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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/12/2025 has been entered.
The office acknowledges Applicants filing of the amended claims and arguments dated 7/12/2025. Claim 15 has been amended. Claims 28-33 has been added new. Applicants arguments have been fully considered but found not to be persuasive. The arguments are addressed below. In light of the amendments, modified and new rejections are presented in this action. The action is made non-final. Claims 15, 25-33 are pending and are examined based on the merits herein.
Response to Applicants arguments
rejections:
Document D1, Kim (US 20080200543), Ghoreschi et al./Kim, Sang-Hee
Applicants argue that the cited documents whether considered alone or in combination clearly fail to teach or suggest Applicant's claimed subject matters. The cited internet link is not understood and does not disclose psoriasis. The cited internet link has no verification of date of material and is not a proper citation. Kim (US 20080200543A1) and Kim; Sang-Hee (US 20080200543) do not disclose psoriasis of any type, much less a mammalian subject as suffering from psoriasis and exhibiting keratosis and/or epidermal hyperplasia as recited in Applicant’s claims. Further Applicants discuss the disclosed in vivo data (Example 2, Fig. 3A, Example 4, Fig. 5). Applicants further argue that the Ghoreschi et al. document is remote and does not disclose Applicant’s compound of Formula 2.
In response, It is noted that the cited reference has been provided by the Applicants as incoming written opinion of the international searching authority (ISA) dated 04/17/2019 (English translation D1: Patent and Clinical Trial Record of Immunoregulatory Treatment ROCKPID, Nov. 26, 2014, labelled as D1). The written opinion in the international preliminary report on patentability clearly states that,
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Hence from such teachings one of ordinary skill in the art would have found it obvious to use compound Formula 2 of the instant claim 15 (which is EC-18 of Document D1 compound) in psoriasis treatment. As to the argument that the cited internet link is not understood and does not disclose psoriasis and it is not a proper citation, it is suggested that Applicants provide a copy of the document (English translation) to provide evidence that it does not teach the claimed subject matter. It is well established that the arguments of counsel cannot take a place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
The prior art reference above clearly teach and suggest the use of EC-18 for treating psoriasis. Kim as cited below teach the same compound, EC-18 as an immunomodulating compound useful for stimulating secretion of IL-4 in T cells and use of EC-18 in human subjects. Ghoreschi has been cited to teach the use of IL-4 therapy in psoriasis. As cited below Avelar Pires teach keratosis and hyperplasia are associated with psoriasis. In other words they are subtypes of psoriasis. From the combined teachings of the prior art a person of ordinary skill in the art before the effective filing date of the invention would have found it obvious to identify subjects with psoriasis associated with keratosis and hyperplasia by histopathological examination to diagnose the medical condition, e.g. psoriasis and administer an effective amount of compound of formula 2 (0.18 g or 2 g/day) (EC18). Document D1 is explicit in teaching that EC-18 can be used for psoriasis condition, a person of ordinary skill in the art would have found it obvious to try administering EC-18 in any subject with psoriasis including subjects with keratosis, severe keratosis and hyperplasia in expectation of achieving reasonable expectation of success. A person of ordinary skill in the art would have been motivated to arrive at the claimed method with a reasonable amount of success and provide therapeutic benefits in treating psoriasis and its symptoms. As to applicants’ arguments in regards to in vivo data (mice model), it is noted that administration of the effective amount of the same compound EC18 to human subjects with psoriasis (e.g. with keratosis) from the combined prior art teachings would result in similar therapeutic effects. The claimed method would have been obvious over the prior art teachings for the reasons in the rejection below.
CN1408406/Kim and Sang-Hee: It is noted that no rejections have been made over these references.
Kim (WO 2015/034247, hereinafter Kim ‘247) in view of FirstReport:
Applicants argue that Kim et al. does not disclose psoriasis of any type, much less a mammalian subject suffering from psoriasis and exhibiting keratosis and/or epidermal hyperplasia as recited in Applicant’s claims. The First Report document is also report and discloses neither psoriasis of any type nor a compound of Formula 2 as Applicant discloses and claims. The cited documents clearly do no discloses or suggest treating a subject suffering from psoriasis and exhibiting keratosis and/or epidermal hyperplasia as Applicant discloses and demonstrate in the examples of the application. Applicant also directs attention to the extensive in vivo data set forth in the application as filed which fully rebuts any prima facie case that may be contended to exist.
In response, Kim ‘247 teach compound of formula 2 (the same compound as in the instant claims) for treating a skin condition, e.g. atopic dermatitis and in the dosage amount of 0.001 to 1000 mg/kg. The First Report document is explicit in teaching that psoriasis and atopic dermatitis are autoimmune skin diseases and the common symptoms includes itchy scaly patches in scalp. From the teachings of the prior art a person skilled in the art would have arrived at using the compound of formula 2 in treating the symptoms of itchy scaly patches in psoriasis subjects. As to applicants’ arguments in regards to in vivo data (mice model), it is noted that administration of the effective amount of the same compound EC18 to human subjects with psoriasis (e.g. with keratosis) from the combined prior art teachings would result in similar therapeutic effects. The claimed method would have been obvious over the prior art teachings for the reasons in the rejection below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15, 18, 20, 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Document D1 (Incoming Written Opinion of ISA report, provided by the Applicants, Patent and Clinical Trial Record of lmmunoregulatory (Treatment ROCKPID, Nov. 26, 2014, reference has not been provided, labelled as D1) in view of Avelar Pires (An Bras Dermatol. 2014;89(2):318-9), Kim (US 20080200543 A1) and Ghoreschi et al. (Nature Medicine, 9, 1, 2003, p 40-46).
