DETAILED ACTION
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 .
In view of the amendment, previous 102(a)(1) rejection on claims 3 and 4 over Jacobsen et al (5,980,496) is hereby withdrawn.
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.
Claim Objections
Claims 24 and 25 are objected to because of the following informalities: Applicant need to change “said initial dose” on line 1 of each of claims 24 and 25 to --- said initial dosage --- (so as to be consistent with the term appearing in claim 1). Appropriate correction is required.
Claim 27 is objected to because of the following informalities: on line 2, applicant needs to insert --- of --- between “body” and “the animal”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2-4, 21 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
First, Claim 2 requires the substance of claim 1 to be a pest control substance. Claim 2 then recites that such pest control substance achieves “b) relieving pain; and c) calming the animal”. There is no support for the pest control substance relieving pain or calming the animal in the originally filed disclosure (present specification treat pain drugs and calming drugs as separate and different from pest control substance (sch as anti-flea compound, anti-tick compound and anti-parasite compound).
Secondly, both claims 2 and 3 recite a first efficacy level (and a second efficacy level) for relieving pain and calming the animal. There is no support in the original disclosure for such limitation. Present specification discusses the first (and the second) efficacy level in relation to the pest control substance only.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "said one or more actives" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
First, Claim 27 recites the limitation "said concentration of one or more active" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Secondly, Applicant recite that the concentration of one or more actives is a concentration of the substance on or in a body of the animal. It is unclear to the Examiner what applicant mean by such limitation. Do applicant mean that the concentration of the active(s) is the same as the concentration of the substance (i.e., the substance does not contain anything other than the actives), or do they mean something else? Appropriate clarification and corrections are required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 4, 7, 9-15 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al (5,980,496) in view of Manion et al (WO 2019/083820 A1).
Jacobsen teaches (see Fig.2, col.5, lines 46-51, col.6, lines 28-36) a drug delivery system in the form of a collar that includes a drug container or reservoir, a drug delivery device, such as a pump and a dispenser. The drug delivery system further contains a controller which is used to command the pump to deliver the drug to the dispenser according to a pre-programmed dosing regimen. In Example 2, Jacobsen teaches that its delivery system automatically delivers the ectoparasiticide permethrin (instant one or more actives of the pest control substance) onto the fur and skin of dogs and cats where the target parasites are ticks and fleas. For untreated dogs and cats, Jacobsen teaches that it is advantageous to first provide an initial loading dose (instant initial dosage amount) of 100 – 1500 microliters (depending on the size of the animal) of permethrin which rapidly raises the parasiticide level on the host animal into the lethal range (i.e., at or above instant first active concentration threshold level necessary for achieving a first efficacy level), thus providing rapid kill of the parasites. Then, to provide a maintenance dose of 10-200 microliters per day of the permethrin to maintain sufficient levels of the parasiticide to control the infestation at an acceptable level (greater than 80% efficacy is typically desired) (instant second active concentration level).
With respect to instant plurality of sub-initial doses delivered at discrete time intervals separated from one another by time gaps and a total amount of the sub-initial doses that equals the initial dosage amount, Jacobsen does not expressly teach such limitation, but it teaches (col.4, lines 21-24) that its invention seeks to avoid doses which may induce toxicity in the host animals and to maximize efficacy with minimal drug doses. Furthermore, Manion teaches ([0001]-[0002]) that spot-on flea or tick medication for dogs and cats delivered as a single macro-dosage initially and then reapplied on a regular basis (for example, monthly) is not ideal for the treatment of fleas because the animal is overdosed immediately following the application and underdosed towards the end of the medication cycle. Manion further teaches (abstract, [0018], [0025]) a microdispenser configured to deliver small bursts of topical medication (25 - 75 picoliters at 10 – 50 Hz) over a period of time and a controller to operate the microdispenser. Manion teaches that rather than delivering a single macro-dosage at the beginning of the treatment cycle, the microdispenser can provide for micro-dosages of the medication throughout the treatment cycle, thereby increasing the efficacy of the medication. Manion’s small bursts of dosing method that provides micro-dosages throughout the treatment cycle teaches instant limitation of plurality of sub-initial doses delivered at discrete time intervals separated from one another by time gaps and a total amount of the sub-initial doses being equal to the initial dosage amount. Since Jacobsen aims to avoid doses which may induce toxicity in the host animals and to maximize efficacy with minimal drug doses, it would have been obvious to one skilled in the art to deliver Jacobsen’s initial loading dose as a plurality of small burst doses delivered at discrete time intervals separated from one another by time gaps with the total amount of the small burst doses being equal to the initial loading dose (as taught by Manion) with a reasonable expectation of increasing the efficacy of the medication.
