DETAILED ACTION
The receipt is acknowledged of applicants’ amendment filed 04/08/2026.
Claims 2-8 and 15-25 are pending and subject of this office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 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 4 and 22-23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites “….active agent ranges from about 1% to about 10% by weight of the multi-phase oral composition….”, claim 22 recites “.…less than about 0.1%....”, and claim 23 recites “…..less than about 0.09995%....”. Claims 4, 22 and 23 depend on claim 21 that has been amended to recite “….from about 0.6% to about 5% by weight of the multi-phase oral composition, of an active agent….”. Therefore, claims 4, 22 and 23 broaden the scope of the amount active agent in multi-phase composition to amount more than that claimed by generic claim 21, from which claims 4, 22 and 23 depend. 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
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), Feng et al. (US 2005/0036958), Montgomery (US 2005/0008584), and Gers-Barlag et al. (US 2003/0175221), all references are of record.
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 0.6% to about 5%, 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.
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 20%, 0.5-9%, 3-8%, generally from 0.5-3%, or 0.5-1.5% (¶ 0049). The composition can be 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. The amounts taught by the examples fall 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 acts as viscosity modifiers include hydrocarbons, petrolatum and polyethylene wax. Thickening agents are present at 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 be 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 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 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”, 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.
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 of 0.6-5% in the composition as claimed by claim 21, Quan teaches active agent in amount 0.01% to about 20%, 0.5-9%, 3-8%, generally from 0.5-3%, or 0.5-1.5%, further Feng teaches 5% peroxide, that reads on active agent and falls within the claimed amount.
Regarding the limitation that the composition is water-in-oil emulsion claimed by claim 21, all the cited references teach 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 be 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 04/08/2026 have been fully considered but they are not persuasive.
Rejection Under 35 U.S.C. § 103 (AIA ) Over Quan, Feng Montgomery and Gres-Barlag
Applicants argue that the rejection relies on an impermissible hindsight reconstruction and fails to establish a reasonable expectation of success or a motivation to combine the references to achieve the full scope of the claimed invention.
In response to this argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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, motivation to combine the references exists, even if different from what applicants had done, and reasonable expectation to achieve the present invention was presented as set forth in this office action. Conclusion of obviousness does not require absolute predictability, only reasonable expectation of success.
Applicants argue that independent claim 21, as amended, requires a multi-phase oral composition where: The concentration of the active agent is from about 0.6% to about 5% by weight of the multi-phase oral composition; and "a ratio of a concentration in weight percent of active agent present in the aqueous phase to the concentration in weight percent of active agent present in the overall multi-phase oral composition is from 5 to 50,000" (Claim 21). The specification highlights the surprising and unexpected benefits associated with this specific ratio and overall active agent concentration range, stating: this surprising combination of seemingly contradictory parameters in the present invention delivers the active agent to the tooth surface and the oral cavity with a high driving force even when the overall concentration or amount of active agent delivered to the tooth surface and the oral cavity is low. Consequently: 1) The high driving force delivers a surprisingly high level [of] efficacy and/or speed, while 2) The low overall/net concentration or low amount of active agent delivered to the tooth surface may help reduce side effects.
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references including ingredients and their amounts, as set forth in this office action, and mechanism of action of the composition is inseparable and expected from the composition. Motivation to combine the references exists, and reasonable expectation to achieve the present invention was presented. Any unexpected results applicants had achieved are expected from combination of the prior art that teaches composition that comprises all the claimed ingredients in the claimed amounts. In addition, regarding applicant's arguments of unexpected superior results in the instant specification, it is the examiner's position that the data in the specification regarding are not unexpected results and therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness...of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
Applicants argue that specification, page 41, lines 14-20, further provides data illustrating this unexpected performance, where compositions with low overall H2O2 concentrations (e.g., less than 0.1% in Example-IA) achieved superior bleaching efficacy (-bb* of -1.95 after 14 treatments) compared to a comparative aqueous gel with a significantly higher H2O2 concentration (5.25% H202 in Comparative Example II, achieving -1.43 after 14 treatments). Specification, pp. 95-98 and Table 1. This demonstrates that the inventive composition achieves "surprisingly high efficacy" even at "low total levels of the active agent." Specification, page 26, line 26-page 27, line 2.
