfactants include cocamidopropyl betaine (i.e., an amphoteric surfactant) (¶ [0097]). The one or more surfactants can also include sodium cocoyl glutamate (i.e., an amino acid surfactant) (i.e., a glutamic acid derived surfactant) and lauryl glucoside (i.e., nonionic surfactant) (i.e., glucoside surfactant) (¶ [0100]). The oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15% (¶ [0102]). The oral care composition can comprise tin, such as from a tin ion source. Suitable tin ion sources include stannous fluoride (¶ [0054]). The oral care composition can comprise from about 0.0025% to about 5% of a tin ion source (¶ [0055]). The oral care composition can comprise calcium, such as from a calcium ion source (¶ [0056]). The calcium ion source can comprise a calcium salt, such as calcium nitrate (i.e., a nitrate ion source) (¶ [0058]). The oral care composition can comprise from about 1% to about 50% of a calcium ion source (¶ [0059]). The oral care composition can comprise a non-calcium abrasive, such as insoluble sodium metaphosphate (i.e., a phosphate source) (¶ [0076]).
The prior art discloses an oral care composition (abstract) comprising one or more surfactants comprising cocamidopropyl betaine (i.e., an amphoteric surfactant) (¶ [0097]), sodium methyl acyl taurate (i.e., a non-sulfate based anionic surfactant (¶ [0096]), sodium cocoyl glutamate (i.e., an amino acid surfactant) (¶ [0100]), and lauryl glucoside (i.e., a nonionic surfactant) (¶ [0100]), a tin ion source (¶ [0054]), calcium nitrate (i.e., a nitrate source) (¶ [0058]), and insoluble sodium metaphosphate (i.e., a phosphate source) (¶ [0076]). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to instant claims 47 and 55, since the oral care composition comprises one or more surfactants and suitable surfactants include sodium methyl acyl taurate (i.e., a non-sulfate based anionic surfactant), cocamidopropyl betaine (i.e., an amphoteric surfactant), lauryl glucoside (i.e., a nonionic surfactamnt), and sodium cocoyl glutamate (i.e., an amino acid surfactant), it would have been obvious to one of ordinary skill in the art to have the composition comprise only these four surfactants.
In regards to instant claim 50, Baig discloses about 0.0025% to about 5% of a tin ion source, such as stannous fluoride, and about 1% to about 50% of a calcium ion source, such as calcium nitrate. Accordingly, the claimed molar ratio would have been obvious when one derives an amount of stannous ions and nitrate ions from these ranges of stannous fluoride and calcium nitrate, converts the amounts to molar amounts, and arrive at a molar ratio that overlaps with the claimed range. 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 46 and 54 reciting wherein the oral care composition is free of sodium lauryl sulfate and sodium lauryl ether sulfate, this limitation would have been obvious since Baig does not require either of these compounds as surfactants and discloses wherein the anionic surfactant may be sodium methyl acyl taurate.
In regards to instant claims 54 and 57, Baig discloses wherein the oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15%. Thus, the claimed weight ratio would have been obvious when one selects an amount of anionic surfactant and an amount of amphoteric surfactant within this range and obtaining a weight ratio that overlaps with the claimed range. 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 54 and 58, Baig discloses wherein the oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15%. Thus, the claimed weight ratio would have been obvious when one selects an amount of amino acid surfactant and an amount of nonionic surfactant within this range and obtaining a weight ratio that overlaps with the claimed range. 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.
2. Claims 53, 59 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Baig et al. (US 2021/0093551, Apr. 1, 2021) (hereinafter Baig) in view of Hayes et al. (US 4,456,585, Jun. 26, 1984) (hereinafter Hayes).
The teachings of Baig are discussed above. Baig does not teach wherein the oral care composition is transparent or translucent.
However, Hayes discloses a visually clear pigmented dentifrice (abstract). Visually clear dentifrices have been marketed in recent years in view of their desirable aesthetic aspect combined with their ability to provide desired hygienic and prophylactic effects to teeth and the oral cavity. In visually clear dentifrices, it is necessary to select insoluble solid components with care since a close match between the refractive index of a solid component and the refractive index of the liquid vehicle is needed in order to provide clarity (col. 1, lines 7-15). The dentifrice is visually clear in appearance to the extent of being transparent or translucent (claim 1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the oral care composition of Baig to be transparent or translucent since visually clear dentifrices are desirable in the art as taught by Hayes. One of ordinary skill in the art would have had a reasonable expectation of success since Hayes discloses wherein matching the refractive index of a solid component to the refractive index of a liquid vehicle provides clarity.
