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 .
Status of the Claims
Pursuant to the amendment dated 06/22/2026, new claims 21 and 22 have been added.
Claims 1-7, 9, and 11-22 are pending and under current examination.
All rejections not reiterated have been withdrawn.
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.
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 1-7, 9, and 11-22 are rejected under 35 U.S.C. 103 as being unpatentable over Leng et al. (US 5,593,663; issue date: 01/14/1997; cited in the IDS filed 06/13/2024) in view of Doering et al. (US 20170135913; publication date: 05/18/2017) and Beck et al. (US 20020146376; publication date: 10/10/2002).
With regard to claims 1-4, 6, 7, and 16-22, Leng discloses an antiperspirant composition comprised of actives that form a liquid crystal phase of greater than one-dimensional periodicity that are free of conventional antiperspirant actives, especially aluminum and/or zirconium salts. Leng directs the artisan of ordinary skill to seek a combination of amphiphilic materials that form a water in oil soluble liquid crystal phase on contact with perspiration (para bridging col 1-2). Leng describes the amphiphilic compounds as having sufficiently rigid structure to physical block openings of skin pores producing perspiration in much the same way as conventional aluminum antiperspirant astringents are thought to work (col 3, lines 1-5). The antiperspirant active physically swells as it forms the liquid crystal structure on contact with perspiration (col 3, lines 13-14). Leng provides a short list of amphiphilic substances that are capable of achieving this liquid crystalline state that includes the glyceryl monolaurate in combination with isostearyl alcohol (49-56). Leng describes glyceryl monolaurate as also having antimicrobial properties (col 4, lines 444-45). These antiperspirant actives may be present in the composition from 5 to 100% by weight (col 4, lines 60-64). The particular combination of glycerol monolaurate and isostearyl alcohol is disclosed as being capable of forming a reverse hexagonal liquid crystal phase (col 7, lines 20-25 and col 8, lines 5-10). The range in weight ratio for glycerol monolaurate to isostearyl alcohol in the example noted above is from 70:30 to 55:45, and Leng directs the artisan of ordinary skill to seek concentrations of the liquid crystal formers that form a hexagonal phase, therefore the examiner considers discovering the optimal quantities of these two substances in any particular formulation, having other permissible ingredients such as a vehicle or a propellant (see col 5) to have been a matter of routine optimization for the artisan of ordinary skill. See MPEP 2144.05(I): 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). Absent evidence of an unexpectedly superior property associated with the ratio of glycerol monolaurate to isostearyl alcohol recited in instant claim 1, the examiner considers this limitation to have been prima facie obvious following the direction provided by Leng. The composition does not require silicone oil and example compositions lack silicone oil.
Leng discloses further that the composition may contain vehicles such as ethanol (col 5, line 9 and the examples disclosed at col 45-55 are brought to 100% wt. with ethanol) and other routine ingredients such as propellant in the case of an aerosol formulation (col 5, line 48); however, Leng does not provide any particular reason to select ethanol and does not provide guidance on the quantity of propellant to include to formulate the composition as an aerosol.
Doering discloses that propellant mixtures such as propane, n-butane, or isobutane can be used in a weight percentage of from 55-80% by weight (0050) in antiperspirant aerosols (title).
It would have been prima facie obvious to formulate Leng’s composition as an aerosol because Leng suggests doing so ( col 5, lines 48-50). With regard to the amount of propellant, it would have been obvious to use the range in propellant disclosed for other aerosol antiperspirant compositions as a starting point for routine optimization to achieve the desired spray, and the range disclosed by Doering overlaps with the range required by the instant claims. See MPEP 2144.05.
Beck discloses that ethanol was known in the art to provide good low temperature storage stability (0035) in compositions for treating sweat (title).
It would have been prima facie obvious to select ethanol as the vehicle from the substances listed by Leng. The skilled artisan would have been particularly motivated to do so in order to enhance the low temperature stability of the composition and had reasonable expectation of success because Leng discloses ethanol as a vehicle in example compositions. With regard to the amount of ethanol, Leng discloses that the ingredients other than the antiperspirant actives may constitute up to 95% of the composition by weight (col 5, lines 50-55). This range overlaps with the range required by the instant claims. See MPEP 2144.05.
With regard to claims 5 and 15, as noted above, Doering discloses propane, isobutane, and butane (C3 and C4 hydrocarbons) as known propellants as of the instant effective filing date (see MPEP 2143(A)).
With regard to claims 9 and 11, the composition may contain a perfume, which is present at 1% by weight in the examples (i.e. fragrance; col 8, line 50)
With regard to claim 12, the composition preferably lacks aluminum and zirconium antiperspirant agents (abstract).