In response to this argument, it is argued that Quan teaches 0.01% to about 20%
of active agent in the multi-phase oral composition that embraces the claimed amounts. Further, example I-A that applicant refer to is directed only to hydrogen peroxide
delivered on strip for 60 minutes, and used with electromagnetic radiation, while the
present claims are directed to any active agent, any multi-phase composition, and not
strip, and did not use any electromagnetic radiation to enhance the effect of the active
agent. Therefore, the results of example I-A does not commensurate in scope with the
instant claims. The objective evidence of nonobviousness must be commensurate in scope with claims that evidence is offered to support. See in Greenfield and DuPont 197 USPQ 227 (CCPA 1978); In re Boesch and Slaney 205 USPQ 215 (CCPA 1980); and In re Tiffin and Erdman 170 USPQ 88 (CCP 1971).
Applicants argue that the specification details that this emulsifier-free approach leads to beneficial results, such as reduced oral/topical irritation and tooth-sensitivity (Specification, Page 13, Line 25 - Page 14, Line 14), while maintaining or even enhancing efficacy. This is contrary to the expectations of one skilled in the art who would anticipate instability or reduced performance upon the removal of an emulsifier from an emulsion, especially given the challenging environment of the oral cavity.
In response to this argument, it is argued that the cited reference would have suggested to one having ordinary skill in the art to remove emulsifiers, as applicants had done, and not teaching instability or reduced performance of the emulsion as applicants assert. Quan teaches composition comprises as low as about 0.001% emulsifier, and Gers-Barlag teaches completely exclude emulsifier from the composition because 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. The reference suggests stability that applicants seek to achieve.
Applicants disagree with the office assertion that "the claimed ratios are achieved" merely by calculating them from the general disclosures of Quan (Office Action, page 22). This is an improper application of hindsight. None of the cited references teach or suggest the criticality or advantage of maintaining the active agent concentration within this specific inter-phase ratio to achieve the demonstrated superior efficacy at lower overall active agent levels and reduced side effects. The focus of the cited publications is on the overall percentage of active agent, or the composition of phases, but not on this sophisticated inter-phase concentration ratio and its surprising performance implications. An ordinary skilled artisan would not have been motivated to arrive at this specific ratio, nor would they have recognized the surprising results associated with it, without the benefit of Applicant's disclosure.
In response to this argument, it is reiterated that the examiner did not apply improper hindsight, rather relied on what was known in the art before the effective filing date of the present invention to construe the rejection. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references, and reasonable expectation to achieve the present invention. Any superior efficacy or surprising performance would be expected from the prior art in combination that suggests the instantly claimed composition, absent evidence to the contrary.
Obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. V. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir. 1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Applicants argue that the combination of Quan, Feng, and Montgomery, even if modified to use petrolatum as a hydrophobic phase, would not teach or motivate the critical feature of an emulsifier-free multi-phase oral composition, particularly in light of the unexpected benefits described in the Applicant's specification. The claimed invention, as amended, represents a non- obvious improvement over the cited prior art.
In response to this argument, it is argued that all the limitations of the current claims are taught by combination of the cited references, explicitly or implicitly, as set forth in this office action. Conclusion of obviousness under 35 U.S.C. 103 (a) does not
require absolute predictability, only a reasonable expectation of success; and
references are evaluated by what they suggest to one versed in the art, rather than by
their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969). In the light of the
foregoing discussion, the Examiner's ultimate legal conclusion is that the subject matter
as defined by the claims would have been prima facie obvious within the meaning of 35
U.S.C. 103 (a).
Applicants argue that while Gers-Barlag may disclose "emulsifier-free" compositions (Gers-Barlag, [0037]), this feature alone does not render the entirety of the claimed invention obvious when combined with the novel and critical concentration ratio and range of active agent that yield unexpected results. There is no teaching in the prior art that combining these features would lead to the observed surprising results.
In response to this argument, it is argued that the claimed composition is taught by combination of the cited references including amounts and ratio of active agents, and Gers Barlag is relied upon for solely teaching water in oil emulsion can be free of emulsifiers. It is noted that applicants argue against Gers-Barlag individually, and one cannot show non-obviousness by attacking the references individually wherein obviousness is based on combination of the references. Gers-Barlag is relied upon for solely showing water-in-oil emulsion can be free of emulsifier and meanwhile has advantage of providing surprising and marked stable emulsion characterized by excellent topical tolerability. The reference satisfies the purpose for which it was applied.
