DETAILED ACTION
The Office Action is in response to the Applicant's reply filed April 6, 2026 to the non-final rejection made on November 5, 2025. Claims 1, 3-4, 9-10 and 12-13 are herein acted on the merits.
Application Priority
This application filed 06/20/2019, claims priority to PRO 62/688,714 filed 06/22/2018.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments with respect to 35 U.S.C. 103 as being unpatentable Klacsová et al. (The effect of aliphatic alcohols on fluid bilayers in unilamellar DOPC vesicles--a small-angle neutron scattering and molecular dynamics study. Biochim Biophys Acta. 2011 Sep;1808(9):2136-46. doi: 10.1016/j.bbamem.2011.04.010. Epub 2011 Apr 29 - IDS) in view of Hassan (US 20080161588 A1) of claims 1, 3-4, and 14 is not persuasive. The rejection is herewith maintained. See response to arguments below.
Applicant’s arguments with respect to the 35 U.S.C. 103 as being unpatentable Klacsová et al. (The effect of aliphatic alcohols on fluid bilayers in unilamellar DOPC vesicles--a small-angle neutron scattering and molecular dynamics study. Biochim Biophys Acta. 2011 Sep;1808(9):2136-46. doi: 10.1016/j.bbamem.2011.04.010. Epub 2011 Apr 29 - IDS) in view of Hassan (US 20080161588 A1), as applied to claims 1, 3-4, and 6-7 and further in view of Dierker (US 2008/0161418 A1) of claim(s) 9-10, 12-13 is not persuasive. The rejection is herewith maintained.
Applicant’s main argument is that three-stage rotor and stator homogenizer process all passed appearance quality testing. Compositions prepared using one-stage rotor and stator homogenizers failed appearance and quality testing. Applicant argues this process as claimed advantageously provides a process for producing liquid crystal structures, comprising cetyl alcohol and potassium cetyl phosphate, hydrogenated palm glycerides without visible agglomerates, while having good appearance, stability profile and skin barrier protection.
Upon further consideration, the Examiner states that while Item 1 AND 4 both pass, the 1 stage rotor and stator of Table 3 Item 5, also, passes. The arguments are not persuasive.
The following rejections are made:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, and 3-4, are rejected under 35 U.S.C. 103 as being unpatentable over Klacsová et al. (The effect of aliphatic alcohols on fluid bilayers in unilamellar DOPC vesicles--a small-angle neutron scattering and molecular dynamics study. Biochim Biophys Acta. 2011 Sep;1808(9):2136-46. doi: 10.1016/j.bbamem.2011.04.010. Epub 2011 Apr 29 - IDS) in view of Hassan (US 20080161588 A1).
A composition prepared according to the process comprising contacting a mixture comprising (1) a negatively charged phospholipid and/or phospholipid derivative; and (2) a fatty alcohol with a rotor and stator homogenizer and homogenizing the mixture using a three-stage rotor and stator homogenizer configuration, wherein the phospholipid or phospholipid derivative is selected from the group consisting of dimyristoylphosphatidylglycerol, dipalmitoylphosphatidylglycerol, di stearoylphosphatidylglycerol, dioleoylphosphatidylglycerol oleoylpalmitoylphosphatidylglycerol, dipalmitoylphosphatidylserine dioleoylphosphatidylserine, dimyristoylphosphatidylinositol, dipalmitoylphosphatidylinositol phosphatidylethanolamine, di stearoylphosphatidylinositol, dioleoylphosphatidylinositol dimyristoylphosphatidylserine, and distearoylphosphatidylserine and wherein the fatty alcohol consists of cetyl alcohol.
Klacsová et al. teaches dioleoylphosphatidylcholine:dioleoylphosphatidylserine (PCPS, DOPC:DOPS = 24.7 mol:mol) bilayers in extruded unilamellar vesicles with incorporated aliphatic alcohols (CnOH, n = 8–18 is the even number of carbons in alkyl chain) (reads on the (2) fatty alcohol emollient wax). The small amount of DOPS present in DOPC bilayers charges the bilayer surface negatively (reads on the negatively charged phospholipid) and thus prevents oligolamellar vesicle formation during extrusion and vesicle aggregation after extrusion, while it does not affect the structure of DOPC bilayer itself (Abstract, and p2137 left col, last para). The samples were hydrated with heavy water and homogenized by vigorous vortex mixing (p2137 right col 2.2. Contrast variation samples). (The product of the DOPC bilayers and aliphatic alcohol reads on the composition of claim 4). The reference uses egg yolk phosphatidylcholine.(Introduction para 2) The reference also teaches incorporated aliphatic alcohols (CnOH, n = 8–18 is the even number of carbons in alkyl chain) (see abstract C16 reads on the cetyl alcohol of the claim 1.
While the reference teaches that samples were homogenized by vigorous vortex mixing, the reference fails to specify a three stage rotor and the energy of at least about 0.18 hp/lb/min.
