DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/31/2025 has been entered.
Election/Restrictions
Claims 17, 26-32 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/9/2024. Newly added claim 33 is withdrawn from further consideration as it is directed to a non-elected species of quaternary ammonium compound.
Response to Arguments
All of Applicant’s arguments filed 5/20/2025 have been fully considered.
Specification
Applicant amendments filed 5/20/2025 are accepted and the objection to the specification is withdrawn.
Claim Objections and Rejections under 112(b)/112(d)
In view of the amendments to the claims addressing the issues noted by the Examiner, all objections and 112(b)/112(d) rejections presented in the office action mailed 7/2/2025 are withdrawn.
Rejections under 103
Applicant argues that all the Baker references do not teach the claimed ratio of 1:7 to 1:14, in fact, the office highlighted prior art teachings showing blend ratios of 1:5 and 1:5.5 which are not within the claimed ranges and thus the prior art does not teach the instant invention.
This is not persuasive. While the Examiner does note that the prior art teaches blend ratios of 1:5 and 1:5.5 the office action clearly states that ranges that are merely close, but not overlapping are expected to have the same properties and thus making the claimed range obvious. In the alternative, the examiner for all three references points to the teachings of the prior art which demonstrate that the prior art also teaches blend ratios with overlap with the claimed ranges (see updated rejection below). In fact, Baker’294 exemplifies an embodiment having a blend ratio of 1:8 which falls directly within the claimed ranges [0141].
Applicant argues that the prior art only exemplifies blend ratios of 1:5 and 1:5.5.
This is not persuasive as the teachings of a references are not limited to the exemplified embodiments. Baker’294 clearly teaches using 2-8% of non-ionic surfactant and 1% CPC, which provides a ratio that overlaps with the claimed ranges.
Applicant argues that the Specification, Figs 2-4 shows that of the conditions tested, peak epidermal skin permeation was observed squarely within the claimed blend ratio (i.e. when a blend ratio of 1:9 used).
This is not persuasive. While Fig 2-3 do show that 1:9 performed slightly better than 1:5, Fig. 5 clearly shows that a blend ratio of 1:5 outperformed 1:9 with respect to dermal skin permeation, 1:9 does not appear to be consistently better than 1:5. Applicant provides no evidence that the results between 1:5 and 1:9 are unexpected or surprising. Applicant provides no evidence that the differences shown in Fig. 2-4 are statistically significant. Applicant has not provided error bars or other explanation in the data suggesting the results represent a single experiment and are not reproducible.
Regarding Fig 2 and 3, both ratios of 1:5 and 1:9 showed an increased permeation and there is no evidence that the entire claimed ranges of 1:7 to 1:14 would have results such as 1:9. In fact it’s unclear if the permeation of 1:7 would be similar to 1:5 or to 1:9 Furthermore, Fig. 2-3 test a single data point comprising .13% BZK+Poloxamer, however, no data has been provided with respect to BZK+Tween 20 or Tween 80; or with respect to CPC as elected.
Double Patenting
The terminal disclaimer filed on 5/20/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,369,578 has been reviewed and is accepted. The terminal disclaimer has been recorded and the rejection is withdrawn.
New Claim Rejections - 35 USC § 112(b)
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15(b) and 15(b)(iii) recite “the oil,” this lack antecedent basis as the claim from which it depends recites “at least one oil” and it’s unclear if “the oil” in claim 15 refer to one oil, more than one oil, or all oils.
Maintained/Modified 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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 4-13, 15-16, 18-25 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2017/0246294).
Baker’294 discloses nanoemulsion compositions for treating allergic and inflammatory diseases (Abs). The nanoemulsions are taught to comprise an aqueous phase and an oil phase [0107] and Baker’294 defined nanoemulsion to mean oil in water dispersions [0038], reading on o/w nanoemulsion as recited by instant claim 1. The nanoemulsion have droplets with a mean particle size of about 0.1-5 microns, preferably 200-800nm [0038 and 0193], this embraces the claimed “less about 1 micron.” Baker’294 discloses a nanoemulsion comprising 5vol% poloxamer-407 (elected surfactant), ethanol (elected solvent), 64 vol% soybean oil (elected oil), water and 1vol% CPC (cetyl pyridiumium chloride, elected quaternary ammonium compound) [0124]. This results in a concentration ratio of CPC to nonionic surfactant of 1:5.5, while this range doesn’t overlap with the claimed 1:7, when ranges are merely close a prima facie case of obviousness as a skilled artisan would have expected them to have the same or similar properties absent evidence showing the claimed range to be critical.
