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
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/10/2026 has been entered.
Status of claims
Claims 15-27 are currently pending.
Claims 22-27 are withdrawn.
Withdrawn Rejection
The NSDP rejection over U.S. Patent 9,173,941
Maintained 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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
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 of the instant claimed ingredients save for preservatives and bittering agents. 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. See KSR rationales A-C.
Response to Arguments
Applicant argues that i) “the cited references are drawn to unrelated fields and different problems”, ii) “the examiner has not articulated sufficient reasoning with rational underpinning”, iii) the “rejection reflects impermissible hindsight”, iv) and that there is “no reasonable expectation of success”.
Applicant specifically states “Kershman is direct to an alcohol-free and sanitizer for humans developed in response to the COVID-19 pandemic…It is not directed to treating any dermatologic skin condition, much less canine pyotraumatic dermatitis, and it contains no preservative system based on caprylic monoesters and undecylenic acid as required by dependent claim 20.” Applicant continues “Keam is an ADISINSIGHT regulatory report describing YCANTH™…a vesicant drug-device combination product approved by the FDA…The denatonium benzoate in YCANTH™ is added specifically because cantharidin is a vesicant whose oral ingestion can cause ‘renal failure, blistering and severe damage to the gastrointestinal tract coagulopathy, seizures, and flaccid paralysis’; the bittering agent functions there to deter potentially fatal oral exposure to a hazardous vesicant solvent system. Keam is a single-product approval summary, not a formulation reference it does not teach incorporation of denatonium benzoate into a lotion, much less an antimicrobial lotion of the type claimed.”
Applicant states that Ataman, Inolex, and SpecialChem are “a product-listing webpage”, “safety data”, and “product marketing pages”.
Applicant cites In re Klein and states that “The problem confronting the inventors here was how to formulate a stable, homogenous hydrophobic, antimicrobial lotion capable of treating canine pyotraumatic dermatitis…with the environmental or biological side effects associated with metal compounds, formaldehyde, antibiotic, and alcohol, i.e., agents previously used in veterinary wound care.”
Regarding ii, applicant states “The Office Action’s sole rationale ‘to incorporate the preservative properties of Lexgard® Natural MB and the bittering properties of denatonium benzoate into the lotion of Kershman’ is a bare recitation of the result to be achieved, not an explanation of why a skilled artisan would have pursued that result.”
Regarding iii, applicant states “The Office Action’s proposed combination of Kershman, Inolex, SpecialChem, Keam, and Ataman reflects impermissible hindsight reconstruction. Only by working backward from the applicant’s disclosure could one identify these five unrelated references and assemble them in the precise manner required to arrive at claim 15.”
Regarding the expectation of success, applicant states “Applicant’s own specification demonstrates that the claimed lotion system is highly sensitive to even small changes in surfactant type and preservative selection and that the path from the Kershman base formulation to the claimed composition is fraught with unpredictable failure modes…First the specification documents that multiple surfactant systems that might appear, on paper, to be interchangeable in fact cause total formulation failure. Tween 20 (a polysorbate monooleate nonionic surfactant ‘causes the lotion to break down in separate phases.’ Lecithin-based surfactants…produced a lotion that ‘was unstable after about a week’ Lamchem® PE-130K a mono- and di-glyceride system differing from Atmos® 300k only in the absence of propylene glycol ‘failed to create a stable lotion and was unsuitable for the present invention’ and the corresponding Control 2 ‘started leaking in about a month.’ “ Applicant continues “Second, the contrast between the specification’s Controls and its successful Examples directly undermines any assertion that success was predictable. Controls 1 and 2 each incorporated Lexgard® Natural MB as the oil-soluble preservative the same ingredient the Examiner proposes adding from Inolex/SpecialChem yet both failed within a week to a month because they used a lecithin-based surfactant…or a mono-di-glyceride system without propylene glycol., rather than the specific Atmos®300K/glyceryl monostearate system and ratio recited in claim 15.”
A veterinary expert is not so far removed from a doctor that treatments applicable to humans, or in this case human skin, would not immediately be recognized by a veterinarian as applicable to other animals, specifically canines. Kershman teaches a composition that overlaps significantly with the instant claims save for slight modifications which are addressed by the secondary references. Said secondary references are all drawn to topical compositions or components that can be included within topical compositions. Therefore, whether the references discuss canines or not is irrelevant unless it can be shown that there is a distinct negative effect upon combining the components when applied to canines.
Regarding applicant’s argument that the Examiner has not articulated sufficient reasoning with rationale underpinning, the instant action recites the following paragraph. This paragraph has been modified from the prior action to address the inclusion of bittering agents.
“Kershman teaches a lotion comprising all of the instant claimed ingredients save for preservatives and bittering agents. 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.
The Kershman composition overlaps significantly with the instant claims such that the composition only requires simple additions of components that are well-known within the art. One of ordinary skill would find the combination obvious as stated above and in view of KSR rationales A-C which are (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way.
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).
Regarding the expectation of success, the results applicant discusses are acknowledged. However, Kershman’s compositions have shown efficacy without the complications discussed by applicant. Additionally, the control compositions differ from the Kershman composition significantly (control 1 uses a lecithin surfactant and control 2 uses lamchem PE-130K surfactants as stated by applicant”. Kershman, however, uses ATMOS® 300K. One of ordinary skill would not immediately conclude that Kershman’s compositions are incompatible with the preservatives and bittering agent.
The rejections are maintained.
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.
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.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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