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 .
Election/Restrictions
Applicant’s election without traverse of Group (I) with the addition of Alcohol:ethyl alcohol, Emollient:castor oil, Denaturant:isopropyl alcohol, Cooling agent:menthol, Additional emollient: glyceryl laurate, Preservative:benzyl alcohol, Antioxidant: BHT in the reply filed on 09/03/2024 is acknowledged and maintained.
Claim Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on November 27, 2024. Claims 1-19 and 29 and new claims 30-34 are pending and are examined in accordance to the elected species. Claims 20-28 are canceled.
Action Summary
Claims 1-4, 12, 15, and 18-19 rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017, are maintained, but modified and revisited to include new claims 30-34.
Claims 5, 6 and 13 rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 as applied to claims 1-4, 12, 15, and 18-19 in further view of Viamonte Jr. (US2005/0019430 A1), are maintained, but modified and revisited to include new claims 30-34.
Claims 7 and 8 rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 as applied to claims 1-4, 12, 15, and 18-19 in further view of Spray-Tish® Menthol, MIMS, March, 2019, are maintained, but modified and revisited to include new claims 30-34.
Claims 9, 10, 16, 17 rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 and Viamonte Jr. (US2005/0019430 A1). as applied to claims 1-4, 5, 6, 12, 15, and 18-19 in further view of HRPA, Scientific Discussion, 12/10/2016, Grodberg (CA1,318,247C), are maintained, but modified and revisited to include new claims 30-34.
Claims 11 and 14 rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017, Viamonte Jr. (US2005/0019430 A1), HRPA, Scientific Discussion, 12/10/2016, Grodberg (CA1,318,247C) as applied to claims 1-4, 5, 6, 9, 10, 12, 15, 16, 17 and 18-19 in further view of Lane (WO2018/211333A1), are maintained, but modified and revisited to include new claims 30-34.
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 30-33 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. 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 recitation of glycerol ester is not supported or described in the instant specification as filed. Therefore, the recitation of glycerol ester constitutes new matter. .
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 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 non-obviousness.
Claims 1-4, 12, 15, 18-19, 30-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017.
Willimann teaches an antimicrobial, antiviral and antifungal composition consisting essentially of: ethanol in an amount of between 5.0% and 75.0% by weight of the total composition, orange oil in an amount of between 0.05% and 60.0% by weight of the total composition, benzalkonium chloride in an amount of between 0.05% and 0.15% by weight of the total composition, jojoba oil in an amount of between 0.1% and 75% by weight of the total composition and vitamin E in an amount of between 0.1% and 4.0% by weight of the total composition. (See claim 2.). Particular preference is given to a composition comprising USP Ethyl Alcohol (190 proof) 50%, Cocos Nucifera 3%, Citrus Sinensis 2%, Simmondsia chinensis (jojoba) 40%, Glycine Soja 4.6%, BHT (preservative), 0.1% Benzalkonium chloride, and 0.1% Vitamin E 0.2%. (See Example 9.) While Willimann does not teach orange oil is a fragrance, the specification teaches orange oil is a fragrance. Moreover, Willimann teaches the composition is applied using a cotton tip of a cotton swab, so that the tip is fully saturated with the composition to the nasal cavity. (See Example 10.) Fully saturated reads on absorbed. Furthermore, Willimann teaches one or more of the following additional ingredients: lauric acid; d-limonene; soy oil; emu oil; grapefruit seed extract; glycine soja; simmondsia chimensis (Jojoba); aloe vera; and a preservative, such as sodium benzoate, BHT, benzalkonium chloride, vitamin E can be used in the composition. (See Abstract.) One can reasonably construe the composition of Willimann to be an Applicator comprising a cotton swab with a cotton tip as an absorbent and a disinfectant composition comprising ethyl alcohol in the amount of 50% and an emollient such as jojoba in the amount of 40%. Since the amount of emollient is the same as claimed, the emollient of the prior art is capable of reducing a stinging sensation produced by contacting a wall of a nasal passage with the alcohol and the emollient being miscible in the alcohol. Since the composition of Willimann is similar to that claimed, the composition of Willimann is capable of being a single phase. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Papesch, 315 F.2d 381, 391 (CCPA 1963) Furthermore, ethyl alcohol 190 proof is 95% ethanol and 5% water. Therefore, the ethyl alcohol taught by Willimann inherently contains 5% water.
