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 .
Amended claims 73-76, 90-92 and withdrawn claims 77-85 are pending.
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, 90-92 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, US 8048888 and Yarmut US6576257, Patel, US6248363, Castro US20200108101 and Petricoin US20200128864 and Fülöp US9447108.
Yarmut, Patel, Castro and Petricoin are new and are added in view of amendments to claims.
According to Applicant,
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emphasis added by the Examiner.
Further, according to Applicant, ‘None of the cited references teaches or suggests a composition comprising a cannabinoid and noncannabinoid encapsulated as claimed. Moreover, there is no basis to contend that formulations including these components are "within the purview of one of skill in the art for routine optimization." In short, the rejection is ‘deficient’.
This Examiner encourages Applicant to contact Examiner’s supervisor or other relevant office personnel for improper office actions.
Applicants arguments are not persuasive.
Applicants above noted accusatory statement ignores explicit reference for expectation of success in the combination, noted in the opening statement of previous rejection (see below).
Amended base claim now includes, terms for therapeutic use, encapsulation microcapsules.
Prior art references teaching these were already highlighted in the previous action.
Therapeutic use of recited ingredients are already known in encapsulated form are known in the prior art. For example,
Castro throughout and claims
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Petricoin throughout and claims
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Yarmut throughout and claims
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Patel, Yarmut throughout and claims 12, 22, 23, 28, 45, 51.
Also see Fülöp throughout, in particular claims 6 and 8 for encapsulating in microspheres of previously known established cannabinoids and non-cannabinoids to make compositions.
Why these issued patents would not be in the purview of one of skill in the art as Applicant implies is unclear.
The rejection is not under Claim Rejections - 35 USC § 102.
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 ingredients for their known benefit since each is well known in the art for their therapeutic use. This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 136 F.2d 715, 718, 58 USPQ 262, 264 (CCPA 1943). Reference Sanchez is explicit with regards to combination.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Previously presented Rejection:
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 standardized 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 73-76, 90-92 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 of U.S. Patent No. 12494139 further in view of 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, US 8048888 and Yarmut US6576257, Patel, US6248363, Castro US20200108101 and Petricoin US20200128864, Fülöp US9447108 and Mendoza, Nat Chem. 2011 Nov 6;4(1):21-5. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter as explained below:
Note that entirety of the rationale presented under Claim Rejections - 35 USC § 103 is incorporated here in the obviousness analysis.
12494139 :
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The difference is that in the claims 12494139 the non-cannabinoid component is terpene, while in the instant base claim it is ‘taxane’.
However, it is well-known that taxanes form a large family of terpenes comprising over 350 members, the most famous of which is Taxol (paclitaxel), a billion-dollar anticancer drug. For example, see Mendoza, Nat Chem. 2011 Nov 6;4(1):21-5, opening statement.
Claims 73-76, 90-92 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 of U.S. Patent No. 11783722, further in view of 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, US 8048888 and Yarmut US6576257, Patel, US6248363, Castro US20200108101 and Petricoin US20200128864 and Fülöp US9447108. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter as explained below:
Note that entirety of the rationale presented under Claim Rejections - 35 USC § 103 is incorporated here in the obviousness analysis.
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The difference is that in the claims 12494139 the non-cannabinoid component is terpene, while in the instant base claim it is ‘taxane’.
However, it is well-known that taxanes form a large family of terpenes comprising over 350 members, the most famous of which is Taxol (paclitaxel), a billion-dollar anticancer drug. For example, see Mendoza, Nat Chem. 2011 Nov 6;4(1):21-5, opening statement.
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 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.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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