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 .
Information Disclosure Statement
The submitted information disclosure statement (IDS) was filed on 10/20/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Application
Applicants' arguments/remarks filed 12/01/2025 are acknowledged. Claims 1 and 5 are currently amended. Claim 3 is canceled. Claims 16-20 are newly added. Claims 1-2, 4-20 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment, filed 12/01/2025 and with respect to applicant’s arguments/remarks: the 35 U.S.C. § 102 rejection of Claim 3 has been withdrawn in view of the cancelation of the claim.
Modified Rejections
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 6-9, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (WO 2005084688 A1).
Claims 1, 4, 6-9, and 10-12,
Wang et al. teach:
A vermifuge injection powder for animals comprising at least one of the antiparasitics such as avilamycin, which is mixed with liquid dispersion to be used, as a solution or an emulsion or a suspension. And the administration can be subcutaneous injection or intramuscular injection, as well as oral taking. The formulation is suitable for the prevention of nematodiasis, a disease in higher animals. The injection powder comprising an antiparasitics of avilamycin according to the present invention displays a very good slow releasing effect. (Abs). Parasitic disease can be oral disease. Antiparasitics means to treat parasitic infections.
A composition of veterinary powder for injection containing drugs in solid dispersion with hydrogenated castor oil and is mixed with glyceryl triacetate, (pg. 5, 1st par.). Suspension of hydrogenated castor oil and avermectins show that the more hydrogenated castor oil content in a certain range, the better the sustained-release effect, but when using vegetable oil as a medium, the maximum amount of hydrogenated castor oil in the liquid preparation is about 1%, due to the swelling of hydrogenated castor oil , the formulation became viscous (gel), and even became a semi-solid state, which may be difficult to remove it from the container and completing the injection process. In summary, powder injections are added with a liquid dispersion medium to overcome the shortcomings of the oil (suspension) agent containing high-concentration hydrogenated castor oil (suspension) for a long time (1-3 months) when the liquid becomes thick and becomes semi-solid. (pg. 3, 1st par.). Hydrogenated castor oil is a hydrogenated vegetable oil. Glyceryl triacetate is a polyol fatty acid ester, is a liquid, oily and somewhat viscous liquid.
A solid dispersion powder containing ivermectin /hydrogenated castor oil (1: 3); take 99 parts of solid dispersion powder containing ivermectin /hydrogenated castor oil (1: 3) and 1 part of di-tert-butyl-p-cresol, also known as Butylated HydroxyToluene (BHT) / Butylated HydroxyAnisole (BHA) / propyl gallate (PG) powder is mixed, to obtain powder injections containing 24.75% of ivermectin; (2) uses, usage and dosage: This agent is used for the control of nematode disease and ectoparasite disease in higher animals such as pigs, cattle, and sheep. When used, it is mixed with triacetate containing 0.6% (w/v) trichloro-tert-butyl alcohol to provide a suspension containing 4.95% of ivermectin to inject subcutaneously. (Example 4, pg. 7, 4th par.). The 24.75% ivermectin/74.25% hydrogenated castor oil is diluted 5-fold down to 4.95% with glyceryl triacetate 99.6% ~ 100%. The final formulation ha 4.95% ivermectin drug/14.85% hydrogenated castor oil and about 80% glyceryl triacetate. Propyl gallate is a synthetic antioxidant used in the food, cosmetic, and pharmaceutical industries to prevent fats and oils from spoiling due to oxidation. (Park. Propyl gallate induces human pulmonary fibroblast cell death through the regulation of Bax and caspase-3. Ann Med. 2024 Feb 19;56(1):2319853).
With regard to claims 2
(1) Composition: avermectin antiparasitic drugs/gasified castor oil (1: 0.3-20, w /w)
solid dispersion fine powder 80-100% (w /w), additives to 100% (w /w); (pg. 4, 1st par.). Additives can be antioxidants (preservatives), diluents, or polyethylene glycol (humectant) or polyvinylpyrrolidone (humectant), or xanthan gum (thickening agent). (pg. 10, 4-6th par.). "Gasified castor oil" is a misnomer; the term likely refers to castor oil that has been subjected to a chemical process to create a gas, or, more likely, to hydrogenated castor oil. (https://www.tomsofmaine.com/pages/ingredient/hydrogenated-castor-oil#:~:text=Hydrogenated%20Castor%20Oil%2C%20also%20known,presence%20of%20a%20nickel%20catalyst).