Thus, Jacobsen in view of Manion renders obvious instant claims 1 and 3.
With respect to instant claim 4, since Jacobsen’s initial loading dose is about 7 to 10 times higher than the maintenance dose, instant second efficacy level (i.e., maintenance level) would be less than the first efficacy level (i.e., initial loading dose level). Thus, Jacobsen in view of Manion renders obvious instant claim 4.
With respect to instant claim 7, as discussed above, Jacobsen’s Example 2 already teaches that the maintenance dosage (instant one or more subsequent dosages) is lower than the initial loading dosage (instant initial dosage amount). Thus, Jacobsen in view of Manion renders obvious instant claim 7.
With respect to instant claims 9-13, Jacobsen teaches (col.6, lines 27-36 and col.6, lines 45-52) that the controller can be programmed to deliver the drug from the reservoir to the dispenser according to a dosing regimen, which can depend on the season, the size of the animal or whether a particular parasite becomes active or dormant. Such guideline given by Jacobsen would render obvious instant limitations of claims 9-13. Thus, Jacobsen in view of Manion renders obvious instant claims 9-13.
With respect to instant claim 14, Manion teaches ([0041]) that the controller may include sensors (instant well-being device) to monitor the temperature, physical activity, cardiac activity and specific motions of the animal. Based on the output of the sensors, the controller may be configured to alter the treatment program of the animal. It is the Examiner’s position that using the sensors to determine the animal’s state (health) and then using such information to determine the dosing regimen for the animal would inherently teach instant synergism limitation of claim 14. Thus, Jacobsen in view of Manion renders obvious instant claim 14.
With respect to instant claim 15, Jacobsen teaches (col.8, lines 7-50) the use of a second drug and cycling the first and second drugs to prevent the development of resistance to the parasiticide in the targeted parasite. Thus, Jacobsen in view of Manion renders obvious instant claim 15.
With respect to instant claims 24 and 25, the Examiner already established above that in view of Manion’s teaching, it would be obvious to one skilled in the art to deliver Jacobsen’s initial loading dose as a plurality of small burst doses delivered at discrete time intervals separated from one another by time gaps with the total amount of the small burst doses being equal to the initial loading dose (as taught by Manion) with a reasonable expectation of increasing the efficacy of the medication. Thus, Jacobsen in view of Manion renders obvious instant claims 24 and 25.
With respect to instant claim 26, as discussed above, Jacobsen teaches (col.8, lines 7-50) the use of a second drug and cycling the first and second drugs to prevent the development of resistance to the parasiticide in the targeted parasite. Jacobsen teaches (col.13, lines 59-67, col.14, lines 1-10) moxidectin as one of the highly desirable drugs for administration in accordance with the principles of its invention. It would have been obvious to one skilled in the art to include moxidectin as the second drug in Jacobsen’s delivery system of its Example 2 with a reasonable expectation of success. As evidenced by applicant (see the last four lines on pg.1 of present specification), moxidectin is a transdermal systemic active that enters the body through the skin. Thus, Jacobsen in view of Manion renders obvious instant claim 26.
With respect to instant claim 27, in Jacobson’s Example 2, there is a loading dose of 100 – 1,500 ml of permethrin (formulated as a 60 w/w % solution) and a maintenance does of 10-200 ml per day administered onto the fur of dogs and cats. Thus, Jacobsen teaches instant limitation “said concentration of one or more actives is a concentration of the substance on or in a body the animal” of claim 27. Thus, Jacobsen in view of Manion renders obvious instant claim 27.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al (5,980,496) in view of Manion et al (WO 2019/083820 A1), as applied to claim 1 above, and further in view of Gladney et al (5,236,954).
