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 .
Claim Interpretation
Claim 37 recites “high shear… high-pressure whipping head…wherein the gas whipping agent is dissolved in the formulation.” The term “high” in reference to the shear and pressure is a relative term which is not defined by the originally filed specification, however, the claim goes on to say that the gas whipping agent is dissolved in the formulation after mixing under said claimed high shear and high pressure conditions, therefore, for purposes of examination, any pressure or shear used which results in the gas whipping agent being dissolved or dispersed in the formulation will be deemed to read on “high shear” and “high pressure whipping ahead”.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it recites the legal phraseology “such that”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [0094 and 00143]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 37-38 and 41-2 are objected to because of the following informalities:
Claim 37(d) recites “wherein after being expelled from the package, the formulation is of reduced density than the formulation in the package; wherein said formulation …” this should read “wherein after being expelled from the package, the whipped formulation is of reduced density than the formulation in the package; wherein said whipped formulation…” to improve claim consistency and readability.
Claim 38 and 41 recites “the formulation”, this should read “the whipped formulation” to improve claim consistency and readability.
Claim 42 recites “said formulation”, this should read “said whipped formulation” to improve claim consistency and readability.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37-43 are 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 37(b) recites “pressure and rates” there is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant is intended to refer back to the controlled temperature, rate of flow and pressure, or if the claims are referencing a different “rates”.
Regarding claim 37, the phrase in parenthesis (“pre-gas or cut-bag pressure) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim then recites “said cut-bag pressure” and “the cut-bag pressure there is insufficient antecedent basis for this limitation in the claim because as discussed above, it is not clear if the above (“pre-gas or cut-bag pressure) is part of the claimed invention.
Regarding claim 37, part (b) says “dispersing” the gas whipping agent in the formulation, then recites “the whipping agent is dissolved in the formulation,” then step (c) recites “pressure maintaining the whipping agent dispersed in the formulation,” thus it’s unclear is the whipping agent simply needs to be dispersed in the formulation or if it must be dissolved.
Claim 37 recites “high bubble density,” “high foam stability,” “high number of bubbles,” “high sensory impact,” “high integrity of shape,” “high spreadability” and “low sound impact. The terms “high” and “low” are relative terms which renders the claim indefinite. The terms “high” and “low” with respect to the characteristics above are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Outside of an attribute density of 0=none and 100 = very strong/very high, there is no indication what degree or score reads on high vs low.
Claims 38-43 are rejected in view of their dependency on claim 37 as they do not cure its deficiencies and thus are deficient for the same reasons.
Claim 39 recites “high barrier bag”. The term “high” is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 39 recites “fill/dispensing” these alternative have opposite functions, thus it’s unclear if “/” is mean to be “and”, “or” or “and/or”.
Claim 40 recite “metal/alloy” A broad range (i.e. metal) or limitation together with a narrow range (i.e. alloy) or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 40 recites the broad recitation metal, and the claim also recites alloy which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. it’s unclear if “/” is mean to be “and”, “or” or “and/or”.
Claim 40 recites the limitation "said container". There is insufficient antecedent basis for this limitation in the claim as it depends from claim 37 which does not recite a container.
Claim 41 recites the limitation "the BOV". There is insufficient antecedent basis for this limitation in the claim as it depends from claim 37 which does not recite a POV pressurized assembly.
Claim 43 recite “high foam stability” and “high temperature”. The term “high” is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 37-39 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,622,922. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding steps (a) and (b): US‘922 teaches a method of preparing a whipped sunscreen formulation, comprising: rapidly mixing a formulation, with all ingredients blended, with a gas propellant in a high shear, continuous-flow, high-pressure whipping head, pressurized under controlled temperature, rate of flow, and pressure, which rapidly mixes the formulation with a series of infusion gas injector ports controlling the gas propellant pressure and rates, wherein said gas propellant is nitrous oxide selected form a finite number of options. US’922 teaches the formulation comprising one or more active agents, which one or more active agent in the formulation is co-mingled with a whipping agent prior to being filled under pressure into said package, wherein said whipping agent is added in sufficient amounts to be dispersed in the formulation. In view of the 112(b) rejections above, as US’922 teaches the whipping agent to be dispersed in the formulation, this reads on high shear and high pressure as recited by the instant claims .
Regarding steps (c) and (d): US’922 teaches filling said formulation into a pressurized package, wherein said pressurized package is under sufficient pressure suitable to maintain the first gas propellant dispersed in the formulation; and wherein said pressurized package is under sufficient pressure to expel said formulation as a whipped formulation upon application of external force on said formulation in said package.
