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 .
DETAILED ACTION
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/18/2025 has been entered.
RCE Review of Claim Status
Claims 1-15 were pending in the prior Office Action.
Upon entry of RCE amendment, Claims 5 and 8 are cancelled
Upon entry of RCE amendment, Claim 6 was amended..
Claims 1-4, 6-7, and 9-15 are pending examination.
Priority Status
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55; EFD is 11/27/2018.
Information Disclosure Statement
Examiner acknowledged the 3 IDS(s) submitted in the prior Office Actions.
Drawings
Examiner acknowledged no (0) drawings were submitted with the Instant Application.
Examiner Responses to Amendments/Arguments
The issues raised in the Office Action are addressed below:
I. Claim Amendments –
Upon RCE Amendment entry, Claim 1 was amended with the additional limitation:
Claim 1 was amended to recite “(c) at least one second polyglyceryl fatty acid ester having an HLB value of 7.0 to 9.0” and “the (b) first polyglyceryl fatty acid ester comprises 4 glycerol units, the fatty acid moiety of the (b) first polyglyceryl fatty acid ester comprises 8 to 10 carbon atoms, the (c) second polyglyceryl fatty acid ester comprises 2 glycerol units.”
II. Response to Affidavit 1.132 –-filed 06/12/2024
Examiner acknowledged Applicant submission of affidavit under 37 §1.132 - filed 06/12/2024 in a prior Office Action.
The Examiner maintains the declaration is insufficient overcome the rejections as set forth in the last Office action, with additional comments for the continued rejection seen below.
The declaration under 37 CFR 1.132 filed 06/12/2024 is insufficient to overcome the
rejections as set forth in the last Office action because:
First, on its face, Applicant’s arguments and data do not commensurate with what is recited in the claims. Applicant also argues that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., 30% less sticky and has at least 20 times less turbidity as well as about 6.4 times smaller droplets) are not recited in the rejected claim(s) and functional properties that were met with the evidence within the prior art. Additionally the declaration is nonetheless insufficient to overcome the new rejection in this Office Action because although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The provided data does not establish the criticality of the hydrophile-lipophile balance (HLB), and its difference between the prior art listed on record. The data used to demonstrate criticality was one example of an HLB of 14, versus what examples used in the prior art. The comparison acknowledged in the prior art was between HLB polyglyceryl compounds of similar HLB values.
Second, the instant claims states an emulsion “comprising: (a) at least one oil; (b) at least one first polyglyceryl fatty acid ester having an Hydrophile-Lipophile Balance (HLB) value of 13.0 or more; (c) at least one second polyglyceryl fatty acid ester having an HLB value of 7.0 to 9.0; and (d) water, wherein the composition has a turbidity of 150 Nephelometric Turbidity Unit (NTU) or less.” The HLB values are functional limitations based on the structure of the fatty acid. If the structure of the fatty acids are met then the functional limitations would be expected. Still further, the art explicitly teaches overlapping ranges with the HLB variables (see 103 rejection below with citations of the locations of the teachings).
In amended Claim 1, the Applicant modified the polyglyceryl fatty acid esters range - (b) at least one first polyglyceryl fatty acid ester having a Hydrophile-Lipophile Balance (HLB) value of 13.0 to 15.0; (c) at least one second polyglyceryl fatty acid ester having an HLB value of 7.0 to 9.0 - and the prior art reads on the amended claims.
Finally, the claims are not commensurate with the scope, the presentation of the data, their application to the claims due to insufficient evidence. Applicant’s comparative Experiment 1 recites composition components with three (3) points of polyglyceryl comparison at HLB’s of 14, 11, and 8.5, respectively. According to the data, Applicant is trying to compare two completely different polyglyceryl compounds with differing HLB values. This comparison cannot be fairly evaluated against each other since the Applicant has given no result of criticality as to how the HLB of 13 would differ from the prior art.
In the prior art presented in this Office Action, it further remains obvious that this type of combination is used. As disclosed below, the prior art uses this similar composition guidelines for micro-emulsion (or nano-emulsion) compositions within the scope of the claims.
As a result, the affidavit is insufficient.
III. Withdrawn Rejections under 35 U.S.C. 103 –
The 35 USC § 103 rejections is withdrawn because Applicant amended independent Claim 1, with the addition of a further limitation:
“(c) at least one second polyglyceryl fatty acid ester having an HLB value of 7.0 to 9.0” and
“the (b) first polyglyceryl fatty acid ester comprises 4 glycerol units, the fatty acid moiety of the (b) first polyglyceryl fatty acid ester comprises 8 to 10 carbon atoms, the (c) second polyglyceryl fatty acid ester comprises 2 glycerol units.”
This necessitated a new rejection.
IV. Response to Claim Rejections under 35 U.S.C. 103 –
Applicant' s arguments with respect to Claim 1-15 (now amended Claims 1-4, 6, 7, and 9-15) have been considered but are moot because the new ground of rejection has been applied with additional prior art references.
V. New Rejections –
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.
