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 .
This office action is in response to the reply filed 7/14/2026.
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Claims 17, 26-32 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim.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 Newly added claim 33 is withdrawn from further consideration as it is directed to a non-elected species of quaternary ammonium compound.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 7/14/2026 have been fully considered.
Rejections under 112(b)
In view of the amendments to the claims addressing the issues noted by the Examiner the 112(b) rejections presented in the office action mailed 3/17/2026 are withdrawn.
Rejections under 103
Applicant argues that the Specification, Figs 2-5 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.
The Examiner would also like to note that the data presented does not have a nexus to the claimed invention, the claims as amended require an anti-inflammatory agent as a main component and this agent is not present in any of the tested embodiments.
Applicant remarks on pages 14-15 regarding the effects of improved permeation and persistence have been considered but are not persuasive as it is unsupported by factual evidence.
Regarding the rejection over Baker’294, Applicant argues that while Baker’294 includes a reference to anti-inflammatory agent, this is merely a passing reference and the reference provides no specific teaching or motivation to select the claimed agent.
This is not persuasive as Baker’294 specifically teaches that anti-inflammatory agents are suitable for use and the use of any of the taught agents in the nanoemulsion would be to include for its anti-inflammatory function and the combination would be expected to yield no more than expected from such an arrangement.
Regarding the rejection over Baker’136, Applicant argues that adapalene is a retinoid and not an anti0inflammatory agent.
This is not persuasive. While Adapalene might be a retinoid, as evidenced by Chen below, it is also an anti-inflammatory agent.
Applicant argues that neither Baler’294 and Baker’136 teach the claimed surfactant ratio and unexpected anti-inflammatory permeation.
This is not persuasive as the rejection presented provide surfactant ratios that overlap or are sufficiently close to the claimed ratio and Applicant has not provided persuasive evidence of the unexpected inflammatory permeation.
Claim Objections
Claim 18 is objected to because of the following informalities.
Claim 18 recites “transdermal or administration” the “or” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 36 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 36 requires the 2nd active agent to moderate an immune response in a subject. While the specification teaches that the composition as a whole is capable of modulating an immune response in a subject, the originally filed disclose does not attribute this effect to the 2nd active on its own. This is a new matter rejection.
New Claim Rejections - 35 USC § 112(d)
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.
Claim 16 is 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 1 defines the oil to be selected from at least one of an animal oil, a plant oil or a vegetable oil. Claim 6 depends from claim 1 and states that the at least one oil can be a silicon oil, this does not further limit the categories of oils recited by instant claim 1. 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.
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, 6-10, 13, 15-16, 18-19 and 34-36 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 and a plant 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 and a plant 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].
Baker’294 teaches that one or more agents including therapeutic and active agents can be added to the composition [0194], these include anti-inflammatory agents [0194]. It would have been prima facie obvious to select and add an anti-inflammatory agent to the nanoemulsion as Baker’294 to arrive at compositions yielding no more than one would expect from such an arrangement.
Instant claim 1 recites “wherein the nanoemulsion …as compared to…” and “after a single administration…” and “after a single administration… application,” these are expected properties of the claimed composition as the prior art makes obvious a composition comprising the claimed nanoemulsion comprising the claimed active 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 comprising the claimed active agent 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 comprising the claimed active agent 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 active agent 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 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 administered by transdermal [0207] or topical [0063] means, reading on alternative embodiments (a) and (b). Regarding the phrase “when not present in a nanoemulsion…” this is an expected property of the claimed composition and its effects on the active agent.
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 [0061]. 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 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.
Regarding claim 35: 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. Baker’294 teaches that the nanoemulsion can comprise one or more additional active agents [0214]. Therefore, it would have been prima facie obvious to use a combination of an antibiotic and an anti-inflammatory agent yielding no more than expected from such an arrangement.
Regarding claim 36: Baker’294 teaches that co-administration (i.e. nanoemulsion + active) preferably elicits an immune response in a subject [0061], as such it would have been obvious to select an active agent that is capable of eliciting (i.e., moderating) an immune response in a subject.
Claim(s) 1, 6-10, 13, 15-16, 18-19 and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2012/0064136), as evidenced by Chen (WO 2016/062283).
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. 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.
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, example 3. As evidenced by Chen, Adapalene is an anti-inflammatory drug (Chen – claims).
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 active agent 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 active agent 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 active agent 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 active agent 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 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’294 teaches that the composition comprising a nanoemulsion can be administered by topical [0038] means, reading on alternative embodiment (b). Regarding the phrase “when not present in a nanoemulsion…” this is an expected property of the claimed composition and its effects on the active agent.
Regarding claim 19: Baker’136 teaches adapalene to be used in amounts of 1%, reading on alternative embodiment (b).
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.
Regarding claim 35: Baker’136 teaches that mixture of active agents can be used [0032], thus it would be obvious to use more than one active agent.
Regarding claim 36: Baker’136 teaches that a suitable active ingredient include an anti-viral agent (which would be expected to modulated the immune response in a subject as it would work against the virus in the subjects system), as such it would have been obvious to include a combination of an anti-viral agent and an anti-inflammatory agent yielding no more than expected from such an arrangement.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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