Document D1 teaches that EC-18 or 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol prevents not only rheumatoid arthritis, but also allergic atopy, nasal discharge, rhinitis, asthma, psoriasis, and the like. It is noted that EC-18 is the same compound of formula 2 of instant claim 15.
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(See Incoming ISA written opinion report, provided by the applicant).
Document D1 is not explicit in teaching identification of the subjects exhibiting keratosis and/or epidermal hyperplasia and administering the human (mammalian) subject with compound of formula 2.
Avelar Pires relates to the case report of a patient with psoriasiform keratosis. The reference teach keratosis and hyperplasia are associated with psoriasis. Further taught is that histopathological examination revealed sections of skin showing epidermis with pronounced psoriasiform hyperplasia associated with hyperkeratosis (see p 318, col. 1, last line to col.2, lines 1-3).
Kim explicitly teach mono acetyl diacyl glycerol derivatives extracted from deer antler for its use as immunomodulating agent (Abstract). Kim teach formula 2 compound, in [0009].
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It is noted that this is the compound as in the instant claim 15. Kim teach that immune regulators can remedy diseases such as skin disease [0003]. Also taught is the method of stimulating secretion of cytokines, e.g. IL-4 in T cells (see claims 14-16). Kim teach the mono acetyl diacyl glycerol derivatives can be provided as health food and the intake might be 0.18- 9.0 g/day and the formulation includes tablets and capsules [0094].
Ghoreschi teach that psoriasis is an inflammatory disease of the skin and small joints that seriously impairs quality of life in 2% of the population and further discusses the use of interleukin-4 therapy in human subjects (See p 40, col. 1, lines 1-2, also Abstract). Further taught is that the symptoms include lesions (table 1).
From the combined teachings of the prior art a person of ordinary skill in the art before the effective filing date of the invention would have found it obvious to identify subjects with psoriasis associated with keratosis and hyperplasia and administer an effective amount of compound of formula 2 (EC18) because (i) Document D1 teach the use of the same compound EC-18 as in instant claim 15 for use in psoriasis (ii) Avelar Pires a person of ordinary skill in the art would have found it obvious to identify human subjects by histopathological examination for diagnosis of psoriasis associated with keratosis and hyperplasia; it is noted that subjects with psoriasis associated with keratosis and hyperplasia are subset of population with psoriasis (iii) Kim teach that EC18 compound is useful for stimulating secretion of IL-4 in T cells and can be administered to human subject(s) (iv) Ghoreschi teach the use of IL-4 therapy in psoriasis. It is obvious from the above teachings that a skilled artisan or a physician would identify the human subject with psoriasis associated with keratosis or hyperplasia (as part of diagnosis) and administer the compound of formula 2 to such patients to derive therapeutic effects. From Avelar Pires, it is obvious that the patient with psoriasis is human (mammalian). From Kim and/or Ghoreschi it is obvious that the subject to be treated for psoriasis include human(s). Further as Document D1 teach use of EC-18 in psoriasis, from such teachings a person of ordinary skill in the art would have found it obvious to try administering EC-18 in any subject with psoriasis including subjects with keratosis, severe keratosis and hyperplasia in expectation of achieving reasonable expectation of success. A person of ordinary skill in the art would have been motivated to arrive at the claimed method with a reasonable amount of success and provide therapeutic benefits in treating psoriasis and its associated subtypes. As to the effective amount one of ordinary skill in the art would have found it obvious from Kim to administer an amount of 0.18-9.0 g/day of EC-18. For example if 0.18 g of EC-18 is administered to an average adult weighing 70 kg, the dosage amount would be 2.57 mg/kg. Document D1 is explicit in teaching that EC-18 can be used for psoriasis condition, a person of ordinary skill in the art would have found it obvious to try administering EC-18 in any subject with psoriasis including subjects with keratosis, severe keratosis and hyperplasia in expectation of achieving reasonable expectation of success. Thus claims 15, 28 are addressed by the combined prior art teachings.. As to claims 25-27, 29-31, Avelar Pires teach keratosis and hyperplasia are associated with psoriasis. A person skilled in the art would have found it obvious to try administering EC-18 in any subject with psoriasis including subjects with keratosis, severe keratosis and hyperplasia in expectation of achieving reasonable expectation of success.