With regard to claim 13,
The preparation of solid dispersion containing avermectin antiparasitic drugs / hydrogenated oil and methods of use are: avermectin quaternary parasite drugs and hydrogenated castor oil with a hydrophilic solvent to dissolve the active ingredient in hydrogenated castor oil under heating conditions and melt, then pour into cold water, fill with cold water and filter. A solid dispersion containing avermectin antiparasitic drugs / hydrogenated castor oil is obtained; (pg. 4, last par. – pg. 5, 1st par.). A solid dispersion powder containing ivermectin /hydrogenated castor oil (1: 3); take 99 parts of solid dispersion powder containing ivermectin /hydrogenated castor oil (1: 3) and 1 part of di-tert-butyl-p-cresol, also known as Butylated HydroxyToluene (BHT) / Butylated HydroxyAnisole (BHA) / propyl gallate (PG) powder is mixed, to obtain powder injections containing 24.75% of ivermectin; (2) uses, usage and dosage. When used, it is mixed with triacetate containing 0.6% (w/v) trichloro-tert-butyl alcohol to provide a suspension containing 4.95% of ivermectin to inject subcutaneously. (Example 4, pg. 7, 4th par.). The 24.75% ivermectin/74.25% hydrogenated castor oil is diluted 5-fold down to 4.95% with glyceryl triacetate 99.6% ~ 100%. The final formulation ha 4.95% ivermectin drug/14.85% hydrogenated castor oil and about 80% glyceryl triacetate.
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 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2005084688 A1), in view of Kim et al. (WO 2016104889 Al).
The teachings of Wang et al. are described in claim 1 above.
Wang also teaches a solid dispersion is prepared by combining avermectin-type anthelmintic drugs with hydrogenated castor oil or polyethylene glycol pyrrolidone or polyethylene glycol or polyvinyl pyrrolidone / ethylcellulose with a molecular weight greater than 1000. (pg. 3, 1st par.).
Wang et al. do not teach monoglyceride of caprylic acid or glyceryl monocaprylate.
Kim et al. teach Dutasteride the product name of AVODART® can be prepared a self-emulsifying drug delivery system by dissolving dutasteride in a mixture of mono- and di-glyceride oil of caprylic/capric acid and butylated hydroxy toluene (BHT). An improvement has developed to be less bulky than AVODART®, by adding a PEG-50 hydrogenated castor oil (HCO-50), a hydrogenated castor oil employed as a surfactant. (pg. 8, lines 13-20). Kim et al. improve dissolution stability of dutasteride by employing a hydrogenated castor oil with appropriate degree of substitution. (pg. 2, lines 2-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare a composition of veterinary powder for injection containing drugs in solid dispersion with a hydrogenated vegetable oil or hydrogenated castor oil dissolved and is mixed with polyol fatty acid ester glyceryl triacetate, taught by Wang et al. and the polyol fatty acid ester can be mono glyceride caprylate taught by Kim et al., since they have proven it would be a self-emulsified drug delivery system to improve absorption.
Claim(s) 1, 8 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2005084688 A1), in view of Zhang et al. (CN110742861A).
Claims 14-15,
The teachings of Wang et al. are described in claims 1 and 8 above. Wang et al. teach the formulation of a drug comprising a polyol fatty acid ester glyceryl triacetate and a hydrogenated vegetable oil, hydrogenated castor oil, which is a SEDDS.
Wang et al. does not teach a method, comprising contacting the pharmaceutical preparation of claim 8 with a mucous membrane of an animal or/and human body.
