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
Non-patent literature reference #1 titled “Ameisen-und Brennessel Juckreiz” filed 6/16/23 was not considered because no English translation was provided.
Election/Restrictions
Applicant’s election without traverse of claims 10-21 in the reply filed on 2/16/26 is acknowledged.
Specification
The use of the term Emser salt®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 21 objected to because of the following informalities:
Regarding claim 21, “the at least additive” should read “the at least one additive.”
Appropriate correction is required.
Claim Interpretation
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use “can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim” as drafted without importing “‘extraneous’ limitations from the specification.” Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (MPEP 2111.02 (II)).
In this application, “for use in a treatment of skin irritations caused by plant or animal effects on or in a skin” is considered future intended use and therefore is not considered to limit the structure of the composition as claimed.
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.
Claim 10-21 rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a composition comprising an osmotically active substance, a hygroscopically active substance, or an osmotically active substance, which are inherent properties of salts and sugars. Ehow (https://www.youtube.com/watch?v=U1jxbYFucbc, May 20, 2015) gives salts and sugars as examples of osmotically active substances and AtlantisDamp (https://www.designingbuildings.co.uk/w/index.php?title=Hygroscopic_Salts&oldid=138210, page 1) gives salts and sugars as examples of hygroscopic substances.
The claims 10-14, directed to a composition comprising a salt or sugar (or osmotically active substances and/or hygroscopically active substances because they are inherent properties of salts and sugars as argued above) are no different from an apple as apples contain salts (Lee (https://link.springer.com/content/pdf/10.1007/978-1-4684-8225-6_14?pdf=chapter+toc) table 14-11, page 319) and sugars (Lee table 14-6, page 313), so the claims are no different from a product of nature, an apple, as there is no limitation that the claimed composition has any material difference from said closest natural counterpart.
Claims 15 and 16 only serve to further limit the osmotically active substances and/or hygroscopically active substances of claim 10 by percentage, so they do not add any additional elements that amount to significantly more than the judicial exception.
Claim 17 claims a solvent and claim 18 claims water as the solvent. Lee discloses water in fresh apples (table 14-5, page 312), a product of nature, so claims 17 and 18 would not add any additional elements that amount to significantly more than the judicial exception. Claim 19 claims a gel former. Lee discloses cellulose and hemicellulose as part of the unavailable carbohydrates in apples, a product of nature, which would read on the instantly claimed gel former because, as disclosed by the instant specification, the composition can contain a cellulose derivative as gel former and thickener. Therefore, claim 19 would not add any additional elements that amount to significantly more than the judicial exception.
Claim 20 claims at least one additive and claim 21 claims the at least one additive is selected from humectants, plant extracts, or buffers. The plant extract, an example of an additive, is naturally occurring in plants including apples, so these claims would not add any additional elements that amount to significantly more than the judicial exception.
No dependent claims add any additional elements that amount to significantly more than the judicial exception, so no claims would pass Step 2B of the subject matter eligibility test for products and processes (MPEP 2106 (II)).
This judicial exception is not integrated into a practical application because the claims are to salts and/or sugars only and the claimed composition does not provide any meaningful limitation thereon. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a claim that recites only salt and/or sugar is patent ineligible as it reads on only naturally occurring compounds. Therefore, as the claims do not differ from their closest natural counterpart they are considered ineligible.
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.
Instant claims 10-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breton (US 5851556 A).
Regarding instant claims 10-11 and 13, Breton teaches a dermatological composition containing, in a dermatological medium, at least one salt of at least one alkaline-earth metal (claim 1). Breton goes on to teach examples: wherein the salt is selected from the group consisting of chlorides, carbonates, borates, nitrates, acetates, hydroxides, sulfates, the salts of fruit acids and the amino acid salts (claim 2), wherein the salt is selected from the group consisting of calcium, magnesium, strontium, beryllium and barium containing salts (claim 3), wherein the salt is a magnesium or strontium salt (claim 4), wherein the salt is strontium chloride or strontium nitrate (claim 5). Breton’s salts read on the osmotically active substance in instant claims 10 and 11 as well as the hygroscopically active substance in instant claims 10 and 13.
Regarding instant claims 12 and 14, Breton teaches that the composition contains at least one active agent chosen from sugars (claim 13), which reads on the osmotically active substance in instant claim 12 and the hygroscopically active substance in instant claim 14.
