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 .
Information Disclosure Statement
Information Disclosure Statement (IDS) filed on 03/17/2023 and 07/30/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Status
Applicant's election with traverse of Group I and the species: a) cationic surfactant: cetrimonium chloride; b) polyol: glycerol/glycerin; c) nonionic surfactant: trideceth-9; d) water is present; e) optional further additives niacinamide, hydroxyethyl urea, and 12-hydroxystearic acid in the reply filed on 07/02/2025 is acknowledged. Examiner notes that in view of the teachings of the prior art, benzalkonium chloride has been rejoined as an additional optional ingredient present (claim 9). The traversal is on the ground(s) that all claims should be examined since the application is a 371 and PCT 13.1 applies. Applicants argue that all claims can be examined without undue burden. Applicants wish to point out that consistent with rule PCT Rule 13.1, more than one invention is permitted if all inventions are so linked as to form a single general inventive concept. In the present application, a composition suitable to deliver antibacterial benefits is claimed as is a method for sanitizing with the composition and a method for preventing adverse skin reactions resulting from the application of such composition. Applicants argue that it is well settled that when a set of inventions is claimed in an international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features.
This is not found persuasive because Per PCT Rule 13.1, the international application shall relate to a group of inventions so linked as to form a single general inventive concept or a “unity of invention” (see MPEP 1850). Per PCT Rule 13.2, “unity of invention” is fulfilled by defining a special technical feature that is shared amidst the claimed inventions. The Rule further specifies that “[t]he expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.” A lack of unity of invention determination begins with a consideration of the claims in light of the description and drawings. Lack of unity of invention may be directly evident “a priori,” or before considering any prior art when no special technical feature is common to each of the independent claims. Alternatively, lack of unity of invention may only become evident “a posteriori,” or after considering the claims in relation to the prior art. The technical feature defining Group I-III is a composition comprising: a) at least 80% by weight water; and b) a cationic surfactant wherein the composition is capable of delivering a bacteria log kill of at least 2 and a viral log inactivation of at least 2 in less than 3 minutes after topical application and further wherein the composition is substantially free (i.e. less than 10% by weight) of ethanol and when total surfactant in the composition is more than 4.5% by weight and cationic surfactant in the composition includes a combination of both cetrimonium chloride and benzalkonium chloride, benzalkonium chloride makes up at least 16.5% by weight of the combination; wherein the composition has less than 0.3% by weight benzalkonium chloride and/or benzethonium chloride; wherein the cationic surfactant is 95 to 100% by weight trimonium compound, dimonium compound or both; wherein the composition comprises no (0.0% by weight) aliphatic alcohol (excluding ethanol and not including diols and polyols); wherein the trimonium compound is an alkyl trimonium compound comprising cetrimonium chloride, cetrimonium bromide, mytrimonium chloride, mytrimonium bromide, behentrimonium methosulfate, cocotrimonium methosulfate, behentrimonium chloride, behentrimonium bromide, steartrimonium chloride, steartrimonium bromide, laurtrimonium chloride, laurtrimonium bromide or a mixture thereof, and wherein the dimonium compound is distearyl dimonium chloride, didecyl dimonium chloride, dicoco dimonium chloride, a mixture thereof or benzethonium chloride and/or benzalkonium chloride. This special technical feature lacks novelty in the art as evidenced by the composition taught by Sondgeroth et al. (US PgPub 20100278906)-of record. Since the common technical feature is taught by the prior art, the common technical feature does not rise to the level of a special technical feature. Thus, the groups lack unity of invention a posteriori and restriction between them is proper. Accordingly, any subsequent patentably distinct invention lacks unity with the first group, see 37 CFR § 1.476 (d). Furthermore, per PCT rule 13.1 and 13.2 search burden is not a criterion for lack of unity of invention.
Claims 14 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/2/2025
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 and 15 are under current examination in view of the elected species to: a) cationic surfactant: cetrimonium chloride; b) polyol: glycerol/glycerin; c) nonionic surfactant: trideceth-9; d) water is present; e) optional further additives niacinamide, hydroxyethyl urea, and 12-hydroxystearic acid and benzalkonium chloride (claim 9).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 at line 3 recites “substantially free (i.e. less than 10% by weight)”. It is unclear if the substantially free is defined as less than 10% by weight because the claim recites this amount in parenthesis. Accordingly, the metes and bounds of the claim is unclear as it is unclear what amount the ethanol can be present to be “substantially free” of ethanol.