Zhang et al. teach Self-emulsifying drug delivery systems (SEDDS), which often comprise oils and surfactants. (Abs). The oil phase of the present invention is selected from: medium chain triglyceride (MCT), polyoxyethylene hydrogenated castor oil (RH40), caprylic. (pg. 3, 5th par.). Patent document GB2380129 A discloses a self-emulsifying pharmaceutical composition, which is a specific composition of cannabinoids in predetermined proportions, which when hydrated forms an emulsion containing a lipophilic drug capable of adhering to mucosal surfaces and allowing the drug to release is controlled. Due to sublingual and/or oral mucosal administration placement, various viscous agents and adhesives are added to the self-emulsifying pharmaceutical composition, so that the drug release time is too long. In order to improve the defects of the prior art, in the present invention, the inventor obtained the best combination of drug, oil phase, emulsifier and co-emulsifier and the best ratio through screening, and prepared the drug with fast drug release speed and stable physical and chemical properties. , Cannabidiol solid self-emulsifying preparation with high bioavailability. (pg. 2, 6th last par.).
With regard to claims 16-18,
Zhang et al. teach sublingual and/or oral mucosal administration. A self-emulsifying pharmaceutical composition, which is a specific composition of cannabinoids in predetermined proportions, which when hydrated forms an emulsion containing a lipophilic drug capable of adhering to mucosal surfaces and allowing the drug to release is controlled. (pg. 2, 7th last par.).
The oral cavity contains teeth and different types of mucosa. The lining mucosa (buccal, sublingual, labial) includes gums, which are gingival mucosa tissues.
https://www.deltadental.com/protect-my-smile/oral-anatomy/anatomy-of-your-mouth-and-throat/
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare a composition of veterinary powder for injection containing drugs in solid dispersion with a hydrogenated vegetable oil or hydrogenated castor oil dissolved and is mixed with polyol fatty acid ester glyceryl triacetate, taught by Wang et al. and the SEDDS are recognized that they adhere to mucosal surfaces and allow the controlled release of drug after sublingual and/or oral mucosal administration, drug adhering to gingival tissue taught by Zhang et al. since they have proven it would improve drug absorption.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2005084688 A1) in view of Zhang et al. (CN110742861A).
Wang et al. teach preparation veterinary powder injections, used for the prevention and treatment of nematode disease, liver fluke disease, tsutsugamushi disease, ectoparasites (mites, cicadas, lice, fly maggots) in higher animals. The administration method is subcutaneous injection or intramuscular injection, and it can also be administered orally. The injection powder comprising an antiparasitics of avilamycin according to the present invention displays a slow releasing effect. (Abs). Parasitic disease can be oral disease. A composition of veterinary powder for injection containing drugs in solid dispersion with hydrogenated castor oil and is mixed with glyceryl triacetate, (pg. 5, 1st par.). Suspension of hydrogenated castor oil and avermectins show that the more hydrogenated castor oil content in a certain range, the better the sustained-release effect, but when using vegetable oil as a medium, the maximum amount of hydrogenated castor oil in the liquid preparation is about 1%, due to the swelling of hydrogenated castor oil , the formulation became viscous (gel), and even became a semi-solid state. (pg. 3, 1st par.). Glyceryl triacetate is a polyol fatty acid ester, a liquid, oily and somewhat viscous liquid
Wang et al. does not teach a method, comprising contacting the pharmaceutical preparation with a mucous membrane of an animal or/and human body.
Zhang et al. teach sublingual and/or oral mucosal administration. A self-emulsifying pharmaceutical composition, which is a specific composition of cannabinoids in predetermined proportions, which when hydrated forms an emulsion containing a lipophilic drug capable of adhering to mucosal surfaces and allowing the drug to release is controlled. (pg. 2, 7th last par.).
The oral cavity contains teeth and different types of mucosa. The lining mucosa (buccal, sublingual, labial) includes gums, which are gingival mucosa tissues.
https://www.deltadental.com/protect-my-smile/oral-anatomy/anatomy-of-your-mouth-and-throat/
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to prepare a composition of veterinary powder for injection containing drugs in solid dispersion with a hydrogenated vegetable oil or hydrogenated castor oil dissolved and is mixed with polyol fatty acid ester glyceryl triacetate, taught by Wang et al. and the SEDDS are recognized that they adhere to mucosal surfaces and allow the controlled release of drug after sublingual and/or oral mucosal administration, drug adhering to gingival tissue taught by Zhang et al. since they have proven it would improve drug absorption.