Willimann does not teach castor oil.
SKelly teaches some oils, like castor, mineral, and jojoba oil, work as both emollients and occlusive. (See page 4.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to replace the jojoba with castor oil to give Applicant’s claimed invention. One would have been motivated with a reasonable expectation of success that the replacement would be functionally equivalent. While Willimann and Skelly do not teach castor oil is a glycerol ester, castor oil as an emollient is a glycerol ester.
Claims 5, 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 as applied to claims 1-4, 12, 15, 18-19, 30-32, and 34 in further view of Viamonte Jr. (US2005/0019430 A1).
The teachings of Willimann and Skelly have been discussed in the above 103 rejection above.
Willimann and Skelly collectively do not teach isopropyl alcohol.
Viamonte Jr. teaches a non-toxic mucosal disinfectant for topical application in the nose has a composition of 91% isopropyl alcohol of at least 50% by weight; sesame oil not exceeding 45% by weight, lemon oil of about 2% by weight, aloe of about 5-10% by weight, and optional components of chlorhexidine gluconate and grapefruit seed extract. All of the components are mixed homogeneously, with the sesame oil supplementing and neutralizing the dehydrating effect of the alcohol. (See Abstract.) While Viamonte Jr. does not recognize isopropyl alcohol is a denaturant, the isopropyl alcohol taught by Viamonte Jr. is capable of being a denaturant. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
It would have been prima facie obvious for a person of ordinary skill in the art at the time of the invention was made to combine the nasal disinfectant composition disclosed by Willimann and Skelly with that set forth by Viamonte Jr. because each is taught by the prior art to be useful for the same purpose (i.e., disinfecting the nose). See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, a person of ordinary skill in the art would reasonably have expected to be successful because both compositions were shown to be useful separately for the exact same purpose and thus would be expected to be similarly useful when used together.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 as applied to claims 1-4, 12, 15, 18-19, 30-32, and 34 in further view of Spray-Tish® Menthol, MIMS, March, 2019.
The teachings of Willimann and Skelly have been discussed in the 103 rejections above.
Willimann and Skelly collectively do not teach menthol.
Spray-Tish® Menthol teaches Spray-Tish Menthol, which contains menthol, cineole, and camnphor, is a nasal decongestant. It clears a stuffy or blocked nose by shrinking the inflamed and swollen blood vessels in the lining of the nose. Spray-Tish Menthol relieves a stuffy or blocked nose (nasal congestion) associated with the common cold, hayfever and rhinitis. While Spray Tish® Menthol does not teach menthol is a cooling agent, menthol is a cooling agent.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the composition taught by Willimann and Skelly by including menthol to give Applicant’s claimed invention. One would have been motivated with a reasonable expectation of success that the inclusion of Spray-Tish Menthol, which contains menthol, would help clearing a stuffy or blocked nose by shrinking the inflamed and swollen blood vessels in the lining of the nose and relieving a stuffy or blocked nose (nasal congestion) associated with the common cold, hay-fever and rhinitis.
Claims 9, 10, 16, 17, 29, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 Viamonte Jr. (US2005/0019430 A1), and Spray-Tish® Menthol, MIMS, March, 2019, as applied to claims 1-4, 12, 15, 18-19, 30-32, and 34 in further view of HRPA, Scientific Discussion, 12/10/2016, Grodberg (CA1,318,247C).
The teachings of Willimann, Skelly, and Viamonte Jr., and Spray-Tish have been discussed in the 103 rejections above. However, Willimann and Skelly teach castor oil, which is a glycerol ester, meeting the claimed limitation of claim 33.
Willimann, Skelly, and Viamonte Jr., and Spray-Tish collectively do not teach glyceryl laurate in the amount of 0.1 to 1.5%. Additionally, Willimann, Skelly, and Viamonte Jr., and Spray-Tish collectively do not teach menthol in the amount of 0.01 to 0.15%.