In the alternative, Baker’294 also discloses a nanoemulsion comprising 2-8vol% Triton X-100 (a non-ionic surfactant), ethanol (elected solvent), 60-70vol% soybean oil (elected oil), water and 1 vol % of CPC [0126] and exemplified using 0.1% CPC with 0.8% Triton X-100 [0141]. Baker’294 teaches Triton X-100 and poloxamer-407 to be equivalent non-ionic surfactants suitable for use thus it would have been prima facie obvious to substitute Triton X-100 for Poloxamer-407 and use Poloxamer 407 in amounts ranging from 2-8vol% with a reasonable expectation of success. This results in a concentration ratio of CPC to nonionic surfactant of 1:2-1:8 for formulation of [0126] and a ratio of 1:8 when using 0.1 CPC and 0.8 non-ionic surfactant, which overlaps or falls within the claimed ratio.
Baker’294 teaches compositions comprising the nanoemulsion, wherein the nanoemulsion is diluted prior to administration the subject, the composition is taught to comprise 0.5-50% of the nanoemulsion, which overlaps with the claimed 0.5 to about 60% [0220].
Baker’294 teaches the composition can be applied topically, intranasally, transdermally, mucosally or orally [0062 and 0266-0267].
Instant claim 1 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
Regarding claims 4: Instant claim 4 states “where at least about 33%...and at least about 0.2% of the weight…” While Baker’294 is silent to these limitations, both Baker’294 and the instant specification teaches that the nanoemulsion can be made using the methods of manufacture disclosed in U.S. 2004/0043041 and U.S. Pat. Nos. 5,103,497 and 4,895,452. These methods include mixing the oil phase and aqueous phases with relatively high shear, thus it would have been prima facie obvious to prepare the nanoemulsion of Baker’294 using one of the methods above and as Baker makes obvious the elected ingredients of the nanoemulsion soybean oil, CPC, poloxamer 407, water and ethanol, made by a method taught by the instant specification to be suitable, the resulting nanoemulsion is expected to have the same properties as the nanoemulsion of the prior art absent evidence to the contrary. Instant claim 4 also recites “the nanoemulsion enhanced delivery…”, these are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected have the same properties.
Regarding claim 5: Instant claim 5 states “where the mean droplet size…does not change by more than about 10%...” While Baker’294 is silent to these limitations, both Baker’294 and the instant specification teaches that the nanoemulsion can be made using the methods of manufacture discloses in U.S. 2004/0043041 and U.S. Pat. Nos. 5,103,497 and 4,895,452. These methods include mixing the oil phase and aqueous phases with relatively high shear, thus it would have been prima facie obvious to prepare the nanoemulsion of Baker’294 using one of the methods above and as Baker makes obvious the elected ingredients of the nanoemulsion soybean oil, CPC, poloxamer 407, water and ethanol, made by a method taught by the instant specification to be suitable, the resultant nanoemulsion is expected to have the same properties as the nanoemulsion of the prior art absent evidence to the contrary. Instant claim 5 also recites “the nanoemulsion enhanced delivery…”, these are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected have the same properties.
Regarding claim 6: Instant claim 6 recites “wherein after a single application … …as compared to…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected have the same properties after application to the desired area.
Regarding claims 7-8: Instant claims 7 recites “wherein after a single application … …as compared to…” Instant claim 8 defines an increase in residence time. These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, Baker’294 also teaches the composition to be , the composition claimed and the composition of the prior art will be expected to have the same properties after application.
Regarding claim 9: Instant claim 9 recites “wherein when the composition is applied … …as compared to…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties after application to the desired area.