Response to Arguments
Rejections Under 35 U.S.C. § 102
Applicant argues that instead of a conventional liquid carrier as used in Wang, the carrier of the present invention is purposely formulated to have a selected gel, semi-solid, or solid state. The selection is controlled by incorporating an amount of a hydrogenated vegetable oil into a polyol fatty acid ester. In practical effect, the hydrogenated vegetable oil functions at least in one aspect as a thickener with respect to the polyol fatty acid ester. The claim recites the relative weight ratio of the components so that the selected state is achieved. The hydrogenated vegetable oil of the claims is formulated as component of the carrier. This right away distinguishes Wang, wherein hydrogenated castor oil firstly is incorporated into powder that is suspended in a liquid carrier. Negative teachings of Wang on Page 3, as discussed further below, would cause the skilled person to avoid using hydrogenated castor oil in the Wang powder in a way that would risk thickening the liquid carrier in which the powder is suspended. Wang talking about a liquid carrier, a liquid state, the intended liquid character of the preparation, and fails to appreciate that the carrier can contribute to sustained release functionality. it can be seen that the veterinary preparation actually prepared in Wang, including hydrogenated castor oil and glycerol triacetate is a liquid solution, liquid emulsion, liquid suspension, liquid emulsion-suspension, or liquid solution-suspension, rather than in a gel state, a semi-solid state, or a solid state.
Applicant’s arguments have been fully considered, but they are not persuasive because a carrier in a formulation is a generally inactive substance (excipient) used as a vehicle to transport, dilute, and distribute an active ingredient. Wang teaches inactive hydrogenated castor oil in the liquid preparation is about 1%, due to the swelling of hydrogenated castor oil, the formulation became viscous (gel), and even became a semi-solid state, so when powder injections are added with a liquid dispersion medium the oil (suspension) agent containing high-concentration hydrogenated castor oil (suspension) for a long time (1-3 months) when the liquid becomes thick and becomes semi-solid, but Wang adds the more hydrogenated castor oil content in a certain range, the better the sustained-release effect, so when using vegetable oil as a medium, even if the content of hydrogenated castor oil reaches more than 10%, the needle passability, motility, and viscosity of the preparation are in a suitable state, and there are no obstacles to administration, and the preparation slow-release fatigue is excellent. In summary, powder injections are added with a liquid dispersion medium to overcome the shortcomings of the oil (suspension) agent containing high-concentration hydrogenated castor oil (suspension) for a long time (1-3 months) when the liquid becomes thick and becomes semi-solid. (pg. 3, 1st par.). Also, the hydrogenated castor oil, a waxy and emollient substance is mixed with a viscous, oily liquid glyceryl triacetate (Triacetin) (pg. 4, 1st par.), and other additives like polyethylene glycol (pg. 10, Claim 6), which can form in-situ gelling state.
Applicant argues that Wang describes a specific composition including a solid dispersion powder including an avermectin-based hydrogenated castor oil (1 :0.3-20, w/w) at 80-100% (w/w), and an additive balanced to 100% (w/w). As formulated, the hydrogenated castor oil is incorporated into a powder with the drug. The hydrogenated castor oil is not formulated into the liquid carrier in order to purposely thicken the carrier to provide a selected gel, semi-solid, or solid state. (Pg. 7, 3rd par.).
Applicant’s arguments have been fully considered, but they are not persuasive because the drug is a solid and hydrogenated castor oil is a waxy emollient substance. It is clearly the solid drug is added into a waxy emollient hydrogenated castor oil and an additive balanced, which Wang teaches triacetin, a viscous oil, to 100%, which would form a solid drug suspended in the gel to semi-solid of triacetin- hydrogenated castor oil.
Applicant argues that Wang does not administer its powder in a solid state. Upon use, the solid dispersion powder is mixed with a liquid dispersion medium to prepare a liquid suspension for subcutaneous administration (Wang, page 5, lines 15-21). On page 5, Wang explains that its liquid dispersions can be hydrophilic or hydrophobic. Wang then provides a laundry list of candidate liquid dispersion media. Liquid vegetable oil and glycerol triacetate are listed. However, this list includes vegetable oil in a liquid state, not as hydrogenated vegetable oil. The main goal of this laundry list is to provide liquid carrier candidates, not thickened liquids
or thickening ingredients to be dissolved in a liquid carrier (pg. 7, 2nd last par.).
