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 .
Modified Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2 and 13-14, 16-19, 21, and 32-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The following flow chart shown in MPEP 2106(III) is used to determine whether claims are subject matter eligible.
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Following the above flowchart, the claims are to a composition of matter (Step 1), the claim are directed to a natural phenomenon (Step 2A), and the claims do not recite additional elements that amount to significantly more than the judicial exception (Step 2B). Therefore, the claims are not eligible subject matter under 35 USC 101.
Analysis
Step 1: The claims recite cosmetic or pharmaceutical composition or homecare product. Therefore, the claims are composition of matter claims.
Step 2A: Step 2A is a two-prong inquiry according to the flowchart shown in MPEP 2106.04(II)(A).
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Prong One: Yes. The claims recite a natural phenomenon. The claims recite a cosmetic or pharmaceutical composition or homecare product comprising 1,2-heptanediol, 1,2-octanediol, and/or 2,3-octanediol and at least one natural polymer, which may be guar gum or xanthan gum. 1,2-heptanediol, 1,2-octanediol, and 2,3-octanediol can be obtained from plant sources and guar gum or xanthan gum are found in nature and thus, the cosmetic or pharmaceutical composition or homecare product claimed is a product of nature (i.e. natural phenomenon). When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception. See MPEP 2106.04(c)(II). In the instant case, 1,2-heptanediol and the at least one natural polymer are found in nature and the claims do not recite 1,2-heptanediol and the at least one natural polymer in such a way that make then markedly different from those found from nature. Thus, the cosmetic or pharmaceutical composition or homecare product limitation is a product of nature exception.
Prong Two: No. The claims do not recite additional elements that integrate the judicial exception into a practical application. Claims 1 and 2, for example, do not require anything more than the two natural ingredients. As for claim 16 reciting “fragrance oils,” and claim 17 reciting “thymol,” these compounds may also be found in nature and thus do not integrate the judicial exception into a practical application.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because although the claims recite a cosmetic or pharmaceutical composition or homecare product, generally linking the judicial exception to a particular technological environment or field of use is not enough to qualify as “significantly more” when recited in a claim with a judicial exception. See MPEP 2106.05(I)(A).
As such, the claims do not amount to significantly more than the exception itself, the claim is not patent-eligible.
Response to Applicant’s Arguments
Applicant argues that the natural polymer within the compositions/products as claimed benefits from a reduced microbial load when present within the claimed combination. This is a markedly different characteristic.
Applicant’s argument has been fully considered but found not to be persuasive. Applicant has not provided any objective evidence supporting Applicant’s assertion. Therefore, since Applicant’s argument is merely speculative, Applicant’s argument is unpersuasive and the rejection is maintained.
Applicant argues that the claims as amended recite specific weight percentages which offer significantly more than the exception. This is a markedly different characteristic.
Applicant’s argument has been fully considered but found not to be persuasive. Applicant has not provided any objective evidence supporting Applicant’s assertion. Therefore, since Applicant’s argument is merely speculative, Applicant’s argument is unpersuasive and the rejection is maintained.
New 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 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.
1. Claims 2, 13-14, 16-18, 21, 32-36, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Baptiste et al., (WO 2018/099570 A1, June 07, 2018) (cited by Applicant on IDS 01/13/2023) (hereinafter Baptiste).
Baptiste discloses a cosmetic blend, comprising or consisting of (a) at least one TRPV1 and/or TRPV3 modulator and (bl) at least one 1,2-alkandiol having 5 to 12 carbon atoms and/or (b2) at least one polyol (i.e., at least one active substance) having 3 to 12 carbon atoms and 3 to 6 hydroxyl groups (Abstract). 1,2 alkandiols act as "boosters" for the TRPV1/TRPV3 modulators and are preferably selected from 1,2-heptandiol (i.e., first linear alkanediol), 1,2-nonandiol (i.e., second linear alkanediol), 1,2-pentandiol, 1,2 hexanediol, 1,2-octandiol and their mixtures ([0021]). The cosmetic compositions comprise the blend of TRPV1/TRPV3 modulators and alkandiols, preferably in an amount suitable to effect warming sensation on human skin or mucous membranes, such as for example amounts of from 0.01 to about 5 % b.w., preferably 0.1 to 2 % b.w. and more preferred about 0.2 to about 1 % b.w. - calculated on the final composition ([0028]). The composition may comprise thickeners, such as xanthan gum ([0047]). Auxiliary substances and additives can be included in quantities of 5 to 99 % b.w., preferably 10 to 80 % b.w., based on the total weight of the formulation ([00114]). The blends may comprise components (a) and (b) in a ratio by weight of from about 10:90 to about 90:10 ([0026]). The compositions may also comprise suitable anti-microbial agents, which are all substances effective against Gram-positive bacteria, including salicylic acid N-alkylamides, such as, for example, n-octylsalicylamide or n- decylsalicylamide ([0099]). The formulations are preferably in the form of an emulsion e.g. W/O and O/W (i.e., a dispersion comprising an oil component) ([00112]) and Table 5 discloses the ingredients of an O/W emulsion comprising 5.00% by weight paraffin oil (i.e., an oil component in an amount of ≥ 1%). The invention also relates to the use of 1,2-alkandiols having 6 to 12 carbon atoms for simultaneously improving warming sensation and dermatological compatibility of TRPVl and/or TRPV3 modulators when applied to human skin or mucous membranes ([00147]). The human TREK-1 receptor is a temperature sensitive, mechano-gated potassium channels, present in human skin and neuronal cells and is known to be involved in the signaling of temperature sensation. Literature indicated that a blockade of the TREK-1 receptor would lead to a better efficacy of TRP-channel activation ([00166]). The results of Table 4 that 1,2 alkandiols are able to inhibit the TREK-1 mediated current in the range of the positive control (fluoxetine), in varying degrees ([00169]).
