DETAILED ACTION
The receipt is acknowledged of applicants’ amendment and request for RCE filed 11/26/2025; and IDS filed 08/25/2025.
Claims 2-8 and 15-25 are pending and subject of this office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/2025 has been entered.
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 .
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,266,581. Although the present claims and the issued claims are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the issued patent since the issued claims and the instant claims are directed to common subject matter as follows: a multi-phase oral composition for delivering active agent comprising an aqueous phase having the active agent and a predominant hydrophobic phase. Claim 1 of the issued patent recites petrolatum. The concentration of the active agent in the aqueous phase, and concentration of active agent in the overall multi-phase composition are also claimed by issued claims. The properties of the instant composition are claimed by the issued claims. The language of the present claims permits the presence of additional element in the issued claims, such as electromagnetic radiation source. The instantly claimed antimicrobial agent reads on the bleaching agent claimed by issued claims. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,147,753. Although the issued claims and the present claims are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the issued patent since the issued claims and the instant claims are directed to common subject matter as follows: a multi-phase oral composition for delivering active agent comprising an aqueous phase having the active agent and a predominant hydrophobic phase. The concentration of the active agent in the aqueous phase, and concentration of active agent in the overall multi-phase composition are also claimed by issued claims. The properties of the instant composition are claimed by the issued claims. The instantly claimed antimicrobial agent reads on the bleaching agent claimed by issued claims. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,253,442. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the issued patent since the issued claims and the instant claims are directed to common subject matter as follows: a multi-phase oral composition for delivering active agent comprising an aqueous phase having the active agent and a predominant hydrophobic phase. Claim 1 of the issued patent recites petrolatum. The concentration of the active agent in the aqueous phase, and concentration of active agent in the overall multi-phase composition are also claimed by issued claims. The properties of the instant composition are claimed by the issued claims. The language of the present claims permits the presence of additional element in the claims of the referenced application, such as electromagnetic radiation source. The instantly claimed antimicrobial agent reads on the bleaching agent claimed by issued claims. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,278,476. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the issued patent since the issued claims and the instant claims are directed to common subject matter as follows: a multi-phase oral composition for delivering active agent comprising an aqueous phase having the active agent and a predominant hydrophobic phase. The concentration of the active agent in the aqueous phase, and concentration of active agent in the overall multi-phase composition are also claimed by issued claims. Claim 1 of the issued patent recites petrolatum in the hydrophobic phase. The properties of the instant composition are claimed by the issued claims. The language of the present claims permits the presence of additional element in the claims of the referenced application, such as electromagnetic radiation source. The instantly claimed antimicrobial agent reads on the bleaching agent claimed by issued claims. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11,259,998. Although the claims at issue are not identical, they are not patentably distinct from each other because Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the issued patent since the issued claims and the instant claims are directed to common subject matter as follows: a multi-phase oral composition for delivering active agent comprising an aqueous phase having the active agent and a predominant hydrophobic phase. Claims 1, 29 and 30 of the issued patent recite petrolatum in the hydrophobic phase. The concentration of the active agent in the aqueous phase, and concentration of active agent in the overall multi-phase composition are also claimed by issued claims. The properties of the instant composition are claimed by the issued claims. The instantly claimed antimicrobial agent reads on the bleaching agent claimed by issued claims. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 11,559,473. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims and the current claims are directed to common subject matter that is composition comprising hydrophilic phase comprising active agent and hydrophobic phase. Claims 1, 14, 16, 22, and 36 of the issued patent recites hydrophobic particles comprising petrolatum, which reads on hydrophobic phase. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 10,849,729. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims and the current claims are directed to common subject matter that is composition comprising hydrophilic phase comprising active agent and hydrophobic phase. Claims 10, 13, and 17 of the issued patent recite petrolatum in the hydrophobic phase. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,607,300. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims and the current claims are directed to common subject matter that is composition comprising hydrophilic phase comprising active agent and hydrophobic phase. Claim 10 of the issued patent recites petrolatum. The present claims are obvious over the issued claims.