Regarding claim 10: Baker’294 teaches that preferred nanoemulsion are non-toxic to animals and humans [0142], which reads on alternative option (a).
Regarding claim 11: Instant claim 11 depends from claim 10 and further limits the types of bacteria with regards to instant claim 10(c), however, as embodiment 10(c) is recited in the alternative, it is an optional embodiment that is not actually required. Claim 11 simply defines the species of bacteria that must be killed, if embodiment 10(c) was required. For purposes of examination, as embodiment 10(c) is optional, then the embodiments of claim 11 are also optional and not required.
In the alternative, embodiments (10c) and claim 11 are reciting a property of the claimed composition and as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art are expected to have the same antibacterial properties.
Regarding claim 12: Baker’294 teaches the nanoemulsions have been shown to inactivate bacteria, both vegetative and spore forms, which reads on alternative option (b).
Regarding claim 13: As discussed above, Baker’294 teaches a concentration ratio of CPC to nonionic surfactant of 1:2-1:8, which overlaps with alternative option (a).
Regarding claim 15: As discussed above Baker’294 teaches an embodiment comprising 0.1% CPC and 0.8% Triton X-100 which reads on alternative embodiment 15(d).
Regarding claim 16: As discussed above, Baker’294 teaches the nanoemulsion to comprise soybean oil and ethanol, which reads on alternative embodiment (b)(ii)/(iii) and (c)(ii).
Regarding claim 18: Baker’294 teaches that the composition comprising a nanoemulsion can be co-administered with one or more antibiotics (reading on therapeutic or active agent), a suitable antibiotic for use include quinolones [0212], this the use of quinolones in the composition is prima facie obvious. This reads on alternative embodiment (g).
Regarding claim 19: While Baker’294 doesn’t specifically teach the concentration in which the therapeutic or active agent should be used, Baker’294 teaches that the appropriate dosage for co-administration can be readily determined by one of skill in the art as those of skill in the art understand that formulation and/routes of administration of the carious agents or therapies used may vary. It is the examiner position that because the art is clear that the amounts of active used can be varied, the instant difference in concentration would not support patentability of the claimed invention unless there is evidence indicating such a concentration to be critical. MPEP 2144.05(II)(A) states “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Regarding claim 20: Instant claim 20 recites “wherein when the composition is applied … …as compared to…” or “after a single supplication… as compared too.” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties after application to the desired area.
Regarding claim 21: Baker’294 teaches the composition to be used for treating allergic disease which reduces allergic immune response, which reads on immunotherapy treatment of alternative embodiment (g).
Regarding claim 22: Instant claim 22 recites ”wherein when a non-nanoemulsion is compared…” This is a property of the claimed composition that occurs when the comparison is made. As the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties when compared to non-nanoemulsion formulations.
Regarding claim 23: Instant claim 23 recites “for treating eye conditions… and optionally the composition further comprises a cyclosporine.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat an eye condition, absent evidence to the contrary. Baker’294 teaches that antibiotic such as cyclosporine can be co-administered with the nanoemulsion, this the addition of cyclosporine into the composition is prima facie obvious.
Regarding claim 24: Instant claim 24 recites “for treating ear infections … “ This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat an ear infections, absent evidence to the contrary.
Regarding claim 25: Instant claim 2 recites “for treating vaginitis … “ This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat vaginitis, absent evidence to the contrary.
Regarding claim 34: Both nanoemulsions taught by Baker’294 above [0214 and 0126] have a single quaternary ammonium compound, CPC, reading on the claimed “consisting of” language.
Claim(s) 1-2, 4-13, 15-16. 18-25 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2012/0064136).
Baker’136 discloses nanoemulsion compositions for anti-wrinkle and anti-aging (Abs). The nanoemulsions are taught to comprise an aqueous phase and an oil phase [0060] and Baker’136 defines “nanoemulsion,” to include dispersions or droplets, as well as other lipid structures that can form as a result of hydrophobic forces that drive apolar residues (i.e., long hydrocarbon chains) away from water and drive polar head groups toward water, when a water immiscible oily phase is mixed with an aqueous phase [0076]. Baker’136 further teaches that an embodiment of the invention is one in which the nanoemulsions comprise droplets of an oily discontinuous phase dispersed in an aqueous continuous phase such as water [0163], thus it’s obvious to formulate the nanoemulsion as an oil-in-water nanoemulsion.
