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 .
Applicants’ amendment filed 8/28/2025 has been entered. Claims 1-4, 6, 12-16, 18, 20-23, 25-27 and 29 were amended. Claims 1-18 and 20-29 are pending examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Rejections - 35 USC § 112
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 2 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 2 recites the phrase "comprising or consisting of up to 5% w/v of the antiparasitic agent" renders the claim indefinite because the scope of the claim cannot be deciphered. It is unclear because the term “comprising” leaves the claim open to the inclusion of other elements, whereas the term “consisting” excludes any element not specified. Therefore the metes and bounds of the claim cannot be deciphered.
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.
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,154,513 (herein 513’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid ophthalmic compositions comprising semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041]. Therefore, it would have been prima facie obvious to combine semifluoroalkanes with antiparasitic agents to produce a combined liquid ophthalmic formulation.
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,357,738 (herein 738’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041]. Therefore, it would have been prima facie obvious to combine semifluoroalkanes with antiparasitic agents to produce a combined liquid ophthalmic formulation.
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,128,010 (herein 010’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041]. Therefore, it would have been prima facie obvious to combine semifluoroalkanes with antiparasitic agents to produce a combined liquid ophthalmic formulation.
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,576,893 (herein 893’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising nebivolol and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,723,861 (herein 861’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising lantanoprost and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,896,559 (herein 559’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite methods of administering liquid compositions comprising semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,682,315 (herein 315’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite methods of administering liquid compositions comprising semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,273,174 (herein 174’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising iodine and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,150,955 (herein 955’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite methods of treating eye disease from demodex by administering liquid compositions comprising iodine and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea caused by demodex (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,226,422 (herein 422’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite methods of treating glaucoma by administering liquid compositions comprising iodine and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea which is known to increase risk of glaucoma (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,813,976 (herein 976’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,400,132 (herein 132’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising ciclosporin and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,510,855 (herein 855’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite liquid compositions comprising metal oxide, cosolvent and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,419,933 (herein 933’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite methods of treating uveitis by administering liquid compositions comprising iodine and semifluoroalkanes and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea which can cause uveitis (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,684,589 (herein 589’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite method of treating blepharitis by administering liquid ophthalmic compositions comprising F6H8 and do not include an antiparasitic compound. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041]. Therefore, it would have been prima facie obvious to combine semifluoroalkanes with antiparasitic agents to produce a combined liquid ophthalmic formulation to treat blepharitis since ocular rosacea frequently causes blepharitis.
Claims 1, 2, 4, 5, 7-9, 11, 14-18 and 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 11-14 of U.S. Patent No. 12,029,757 (herein 757’) in view of Kaoukhov et al. (US 2009/0093421). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims do not specify an antiparasitic compound in the claims. It is for this reason that Kaoukhov et al. is joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041].
Response to Arguments
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive. Applicant argues 12/029,757 only recites a semi-solid composition rather than a liquid composition as claimed. The Examiner is not persuaded by this argument because Kaoukhov et al. has been joined. Kaoukhov et al. teach administration of ivermectin (antiparasitic compounds) for the treatment of ocular rosacea (abstract; claim 2). The formulations are preferably prepared in liquid form as an eyewash or eye drops [0041]. Therefore, it would have been prima facie obvious to combine semifluoroalkanes with antiparasitic agents to produce a combined liquid ophthalmic formulation.
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 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 103 which forms the basis for all obviousness rejections set forth in this Office action:
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.
Claims 1, 2, 4, 5, 7-9, 11, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Loscher et al. (CA 3112504; filing date September 20, 2019).
Applicant’s Invention
Applicant claims an antiparasitic composition comprising an antiparasitic agent and a semifluorinated alkane. (claim 1)
Determination of the scope and the content of the prior art
(MPEP 2141.01)
With respect to claims 1, 2, 4, 5, 7-9, 11, 14 and 15 Loscher et al. teach ointments useful in the treatment of diseases or conditions associated with the lipid barrier damage of the skin comprising a semifluorinated alkane and a solid thickening agent, e.g. a wax, a triglyceride, cetyl alcohol, cetyl palmitate or tetradecanol (abstract). The ointments function as protectives and emollients for the skin and are used as vehicles for medicinal substances (page 1, lines 7-10). The ointment is a homogeneous, semi-solid preparation and is intended for external application to the skin or mucous membrane (page 5, lines 31-32). The semifluorinated alkanes are linear or branched alkanes and preferably have the formula CF3(CF2)n(CH2)mCH3, wherein n and m are independently selected from the range of 2 to 10 and the preferred semifluorinated alkanes are selected from F4H5, F4H6, F4H8, F4H10, F6H8 and F6H10 with F4H8, F6H8 and F6H10 being most preferred (page 6, lines 15-26; limitation of claims 5 and 11). Preferably the composition does not comprise any preservative or water (page 8, lines 1-2; page 9, lines 23-31; limitation of claim 9). The composition may further comprise an active ingredient preferably selected from antiseptics, corticosteroids, antibiotics, calcineurin inhibitors, anaesthetics, retinoids, vitamin D analogues, immunosuppressants, prostaglandins analogues, capsaicinoids, and avermectins, most preferably the active ingredient is selected from ivermectin (page 8, lines 4-12; limitation of claims 4 and 14). The total concentration of active ingredient can range from up to 10 percent by weight with respect to the total weight of the composition, preferably 0.05-5% (page 8, lines 14-19; limitation of claim 14). Optionally, the composition may further comprise an excipient such as a cosolvent or an oily material in a concentration of up to 45 percent by weight with respect to the total weight of the composition, preferably 1-10% (page 8, lines 21-30; limitation of claims 7 and 14).
