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
Election of Species and Status of the Claims
Applicant’s election without traverse of ‘Example 3, Table 2’ as the single specific dosage form in the response filed on March 30th 2026 is acknowledged. Claims 1-6, 8, 11-12, and 14-25 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on March 14th 2024 and January 16th 2026 are in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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 1 and its dependent claims are 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 1 is indefinite for the phrase:
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,
because one of ordinary skill in the art could not reasonably determine the metes and bounds of the Markush groups described by the claim. There is no clear divide between the chemical structural moieties described as R3-R4 combination groups and the other parts of the dosage form composition. Furthermore, the verbiage describing the further components of the composition makes it unclear which components are necessary portions of the claimed compositions.
For the purpose of examination, the phrase will be interpreted as:
“…
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;
pyrantel pamoate;
a macrocyclic lactone compound;
and a carrier comprising:
at least one flavor;
and a stabilizing component comprising magnesium carbonate, porous silica, or a mixture thereof.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 6, 8, 11-12, and 15-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kolhe (WO 2020/051106 A1 published on March 12th 2020).
Claim 1 is directed towards a palatable chewable veterinary tablet comprising:
An isooxazoline compound such as fluralaner
Pyrantel pamoate
A macrocyclic lactone compound, such as moxidectin
A flavor
A porous silica
Kolhe teaches a palatable chewable veterinary tablet comprising:
Fluralaner (Kolhe, pg. 29, claim 1)
Pyrantel pamoate (Kolhe, pg. 29, claim 3)
Moxidectin (Kolhe, pg. 29, claim 1)
A natural animal based palatant (i.e. a flavor) (Kolhe, pg. 29, claim 1)
Kolhe further states that the composition includes a disintegrant and specifies a list of 15 disintegrant choices, including magnesium aluminum silicate (i.e. a porous silica). See MPEP 2131.02(III):
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
As Kolhe teaches the five components of the composition, Kolhe anticipates claim 1.
Claim 2 limits the macrocyclic lactone of claim 1 to moxidectin and is anticipated by Kolhe for the same reasons as claim 1.
Claim 4 limits the porous silica in claim 1 to magnesium aluminosilicate, and is anticipated by Kolhe for the same reasons as claim 1.
Claim 6 requires that the composition of claim 1 additionally comprises at least one poloxamer. Kolhe teaches that the moxidectin blend that was used in the composition contains Poloxamer P 188 (Kolhe, pg. 14). Kolhe thereby anticipates claim 6.
Claim 8 requires that the composition of claim 1 additionally comprises an antioxidant. Kolhe teaches the addition of butylated hydroxytoluene in the tablet preparation (Kolhe, pg. 15). Kolhe thereby anticipates claim 8.
Claims 11 and 12 limit the isooxazoline compound of claim 1 to fluralaner and are anticipated by Kolhe for the same reasons as claim 1.
Claim 15 is directed towards a method of treating or preventing a parasite infection in a non-human animal via administration of the composition of claim 1. Kolhe teaches the treatment/prevention of parasitic infections (Kolhe, pg. 31, claim 15), in canines (Kolhe, pg. 30, claim 14) via administration of the composition. Claim 15 is thereby anticipated by Kolhe.
Claim 16 limits the macrocyclic lactone of claim 2 to moxidectin and is anticipated by Kolhe for the same reasons as claim 2.
Claim 17 limits the poloxamer of claim 6 to Poloxamer P 188, and is anticipated by Kolhe for the same reasons as claim 17.
Claim 18 limits the antioxidant of claim 8 to butylated hydroxyl toluene and is anticipated by Kolhe for the same reasons as claim 8.
Claim 19 limits the flavor in the composition of claim 19 to a natural flavor. As Kolhe’s flavor is “a natural animal based palatant” (Kolhe, pg. 29, claim 1), Kolhe anticipates claim 19.
Claim 20 limits the natural flavor in claim 19 to pork liver flavor. Kolhe teaches organ meats, including liver, from animals, including pork, as flavorants:
Natural animal meat based palatants can be obtained from meat, meat products, organ meat, and mixtures thereof. For example, an oral veterinary composition medication might include animal based and/or non-animal based flavorings such as dried or powdered meat and meat parts such as beef, pork, chicken, turkey, fish, and lamb; organ meats such as liver and kidney
[Kolhe, pg. 17]
Kolhe is thereby anticipatory of “pork liver flavor,” and claim 20. See MPEP 2131.02(III).
Claims 21-23 limit the isooxazoline compound of claim 1 to fluralaner and are anticipated by Kolhe for the same reasons as claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kolhe (WO 2020/051106 A1 published on March 12th 2020).
Claim 5 requires that, in the method of claim 1, the tablet comprises about 2-10% of the porous silica. For the teachings of Kolhe as they are relevant to claim 1, see the above 102 rejection for claim 1.
Regarding the amount of magnesium aluminosilicate present, Kolhe teaches that the composition includes a disintegrant selected from a group that contains magnesium aluminosilicate (Kolhe, pg. 18), and that the disintegrant is present in an amount of 10-18% (Kolhe, pg. 19). As Kolhe’s range overlaps with applicant’s range, one of ordinary skill in the art would have had a reasonable expectation of success in developing such a composition containing 2-10% magnesium aluminosilicate, and limitation 5 is therefore obvious. See MPEP 2144.05(I):
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Claim 5 is thereby prima facie obvious
Claims 3, 14, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kolhe (WO 2020/051106 A1 published on March 12th 2020) and Majumdar (US 2017/034593 A1 published on December 14th 2017).