Baker’136 teaches the composition to be topically applied [0159] to skin [0160].
Table 3 of Baker’136 shows a nanoemulsion comprising 6.279% soybean oil, .592% tween 20, ethanol, 0.107% CPC and water, etc. [0179]. This results in a concentration ratio of CPC to nonionic surfactant of 1:5.5, while this range doesn’t overlap with the claimed about 1:7, when ranges are merely close a prima facie case of obviousness as a skilled artisan would have expected them to have the same or similar properties absent evidence showing the claimed range to be critical.
In the alternative, Baker’134 further teaches the nano emulsion composition to comprise 0.3-4% of the non-ionic surfactants (i.e. poloxamer 407) and 0.01-2% of a cationic agent (i.e. CPC), which results in a ratio of CPC to nonionic surfactant (1:.15-400) that overlaps with the claimed ranges and overlapping ranges are prima facie obvious.
Baker’136 teaches compositions comprising 10-60% of the BN-001 nanoemulsion, wherein the nanoemulsion has been diluted, these composition have viscosities ranging from 2.5-11.5 cp, which reads on less than 1000cP as recited by instant claim 2. The particle size is taught to not change with dilution and the particle size ranges 178-181 which reads on less than 1000nm (i.e. 1 micron), as recited by instant claim 1.
While Baker’136 teaches an average diameter, the instant specification teaches the droplets to have an average or a mean diameter size of about 250nm to about 1000nm, thus showing average and mean to be interchangeable. Furthermore, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
While the Example above uses tween 20 as the non-ionic surfactant, Baker’136 teaches that poloxamer 407 is also a suitable surfactant for use and its prima facie obvious to substitute one known equivalent for the other as they are both taught by the prior art to be used for the same purpose.
Instant claim 1 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
Instant claim 2 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
Regarding claim 4: Instant claim 4 states “where at least about 33%...and at least about 0.2% of the weight…” While Baker’136 is silent to these limitations, both Baker’136 and the instant specification teaches that the nanoemulsion can be made using the methods of manufacture discloses in U.S. 2004/0043041 and U.S. Pat. Nos. 5,103,497 and 4,895,452. These methods include mixing the oil phase and aqueous phases with relatively high shear, thus it would have been prima facie obvious to prepare the nanoemulsion of Baker’136 using one of the methods above and as Baker makes obvious the elected ingredients of the nanoemulsion soybean oil, CPC, poloxamer 407, water and ethanol, made by a method taught by the instant specification to be suitable , the resultant nanoemulsion is expected to have the same properties as the nanoemulsion of the prior art absent evidence to the contrary. Instant claim 4 also recites “the nanoemulsion enhanced delivery…”, these are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected have the same properties.
Regarding claim 5: Instant claim 5 states “where the mean droplet size…does not change by more than about 10%...” While Baker’136 is silent to these limitations, both Baker’136 and the instant specification teaches that the nanoemulsion can be made using the methods of manufacture discloses in U.S. 2004/0043041 and U.S. Pat. Nos. 5,103,497 and 4,895,452. These methods include mixing the oil phase and aqueous phases with relatively high shear, thus it would have been prima facie obvious to prepare the nanoemulsion of Baker’136 using one of the methods above and as Baker makes obvious the elected ingredients of the nanoemulsion soybean oil, CPC, poloxamer 407, water and ethanol, made by a method taught by the instant specification to be suitable , the resultant nanoemulsion is expected to have the same properties as the nanoemulsion of the prior art absent evidence to the contrary. Instant claim 5 also recites “the nanoemulsion enhanced delivery…”, these are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected have the same properties.
Regarding claim 6: Instant claim 6 recites “wherein after a single application … …as compared to…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected have the same properties after application to the desired area.
Regarding claims 7-8: Instant claims 7 recites “wherein after a single application … …as compared to…” Instant claim 8 defines an increase in residence time. These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, Baker’294 also teaches the composition to be , the composition claimed and the composition of the prior art will be expected to have the same properties after application.
