Notice of 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 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 1-4 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 1 recites "without having to form a liquid-powder slurry" in line 1, however the
metes and bounds of this recitation are unclear. Is the formation of a liquid-powder slurry necessarily excluded or only optionally excluded if it doesn't "have to" be formed? Can some slurry be formed in the
process? Can any slurry at all be present? The claim language is interpreted to not require but to not necessarily exclude slurry formation in the process of filling an aerosol container.
On the whole, in claim 1, the use of present tense verbs with regard to nouns or components
instead of in regard to active steps of the claimed method is confusing and unclear. The claim is replete
with this type of language such that it is wholly unclear which components are requisite to the claims and
which are structures capable of being maneuvered but not stepwise actually maneuvered in the process
claimed. Appropriate clarification throughout the entirety of the claim is critically necessary to
understand the meaning of the claim.
Lines 2-3 of claim 1 recites "the first phase comprising adding powder " however this does not
make sense. A first phase is interpreted as an object or a composition in the instant context and not a
stepwise process of powder addition. It is unclear how a first phase [composition] comprises an action
rather than components themselves. Similarly unclear are parallel recitations with regard to the second
phase as in lines 3 and with regard to the third phase in line 6.
The hypothetical context of the powder remaining in powder format without any contact with
liquid in line 4 is interpreted as a hypothetical possibility which the claimed structural components may
perform but no actual stepwise requirement within the claimed process of filling an aerosol cannister.
Where a powder is present it is interpreted to remain in powder format where it is not contacted with
liquid.
Regarding lines 7-8, these lines are considered to describe a property inseparable from the
form otherwise addressed in the claim. The meaning of "maintains its potency and particle size integrity to form a final aerosol product" is unclear. What is potency? What characteristic is maintained? What form is being described? What is a final product herein? As such, what are the metes and bounds of this term?
Claim 2 recites "Corn/Rice/Tapioca Starch" is unclear because it is unclear
whether what is claimed is a mixture of these, or a mixture of these in the alternative with the additional
items recited in a series with each series member being separated by a comma.
It is unclear if the amounts recited in lines 3,5,11 and 12 are ranges for each of the three phases
described or if the ranges respectively refer to amounts of magnesium stearate and essential oils.
Additionally, the term "about" coupled with the end points of range is unclear in view of the
ambiguous and subjective and variable definition presented at paragraph [0044] of the specification as
filed.
Claim 3 recites “specialized powder filling equipment including filling nozzles in lines 1-2, is unclear as to what makes the filling nozzles described to be special. Appropriate clarification is required.
Claim 4 recites the term “about” coupled with the end points of ranges is unclear in view of the
ambiguous and subjective and variable definition.
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.
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over Di Giovanni WO2009013213 in view of Hammer US2012/0282190A1.
Claim 1 recites a process of filling an aerosol canister without having to form a liquid-powder slurry prior to filling, comprising a first phase, a second phase, and a third phase; the first phase comprising adding powder to an aerosol canister; the second phase comprising adding liquid to the aerosol canister, wherein the powder remains in powder format without any contact with liquid until the
point of filling to prevent particle agglomeration that increases particle size beyond functional
spray requirements; and the third phase comprises adding propellant to the aerosol canister to
complete the filling of the canister, wherein the powder maintains its potency and particle size
integrity to form a final aerosol product.
Di Giovanni teaches a method of charging an aerosol canister with a propellant drug formulation
wherein an aerosol canister is selected and to which a dry powder active drug form is added, and a
propellant is separately introduced into said aerosol canister (see abstract, in particular). This teaching is
considered to teach the stepwise addition of a first phase and subsequently a third phase to an aerosol
canister. Other components may be added such as surfactants, solvents, excipients, and adjuvants in
liquid form for instance and may be added subsequent to the metered addition of the powder form to the
aerosol container (see page 7, lines 12-16 in particular); this teaching is considered to meet the instant
limitation of stepwise introducing a liquid excipient to a canister subsequent to a powder composition.
Further regarding claim 1 in particular, Di Giovanni describes separate filling of a canister with non-
propellant components wherein a first step includes the addition of dry powder form into the canister by
metering which suggests a nozzle present and capable of performing the function otherwise described in
claim 7 (see Di Giovanni page 2, first paragraph; paragraph bridging pages 2 and 3; see also page 3, third
paragraph; see also Figures 3C as further described in the paragraphs bridging pages 12 and 13; see also
page 14; Figure 5b and description thereof which includes a valve skirt which may constitute a special
filling nozzle component as instantly claimed).
Di Giovanni docs not specifically teach the particular phase one through three components as
instantly recited which are otherwise addressed below. It would have been prima facie obvious to one of
ordinary skill in the art at the time of the invention to incorporate the powder, liquid, and propellant
components further addressed below in a canister loaded as taught by Di Giovanni, with a reasonable
expectation of success. One would have been motivated to do so for each of the specific reasons outlined
below with regard to each phase and component thereof.
