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
Response to Amendments
The amendments made to the claims 05/29/2026 have been entered.
In view of the amendments made, the claim objection made in the prior office action has been withdrawn.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted as of this office action.
Species Election
Applicant elected Group I, claims 1-6 and 15 and the following species.
The elected species are:
-petrolatum (lipid)
-lecithin (phospholipid surfactant)
-the combination of sorbitol and glycerin (humectant)
-melatonin (calming ingredient)
-tiglinaldehyde (pheromone)
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.
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) 1-6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz-Cano (Animals, 2022, 12, 2089) in view of Nordgren (US2016/0347829), Hodge (WO2001017364), Gupta (Springer, Nutraceuticals in Veterinary Medicine, May 2019, p. 422) and Low (AJVR, Vol. 75, No. 7, 2014).
In view of claim 1 and 4-5, Ruiz-Cano on p. 10-16 teaches broadly to the effects that melatonin has on dogs. Ruiz-Cano on p. 14, sec. 3.2 states “Melatonin behaves as an anxiolytic molecule with relevant sedative and calming properties and is used to prevent or treat states of anxiety or depression.” “ Ruiz-Cano in the same paragraph also states “In the surgical pre-operative, dogs treated with melatonin required lower doses of the anesthetic propofol due to the previous calming action of melatonin.”
Therefore the effects of melatonin when administering to canines is well known. However, Ruiz-Cano does not discuss additional components such as a lipid, phospholipid surfactant, and humectants. Ruiz-Cano also does not mention additional calming ingredients including and/or an additional pheromone. This is addressed by the combination of Nordgren, Hodge, Nouvel, and Low.
Nordgren is drawn to compositions for the treatment of disorders and diseases caused by oral health compromising (OHC) microorganisms. Nordgren in its abstract states “The present invention encompassed methods and compositions for inhibiting, treating, and preventing dental diseases in human and non-human animals, particularly domesticated companion animals.”
In regards to claims 1, 3-5 and 15, Nordgren starting on p. 20, lists tables 1-33, which are compositions formulated to deliver an antibacterial antibody to a dog’s mouth. Nordgren contemplates mineral oil (petrolatum) in para. [0089], lecithin as a transfer agent (p. 28, para. [0239]), sorbitol (p. 11, para. [0104]) and glycerin (para. [0089]). Nordgren also lists beef flavoring in multiple examples. Table 1 specifically lists beef flavoring and artificial meat flavoring.
Note: Applicant includes “mineral oil” within the instant specification in discussion of petrolatum. Specifically, the specification in para. [0025] states “Preferred examples include petrolatum, a mineral oil (Vaseline Oil) which may be any petroleum based product…”. Therefore, petrolatum is being interpreted to also include mineral oil.
Regarding claims 4 and 5, Hodge on p. 9, l. 18-27 states “In a fifth aspect of the invention, the functional additives will include a combination of Valerian root extract…Kava root extract…vitamin B complex and magnesium…The functional additive being provided in amounts sufficient to promote or maintain reduction of stress and/or improved behavior of a pet animal when the pet food product is provided to the pet animal on a daily basis. In addition to or in partial substitution for Valerian root extract and/or Kava root extract, Gingko Bilboa extract and St. John’s Wort extract…may be added in a physiological relevant amount to develop their known nerve calming properties.”
Gupta affirms the use of valerian root extract as a calming agent on p. 422, sec. 4.5 where it states “Valerian is a temperate root that is commonly used for the treatment of insomnia and anxiety…The anxiolytic properties of Valerian root extracts are well reported in animal models and in humans, suggesting its use as an alternative to anxiolytic drugs.” Gupta continues “In addition to the abovementioned herbal extracts, there are reports on the beneficial use of rosen root, lemon balm, chamomile, and lavender oil in reducing anxiety and stress in animals and humans.”
Regarding claims 2 and 6, Nouvel (US 8,741,965, published 2014) in col. 6, l. 25-43 contemplates 2-methylbut-2-enal (also known as tiglinaldehyde or tiglic aldehyde) in a formulation in an amount that is effective to “positively modify or alter the behavior (e.g. calm, reduce nervousness, or lower the heart rate) of a particular animal. Nouvel in Fig. 1 teaches heart rate over time after collar application of a collar containing the compound 2-methylbut-2-enal (referred to as “rabbit pheromone” or “RP” thereafter). Nouvel in col. 4, l. 11-16 states “Fig. 1 is a graphic representation of a comparative test of dogs receiving treatment with current calming products available on the market (Product 1 and Product 2), a placebo, and a composition comprising 2-methylbut-2-enal…”. Fig. 1 is shown below.
Nouvel, Fig. 1
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Regarding claim 15, Nordgren on p. 13, para. [0130] contemplates the combination of one or more humectants (sorbitol and glycerin). Additionally, Nordgren on p. 12, para. [0114] contemplates concentrations of humectants. Considering the ratio as claimed in claim 15, modifications to the formulation would be well within the skillset of one of ordinary skill in the art.
Additionally, regarding claim 2, which is drawn to an embodiment comprising less than about 0.001 wt. % pheromone, the modification of the amount of pheromone in the composition is considered within the skillset of one of ordinary skill in the art.
The MPEP section 2144.05, subsection II states
“The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”
Controlling the amount of pheromone within the composition is an adjustment of a particular working condition, one of ordinary skill in the art would have found claim 2 obvious at the time of the effective filing date.