While US’922 does not teach selecting the amounts of whipping agent and pressure based on sensory impact testing, US’922 teaches the resulting whipped formulation to have at least about 60% of the gas bubbles to have a size of less than 100 µm which reads on the majority of the bubbles having a size of less than 20µm, reading on a claimed physical characteristic and while the reference is silent to high sensory impact, since the whipped formulation is made in the manner as the instant claims and the resultant foam has the claimed physical characteristics, it would be expected to have one or more of the claimed high sensory impacts and the whipping agent and pressure would have necessarily been present in amounts effective to achieve this.
Regarding claim 38-39: US’922 teaches that the package comprises a pressure generating and maintaining component, wherein said component comprises one or more second gas and/or liquid propellants which are not co-mingled with the formulation and said package is a bag on valve (BOV) pressurized assembly, comprising a two-way fill and dispensing valve, an attached internal high barrier bag affixed to said valve, and rigid container adapted to holding positive pressure, affixed to the valve.
Claims 37 and 39-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,612,551, as evidenced by Xing (US 2012/0107253). Although the claims at issue are not identical, they are not patentably distinct from each other:
Regarding steps (a)-(d): US’551 discloses making a whipped formulation by: (i) blending the formulation comprising an amount of a whipping agent and said one or more skincare active agents; and
(ii) rapidly mixing said formulation with a series of infusion gas injector ports controlling the whipping agent pressure and rate of flow of the formulation, in a high shear, continuous-flow, high-pressure whipping head, pressurized under controlled temperature, rate of flow, and pressure, saturating the whipping agent into the formulation; wherein said pressurized package is under sufficient pressure suitable to maintain the whipping agent dispersed in the formulation; and wherein said pressurized package is under sufficient pressure to expel said formulation as a whipped formulation upon application of external force on said formulation in said package; wherein said whipping agent is nitrogen, nitrous oxide, carbon dioxide, argon, air, oxygen, or a combination thereof; wherein said whipped formulation is a reduced density gas emulsion with a multitude of gas microbubbles continuously distributed throughout the whipped formulation. In view of the 112(b) rejections above, as US’922 teaches the whipping agent to be dispersed in the formulation, this reads on high shear and high pressure as recited by the instant claims .
While US’551 does not teach selecting the amounts of whipping agent and pressure to base on sensory impact testing, US’551 teaches the resulting whipped formulation to have a multitude of bubbles reading on a high number of bubbles which reads on a claimed physical characteristic and the whipped formulation is taught to readily and easily spreadable, which reads on high spreadability (i.e. high impact characteristic), as such the amounts of whipping agent and the pressure were necessarily chosen to achieve the claimed sensory impact, this choice is simply a matter of design choice.
Regarding claim 39: US’551 teaches said package is a bag on valve (BOV) pressurized assembly, comprising a two-way fill and dispensing valve, an attached internal high barrier bag affixed to said valve, and rigid container capable of holding positive pressure, affixed to the valve.
Regarding claim 40: US’551 teaches the container is glass, barrier resin, metal or alloy, or another material capable of holding positive pressure.
Regarding claim 41: US’551 teaches the BOV pressurized assembly dispenses the formulation in a metered dispensing system.
Regarding claim 42: US’551 teaches the formulation to comprise zinc oxide, as evidenced by Xing, zinc oxide is a sunscreen active as such the formulation of US’551 is considered a sunscreen.
Claims 37, 38 and 38-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,612,551 as evidenced by Xing (US 2012/0107253) in view of Hilgers (US 2013/0233310). Hilgers is cited on the 3/17/2025 IDS.
The teachings of claims 37 and 38-42 are discussed above, however, US’551 does not teach the pressure maintaining component to be a propellant which is not co-mingled with the formulation.
Hilgers teaches a dermatological composition in a BOV container, wherein a liquid foaming agent is mixed with the dermatological composition [0019-0025] and teaches that the pressurized gas surrounding the flexible bag is nitrogen or air (i.e. reading in liquid or gas propellants) (Hilgers – claim 3), this gas is no co-mingled with the dermatological composition.
It would have been prima obvious to use a propellant such as nitrogen or gas in the BOV assembly of US’551 as the pressurizing agent in the container wherein the gas is not co-mingled with the formulation as Hilgers teaches that these gas are commonly used in BOV containers when being used with dermatological compositions.
Claims 37-38 and 42-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,826,440 in view of Loechel (WO 2012/154918). Loechel is cited on the 3/17/2025 IDS.
