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 01/15/2026, claim 14 has been cancelled. Claims 3 and 13 were cancelled previously. Claims 1, 2, 4-12, and 15-23 are pending. Claims 12, 21, 23 stand withdrawn without traverse.
Claims 1, 2, 4-11, 15-20, and 22 are under current examination.
Claim Rejections - 35 USC § 112
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.
Claims 4-10 are 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.
Claims 4-10 depend from higher numbered claims, thus they do not depend from a claim previously set forth.
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.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive.
Applicant cites 37 CFR 1.126 as requiring original numbering of claims and that the examiner may renumber the claims when the application is ready for allowance. Applicant asserts that it is not the responsibility of the Applicant to renumber the claims. This argument is inconsistent with the statutory basis for the rejection, as the statue reads: “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.” Neither of the regulations cited by Applicant indicate that it is not Applicant’s responsibility to properly number their claims according to 35 USC 112(d). Applicant is correct that claims may not be renumbered; however, they may be amended to be in proper dependent form. For example, one of several way to correct dependency by amendment would be for the relevant claims to be cancelled and new claims having proper dependency could be added.
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, 2, 4-11, 15-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Styczynski et al. (US 2003/0035818; publication date: 02/20/2003; of record) in view of Herman et al. (Journal of Pharmacy and Pharmacology Vol 67, pages 473-485; publication year: 2014; of record) and Oblong et al. (US 20050003024; publication date: 01/06/2005; of record) as evidenced by Fotinos et al. (US 2001/0019722; publication date: 09/06/2001).
In examples 2-5 on page 3, Styczynski discloses a composition for reduction of hair growth (title, abstract) comprising 2-15% DFMO (i.e. eflornithine), 5% polyoxyethylene ether (which acts as a penetration enhancer, see 0015), 3.84 up to 4.24% glyceryl stearate (an oil in water emulsifier), 2.76 up to 3.05% cetearyl alcohol (an emulsion stabilizer), 1.51 up to 1.67% stearyl alcohol (an emulsifier), 0.5 up to 0.56% dimethicone (i.e. polydimethyl siloxane; a defoaming agent), 5% urea (a moisturizing agent, see Fotinos 0059: “skin conditioners that attract moisture to the skin such as glycerol or urea”), 0.4 to 0.78% preservative, and water (a carrier). Styczynski also discloses including a penetration enhancer (e.g. terpenes, cis-fatty acids), laurocapram etc.) at concentrations of e.g. 0.1-20% (0027).
With regard to claim 1, in Styczynski’s examples the quantity of eflornithine overlaps with the range recited in the instant claims, rather than falling within the claimed range. See MPEP 2144.05: 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). Additionally, the amount of dimethicone, urea, and cetostearyl alcohol in the examples falls outside the range for defoaming agent, moisturizing agent, and emulsion stabilizer recited in the instant claims; however, 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). In this case, no evidence of record establishes that the minor difference in dimethicone imparts a patentably distinct property to the instant invention. Also, see MPEP 2123. Finally, Styczynski does not characterize the example compositions as creams; however, Styczynski teaches that the type of composition may be, inter alia, a cream (0018) so formulating it as such would have been obvious because such was within the scope of the disclosed invention.
With regard to claim 1, Styczynski teaches that the composition may contain penetration enhancers (0027) and other hair growth inhibitors (0020) but does not disclose including lavender oil in the composition.
Herbert discloses that lavender oil penetrates the skin and is quickly cleared from the body (paragraph bridging pages 481-482) and that essential oils (including lavender oil) may be preferrable to synthetic materials as penetration enhancers in transdermal drug delivery because they are safe and suitable to promote percutaneous absorption of hydrophilic and hydrophobic drugs from topical formulations (abstract, title).
Oblong discloses that lavender oil inhibits hair growth (0142).
With regard to claims 1, 4, and 22, it would have been prima facie obvious to add lavender oil to Styczynski’s compositions. It would have been obvious to combine lavender oil with the penetration enhancers and it would have been obvious to combine lavender oil with the hair growth inhibitors of Styczynski’s invention because it was known to serve both of these purposes. See MPEP 2144.06. Additionally, one having ordinary skill would have been motivated to add lavender oil particularly because this substance could simultaneously enhance delivery of the DMFO (eflornithine) and provide additional hair growth reduction itself. The skilled artisan would have had reasonable expectation of success because this would merely have required adding the lavender oil to the compositions during formulation. With regard to the amount of lavender oil required by the instant claims, Styczynski discloses a range for penetration enhancer of 0.1-20% by weight (0027). One having ordinary skill could have used this range as a starting point to optimize the amount of lavender oil required to achieve the known effects on penetration and hair growth.
