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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/16/2025 has been entered.
Status of Claims
The arguments filed on 06/02/2025 are acknowledged and have been fully considered. Claims 1-2, 4, 9, 11-15, 17-19, 31-35 are now pending. Claim 1 is amended; claims 18-19 and 31-35 are withdrawn; claims 3, 5-8, 10, 16, and 20-30 are cancelled.
Claims 1-2, 4, 9, 11-15, and 17 will be examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/12/2025 has been considered here.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Modified Rejections
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.
Claims 1-2, 4, 9, 11-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013036961 A1 (Bucks, 2013; as submitted on IDS of 10/10/2023 as API Genesis LLC) in view of US PGPUB 20090264839 A1 (Kriksunov, 2009), US PGPUB 20170340649 A1 (Rana et al., 2017), “Final report of the safety assessment of isobutane, isopentane, n-butane, and propane” (Mary Ann Liebert, Inc. Publishers, 1982; referred to as Mary), “Safety Data Sheet Isopentane (20-85%/A31(15-80%)” (Aerosol Supplies Australia PTY LTD, 2016; referred to as Aerosol), Tuntarawongsa (2012), and US PGPUB 20190060193 A1 (Schmaus, 2019) as evidenced by “Dermatology Times” (2017), “Canada” (2017), “ATPextreme” (2014), “Holzer” (2008), and “SpecialChem” (2014).
Regarding the limitations of instant claim 1, for instance, discloses a composition comprising: 0.20-30 wt% of a capsaicinoid (i.e., capsaicin or sensate) (see Bucks, page 17, paragraph 3); 30-70 wt% of methyl salicylate; 1-20 wt% menthol; and 1-20 wt% camphor (see Bucks, page 19, paragraph 2). In regards to the methyl salicylate, a sensate is known in the art as a substance that induces a certain sensation when applied to the skin (see Dermatology Times, paragraph 1). As for the use of methyl salicylate in the composition, Canada teaches that methyl salicylate, menthol, and capsaicin are used to treat pain by irritating the skin surface (i.e. inducing a sensation on the skin) (see Canada, page 3, paragraph 2). As such, one with ordinary skill in the art would understand that the methyl salicylate is a sensate.
The Examiner acknowledges five deficiencies from this disclosure. First, the practiced composition does not appear to contain 10-15 wt% ethanol as claimed.
The reference addresses this, however, disclosing that in other embodiments, methyl salicylate is replaced in whole or in part by an alcohol such as ethanol (see Bucks, page 19, first full paragraph).
Thus, based on the immediate alternative teachings of Bucks, a person of ordinary skill in the art would have a reasonable expectation of meeting the claimed ethanol limitation, such that ethanol is present in an amount greater than 10 wt% of the composition. However, the minimum amount of ethanol is taught to be 30% by weight, which is greater than claimed amount of ethanol. To remedy this deficiency, examiner points towards reference Schmaus, which teaches an aerosol spray (see Schmaus, paragraph 0038) for inhibiting stinging, pricking, tingling and burning sensations on the skin (see Schmaus, abstract). The composition comprises menthol (see Schmaus, paragraph 0269), camphor (see Schmaus, paragraph 0134), ethanol (see Schmaus, paragraph 0281), and a propellant (see Schmaus, paragraph 0301). It is taught that ethanol is a carrier material (see Schmaus, paragraph 0281). It is also taught that the carrier material is used in an amount from 10 to 90% by weight (see Schmaus, claim 5). As this is a broad amount, it is worth noting that Schmaus teaches that the amount of ethanol varies in the composition and teaches an example with 13.0% of ethanol in a spray composition (see Schmaus, Table 6, formulation F10).
Secondly, the practiced invention, though disclosed as a spray formulation (see Bucks, page 44, paragraph 1), does not expressly teach the use of propellants as claimed or that it is necessarily an aerosol form.
Thirdly, the practiced invention does not teach the use of histamine dihydrochloride in any amount. It is the examiner’s position that Bucks does teach the amounts of the menthol and camphor in ranges that overlap with the instant claims, however as the ranges are broader than the instant claims, Kriksunov provides motivation to use the menthol and the camphor in ranges that are closer to those as taught in the instant claims.