As discussed above, Jacobsen in view of Manion teaches instant claim 2 except for instant limitation (a), (b) or (c). Gladney teaches (col.3, lines 25-43) that applying a topical composition comprising 65 wt.% permethrin in a solvent carrier 2-(2-methoxyethoxy)ethanol is effective for control of ectoparasite, such as fleas, flies and ticks, on some mammals while remaining non-toxic and non-irritating to the host. Gladney further teaches (see Experiment I in col.7) that application of 1 mL of its inventive permethrin composition to the shoulders of dogs weighing less than 15 kg is effective in controlling 93% of fleas on the 3rd day (72 hours) (see Table 3, Group 2). Based on Gladney’s teaching, it is the Examiner’s position that Jacobsen’s permethrin concentration in Example 2 would naturally achieve (since Jacobsen’s permethrin concentration is at a slightly lower concentration but can be administered at a higher amount) instant limitation (a) i.e., performing an initial kill of pests that have infested the animal before administration of the initial dosage amount, wherein said initial kill is achieved within about 72 or 96 hours. Thus, Jacobsen in view of Manion and further in view of Gladney renders obvious instant claim 2.
Claim(s) 5 and 21-23 rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al (5,980,496) in view of Manion et al (WO 2019/083820 A1) as applied to claim 1 above, and further in view of Sahin et al (“The Operational Multiple Dosing Hal-life: A Key to Defining Drug Accumulation in Patients and to Designing Extended Release Dosage Forms”, Pharm Res. Vol.25 (12) (2008), pg.2869-2877).
As discussed above, Jacobsen teaches a drug delivery system which uses a controller to deliver dosages of permethrin to the skin of dogs at discrete time interval. Jacobsen does not teach instant limitation “wherein each of said time gaps is smaller than a half lifetime of one or more actives on said skin, so that a concentration of said one or more actives on said skin is maintained above an efficacy threshold during the entire time of treatment”. However, as evidenced by Sahin (see the 2nd paragraph under INTRODUCTION), the half-life of a drug is the time interval in which half the drug in a system is lost. Sahin teaches that If a drug is dosed at a frequency equal to the drug’s half-life, the patient exposure to the drug at steady-state during a dosing interval will be twice the exposure of a single first dose. If the dosing interval is less than the half-life of the drug, then the exposure will be greater than double, and if the dosing interval is greater than the half-life of the drug, the exposure will be less than double (in all three of these cases, the concentration of the drug will be maintained above the efficacy threshold during an entire time of treatment if an appropriate dosing amount is chosen). Since Jacobsen (see col.4, lines 22-25) aims to avoid individual doses which may induce toxicity in the host (i.e., avoid individual high doses), under the guidelines given by Sahin, it would be obvious to one skilled in the art to administer Jacobsen’s permethrin at a time interval shorter than the half-life time of the drug (i.e., more frequent dosing) to avoid high individual doses while maintaining the drug concentration above the efficacy threshold during the entire time of treatment with minimal drug doses. Thus, Jacobsen in view of Manion, and further in view of Sahin renders obvious instant claims 5 and 21-23.
Response to Arguments
In summary, applicant argue that Manion teaches away from delivering a single macro-dosage at the begging of a treatment cycle and instead teaches a method that provides for microdosages of the medication throughout the treatment cycle and argue that there is no teaching in Manion of instant limitation “wherein said initial dosage amount comprises a plurality of sub-initial doses delivered at discrete time intervals separated from one another by time gaps and a total amount of said sub-initial doses equals said initial dosage amount”. The Examiner disagrees. Under the broadest interpretation, the term “initial dosage” as recited in claim 1 is arbitrary, relative and subjective. Any grouping of the first n doses (n being a positive integer) could be called the initial dosage. Since Manion already teaches delivering small bursts of topical medication over a period of time, Manion’s small bursts of doses that occur earlier in the treatment cycle still teach instant initial dosage, which amount comprises a plurality of sub-initial doses delivered at discrete time intervals separated from on another by time gaps, with the total amount of the sub-initial doses being equal to the initial dosage amount (one can group any number of earlier doses and call them “the initial dosage”).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
January 10, 2026