Joint Inventors
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 1-4, 6-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Esteves, et. al WO 2016/091939 A1 (hereinafter “App’939”) and in view of Y. Ikeda, et al. in US 2017/0087064 A1 (hereinafter “App’064”), as evidenced Rousseau, et. al - Chapter 4.55 - Microemulsions as nanoscale delivery systems (pub’d in 2011; hereinafter “Rousseau”).
With respect to Claim 1, App’939 teaches a composition in the form of a nano- or micro-emulsion (abstract; pg. 17, 20-25; lns. pg. 18, lns. 5-14), comprising: .
(a) at least one oil (abstract; pg. 9, lns. 5-14);
(b) at least one first polyglyceryl fatty acid ester (abstract; pg. 6, lns. 5-7) having an HLB value of 13.0 or more (pg. 9, lns. 22-26);
(c) at least one second polyglyceryl fatty acid ester (abstract; pg. 6, lns. 5-7) having an HLB value of 7.0 to 9.0 (pg. 9, lns. 22-26); and
(d) water (abstract; pg. 9, lns. 5-14);
wherein the (b) first polyglyceryl fatty acid ester comprises 4 glycerol units,
the fatty acid moiety of the (b) first polyglyceryl fatty acid ester comprises 8 to 10 carbon atoms,
the (c) second polyglyceryl fatty acid ester comprises 2 glycerol units,
and the composition has turbidity of 150 Nephelometric Turbidity Unit (NTU) or less.
Though App’939 teaches an overlapping range, the prior art fails to teach an embodiment of the claimed range. However, as evidenced by Rousseau, the calculation for hydrophile-lipophile balance (HLB) would have been obvious to one having ordinary skill in the art as this calculation allows one to arrive at an overlapping range. Also, within the Instant Specification, the criticality of the HLB range chosen in the Claims has not been stated.
According to MPEP 2144.05: Overlapping ranges
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”).
Further, App’939 discloses “- a first fatty acid ester of (poly)glycerol have an HLB (Hydrophilic Lipophilic Balance) value of from 10.0 to 13.0; and/or - a second fatty acid ester of (poly)glycerol have an HLB (Hydrophilic Lipophilic Balance) value of from 7.0 to 9.0.”
With the specified embodiment (pg. 9, lns. 22-36), App’939 gives an overlapping range to the Instant Claims for the first fatty acid ester of polyglycerol (pg. 9, lns. 22-26) with an HLB value of from 10.0 to 13.0, as well as for the second fatty acid ester of polyglycerol (pg. 9, lns. 22-26) with an HLB value of from 8.0 to 10.0.
Respectively, the glycerol units for each are two (2) to six (6) glycerol units for the second fatty acid ester. For the second fatty acid ester of polyglycerol the glycerol units for each are 1 to 3 glycerol units.
App’939 fails to teach a specific embodiment reciting the second polyglyceryl fatty acid ester as seen in the additional limitation. App’939 though discloses the first polyglyceryl fatty acid ester comprises 4 glycerol units with a fatty acid moiety of 8 to 10 carbon atoms (e.g., polyglyceryl-4 caprate as seen in the embodiment on pg. 8, lns. 10-22 which has an HLB of 13.0 to 15.0).
App’064 nonetheless teaches Claim 1: wherein the fatty acid moiety of the (b) first polyglyceryl fatty acid ester comprises 8-10 carbon atoms (para. [0014], [0103], [0143]-[0144]). App’064 also teaches the second polyglyceryl fatty acid ester comprises 2 glycerol units. An example seen in the prior art of App’064 is polyglyceryl-2 caprylate (paras. [0144]-[0145] which as referenced above has an HLB of 7.0 to 9.0).
Therefore, combination of App’939 and App’064 discloses the micro-emulsion (or nano-emulsion) composition comprising an:
Oil Phase (a): The choice of oil depending on the solubilization of actives, and stability.
First Polyglyceryl Fatty Acid Ester (b): This ester is characterized by a high HLB value, between 13.0 and 15.0. This high hydrophilicity enables it to stabilize the continuous (oil or water) phase by reducing the boundary or interfacial tension.
Second Polyglyceryl Fatty Acid Ester (c): The second ester has a lower HLB value (between 7.0 and 9.0), implies a higher lipophilicity. This component helps in interfacial film properties and help in controlling other parameters in the emulsion. The combination of a higher and lower HLB ester enables the formulation to achieve a balanced boundary tension that is conducive to the emulsification in the continuous phase.
Water (d): The water content is optimized to achieve desired viscosity, physical properties, and overall stability of the formulation.
The combination of a high HLB emulsifier (first polyglyceryl fatty acid ester) and a lower HLB emulsifier (second polyglyceryl fatty acid ester) is critical to forming and stabilizing the micro-/nano-emulsion system. The ratio of these esters is adjusted (indicating it is result effective variable) to achieve a beneficial boundary film and distribution.
Hence, it would be obvious to one in the art, the combination of App’939 and App’064 teaches: 1) the specified polyglyceryl fatty acid esters reading on the claims, but 2) those polyglyceryl fatty acid esters that fall within the claimed HLB values (App’064- paras. [0313]-[0317]), the fatty acid moieties taught overlap with the Instant Application.