Applicants argue that Ger-Berlag is non-analogous art and should not be used to support an obviousness rejection against the pending claims. A reference is considered analogous art if it is: (1) from the same field of endeavor, regardless of the problem addressed; or (2) if not from the same field of endeavor, is reasonably pertinent to the particular problem with which the inventor was involved.
In response to this argument, the examiner respectfully disagrees because Gers Barlag is a topical composition in the form of water-in-oil emulsion as claimed and comprises active agents in effective amounts. Therefore, the reference is analogous art, from the same field of endeavor, which is topical composition, and is reasonably pertinent to the particular problem with which the inventor was involved, which is topical delivery of active agent from water in oil emulsion.
Applicants argue that Gers Barlag is from “Different Field of Endeavor” because Gers-Barlag is directed to emulsifier-free finely disperse systems of oil-in-water and water- in-oil type emulsions (Title), specifically for "cosmetic or dermatological preparations" (Abstract, [0001]). Gers-Barlag repeatedly emphasizes its application to "skin care" ([0011]), "deodorants" ([0013]), and "medicinal topical compositions" for skin treatment ([0014]). The problems it aims to solve relate to "skin tolerability" ([0025]), "higher stability" in cosmetic/dermatological preparations, and "excellent cosmetic properties" without leaving a "dry or dull impression on the skin" ([0040]). In contrast, claim 21 relates to a "multi-phase oral composition for delivering one or more active agents." The specification consistently describes the invention in the context of "oral care" (Page 1, Line 1, Page 6, Line 6), specifically for "delivering active agents to teeth" (Page 6, Line 5) and treating "oral conditions" such as "whitening/bleaching teeth" (Page 6, Line 16). The benefits described are related to "oral/topical irritation and/or tooth-sensitivity" (Page 13, Line 25; Page 17, Lines 1-3). The fields of "skin care/dermatological preparations" and "oral care compositions" are distinct. A person of ordinary skill in the art in oral care would not typically look to references disclosing skin care formulations to solve problems related to the unique physiological environment of the oral cavity. The oral environment presents challenges such as salivary dilution, mastication forces, and specific interactions with dental and mucosal tissues, which are not relevant or analogous to skin application. Therefore, Gers-Barlag is not from the same field of endeavor as the claimed invention.
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references. The reference is directed to a topical emulsion composition as instant composition. The intended use of the composition, even if claimed, does not impart patentability to composition claims. The reference is in the field of applicant endeavor of topical emulsion composition as instantly claimed composition, and the reference is concerned with the same problem applicants are concerned with which is water-in-oil emulsion free of emulsifier. It is proper to be relied on Gers Barlag for rejecting the claims as being in the field of applicant’s endeavor. Further, it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Applicants argue that Gers Barlag is “Not Reasonably Pertinent to the Problem” because the specific problems addressed by Gers-Barlag are not reasonably pertinent to the problems addressed by the present application. Gers-Barlag focuses on achieving stable, emulsifier-free Pickering emulsions for skin tolerability (Abstract, [0025], [0026]). Its motivation is to overcome issues like allergic reactions or oversensitivity on the skin due to emulsifiers ([0015]). In contrast, the present application is aimed at providing multi-phase oral compositions that deliver active agents with "improved efficacy" for oral conditions (Page 1, Line 21) and, crucially, a "surprisingly high level of efficacy combined with low oral/topical irritation and/or tooth- sensitivity" (Page 19, Lines 20-22). The problem of skin irritation is vastly different from oral irritation or tooth sensitivity. The physiological mechanisms and acceptable levels of irritation differ significantly between skin and oral tissues. The success criteria and specific technical considerations for achieving effective and safe delivery of active agents in the oral cavity (e.g., substantivity on teeth, resistance to salivary dilution, taste perception, effects on enamel/dentin) are entirely different from those for skin.
