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 27-57.
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 27, 28, 31-44 and 48-55 are rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) in view of Cordon (US 4,075,316, Feb. 21, 1978).
Labib et al. disclose a cleaning composition comprising a carrier fluid and Minute Fibrils suspended in the carrier fluid (abstract). Minute Fibrils is a term coined to encompass what the industry terms as microfibrillated cellulose (¶ [0028]). Fibrillated polymers are polymers with thicker polymer bundle segments, from which branch thinner polymer bundle segments (¶ [0010]). The Minute Fibrils (i.e. claimed fibrillated polymer) may have large diameter fibrils having a diameter from about 100 nm to about 20,000 nm and small diameter fibrils having a diameter from 10 to 90 nm (¶ [0031]). The Minute Fibril composition is used for removing dental biofilm and dental plaque from teeth or oral cavity. The composition comprises an effective base material to make a new class of dentifrice (toothpaste), which can be specifically tailored for removing dental biofilm, plaque and preventing gingivitis. The network composition is different from current toothpaste formulation/base in that they possess a network structure that has sufficient strength to make contact with tooth surface during brushing. The stiffness of the network can be adjusted by inclusion of stiffening additives such as microcrystalline cellulose. Surfactants and flavors can be included in the composition (¶ [0187]). The microcrystalline cellulose may be in the form of a fiber (¶ [0078]). The microcrystalline cellulose may be included at a concentration from about 0.1 to 10% by weight of the Minute Fibril composition (¶ [0073]). The hardness of the fluid Minute Fibril network composition can be increased by including solid particles at suitable concentration from 0.1 to 5% by weight of the Minute Fibril composition (¶ [0076]). Hardness can be described using the Mohs hardness scale. It is believed that the hardness of cellulose is about 3 on the Mohs hardness scale (¶ [0077]). Suitable solid particles include silica (i.e. claimed abrasive particle) having a particle size ranging from 50 nm to several microns possibly in the range from 50 to 100 microns. The solid particles are distributed onto the fibers and on the spaces between them within a Minute Fibril network (¶ 0079]). A suitable carrier fluid is water (¶ [0208]). Carboxymethyl cellulose may be incorporated to function substantially as a surfactant (¶ [0089]). The composition comprises from about 0.01% to about 0.5% surfactant (Table 10). The stiffness (G’ or elastic modulus) and strength (yield shear stress) of the composition is usefully larger than that of the biofilm in order to achieve its more complete removal. The network needs to be strong enough, having high yield stress, so that it can maintain sufficient elastic properties during flow in order to achieve effective removal of biofilm (¶ [0286]). Viscosity modifiers may be incorporated to increase the viscosity of water to prevent possible separation of components, provide stability, and provide a composition with a longer shelf life (¶ [0113]). It is desirable that the storage modulus G’ of the composition is larger than the loss modulus G” (¶ [0142]). The cleaning can be accomplished by application of manual scrubbing or by mechanical means including automated brushes (¶ [0191]). The composition may include an antimicrobial additive (¶ [0103]). The composition may additionally include glycerol as a humectant (¶ [0117]).
Labib et al. differ from the instant claims insofar as not disclosing wherein the silica has a hardness of less than 3 on a Mohs Hardness Scale, wherein the composition comprises a source of fluoride ions and 55%-85% water, and wherein all the solid particles in the composition have a maximum dimension that is smaller than a spacing between human teeth at a gumline.
However, Cordon discloses a dentifrice containing a dental abrasive having a Mohs hardness of less than about 6 (e.g. 2 to 5) (col. 1, lines 11-15). The dental abrasive of Mohs hardness less than about 6 may be silica (col. 1, lines 44-49). The dentifrice may be a toothpaste (col. 5, line 19). The composition may also contain a fluorine-containing compound having a beneficial effect on care and hygiene of the oral cavity, e.g. diminution of enamel solubility in acid and protection of the teeth against decay. Examples of fluorine-containing compounds include sodium fluoride (col. 4, lines 51-56). The composition may contain 5-80% water (col. 2, line 49). It is preferable that the dental abrasive of Mohs hardness less than 6 have a particle size less than 20 microns to avoid any gritty feel (col. 2., lines 16-18).
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. Labib et al. disclose wherein the composition is in the form of a toothpaste and comprises silica. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated silica with a Mohs hardness less than about 6 (e.g. 2 to 5) into the composition of Labib et al. since this is a known and effective silica for toothpaste compositions as taught by Cordon.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium fluoride into the composition of Labib et al. motivated by the desire to provide a beneficial effect on care and hygiene of the oral cavity, e.g. diminution of enamel solubility in acid and protection of the teeth against decay as taught by Cordon.