With respect to claim 1, the ointments are prepared by mixing components together and gently heating the mixture in a water bath to form a clear, homogenous solution which is then cooled to form a semi solid (page 15, line 29 through page 16, line 2). Additionally, Loscher teach cosolvents added to the composition include liquid triglycerides, mineral oils and vegetable oils (page 9, lines 6-14).
With respect to claim 8, Loscher et al. teach alcohol as an optional ingredient which can be omitted when formulating the composition.
Claim 15 is drawn to an inherent property of the composition when it is applied.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Loscher et al. teach ointments useful in the treatment of diseases or conditions associated with the lipid barrier damage of the skin comprising a semifluorinated alkane and an active ingredient is selected from ivermectin. The ointments are prepared by heating which forms a homogenous liquid solution. Therefore, the composition can be in the form of a semi solid or a liquid depending on the temperature (see also claim 27 on page 13).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Therefore, it would have been prima facie obvious to one of ordinary skill to use the teachings of Loscher et al. to form a liquid antiparasitic composition comprising 0.5-5% ivermectin, F6H8 and excipients selected from cosolvents and oily excipients with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings of Loscher et al. form a liquid ointment by combing 0.5-5% ivermectin, F6H8 and liquid triglycerides a temperature above room temperature to form a liquid composition.
Response to Arguments
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive.
Applicant argues that one skilled in the art would not be motivated to change the semisolid to a liquid solution because Loscher teach that less viscous ointments have the advantageous of being less viscous than other water free ointments which allows it to penetrate in the stratum corneum quicker. The Examiner is not persuaded by this argument because it is well known in the art to heat semisolid ointment to temperatures above room temperature to form liquids when different modes of application are desired. Additionally, Loscher teach cosolvents added to the composition include liquid triglycerides, mineral oils and vegetable oils which would aid in forming liquid formulations. Additionally, the formulations taught by Loscher required the same components as the claimed composition and therefore the properties of the composition would be inherent to the formulation.
Claims 3, 10, 12, 13, 16, 17, 20-22, 28 and 29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Loscher et al. (CA 3112504; filing date September 20, 2019), as applied to claims 1, 2, 4, 5, 7-9, 11, 14 and 15 in view of Roos et al. (Pharmacotherapy of Ectoparasitic Infections, Drugs, 2001: Volume 61(8), pages 1067-1088).
Applicant’s Invention
Applicant claims an antiparasitic composition comprising an antiparasitic agent and a semifluorinated alkane. (claim 1)
Applicant claims a method of treating a parasitic infestation comprising administering the composition of claim 1. (claim 16)
Applicant claims a method for large-area application comprising topically administering the composition of claim 1. (claim 28)
Determination of the scope and the content of the prior art
(MPEP 2141.01)
The teachings of Loscher et al. are addressed in the above 103 rejection.
With respect to claims 3, 10, 12, 13, 16, 17, 20-22, 28 and 29, Loscher et al. teach ointments antiparasitic composition comprising 0.5-5% ivermectin, F6H8 and excipients selected from cosolvents and oily excipients. Loscher et al. also teach a medicament used to treat or prevent a disease or condition associated with the lipid barrier damage of the skin which encompasses diseases such as dermatitis, psoriasis and acne, as well as conditions such as dry skin and itchiness (page 10, lines 5-13).
Loscher et al. also teach methods of treating the disease or condition comprising administering the composition topically to the skin of a subject suffering from a disease or condition associated with lipid barrier damage of the skin (page 10, lines 5-25).
Claims 17, 22 and 28 recite applying the composition by a non-touch application. Loscher et al. teach a kit comprising a container for holding the composition selected from a jar, a tube, a dispenser or other types of containers suitable for holding the composition which have a pump or squeeze mechanism (page 11, lines 1-6). Therefore, non-touch applications are encompassed by the teachings of Loscher.
Claims 22 and 29 are drawn to an inherent property of the composition when it is applied.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Loscher et al. do not teach the specific antiparasitic agents permethrin, crotamiton, lindane or benzylbenzoate. Loscher et al. do not link diseases or conditions associated with lipid barrier damage of the skin to antiparasitic compositions or methods of treating parasitic infestation. It is for this reason Roos et al. is joined.