Baptiste discloses cosmetic compositions containing 1,2-heptandiol, 1,2-nonandiol, and their mixtures ([0021]) and xanthan gum ([0047]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the limitation of claims 2 and 18 reciting 0.3 to 3.0% by weight of a mixture and 0.5 to 1.0% by weight, respectively, as discussed above, Baptiste teaches the cosmetic compositions comprise the blend of TRPV1/TRPV3 modulators and alkandiols preferably in an amount suitable to effect warming sensation on human skin or mucous membranes, such as for example amounts of from 0.01 to about 5 % b.w. and the blends may comprise components (a) and (b) in a ratio by weight of from about 10:90 to about 90:10. Thus, the claimed amount would have been obvious since after selecting an amount of alkanediols within the ratio and mixture weight disclosed by Baptiste, one would have arrived at an amount of alkanediols that overlaps with the claimed amount. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claims 13, 32, and 33 reciting “an alkanediol having a maximum water solubility of less than or equal to 10 % by weight,” “less than or equal to 5 % by weight,” and “less than or equal to 1.4 % by weight,” respectively, as noted in the instant specification in paragraphs [0169] and [0170]) 1,2-heptanediol has a maximum water solubility of less than or equal to 1.4% by weight. Accordingly, because Baptiste discloses a composition comprising 1,2-heptanediol, Baptiste teaches an alkanediol having a maximum water solubility of less than or equal to 1.4% by weight.
Regarding the ratio of first linear alkanediol to second linear alkanediol recited in claims 14 and 34-36, as discussed above, Baptiste discloses that the results of Table 4 indicate that different 1,2 alkandiols are able to inhibit the TREK-1 mediated current in the range of the positive control in varying degrees. Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed ratio through routine experimentation depending on the desired level of TREK-1 inhibition.
2. Claims 19, 23, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Baptiste et al., (WO 2018/099570 A1, June 07, 2018) (cited by Applicant on IDS 01/13/2023) (hereinafter Baptiste) in view of Faergemann et al. (US 2009/0221716 A1, Sept. 03, 2009) (cited by applicant on IDS 01/13/2023) (hereinafter Faergemann).
As discussed above, Baptiste makes obvious the limitations of claim 2 but does not teach wherein the mixture comprises a 2,3 alkanediol, such as 2,3-pentanediol, 2,3-hexanediol, 2,3-heptanediol, 2,3-octanediol, or 2,3-nonanediol in the amounts of 0.5-1.0%, 0.001-0.5%, 0.005-0.1% and 0.01-0.075% by weight based on the total weight of the composition or homecare product or a method of reducing the antimicrobial load of a natural polymer, or replacing an antimicrobial agent, in a cosmetic or pharmaceutical composition or homecare product.
However, Faergemann discloses a composition comprising at least 3 different diols including heptane-1,2-diol, heptane-2,3-diol, pentane-1,2-diol, and hexane-1,2-diol ([0018]). The composition may be a pharmaceutical, cosmetic, antimicrobial or preservative composition ([0001]). The pharmaceutical composition may be an emulsion, lotion, cream, or ointment ([0028]). The exact dose of the pharmaceutical composition is dependent on the activity of the compound, manner of administration, nature and severity of the disorder, age and body weight of the patient, and different doses may be needed ([0029]). The pharmaceutical composition may be used to treat an antimicrobial infection ([0035]). If the composition is used as an antimicrobial composition the number of diols is depending on which microbe is to be inactivated ([0021]). The composition, pharmaceutical composition, cosmetic composition, antimicrobial composition or preservative composition can be used to inactivate microorganisms such as gram positive bacteria ([0033]). Faergemann teaches that by combining, specific different diols, it has surprisingly been found that it is possible to reduce/inhibit the growth of microorganisms to a higher extent compared to when the diols was used alone or combinations of similar diols ([0007]).
As discussed above, Baptiste discloses a cosmetic blend, comprising 1,2-heptandiol, 1,2-nonandiol, 1,2-pentandiol, 1,2 hexanediol, 1,2-octandiol and their mixtures and anti-microbial agents effective against Gram-positive bacteria. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the cosmetic blend of Baptiste further comprising heptane-2,3-diol motivated by the desire to inactivate various microorganisms since varying the number of diols inactivates different microbes as taught by Faergemann.
Regarding the claimed amounts of 0.5-1.0%, 0.001-0.5%, 0.005-0.1% and 0.01-0.075% of the 2,3-alkanediol in the mixture, Faergemann teaches that the exact dose of the pharmaceutical composition is dependent on the activity of the compound, manner of administration, nature and severity of the disorder, age and body weight of the patient, and different doses may be needed. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of 2,3-alkanediol through routine experimentation depending on these factors. "[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.” See MPEP 2144.05.
Regarding claim 23, as discussed above, Baptiste discloses a cosmetic blend, comprising or consisting of at least one 1,2-alkandiol, preferably selected from 1,2-heptandiol, 1,2-pentandiol, 1,2 hexanediol, and their mixtures. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the composition of Baptiste in a method of replacing an antimicrobial agent, in a cosmetic or pharmaceutical composition or homecare product since compositions comprising these three alkanediols to can be used to inactivate microorganisms as taught by Faergemann.
Conclusion
Claims 2, 13-14, 16-19, 21, 23, and 32-40 are rejected.
No claims are allowable.
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 Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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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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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614
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