Nordgren teaches formulations designed to take a compound or antimicrobial and administer to a dog’s mouth for dental hygiene purposes. However, considering the antimicrobial effect is from the antibody within Nordgren, one of ordinary skill in the art could easily envision modifying the compositions of Nordgren to include melatonin in place of the antibacterial taught. Additionally, one of ordinary skill would find it obvious to further modify the composition to include valerian root extract (valerian), chamomile, Saint John’s Wort, and tiglinaldehyde as taught by Hodge, Gupta and Nouvel. One of ordinary skill would find motivation to make the combination as the art has shown the additional ingredients all share a similar purpose as anxiolytic compounds that reduce anxiety and/or stress in dogs.
Regarding the limitation that “the canine calming gel is configured to adhere to a canine’s gums during transmucosal administration”, Low on p. 654 teaches administration of a gel directly to a canine’s oral cavity (gums). Additionally, Nordgren on p. 24, Table 35 and in para. [0194] discloses application of a gel to “the top and bottom gingival line on both sides of the mouth”.
The MPEP section 2144.06 states:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have modified the formulations of Nordgren by instead using melatonin, valerian root, and tiglinaldehyde in place of an antibacterial. One of ordinary skill would also find it obvious to formulate the composition into a gel form that can be applied directly to a canine’s gums. One of ordinary skill in the art would be motivated to make the modification as the anxiolytic compounds could then be administered orally or to the mucosal cavity of a dog using the formulations of Nordgren.
Low has been added to the rejection as necessitated by amendments made to the claims.
Response to Arguments
Applicant’s arguments submitted in the remarks of 05/29/2026 have been considered but are not persuasive.
Applicant argues that the Examiner has used impermissible hindsight to make the rejections.
Further, applicant argues that i) Nordgren is directed to entirely different field and purpose and that Nordgren does not teach the claimed components in the claimed roles or ranges, and ii) Hodge and Gupta do not fill the gaps. Applicant also argues that the reliance on MPEP 2144.06 is misplaced because “the cited references are not directed to the ‘same purpose’ and “Kerkhoven involved the combination of two individually known spray-dried detergents into a single spray-dried ingredient”.
Applicant states “Nordgren is directed to compositions containing antimicrobial IgGY antibodies for the treatment and prevent of dental diseases in companion animals” The entire purpose and inventive concept of Nordgren centers on delivering antibacterial IgGY antibodies to the oral cavity to combat oral health-compromising microorganisms. Nordgren’s formulations are designed as solid chewable veterinary compositions, not gels, and are formulated to deliver an antibacterial active agent, not calming ingredients”.
The instant disclosure is drawn to a composition designed to be administered to the oral cavity of a canine. As applicant has stated, Nordgren is drawn to delivering an active ingredient to the oral cavity of a canine. The effect of the composition depends on the active ingredient which, in Nordgren, is the antibacterial IgGY antibody. The instant claims make use of a different active, melatonin, but one of ordinary skill would find it obvious to make use of a formulation designed to administer an ingredient to an oral cavity with a separate active ingredient. The full composition of Nordgren is not needed for one of ordinary skill to recognize that the active ingredient of Nordgren can be replaced with a separate active ingredient.
In re Kerkhoven is invoked to explain the combination of the anxiolytic compounds known separately within the art.
Additionally, applicant states “The examiner has not articulated how or why a person of ordinary skill in the art would convert a solid chewable dental treatment into a flowable calming gel…”. Gel formulations are discussed by Nordgren and a separate gel formulation in Low indicate gel formulations are well known within the art as effective methods to administer actives to the oral cavity. KSR B summarizes motivation in that it would only take a substitution of one known ingredient (IgGY antibody) for another (melatonin) to achieve the general composition claimed.
Regarding impermissible hindsight, 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).
Applicant then states that the specific ratios and composition are “Not Merely Routine Optimization” and that the claimed invention “Produced Unexpected Results”.
Applicant’s arguments regarding the specific ratios points to examples disclosed within the specification as working examples. Applicant also states “The burden is on the Examiner to establish a prima facie case of obviousness, not on the Applicant to prove nonobviousness at this stage.”
Regarding the unexpected results, applicant states that “the claimed canine calming gel achieves a dual-delivery mechanism (transmucosal absorption through the dog’s gums combined with oral ingestion that provides extended release of calming ingredients.” Applicant continues “Additionally, the calming gel is eagerly ingested by dogs and is administered through a novel dispenser mechanism in which the gel is pushed through opening and licked off by the dog, simultaneously applying the gel to the gums for transmucosal delivery. None of the cited references teach or suggest this mode of administration or a gel formulation designed to achieve it.”
It is still not clear how the working examples are distinct from routine optimization that one of ordinary skill in the art would undertake in formulating the compositions. The claimed ingredients and their effects are well known within the art. Therefore, one of ordinary skill could easily combine them assuming necessary motivation (as discussed above). The concentrations and ratios of the ingredients can be easily modified by one of ordinary skill. It has not been shown what specific property of the formulation is dependent on the specific ratios and or whether this undisclosed property is an unexpected advantage over what is known within the art.
Regarding the dual administration effect, it is well known within the medical arts that diffusion via the mouth and via ingestion are intimately tied together. The oral cavity is the first portion of the digestive system where compounds and/or compositions are broken down and delivered to the body via the blood stream. Ingestion logically follows this step with similar effects.
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
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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