Claims 2-8, and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,123,270 in view of Feng et al. (US 2005/0137109, IDS filed 10/18/2021). The issued claims and the current claims are directed to common subject matter that is emulsion comprising hydrophilic phase comprising active agent and hydrophobic phase. The difference between the present patent and the issued claims is that the issued claims do not recite petrolatum in the hydrophobic phase as claimed by the current claims. Feng teaches dental bleaching compositions comprising teeth whitening agent, and a matrix of petrolatum for holding the whitening agent in such a manner that the whitening agent is released to surface of a tooth (abstract; (¶¶ 0012, 0015, 0026). Feng used the petrolatum as a matrix which means petrolatum surrounds the whitening agent composition. Such structure comprising hydrophobic petrolatum surrounding hydrophilic whitening agent, and forming continuous phase surrounding the droplets of the active agent that form discontinuous phase reads on water-in-oil emulsion. Feng teaches composition comprising hydrophilic and hydrophobic ingredients. The reference teaches that a second phase of water soluble polyvinyl pyrrolidone (PVP) can be present in the petrolatum matrix, which is a hydrocarbon (¶¶ 0026, 0027). This teaching implies the presence of first phase comprising the active agent, and second phase outer petrolatum that reads on hydrophobic phase. Feng teaches composition comprising 5% hydrogen peroxide (teeth whitening agent). The composition is advantageous because it can be applied by consumer without a dental professional by convenient means such as tray, mouth guard, stint, wand applicator or alternative means (¶ 0024). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide water-in-oil emulsion comprising hydrophilic phase comprising therapeutic agent, in a predominant hydrophobic phase as claimed by the issued claims, and replace the hydrophobic hydrocarbon phase with another hydrocarbon petrolatum phase taught by Feng. One would have been motivated to do so because Feng teaches that petrolatum holds the whitening agent in such a manner that the whitening agent is released to surface of a tooth wherein the composition is advantageous because it can be applied by consumer without a dental professional by convenient means. One would have reasonably expect formulating water in oil emulsion composition comprising petrolatum in a hydrophobic phase and a teeth whitening agent that is released to the teeth when applied by convenient manner by the consumer without a dental professional, and successfully whitens the teeth.
Applicants must bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003). Example of copending applications: claims 1-24 of application 17/890,533; claims 1-20 of application 17/738,047; claims 1-20 of application 17/529,716; claims 1-24 of application 17/410,188.
Similarly, many issued patent recite claims that constitute double patenting with the currently pending claims. For examples: US Patents: 11,413,127; 11,872,099, 12,059,317, 12,029802, 12,133905, 12,280,128; and any other patent issued from continuation applications of the above patents. Applicants must bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other issued patent, which are "material to patentability" of the application in question.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-8, and 15-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 21 as amended recites “….the composition does not comprise….a crosslinked polymer of ethylenically unsaturated monomer”. Applicants refer to page 54, lines 21-22; an page 56, lines 10-14 for support because this passage of the specification discloses “the composition may comprise a thickening agent, viscosity modifier or particulate filler such as Carbopol®”. However, nowhere applicants disclosed composition free of “a crosslinked polymer of and ethylenically unsaturated monomer”, or composition free of thickener, viscosity enhancer, etc. Applicants did not envisage the present invention free from such ingredients. Even with the term “may”, applicants did not disclose with sufficient specificity that the present invention is free from such elements. No examples show absence of these elements or they are undesirable. If applicant contends there is support for this limitation, then applicant is requested to specify the page and line of said support. In accordance to MPEP 714.02, applicant should specifically point out to where in the disclosure a support for any amendment made to the claims can be found.