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated 5-80% water into the composition of Labib et al. since the composition comprises water and is in the form of a toothpaste and 5-80% water is a known and effective amount of water to formulate a toothpaste composition as taught by Cordon.
It would have been prima facie obvious to one of ordinary skill in the art to formulated the solid particles of Labib et al. to have a particle size of less than 20 microns motivated by the desire to avoid any gritty feel as taught by Cordon. Paragraph [00166] of the instant specification disclose wherein 25 microns is a suitable particle size to flow between teeth. Therefore, since it would have been obvious to have formulated the solid particles of Labib et al. to have a particle size less than 20 microns, the solid particles have a maximum dimension that is smaller than a spacing between human teeth at a gumline.
In regards to the instant claims 27 and 54 reciting 7% to 40% abrasive particles, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05. In the instant case, the claimed amount of 7% is close to the 5% disclosed in the prior art that one of ordinary skill in the art would have expected them to have the same properties. Therefore, an amount of 7% would have been obvious. Additionally, Labib et al. disclose wherein cellulose having a hardness of 3 is suitable for the composition and wherein cellulose may be included in a concentration from about 0.1 to 10%. As discussed above, it would have been obvious to have incorporated silica having a hardness less than 6 (e.g. 2 to 5) into the composition. As such, it would have been obvious to one of ordinary skill in the art to have optimized the amount of silica to up to 10% since silica is added to impart hardness and components having substantially the same hardness level may be included in such amounts.
In regards to the instant claims 27 and 54 reciting wherein said abrasive particles are compatible with a fluoride source, Cordon discloses a composition comprising silica and sodium fluoride. Therefore, it is obvious that silica (i.e. claimed abrasive particle) is compatible with a fluoride source.
In regards to the instant claims 27 and 54 reciting wherein said abrasive particles are entangled in a network of said thicker fibrils and said thinner fibrils, Labib et al. disclose wherein solid particles are distributed onto the fibers and on the spaces between them within a Minute Fibril network. Accordingly, it would have been obvious to one of ordinary skill in the art to have abrasive particles entangled in the thicker and thinner fibrils.
In regards to the instant claims 27 and 54 reciting a sufficient amount of water so that said composition has viscoelastic fluid properties, Labib et al. disclose wherein the composition is viscous and elastic. Therefore, it would have been obvious to one of ordinary skill in the art that the composition of Labib et al. has a sufficient amount of water so that said composition has viscoelastic fluid properties.
In regards to instant claims 28, 43 and 51, since Labib et al. disclose wherein the composition removes plaque and disclose wherein adding stiffening additives provides the composition with better contact with tooth surface during brushing, it would have been obvious to one of ordinary skill in the art that the composition of Labib et al. may be optimized such that it meets the claimed plaque removal test.
In regards to instant claim 31, Labib et al. disclose wherein adding stiffening additives provides the composition with better contact with tooth surface during brushing. Accordingly, it would have taken no more than the relative skill of one of ordinary skill in the art through routine experimentation to have arrived at the claimed friction factor depending on the level of contact with tooth surface desired.
In regards to instant claims 36 and 37, Labib et al. disclose wherein the elastic modulus and yield shear stress of the composition should be larger than that of the biofilm in order to achieve its more complete removal. Therefore, since the elastic modulus and yield shear stress affect biofilm removal, it would have taken no more than the relative skill of one of ordinary skill in the art through routine experimentation to have arrived at the claimed elastic modulus and yield shear stress depending on the level of biofilm removal desired.
In regards to instant claim 38, Labib et al. disclose wherein viscosity affects separation of components, stability, and shelf life. Accordingly, it would have taken no more than the relative skill of one of ordinary skill in the art through routine experimentation to have arrived at the claimed viscosity depending on the amount of separation of components, stability, and shelf life desired.
In regards to instant claim 39, Labib et al. disclose wherein it is desirable that the storage modulus G’ (elastic modulus) of the composition is larger than the loss modulus G”. Therefore, it would have been obvious to one of ordinary skill in the art to have the storage modulus G’ (elastic modulus) larger than the loss modulus G” at any oscillatory stress.
In regards to instant claim 44 reciting 10% to 30% abrasive particles, Labib et al. disclose wherein cellulose having a hardness of 3 is suitable for the composition and wherein cellulose may be included in a concentration from about 0.1 to 10%. As discussed above, it would have been obvious to have incorporated silica having a hardness less than 6 (e.g. 2 to 5) into the composition. As such, it would have been obvious to one of ordinary skill in the art to have optimized the amount of silica to up to 10% since silica is added to impart hardness and components having substantially the same hardness level may be included in such amounts.