With regard to claim 2, Styczynski teaches that the DFMO may be in salt form (0012) and that DFMO hydrochloride was a commercially used salt for topical application as of the instant effective filing date (0007). It would have been prima facie obvious to use DFMO hydrochloride (i.e. eflornithine HCl) as the salt in Styczynski’s invention because one having ordinary skill would have recognized this as suitable and already established in the clinic (see MPEP 2144.07).
With regard to claims 5-9, 15-18, and 20, as noted above, the example compositions contain glyceryl stearate, cetostearyl alcohol, stearyl alcohol, polydimethylsiloxane, citric acid. As the citric acid is dissolved in the composition, the examiner considers the limitation of instant claim 9 requiring citric acid anhydrous to limit the starting material used to form the cream; however, both citric acid and citric acid anhydrous would dissolve into the aqueous vehicle therefore this limitation does not structurally distinguish the product, as claimed, from the examples disclosed by Styczynski.
With regard to claims 10 and 19, the preservatives include phenoxyethanol and methyl- and propyl-parabens (footnote 3 in the table following para 0026).
With regard to claim 11, Styczynski does not disclose that the composition is an oil-in-water emulsion.
Oblong discloses that topical formulations may be in a wide variety of forms including oil-in-water emulsions (0076). It would have been prima facie obvious to formulate Styczynski’s creams as oil-in-water emulsions because this was routine practice as of the instant effective filing date (see MPEP 2143(D)). In this case, it was known to apply the technique of emulsification to cosmetic compositions containing emulsifiers, water, and oil phases, such as those disclosed by Styczynski to generate a topical oil-in-water emulsion.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive.
On page 11, Applicant argues that Herman teaches that lavender oil is cytotoxic to skin cells. Herman teaches that "lavender (Lavandula angustifolia) oil composed of linalyl acetate (51%) and linalool (35%) is cytotoxic to human skin cells in vitro (endothelial cells and fibroblasts) at a concentration of 0.25% (v/v) and causes membrane damage. Moreover linalyl acetate cytotoxicity was higher than that of the essential oil itself." Herman, p. 481, col. 1. Due to this cytotoxicity, it would not be obvious to use lavender oil in a topical formulation as recited in claim 1.
This argument is not persuasive because it does not accurately reflect the teachings of Herman. In fact the statement cited by Applicant Moreover linalyl acetate cytotoxicity was higher than that of the essential oil itself." Herman, p. 481, col. 1, is followed by the statement “suggesting suppression of its activity by an unknown factor in the oil”. Thus, Herman promotes use of essential oils themselves rather than isolated components found in essential oils. Herman discloses that penetration enhancers can be associated with some toxicity and that this needs to be balanced with there benefits for enhanced drug delivery across the skin. Herman promotes essential oils as being superior in terms of toxicity profile to traditional penetration enhancers and states that an optimal concentration must be found to avoid toxicity. Herman reports that some components of lavender oil are harmful to skin cells in a tissue culture model; however, also indicates that the oil itself is less so (as pointed out above). Finally, Herman teaches that the optimal amount of essential oil as a penetration enhancer must be determined experimentally (page 478, right col). The examiner points out that the optimal amount for in vivo use would not be identical to the optimal amount found in tissue culture studies. Therefore, the examiner does not consider Herman to teach away from using lavender oil as a penetration enhancer, merely to teach caution in determining the optimal dose of any penetration enhancing essential oil.
On page 11, Applicant argues that paragraph [0142] of Oblong is devoted to hair growth inhibiting compounds, and covers three columns of Oblong. While lavender oil is mentioned in Paragraph [0142], that is the only time it is mentioned in the document. Given the large number of hair growth inhibiting compounds presented by Oblong, a person of ordinary skill in the art would not have found it obvious to select an oil known from the teachings of Herman to be cytotoxic.
As explained above, the examiner does not consider Herman to discourage use of lavender oil, but rather the encourage the use of essential oils, including lavender oil, with the caveat that an optimal dose must be discovered by experimentation to balance the benefit in terms of penetration efficacy with potential irritation to the skin. Regarding the fact that lavender oil was disclosed by Oblong as one of many substances reducing hair growth, the Examiner directs attention to Merck &Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Circ. 1989), which states with regards to its more than 1200 combinations: that the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art.” Furthermore, it is noted that Applicants do not identify any secondary consideration demonstrating criticality or anything unexpected about the combination of two known prior art pharmaceutical agents. See also MPEP 2144.06(I): "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617