Applicant’s arguments have been fully considered, but they are not persuasive because Wang may teach different formulations and different drugs in one prior art. Wang teaches some different drugs and some different formulations and not using hydrogenated castor oil, for example, a mixture of acetal glycerol with 3-10% (W / V) polyvinylpyrrolidone is also a viscous gel and without polyvinylpyrrolidone is a viscous liquid. (pg. 5, 2nd par.) However, Wang teaches the drug is a solid and hydrogenated castor oil is a waxy emollient substance. It is clearly the solid drug is added into a waxy emollient hydrogenated castor oil and an additive balanced, which Wang teaches triacetin, a viscous oil, to 100%, which would form a solid drug suspended in the gel to semi-solid of triacetin- hydrogenated castor oil. (pg. 5, 1st par.). Again, Wang may teach different formulations and different drugs in one prior art, but Wang teaches gel to semi-solid of triacetin- hydrogenated castor oil. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results
Applicant argues that the specific combination of a thickening amount of a hydrogenated vegetable oil and a polyol fatty acid ester is not disclosed or suggested on Wang page 5. Consequently, the content of Wang at page 5 fails to provide any teaching, motivation of suggestion to combine solvent options on page 5 with any thickening ingredient or to even remotely suggest that thickening any of the solvent options is a desired practice in the Wang strategy. Indeed, the emphasis on page 5 that these options are liquids further teaches away from thickening these with any ingredient (pg. 7, last par.- pg. 8, 1st par.).
Applicant’s arguments have been fully considered, but they are not persuasive because of the explanation above.
Applicant argues that at no point does this passage ever teach or suggest that thickening is desired. No nexus of any kind is provided to the prior art powder discussed on page 3. The solvent list on page 5 is used in the Wang preparation, not with the prior art practice on page 3. There is no valid reason why the skilled worker would ever look to powder ingredients in a different prior art embodiment for inclusion in any solvent options on page 5. Ony (?) (Only?) hindsight powers making a combination of unrelated ingredients in unrelated embodiments (pg. 8, 2nd par.).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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 argues that In contrast to the amended claims, page 5 of Wang discloses a powder that includes hydrogenated castor oil and a drug, but the powder does not contain any glyceryl triacetate. The carrier in which the powder is suspended may, as one option, include glyceryl triacetate, but by Wang's definition it must be a liquid. Page 5 on its own fails to reach the amended claims. (pg. 8, 3rd par.).
Applicant’s arguments have been fully considered, but they are not persuasive because of the explanation above.
Applicant argues that The Office Action attempts to cure the deficiencies of Wang page 5 by turning to the background discussion appearing at Wang page 3. It is noted that Wang discloses in its background section that the higher the content of hydrogenated castor oil within a certain range when incorporated into a powder to be suspended in a liquid carrier, the better is the sustained release effect. However, when vegetable oil is used as the medium, the maximum amount of hydrogenated castor oil in the liquid preparation must be limited to about I%, because when excessive, after storage for 1 month, the preparation becomes viscous or even semi-solid due to the swelling of hydrogenated castor oil (specification, the bridge paragraph between page 2 and page 3). The Examiner relies on the thickening of the vegetable oil in the prior art practice as the basis for asserting that Wang discloses the carrier for sustained-release of a drug of claim 1 of the present application, which is in a gel state, a semi-solid state, or a solid state. (pg. 8, 4th par.). The Office Action proposes that the thickening problem occurring on page 3 when too much hydrogenated castor oil is used in a powder suspended in vegetable oil somehow guides the skilled worker to use the same material to purposely thicken glyceryl triacetate on page 5 of Wang. (pg. 8, 2nd last par.).