Regarding steps (a) to (d): US’440 teaches a thermal stable whipped formulation. The formulation is made by (a) Filling a formulation into a package comprising one or more active agents and one or more thermal stabilizing agents, said one or more active agents and one or more thermal stabilizing agents co-mingled with a gas propellant prior to being filled under pressure into said package; wherein said propellant is added in sufficient amounts to be dispersed in the formulation; the gas propellant being dispersed in the formulation by rapidly mixing the formulation, with all ingredients blended, in a high shear, continuous-flow, high-pressure whipping head, pressurized under controlled temperature, rate of flow, and pressure, which rapidly mixes the formulation with a series of infusion gas injector ports controlling the gas propellant pressure and rates; wherein said pressurized package is under sufficient pressure suitable to maintain the gas propellant dispersed in the formulation; and wherein said pressurized package is under sufficient pressure to expel said formulation as a whipped formulation upon application of external force on said formulation in said package.
US’440 teaches formulation remains stable after the formulation is expelled from the package after storage for at least one day to up to one month at a temperature up to about 50° C, which reads on desired sensory impact of high foam stability at a high temperature. The whipped formulation also comprises has at least about 60% of the gas bubbles at ≤100 μm, after the formulation is expelled from the package and at least about 40% of the gas bubbles at ≤60 μm, after the formulation is expelled from the package, which reads on the desired characteristic of majority of bubbles having a size of less than 20µm.
While US’440 isn’t specific to the whipped formulation having reduced density from the formulation in the package, US’440 teaches the resulting formulation to have a bubbles and this is expected to lead to a formulation having reduced density.
While US’440 does not teach selecting the amounts of whipping agent and pressure to base on sensory impact testing, US’440 teaches the resulting whipped formulation have claimed desired characteristics and high sensory impact property, as such the amounts of whipping agent and the pressure were necessarily chosen to achieve the claimed sensory impact, this choice is simply a matter of design choice.
Regarding claim 38: US’440 teaches said package comprises a pressure generating and maintaining component, wherein said component comprises one or more gas and/or liquid propellants which are not co-mingled with the formulation.
Regarding claim 42: US’440 teaches said formulation is a sunscreen and said one or more active agents include one or more sunscreen active agents.
Regarding claim 43: As discussed above, the whipped formulation of US’440 has high foam stability at high temperatures.
However, US’440 does not teach the gas whipping agent to be nitrous oxide.
Loechel discloses a cosmetic composition in a container comprising at least one inner bag and an
outer container, wherein the outer container is filled with a propellant compressing the inner bag (Abs). Loechel teaches that the cosmetic composition is contained in a flexible bag with a valve, wherein
the composition in the bag contains at least one propellant (reading on whipping agent blended with the
formulation), and can be discharged from the bag as a foam, especially a mouse, resembling a whipped
cream (i.e., reading on whipped formulation expelled from a package). When the bag is filled with the
cosmetic composition and the at least one propellant, it can be inserted into an aerosol can, and the
remaining interior space in the aerosol can is then filled with a propellant, such as a compressed gas, e.g.
nitrogen, or compressed air, or any other desired propellant, comprising a propellant not co-mingled with the formulation. Loechel teaches carbon dioxide to be the preferred propellant for use inside the inner bag of the container, however, carbon dioxide is not the sole propellant and can be used in combination with nitrous oxide (N2O) (Pg. 9).
It would have been prima facie obvious to use nitrous oxide as the gas propellant of US’440 as Loechel teaches that this gas is suitable for use in composition wherein the gas is directly mixed with the cosmetic formulation and its prima facie obvious to pursue the known options within the technical grasp of a skilled artisan.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hilgers (US 2013/0233310): Hilgers discloses a bag-on-valve aerosol container includes a chamber, where a pressurized gas is contained, surrounding a flexible bag, and where a closable outlet is in fluid communication with the flexible bag. The flexible bag includes a leave-on dermatological composition having an oil-in-water emulsion, comprising one or more oils. The product compartment further includes one or more physical foaming agents having a standard boiling point of -50 to 70° C (Abs).
Hilgers teaches the dermatological composition to comprise a physical foaming agent, such as isobutene and isopentane (selected from a finite number of options) [0018].
Hilgers teaches the BOV container to be filled comprising the steps of:
(a) pressurizing a can with a pressurizing gas;
(b) bringing a valve assembly comprising a flexible bag, a valve and a disc into the can such that the pressurizing gas surrounds the flexible bag;
(c) attaching the valve assembly with its disc to the can such that the aerosol container is closed; and
(d) filling through the valve one or more physical foaming agents as liquids into the flexible inner bag; and
(e) subsequently adding thereto, the leave-on dermatological composition.