Fourthly, the practiced invention does not teach the amounts of a film-forming agent. In regards to claim 1 and 9, Schmaus further teaches that the composition comprises vinyl pyrrolidone/dimethylaminoethyl methacrylate/vinyl caprolactam terpolymers (see Schmaus, paragraph 0123). Further, Schmaus teaches an example of a calming body spray (see Schmaus, paragraph 0333) comprising acylates/C10-30 alkyl acrylate crosspolymer in the amount of 0.2% by weight. Acylates/C10-30 alkyl acrylate crosspolymer is listed as an equivalent of vinyl pyrrolidone/dimethylaminoethyl methacrylate/vinyl caprolactam terpolymers (see Schmaus, paragraph 0123), thus it would be obvious to use one or the other in similar or same amounts in similar compositions. Further in regards to claims 11-12, Schmaus teaches the use of isopulegol as a cooling agent, along with menthol (see Schmaus, paragraph 0269). Isopulegol is taught as a TRPM8 agonist (see Holzer, Table 1). It is taught that a TRPM8 agonist, similar to menthol, can be used in the formulation as well (see Bucks, page 31, paragraph 1).
Fifthly, while the amounts of the camphor and menthol taught in the art overlap with the instantly claimed amounts, it is not taught that the camphor and menthol form a eutectic mixture together. In this regard, Tuntarawongsa is referred to as it teaches that menthol and camphor form a eutectic mixture at room temperature in a ratio of 5:5 (i.e., in a 1:1 ratio), which is easily envisaged by one with ordinary skill in the art using the teachings of Bucks. As such, one with ordinary skill in the art would understand that the combination of teachings of the prior art renders it obvious to arrive at the composition as instantly claimed. As the combined teachings of the prior art arrives at the composition as claimed, the properties, such as the formation of a eutectic mixture, applicant discloses and/or claims would necessarily follow absent evidence to the contrary, especially as the teachings of Tuntarawongsa teaches that the use of camphor and menthol in these amounts would lead to the formation of a eutectic mixture.
Rana teaches a topical spray composition for treating skin conditions (see Rana, abstract) comprising menthol (see Rana, paragraph 0052) and a propellant system comprising butane, propane, isobutane, isopentane and mixtures thereof (see Rana, paragraph 0047). The propellant is present in an amount of from about 3% w/w to about 85% w/w based on the total weight of the composition (see Rana, paragraph 0047). Further it is taught that the use of a propellant helps in propelling the composition from the container (see Rana, paragraph 0047).
Aerosol teaches a propellant system comprising isopentane in an amount of 20-85%, isobutane in an amount of 13.5-80%, and butane in an amount of <8% (see Aerosol, page 2, Section 3).
Mary teaches that the combination of isobutane and propane has consistently less chances of having erythema and edema through exposure as compared to the Isobutane alone (see Mary, Table 5).
Using the teachings of Rana, Mary, and Aerosol, one with ordinary skill in the art can easily envisage a propellant system comprising 55 wt. % of isopentane and 7 wt.% of propane and 23 wt.% of isobutane as Rana teaches that butane, isobutane, propane, and isopentane can be used as equivalents and together in mixtures (see Rana, paragraph 0047). Further Mary teaches that the combination of isobutane and propane have less chance of dermal irritation (see Mary, Table 5). Aerosol teaches that the propellant system is comprised of three propellants in the amount of 55 wt. % of isopentane and 7 wt.% of butane and 23 wt.% of isobutane. Substituting the butane of Aerosol with the propane of Rana and Mary is easily envisaged as the mixture of isobutane and propane are known to have less of a reaction to skin. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to the third deficiency, Kriksunov teaches a spray composition (see Kriksunov, paragraph 0014) comprising the use of external analgesics such as menthol in amounts from 1.25-16%, camphor in amounts from >3% to 11%, as well as histamine dihydrochloride in amounts from 0.025-0.10% (see Kriksunov, paragraph 0028). Kriksunov teaches that histamine dihydrochloride is an irritant that produces vasodilation.
In regards to claims 13-14 and 16, it is taught in Bucks that the composition comprises clove oil or an essential oil in the amount from 0-4.6% (see Bucks, page 31, paragraph 7).