Regarding instant claim 15, Breton teaches 3.00% magnesium chloride in Example 1: Make-up removing lotion for the face for sensitive skins, 2.00% calcium nitrate in Example 2: Make-up removing lotion for the face for sensitive skins, and 5.00% magnesium chloride in Example 3: Face care milk for sensitive skins (page 9). 3.00% magnesium chloride, 2.00% calcium nitrate, and 5.00% magnesium chloride all are salts that fall within the instant claimed range of 1% to 30% by weight of the composition and therefore anticipate that presently claimed (See MPEP 2131.03 regarding anticipation of ranges). Further, Breton teaches Examples 4-8, 10-24 which read on instant claim 15 for the same reason (pages 9-12).
Regarding instant claim 16, Breton teaches 2.00% calcium nitrate in Example 2: Make-up removing lotion for the face for sensitive skins (page 9), which falls within the instant claimed range of 1.5% to 2.5% by weight of the composition and therefore anticipates that presently claimed (See MPEP 2131.03 regarding anticipation of ranges). Therefore, Breton’s range anticipates the instant claimed range.
Regarding instant claim 17 and 18, Breton teaches the dermatologically acceptable medium is an aqueous, oily or aqueous-alcoholic solution, a water-in-oil emulsion, and an oil-in-water emulsion (claim 11), all of which read on the solvent in instant claim 17, and all of which contain water and thus read on water in instant claim 18. Further, Breton teaches the medium contains, in addition, at least one of mineral and thermal water (claim 12).
Regarding instant claim 19, Breton teaches at least one adjuvant chosen from hydrophilic gelling agents and lipophilic gelling agents (claim 14), wherein the gelling agents are cellulose derivatives (claim 15). Examples 5-6, 8, 12-13, 15 teach hydroxypropyl cellulose and Example 22 teaches a gelling agent (pages 10-12). The gelling agents, cellulose derivatives, and hydroxypropyl cellulose read on the instantly claimed gel former because as disclosed by the instant specification, the composition can contain a carbomer and/or a cellulose derivative as gel former and thickener, for example hydroxyethylcellulose [0039].
Regarding instant claims 20-21, Breton teaches that the composition contains at least one active agent chosen from plant extracts (claim 13). Breton also teaches alpha- and beta-hydroxycarboxylic or beta-ketocarboxylic acids and their salts which could be combined to form the buffer in instant claim 21 [128]. Both the plant extract and the alpha- and beta-hydroxycarboxylic or beta-ketocarboxylic acids and their salts (buffers) are examples of additives.
Double Patenting (Non-Statutory)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Instant claims 10, 11, 13, 17-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 23 of copending Application No. 17997499 (‘499, reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 10, 11, 13, 17, and 18 are anticipated by ‘499’s claims; and instant claims 19-21 are obviated by ‘499’s claims in view of Breton (US 5851556 A) as evidenced by SidleyChemical (from the Wayback Machine dated 12/12/2013 (https://web.archive.org/web/20131212030329/https://celluloseether.com/sidleycel-hydroxyethyl-cellulose/)) and Athiban (https://pmc.ncbi.nlm.nih.gov/articles/PMC3410334/).
Regarding instant claims 10, 11, and 13, claim 1 of ‘499 teaches a dermatological composition consisting of: at least one antiperspirant active ingredient comprising 1-hexylpyridinium chloride, and claim 23 of ‘499 teaches a dermatological composition consisting of: at least one antiperspirant active ingredient comprising an ionic liquid, wherein the ionic liquid has at least one cation and at least one anion, wherein the at least one cation is a pyridinium cation and the at least one anion comprises chloride. Both 1-hexylpyridinium chloride and the ionic liquid read on the salt in instant claims 11 and 13, which is an example of the osmotically active substance in instant claims 10 and 11 and the hygroscopically active substance in instant claims 10 and 13.
Regarding instant claims 17 and 18, claim 1 and 23 of ‘499 further teach the composition consists of water.
Regarding instant claim 19, claims 21 and 24 of ‘499 teach that the compositions further comprise a viscosity regulator, which reads on the instantly claimed gel former.
Regarding instant claims 20 and 21, claims 21 and 24 of ‘499 teach that the compositions further comprise an antibacterial active ingredient, which reads on the instantly claimed plant extracts and additive.
The claims of ‘499 do not teach examples of those compounds that would have sufficient specificity to anticipate the instantly claimed gel former, plant extracts, or additive, but they do render the instant claims obvious.
Regarding instant claim 19, Breton teaches at least one adjuvant chosen from hydrophilic gelling agents and lipophilic gelling agents (claim 14), wherein the gelling agents are cellulose derivatives (claim 15). Examples 5-6, 8, 12-13, 15 teach hydroxypropyl cellulose. The hydroxypropyl cellulose reads on the instantly claimed gel former because as disclosed by the instant specification, the composition can contain a carbomer and/or a cellulose derivative as gel former and thickener, for example hydroxyethylcellulose [0039].
