DETAILED ACTION
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 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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim does not recite any limitations. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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, 3-6, 8-9, 14-15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Leng et al. (US Patent No. 5,593,663 - previously cited) in view of Leng et al. (WO 94/24993 – henceforth Leng B Beck et al. (previously cited) ) and Hough et al. (previously cited) and as evidenced by the SF 1202 MSDS (previously cited).
Leng et al. teach an antiperspirant composition with antiperspirant actives consisting of one or a combination of lipid substances (see abstract and (column 3 lines 41-54). They further detail a combination consisting of isostearyl alcohol and glyceryl monolaurate that is preferred at an isostearyl alcohol to glyceryl monolaurate weight ratio of 30:70 to 45:55 (see example 21 and column 8 lines 18-19; instant claim 1). They detail examples that include the lipid mixture in the absence of aluminum or zirconium based antiperspirant actives (see examples 7-15). Leng et al. also teach that the proportion of the lipid active is about 5 to about 100 wt%, or more preferably about 10 to 80 wt% (see column 4 lines 60-63). Exemplary compositions are taught that employ a composition base that has a volatile silicone and ethanol (see composition 15). Leng et al. further teach humectants as an envisioned optional ingredient, where glycerol is a named variety (see column 5 lines 6-7 and 39; instant claims 8-9). They go on to teach various forms in which the composition is envisioned and list roll-on lotions, liquid spray, solid, and propellant driven aerosol (see column 5 lines 47-50; instant claim 1). Leng et al. do not exemplify a humectant in combination with the silicone oil, ethanol, antiperspirant lipids or an aerosol formulation.
Leng B teach an antiperspirant composition, wherein the antiperspirant actives are at least one amphiphilic compound (see abstract). They go on to detail that the amphiphilic compound is preferably a mixture of lipids and specifically preferred in the form of a combination of isostearyl alcohol and glyceryl monolaurate (see page 10 lines 4-18). Leng B teaches various forms in which the composition is envisioned and list roll-on lotions, liquid spray, solid, and propellant driven aerosol (see column page 15 lines 23-25; instant claim 1). Leng B further teach an example of an aerosol form that includes a mixture of isostearyl alcohol and glyceryl monolaurate at 10.22 wt%, volatile silicone at 34.71 wt%, ethanol at 17 wt%, and dimethyl ether propellant at 35 wt%, in the absence of aluminum or zirconium based antiperspirant actives (see composition 6).
Beck et al. teach various cosmetic forms for the delivery of antiperspirant and deodorant actives that includes roll-on, stick, and aerosol (see abstract, paragraph 54, and examples). An aerosol example includes a fatty acid ester, cyclomethicone sold under the name DC245 at 14.4 wt%, ethanol at 20 wt%, dimethyl ether propellant at 40 wt%, and antiperspirant active at 9.2 wt% (see example 2.3; instant claims 1 and 3-4). They also teach the inclusion of sensory ingredients at a proportion up to 20 wt%, where humectants are a named variety as is glycerol (see paragraph 46; instant claims 1 and 8-9). Beck et al. further detail antiperspirant active present at 0.5 to 60 wt% (see paragraph 30).
Hough et al. teach both DC 245 and SF1202 as volatile silicone fluids to include in antiperspirant compositions (see abstract and paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select isostearyl alcohol and glyceryl monolaurate at the preferred isostearyl alcohol to glyceryl monolaurate weight ratio of 30:70 to 45:55 for the composition of Leng et al. because it is preferred. This range meets the limitations of that instantly claimed. It would additionally have been obvious to formulate the actives as an aerosol because it is a form Leng et al. explicitly envision and that Leng B exemplifies as suitable and contemplated for the same combination of antiperspirant components. The selection of the antiperspirant composition base of Beck et al. as the aerosol composition base in combination with the isostearyl alcohol/glycerol monostearate actives of Leng et al. would also have been obvious. This choice would have been obvious because Leng B teach that a similarly constructed aerosol base is suitable for delivering the amphiphilic antiperspirant components and it was a known aerosol base taught for antiperspirant active delivery. The result is a composition that is free from aluminum or zirconium antiperspirant salts. It also would have been obvious to add glycerol as a humectant at a proportion within the range taught by Beck et al. because they suggest to do so and Leng et al. teach it as a particular humectant they envision. This modification in light of the Leng et al. range of lipid antiperspirant active blend of about 5 to about 100 wt% suggests a range of compositions with at least 5 wt% of the isostearyl alcohol and glyceryl monolaurate being present. Given the ranges of proportions for the antiperspirant active of Leng et al. and Beck et al., adjusting the antiperspirant active proportion of the example of Beck et al. downward to 5 wt% of the Leng et al. isostearyl alcohol and glyceryl monolaurate at an isostearyl alcohol to glyceryl monolaurate weight ratio of 30:70 to 45:5 is within this obvious range, as is filling the remaining mass with the humectant (e.g., 4.2 wt%). This then provides 5 wt% of a 16:9 ratio of isostearyl alcohol/glycerol monolaurate active blend, DC245 (volatile silicone oil) at 14.4 wt% and ethanol at 20 wt%. These proportions yield weight ratios of (a) 0.56 