As such, in regards to claims 1, 4, and 13-14, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Bucks with the teachings of Kriksunov, Rana, Mary, Tuntarawongsa, and Aerosol to formulate a topical analgesic spray composition as claimed. It would be obvious to one with ordinary skill in the art to do so as the combination of the propellants is known in the art as they are conventional and non-ozone depleting hydrocarbon propellants. Further the use of a propellant would be beneficial to the composition of Bucks as it helps in propelling the composition from the container (see Rana, paragraph 0047) to the skin efficiently. It would be obvious to one with ordinary skill in the art to combine the teaching of Bucks and Rana, Aerosol, Tuntarawongsa, and Mary according to the known method of using a propellant to propel a topical composition out of the container to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claims 1-2, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Bucks with the teachings of Kriksunov, Rana, Mary, Tuntarawongsa, and Aerosol to formulate a topical analgesic spray composition as claimed. It would be obvious to one with ordinary skill in the art to use the histamine dihydrochloride of Kriksunov in an amount from 0.025-0.10% as an irritant that produces vasodilation as the vasodilation is known to increase oxygen and nutrient delivery within the body, while also helping remove waste products from muscles that contribute to muscle fatigue and failure (see ATPextreme, page 1). This would benefit the composition of Bucks, Rana, Mary, Tuntarawongsa, and Aerosol as it is used to relieve pain that is associated with arthritis as well as pains and muscle aches caused by sports injuries or physical work (see Bucks, page 7, paragraph 2). Further in regards to the amounts of menthol and camphor used, Kriksunov provides further guidance to one with ordinary skill in the art to use specific amounts of the actives in the composition of Bucks. Specifically to the teaching of the amount of camphor, “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) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” One with ordinary skill in the art would reasonably expect that a composition comprising greater than 3% of camphor (i.e. 3.01%) would have the same properties as a composition comprising 3% of camphor. One with ordinary skill in the art would be motivated to combine the teachings of Bucks, Rana, Mary, and Aerosol with the teachings of Kriksunov according to the known method of using an irritant that produces vasodilation in a spray composition to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further in regards to claims 1 and 9, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Bucks, Kriksunov, Rana, Aerosol, Tuntarawongsa, and Mary with Schmaus to formulate as instantly claimed as the references teach an analgesic spray composition with similar compounds to provide a calming effect such as reducing stinging, pain, or discomfort. Further it is known in the art that the use of a film former is common in skin and hair products as they form a supple, cohesive, and continuous layer that leaves a silky and smooth effect on the skin (see SpecialChem, page 1). It would be obvious to one with ordinary skill in the art at the time of the effective filing date to combine the composition of Bucks, Kriksunov, Rana, Aerosol, Tuntarawongsa, and Mary with the essential oils and polymer of Schmaus according to the known method of using a film former in an aerosol spray (see Schmaus, paragraphs 0277-0279) to yield predictable results with a reasonable expectation of success of formulating a stabilized analgesic spray composition. One with ordinary skill in the art would be motivated to combine prior art elements with a reasonable expectation of success.
In regards to claims 1 and 11-12, using the amounts taught in Bucks, Kriksunov, Rana, Aerosol, Tuntarawongsa, and Mary with Schmaus it is possible for one with ordinary skill in the art to envisage the composition of the instant claims. For example, using 1.5% weight of a capsaicinoid (i.e. capsaicin), 13.0% by weight of ethanol, 50% by weight of isopentane, 5% by weight of propane, 20% by weight of isobutane, 4% by weight menthol, 3% by weight camphor, and 3% of a cooling agent, such as isopulegol, the amounts overlap with the claimed invention. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further, it is noted that the effect of methyl salicylate, menthol, and capsaicin on the skin (i.e. a serious burn vs. healing properties) (see Canada, page 4, Safety Review Findings) is a variable that can be modified, among others, by adjusting amount of methyl salicylate (i.e. fragrance), the effect of methyl salicylate, menthol, and capsaicin changing as amount of methyl salicylate is changed, the amount of methyl salicylate would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed adjusting amount of methyl salicylate cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, adjusting amount of methyl salicylate in Buck to obtain the desired balance between the effect of methyl salicylate, menthol, and capsaicin as taught by Canada (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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 In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim 17 recites that the spray composition of claim 1 has a drying rate of at least 0.05 g/min as determined by a gravimetric evaluation at about 75 °F and at about 30% RH. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed generic composition discussed therein (see e.g., Spec., ¶¶[53], [55]-[57], and [134]). As such, consistent with MPEP §2111.01(IV), and §2112.01(I) and (II), the Examiner submits that where Applicants’ defining composition is taught in the prior art, the recited limitation of claim 17, will also be considered met.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable WO 2013036961 A1 (Bucks, 2013; as submitted on IDS of 10/10/2023 as API Genesis LLC) in view of US PGPUB 20090264839 A1 (Kriksunov, 2009), US PGPUB 20170340649 A1 (Rana et al., 2017), “Final report of the safety assessment of isobutane, isopentane, n-butane, and propane” (Mary Ann Liebert, Inc. Publishers, 1982; referred to as Mary), “Safety Data Sheet Isopentane (20-85%/A31(15-80%)” (Aerosol Supplies Australia PTY LTD, 2016; referred to as Aerosol), Tuntarawongsa (2012), and US PGPUB 20190060193 A1 (Schmaus, 2019) as applied to claims 1-2, 4, 9, 11-14, and 17 above, and further in view of NPL1 (Arthritis Foundation, 2016; screen shot of Wayback Machine from htps://web.archive.org/web/20160504235726/http://blog.arthritis.org/living-with-arthritis/health-benefits-flaxseed-anti-inflammatory/; as submitted on PTO-892 of 09/23/2021) as evidenced by “Dermatology Times” (2017), “Canada” (2017), “ATPextreme” (2014), “SpecialChem” (2014), and “Holzer” (2008).