Claim 3 requires that, in the tablet of claim 1, magnesium carbonate is present in an amount of about 1-4%. For the teachings of Kolhe as they are relevant to claim 1, see the above 102 rejection for claim 1.
Regarding the presence of magnesium carbonate, Kolhe does not explicitly teach the inclusion of magnesium carbonate in the veterinary composition. However, one of ordinary skill in the art would have had a reasonable expectation of success in including magnesium carbonate, because it is known in the art to be used in such compositions. For example, see Majumdar, who teaches similar fluralaner containing veterinary compositions (Majumdar, pg. 12), and further teaches magnesium carbonate as a possible excipient (Majumdar, pg. 8, paragraph [0056]). Majumdar additionally teaches the presence of excipients of this category at a concentration of 3% (Majumdar, pg. 10-11, Examples 6-9, see Magnesium Stearate). One of ordinary skill in the art would therefore have had a reasonable expectation of success in developing such a composition containing 3% magnesium carbonate, and limitation 4 is therefore obvious.
Claim 14 is directed towards a process for preparing the composition of claim 1, comprising separate preparation of three granular mixtures:
isooxazoline compound, pyrantel pamoate, disintegrant, filler, surfactant, colarant, cellulosic polymer
moxidectin, magnesium aluminosilicate, filler, magnesium carbonate, polymer, antioxidant
flavorant, filler, disintegrant, colorant, glidant
followed by the blending of all 3 granular mixtures, addition of a lubricant, and compression into tablets.
Kolhe’s composition is prepared in an analogous manner, by separately preparing
The isooxazoline mixture:
The sarolaner and pyrantel pamoate granulation is prepared by: 1 ) dry blending sarolaner and pyrantel pamoate with a disintegrant, filler, and colorant; 2) preparing a binder solution with a solvent and binder; 3) blending the sarolaner and pyrantel pamoate blend with the binder solution and at least one additional solvent to prepare a sarolaner-pyrantel granulate in a high-shear mixer granulator; 4) dry and mill the sarolaner-pyrantel granulate.
[Kolhe, pg. 21]
The moxidectin mixture:
The moxidectin granulation is prepared by: 1 ) dissolving meglumine in at least one solvent; 2) suspending HPMC in ethanol and then dissolving the suspension in water; 3) dissolving moxidectin in a solvent with BHT; 4) mixing the HPMC solution and the moxidectin solution to prepare a moxidectin granulating solution, i.e., the moxidectin-polymer dispersion; 5) dry blending at least one filler with a disintegrant; 6) spray drying the meglumine solution onto the dry blended filler and disintegrant to prepare a meglumine granulate; 7) spray dry the moxidectin granulating solution onto the meglumine granulate to prepare the stabilized moxidectin granulation; and 8) dry and mill the stabilized moxidectin granulation. The final moxidectin granulation comprises about 19 to 20w/w% of the final weight of the tablet; accounting for about 0.027w/w% (~0.03w/w%) moxidectin of the final tablet weight
[Kolhe, pg. 20-21]
Preparing the flavorant mixture and adding to the other two to develop the final product:
The palatable admixture is also a granulation that is prepared by mixing palatants with fillers, binders, and a sweetener with water in a fluid bed granulator; drying and milling the final granulation. The final palatable granulation (palatant admixture) comprises about 35 to 50w/w% of the final weight of the tablet; preferably about 40 to 45w/w% of the final weight of the tablet; and more preferably about 42w/w% of the final weight of the tablet.
The final dry blend is prepared by: 1 ) blending at least one disintegrant with a colorant and glidant to prepare a colored disintegrant/glidant mixture; 2) blending the palatable granulation (palatable admixture), sarolaner-pyrantel pamoate granulation, and stabilized moxidectin granulation with the colored disintegrant/glidant mixture; 3) blending the mixture with a lubricant and compressing the blend into finished palatable hard chewable tablets.
[Kolhe, pg. 21]
One of ordinary skill in the art would recognize the methods as being substantially similar with only minor tweaks in the preparation process (such as the addition of the magnesium carbonate). One of ordinary skill in the art would therefore have a reasonable expectation of success in preparing applicant’s composition via a process analogous to Kolhe’s procedure, and claim 14 is prima facie obvious.
Claim 24 is directed towards the tablet of claim 1 wherein the isooxazoline compound is fluralaner, the macrocyclic lactone compound is moxidectin, the flavor is pork liver flavor, and the stabilizing component comprises a mixture of magnesium carbonate and porous silica.
For the teachings of Kolhe as they relate to the presence of fluralaner, moxidectin, pork liver, and porous silica, see the above 102 rejections for claims 1 and 20. For the teachings of Majumdar as they relate to the presence of magnesium carbonate, see the above 103 rejection for claim 3. For the reasons described in each of the aforementioned rejections, claim 24 is prima facie obvious
Claim 25 is directed towards the tablet of claim 24, further comprising a poloxamer and an antioxidant. For the teachings of Kolhe as they relate to the presence of a poloxamer and an antioxidant, see the above 102 rejections for claims 6, 8, 17, and 18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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