glycerol monolaurate to isostearyl alcohol, (b) 0.14 amphiphilic material to (ethanol + volatile silicone), (c) 0.58 volatile silicone to (ethanol + amphiphilic material), and (d) 1 ethanol to (amphiphilic material + volatile silicone) (as calculated by the examiner). These proportions also yield ethanol at 33 wt% and volatile silicone within the tri-component mixture consisting of volatile silicone, ethanol, and amphiphilic material at 36.5 wt% (see instant claims 17 and 19-20). The weight ratio ranges of instant claim 1 simplify to (a) 0.33 to 0.81 glycerol monolaurate to isostearyl alcohol, (b) 0.11 to 0.67 amphiphilic material to (ethanol + volatile silicone), (c) 0.1 to 1.2 volatile silicone to (ethanol + amphiphilic material), and (d) 0.43 to 1.5 ethanol to (amphiphilic material + volatile silicone) (as calculated by the examiner). The ratio of ethanol to amphiphilic material is 4 in this embodiment (see instant claims 14-15 and 21). The proportions that are rendered obvious, therefore, fall within the range of instantly claimed ratio ranges, indicating that the range of ratios for claimed pairings of components provided by the prior art based composition overlap with those instantly claimed and render the claimed ranges obvious. “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)” (see MPEP 2144.05; instant claim 1). Similarly, the range of proportions for the humectant, more broadly, overlaps with that instantly claimed, thereby rendering them obvious as well. Further, ignoring the contribution of propellant, the proposed 5 wt% isostearyl alcohol and glyceryl monolaurate containing composition can provide ethanol at 33 wt% as well as volatile silicone at 24 wt% (see instant claims 17-18). It additionally would have been obvious to exchange SF1202 for the DC 245 in the modified composition of Leng et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The SF1202 MSDS detail that it contains greater than 90% decamethylcyclopentasiloxane and would have a vapor pressure of about 3 mmHg (400 Pa) at 25⁰C (see pages 1 and 4; instant claims 1 and 5-6). Thus the modified composition provides a volatile silicone according to instant claim 1 and instant claims 5-6. Therefore claims 1, 3-6, 8-9, 14-15, and 17-21 are obvious over Leng et al. in view of Leng B, Beck et al., and Hough et al. as evidenced by the SF 1202 MSDS.
Claims 1, 3-6, 8-9, 11-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Leng et al. in view of Leng B, Beck et al., and Hough et al. as evidenced by the SF 1202 MSDS as applied to claims 1, 3-6, 8-9, 14-15, and 17-21 above, and as further evidenced by Faivre et al. (previously cited).
Leng et al. in view of Leng B and Beck et al. as evidenced by the 245 Fluid MSDS render obvious the limitations of instant claims 1, 3-6, 8-9, 14-15, and 17-21, where a humectant is present in a composition with the 16:9 ratio of isostearyl alcohol/glycerol monolaurate active blend of Leng et al. in an aerosol base, patterned after that of example 2.3 taught by Beck et al. In addition, Beck et al. exemplify an antiperspirant aerosol composition with 1.5 wt% allantoin (see example 2.5). Faivre et al. teach allantoin and polyhydric alcohols as envisioned humectants in an antiperspirant composition (see abstract paragraph and 115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include glycerol, a polyhydric alcohol humectant, at 1.5 wt% in the modified composition of Leng et al. based upon example 2.3 of Beck et al. because Beck et al. already envision this proportion for humectant in their composition. In a further, application of the aerosol base of Beck et al., the presence of 10 wt% of 16:9 ratio of isostearyl alcohol/glycerol monolaurate active blend is embraced by the Leng et al. range of lipid antiperspirant active blend of about 5 to about 100 wt% and more preferably about 10 to 80 wt%. Proportionate adjustment of the non-propellant components to accommodate this increased proportion of antiperspirant active as well as humectant results in 10 wt% of a 16:9 ratio of isostearyl alcohol/glycerol monolaurate active blend, DC245 at 11.64 wt% and ethanol at 16.2 wt%. These proportions yield weight ratios of (a) 0.56 glycerol monolaurate to isostearyl alcohol, (b) 0.36 amphiphilic material to (ethanol + volatile silicone), (c) 0.44 volatile silicone to (ethanol + amphiphilic material), and (d) 0.74 ethanol to (amphiphilic material + volatile silicone) (as calculated by the examiner). The weight ratio ranges of instant claim 1 simplify to (a) 0.33 to 0.81 glycerol monolaurate to isostearyl alcohol, (b) 0.11 to 0.67 amphiphilic material to (ethanol + volatile silicone), (c) 0.1 to 1.2 volatile silicone to (ethanol + amphiphilic material), and (d) 0.43 to 1.5 ethanol to (amphiphilic material + volatile silicone) (as calculated by the examiner). The ratio of ethanol to amphiphilic material is 1.6 in this embodiment (see instant claim 14). The proportions that are rendered obvious, therefore, fall within the range of instantly claimed ratio ranges, indicating that the range of ratios for claimed pairings of components provided by the prior art based composition overlap with those instantly claimed and render the claimed ranges obvious (see MPEP 2144.05; instant claim 1). Similarly, the range of proportions for the humectant overlaps with that instantly claimed, thereby rendering them obvious as well. Further, ignoring the contribution of propellant, the proposed 10 wt% isostearyl alcohol and glyceryl monolaurate containing composition can provide amphiphilic material at 16.7 wt%, glycerol humectant at 2.5 wt% as well as volatile silicone at 19.4 wt% (see instant claims 11-13, 16, and 18). Therefore claims 1, 3-6, 8-9, 11-16, and 18-21 are obvious over Leng et al. in view of Leng B, Beck et al., and Hough et al. as evidenced by the SF 1202 MSDS and Faivre et al.