Thus, the HLB values are functional limitations since they are based on the structure of the fatty acid. If the structure of the fatty acids is met, then the functional limitations would be expected to be met as well including their HLB values. Also, in addition with the evidentiary reference, this equally indicates these values based on result-effective variables. And as such, the result-effective variables are dependent on the structure and concentration (which can be calculated).
With respect to Claims 2-4, 6-7, 9-11 and 13-15, App’939 continues teaching:
Claim 2: wherein the average HLB (pg. 9, lns. 22-26) of the (b) first polyglyceryl fatty acid ester(s) and the (c) second polyglyceryl fatty acid ester(s) in the composition ranges from 11.5 to 14.0 (pg. 9, lns. 22-26);
Claim 3: wherein the (a) oil is selected from polar oils (pg. 11, lns. 17-18);
Claim 4: wherein the amount of the (a) oil(s) in the composition ranges from 0.01% to 20% (0.50% to 50%; pg. 15, lns. 9-12) by weight relative to the total weight of the composition;
Claim 6: wherein the fatty acid moiety of the (b) first polyglyceryl fatty acid ester comprises 10 carbon atoms (reads on polyglyceryl-4 caprate as seen in the embodiment on pg. 8, lns. 10-22 which has an HLB of 13.0 to 15.0)
Claim 7: wherein the weight ratio of the amount of the (b) first polyglyceryl fatty acid ester(s)/the amount of the (a) oil(s) in the composition ranges from 0.6 to 1.3 (reads on 0.5 to 10; pg. 15, lns. 15-18);
Claim 9: wherein the fatty acid moiety of the (c) second polyglyceryl fatty acid ester comprises 14 or more carbon atoms (pg. 7, lns. 8-9; pg. 9, lns. 5-14);
Claim 10: wherein the weight ratio of the amount of the (c) second polyglyceryl fatty acid ester(s)/the amount of the (a) oil(s) in the composition ranges from 0.1 to 0.9 (reads on 0.5 to 10; pg. 15, lns. 15-18);
Claim 11: wherein the weight ratio of (the total amounts of the (b) first polyglyceryl fatty acid ester(s) and the (c) second polyglyceryl fatty acid ester(s))/the amount of the (a) oil(s) is 1.6 or less (reads on 0.5 to 10; pg. 15, lns. 15-18);
Claim 13: wherein the composition is in the form of an O/W emulsion (pg. 17, lns. 37-38); wherein the particle size of the (a) oil is 35 nm or less (20nm or less; pg. 18, lns. 5-7; 10 nm to 150 nm; pg. 18, lns. 35-38);
Claim 14: a cosmetic process for treating a keratin substance, comprising: applying the composition according to Claim 1 to the keratin substance (pg. 19, lns. 19-22).
With respect to claim 12, App’939 continues teaching a composition in the form of a nano-emulsion or microemulsion, comprising: at least one fatty acid ester of (poly)glycerol; c) at least one polyol; e) at least one oil and f) water.
App’939 fails to teach an embodiment free from a polyglyceryl fatty acid ester. However, App’939 does teach an overlapping range in regards to a composition free from a polyglyceryl fatty acid ester comprising 5 or more glycerol units (pg. 8, lns. 25-32).
The absence of polyglyceryl fatty acid ester with five or more glycerol units is specified to control physical properties of the final composition, such as: reduced stickiness, emulsion stability which affects the hydrophilic-lipophilic balance (HLB) of the emulsifier. Limiting the chain length (to, for example, 2-4 units) helps form specific stable nano- or micro-emulsions with desired oil particle sizes.
A formulation containing at least one oil, a high HLB polyglyceryl fatty acid ester (13.0–15.0 HLB, e.g., polyglyceryl-4 caprate), a lower HLB polyglyceryl fatty acid ester (7.0–9.0 HLB, e.g., polyglyceryl-2-diisostearate), and water is well within the scope of existing cosmetic and pharmaceutical emulsion systems.
Nevertheless, it would have been prima facie obvious to one having ordinary skill in the art to arrive at an overlapping range because with the information above, as well as what is commonly known in the art, according to MPEP 2144.05: Overlapping ranges -
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.);
In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of “50 to 100 Angstroms” considered prima facie obvious in view of prior art reference teaching that “for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.”).
Therefore, it would have been obvious to one having ordinary skill in the art to arrive at the claimed range through substituting one glycerol for another taught to have the same function. The art teaches that glycerol units from 1-12 would be expected to have the same function. Thus, one would predict substituting to a smaller glycerol unit would be expected to have similar abilities to form compositions (KSR – prong B rationale).
Also, based on the teachings and language of App’939, one could readily extend the range to 5 or more glycerol units as there is an expectation of success, based on the range given in the prior art of 1-to 12 glycerol units. This would lead one to an overlapping range with the instant claims.
Above, Examiner made the case that an overlapping range exists. In addition, App’939
teachings at (pg. 8, lns. 25-32) can be considered a close range. Thus, according to MPEP 2144.05 the limitation “more than 5 glycerol units” is met as either an overlapping range based on the logic and/or a close range based on the explicit teaching.
Close Ranges:
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”).
Conclusion
Claims 1-4, 6-7 and 9-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached on (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621