Claim 1 recites that “the composition comprises no (0% by weight) aliphatic alcohol (excluding ethanol and not including diols and polyols)”. The metes and bounds of the claim are unclear because it is unclear if the excluding ethanol and not including diols and polyols is required by the claim or not.
Claim 1 recites wherein the trimonium compound is an alkyl trimonium compound comprising cetrimonium chloride, cetrimonium bromide, mytrimonium chloride, mytrimonium bromide, behentrimonium methosulfate, cocotrimonium methosulfate, behentrimonium chloride, behentrimonium bromide, steartrimonium chloride, steartrimonium bromide, laurtrimonium chloride, laurtrimonium bromide or a mixture thereof, and wherein the dimonium compound is distearyl dimonium chloride, didecyl dimonium chloride, dicoco dimonium chloride, a mixture thereof or benzethonium chloride and/or benzalkonium chloride. Here, it is unclear if the claim even requires a trimonium and dimonium compound because the claim recites “”or benzethonium chloride and/or benzalkonium chloride”. Thus, it is unclear if the claim can require benzethonium chloride and/or benzalkonium compound in alternative to trimonium and dimonium compound or if the benzethonium chloride is meant to be an alternative to just dimonium compounds. The metes and bounds of the clam are unclear.
Furthermore, the claim is interpreted as an open Markush due to the language comprising followed by a Markush for trimonium compound, thus it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022)
Claim 1 recites that “when total surfactant in the composition is more than 4.5% by weight and cationic surfactant in the composition includes a combination of cetrimonium chloride and benzalkonium chloride, benzalkonium chloride makes up at least 16.5% by weight of the combination”. However, claim 1 later recites that the cationic surfactant is 95-100% trimonium compound, dimonium compound or both. When cationic surfactant is 95-100% by weight of the trimonium compound, dimonium compound or both, then the benzalkonium chloride earlier recited cannot exceed 16.5% by weight rendering the claim unclear what amounts the cationic surfactant can be present.
Claim 6-9 recites that the composition “further comprises” a list of ingredients which is interpreted as a Markush group selected from the group comprising due to the presence of alternatives. Thus, it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022).
Claim 6 recites “the dissolution auxiliary selected from”. However, the claim does not earlier recite any dissolution auxiliary. Furthermore it is unclear if the mixtures thereof recited in the claim is only for the dissolution auxiliary or is inclusive of all the further ingredients recited earlier in claim 6.
Claim 7 recites niacinamide and (vitamin B3 in parenthesis). However, niacinamide is one type of vitamin B3, thus vitamin B3 is considered a genus. It is unclear if the claim is meant to include niacinamide species or if the claim is meant to include the broader genus of vitamin B3 which is in parenthesis. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation vitamin B3 in parenthesis, and the claim also recites niacinamide which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites “octopirox” in the claim. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe piroctone olamine and, accordingly, the identification/description is indefinite. The claim also recites piroctone in parenthesis which is not the same compound as piroctone olamine, so it’s unclear if the claim meant to recite piroctone olamine or piroctone. It is suggested that the claim can recite piroctone olamine.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 10-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verboom et al. (United States Patent Publication 20030191035).
Verboom exemplifies a composition at Table 3 comprising 93.34% water with cetrimonium chloride at 3.40%. Benzalkonium chloride is not added in Table 3 thus the proviso “when total surfactant in the composition is more than 4.5% by weight and cationic surfactant in the composition includes a combination of both cetrimonium chloride and benzalkonium chloride, benzalkonium chloride makes up at least 16.5% by weight of the combination” is not required. The composition can comprise preservatives to kill bacteria, see paragraph [0024]. Table 3 utilizes the cetrimonium chloride on its own thus is considered 100% cetrimonium chloride (cationic surfactant). Table 3 has no ethanol or benzalkonium chloride.
Regarding instant claim 15, the recitation “to be applied under a face mask and personal protective equipment” is a recitation of the intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the prior art structure is to aqueous compositions with cetrimonium chloride of which Verboom teaches, and therefore the composition would be capable of being applied to a face mask and personal protective equipment.
With regards to the composition being capable of delivery a bacteria log of at least 2 and a viral log inactivation of at least 2 in less than 3 minutes, since Verboom anticipates the instantly claimed composition with the elected cationic surfactant to cetrimonium chloride with at least 80% water, the composition would necessarily be capable of having the intended log inactivation as this would be the natural result of applying the claimed product. Furthermore, products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
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.
