DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Preliminary Amendments and Remarks, filed 21 March 2025, in the matter of Application N° 19/113,906. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 12 and 13 have been canceled. Claims 16-21 are newly added and supported by the originally filed disclosure.
Claims 1-11, 14, and 15 have all been amended. The amendments to the claims remove recitations of improper multiple dependency and correct issues pertaining to lack of antecedent basis (e.g., changing “An” to “The” in the preambles).
No new matter has been added.
Thus, claims 1-11 and 14-21 now represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 24 July 2025 is acknowledged and has been considered.
Claim Objections
Claim 3 is objected to because it appears to be missing the term “further” before comprising. 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.
Claim 7 is 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 7 recites the limitation “the antiperspirant salt” in the second line of the claim. There is insufficient antecedent basis for this limitation in instant claim 1.
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. Applicants are 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 1-11 and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US Pre-Grant Publication Nº 2007/0178053 A1; herein referred to as “Franklin 1”) in view of Franklin et al. (US Pre-Grant Publication Nº 2016/0136066 A1; ISR/IDS reference of record; herein referred to as “Franklin 2”).
The instantly claimed invention is directed to an emulsion antiperspirant composition comprising:
an aqueous disperse phase comprising an aluminium-containing antiperspirant active and at least 10% by weight glycerol present in the aqueous disperse phase;
an oily continuous phase comprising one or more oils and having less than 0.1% by weight of cyclic silicone present in the oily continuous phase;
a nonionic emulsifier; and
a volatile propellant.
The claim adds that the aqueous disperse phase comprises at least 50 wt% of the total composition, excluding the propellant, and that the nonionic emulsifier is a PEG-dimethicone.
Franklin 1 discloses an antiperspirant base composition in the form of a liquid emulsion comprising a continuous oil phase, a dispersed aqueous phase and an emulsifier, which is suitable for combining with a propellant to form an aerosol composition (see e.g., claim 1).
The aqueous phase is further taught as representing from 45% to 80% by weight of the base composition and comprising from 20% to 50% based on said phase of a water-soluble astringent antiperspirant active salt, as well as from 2% to 20% of a polyhydric humectant.
Regarding the polyhydric humectant, glycerol is disclosed as being the preferred species. See e.g., ¶[0048]. Paragraph [0050] further discloses that the preferred amount of glycerol ranges from 10% to 30%.
The oil phase is further taught by claim 1 as representing from 20% to 55% based on the base composition and that it comprises a volatile silicone oil which represents at least 25% of the oil phase and a sensory modifying oil representing at least 20% of the oil phase.
Regarding the volatile silicone oil, ¶[0025] further defines the oil as being represented by linear or cyclic siloxanes (silicones). Paragraph [0026] adds that the volatile silicone oil more preferably represents greater than 25% of the oil phase and more preferably still, greater than 30%, while also representing less than 70% (i.e., a most preferred range being from 30% to 70% of the oil phase).
Lastly, regarding the emulsifier, claims 21 and 22 further define the component as being a silicone copolyol that is a dimethicone copolyol. Paragraph [0054] further defines the emulsifier as being non-ionic and including polyoxyalkylene or polyol fatty ethers or esters, including in particular polyoxyethylene or polyoxypropylene alkyl ethers or esters containing a small number of such oxyalkylene units, e.g., 2 to 5, and an alkyl of at least 12 carbon atoms length. This is interpreted as the non-ionic dimethicone emulsifier as possessing a “PEG” component to it. Exemplified emulsifiers include Abil EM90, which per such state-of-the-art showings as Evonik, has an INCI name of: cetyl PEG/PPG-10/1 dimethicone (www.evonik.com/en/products/cs/pr_52003302.html).
The foregoing is considered to teach the limitations recited by instant claims 1, 2, 10, 11, 14, and 19.
Regarding the limitations recited by instant claim 8, Franklin 1 further discloses that the propellant is a liquifiable propellant formed from a material having a low boiling point typically boiling below -5ºC, often below -15ºC, and commonly below -50ºC. Such liquids are understood by persons of skill in the art as being in gaseous form at room temperature. Species of propellants are disclosed in ¶[0060].
Claim 11 of the reference discloses that the antiperspirant active and humectant are present in a weight ratio ranging from 0.3:1 to 0.75:1. Such is considered to read on the recited weight ratio range of 1:4 (0.25:1) to 4:1 of instant claim 9 and the recited weight ratio range of 1:2 (0.5:1) to 3:1 of instant claim 18.
The limitations recited by instant claim 17 require that the aluminium-containing antiperspirant active be present in the composition in an amount ranging from 2% to 15% by weight of the composition. Claim 24 discloses that the antiperspirant active is present in the overall composition in an amount ranging from 3% to 18% by weight.
This descends from the disclosure of claim 24 teaching an aerosol composition containing 12% to 60% of the aerosol being due to the base composition and the remaining 60% to 88% of the composition is due to the liquifiable propellant.
Claim 1 is referenced by claim 24 and teaches that 45% to 80% of the base composition is the dispersed aqueous phase within which the active antiperspirant resides.
Calculating from claim 1, 45% to 80% of the aqueous phase in the base composition translates to a range of 5.4% to 48% by weight of the aqueous phase in the overall composition (i.e., aerosol included). The 20% to 50% of the aluminium-containing antiperspirant active within the aqueous phase calculates to being present in the overall composition in a range of 1.08% to 24% by weight. Claim 24 narrows the amount of active to 3% to 18% by weight of the overall composition, thereby meeting the limitations of the claim.