Hassan et al. teaches the making of colloids or emulsions for a range of products including pourable vegetable oils, frying oil, peanut butter stabilizers, cosmetics, etc [0036]. The method of making can include using a disperser. The disperser IKA model DR 2000/4 is a high shear, three stage dispersing device useful in making such. Three rotors in combination with a stator are aligned in series to create the dispersion of hydrogen in liquid medium comprising base oil. Mixed high shear device inlet stream enters the high shear device at a high shear device inlet and enters a first stage rotor/stator combination having circumferentially spaced first stage shear openings. The coarse dispersion exiting the first stage enters the second rotor/stator stage, having second stage shear openings. The reduced bubble-size dispersion emerging from the second stage enters the third stage rotor/stator combination having third stage shear openings. The dispersion exits the high shear device via a high shear outlet as high shear device dispersion outlet stream. In embodiments, the shear force increases stepwise longitudinally along the direction of the flow [0116]. “The stator can be adjusted to obtain the desired gap between the rotor and the stator. The grooves change directions in each stage for increased turbulence.” [0117] Reads on increasing turbulence in each stage). A discrete reactor is desirable in some applications, however, to allow for increased residence time, agitation and heating and/or cooling. [0122] (Renders obvious modifying a discrete reactor to allow for increased residence time). Hassan describes “high shear device delivers a certain amount of energy per volume/weight of fluid. In embodiments, the high shear device delivers at least 300 L/h (or 5L/min, depending on agent i.e. water: 11lb/min) with a power consumption of 1.5 kW (or 2hp) at a nominal tip speed of at least 4500 fpm[0119], (in other words the high shear device delivers an energy of at least about 0.18hp/lb/min).
One of ordinary skill in the art at the time of filing would have been motivated to incorporate the specific disperser IKA model DR 2000/4 to homogenize the formulation of Klacsová et al. The motivation to use the disperser IKA model DR 2000/4 is because Klacsová et al. teaches the samples were homogenized by vigorous vortex mixing and Hassan et al. teaches IKA model DR 2000/4 is a high shear, three stage dispersing device which creates dispersions of hydrogen in liquid medium comprising base oil, with reduced bubble-size useful for cosmetics. The skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 9-10, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Klacsová et al. (The effect of aliphatic alcohols on fluid bilayers in unilamellar DOPC vesicles--a small-angle neutron scattering and molecular dynamics study. Biochim Biophys Acta. 2011 Sep;1808(9):2136-46. doi: 10.1016/j.bbamem.2011.04.010. Epub 2011 Apr 29 - IDS) in view of Hassan (US 20080161588 A1), as applied to claims 1, 3- 4, and further in view of Dierker (US 2008/0161418 A1) .
Klacsová et al. and Hassan are as discussed above.
Klacsová et al. and Hassan fail to teach the specific composition of claim 9-10, 12-13.
Dierker teaches a cosmetic composition (see the first composition in the table) containing 1.0 wt.% of cocoglyceride (instant emollient), 5.0 wt.% of caprylic/capric triglyceride (instant emollient), 6.0 wt.% of aiethyidecane (instant emollient), 0.5 wt.% of potassium cetyl phosphate (instant emulsifier), 0.3 wt.% of carbomer (instant gelling agent) and water. In addition to those components above (which represent instant emollient, emulsifier, gelling agent and water), Dierker’s composition a/so contains glycerol stearate (Cutine GMS-V), glycerine and dimethicone. Dierker states ([(0034]) that glycerol esters of higher fatty acids (such as glycerol stearate) are being used to improve the consistency of cosmetics With respect to instant 1.5-3% of an emollient wax, Dierker’s cosmetic composition discussed above contains 5.0 wt.% of Emulgade PL68/50 (a mixture of 50% cetearyl glucoside and 50% cetearyl alcohol (cetearyl alcohol is a mixture of cetyl alcohol (instant emollient wax) and stearyl alcohol)). Since there is 5 wt.% of Emulgade 68/50 present in Dierker’s first composition, this means that there are 2.5 wt.% of cetearyl glucoside and 2.5 wt.% of cetearyl alcohol present in Dierker’s first composition. Furthermore, since ceteary| alcohol is a mixture of cetyl alcohol and stearyl alcohol, this means that the amount for the cetyl alcohol present in the mixture of cetyl alcohol and stearyl alcohol (as contained in Dierker’s 5.0 wt.% of Emulgade PL 68/50) would have to be greater than 0 wt.% and less than 2.5 wt.%. Such range for the cetyl alcohol (instant emollient wax) overlaps with instant range of 1.5-3% for the emollient wax, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)
Dierker’s cosmetic composition discussed above contains (i) 12.0 wt.% of the sum of cocoglyceride, caprylic/capric triglyceride and diethyldecane (instant emollients), (ii) greater than 0 wt.% and less than 2.5 wt.% of cetyl alcohol (instant emollient wax), (iii) 0.5 wt.% of potassium cetyl phosphate (instant emulsifier) and (iv) 0.3 wt.% of carbomer (instant gelling agent). Dierker’s cosmetic composition as discussed above contains emollients in the amount of 12.0 wt.%. However, in [0031], Dierker clearly teaches that its oil/emollients can be present in the amount that ranges from 1 to 50 wt.% (in particular, 0-8 wt.%). Dierker’s cosmetic composition contains 0.3 wt.% of carbomer (instant gelling agent). The amount 0.3 wt.% for the carbomer is very close to the lower end of instant ranges of 0.4-0.6% of claim 9, thus rendering instant range prima facie obvious. Where the claimed ranges and prior art do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Titanium Metals Corporation of America v. Banner, 227 USPQ 773 (Fed. Cir. 1985). Thus, Dierker’s teaching renders obvious instant claim 9.
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
Applicant's amendment necessitated the new 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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