Applicant’s arguments have been fully considered, but they are not persuasive because Wang also teaches when the powder injection of the present invention is added with vegetable oil, even if the content of hydrogenated castor oil reaches more than 10%, the needle passability, motility, and viscosity of the preparation are in a suitable state. Therefore, there are no obstacles to administration, and the preparation slow-release fatigue is excellent. (pg. 3, 1st par.). Again, one with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things.
Applicant argues that Wang fails to disclose polyol fatty acid ester, but rather discloses vegetable oil instead. In other words, the background section of Wang fails to disclose a viscous or even semi-solid preparation including both hydrogenated castor oil and polyol fatty acid ester. In the meantime, lines 15-21 in page 5 of the specification of Wang discloses a liquid suspension including hydrogenated castor oil and polyol fatty acid ester (glycerol triacetate ), but fails to disclose a viscous or even semi-solid preparation including both hydrogenated castor oil and polyol fatty acid ester. Thus, claim 1 is at least novel upon Wang as "each and every element
of the claimed invention" must be disclosed either explicitly or inherently, and the elements must
be "arranged or combined in the same way as in the claim." (pg. 9, 3rd par.).
Applicant’s arguments have been fully considered, but they are not persuasive because the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. As Wang does not teach monoglyceride of caprylic acid or glyceryl monocaprylate. Instead Kim teaches it in claims 1 and 5. Please see the rejection of claims 1 and 5.
Applicant argues that, in contrast, page 5 discusses a formulation intended to be part of Wang's invention. The two passages describe completely different embodiments, one being a problematic prior art approach, and the other being liquid carrier options for use in the Wang preparation. It is fundamentally improper to fortuitously pick and choose individual features from different, unrelated embodiments in order to reconstruct the claimed invention. It is even more improper when one of the embodiments is a criticized practice of the prior art. (pg. 9, 2nd last par.). It is true that Wang warns that storage is problematic if too much hydrogenated castor oil is used. After storage for 1 month, Wang warns that excessive hydrogenated castor oil cause the preparation to become viscous or even semi-solid due to the swelling of hydrogenated castor oil (specification, the bridge paragraph between page 2 and page 3). The swelling according to Wang makes it difficult for the suspension to be withdrawn from a container to complete an iniection procedure. (pg. 9, last par.). Also, arguments not reciting here on pg. 10-12, all pars.
Applicant’s arguments have been fully considered, but they are not persuasive because these arguments are already explained above.
Rejections Under 35 U.S.C. § 103
Applicant argues that, in Claims 1 and 5, even if Kim is combined with Wang in the proposed manner, the deficiencies of Wang discussed above are not cured. Kim discloses a self-emulsifying drug delivery system including dutasteride, PEG-40 hydrogenated castor oil, mono- or di-glycerides of caprylic/capric acid (claims 1 and 3 of Kim). However, Kim also fails to disclose a gel state, semi-solid state, or solid state preparation or carrier. Thus, Kim in view of Wang still fails to teach or suggest "a carrier for sustained-release of a drug, wherein the carrier is in a gel state, a semi-solid state, or a solid state, ... " as required by claim 1PEG-40 hydrogenated castor oil or PEG-50 hydrogenated castor oil are not hydrogenated castor oil. (pgs. 13-14).
Applicant’s arguments have been fully considered, but they are not persuasive because the arguments are not persuasive as explained above. Kim is not curing Wang. The basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. Wang teaches hydrogenated castor oil and gel state. Kim is added to teach monoglyceride of caprylic acid or glyceryl monocaprylate. Kim teaches a PEG-50 hydrogenated castor oil (HCO-50), a hydrogenated castor oil employed as a surfactant. Kim et al. improve dissolution stability of dutasteride by employing a hydrogenated castor oil with appropriate degree of substitution. Even though Kim is not added to teach gel state, but Kim states the SEDDS and provides drug release for longer than 6 months of in Fig. 1, which indicates it is a viscous formulation for long term release. A self-emulsifying drug delivery system (SEDDS) can be engineered to be viscous or to form a gel in situ (upon contact with gastrointestinal fluids) to achieve specific drug release profiles, such as sustained release or enhanced bioadhesion.
