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 .
Detailed Action
Filing Receipt and Priority
The filing receipt states the instant application does not claim benefit of any earlier filed application or patent.
The effective filing date is 03/09/2024.
Information Disclosure Statement
The IDS received 08/13/2025 has been considered. The assertion is also acknowledged.
Election/Restriction
Newly submitted claims 21-27 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims are drawn to additional ingredients including denatonium benzoate, vitamin E, a preservative, an additional surfactant, additional oil, additional humectant, and additional antimicrobial agent. Each of these additional would add additional properties to the composition of claim 15.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22-27 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
At examiner’s discretion, search and examination have been broadened to include the bittering agent denatonium benzoate (claim 21).
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of claims
Claims 1-14 have been canceled by applicant.
Claims 15-27 are currently pending.
Claims 22-27 are withdrawn.
Withdrawn Rejections
In view of the amendments made, the 112(b) rejection made in the prior office action is withdrawn.
Modified 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.
Claim(s) 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kershman (US11,484,483) in view of Inolex (Inolex, Lexgard Natural Safety Data Sheet, revision date: 03/16/2015, url=https://safety365.sevron.co.uk/substances/accessSDS/SDS-6891-5788b5cea3fa05.63919447, accessed 06/23/2025), SpecialChem (Lexgard Natural MB, last edit date: 09/27/2023 url=https://cosmetics.specialchem.com/product/i-inolex-lexgard-natural-mb, accessed 06/23/2025), Keam (Pediatric Drugs, 2024, 26:95-100, published online 2023), and Ataman Chemicals (Denatonium Benzoate, url=https://www.atamanchemicals.com/denatonium-benzoate_u24607/, copyrighted 2020, accessed 11/25/2025).
Regarding claim 15-19, Kershman in col. 6 teaches a composition comprising Atmos® 300, mineral oil, glycerin, hyaluronic acid, water, and benzalkonium chloride, shown below.
Kershman contemplated composition
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Glycerin, as a humectant, is contemplated to be within the instant claimed range (4.0 to 30.0 wt%). Mineral oil, as an oil, is contemplated to overlap with the instantly claimed range (1.0-20.0 wt %). Hyaluronic acid, as a gelling agent, is contemplated to be within the instantly claimed range (0.01 – 5.0 wt%). Benzalkonium chloride is contemplated to be within the instantly claimed range (0.01 – 10.0 wt%).
Additionally, Kershman in col. 2, l. 16 states “The present invention is a topical lotion having a sanitizing properties that has a continuous phase of oil enveloping the aqueous phase.”
Kershman does not explicitly discuss or contemplate Lexgard® Natural MB. This is addressed by the combination of Inolex, SpecialChem, and Keam.
Regarding claims 15 and 20, Inolex teaches a composition comprising glyceryl caprylate and glyceryl undecylenate called Lexgard® Natural. SpecialChem teaches this specific combination is Lexgard® Natural MB. SpecialChem also teaches that “Lexgard® Natural MB by Inolex is an all-natural emollient, co-emulsifier, skin re-fatting agent and biostatic system. It is a multi-functional ingredient system for self-preserving cosmetics.” SpecialChem continues “Lexgard® Natural MB is recommended for use in w/o or o/w emulsion systems such as skin care cream and lotions.”
Keam on p. 97, left col., para. 1 states “The cantharidin 0.7% topical solution formulation includes gentian violet to help distinguish treat and untreated lesions during application, and denatonium benzoate, a bittering agent to deter potential oral ingestion.” Keam essentially teaches the successful inclusion of denatonium benzoate into a lotion composition.
In addition to Keam, Ataman Chemicals (herein after Ataman) discusses sodium benzoate and its incorporation into several products. Ataman on p. 1, para. 1 states “Denatonium benzoate is a bittering agent. Denatonium Benzoate is a bitter chemical used to denature alcohol. When alcohol is denatured, Denatonium Benzoate becomes undrinkable due to the bitter taste it contains. Denatonium Benzoate is considered the bitterest chemical compound with a variety of uses in the production of cleansers, automotive supplies, and health and beauty products.” Therefore, within the art, denatonium benzoate is known as a bittering agent. Combined with the teachings from Keam, one of ordinary skill in the art would know that denatonium benzoate can successfully be added to a lotion composition in order to make use of its aversive properties.
Kershman teaches a lotion comprising all but one of the instant claimed ingredients. Inolex and SpecialChem teach a composition that can be added to lotions for self-preservation. Keam teaches denatonium benzoate in a lotion composition and Ataman teaches the bittering properties of denatonium benzoate are well known.
Therefore, it would have been obvious to one of ordinary skill in the art to have combined the composition of Kershman with the composition of Inolex and SpecialChem and further include denatonium benzoate as discussed by Keam and Ataman to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill in the art would have been motivated to make the combination to incorporate the preservative properties of Lexgard® Natural MB and the bittering properties of denatonium benzoate into the lotion of Kershman.
The rejection has been modified to include Keam and Ataman as necessitated by amendments made to the claims.
Response to Arguments
Applicant’s argues that a prima facie case of obviousness has not been met as the art discussed in the rejection does not teach bittering agents. The rejection has been modified to include bittering agents, specifically denatonium benzoate.
Maintained Double Patenting
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.
U.S. Patent 11,484,483
Claims 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,484,483 (Kershman) in view of Inolex, SpecialChem, Keam, and Ataman cited above.
Kershman claims compositions which are lotions comprising a surfactant, oil, oil soluble preservative, humectant, gelling agent, water, and antimicrobial agent (claim 15). Kershman also claims similar compositions made by processes as claimed in claims 1-14. Inolex and SpecialChem teach Lexgard® Natural MB as a preservative. Keam and Ataman discuss denatonium benzoate as a bittering agent in compositions. As discussed in the 103 rejection above, one of ordinary skill would find it obvious to include Lexgard® Natural MB and denatonium benzoate into the composition of Kershman via the teachings of Inolex, SpecialChem, Keam, and Ataman.
U.S. Patent 9,173,941
Claims 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,173,941 (Shear) in view of Kershman, Inolex, SpecialChem, Keam, and Ataman cited above.
Shear claims a sustained release composition comprising a lotion comprising a humectant, water, bittering agent, oil, and surfactant. Shear also claims similar compositions made by the processes as claimed in reference claims 1-9. The combination of Kershman would make obvious the addition of the oil soluble preservative, gelling agent, and antimicrobial agent. The combination of Inolex and SpecialChem make obvious the combination of Lexgard® Natural MB. Keam and Ataman discuss denatonium benzoate as a bittering agent in compositions. As discussed in the 103 rejection above, one of ordinary skill would find it obvious to include Lexgard® Natural MB and denatonium benzoate into the composition of Kershman via the teachings of Inolex, SpecialChem, Keam, and Ataman.
Rejection of claim 21 and the addition of Keam and Ataman have been necessitated by amendments made to the claims.
Response to Arguments
Applicant has requested that the non-statutory double patenting rejections be held in abeyance until allowable subject matter has been identified. The rejections are maintained for the time being until allowable subject matter has been acknowledged.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624