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 .
18202567
Election/Restrictions
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100
354
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cannabidiol
Contrary to Applicants belief, claims 77, 78, 79, 80-85 do not read on the elected species. As such claims 73-76, 86-92 are examined.
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.
Claims 73-76, 86-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez, International Journal of Pharmaceutics, 2020, Vol 574, 118916, 1-12 Available online 4 December 2019; FSanchez, European Journal of Pharmaceutics and Biopharmaceutics, 2020, Vol 154, 246-258; Zohar, WO2020194237; Haghiralsadat, Cell Journal, Vol 19, Suppl 1, Spring 2017; Singh, Research in Pharmaceutical Sciences, October 2010; 5(2): 65-77; US 8455477 and c US 8048888.
Sanchez titled “CBD loaded microparticles as a potential formulation to improve paclitaxel and doxorubicin-based chemotherapy in breast cancer'.
At page 118916 column A, just above Materials and Methods Sanchez teaching is drawn to the activity of CBD (claim 73) in solution and encapsulated (claims 74, 86) in PLGA-microparticles, designed for parenteral administration, when combined with paclitaxel or doxorubicin (claim 75) in breast cancer cells in order to obtain a possible synergistic effect (claim 92), being a first in vitro approach to the advantages of including CBD formulations in standardised chemotherapy regimens.
Sanchez discloses formulations for treating breast cancer comprising cannabidiol polymeric microparticles combined with anti-cancer agents such as paclitaxel (PTX) and doxorubicin (DOX) (see Abstract; pages 2, 2.2.3 and 2.4.2), wherein the formulation is administered to CAM tumor animal models (see pages 10, 3.5).
FSanchez titled 'Enhancing ovarian cancer conventional chemotherapy through the combination with cannabidiol loaded microparticles' discloses combination therapies for ovarian cancer, comprising cannabinoid microparticles and anti-cancer drugs such as, paclitaxel, cisplatin, or doxorubicin administered to ovarian cancer cell lines (SKOV-3) (see Abstract; pages 249, 2.4.5 - 2.4.6), and CAM models in in ova studies (see pages 255, 3.4).
Similarly, synergistic combination of the elected species are taught by Zohar, which discloses cannabidiol and doxorubicin administered to non-resistant ovarian cancer cell lines to produce a synergistic anti-cancer effect (OVCAR8) (see pages 20-21, Example 1, [0190]), wherein the agents can be administered in the form of capsules, syrups or tablets (see pages 18, [O101]), and kits thereof (pages 30, Claims 32-36).
Claims 86-92 are drawn to the encapsulation characteristics, and the dosage form of the composition; administering the composition of the active ingredients taught above. These are within the purview of one of skill in the art for routine optimization, see Singh and Haghiralsadat). Therefore, the dependent claims add obvious features which a skilled worker would optimize using routine trial and error and without inventive ingenuity. Haghiralsadat teaches formulation of liposomal doxorubicin (L- DOX) (claim 76, claim ). L-DOX encapsulate DOX with 84% efficiency. The resulting nanoparticles were round, with a suitable particle size, and stable for 14 days. These nanoparticles allowed for adequately controlled DOX release, increased cell permeability compared to free DOX, and increased tumor cell death. L-DOX provided a novel, more effective therapy for OS treatment. Singh titled ‘Microencapsulation: a promising technique for controlled drug Delivery’ is invoked for microcapsulated dosage forms (claims 89-90). According to Singh at page 74 top of column A, “Microspheres and microcapsules are established as unique carrier systems for many pharmaceuticals and can be tailored to adhere to targeted tissue systems. Hence, microcapsules and microspheres can be used not only for controlled release but also for targeted delivery of drugs to a specific site in the body”. For simultaneous, , separate or sequential administration of anticancer compositions see claim 3 of US 8455477 and claim 5 of US 8048888.
As such nothing unobvious is seen in the claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marriott, Pharmaceutical Compound and Dispensing, Second Edition, 2010, 1-288. Ansel, Pharmaceutical Dosage Forms and Drug Delivery Systems, 1999.
Stephen B. Hulley, Designing Clinical Research, 4th Edition, pages 1-367, 2013.
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.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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