HRPA teaches the use of 0.1% Menthol in nasal spray for the relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis and to aid drainage of secretions in affections of the paranasal sinuses. (See Section I and Section II.1.)
Grodberg teaches an antiseptic composition comprising ethyl alcohol in the amount of 70%, monolaurin in the amount of 0.5%, mint scent in the amount of 0.025% and water. (See Example 2.) Monolaurin is another name of glyceryl laurate. Moreover, Grodberg teaches the monolaurin in the antiseptic composition is believed to enhance the activity of and substantially decrease the time required for the ethyl alcohol to inactivate or destroy the potentially harmful skin microorganisms. (See page 7; seventh paragraph.) Grodberg also teaches the monolaurin brings about the rapid wetting and penetration of the microorganism with the ethyl alcohol active microbiocide thus causing rapid inactivation of the microorganism and also acts as a surface-active agent and emulsifying agent and effects in rapid wetting of the microorganisms contacted with the antiseptic composition. (See page 10; sixth paragraph.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the composition taught by Willimann, Skelly, and Viamonte Jr. by including menthol in the amount of 0.1% and monolaurin (aka glyceryl laurate) in the amount of 0.5% to give Applicant’s claimed invention. One would have been motivated by the fact that menthol in the amount of 0.1% can provide relief of nasal congestion due to colds, hay fever or other allergic rhinitis, sinusitis and to aid drainage of secretions in affections of the paranasal sinuses. (See Section I and Section II.1.) as taught HRPA and also because Grodberg also teaches the monolaurin in the amount of 0.5% brings about the rapid wetting and penetration of the microorganism with the ethyl alcohol active microbiocide thus causing rapid inactivation of the microorganism and also acts as a surface-active agent and emulsifying agent and effects in rapid wetting of the microorganisms contacted with the antiseptic composition. (See page 10; sixth paragraph.) as taught by Groberg. One would have a reasonable expectation of providing effective disinfecting effect with the modified composition that include menthol in the amount of 0.1% and monolaurin (aka glyceryl laurate) in the amount of 0.5% with success.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017, Viamonte Jr. (US2005/0019430 A1), Spray-Tish® Menthol, MIMS, March, 2019, HRPA, Scientific Discussion, 12/10/2016, and Grodberg (CA1,318,247C) as applied to claims 1-19 and 30-34 in further view of Lane (WO2018/211333A1).
The teachings of Willimann, Skelly, Viamonte Jr., Spray-Tish, HRPA, and Grodberg have been discussed in the 103 rejections above.
Willimann, Skelly, Viamonte Jr., Spray-Tish, HRPA, and Grodberg collectively do not teach polyaminopropyl biguanide and benzyl alcohol.
Lane teaches preservative systems comprising xylitol ester and/or xylitol ether, capryly! glycol, ethylhexylglycerin, and 1,3-propanediol for useful in protecting various formulations, including cosmetics and personal care products, from microbial contamination. (See Abstract and page 1; lines 9-11.) Moreover, Lane teaches the preservative systems can include benzyl alcohol and polyamino biguanide. (See page 4, lines 21-24, and page 2; lines 9-14.) Furthermore, Lane teaches the preservative system can be a part of nasal decongestants. (See page 4; line 10.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to replace the preservative taught by Willimann with the benzyl alcohol and the polyamino biguanide taught by Lane to give Applicant’s claimed invention. One would have been motivated with a reasonable expectation of success that the replacement would be functionally equivalent.
Acknowledgement is made of the receipt and entry of Applicant’s remarks/arguments filed on November 26, 2024.
Applicant’s argument
Appellant argues that Example 9 includes 50 wt. % ethanol and 40 wt. % Jojoba oil. Table 1 of the attached document "Solubility of Jojoba Oil in Organic Solvents" (Ex. 1) shows that as little as 0.2 g of Jojoba oil is insoluble in 5 mL of ethanol (1g/25 mL). Even assuming that Willimann employed 190 proof ethanol in Example 9, the ratio of Jojoba oil to ethanol is
0.4 g/0.63 mL, or 15.8 g/25 mL-a far greater amount of oil. Willimann teaches that a user should shake and mix the components, further evidencing that the Jojoba oil is not miscible in the ethanol.
