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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mody et al. U.S. Publication No. (2016/0015259 A1) and evidenced by Saltzman et al. (WO2018081138 A1).
With respect to claim 1, Mody et al. discloses a method for visually utilizing a fallopian birth control system (Abstract, Examples of visualization modalities are endoscopes and body insertable ultrasound imaging devices); [0071], [0080] and [0101, Plugging or blocking a lumen such as a blood vessel, fallopian tubes (e.g. using an implant, fusing the cornus using tissue sealing methods) for contraception), ducts, glands, etc.],
comprising the steps of:
applying botulinum toxin and or other anesthetic interiorly to a fallopian tube of a patient [0104, Injecting or infusing anesthetic (e.g. an anesthetic liquid or gel) into an anatomical region. In one such embodiment, a local anesthetic is injected at one or more regions (e.g. fundal region, cornua, mid uterine region, cervix, lower uterine region) in the uterine wall or around the uterus. The anesthetic may be introduced before, during, or after a treatment] and [0087, In the method shown in FIG. 1S, any of the method and device embodiments herein may be used to create an access channel to the uterine cavity. Thereafter, a tubal occlusion device 104 (working device 104) is inserted transcervically into the uterine cavity and is navigated through the uterine cavity such that it enters a fallopian tube]; and
followed by delivery of an occlusion-creating substance [0112, gels, mechanical barriers such as coils or sheets and removable balloons].
With respect to claim 2, Mody et al. discloses the applying step includes inserting a biodegradable substance [0114, placing an implant post-procedure. Examples of such procedures are placing a levonorgestrel eluting implant post an endometrial ablation procedure]. Note: levonorgestrel is biodegradable as evidenced by Saltzman et al. who discloses biodegradable contraceptive implant in (Abstract, progestin is levonorgestrel (LNG), a hormone that prevents pregnancy by preventing the release of an egg from the ovary or by preventing fertilization of the egg by sperm. The implant may be inserted subcutaneously, allowing degradation over a period of up to about 18 or 24 months, eliminating the need for removal by a trained practitioner).
With respect to claim 5, Mody et al. discloses the applying step includes the path of delivery at a cornual entrance from a uterus to a Fallopian canal [0087, In the method shown in FIG. 1S, any of the method and device embodiments herein may be used to create an access channel to the uterine cavity. Thereafter, a tubal occlusion device 104 (working device 104) is inserted transcervically into the uterine cavity and is navigated through the uterine cavity such that it enters a fallopian tube] and [0104].
With respect to claim 6, Mody et al. discloses the applying step includes the path of delivery through an abdominal wall [0004, artificially created surgical openings leading to target anatomical regions are kept as small as possible to reduce the invasiveness of the procedure. For example, laparoscopic openings are kept as small as possible to reduce the pain, scarring, and medical risks of laparoscopic procedures]. Note: Laparoscopic procedures refer to a minimally invasive surgical technique using a camera (laparoscope) through small incisions (keyholes) in the abdomen.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mody et al. as applied to claim 1 above, and further in view of Donovan U.S. Publication No. (2004/0033241 A1).
With respect to claim 3, Mody et al. substantially discloses the invention as claimed except wherein the applying step includes inserting a permanent non-degradable substance.
Donovan however, teaches an implantable botulinum toxin delivery system [0002] comprising an implant made of a nonbiodegradable polymer [0127].
In view of the teachings of Donovan, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Mody et al. by incorporating implantable device that is a permanently non-degradable substance and is safely removable to reverse a fallopian birth control system procedure.
With respect to claim 4, Mody et al. substantially discloses the invention as claimed except the applying step includes inserting a sliver of porous polymer infused with botulinum toxin.
Donovan however, teaches in [0002, an implantable botulinum toxin delivery system]; Donovan further teaches and suggests in [0009, an implant can be in the form of solid cylindrical implants, pellet microcapsules, or microspheres. Since a biodegradable implant releases drug while degrading there is typically no need to remove the implant. See e.g. Drug Development and Industrial Pharmacy 24(12); 129-1138:1998. A biodegradable implant can be based upon either a membrane or matrix release of the bioactive substance. Biodegradable microspheres can be implanted by injection through a conventional fine needle or pressed into a disc and implanted as a pellet] which suggests that the implant is a matrix implant to which the botulinum toxin is infused, see para [0123]-[0124]. Note: microspheres are porous which would have allowed for the release of bioactive substance (botulinum toxin).
In view of the teachings of Donovan, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Mody et al. by incorporating a sliver of porous polymer infused with botulinum toxin in order to provide in vivo release of therapeutic amounts of botulinum toxin in a human patient over a prolonged period of time (abstract) of Donovan.
Conclusion
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786