Declaration
The declaration under 37 CFR 1.132 filed July 2, 2025 is insufficient to overcome the rejection of claims 1, 3-6, 8-9, 11-16, and 18 based upon Leng et al. in view of others as set forth in the last Office action because: the showing is not commensurate in scope with the claims (see MPEP 716.02(d)).
The declarant provides a showing of the stability performance of two compositions within the scope of the claims as compared to two compositions outside the scope of the claims. They differ in regard to a required ratio amongst the tri-component mixture consisting of a claimed volatile silicone, amphiphilic material, and ethanol. One of the three claimed humectants was included and one concentration of this component was tested in all the compositions analyzed in the showing. The results (e.g., phase stable or unstable) parallel those in the specification when the same compositions, devoid of propellant, were tested which is suggestive that the propellant employed by the declarant does not impact stability. The showing is suggestive of the criticality of the claimed ratio ranges and component combinations; however, it is not evident that the outcome is representative of the full claim scope.
The claims require one of three possible humectants that is present at 0.1 to 10 wt% in the total composition, excluding the propellant. The showing only tests glycerol as the humectant at one concentration. While the results could reasonably be extended from glycerol to propylene glycol, since they are similarly structured polyols, there is no clear reason they would extend to the third humectant, hydroxyethylurea. This third humectant option has nitrogen groups that are not present in the other humectants and it is not clear that they would be expected to interact with other composition components in the same way as compounds with no nitrogen groups. The declarant does not speak to the structural difference amongst the claimed humectants and the specification does not discuss any structural features of humectants that predisposes them to stability issues when incorporated into compositions with the claimed volatile silicone, ethanol and amphiphilic material at particular ratios. The specification shows only stable varieties of compositions with hydroxyethylurea; thus it is not clear from the specification that it even shares the stability issue shown to occur with glycerol and propylene glycol. In addition, a single concentration of glycerol was tested, while the claims recite a range of 0.1 to 10 wt% for the humectant component. There is no evidence that instability is an issue through the range of claimed humectant proportions or through the range of possible proportions of the other required components. The declarant does not provide any discussion of why one would expect the instability seen at 4 wt% through the range of concentrations that extend down to 0.1 wt% and up to 10 wt%. They also do not discuss the prevalence of the stability issue through the scope of compositions that have different overall amounts of claimed ingredients (e.g., ethanol, amphiphilic material, and volatile silicone). Therefore the showing is not commensurate in scope with the claims which makes the showing insufficient to overcome the prima facie case of obviousness.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments filed July 2, 2025 have been fully considered and area not persuasive. New grounds of rejection are detailed to address the new claim limitations.
The applicant argues that Leng B does not exemplify a composition with its ethanol, volatile silicone and amphiphilic material that fulfills each of the required component ratios. Since this reference is not the sole reference relied upon in the rejection, such a teaching is not required in order to render the instant claims obvious. The rejection details teachings from multiple references that collectively render the claims obvious. The claimed amphiphilic material was known in combination with a propellant, volatile silicone, and ethanol. The propellant, ethanol, and volatile silicone containing carrier was also known for other antiperspirant actives intended to be delivered via propellant (e.g., Beck et al.) and provided or taught at relative amounts that yield ratios overlapping with those instantly claimed. In addition, a claimed humectant was envisioned to be included in antiperspirant compositions with the claimed amphiphilic material and was known in antiperspirants at a claimed proportion. Application of the carrier of Beck et al to the composition of Leng et al., in light of Leng B teaching the active of Leng et al. in an aerosol carrier similar to Beck et al., is obvious as is adjusting the proportion of antiperspirant active within the range taught by Leng et al. There is no evidence that the claimed combination of components yields an unexpectedly superior outcome due to the combination or due to particular proportions and the evidence of record is not sufficient to demonstrate the criticality of the claimed ratios across the claimed scope.
It is acknowledged that the declarant noted typographical errors in Table 1 of the specification. The applicant is encouraged to apply these corrections, as they are detailed in the declaration, via amendment to the specification. It is also noted that the example in the specification states that DC245 is cyclopentasiloxane at line 32 on page 8. This also appears like it may be a typographical error, given that the DC 245 reference (previously cited) describes the material as predominantly decamethylcyclopentasiloxane. The applicant is encouraged to review the text of the specification to verify it reflects their desired/intended text. If an additional correction is warranted, a statement via declaration attesting to the validity and source of the change is encouraged for proper support.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (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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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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