Regarding the first phase components, Hammer teaches aerosol formulations as well as their methods of making; the formulations may be used in body-treating applications such as a dry shampoo product (see abstract, in particular). The dry shampoo product may comprise at least one starch material
which desirably functions as an oil absorber; rice starch is named as an example of a suitable starch
material (see first five lines of [0013]). A clay material may be included for its desirable benefits as an oil
absorber and/or a suspending agent wherein kaolin is named as a suitable clay agent (see [0012]).
Hammer teaches that in some embodiments magnesium stearate in the alternative is not included where no colored residue is desired; this teaching indicates an alternative embodiment in which magnesium stearate may be included for instance in a low amount (see [0027]). As to the stepwise addition of these components, Hammer explicitly teaches that the aerosol dry shampoo formulation may be prepared by loading an aerosol container with a dry shampoo composition for instance as a powder followed by addition of a propellant (see [0028]). As to propellants, Hammer overlaps Di Giovanni's teaching by teaching a propellant may be included; Hammer specifies isobutane for instance in an amount of 75-80% by weight of the total formulation (see [0034], Example 1 for instance).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Di Giovanni WO2009013213 in view of Hammer US2012/0282190A1, in view of GB1218222, in view of Schwab US2018/0015238A1, in view of Fowler US 5635469, and in view of Horenziak US 20180066206.
Regarding claim 2, Di Giovanni in view of Hammer discloses the process of Claim 1, but fails to explicitly teach wherein the first phase comprises a powder blend including a mixture of Corn/Rice/Tapioca Starch, Benzothonium Chloride, Calamine Powder, Kaolin, Sodium Bicarbonate, Magnesium Stearate between about 10% w/w and about 14% w/w, wherein the powder remains in powder format without contact with liquid until the point of filling to prevent particle agglomeration that would increase average particle size by more than 75% as demonstrated through comparative particle size analysis; the second phase comprises a liquid blend including a mixture of alcohol, silicone, sorbitan oleate, bisabolol, isopropylmyristate, fragrance, essential oils comprising the remainder after powder and propellant phases, wherein the liquid phase is heated to approximately 35°C and nitrogen purge is applied to maintain anhydrous conditions; and the third phase comprises a propellant blend including HFC 152a,
propane, and isobutane between about 55% w/w and about 70% w/w, wherein the process achieves statistical process control capability (Cpk) improvement from below 0.20 to above 0.60 compared to conventional slurry-based methods.
However GB1218222 cures this deficiency. GB1218222 teaches a process for preparing a dry shampoo in aerosol form (see title, in particular). GB1218222 teaches the combination of dry powder components with a propellant and dispersant agents. GB1218222 teaches benzethonium chloride to be present as a dispersing agent (see claim 8) as well as sodium bicarbonate as a mild alkali desirably and necessarily
included (see claim (limitation of "Sodium bicarbonate" in first powder component of instant claim 6).
The dry shampoo powder is noted to also include rice starch (see Example) wherein the dry powder
components are present in an amount of "about 6%" which is considered overlapping with the instantly
claimed range of about 8 to 12% wherein the instant specification as filed defines about such that
GB1218222's range is included; see GB1218222's Example at the top of page 3 of the publication.
Both Hammer and GB1218222 are directed to formulations for dry shampoos including
propellants and their methods of making. It would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to include sodium bicarbonate as taught by GB1218222 to the
aerosol shampoos of Hammer, with a reasonable expectation of success. One would have been motivated
to do so to convey its desirable mild alkali benefit properties in combination with additional known dry
powder shampoo components including benzothonium chloride and starch components as taught by
GB1218222.
Hammer does not teach the calamine powder component instantly recited in claim 6 in the first
phase. Schwab cures this deficiency. Schwab teaches a spray canister device for spraying a solution to a
surface arca of a human body (see abstract, in particular). Calamine, kaolin, and topical starch are taught
as commonly included elements to be administered by spray canister device (see [0025]).
Both Hammer and Schwab are directed to formulations for topical spray application, and Di
Giovanni and Schwab are both directed to methods of filling spray canisters with body treating
formulations. It would have been prima facie obvious to one of ordinary skill in the art at the time of the
invention to add calamine as taught by Schwab into the canister devices of Di Giovanni in formulations of
Hammer with a reasonable expectation of success. One would have been motivated to do so in addition
to or in place of a portion of kaolin or topical starch components commonly used as taught by Schwab to
be state of the art in spray canister cleaning or medicated solution to be applied to the human body by
spray application from a canister.
Regarding the second phase components, Di Giovanni teaches alcohol components preferably
ethanol may be included to improve dispersion (see page 27, line 13) and further regarding particular dry
shampoo formulations, Hammer teaches alcohol such as ethanol maybe included in an amount between
about 1 to about 20% (see [0026]) as well as cyclomethicone in an amount between about 0.1 and 15%
(cyclomethicone is a silicone), as well as at least one additive in an amount of 0.1 to 10% (see [0026]),
components present in a range overlapping or nearly overlapping the instantly recited range of about 8 to
about 12% in view of the definition of "about" presented in the specification as filed. Fragrance oils and
natural fragrance oils are included among additive components ("fragrance" and "essential oil" as in
claim 6)(sec [0015] and [0017]). GB1218222 specifics that isopropyl myristate and sorbitan
monolaureate are used in particular combination with perfume and alcohol which is ultimately added to a
dry shampoo powder components along with a propellant.