Regarding claims 32-33, a person of ordinary skill in the art would have found it obvious to administer 2 g of EC-18 from Kim’s teaching as Kim teach the mono acetyl diacyl glycerol derivatives can be provided as health food and the intake might be 0.18- 9.0 g/day. It is within the skill of a physician to routinely optimize the dosage amount based on weight, disease severity, age etc. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 15, 18, 20, 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2015/034247 A1, published 12.03.2015) in view of FirstReport (https://www.hmpgloballearningnetwork.com/site/frmc/article/autoimmune-diseases-psoriasis-and-atopic-dermatitis, Oct 2016) and Avelar Pires (An Bras Dermatol. 2014;89(2):318-9),
Kim teach monoacetyldiacylglycerol compound as an active ingredient for treating atopic dermatitis (abstract, claims 1, 4, 14). Kim is explicit in teaching the following monoacetyldiacylglycerol compound, compound of formula 2 for use in the method of treating atopic dermatitis (see claim 4, also p 4, lines 7-9).
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Kim teach that EC-18 is a type of monoacetyldiacylglyceride and has been isolated from deer antler (see p 3, line 21). The compound represented by chemical formula 2 is called 1-palmitoyl-2-linoleoyl-3-acetylglycerol, and is referred to herein as PLAG or EC-18 (see p 4, lines 10-12). Kim teach that the active ingredient can be formulated as powder, gel, cream etc. (see p 7, lines 22-24). Also EC-18 is useful for patient with mild skin rashes (see p 8, line 17, example 5, p 11). Kim further teach that the method of treatment include administering a pharmaceutical composition comprising the monoacetyldiacylglycerol compound of Formula 1 in a pharmaceutically effective amount; suitable total daily doses may be determined by the practitioner within the correct medical judgment and are generally in amounts of 0.001 to 1000 mg/kg, preferably 0.05 to 200 mg / kg, more preferably 0.1 to 100 mg and the amount may be administered once to several times daily. The specific therapeutically effective amount can be achieved depending on various factors such as age, weight, diet, route of administration etc. (see p 8, last four lines to page 9, lines 1-4).
Kim is not explicit in teaching the use of compound of chemical formula 2 in psoriasis as claimed.
First Report teach that psoriasis and atopic dermatitis are autoimmune skin diseases (See Title, p 1, Psoriasis, line 1, p 3, Atopic dermatitis, line 1). Psoriasis symptoms include patches of abnormal skin that are red, itchy and scaly and appears on the scalp, knees, elbows, hands and feet (see p 1, Psoriasis, lines 3-5). Atopic dermatitis condition presents itchy, dry red scaly patches on the skin and these itchy patches generally appear on the face, forehead, and scalp, but can also be present anywhere on the body (see p 3, lines 3-5). The reference also discusses regarding participant surveys (with human patients with psoriasis and atopic dermatitis) (See p 1-3).
Avelar Pires relates to the case report of a patient with psoriasiform keratosis. The reference teach keratosis and hyperplasia are associated with psoriasis. Further taught is that histopathological examination revealed sections of skin showing epidermis with pronounced psoriasiform hyperplasia associated with hyperkeratosis (see p 318, col. 1, last line to col.2, lines 1-3).
From the teachings of the prior art a person of ordinary skin in the art before the effective filing date of the invention would have found it obvious to arrive at the claimed method because (i) First Report teach that both psoriasis and atopic dermatitis are autoimmune skin diseases and the common symptoms includes itchy scaly patches in scalp (ii) Avelar Pires teach histopathological examination revealed sections of skin showing epidermis with pronounced psoriasiform hyperplasia associated with hyperkeratosis. The reference teach keratosis and hyperplasia are associated with psoriasis (iii) Kim teach that EC-18 (1-palmitoyl-2-linoleoyl-3-acetylglycerol) is useful for treating atopic dermatitis. From the teachings of the prior art a person skilled in the art would have found it obvious to try using chemical formula 2 compound (EC-18) of Kim that has been shown to be useful for one skin condition, atopic dermatitis to use in the treatment of another skin condition, psoriasis. It is obvious from the above teachings that a skilled artisan or a physician would identify the human subject with psoriasis associated with keratosis or hyperplasia (as part of diagnosis) and administer the compound of formula 2 to such patients to derive therapeutic effects. From Avelar Pires, it is obvious that the patient with psoriasis is human (mammalian) and the subjects of Kim include human. A person of ordinary skill in the art would have found it obvious to administer EC-18 in an amount of 0.001 to 1000 mg/kg per day for the treatment of psoriasis from Kim’s teachings and this falls within the amounts taught by the instant specification as the effective amount. A person of ordinary skill in the art would have been motivated to use EC-18 for psoriasis to obtain therapeutic benefits in psoriasis subjects. Thus claims 15, 28 are addressed. As to claims 25-27, 29-31, Avelar Pires teach keratosis and hyperplasia are associated with psoriasis. A person skilled in the art would have found it obvious to try administering EC-18 in any subject with psoriasis including subjects with keratosis, severe keratosis and hyperplasia in expectation of achieving reasonable expectation of success. Regarding claims 32-33, a person of ordinary skill in the art would have found it obvious to administer, for example 2 g of EC-18 to a subject with psoriasis from the prior art teachings.
Conclusion
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627