The limitations recited by instant claim 20 require that the weight ratio of the aqueous phase to the oil phase range from 50:50 to 90:10 (1:1 to 9:1).
As discussed above, claim 1 discloses that the base composition is composed of an aqueous phase ranging from 45% to 80% by weight of the base and an oil phase ranging from 20% to 55% by weight of the base. The foregoing disclosure teaches an aqueous-to-oil phase weight ratio ranging from about 0.69:1 to 4:1 (i.e., AP:OP ratios of 45%:20% and 80%:20%, etc.), thereby meeting the limitations of the claim.
The limitations recited by instant claim 21 require that the weight ratio of the volatile propellant to the base composition range from 60:40 to 90:10 (1.5:1 to 9:1).
As discussed above, claim 24 discloses that the overall aerosol composition contains a base composition ranging from 12% to 60% by weight and a propellant ranging from 60% to 88% by weight of the base. The foregoing disclosure teaches a propellant to base weight ratio ranging from 1:1 to about 7.3:1, thereby meeting the limitations of the claim.
Claim 15 is directed to a method of attaining an antiperspirant effect comprising the topical application of the composition of claim 1 to a surface of the human body. Claim 33 of the reference is considered to meet the limitations of the instant claim.
Finally, the limitations of instant claims 3-7 and 16 are directed to further limiting the composition and aluminium-containing antiperspirant active agent recited by claim 1.
Claims 3 and 4 recite that the composition of claim 1 further comprise a water-soluble calcium salt and an amino acid, defined later as being calcium chloride and glycine. Claim 7 recites that the antiperspirant salt is heated with a water-soluble calcium salt and an amino acid. Herein, for the purposes of consideration on the merits, claim 7 is considered as reciting product-by-process limitations, and therefore, broadly and reasonably interpreted as presenting the same subject matter as recited by instant claim 3.
Claim 5 recites that the aluminium-containing antiperspirant active is of formula Al2OH4.7Cl1.3 to Al2OH4.9Cl1.1.
Claims 6 and 16 are both directed to the Band III content of the active as measured by size exclusion chromatography (SEC), presenting respective content values of greater than 30% and greater than 50%.
Regarding the foregoing limitations, Franklin 1 discloses that the antiperspirant active is aluminium chlorohydrate (see e.g., claim 15). Paragraph [0042] further defines the term aluminium chlorohydrate as encompassing materials with specified figures for x and y, such as aluminium sesquichlorohydrate and materials in which the chlorohydrate is present as a complex. “Figures x and y” are in reference to the disclosed empirical formula: Al2(OH)xCly, in which x+y = 6 and y is defined as being 0.5 < y < 1.8.
Here, the Examiner acknowledges that the foregoing definition encompasses the instantly claimed aluminium-containing active agent, and while ¶[0043] teaches and suggests that other species of the empirical formula are employable in the practiced compositions, the instantly claimed compounds are not expressly disclosed by Franklin 1.
Similarly, Franklin 1 is silent as to the recited Band III properties of claims 6 and 16.
The teachings of Franklin 2, however, are considered to remedy each of these deficiencies.
Franklin 2, like Franklin 1, is directed to an aqueous antiperspirant composition in emulsion form containing an aluminium active agent, a water-soluble calcium salt, and an amino acid (see e.g., Abstract; claim 1).
The aluminium active of the practiced composition is further defined as being aluminium sesquichlorohydrate having a formula of Al2OH4.4Cl1.6 to Al2OH4.9Cl1.1, and is more narrowly defined as having a formula ranging from Al2OH4.7Cl1.3 to Al2OH4.9Cl1.1 (see claims 1 and 4). Claims 5 and 6 disclose the instantly recited Band III limitations. Claim 2 discloses that the calcium salt is calcium chloride and the amino acid is glycine.
Furthermore, claim 3 discloses that the composition is an emulsion and that it further comprises an emulsifier. Paragraphs [0060] and [0061] preferably define the emulsifier as being non-ionic.
Lastly, regarding Franklin 2’s compositions, it is noted that the type of emulsion disclosed is an “oil-water” emulsion, with the aqueous composition having a continuous phase that is predominantly (i.e., greater than 50%) water.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment.
Franklin 1 is considered to teach and suggest each of the recited limitations of the claimed invention, including the instantly claimed aluminium sesquichlorohydrate genus. It does not, however, expressly disclose the recited species of aluminium active, nor does it teach combining them with calcium chloride or glycine.
Franklin 2 is considered to remedy this compositional deficiency by also disclosing antiperspirant compositions, but wherein the active is Al2OH4.7Cl1.3 to Al2OH4.9Cl1.1, and that said active is formulated with glycine and calcium chloride.
Additionally, Franklin 2 identifies the combination of Al2OH4.7Cl1.3 to Al2OH4.9Cl1.1 with glycine and calcium chloride as providing improved sweat weight reduction (SWR) over those comparative embodiments that do not contain glycine and calcium chloride. See ¶[0096] and ¶[0097] of Franklin 2.
Thus, were the ordinarily skilled artisan to modify the aluminium antiperspirant active agent of Franklin 1 to contain the combination of aluminium sesquichlorohydrate, calcium chloride, and glycine disclosed by Franklin 2, it would present said artisan with a reasonable expectation of producing an improved composition over that which is disclosed by Franklin 1. It would also guide the skilled artisan to producing the instantly claimed composition and method of using it.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