Response to Arguments
Applicant argues that the sheer number of listed surfactants makes any selection of a single surfactant non-obvious without guidance from Baig.
The Examiner does not find Applicant’s argument to be persuasive. A reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Thus, Baig disclosing a number of surfactants does not make any selection of a single surfactant non-obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that Baig does not provide any teaching or suggestion to choose four surfactants, let alone the four recited surfactants.
The Examiner does not find Applicant’s argument to be persuasive. Baig discloses wherein the composition can comprise one or more surfactants. Thus, it would have been obvious to one of ordinary skill in the art to have selected any number of surfactants from the teachings of Baig. Applicant has not shown wherein the claimed four surfactants are critical compared to other surfactants. Therefore, since Baig teaches the claimed four surfactants, the claimed surfactants are obvious and Applicant’s argument is unpersuasive.
Applicant argues that the Office selects calcium nitrate from a list of calcium salts – not nitrate ion sources.
The Examiner does not find Applicant’s argument to be persuasive. Calcium nitrate from a list of calcium salts still meets the limitation of a nitrate ion source. As such, Applicant’s argument is unpersuasive.
Applicant argues that nothing in Baig teaches or suggests the importance of nitrate ion sources.
The Examiner does not find Applicant’s argument to be persuasive. Since Baig teaches wherein the composition may comprise calcium nitrate, a composition comprising a nitrate source would have been obvious since calcium nitrate is a nitrate source. Applicant has not shown wherein having a nitrate ion source is critical. Therefore, it is not necessary for the prior art to disclose the importance of a nitrate ion source. As such, Applicant’s argument is unpersuasive.
Applicant argues that Baig provides no guidance on which calcium compound to select.
The Examiner does not find Applicant’s argument to be persuasive. Choosing from a finite number of identified, predictable solutions support a conclusion of obviousness. See MPEP 2143(I). Therefore, selecting calcium nitrate from a finite number of suitable calcium ion sources would have been obvious. Also, Applicant has not shown wherein selection of calcium nitrate is critical. As such, Applicant’s argument is unpersuasive.
Applicant argues that Baig explicitly teaches abrasives, but Baig does not teach or suggest the importance of phosphate sources.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein having a phosphate ion source is critical. Therefore, it is not necessary for the prior art to disclose the importance of a phosphate ion source. As such, Applicant’s argument is unpersuasive.
Applicant argues that the Office uses the instant claims to choose sodium metaphosphate from a laundry list of abrasives – not phosphate sources.
The Examiner does not find Applicant’s argument to be persuasive. Nothing in the claims limits the phosphate source to not be an abrasive. As such, the sodium metaphosphate of Baig still meets the claims and Applicant’s argument is unpersuasive.
Applicant argues that Baig provides no teaching or suggestion to combine these specific elements together.
The Examiner does not find Applicant’s argument to be persuasive. It would have been obvious to combine the prior art elements since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A). Applicant has not shown wherein this would not have been obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that the fact that several of the elements the Office chooses from Baig are not used for their purpose disclosed in Baig indicates that Baig provides no guidance to arrive at the present composition.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein the elements are not used for their purpose disclosed in Baig. The elements are used for their purpose disclosed in Baig. The prior art does not need to teach the elements used for the same purpose as Applicant. See MPEP 2144(IV). As such, Applicant’s argument is unpersuasive.
Applicant argues that improper hindsight reconstruction was relied on.
The Examiner does not find Applicant’s argument to be persuasive. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Applicant has not shown wherein knowledge gleaned only from applicant’s disclosure was used. As such, Applicant’s argument is unpersuasive.
Applicant argues that Baig does not teach the combination of an anionic surfactant and an amphoteric surfactant nor the combination of an amino acid based surfactant and a nonionic surfactant, let alone ratios of the combined surfactants.
The Examiner does not find Applicant’s argument to be persuasive. Baig discloses wherein the oral care composition can comprise one or more surfactants. Thus, it would have been obvious to one of ordinary skill in the art to have selected any number of surfactants disclosed by Baig, which includes the claimed surfactants. Applicant has not shown wherein combination of surfactants is critical, thus selecting any number of surfactants from the teachings of Baig remains obvious. Baig further discloses wherein the oral care composition can comprise one or more surfactants each at a level from about 0.01% to about 15%. Thus, after selecting the surfactants, the claimed ratios between various surfactants would have been obvious from this range. Applicant has not shown wherein the claimed ratios are critical. Thus, the claimed ratio remains obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that the specification demonstrates that the recited four-surfactant system achieves unexpected superior results that rebut any prima facie case of obviousness.