This method allows the liquid foaming agent to be readily and spontaneously mixed with the dermatological composition [0019-0025].
Hilgers teaches that the pressurized gas surrounding the flexible bag is nitrogen or air (Hilgers – claim 3),i.e. positive pressure, and the gas is not co-mingling with the dermatological composition. Hilgers teaches that the outlet in communication with the flexible bag comprises a valve and an actuator. When the actuator is activated, e.g. pressed (i.e. external pressure), the product comprised in the flexible inner bag is discharged. Hilgers teaches that all BOV aerosol containers delivered a rich foam that did not drip from the skin and allowed for easy spreading, reading on thus reading on whipped formulation providing a desired sensory impact to the user such as positive appearance, high spreadability, etc. Hilgers teaches a BOV package made of aluminum or tin plate and teaches the valve to be used to fill and dispense the formulation. Hilgers teaches an advantageous embodiments to be a sunscreen comprising one or more UV-filters ([0053] and Hilgers – claim 10). Hilgers does not teach the claimed step (b), in particular, “rapidly mixing…with a series of infusion gas injector ports. saturating the whipping agent into the formulation”.
Loechel (WO 2012/154918) : Loechel discloses a cosmetic composition in a container comprising at least one inner bag and an outer container, wherein the outer container is filled with a propellant compressing the inner bag (Abs). Loechel teaches that the cosmetic composition is contained in a flexible bag with a valve, wherein the composition in the bag contains at least one propellant (reading on whipping agent blended with the formulation), and can be discharged from the bag as a foam, especially a mouse, resembling a whipped cream (i.e., reading on whipped formulation expelled from a package). When the bag is filled with the cosmetic composition and the at least one propellant, it can be inserted into an aerosol can, and the remaining interior space in the aerosol can is then filled with a propellant, such as a compressed gas, e.g. nitrogen, or compressed air, or any other desired propellant, comprising a propellant not co-mingled with the formulation. The valve of the bag can serve for sealing the bag as well as the can. For this purpose, two sealing’s can be provided. A first or outer sealing can serve to seal the space between the can and the bag. A second, or inner sealing can serve to seal the valve of the bag. A dispenser cap is favorably attached to the valve and is activated by downward pressure on the cap (i.e. external pressure) (Pg. 4). Loechel teaches carbon dioxide to be the preferred propellant for use inside the inner bag of the container, however, carbon dioxide is not the sole propellant and can be used in combination with nitrous oxide (N2O) (Pg. 9). Loechel teaches that the outer container is formed from a metal and comprises a propellant, such as air, nitrogen, carbon dioxide, an organic propellant or any other suitable gas. Loechel also teaches the propellant to have a set positive pressure, reading on “package is pressurized”. Loechel teaches that UV-filters can be added into the composition, thus reading on the active ingredient being a sunscreen active. While the art doesn’t teach the package is pressurized to maintain the whipping agent dispersed in the formulation, this is expected as the claim teaches this to be achieved by pressuring the package, and the art does this (Pg. 19). Loechel does not teach the claimed step (b), in particular, “rapidly mixing…with a series of infusion gas injector ports. saturating the whipping agent into the formulation”.
Lowry (US 3,710,538), cited on the 3/17/2025 IDS: Lowry teaches a method and apparatus for filling pressurized packages and aerosol dispensers. The product which is to be dispensed is initially whipped or beaten in a suitable pressurized beating machine so that minute gas bubbles are incorporated into the product. The gas used for pressurizing the beating machine may be the same as the propellant gas which is used in the dispenser. With the product thus initially treated it is pumped, while maintained under pressure, into a suitable canister which is itself maintained in a pressurized atmosphere of the propellant gas, and the pump will, with minimum work exerted on the product, displace a predetermined quantity thereof into the canister which is in the pressurized atmosphere. While this canister is still in the pressurized atmosphere it is capped so that it becomes closed with a conventional valve release, and then the thus-closed canister is removed from the pressurized atmosphere. Thereafter, the valve of the canister can be actuated to release the product therefrom, with the product expanding in volume as it discharges out of the canister (Abs). Lowry does not teach the claimed step (b), in particular, “rapidly mixing…with a series of infusion gas injector ports. saturating the whipping agent into the formulation”.
Conclusion
No claims are allowable.
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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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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