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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/08/2026 has been entered.
Status of the Claims
Pursuant to the amendment dated 07/08/2026, claims 4-10, 12, and 21 have been cancelled and new claims 24-33 have been added. Claims 3, 13, and 14 were cancelled previously. Claims 1, 2, 11, 15-20, and 22-33 are pending. New claims 32 and 33 belong with the invention of group II set forth in the restriction/election requirement mailed 08/13/2025 and are hereby withdrawn, and claim 23 stands withdrawn without traverse.
Claims 1, 2, 11, 15-20, 22 and 24-31 are under current examination.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
This is a new matter rejection. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner is unable to find support in the application, as filed, for excluding all substances falling within the broad genus “polyethylene glycol ether” recited in claim 30, line 22. The specification describes the single species “macrogol cetostearyl ether”; however, this fails to establish that Applicant was in possession of the full scope of the phrase “wherein the formulation does not contain a polyethylene glycol ether”.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the new matter concerns outlined above.
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, 11, 15-20, 22 and 24-31 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; of record).
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 and up to 4.09% PEG-100 stearate (i.e. macrogol stearate; both 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 claims 1, 22, and 30, 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, 22, and 30, 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 the limitation of instant claim 30 requiring the composition not to contain a polyethylene glycol ether, the examiner notes that the polyethylene glycol ether is taught to function as a penetration enhancer, and lavender oil is also taught to function as a penetration enhancer. It would have been prima facie obvious to exchange the penetration enhancer, polyethylene glycol ether, with another substance known to serve the same purpose, lavender oil. See MPEP 2144.06.
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 15-18, 20, and 24-28, 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 19 and 29, 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.
With regard to claim 31, the ranges in amounts and ratios of the two oil in water emulsifiers taught in example compositions by Styczynski embrace the claimed ratio and amounts. See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
On page 10, Applicant argues that Oblong does not teach an amount of lavender oil to use to inhibit hair growth, does not disclose any working examples using lavender oil to inhibit hair growth.
Regarding the argument that Oblong does not teach an amount of lavender oil to inhibit growth, the examiner points out that the artisan of ordinary skill would have been an individual with e.g. a Ph.D. in formulations science and would, as a matter of routine, test several concentrations of any active agent to determine the optimal dose. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A).
Regarding the argument that no examples are taught by Oblong, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
On pages 10-12, Applicant argues that data in the instant specification establishes unexpectedly superior hair growth inhibition of the claimed composition, sufficient to overcome the obviousness rejection with a persuasive showing of unexpected results. Particularly, Applicant points to FIG 1 as showing that a formulation with lavender oil alone can’t show the hair growth inhibition activity; FIG 8 as showing that a formulation with 13.9% eflornithine is not sufficient to inhibit hair growth up to 18 days; FIG 3 as showing that the formulation with 3.0% eflornithine and 4.0% of lavender oil is good enough to inhibit hair growth until day 11; FIGs 4 and 5 as showing inhibition of growth after 11 days at both 5% and 10% eflornithine and 4% lavender oil; and FIG7 as showing that 4% lavender oil and 13.9% eflornithine as inhibiting h air growth for 18 days. Applicant argues that in each case there is a clear visual distinction after 11 days (or 18 days for 4% lavender oil/13.9% eflornithine) between the test group and the control group. Applicant argues that neither 4% lavender oil nor 13.9% eflornithine individually inhibits hair growth for an 11-day period. Applicant argues that this contradicts the examiner’s assertion that lavender oil inhibits hair growth however, the present disclosure demonstrates that a relatively small amount of eflornithine in combination with lavender oil inhibits hair growth for at least 11 days. Applicant argues that this result is unexpected and asserts that lavender oil and eflornithine act synergistically to produce a greater than expected result, pointing to MPEP 716.02(a).
The examiner respectfully disagrees with Applicant’s characterization of these data as unexpectedly superior: Figure 1 shows 4.0% lavender oil is effective in the absence of eflornithine through 11 days post shaving (i.e. lavender oil is effective on its own), and Figure 8 shows that 13.9% eflornithine is effective in the absence of lavender oil through 11 days. When these two substances are combined at the above concentrations, 4.0% lavender oil and 13.9% eflornithine, hair growth is inhibited for longer, up to the 18th day post shaving. One having ordinary skill would have predicted both substances to be effective in isolation as they are both taught for the purpose of inhibiting hair growth, and the skilled artisan would have predicted that combining both of these hair growth inhibitors at concentrations shown to be effective would provide greater efficacy. This is especially true in view of the fact that lavender oil was also taught for increasing penetration of substances into the skin. If a medicine such as eflornithine whose site of action is within the skin is delivered to this site more effectively, one having ordinary skill would also have predicted improved effectiveness. Finally, figures 2-7 generally show an positive correlation between concentration of eflornithine or lavender oil and duration of hair growth inhibition. This establishes a standard dose-response for the drug, that also would have been predicted by the artisan of ordinary skill. For any active agent, efficacy generally is expected to increase with dose, within the relevant range of concentrations. The data are also not commensurate in scope with the claims, as the improvement in efficacy of eflornithine in combination with lavender oil up to 18 days post shaving is only seen at concentrations of 13.9% eflornithine ad 4.0% lavender oil. 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. (Emphasis added.)
On page 12, Applicant argues that Styczynski does not show lavender oil in combination with eflornithine therefore Styczynski does not teach or suggest the unexpected results presented in the present disclosure.
Please see above regarding the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results (MPEP 716.02(b)). Regarding Styczynski, Herman, and Oblong not teaching both eflornithine and lavender oil, In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s arguments on page 13 that Styczynski describes the polyoxyethylene ether as an essential component as well as the argument that the prior art does not teach the limitations of instant claim 31 regarding the amount and ratio of oil in water emulsifiers, this has been addressed in the rejection supra.
On page 14, Applicant states that a Global Substance Registration System Report Glyceryl Stearate/PEG-100 Stearate has been attached; however, this document does not appear to have been filed and was not cited on an IDS therefore was not considered by the examiner for these reasons.
On page 14, Applicant argues that Styczynski teaches that compositions containing 2.5% by weight of a polyoxyethylene ether have inferior efficacy and thus one having ordinary skill would not have been motivated to use PEG-100 stearate (i.e. macrogol stearate) at the concentration required by instant claim 31 of 2.5%.
The examiner points out that macrogol stearate (i.e. PEG-100 stearate) is a polyoxyethylene ester, and taught by Styczynski as an oil in water emulsifier. One having ordinary skill would not have construed the teachings regarding the polyoxyethylene ether that Styczynski employes as a penetration enhancer to apply to the oil in water emulsifiers. (Also, if macrogol stearate were an ether, claims 30-31 would be internally contradictory as this category, the PEG ether, is excluded from the invention delimited in these claims.)
Conclusion
No claims are allowed. 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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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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