In regards to instant claim 55 reciting the device used, Labib et al. disclose wherein the composition is contacted with tooth surface during brushing and disclose wherein the cleaning can be accomplished by manual scrubbing. Accordingly, using a manual toothbrush would have been obvious to one of ordinary skill in the art.
2. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) in view of Cordon (US 4,075,316, Feb. 21, 1978) and further in view of Riesinger (US 2014/0221948, Aug. 7, 2014).
The teachings of Labib et al. and Cordon are discussed above. Labib et al. and Cordon do not disclose wherein the composition comprises particles of a superabsorbent polymer.
However, Riesinger discloses wherein superabsorbent polymers bind bacteria and proteins (¶ [0090]). Superabsorbent polymers also dry out biofilms so that cracks form through which copper or copper ions can deploy their biofilm-degrading action (¶ [0209]). Copper possesses antimicrobial properties (¶ [0042]). Superabsorbent polymers may be in the form of a granulate or a powder (¶ [0085]).
The composition of Labib et al. comprises antimicrobial additives. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated particles of a superabsorbent polymer into the composition of Labib et al. motivated by the desire to dry out biofilms such that it cracks to allow the antimicrobial additive to better degrade the biofilm as taught by Riesinger.
3. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) in view of Cordon (US 4,075,316, Feb. 21, 1978), Riesinger (US 2014/0221948, Aug. 7, 2014), and further in view of Toreki et al. (US 2010/0247615, Sep. 30, 2010).
The teachings of Labib et al., Cordon, and Riesinger are discussed above. Labib et al., Cordon, and Riesinger do not disclose wherein the superabsorbent polymer is surface cross-linked.
However, Toreki et al. disclose wherein a preferred method of improving absorption and retention properties of SAP (superabsorbent polymer) particles is to surface crosslink the SAP particles (¶ [0070]).
It would have been prima facie obvious to one of ordinary skill in the art to have incorporated particles of a superabsorbent polymer that are surface cross-linked into the composition of Labib et al. since this is a known and desirable form of a superabsorbent polymer particle in that it has better absorption and retention properties as taught by Toreki et al.
4. Claims 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) in view of Cordon (US 4,075,316, Feb. 21, 1978) and further in view of Cai et al. (US 2009/0306223, Dec. 10, 2009).
The teachings of Labib et al. and Cordon are discussed above. Labib et al. and Cordon do not disclose wherein the microcrystalline cellulose has a size larger than 25 microns or 50 microns and has an aspect ratio larger than 3.
However, Cai et al. disclose fibers having an aspect ratio of more than 10 to 1,000. The fibers can be used in personal care (abstract). The fibers have a length of 0.1 to 100 micrometer (claim 3). The fibers may be microcrystalline cellulose (claim 6).
Labib et al. disclose wherein the microcrystalline cellulose may be in the form of a fiber. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a microcrystalline cellulose fiber having an aspect ratio of more than 10 to 1,000 and a length of 0.1 to 100 micrometer since this is an effective microcrystalline cellulose known in the art as taught by Cai et al.
5. Claims 56 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Labib et al. (US 2018/0094214, Apr. 5, 2018) in view of Cordon (US 4,075,316, Feb. 21, 1978) and further in view of Gottenbos (US 2017/0197071, Jul. 13, 2017).
The teachings of Labib et al. and Cordon are discussed above. Labib et al. and Cordon do not disclose wherein the composition is applied using a fluid delivery device that delivers the composition with air or without air.
However, Gottenbos discloses a system for the administration of oral care actives (¶ [0001[). The system comprises a dental appliance such as an electric flossing device (¶ [0018]). An electric flossing device is a device that serves to clean interdental spaces generally by spraying air, by spraying liquid, or a combination thereof. Such a device can also be of use in order to direct a magnetic oral care composition to the backside of teeth, by the force of spraying, after which the composition can be attracted to the back surface of the teeth by the action of a magnet (¶ [0019]).
It would have been prima facie obvious to one of ordinary skill in the art to applied the composition of Labib et al. using an electric flossing device that sprays air or liquid since the composition is an oral composition and an electric flossing device that sprays air or liquid is a known and effective device for delivering an oral composition as taught by Gottenbos.
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 27-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 11,918,677, claims 1-32 of U.S. Patent No. 12,060,539, and claims 1-34 of U.S. Patent No. 12,064,495. 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.
Conclusion
Claims 27-57 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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