Regarding claim 9: Instant claim 9 recites “wherein when the composition is applied … …as compared to…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties after application to the desired area.
Regarding claim 10: Baker’136 teaches the nanoemulsions to be stable at about 40°C for at least up to 3 years, reading on alternative embodiment (f) [0089].
Regarding claim 11: Instant claim 11 depends from claim 10 and further limits the types of bacteria with regards to instant claim 10(c), however, as embodiment 10(c) is recited in the alternative, it is an optional embodiment that is not actually required. Claim 11 simply defines the species of bacteria that must be killed, if embodiment 10(c) was required. For purposes of examination, as embodiment 10(c) is optional, then the embodiments of claim 11 are also optional and not required.
In the alternative, embodiments (10c) and claim 11 are reciting a property of the claimed composition and as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art are expected to have the same antibacterial properties.
Regarding claim 12: Baker’136 teaches the nanoemulsions to be effective at killing bacterial, reading on alternative embodiment (a).
Regarding claim 13: As discussed above, Baker’136 teaches a concentration ratio of CPC to nonionic surfactant which overlap with the claimed 1:7 or is merely close, which reads on alternative option (a).
Regarding claim 15: As discussed above, Baker’136 teaches the nanoemulsion to comprise 0.01-2% of a cationic agent (i.e. CPC), which reads on alternative embodiment (d).
Regarding claim 16: As discussed above, Baker’136 teaches the nanoemulsion to comprise soybean oil and ethanol, which reads on alternative embodiment (b)(ii)/(iii) and (c)(ii).
Regarding claim 18: Baker’136 teaches that the composition comprising a nanoemulsion can be co-administered with adapalene (reading on therapeutic or active agent) that is suitable for topical administration. This reads on alternative embodiment (b).
Regarding claim 19: Baker’136 teaches adapalene to be used in amounts of 1%, reading on alternative embodiment (b).
Regarding claim 20: Instant claim 20 recites “wherein when the composition is applied … …as compared to…” or “after a single supplication… as compared too.” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties after application to the desired area.
Regarding claim 21: Baker’136 teaches the composition to be topically applied, which reads on alternative embodiment (b).
Regarding claim 22: Instant claim 22 recites ”wherein when a non-nanoemulsion is compared…” This is a property of the claimed composition that occurs when the comparison is made. As the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties when compared to non-nanoemulsion formulations.
Regarding claim 23: Instant claim 23 recites “for treating eye conditions… and optionally the composition further comprises a cyclosporine.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat an eye condition, absent evidence to the contrary.
Regarding claim 24: Instant claim 24 recites “for treating ear infections … “ This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat an ear infections, absent evidence to the contrary.
Regarding claim 25: Instant claim 2 recites “for treating vaginitis … “ This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat vaginitis, absent evidence to the contrary.
Regarding claim 34: Both nanoemulsions taught by Baker’136 above [0179] have a single quaternary ammonium compound, CPC, reading on the claimed “consisting of” language.
Claim(s) 1, 3, 6-13, 15-16, 21-25 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2012/0003277).
Baker’277 discloses nanoemulsion vaccines and teaches a composition comprising 60% of a nanoemulsion (i.e. reading on diluted nanoemulsion as claimed), wherein the nanoemulsion comprises water, 37.67% soybean oil, 4.04% ethanol, 3.55% polysorbate 80 (i.e. tween 80, reading on non-ionic surfactant) and 0.64% of CPC (table 1). This results in a concentration ratio of CPC to nonionic surfactant of 1:5.5, while this range doesn’t overlap with the claimed 1:7, when ranges are merely close a prima facie case of obviousness as a skilled artisan would have expected them to have the same or similar properties absent evidence showing the claimed range to be critical.
In the alternative, Baker’227 further teaches the nano emulsion composition to comprise 0.1-3% of the non-ionic surfactants (i.e. polysorbate 80) and 0.001-5% of a cationic surfactant/agent (i.e. CPC), which results in a ratio of CPC to nonionic surfactant (1:.05-300) that overlaps with the claimed ranges and overlapping ranges are prima facie obvious [0150-0152].
