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 information disclosure statement (IDS) submitted on 12/20/23, 11/14/25, 02/12/26, 5/19/26 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-15 and 20-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Kishore et al (US 2018/0214450 A1 hereafter Kishore) in view of Kraus (EP 3 226 904 B1 hereafter Kraus) and Garnon et al Fragile X Related Protein FXR1P Regulates Proinflammatory Cytokine Tumor Necrosis Factor Expression at the Post Transcription Level; The Journal of Biological Chemistry, vol. 280, No. 7, Issue of February 18, pp. 570-5763, 2005).
Kishore discloses a method of treating a subject diagnosed with carious conditions including post-traumatic stress syndrome or autism spectrum disorder with a formulation comprising ticagrelor [abstract, 0069]. The conditions including elevated TNF-alpha [0068-0069]. The dosage form can be oral or a in the form of an emulsion or microemulsion [0136].
While Kishore discloses a ticagrelor formulation including an emulsion, however the reference is silent to the specific administration steps of claims 3. These administration steps are known in the art as seen in the Kraus.
Kraus discloses a formulation comprising a first container comprising an oil/surfactant/cosurfactant mixture and a second container comprising an aqueous solution [0048-0051]. The formulation is present as a liquid lipid nanocarrier emulsion comprising oil nanoparticles suspended in an aqueous phase [0059-0061]. The administration can take place with a dual chamber injector [0086-0090]. The formulation comprises lecithin [0052]. The oil can be a triglyceride [0072], the surfactant can be a polysorbate or sorbitan and cosurfactant such as propylene glycol [0052-0056]. The oil is present from 1-25%, the surfactant and cosurfactant are present 1-2% [0055-0056]. It would have been obvious to combine the nanoemulsion of Kraus with the ticagrelor of Kishore as they solve the same problem of delivering active agents with emulsions.
With regard to the length of treatment and pharmokinetics of the dosage form, it is the position of the Examiner that such limitations would be determined through routine experimentation by those of ordinary skill in the art. Kishore analyses plasma concentrations for ticagrelor for up to 14 days to find the optimum dosage amount for the oral dosage form [Figure 5B]. These determinations are routine in determining a proper treatment regimen as various concentrations are tested over time [Figures 5, 5A]. 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
Regarding the treatment of Fragile X Syndrome, and elevated cytokine conditions, it is the position of the Examiner that since such conditions are related to increased TNFα inflammation, a diagnosis for related TNFα conditions such as autism spectrum disorder, anxiety, diabetes and the like would also cover treatments for these other conditions.
Garnon establishes that the same Fragile X related protein FXR1P also plays a role in regulating TNF expression such that the decreases in expression corresponded to a decrease in TNF production [abstract]. As TNFα is a pro-inflammatory cytokine, methods for treating elevated TNFα would also be useful against related conditions including Fragile X syndrome and elevated cytokine neuroinflammation It would have been obvious to treat these conditions with the combination of the prior art as they solve the same problem. It would have been obvious to combine the prior art with an expected result of a stable method for treating various conditions with an oral ticagrelor formulation.
It would have been obvious to combine the prior art with an expected result of a stable method for treating various conditions with an oral ticagrelor formulation. It would have been obvious to apply the specific emulsion formulation of Kraus to the suggested emulsion of Kishore as they solve the same problem of drug delivery with emulsion formulations. It would have been obvious to optimize these treatments to maximize their effectiveness as seen in Kishore and apply them to treat a variety of related conditions related to elevated TNFα levels in a patient as the same mechanism is relate to several conditions including autism spectrum disorder anxiety, fragile X syndrome and other as seen in Garnon. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable treatment method for various TNFα conditions.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Kishore et al (US 2018/0214450 A1 hereafter Kishore) in view of Kraus (EP 3 226 904 B1 hereafter Kraus) as applied above in further view of Sinha et al (US 2008/0254036 hereafter Sinha).
As discussed above the combination of Kishore and Kraus discloses a method of treating various conditions including PTSD and TNF disorders comprising administration of a liquid lipid nanocarrier system comprising ticagrelor and at least lecithin as a second compound in the formulation. The nanoemulsion comprises an oil/surfactant/cosurfacant mixture and an aqueous phase. The combination is silent to the ions of the instant claims, however citrate ions can be included in the formulation of Kraus. The inclusion of specific ions in ticagrelor formulations is known in the art as seen in the Sinha patent.
Sinha discloses a formulation comprising ticagrelor in the form of an emulsion [0023, 0050, 0095, 0146]. The formulation further comprises ions in the form of salt carrier for the ticagrelor including magnesium, zinc, arginine and lysine [0031, 0038]. The formulation further comprises surfactants like propylene glycol [0147]. It would have been obvious to include the ions of Sinha into the formulation of Kishore in order to improve the solubility of the ticagrelor.
With these aspects in mind it would have been obvious to combine the prior art in order to produce a means to treat various conditions with ticagrelor. It would have been obvious to include the carrier ions of Sinha to the combination of Kishore/Kraus in order to improve the solubility of the ticgrelor. The combination would have been obvious as they prior art solve the same problem of delivering ticagrelor to the body. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a method for treating PTSD.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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