Further, it has been held that “Any negative limitation or exclusionary proviso must have basis in the original disclosure.” See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977). In In re Johnson, the court noted that any negative limitation or exclusionary proviso must have basis in the original disclosure. Only if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. In the present case the negative limitation/exclusionary proviso does not have basis in the original disclosure, and the alternative elements were not positively recited in the specification, they are generically disclosed, so the Applicants’ argument is not relevant to the current issues. See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff'd mem., 738 F.2d 453 (Fed. Cir. 1984). Any claim containing a negative limitation, which does not have basis in the original disclosure, should be rejected under 35 U.S.C. 112, first paragraph as failing to comply with the written description requirement. In Purdue Pharma LP v Faulding, Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir. 2000), the court noted that with respect to In re Ruschig, 371 F.2d 990, 154 USPQ 118 (CCPA 1967), “Ruschig makes clear that one cannot disclose a forest in the original application, and then later pick out a tree of the forest and say, “here is my invention”. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.” Purdue is relevant in this case, because the Applicants disclosed a genus (“a forest”) in the original application, then later picked out two specific compounds (“a tree of the forest”), and are now saying, “here is my invention”. In order to satisfy the written description requirement, according to Purdue, the Applicants must disclose the specific compounds in the originally filed disclosure.” (See (56 USPQ2D 1481). More from Purdue: The case of In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967), is instructive here (see page 1487). The claim at issue in that case was directed to a single compound. The appellants argued that, although the compound itself was not disclosed, one skilled in the art would find support for the claimed compound in the general disclosure of the genus of compounds to which the claimed compound belonged. The Ruschig court rejected that argument, stating: [i]t is an old custom in the woods to mark trails by making blaze marks on the trees. It is of no help in finding a trail or in finding one's way through the woods where the trails have disappeared-or have not yet been made, which is more like the case here-to be confronted simply by a large number of unmarked trees. We are looking for blaze marks, which single out particular trees. We see none. Id. at 994-95, 154 USPQ at 122.
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genetech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-8, and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Quan et al. (US 2005/0137109, of record), Feng et al. (US 2005/0036958, of record), Montgomery (US 2005/0008584, of record), and Gers-Barlag et al. (US 2003/0175221, currently cited on PTO 892).
Applicant Claims
Claim 21 is directed to a multi-phase oral composition for delivering one or more active agents comprising:
a) from 0.5% to less than 50%, by weight of the multi-phase oral composition, of an aqueous phase having from about 0.001% to about 20%, by weight of the multi-phase oral composition, of an active agent; and
b) a hydrophobic phase comprising from greater than 50% to 99.5%, by weight of the multi- phase oral composition, of petrolatum,
wherein a ratio of a concentration in weight percent of the active agent present in the aqueous phase to a concentration in weight percent of the active agent present in the multi- phase oral composition is from 5 to 50,000,
wherein the multi-phase oral composition is a water-in-oil emulsion having droplets of the aqueous phase dispersed within the hydrophobic phase and the multi-phase oral composition does not comprise an emulsifier or a crosslinked polymer of an ethylenically unsaturated monomer.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Quan teaches a safe composition for delivering effective amount of active agent to teeth. The composition comprises an aqueous phase; hydrophilic active agent in the hydrophilic phase; and inert hydrophobic phase. The composition provided alone or with a carrier such as an integral strip carrier (¶¶ 0005- 0017, 0179). The inert hydrophobic phase is the predominant portion in the composition relative to the aqueous phase (¶ 0010), and is present in amounts of about 30% to about 90% (¶ 0051). The aqueous phase can be about 1% to about 45% of the compositions (¶ 0047). The active agent is present in a safe and effective amount of about 0.01% to about 50% (¶ 0049). The composition can be a water in oil emulsion (¶ 0041). Examples 1 through 3 in paragraph (¶ 0178) teach compositions comprising 4.1%, 4.24% and 4.1% of water; and 77.9%, 93.33%, and 73.9% of mineral oil. Example 1, 3-5 show 17% active agent in the aqueous phase relative to the active agent in the multi-phase oral composition, that falls within the claimed amount. The amounts taught by the examples falls within that claimed by instant claim 1 and further show predominance of the hydrophobic phase. The composition comprises a safe and effective amount of a thickening agent that also act as viscosity modifiers include hydrocarbons, petrolatum and polyethylene wax. Thickening agents are present in amount of 20% (¶¶ 0052, 0073-0076). Such thickeners are hydrophobic in nature and would be present in the hydrophobic phase of the composition. The reference teaches hydrogen peroxide as an active gent. The reference discloses active agents can further include anti-caries, fluoride ion source, anti-calculus agents, anti-antimicrobial agents, anti-inflammatory agents, antagonists, desensitizing agents, and nutrients (¶¶ 0122-0156). Any hydrophilic active agents of the above agents would expected to reside in the hydrophilic phase because the composition is water-in oil emulsion. The reference teaches emulsifier can be present in the composition in amount as low as about 0.001% (¶ 0059).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Quan teaches hydrophobic phase comprising hydrocarbons and petrolatum, the reference does not exemplify petrolatum as claimed by claim 21. While Quan teaches very low concentration of emulsifier in the composition, as low as about 0.001%, the reference does not explicitly teach composition does not comprise emulsifier or crosslinked polymer of and ethylenically unsaturated polymer as claimed by claim 21.