Baker’227 teaches poloxamer 407 to be a suitable non-ionic surfactant along with Tween 80 (i.e. polysorbate 80) [0143-0144], as such it would have been obvious to substitute one for the other with a reasonable expectation of success.
Baker’277 defines nanoemulsion to mean oil in water dispersions, reading on o/w nanoemulsion as recited by instant claim 1.
Baker’277 teaches that suitable forms include, nasal, buccal, rectal, vaginal, topical, or nasal spray [0161] and the composition can be applied to skin, tissue and mucosal cells [0086].
Instant claim 1 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
Table 2 of Baker’277 teaches the composition to have a mean particle size ranging from 419-477nm and a zeta potential of 25.9mV, 41.7mV, etc., (all greater than 20mV as required by instant claim 3).
Regarding claim 3: Instant claim 3 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion, the claimed zeta potential and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
Regarding claim 6: Instant claim 6 recites “wherein after a single application … …as compared to…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion, and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will inherently have the same properties after application to the desired area.
Regarding claims 7-8: Instant claims 7 recites “wherein after a single application … …as compared to…” Instant claim 8 defines an increase in residence time. These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, Baker’294 also teaches the composition to be , the composition claimed and the composition of the prior art will inherently have the same properties after application.
Regarding claim 9: Instant claim 9 recites “wherein when the composition is applied … …as compared to…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will inherently have the same properties after application to the desired area.
Regarding claim 10: Baker’277 teaches that the composition was stable at 5° and 25° for at least 18months, which reads on alternative embodiments (g) and (h), see table 4.
Regarding claim 11: Instant claim 11 depends from claim 10 and further limits the types of bacteria with regards to instant claim 10(c), however, as embodiment 10(c) is recited in the alternative, it is an optional embodiment that is not actually required. Claim 11 simply defines the species of bacteria that must be killed, if embodiment 10(c) was required. For purposes of examination, as embodiment 10(c) is optional, then the embodiments of claim 11 are also optional and not required.
In the alternative, embodiments (10c) and claim 11 are reciting a property of the claimed composition and as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will inherently have the same properties
Regarding claim 12: Instant claim 12 recites “where the composition is effective in killing… when applied topically…” These are expected properties of the claimed composition, as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will inherently have the same properties after application to the desired area. Table 6 of Baker’277 shows that the nanoemulsion is capable of killing and/or inactivating bacteria.
Regarding claim 13: As discussed above, Baker’277 teaches a concentration ratio of CPC to nonionic surfactant which is merely close or which overlaps with the claimed range , which reads on alternative option (a).
Regarding claim 15: As discussed above, Baker’277 teaches the nanoemulsion to comprise 0.001-5% of a cationic surfactant/agent (i.e. CPC), which reads on alternative embodiment (d).
Regarding claim 16: As discussed above, Baker’277 teaches the nanoemulsion to comprise soybean oil and ethanol, which reads on alternative embodiment (b)(ii)/(iii) and (c)(ii).
Regarding claim 21: Baker’277 teaches the nanoemulsion vaccines (title), reading on alternative embodiment (g).
Regarding claim 22: Instant claim 22 recites ”wherein when a non-nanoemulsion is compared…” This is a property of the claimed composition that occurs when the comparison is made. As the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios, the composition claimed and the composition of the prior art will be expected to have the same properties when compared to non-nanoemulsion formulations.
Regarding claim 23: Instant claim 23 recites “for treating eye conditions… and optionally the composition further comprises a cyclosporine.” This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat an eye condition, absent evidence to the contrary.
Regarding claim 24: Instant claim 24 recites “for treating ear infections … “ This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat an ear infections, absent evidence to the contrary.
Regarding claim 25: Instant claim 2 recites “for treating vaginitis … “ This is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art makes obvious the claimed composition, the composition of the prior art is capable of being used to treat vaginitis, absent evidence to the contrary.
Regarding claim 34: Both nanoemulsions taught by Baker’136 above (table 1) have a single quaternary ammonium compound, CPC, reading on the claimed “consisting of” language.
