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
Effective Priority Date
Regarding the remarks submitted 10/20/2025, applicant is correct to state that only claims which do not recite melatonin would find support in the earlier filed applications. This includes claims 7-14 and 16-19.
Therefore, claims 1-6 and 15, which comprise melatonin, have an effective filing date of 01/30/2023.
Claims 7-19 have an effective filing date of 12/14/2019.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted as of this office action.
Species Election
Applicant’s election of invention group I, claims 1-6 and 15 and species, made in the remarks submitted 04/30/2025, was acknowledged in the prior office action. 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)
Applicant states the elections read on claims 1-6 and 15.
Newly submitted claims 18-19, directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 18 and 19 are drawn to embodiments of claim 1 wherein the calming gel further comprises a breath freshening agent. Claim 1 has been amended to remove the limitations “wherein the canine calming gel does not contain breath freshening agents” and wherein the breath freshening agents are selected from a group (see new claim 19 for full listing).
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 Accordingly, claims 18-19 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
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.
Withdrawn Rejections
The 112(a) written description rejection made in the prior office action has been withdrawn. See examiner’s the modified 103 rejection below and the examiner’s comments.
In view of the amendments made, the 112(b) rejection made in the prior office action has been 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) 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) and Gupta (Springer, Nutraceuticals in Veterinary Medicine, May 2019, p. 422).
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, and Nouvel.
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 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.
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.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.”
Therefore, the limitation in claim 15 would be obvious to one of ordinary skill in the art.
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 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. Similar to discussion of claim 15 above,
“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.”
Therefore, as 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.
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 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.
Response to Arguments
Applicant, in response to the 103 rejection, argues that the “specific ratios of the aqueous and oil components are critical in order to produce a canine calming gel that is stable…” Applicant further states “the ratio of oil to surfactant is critical to achieve adherence of the canine calming gel to the oral mucosa of the canine, without which the composition fails to work for its intended purpose.” Applicant concludes “the specific amounts and ratios of lipid, phospholipid surfactant and humectant are critical in order to produce a canine calming gel that is accepted by canines…”.
This argument is unpersuasive because applicant asserts that “other ratios were tried, but those ratios did not produce a canine calming gel that was stable” without providing evidence that these other compositions have failed. The instant specification is silent to other compositions with different ratios and applicant has not pointed to anywhere within the art that would indicate that other compositions have failed. Without evidence that shows the failure of these compositions with different ratios, the argument is unpersuasive.
The rejection is maintained.
New Objection
Claim 4 states “valerian” twice.
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624