Feng teaches dental bleaching compositions comprising teeth whitening agent, and a matrix of petrolatum for holding the whitening agent in such a manner that the whitening agent is released to surface of a tooth (abstract; ¶¶ 0012, 0015, 0026). Feng used the petrolatum as a matrix which means petrolatum surrounds the whitening agent composition forming multi-phase composition. Such structure comprising hydrophobic petrolatum surrounding hydrophilic whitening agent, and forming continuous phase surrounding the droplets of the active agent that form discontinuous phase reads on water-in-oil emulsion. Feng teaches composition comprising hydrophilic and hydrophobic ingredients. Feng teaches the use of emulsifying agent in paragraph [0036] implying the composition is emulsion. The reference teaches that a second phase of water soluble polyvinyl pyrrolidone (PVP) can be present in the petrolatum matrix, which is a hydrocarbon (¶¶ 0026, 0027). This teaching implies first phase of the active agent, and water soluble PVP, and outer petrolatum hydrophobic phase. Feng teaches composition comprising 5% hydrogen peroxide (teeth whitening agent), 5% water, 5% polyoxyalkylene (solvent), 74.250% white petrolatum, 10% polyvinyl pyrrolidone, 0.250% flavor(s) and 0.500% sodium saccharin (¶¶ 0020, 0030, 0038). In example 1, the composition comprises 5% of the total composition of hydrogen peroxide. Since the petrolatum forms the outer hydrophobic matrix, and the hydrophilic phase comprises 5% water, 5% peroxide and 5% solvent (polyoxyalkylene), then the aqueous phase forms 15% of the total composition. Accordingly, hydrogen peroxide forms 5% of the total composition, and forms 5% of the 15% of the hydrophilic phase, which is 33% of the aqueous phase. Note, PVP forms a separate phase. Feng teaches steps of applying a therapeutically effective amount of peroxide composition to one or more teeth leaving the bleaching composition in contact with the one or more teeth such that the bleaching composition may whiten the tooth (¶ 0017). The composition is advantageous because it can be applied by consumer without a dental professional by convenient means such as tray, mouth guard, stint, wand applicator or alternative means (¶ 0024).
Montgomery teaches oral therapeutic dental composition comprising teeth whitening agent forming therapeutic agent phase dispersed in a carrier or film providing water-in oil emulsion. The less water soluble carrier or film provides reduced solubilizing effect of saliva and prolonged release of the therapeutic agent (abstract; ¶¶ 0016-0018, 0021). The carrier is hydrophilic comprising petrolatum, waxes, polyethylene glycol, fatty compounds, etc., and combination thereof (¶ 0023). The reference the carrier comprises 50-99% petrolatum (¶ 0028; claims 1, 6). Therapeutic whitening agent includes peroxides (¶ 0031).
