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 1/10/24 was submitted 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 § 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) 1-3, 6-10, 13, 28, 29, 32-34, 38, 39, 41 and 50 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Kulkarni et al (WO 2017/122161 A1 hereafter Kulkarni).
Kulkarni teaches a composition for intranasal administration comprising an API, benzalkonium chloride and propylene glycol [Example 1]. The dosage form is a solution (Examples). The formulation comprises benzalkonium chloride at a concentration up to 0.5 w/w [Example 1]. The formulation further comprises a pH modifier (pg. 10, lin. 24-30). The API is a painkiller such as sumatriptan (pg. 11, lin. 3-5; claims). The reference discloses a method for treating migraines with the intranasal formulation (abstract, claims). The formulation also discloses a kit comprising the formulation that treats migraines (claims). These disclosures render the claims anticipated.
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) 1-13, 26-41, 49 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over the disclosures of Kulkarni et al (WO 2017/122161 A1 hereafter Kulkarni).
As discussed above, Kulkarni discloses an intranasal formulation comprising an API, benzalkonium chloride, propylene glycol and pH adjusters. The formulation is applied in a method for treating migraines. The formulation however exemplifies different ranges for the components. The reference discloses that the active agent can be present at concentrations of 50%, 25%, 12.5% and 5% where these are all found to be effective (pg. 8, lin. 25-31). The reference discloses that the propylene glycol is present at a concentration of about 20% (Example 1). Those of ordinary skill in the art would have been motivated to optimize the concentrations through routine experimentation in order to produce a safe and stable formulation for treating migraines.
Regarding the Cmax f the administered formulation, the reference compares the intranasal to the oral dosage form, with the Cmax of the intranasal presentation being more than 1.5 times that of the oral formulation (pg. 18, lin. 20-35). The intranasal formulation comprises flux enhancers for crossing the blood brain barrier, however it is unclear if the oral formulation lacks the BZK and PPG as recited in the claims. However, as the formulation of Kulkarni would have the same compositional components as the instant claims, it would have been expected for the composition to behave in the same way. Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) .
Further, The Office does not have the facilities for examining and comparing applicant’s product with the product of the prior art in order to establish that the product of the prior art does not possess the same material structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
With these aspects in mind it would have been obvious to follow the teachings and suggestions of The Kulkarni formulation to produce stable intranasal formulation useful in treating migraines. It would have been obvious to modify and optimize the dosage for of Kulkarni in order to produce a stable and fast acting formulation as these modification would have been within the skill of those or ordinary skill in the art. One of ordinary skill in the art would have been motivated to modify and optimize the prior art with an expected result of a stable migraine treating nasal spray.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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