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 .
Acknowledgment of Papers Received: Amendment/Response dated 3/31/26.
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, 26-37, 41 and 49-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Kulkarni et al (WO 2017/122161 A1 hereafter Kulkarni) in view of Horn et al (US 2012/0156244 A1 hereafter Horn).
Kulkarni discloses 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).
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). Lower concentrations of the propylene glycol solvent are known in the art as seen in the Horn patent.
Horn discloses an intranasal formulation comprising painkiller active agents such as sumatriptan [claims 8]. The formulation comprises solvents such as water and propylene glycol, present at 2% [0109]. The intranasal formulation is a nasal spray [Tables]. Horn establishes the level of skill in the art regarding the concentration of solvents and it would have been obvious to apply these concentrations to Kulkarni in order to produce a stable formulation.
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. Horn establishes the level of skill in the art regarding the concentration of propylene glycol as a solvent components and it would have been obvious to apply the compounds in these concentrations as it provides a stable formulation. It would have been obvious to modify and optimize the dosage of Kulkarni as seen in Horn 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13, 26-37, 41 and 49-53 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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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