The combined teachings of Bucks, Kriksunov, Rana, Aerosol, Mary, Tuntarawongsa, and Schmaus have been described supra. Further, in regards to claim 15, it is taught that the composition of Bucks comprises an anti-inflammatory agent as well (see Bucks, page 33, paragraph 3)
The combination of Bucks, Kriksunov, Rana, Aerosol, Mary, Tuntarawongsa, and Schmaus are silent on the use of linseed oil in the composition.
NPL1 teaches that flaxseed (AKA linseed) is a known anti-inflammatory (see NPL1, page 1, paragraph 3). Further, NPL1 teaches that flaxseed oil contains the highest amount of alpha-linoleic acid, which is an omega-3 fatty acid and also decreases pro-inflammatory compounds (see NPL1, page 1, paragraph 4).
In regards to claim 15, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Bucks, Kriksunov, Rana, Aerosol, Mary, Tuntarawongsa, and Schmaus with NPL1 to formulate an analgesic spray composition, as flaxseed oil is known to have beneficial compounds such as alpha-linoleic acid, that reduce pro-inflammatory compounds. One with ordinary skill in the art would be motivated to combine the spray composition of Bucks, Kriksunov, Rana, Aerosol, Mary, Tuntarawongsa, and Schmaus with the flaxseed oil of NPL1 according to the known method of making an analgesic spray comprising an anti-inflammatory agent to yield predictable results with a reasonable expectation of success of formulating an anti-inflammatory analgesic spray that can reduce pro-inflammatory compounds. One with ordinary skill in the art would be motivated to combine prior art elements with a reasonable expectation of success.
Further, in regards to the limitation of the composition comprising 0.005 to 0.05 wt. % of linseed oil, it is noted that the amount of flaxseed oil is clearly a result effective variable that must be determined based on a variety of factors including the age, body weight, and health of the patient, the condition(s) to be treated and their severity, the route(s) of administration, the particular drug(s) used, adverse drug effects or toxicity, clinical response to treatment, etc., and is routinely optimized by the skilled artisan as NPL1 teaches that there are known side effects of using flaxseed oil, such as low cholesterol and increased bleeding (see NPL1, page 2, paragraph 4). Applicant is advised that recitation of dosages, without more, is generally insufficient to patentably distinguish over the prior art.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
Applicant argues that the motivation regarding the propellant combination is flawed. Specifically, applicant first argues that the data showing that isobutane causes dermal irritation and as such, one would be motivated to remove it completely. In response, it is noted that while isobutane on its own had the highest PII score of 2.025, it also had the lowest at 0.29. There is great variability in the PII score of the isobutane on its own, while the combination of isobutane and propane was consistently low, with a high of 0.855 (see Mary, Table 5). This is motivation for one with ordinary skill in the art to use the combination of the two over just isobutane as consistency of a product is very important.
Applicant secondly argues that butane and propane have similar irritation profiles and as such would not motivate one with ordinary skill in the art to replace one for the other. Applicant points towards the teaching that both n-butane and propane were mildly irritating to the skin of rabbits to support that a like-for-like substitution is not proper. However, the motivation for the rejection is not a substitution argument, rather there is a known benefit of using propane over butane in this case as the combination of isobutane and propane are known to have less of a reaction to skin. Mary teaches “A propane-isobutane mixture…caused no skin irritation in 125 human volunteers” (see Mary, abstract). This statement and the data of Table 5 would lead one with ordinary skill in the art to expect that reduced dermal irritation is a benefit of the combination of isobutane and propane.