Gers-Barlag teaches water-in-oil emulsion free of emulsifier provides surprisingly and markedly stable emulsion characterized by excellent topical tolerability (¶¶ 0037-0040).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide water-in-oil emulsion comprising hydrophilic phase comprising therapeutic agent, e.g. teeth whitening agent, and a predominant hydrophobic phase forming 30-99% of the emulsion wherein the hydrophobic phase comprises saturated hydrocarbons, mineral oils and petrolatum as taught by Quan, and replace the hydrophobic phase that comprises hydrocarbon, mineral oils and petrolatum with petrolatum phase taught by Feng. One would have been motivated to do so because Feng teaches that petrolatum holds the whitening agent in such a manner that the whitening agent is released to surface of a tooth wherein the composition is advantageous because it can be applied by consumer without a dental professional by convenient means. One would have reasonably expect formulating water in oil emulsion composition comprising at least 50% petrolatum in a hydrophobic phase and a teeth whitening agent that is released to the teeth when applied by convenient manner by the consumer without a dental professional, and successfully whitens the teeth.
Further, one having ordinary skill in the art would have used 50-99% petrolatum as taught by Montgomery in the hydrophobic phase of the composition taught by the combination of Quan and Feng because Montgomery teaches the less water soluble the hydrophobic phase of water-in-oil composition provides reduced solubilizing effect of saliva and prolonged release of the hydrophilic therapeutic agent.
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide water-in-oil emulsion comprising hydrophilic phase comprising therapeutic agent, and a predominant hydrophobic phase comprising petrolatum as taught by the combination of Quan, Feng and Montgomery wherein the composition comprises as low as about 0.001% emulsifier as taught by Quan, and completely exclude emulsifier from the composition as taught by Gers-Barlag. One would have been motivated to do so because Gers-Barlag teaches emulsion free of emulsifier provides surprisingly and markedly stable emulsion characterized by excellent topical tolerability. One would have reasonably expect formulating stable water in oil emulsion composition free of emulsifier that is markedly stable and has excellent patient tolerability.
Regarding the limitation of claim 21 that “the multi-phase oral composition does not comprise an emulsifier or crosslinked polymer of an ethylenically unsaturated monomer”, it is noted that Quan teaches emulsifier can be present in the composition in amount as low as about 0.001%, and in view of the term about of the reference, the amount of the emulsifier taught by Quan can be so little so that it can be completely eliminated as taught by Gers-Barlag to obtain more stable tolerable emulsion that comprises no crosslinked polymer of an ethylenically unsaturated monomer.
Regarding the amount of aqueous phase in the composition as claimed by claim 21, Quan teaches very low level of aqueous phase in the composition, preferably 2-5%, and Examples 1 through 3 in paragraph teach compositions comprising 4.1%, 4.24% and 4.1% of water, all fall within the claimed 0.002% to less than 50%.
Regarding the amount of hydrophobic phase as claimed by claim 21, the combination of the references teaches replacing the hydrophobic phase taught by Quan that forms 77.9%, 93.33%, and 73.9% of the composition with petrolatum taught by Feng or Montgomery that comprises 55-99% petrolatum, therefore, obtaining composition comprising 77.9%, 93.33%, and 73.9%, or 50-99% of hydrophobic phase of petrolatum.
Regarding the amount of the active agent in the composition as claimed by claim 21, Example 1, 3-5 of Quan teaches 6% and 17% active agent that fall within the claimed amount of 0.001-20%.
Regarding the limitation that the composition is water-in-oil emulsion claimed by claim 21, all the cited references teaches composition in the form of water-in oil emulsion.
Regarding the concentration of the active agent in the aqueous phase to the concentration of the active agent in the overall composition as claimed by claims 21, 2-3 of 5-50,000% (claim 21), 10-50,000% (claim 2), at least 15-50,000% (claim 3), Quan teaches active agent is present in a concentration of about 0.1% to about 20% of the total composition, and the aqueous phase is as low as 2-5% of the composition, and the hydrophobic phase is 30-90%, therefore the claimed ratios are achieved.