Roos et al. teach permethrin is the treatment of choice for lice and scabies in the US and Great Britain, whereas lindane is recommended for scabies because of its effectiveness (abstract). Ivermectin is a newer oral drug for treatment of ectoparasites (abstract). Scabies cause intense pruritus (itchiness) (page 1068, section 1.1), lice cause excoriations and secondary eczematisation (eczema) (page 1069, section 1.2) and fleas cause painful pruritic urticarial papules (page 1069, section 1.5). Frequently used drugs are lindane, permethrin and crotamiton and ivermectin has been shown to be effective in treating scabies and lice and other agents include benzyl benzoate (section 2.1). Toxicity from permethrin (5% cream) is 40 to 400 times lower than a topical lindane (1% lotion) but must be rinsed off 8-14 hours after topical application to minimize the risk of allergic contact dermatitis (page 1076, section 2.2.2.). Crotamiton (10% cream, 10% gel and 5% lotion) is effective in treating scabies and has antipruritic function and few adverse effects (page 1077, section 2.2.3.). Ivermectin is used orally and topically to treat scabies but has been associated with pruritus (page 1080, section 2.3.1).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Both Loscher et al. and Roos et al. teach using ivermectin in topical form as an antiparasitic agent. Roos et al. teach that permethrin, crotamiton and ivermectin are known to be used interchangeably to treat ectoparasites. Permethrin, crotamiton and ivermectin are known to treat scabies and lice which cause itchiness. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Loscher et al. and Roos et al. to form an antiparasitic composition comprising 0.5-5% permethrin or 0.5-5% crotamiton with F6H8 and excipients selected from cosolvents and oily excipients and apply the composition topically to control pests with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings of Loscher et al. and Roos et al. to form an ointment comprising 0.5-5% permethrin, F6H8 and excipients selected from cosolvents and oily excipients to treat of diseases or conditions associated with the lipid barrier damage of the skin because Roos et al. teach substituting permethrin in place of ivermectin to prevent scabies and lice which cause itchiness . Furthermore, one of ordinary skill in the art would have been motivated before the time of filing to combine the teachings of Loscher et al. and Roos et al. to form an ointment comprising 0.5-5% crotamiton, F6H8 and excipients selected from cosolvents and oily excipients to treat of diseases or conditions associated with the lipid barrier damage of the skin because Roos et al. teach substituting crotamiton in place of ivermectin since it is known to be antipruritic and because Roos et al. teach substituting permethrin in place of ivermectin to prevent scabies and lice which cause itchiness.
Response to Arguments
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive for the reasons set forth in the above response.
Claims 6, 18 and 23-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Loscher et al. (CA 3112504; filing date September 20, 2019) in view of Roos et al. (Pharmacotherapy of Ectoparasitic Infections, Drugs, 2001: Volume 61(8), pages 1067-1088), as applied to claims 3, 10, 12, 13, 16, 17, 20-22, 28 and 29 in further view of McKinnon et al. (GB 2150437; filing date September 27, 1984).
Applicant’s Invention
Applicant claims an antiparasitic composition comprising an antiparasitic agent and a semifluorinated alkane. (claim 1)
Applicant claims a method of treating a parasitic infestation comprising administering the composition of claim 1. (claim 16)
Applicant claims a method of topical applications of an antiparasitic composition comprising applying the composition with a wipe, a roll-on dispenser, a spray dispenser or a dropper. (claim 16)
Applicant claims a kit comprising a) an antiparasitic composition of claim 1 and b) a wipe, a spray dispenser, a roll-on dispenser or a dropper. (claim 27)
Applicant claims a method for large-area application comprising topically administering the composition of claim 1. (claim 28)
Determination of the scope and the content of the prior art
(MPEP 2141.01)
The teachings of Loscher et al. and Roos et al. are addressed in the above 103 rejection.
With respect to claims 36, 18 and 23-27, Loscher et al. teach a kit comprising a container for holding the composition selected from a jar, a tube, a dispenser or other types of containers suitable for holding the composition which have a pump or squeeze mechanism (page 11, lines 1-6). Therefore, various dispensers are implied in the teachings of Loscher et al.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Loscher et al. and Roos et al. do not a wipe, a spray dispenser, a roll-on dispenser or a dropper. It is for this reason McKinnon et al. is joined.
McKinnon et al. teach a roll-on applicator used to apply medicaments, insecticides and ectoparasiticides to the skin of an animal (abstract). The roll-on applicator allows for a method of applying topically veterinary agents, while protecting the person applying the product by avoiding contact with the agent (page 1, lines 22-25). Insecticides that can be applied include pyrethroids such as permethrin (page 2, lines 13-17). The roll-on applicator allows for more direct application to control fleas on an infested area (page 2, lines 34-40).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Loscher et al., Roos et al. and McKinnon teach topical formulations comprising antiparasitic compounds. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Loscher et al., Roos et al. and McKinnon et al. to use a roll-on dispenser the deliver an antiparasitic composition with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings of Loscher et al., Roos et al. and McKinnon et al. and utilize a roll-on dispenser to deliver an antiparasitic formulation because McKinnon et al. teach roll-on applicator allows for more direct application to control fleas on an infested area while protecting the person applying the product from contacting the agent.
Response to Arguments
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive for the reasons set forth in the above response.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617