Applicant argues that, in claims 1 and 14-15, Zhang discloses a cannabidiol solid self-emulsifying preparation including a cannabidiol self-emulsifying delivery system and a solid carrier ( claims 1 and 4 of Zhang). However, as discussed above, Wang teaches that the preparation becoming viscous or even semisolid is an unwanted situation, i.e., such a viscous or even semi-solid preparation is infeasible and should be avoided. Thus, Wang actually teaches away from the solid preparation of Zhang. Thus, the combination of Wang and Zhang in such a way as to reach claim 1 is not obvious to the skilled person in the art. nowhere in Wang itself mentions that its veterinary preparation is a SEDDS. Although Wang mentions that the adjuvants include an emulsifier OP, this does not indicate that the preparation of Wang satisfies the characteristic feature that "the free energy required for emulsification is very low, and the system spontaneously forms an oil-in-water emulsion with emulsified particles smaller than 5 μm under mild stirring in a 37°C water bath in vitro or under gastrointestinal peri stalsis." The disclosures of Wang, Zhang and GB2380129A cannot prove that the veterinary preparation of Wang is a SEDDS.
Applicant’s arguments have been fully considered, but they are not persuasive because Zhang is added to teach the pharmaceutical preparation with a mucous membrane of an animal or/and human body and wherein the mucous membrane is the sublingual and/or oral mucosal administration. Again, the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. Also, as explained above, there is no problem with Wang’s teachings, so Wang’s teachings should have no problems either. And also, as explained to Kim, a self-emulsifying drug delivery system (SEDDS) can be engineered to be viscous or to form a gel in situ (upon contact with gastrointestinal fluids) to achieve specific drug release profiles, such as sustained release or enhanced bioadhesion. In the NFR Zhang’s teaching is added to teach mucous tissues, even though Zhang may teach more and other things. About Zhang’s SMEEDs: in short, Zhang teaches formulation of cannabidiol, oil phase, of emulsifier, and co-emulsifier. (pg. 2, 3rd last, 2nd last and last pars; and pg. 3, pars 1-4). They are a combination of drug, oil, emulsifier and co-emulsifier; with the list of oils, emulsifiers and co-emulsifiers (pg. 3, pars 5-8), so they are SEDDS.
Applicant argues that, The disclosures in Wang, Zhang and GB2380129A cannot prove that the veterinary preparation of Wang is capable of being administered through the sublingual and/or oral mucosal surface. Furthermore, the purpose of administration through the mucosal surface in GB2380129A is to solve the problem that "this first pass through the liver may result in the removal of a substantial proportion of an ingested medicament. The first pass effect is more pronounced for some drugs than others; in the case of cannabinoids more than 90% of an ingested dose is removed during the first pass" (lines 20-25 of page 1 of the specification of GB2380129A). However, the drug in Wang is not a cannabinoid. The preparation of Wang is used for the prevention and treatment of parasites in animals, with administration routes being subcutaneous injection or intramuscular injection, and also oral administration (the abstract of Wang). There is no evidence showing that the veterinary preparation of Wang can achieve parasite prevention and treatment effects through sublingual and/or oral mucosal administration.
Therefore, upon the teachings of Wang, Zhang and GB2380129A, the person skilled in the art
cannot be suggested to administrate the veterinary preparation of Wang through the sublingual
and/or oral mucosal surface. Accordingly, claim 14 is also unobvious over Wang in view of Zhang. At least for reasons similar to those given above, claims 19 and 20 are also novel and
unobvious over the cited references taken alone or in combination, and thus are patentable.
Applicant’s arguments have been fully considered, but they are not persuasive because the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things. Wang, Kim or , each teaches many things and different things, but one with skill in the art would select parts they need to combine to get the final better results they want. Zhang teaches Patent document GB2380129 A discloses a self-emulsifying pharmaceutical composition, which is a specific composition of cannabinoids in predetermined proportions, which when hydrated forms an emulsion containing a lipophilic drug capable of adhering to mucosal surfaces and allowing the drug to release is controlled. Due to sublingual and/or oral mucosal administration placement, various viscous agents and adhesives are added to the self-emulsifying pharmaceutical composition, so that the drug release time is long.
Conclusion
Applicants' 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 extension fee 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 date of this final action.
Correspondence
No claim is allowed
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615