The Examiner does not find Applicant’s argument to be persuasive. Applicant compares Example A containing four surfactants against Comparative Compositions 1-3, which were each missing one of the claimed surfactants. Example A demonstrated the best foaming. The Examiner does not find this result to be unexpected. Example A has more surfactants than Comparative Compositions 1-3. Surfactants are foaming agents. Thus, one of ordinary skill in the art would reasonably expect a composition with more foaming agents (i.e., surfactants) to have better foaming compared to compositions comprising fewer foaming agents (i.e., surfactants). Furthermore, Example A does not necessarily have better foaming since at 60 sec Example A has a foam volume of 328 mL and Comparative Composition 3 has a foam volume of 341 mL. Additionally, at 120 sec, Example A has a foam volume of 449 mL and Comparative Composition 3 has a foam volume of 435 mL. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See MPEP 716.02. Applicant has not shown wherein this difference in foam volume is to an extent that the difference is really unexpected. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Applicant has not shown wherein the difference is of statistical and practical significance. As such, Applicant’s argument is unpersuasive.
Applicant argues that the inventors discovered that four surfactant oral care compositions provide superior oral health benefits, achieve desirable foaming characteristics, and enhanced phase stability and these benefits along with others could be obtained while achieving an oral care composition that is translucent and/or transparent with minimal amounts or without sodium lauryl sulfate and sodium lauryl ether sulfate. The three comparators which only had three surfactants were not reported to have sufficient transparency.
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). As such, Applicant’s argument is unpersuasive since Applicant has not provided objective evidence supporting their conclusory statements. Furthermore, Applicant has not shown wherein the three comparators which only had three surfactants did not have sufficient transparency. As such, Applicant’s argument is unpersuasive.
Applicant argues that one of ordinary skill in the art would not have a reasonable expectation of success in achieving transparency/translucency with Baig’s composition because Baig’s composition includes multiple insoluble solid components that could affect clarity, and the four surfactant system requires careful formulation to maintain phase stability and clarity.
The Examiner does not find Applicant’s argument to be persuasive. Baig does not disclose wherein the composition requires multiple insoluble solid components. Baig’s composition requires only hops. Applicant has not shown wherein hops would affect clarity. Additionally, as discussed in the rejection, one of ordinary skill in the art would have had a reasonable expectation of success since Hayes discloses wherein matching the refractive index of a solid component to the refractive index of a liquid vehicle provides clarity. Applicant has not shown wherein matching the refractive index of a solid component to the refractive index of a liquid vehicle would not provide clarity. 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 40-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4-21 of copending Application No. 18/515,651 in view of Baig et al. (US 2021/0093551, Apr. 1, 2021) (hereinafter Baig).
The pendings claims differ from the copending claims insofar as reciting a non-sulfate based anionic surfactant, a nonionic surfactant, a nitrate ion source, and a phosphate source. However, Baig discloses an oral care composition (abstract) comprising one or more surfactants such as anionic, cationic, nonionic, zwitterionic, amphoteric, and betaine surfactants (¶ [0092]). Suitable anionic surfactants include sodium methyl acryl taurate (¶ [0096]). The composition can comprise calcium nitrate to deliver calcium ions to the oral cavity (¶ [0058]). The composition can comprise insoluble sodium metaphosphate as an abrasive (¶ [0076]). Therefore, it would have been obvious to one of ordinary skill in the art to have incorporated a non-sulfate based anionic surfactant and a nonionic surfactant since oral care composition may comprise more than one surfactant and these are known surfactants as taught by Baig. It would have been obvious to one of ordinary skill in the art to have incorporated calcium nitrate motivated by the desire to provide calcium ions into the oral cavity and it would have been obvious to one of ordinary skill in the art to have incorporated insoluble sodium metaphosphate motivated by the desired to provide an abrasive to the composition.
This is a provisional nonstatutory double patenting rejection.
Claims 40-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-15 and 18-24 of copending Application No. 18/513,925 (reference application) and claims 37-56 of copending Application No. 18/436,344 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because although the copending claims do not recite the exact combination of a non-sulfate based anionic surfactant, an amphoteric surfactant, a nonionic surfactant, and an amino acid surfactant, the copening claims recite wherein the composition comprises one or more surfactants and these surfactants would have been obvious from the copending dependent claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 40-60 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TRACY LIU/ Primary Examiner, Art Unit 1614