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 .
Election/Restrictions
PNG
media_image1.png
68
614
media_image1.png
Greyscale
Upon further considerations pending claims 2, 4, 6-9, 11-13, 15-17, 19, 22-29, 31-40 are examined together
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.
Claim(s) 2, 4, 6-9, 11-13, 15-17, 19, 22-29, 31-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besidski WO2007/073303; Quding PAIN, vol. 154, no. 6, 19 February 2013, pages 808-812; Rowen US9757401; Fracassi US10588871; and Barr US6653352.
Besidski the active ingredient of compound of the instant claim at page 60 top on the list Entry #52 (Besidski claims 1,and claim 25selection from a single list) in a pharmaceutical composition (claim 28) suitable for topical administration to treat pain (see Besidski page 19 for topical administration e.g. as an ointment, patch or cream). Besidski teaches use to treat ‘pain’ occurs more 60 times. This compound is AZD1386 as admitted to in specification page 2. Quding teaches the TRP activity of AZD1386 and its use for treating pain after tooth extraction. Quding does not teach for topical use.
As such base method claim 2 limitations are found in the above teachings.
Limitations of (dependent) claims 4, 6-9, 11-13, 15-17, 19, 22-29, 31-40 (methods and compositions) are drawn to amount (W/W 4, 11) of the active ingredient, topical use, surface applied (6-9 ), excipients such as penetration enhancers (9, 11), solubility enhancers (12, 13, 15), sequestering agents (19, 29) ratios/amount of these (16) generically, specifically (17, 19) and specific pain (34) in the method claims and in the corresponding composition (claims 22-29, 31, 32, 33 40). These features (common pharmaceutical excipients, choice of excipients content) in topical creams are routinely used and are within the repertoire of one the skilled person in the art engaged in arriving at new formulations of pharmaceutically active old compounds. For example, see Rowen section under Description and Claims which teaches transient receptor (TRP) modulator compound compositions for topical administration with recited excipients:
PNG
media_image2.png
472
830
media_image2.png
Greyscale
Likewise, see Fracassi section under claims 1, 9, 12-14 and 18-19 for topical formulation (gel, cream, sequestering agent etc.).
See Barr section under claims for patch cream formulation for (different) pains for skin, solubility agents.
Neuropathic pain market size is about 10 billion US $ as per Applicant provided NPL#16 in IDS 09/04/2024 .
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant active ingredient and excipients for their known benefit since each is well known in the art for their beneficial properties. Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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).
Therefore nothing unobvious is seen in the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Prosecution Insights