Regarding claim 4 that the active agent is from 1-10%, Quan teaches about 0.1% to about 20%, and preferably 0.5-9%, and more preferably 0.5-3%, and exemplifies 6% by example 2. Further, based on the used active agent, the amount can be determined.
Regarding the properties claimed by claims 5-8 and 17-18, they are expected by the composition taught by combination of the cited references that teaches composition comprising the claimed elements in the claimed amounts.
Regarding testing methods claimed by claims 5-8 and 17-18, such methods are not part of the claimed composition. It is only an in-vitro diagnostic test that would inherently provide the same results if run on prior art composition. The recitation of these in-vitro tests does not impart patentability to claims directed to composition. The burden is on applicants to show that the claimed testing process resulted in novel and unobvious difference between the claimed composition and prior art composition since the Patent Office does not have the facilities for preparing the claimed materials and comparing them with the prior art inventions. See In re Best, 562 F.2 1252, 195 USPQ 430 (CCPA 1977); and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113. Compositions with the ingredients in the amounts as required as set forth in the instant claims are taught by the prior art and therefore the burden is shifted to applicant to demonstrate that the compositions of Quan do not have the features relied upon.
Regarding the active agents claimed by claim 15, Quan, Feng and Montgomery teach hydrogen peroxide that has antimicrobial effect. Further, Quan teaches anti-caries, fluoride ion source, anti-calculus agents, anti-antimicrobial agents, anti-inflammatory agents, antagonists, desensitizing agents, and nutrients. Any hydrophilic active agents of the above agents would expected to reside in the hydrophilic phase.
Regarding claim 16 that hydrophobic phase comprises mineral oil thickened with wax, mineral oil thickened with polyethylene, or petrolatum, Quan teaches mineral oils in the hydrophobic phase and also discloses hydrophobic thickeners such as polyethylene wax and petrolatum that are hydrophobic in nature and will be in the hydrophobic phase providing mixture of mineral oils with polyethylene wax or petrolatum that meets the claim. Montgomery teaches wax, polyethylene glycol or combination thereof in the hydrophobic phase.
Regarding the carrier claimed by claim 19 and strip claimed by claim 20, Quan teaches carrier for the composition that can be strip.
Regarding the amount of the active agent of less than about 0.1, and less than 0.09995% as claimed by claims 22-23, respectively, Quan teaches 0.01% to about 50% of active agent in the multi-phase oral composition that embrace the claimed amounts.
Regarding the two-dimension density and cross-sectional area as claimed by claims 24 and 25, the cited references in combination teaches the instantly claimed multi-phase composition comprising the same ingredients in overlapping amounts, and it is expected that the composition would have the same two dimensional density, absent evidence to the contrary. One having ordinary skill in the art would have determined the required cross sectional area of the droplet based on the used drug.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 06/18/2025 have been fully considered but they are not persuasive.
Rejection Under 35 U.S.C. § 103 (AIA ) Over Quan and Feng
The focus of applicant’s argument is regarding Candau's reference. Applicants argue that Candau provides a specific solution for creating a stable emulsifier-free emulsion. Specifically, Candau discloses that composition stability is achieved by incorporating "at least one crosslinked polymer of at least one ethylenically unsaturated monomer" (Candau, Abstract; col. 3, lines 5-11; claim 7). These polymer products (e.g., Carbopol® and Pemulen®) mentioned in Candau function as the primary stabilizing agent in the absence of a traditional emulsifier. Thus, Candau is not directed to simply omitting an emulsifier, but to replacing the function of the emulsifier with a specific class of polymer stabilizer. Amended claim 21 now explicitly excludes the very solution that Candau proposes.
This argument is moot in view of the newly cited reference to Gers-Barlag because the reference clearly teaches emulsion free of emulsifier and does not contain any crosslinked polymer of an ethylenically unsaturated monomer.
Non-Statutory Double-Patenting Rejection
The examiner acknowledges that applicants consider filing a terminal disclaimer upon indication of allowable subject matter for the non-statutory obviousness-type double patenting rejection. Therefore, the double patenting rejection are maintained.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./