Regarding instant claims 20-21, Breton teaches that the composition contains at least one active agent chosen from plant extracts (claim 13), and discloses Aloe vera as an example [116].
Therefore, before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the dermatological composition taught by the claims of ‘499 and substitute the viscosity regulator and antibacterial active ingredient with hydroxyethylcellulose (a gel former) and Aloe vera (a plant extract) respectively as taught by Breton. One would be motivated to substitute the viscosity regulator with hydroxyethylcellulose (a gel former) because as taught by SidleyChemical, in the daily chemical industry such as lotion, cosmetics, and ointment, hydroxyethyl cellulose acts as a thickener, dispersing agent, binder and stabilizer to increase the density, lubrication, and mercerized appearance of products (Page 1). One would be motivated to substitute the antibacterial active ingredient with Aloe vera (a plant extract) because as taught by Athiban, Aloe vera gel can be used effectively for decontamination (Conclusion, page 5), and as evidenced by Table 1 (page 4), Aloe vera had greater zones of inhibition (against contamination) than the control of normal saline (24 mm, 21 mm, and 24 mm compared to no zone, no zone, and no zone, respectively). Further, simple substitution of known skincare additives for other skincare additives of the specification of ‘499 are obvious modifications and within the purview of the skilled artisan.
The foregoing analysis establishes that the conflicting claims are not patentably distinguishable from the claims of the present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant claims 10, 11, 13, 17-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 10 of U.S. Patent No. 9404110 (‘110). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by ‘110’s claims.
Regarding instant claims 10, 11, and 13, claim 1 of ‘110 teaches a pharmaceutical composition for topical application comprising (d) at least one additive comprising a salt or an ionic liquid, which reads on the salt in instant claims 11 and 13, which is an example of the osmotically active substance in instant claims 10 and 11 and the hygroscopically active substance in instant claims 10 and 13.
Regarding instant claims 17 and 18, claim 1 of ‘110 teaches the composition is in the form of either (i) a water-in-oil-in-water emulsion or (ii) a water-in-oil emulsion, each of said emulsions comprising a dispersed, discontinuous, internal aqueous phase, which reads on water in instant claim 17, which is an example of the solvent in instant claim 18.
Regarding instant claim 19, claim 10 of ‘110 teaches a consistency agent in the composition that can be selected from the group consisting of carbomers and cellulose, which reads on the instantly claimed gel former because as disclosed by the instant specification, the composition can contain a carbomer and/or a cellulose derivative as gel former and thickener, for example hydroxyethylcellulose [0039].
Regarding instant claims 20 and 21, claim 5 of ‘110 teaches the composition further comprises at least one humectant factor, which reads on the humectant in instant claim 21, which is an example of the additive in instant claim 20.
The foregoing analysis establishes that the conflicting claims are not patentably distinguishable from the claims of the present application.
Instant claims 10, 11, 13, 17-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 10 of U.S. Patent No. 9249413 (‘413). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by ‘413’s claims.
Regarding instant claims 10, 11, and 13, claim 1 of ‘413 teaches a pharmaceutical composition for topical application comprising (d) at least one additive, comprising a salt or an ionic liquid, which reads on the salt in instant claims 11 and 13, which is an example of the osmotically active substance in instant claims 10 and 11 and the hygroscopically active substance in instant claims 10 and 13.
Regarding instant claims 17 and 18, claim 1 of ‘413 teaches the composition is in the form of either (i) a water-in-oil-in-water emulsion or (ii) a water-in-oil emulsion, each of said emulsions comprising a dispersed, discontinuous, internal aqueous phase, which reads on water in instant claim 17, which is an example of the solvent in instant claim 18.
Regarding instant claim 19, claim 10 of ‘413 teaches a consistency agent in the composition that can be selected from the group consisting of carbomers and cellulose, which reads on the instantly claimed gel former because as disclosed by the instant specification, the composition can contain a carbomer and/or a cellulose derivative as gel former and thickener, for example hydroxyethylcellulose [0039].
Regarding instant claims 20 and 21, claim 5 of ‘413 teaches the composition further comprises at least one humectant factor, which reads on the humectant in instant claim 21, which is an example of the additive in instant claim 20.
The foregoing analysis establishes that the conflicting claims are not patentably distinguishable from the claims of the present application.
Conclusion
Claims 10-21 are rejected.
Claim 21 is objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLY S LIU whose telephone number is (571)272-8235. The examiner can normally be reached Monday-Friday 8:00 AM - 5:00 PM.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/ALLY S LIU/Examiner, Art Unit 1611