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 1-3, 5, 8-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Glen Mouser (United States Patent Publication 20170354705) in view of Sondgeroth et al. (United States Patent Publication 20100278906).
Claim interpretation: claim 1 recites: when the total surfactant is more than 4.5% and there is a mixture of cetrimonium chloride with benzalkonium chloride, the benzalkonium chloride makes up at least 16.5%, however this limitation is not required and is only when the total surfactant is more than 4.5% and there is the combination of both. The instant claims are being examined to the elected cationic surfactant of cetrimonium chloride. The species election has been extended to allow for benzalkonium chloride in the formulation in view of the cited art below.
The instant claims are being examined to the elected cationic surfactant of cetrimonium chloride, glycerol polyol, trideceth-9 nonionic surfactant, water, and further ingredients of niacinamide, hydroxyethyl urea, and 12-hydroxystearic acid, and benzalkonium chloride.
Mouser teaches sanitizing compositions comprising water from 60-96% by weight, cetrimonium chloride selected as a conditioner present from 0.1-9% and benzalkonium chloride from .0.1-0.13% by weight, and glycerol (aka glycerin), see claim 1 and 18. The composition can comprise excipients such as a nonionic surfactant and vitamins including vitamin E, see claim 1 and paragraphs [0053] and [0063] 0070. The composition can comprise humectants such as hydroxyethyl urea, see paragraph [0058]. Ethanol is not a required component in the composition and claim 1 is to compositions which do not contain ethanol. Mouser teaches a foaming, lotion, or gel hand sanitizing composition., consisting essentially of: a. water as a solvent and carrier from about 60% to about 96% by weight sufficient to operate as a carrier and solvent for the composition; b. Tetrasodium EDTA from about 0.001% to about 0.1%, by weight; c. Benzathonium Chloride as a preservative from about 0.1% to about 1.0% by weight; d. a conditioner selected from the group of conditioners consisting of: Stearylkonium Chloride, Behentrimonium Chloride and Cetrimonium Chloride from an amount of about 0.1% to about 9% by weight; e. Glycerin from about 0.1% to about 1.4% by weight. f. a surfactant from about 0.02% to about 7.9% by weight; g. mineral salts from about 0.1% to about 1.4% by weight; h. a skin protectant from about 0.1% to about 1.4% by weight; i. an antioxidant vitamin from about 0.01% to about 1.4% by weight; and j. Benzalkonium Chloride from about 0.01% to about 0.13% by weight, sufficient to sanitize hands during the use of the composition. Mouser expressly teaches that the alternative preservative to banzathonium chloride can be cetrimonium chloride see paragraph [0061]. The total surfactant is suggested to be inclusive of less than 4.5% given the teaching of about 0.02%.
Mouser does not teach that the surfactant can include 95-100% of a cationic surfactant such as dimonium and/or trimonium compound (e.g. elected cetrimonium chloride).
Sondgeroth et al. teach antimicrobial sanitizing compositions for hands which comprise cationic surfactant, 30-90% water and are substantially free of ethanol, see example 3 and claim 1. The cationic surfactant can include cetrominoum chloride on its own or mixtures thereof, see claims 1, 6 and paragraph [0021]. Since the cationic surfactant can be alone it can comprise the total amount 100% of cetrimonium chloride. The composition can further comprise glycerin polymer as a polyol, see paragraph [0024]. The composition can comprise benzalkonium chloride, see abstract and claim 1. The composition provides a significant reduction of skin irritation, inflammation dryness or redness, is stable, long lasting, aesthetically pleasing and moisturizing, see abstract and paragraph [0014].
It would have been prima facie obvious to provide the surfactant of Mouser as the cationic surfactant of cetrimonium chloride.
One of ordinary skill in the art would have been motivated to do so because Sondgeroth et al. teach that a cationic surfactant with benzalkonium chloride and water provides for a long lasting moisturizing composition that reduces inflammation and dryness.
There would have been a reasonable expectation of success given both Mouser and Sondgeroth teach compositions for sanitizing hands which comprise surfactants.
Regarding instant claim 14, Mouser teaches that the polyol can comprise glycerin (aka glycerol), and that thickener can be added to adjust the viscosity of the composition (paragraph [0075]). However Mouser does not teach the viscosity of under 30,000cps.
Sondgeroth et al. teach formulation antimicrobial compositions where the viscosity can range from 10,000-1,000,000 centipoise.