Examiner’s response
In response, the Examiner finds Applicant’s argument not persuasive. Table 1 of the attached document "Solubility of Jojoba Oil in Organic Solvents" (Ex. 1) may show that as little as 0.2 g of Jojoba oil is insoluble in 5 mL of ethanol (1g/25 mL). However, the same table of the same document which is considered by the Examiner, also demonstrates that the 0.2 g of jojoba oil in the 20 ml of ethanol is soluble and the solubility experiment was conducted at 15oC Moreover, the 0.2 g of jojoba oil in 1.0 ml of ethanol amounts to 20% jojoba oil and 80% methanol; the 0.2 g in 5 ml amounts to 4% jojoba oil and 96% ethanol; the 0.2 g in 1.0 ml amounts to 20% jojoba oil in 80% ethanol at 15oC. The 20% jojoba oil and 80% methanol and the 4% jojoba oil and 96% ethanol, which are insoluble are outside of the range of 50-70% ethanol and 20-40% castor oil claimed. The 20% jojoba oil in 80% ethanol, which is soluble is within the range claimed in claim 15 even at 15oC. Furthermore, the claim only requires at least 40% of at least one C1-C3 alcohol which can be methanol, ethanol, propanol, isopropanol and any amount of emollient, the emollient being miscible in the alcohol at any amount effective to reduce a stinging sensation produced by contacting a wall of a nasal passage with the alcohol. In fact, solubility can definitely depend on concentration, as well as temperature, pressure, and the nature of solute and solvent. In the present case, the concentration of the emollient, the nature of the emollient, the nature of the C1-C3 alcohol, temperature, and pressure are not recited in the claim. Specifically, ethanol tends to be more polar and can dissolve a wide range of polar compounds whereas isopropyl alcohol can be more effective for dissolving certain oils or non-polar substances. Lastly, just because Willimann teaches that a user should shake and mix the components, does not mean jojoba oil and ethanol are not miscible.
Applicant’s argument
Appellant argues that claim 16 specifies isopropyl alcohol in an amount ranging from 1 to 7%. The Office Action cites Viamonte for isopropyl alcohol, but Viamonte teaches a level of at least 50 wt.% isopropyl alcohol, contrary to claim 16. Claim 18 recites a single-phase solution, which distinguishes Willimann because Willimann has at least two phases, ethanol and oil.
Examiner’s response
In response, the Examiner finds Applicant’s argument not persuasive. First, Viamonte was not used in the rejection for claim 16. Viamonte was used in the rejection of claims 5, 6 and 13 in order to show that isopropyl alcohol has been effective in nasal formulations. Claim 16 was rejected under Willimann (US 8,778,415 B2) in view of Skelly, What Do Emollients, Occlusives, and Humectants Have to Do with Your Skin? 2017 Viamonte Jr. (US2005/0019430 A1), and Spray-Tish® Menthol, MIMS, March, 2019, as applied to claims 1-4, 12, 15, 18-19, 30-32, and 34 in further view of HRPA, Scientific Discussion, 12/10/2016, Grodberg (CA1,318,247C). The amount of isopropyl alcohol recited in claim 16 was addressed by Willimann. Willimann teaches in one preferred embodiment; the antiseptic solution is USP ethyl alcohol. In another preferred embodiment, the antiseptic solution is hydrogen per oxide. Other alcohols and antiseptic agents are contemplated for use in the composition as the antiseptic solution, either alone or as a combination. The amount of the antiseptic solution is between 5% and 75%. (See column 3, lines 36-49) So, 5% of other alcohol is contemplated as part of the teaching of other alcohol of Willimann. Therefore, one would expect isopropyl alcohol to be used at concentration of 5%.
Conclusion
Claims 1-19, 29 and 30-34 are not allowed.
THIS ACTION IS MADE FINAL. 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.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628