With regard to claim 13, the composition may further comprise an antimicrobial agent (col 5, line 21).
With regard to claim 14, Leng discloses a method of preventing or reducing perspiration at the human skin surface, the method comprising applying the antiperspirant composition described therein (e.g. claim 5).
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive.
On page 5, Applicant provides a 3-component phase diagram illustrating examples 1-4 per the instant invention vs. comparative examples presented in table 1, page 7 of the instant specification. Applicant argues that the shaded area of the diagram represents the area covered by the pending claims, example 1-4 are found within the shaded area, and comparative examples are found outside the shaded area. Applicant argues that the stability achieved by the instant invention occupies a narrow area within the phase diagram and that this is not suggested by the cited prior art. On page 9, Applicant argues further that the compositions exemplified in Beck contain aluminum and or zirconium based antiperspirant actives, that Beck discloses multiple antiperspirant formulation formats, is not focused on aerosols, and the skilled artisan would not look towards Beck for guidance in formulating and stabilizing organic lipids.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, the result is not clearly unexpected as ethanol is disclosed as a suitable solvent by Leng and Beck teaches that ethanol enhances storage stability. It would be a matter of routine for one of ordinary skill to determine the quantity of ethanol that was suggested by Leng to provide a stabilizing effect to the composition, as taught by Beck. Moreover, the data are wholly subjective in nature, thus the practical and statistical significance of “good” vs. e.g. “inferior” stability cannot be assessed at this point. With regard to the argument that one having ordinary skill would not have looked to Beck to formulate antiperspirants comprising lipids, the examiner respectfully disagrees that the references is non-analogous art. Both references are in the field of antiperspirant compositions and therefore properly combined under 35 USC 103. Moreover, Beck provides guidance as to formulation of aerosols using closely related structurants such as stearyl alcohol (0043); Aerosol compositions of the invention may comprise from 30 to 99 parts by weight, and particularly 30 to 60 parts by weight of propellant and the remainder (respectively 70 to 1 and particularly 70 to 40 parts by weight) of the antiperspirant/deodorant base composition (0055). Nothing of record establishes that the teachings contained in Beck regarding stability enhancement properties of ethanol could not be extrapolated to other aerosol compositions. See also MPEP 2123: Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
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 1-7, 9, and 11-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18715937 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the cited copending application embrace an aerosol composition comprising a mixture of isostearyl alcohol and glycerol monolaurate, ethanol, propellant (specifically C3 or C4 alkanes), fragrance and antimicrobial agent in amounts overlapping with the amounts required by the instant claims. The claims of the copending applications exclude aluminum and zirconium salts and exclude volatile silicone oils.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 7, and 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14 of copending Application No. 18718976 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the cited copending application embrace an aerosol composition comprising a mixture of isostearyl alcohol and glycerol monolaurate, ethanol, propellant, and antimicrobial agent in amounts overlapping with the amounts required by the instant claims. The claims of the copending applications exclude aluminum and zirconium salts and exclude volatile silicone oils.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14 of copending Application No. 18718976 (reference application) as applied to claims 1-4, 6, 7, and 12-22 above, and further in view of Doering et al. (US 20170135913; publication date: 05/18/2017).
The relevant limitations of the ‘976 application are set forth above and do not specify the identity of the volatile propellant.
Doering discloses that propellant mixtures such as propane, n-butane, or isobutane can be used in a weight percentage of from 55-80% by weight (0050) in antiperspirant aerosols (title).
It would have been prima facie obvious to use propane, n-butane, or isobutane as the propellant in the ‘976 invention because these substances were routinely used for this purpose as of the instant effective filing date (see MPEP 2143(A)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14 of copending Application No. 18718976 (reference application) as applied to claims 1-4, 6, 7, and 12-22 above, and further in view of Leng et al. (US 5,593,663; issue date: 01/14/1997).
The relevant limitations of the ‘976 application are set forth above and do not mention a fragrance. Leng discloses including a perfume (i.e. a fragrance) at 1 % by weight in an aerosol antiperspirant composition (col 8, line 50). It would have been prima facie obvious to include a fragrance in the ‘976 invention. The artisan of ordinary skill would have been motivated to do so in order to provide a pleasing smell to the composition and would have had reasonable expectation of success because such was routine as of the instant effective filing date (see MPEP 2143(A)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 06/22/2206 have been fully considered but they are not persuasive.
On page 10, Applicant requests that the examiner withdrawn the double patenting rejections until the claims are in final form and otherwise in condition for allowance.
Applicant’s request is noted. The rejections are provisional and apply to the claims as the are currently worded and are therefore maintained.
Conclusion
No claims are 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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617