New Claim Rejections - 35 USC § 103
Claim(s) 1, 2, 4-13, 15-16, 18-25 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2017/0246294), as applied to claims 1, 4-13, 15-16, 18-25 and 34 above, and further in view of Baker (US 2012/0064136).
As discussed above, Baker’294 makes obvious the limitations of claims 1, 4-13, 15-16, 18-25 and 34, however, does not teach the viscosity of instant claim 2.
Baker’136 discloses nanoemulsion compositions for anti-wrinkle and anti-aging (Abs). The nanoemulsions are taught to comprise an aqueous phase and an oil phase [0060] and Baker’136 defines “nanoemulsion,” to include dispersions or droplets, as well as other lipid structures that can form as a result of hydrophobic forces that drive apolar residues (i.e., long hydrocarbon chains) away from water and drive polar head groups toward water, when a water immiscible oily phase is mixed with an aqueous phase [0076]. Baker’136 further teaches that an embodiment of the invention is one in which the nanoemulsions comprise droplets of an oily discontinuous phase dispersed in an aqueous continuous phase such as water [0163],
Table 3 of Baker’136 shows a nanoemulsion comprising 6.279% soybean oil, .592% tween 20, ethanol, 0.107% CPC and water, etc. [0179].
Baker’136 teaches compositions comprising 10-60% of the BN-001 nanoemulsion, wherein the nanoemulsion has been diluted, these composition have viscosities ranging from 2.5-11.5 cp, which reads on less than 1000cP as recited by instant claim 2. The particle size is taught to not change with dilution and the particle size ranges 178-181 which reads on less than 1000nm. Baker’136 teaches that the viscosity significantly decreases as a function of the decrease in particle concentration [0210].
Instant claim 2 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baker’294 with those of Baker’136. One of skill in the art would have been motivated to formulate the nanoemulsion to have viscosity such as taught (2.5-11.5 cp) by Baker’136 as Baker’136 teaches these viscosities to be suitable for diluted nanoemulsions and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan. One of skill in the art would have a reasonable expectation of success as both Bakers discloses diluted nanoemulsions comprising CPC, soybean oil, ethanol and non-ionic surfactants.
Claim(s) 1, 3, 4-13, 15-16, 18-25 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2017/0246294), as applied to claims 1, 4-13, 15-16, 18-25 and 34 above, and further in view of Baker (US 2012/0003277).
As discussed above, Baker’294 makes obvious the limitations of claims 1, 4-13, 15-16, 18-25 and 34, however, does not teach the zeta potential of instant claim .
Baker’277 discloses nanoemulsion vaccines and teaches a composition comprising 60% of a nanoemulsion (i.e. reading on diluted nanoemulsion as claimed), wherein the nanoemulsion comprises water, 37.67% soybean oil, 4.04% ethanol, 3.55% polysorbate 80 (i.e. tween 80, reading on non-ionic surfactant) and 0.64% of CPC (table 1).
Table 2 of Baker’277 teaches the composition to have a mean particle size ranging from 419-477nm and a zeta potential of 25.9mV, 41.7mV, etc., (all greater than 20mV as required by instant claim 3). Baker’277 teaches that the zeta potential above 30 mV is used to induce a desired immune response in a host administered the same [0019].
Regarding claim 3: Instant claim 3 recites “wherein the nanoemulsion …as compared to…” This is an expected property of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion, the claimed zeta potential and the claimed quaternary ammonium compound and nonionic surfactant in the claimed ratios.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Baker’294 with those of Baker’277. One of skill in the art would have been motivated to formulate the nanoemulsion to have zeta emulsion such as taught (above 30 mV) by Baker’277, as Baker’277teaches these zeta potentials to be suitable for diluted nanoemulsions and teaches that the zeta potential above 30 mV is used to induce a desired immune response in a host administered the same and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan. One of skill in the art would have a reasonable expectation of success as both Bakers discloses diluted nanoemulsions comprising CPC, soybean oil, ethanol and non-ionic surfactants.
Conclusion
No claims are allowable.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613