It would have been obvious to adjust the viscosity of Mouser using thickener within the viscosity range suggested by Sondgeroth. One of ordinary skill in the art would have been motivated to do so because Mouser teaches that viscosity is adjustable with the use of a thickener and Sondgeroth teaches that the viscosity of aqueous composition having cationic surfactant can be adjusted to 10,000-1,000,000. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding instant claim 15, the recitation “to be applied under a face mask and personal protective equipment” is a recitation of the intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the prior art structure is to aqueous compositions with cationic surfactant which the modified Mouser teaches, and therefore the composition would be capable of being applied to a face mask and personal protective equipment.
With regards to the composition being capable of delivery a bacteria log of at least 2 and a viral log inactivation of at least 2 in less than 3 minutes, since Mouser in view of Sondgeroth arrive at the instantly claimed composition with the elected cationic surfactant to cetrimonium chloride in an amount inclusive of 0.02 (0.1-9% in Mouser-consistent with the 0.02% utilized in the instant specification) with at least 80% water, the composition would necessarily be capable of having the intended log inactivation as this would be the natural result of applying the claimed product. Furthermore, products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Glen Mouser (United States Patent Publication 20170354705) and Sondgeroth et al. (United States Patent Publication 20100278906) as applied to all claims 1-3,5,8,9-13 and 15 above, and further in view of Taylor et al. (United States Patent 6616922).
The teachings of the modified Mouser are discussed above.
The modified Mouser does not expressly teach that the nonionic surfactant is Trideceth-9 (the elected nonionic surfactant).
However, Taylor et al. teach antibacterial compositions for sanitizing hands which comprise quaternary ammonium antibacterial agents and nonionic surfactant, see abstract and claims 1, 11 and 20. The nonionic surfactant includes trideceth-9, see column 11, lines 53-58.
It would have been prima facie obvious to provide the non-ionic surfactant of Mouser with trideceth-9.
One of ordinary skill in the art would have been motivated to do so because Mouser teaches the presence of a non-ionic surfactant and Taylor teaches that suitable nonionic surfactants for hand cleaning compositions include trideceth-9.
The substitution of the nonionic surfactant of Mouser for Tridecth-9 would have yielded predicable results with a reasonable expectation of success because Mouser teaches the genus of nonionic surfactant can be used with the hand sanitizer formulation.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Glen Mouser (United States Patent Publication 20170354705) in view of Sondgeroth et al. (United States Patent Publication 20100278906) as applied to all claims 1-3,5,8,9-13 and 15 above, and further in view of Sternoff et al. (United States Patent Publication 2013/0022643).
Mouser teaches the inclusion of thickeners [0074], however Mouser does not expressly teach the inclusion of 12-hyroxystearic acid.
However, Sternoff et al. teach topical antimicrobial compositions including hand sanitizing compositions which can comprise 12-hydroxystearic acid as a gellant, see paragraphs [0007] and [0060].
It would have been prima facie obvious to substitute the thickeners of Mouser for 12-hydroxyperopyl cellulose.
One of ordinary skill in the art would have been motivated to do so because Sternoff teaches that 12-hydroxytearic acid can be added to impart gelling properties to hand sanitizer compositions. There would have been a reasonable expectation of success given the thickeners of Mouser can comprise stearates.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Glen Mouser (United States Patent Publication 20170354705) in view of Sondgeroth et al. (United States Patent Publication 20100278906) as applied to all claims 1-3,5,8,9-13 and 15 above, and further in view of Hilina et al. (JP6431180).
The teachings of the modified Mouser are discussed above.
The modified Mouser teaches that the skin condition agent can be nicatinamide, see paragraph [0053]. It is believed that Mouser misspelled nicotinamide as nicatinamide, however Mouser does not expressly teach that the vitamin is niacinamide (nicotinamide).
However, Hilina et al. teach aqueous antimicrobial compositions which comprise cationic actives, see abstract and claim 1. The antimicrobial composition can be applied as a hand sanitizing composition, see page 3. The composition includes nicotinamide (also known as niacinamide) as a skin condition agent which maintains skin barrier, see page 12.
It would have been prima facie obvious to one of ordinary skill in the art to substitute the vitamin of Mouser for nicotinamide. One of ordinary skill in the art would have been motivated to do so because nicotinamide is taught by Pederson as also providing skin conditioning properties to the skin.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
Prosecution Insights