Hammer teaches herb and/or plant extracts may be included as additives or functional agents but
does not specify bisabolol in particular (see [0015]), nor does Hammer teach sorbitan oleate.
Fowler cures this deficiency. Fowler teaches a cleansing product wherein sorbitan oleate and
sorbitan [mono ]laurate are taught as functional equivalent emollient components (see column 12, lines 11
and 13) such that it would have been obvious to substitute one for the other in the formulations of
Hammer and GB1218222 otherwise addressed above. Fowler further specifies bisabolol among
additional active ingredients which may be provided for aesthetic benefit (see column 17, line 48)
alongside or in the alternative to essential oil and/or fragrance type functional components otherwise
addressed above in regard to Hammer.
Hammer and Fowler are both directed to topically applicable cleansing formulations. It would
have been prima facie obvious to one of ordinary skill in the art at the time of the invention to add
sorbitan oleate, bisabolol, and isopropyl myristate as in Hammer, GB1218222, and Fowler into a single
formulation where each is respectively known in the art for its functional benefit. One would have been
motivated to include sorbitan oleate as an emollient as taught by Fowler, bisabolol as an aesthetic benefit
agent as taught by Fowler, and isopropyl myristate as taught by GB1218222 in an embodiment and as
further taught by Fowler as an acceptable conventional emollient (column 11, line 58).
Regarding the third phase which is the propellant mixture, Di Giovanni generally teaches
propellants to be liquified gas propellants including fluorocarbons or hydrogen-containing
chlorofluorocarbon propellants (see page 26, lines 9-27), however Di Giovanni does not teach the
particular instantly elected combination of HFC152A, isobutane, and propane. As noted above, Hammer
teaches overlapping propellant components to be useful in a range within the instantly claimed range in an
analogous formulation which is a dry shampoo; see Hammer's Example 1 as noted above. An additive
such as an anti-dandruff agent which may be benzethonium chloride may be included (see [0018]).
Hammer also teaches isobutane among aerosol propellants for instance (see [0022]). None of the
aforementioned references teaches all of HFC152A, isobutane, and propane propellants as instantly
elected.
However Horenziak cures this deficiency. Horenziak teaches the manufacture of a spray product in a container wherein particles and/or perfume components and additional components are loaded and may be in the form of an aerosol (see [0090]) wherein a solvent system may comprise alcohols such as
ethanol, propanol, isopropanol, and butanol for instance (see [0095]) in a packaged dispenser (see [0108]
and [0110]). The packaged spray product may include a propellant which may be a liquefied gas
propellant such as HFC hydrofluorocarbon propellants (see [0119] and [0120]) and further may comprise
a mixture of propane and isobutane for instance (see [0126]). Examples include these particular
components (see [0127] and [0129]). Because there is not a single composition embodiment particularly
combining HFC152A, isobutane, and propane but rather two embodiments wherein a first embodiment
comprises propane and isobutane and wherein a second embodiment comprises butane and HFC152a (see
[0127] and [0129]), it is the examiner's position that it would have been prima facie obvious to one of
ordinary skill in the art to mix and match these known functional equivalents from among those particular
chosen for embodiments in Horenziak's teachings, with a reasonable expectation of success. One would
have been motivated to do so since Horenziak generally teaches these propellants as functional
equivalents which may be used in combination (see [0126] and [0126] for instance). One reasonably
would have expected success from doing so because absent evidence to the contrary one reasonably
would have expected each known functional propellant to retain its functional efficacy in combination
with another functional propellant known to be useful in sprayable product applications as demonstrated
in Horenziak's embodiments. Moreover, it is the examiner's position that to do so would have
constituted a combination of prior art elements according to known methods to yield predictable results
and/or a simple substitute of one known element for another to obtain predictable results. In the instant
case, as shown above, the prior art teaches each propellant instantly elected wherein the only missing
piece is the lack of actual combination in a single embodiment. Additionally, one would reasonably
expected to combine the known elements since the prior art teaches propellants to be used in combination
and that in doing so each propellant would have merely performed the same function as if done separately
as one of ordinary skill in the art would have recognized specifically based on Horenziak's teachings of
each of these known propellant agents used in a method of dispensing a cosmetic and/or pharmaceutical
product from a package with a reasonable expectation of predictable results.
Conclusion
Claims 3 and 4 are rejected under 112(b) and depend from rejected claim 2. As presently written claims 3 and 4 are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C HIBBERT-COPELAND whose telephone number is (571)270-0601. The examiner can normally be reached M-TH 9am -5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at 5712701926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY C HIBBERT-COPELAND/Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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