Thirdly, applicant argues that because there is no direct comparison or data showing butane vs. propane in multicomponent systems, one with ordinary skill in the art would have to fall back on the observation that propane and butane showed comparable levels of irritation and not expect a difference in irritation using an isobutane/n-butane combination over an isobutane/propane combination. However, it is clearly stated that there is a known benefit of using the isobutane/propane combination over just isobutane. Further it is not clear why one with ordinary skill in the art would ignore this known benefit over a lack of comparison data as again, the combination of isobutane and propane is known to reduce dermal irritation, specifically in humans, as taught in Mary.
Applicant further argues that Mary gives reason to not modify the teachings of Aerosol by directly undercutting the motivation by pointing toward Mary’s teaching that the “short period of contact makes the absence of sensitization, phototoxicity, and photosensitization studies relatively unimportant” (see Mary, Discussion) and that the motivation relies on improper hindsight. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, it is pointed out that the benefits discussed are not related to any of those issues. Mary clearly teaches that the combination of isobutane and propane has reduced dermal irritation, which is the motivation for modifying the teachings of Aerosol and Rana. While those studies may not be relevant, the teachings of Mary do show that there is benefit to using the combination on the skin.
In regard to applicant’s argument that the range taught in the art is broad, MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Further applicant argues that the use of isopentane in the amount claimed has a specific and active sensory benefit, it is pointed out that the art doesn’t need to teach the specific benefit in order for the limitation to be obvious, especially as the claim limitation is drawn to the amount of isopentane only. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that the there is no teaching or motivation for the ethanol concentration to be from 10-15 wt.% as the example used to teach this limitation in the art does not contain menthol, camphor, or any film-forming agents. However it is pointed out that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). Further, 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). It is within the purview of one with ordinary skill in the art to look at all of the examples within Schmaus and modify the teachings as discussed in the rejection above.
Further, it is taught that ethanol is a carrier material (see Schmaus, paragraph 0281). It is also taught that the carrier material is used in an amount from 10 to 90% by weight (see Schmaus, claim 5). As this is a broad amount, it is worth noting that Schmaus teaches that the amount of ethanol varies in the composition and teaches an example with 13.0% of ethanol in a spray composition (see Schmaus, Table 6, formulation F10).
Lastly, applicant argues that the formation of a eutectic mixture of the menthol and camphor is able to overcome the prior art rejection. Applicant argues that reliance on the principle that "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 and optimizing ranges through routine experimentation is improper hindsight. First, there is no reliance on optimization through routine experimentation in regards to this limitation. The motivation for the routine optimization through experimentation is for the amount of methyl salicylate as the effects of methyl salicylate, menthol, and capsaicin on the skin (i.e. a serious burn vs. healing properties) (see Canada, page 4, Safety Review Findings) is a variable that can be modified, among others, by adjusting amount of methyl salicylate (i.e. fragrance), the effect of methyl salicylate, menthol, and capsaicin changing as amount of methyl salicylate is changed, the amount of methyl salicylate would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, adjusting amount of methyl salicylate in Buck to obtain the desired balance between the effect of methyl salicylate, menthol, and capsaicin as taught by Canada (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[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 In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Second, the rejection has been modified to be in view of Tuntarawongsa as discussed above. Tuntarawongsa teaches that menthol and camphor form a eutectic mixture at room temperature in a ratio of 5:5 (i.e., in a 1:1 ratio), which is easily envisaged by one with ordinary skill in the art using the teachings of Bucks. As such, one with ordinary skill in the art would understand that the combination of teachings of the prior art renders it obvious to arrive at the composition as instantly claimed. As the combined teachings of the prior art arrives at the composition as claimed, the properties, such as the formation of a eutectic mixture, applicant discloses and/or claims would necessarily follow absent evidence to the contrary, especially as the teachings of Tuntarawongsa teaches that the use of camphor and menthol in these amounts would lead to the formation of a eutectic mixture. As such, there is no longer reliance on the principles discussed in In re Spada.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, there is no hindsight reasoning applied as the prior art recites the amounts of menthol and camphor as instantly claimed. One with ordinary skill in the art would expect the formation of a eutectic mixture when menthol and camphor are placed together in the claimed amounts as taught by Tuntarawongsa, unless applicant is able to show that the eutectic mixture is not formed when both the camphor and menthol are placed together in the amounts claimed.
In regards to the arguments against the dependent claims, the rejection over claim 1 is modified as necessitated by amendment and as such the arguments presented are moot.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611