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 .
Previously presented double patenting rejection is overcome by the approved terminal disclaimers.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tachibana US 20230128162 = US 12559474= US Application 17790358; Unoh, bioRxiv (2022), 1-52 and Sun Int J Nanomedicine 2012 Nov 12;7:5733–5744, Zhao, Rev Bras Farmacogn 24(2014): 584-590; Wang, Pharmaceutics 2022, 14, 1901.
The references of Tachibana and Unoh predates the instant priority date as explained below:
The priority date for 17790358 is
PNG
media_image1.png
84
382
media_image1.png
Greyscale
Unoh date of
PNG
media_image2.png
99
644
media_image2.png
Greyscale
The priority date for instant case is
PNG
media_image3.png
116
630
media_image3.png
Greyscale
Tachibana teach at published application 20230128162 page 362 column B
PNG
media_image4.png
432
351
media_image4.png
Greyscale
At sheet 3 of 15 Tachibana crystal shows the diffraction pattern
PNG
media_image5.png
350
652
media_image5.png
Greyscale
At sheet 3 of 4 of instant claim crystal shows the diffraction pattern
PNG
media_image6.png
290
546
media_image6.png
Greyscale
Unoh also teach fumaric crystal of the compound at page 16 just below the Figures.
Given the error rate and peak positions, the crystal of Tachibana is the same as the instant crystal. s
The properties of the compound of Tachibana and Unoh (co-author Tachibana) and its disclosed property and use is the same as the instantly pictured compound and its intended use are the same.
The difference is the limitation with respect to particle size of the compound and method of making it (by pulverizing the crystal).
The teachings of Sun, Zhao and Wang are invoked to cure the deficiency of Tachibana and Unoh. Sun teaches the effect of particle size on solubility, dissolution rate, and oral bioavailability.
Zhao, teaches the effect of superfine pulverization on physicochemical and medicinal properties of Qili Powder;
Wang Review (state of the art) teaches Particle Engineering Methods of pulverizing APIs.
Taken together, Sun, Zhao and Wang teach that in the pharmaceutical industry, controlling the D90 particle size—the size below which 90% of the crystal population exists—is critical for ensuring consistent bioavailability, dissolution rates, and manufacturability, particularly for poorly soluble drugs. Size reduction, or pulverization (comminution), is used to achieve target API (Active Pharmaceutical Ingredient) particle sizes, with techniques often resulting in D90 values in the low micrometer or even nanometer range.
Position taken is that pulverizing to desired size claims 1-16, dosing claims 17 and use of known excipients claims 18-20 are routinely used methods known to one of skill in the art of pharmaceutical art. For example, not in the rejection statement references (to avoid clutter) Marriott, Pharmaceutical Compound and Dispensing, Second Edition, 2010, 1-288 and Ansel, Pharmaceutical Dosage Forms and Drug Delivery Systems, 1999 and . 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).
The limitations of the crystal with respect to crystallinity and the intended method of its are known in the teachings of Tachibana and Unoh; optimization of paratactical properties such as bioavailability by arriving at desired particle sizes by pulverization are known in the art.
As such nothing unobvious is seen in the claims.
THIS ACTION IS MADE FINAL. 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 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