In response to this argument, it is reiterated that the present claims are directed to composition, and all the elements of the claimed composition are taught by the cited references. The reference is directed to a topical emulsion composition as instant composition and is concerned to eliminate emulsifiers from the topical composition. The intended use of the composition, even if claimed, does not impart patentability to composition claims. The reference pertinent to the problem with it applicants are concerned, which is providing topical composition in the form of emulsion free of emulsifier. It is proper to be relied on Gers Barlag for rejecting the claims as being in the field of applicant’s endeavor and penitent to the problem of topical emulsion composition. Further, it has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Applicants argue that there is no teaching or suggestion in Gers-Barlag that its emulsifier-free Pickering emulsions for skin care would be effective or even suitable for use in the oral cavity, let alone solve the specific problems of improved efficacy and reduced oral/tooth sensitivity. The concerns of skin application (e.g., protection against environmental influences, delaying skin aging, controlling body odor as deodorants) are wholly unrelated to the dental problems addressed by the Applicant's invention. Therefore, Gers-Barlag is neither from the same field of endeavor nor is it reasonably pertinent to the problem addressed by the present application, and thus, it should be considered non-analogous art.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the references exists and reasonable expectation to achieve the present invention was presented. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references. It has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Applicants argue that claims 5 and 6 recite specific and distinct cone penetration consistency values for the hydrophobic phase of the multi-phase oral composition. Claim 5 specifies a cone penetration consistency value of about 100 to about 500, and claim 6 further refines this range to about 100 to about 300. The rejection fails to demonstrate how Quan alone or in combination with the other cited publications, teaches or suggests these specific, critical ranges.
In response to this argument, the examiner maintains that any properties applicants achieved are expected by the composition taught by combination of the cited references that teaches composition comprising the claimed elements in the claimed amounts. Further, the testing method claimed by the claims 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.
Applicants argue that Applicant previously submitted a declaration under 37 C.F.R. § 1.132 from Dr. Jayanth Rajaiah on July 18, 2023 (the "Declaration"), which is incorporated herein in its entirety. The Declaration provides experimental data regarding the cone penetration consistency values of compositions similar to those disclosed in Quan. The Declaration details the preparation and testing of various hydrophobic phases, including those comprising mineral oil, olive oil and petrolatum, which are key components of the hydrophobic phase in Quan's compositions. The experimental results in the Declaration clearly show that the cone penetration consistency values for the hydrophobic phases derived from Quan exceeded the highest value measurable on the penetrometer (610 units) by a wide margin. Declaration, Page 6, Item 18. These experimentally determined values of "greater than 610 units" are well outside the claimed ranges of claims 5 and 6. A person of ordinary skill in the art, in attempting to reproduce or modify the compositions of Quan would encounter hydrophobic phases with significantly higher cone penetration consistency values than those claimed.
In response to this argument, it is argued that the declaration did not show any attempt to reproduce the hydrophobic phase of Quan with the claimed amount of petrolatum and never tested the modification of Quan with the amount of petrolatum taught by Montgomery and used by applicants. Applicants tested hydrophobic phase comprising mineral oil while the rejection based on replacing the entire hydrophobic phase of Quan with that of Montgomery comprising 50-99% petrolatum as claimed. A person of ordinary skill in the art, in attempting to reproduce or modify the compositions of Quan would encounter hydrophobic phases comprising 50-99% petrolatum that is expected to have the claimed cone penetration consistency as claimed, since materials and their properties are inseparable.
Applicants argue that Declaration highlights the practical implications of these high penetration values in Quan's compositions. The compositions exemplified by Quan (Examples 1, 2, and 4) were observed to exhibit "substantial macroscopic separation" after only 48 hours. Declaration, Page 3, Item 8; Page 4, Item 10; Page 4, Item 12. This macroscopic instability is visually evident in Attachments 1-12 of the Declaration. In contrast, the Applicant's invention (Example I-A) demonstrated stability with "no macroscopic separation" even after 48 hours, as shown in Attachments 14-17 (Rajaiah Decl., Page 5, Item 16). This fundamental difference in stability, directly linked to the physical properties of the hydrophobic phase, would teach away from utilizing the hydrophobic phases of Quan et al. to achieve the stable compositions of the present invention, which require specific cone penetration values. Therefore, Quan not only fails to disclose or suggest the specific cone penetration consistency values recited in claims 5 and 6, but its teachings lead to compositions with undesirable instability, thereby teaching away from the claimed invention.
In response to this argument, it is argued that the declaration refers only to the
system described in the above referenced application and not to the individual claims of
the application. The declaration compares example 1A of the present invention that
comprises very specific composition comprising 0.2857% of 35% aqueous solution of
hydrogen peroxide and 99.7134% petrolatum. The claims language permits the presence of other ingredients taught by Quan in either phase of the claimed emulsion.
Further, applicants showed stability with only very specific amount of each ingredient while the claims recite broader ranges of each ingredient. Stability of the composition taught by combination of the cited references is inseparable from the composition drawn from combination of the cited references. The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
Further Quan does not teach away from the present invention. "A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant." In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994).
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, double patenting rejections are maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./
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