CTNF 18/694,137 CTNF 79060 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 7 is objected to because of the following informalities: the claim includes multiple sentences . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 requires the cable to removably anchored at said distal end of said container, and said plunger axially slides on said cable with respect to said container during said filling and claim 1 requires said cable connected to said plunger and extending from said first surface of said plunger toward said proximal end of said container which appears to create an indefinite issue. One of ordinary skill in the art would find the limitations of claim 14 indefinite and unclear because the claim requires the cable to be anchored to the distal end of said container and also connected to the plunger in such a way the plunger can slide over the cable as well as pull the plunger towards the proximal end. This arrangement is unclear and the specification and drawings fail to provide further comprehension. The drawings fail to illustrate this arrangement and the specification fails to provide further description. The specification recites a cable anchor 1007 in fig. 10A and 10B but its unclear how this arrangement would have the cable be removably anchored to the container and also allow the plunger to be pulled by the cable and the plunger slide over the cable. It’s unclear how the cable is removable anchored to the container and performs the functions as claimed. Further clarification is requested. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 1, 2, 9, and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kamrava et al., US Patent Pub. 2022/0288304 . Re. claims 1-2, Kamrava discloses a system comprising an output (outlet/912/end) for connection to a medication delivery mechanism (906/904/902); a container (202) for said medication in fluid communication with said output; a plunger (204) disposed in said container and having a first surface in communication with said medium, said first surface facing a proximal end of said container (proximal orientation is the end with the reel/gear); and a cable (904) connected to said plunger and extending from said first surface of said plunger toward said proximal end of said container and exiting out of said container via said proximal end of said container (proximal end if the end at the reel end (906)), see fig. 9 and paragraph 0040 [Figure 10A shows an alternative embodiment]. Re clm. 2, Kamrava discloses wherein, when said plunger is positioned at a distance from said proximal end of said container, pulling of said cable out of said container causes axial displacement of said plunger with respect to said container toward said proximal end of said container, said axial displacement of said plunger causing delivery of said medication, see para 0040. Re. clm. 9, Kamrava discloses a septum (910) configured at said proximal end of said container, wherein said septum comprises said output for connection to said medication delivery mechanism, said septum providing leak proof communication between said output and said container, see fig. 9 and para 0040. Re. clm. 10, Kamrava discloses a septum (910) configured at said proximal end of said container, wherein said cable exits said container via said septum, and said septum provides leak proof communication between said cable and said container, see fig. 9 and para 0040 . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-22-aia AIA Claim s 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kamrava et al., US Patent Pub. 2022/0288304 as applied to claim s 1, 2 above, and further in view of Laurence et al. US Patent Pub. 2018/0085517 . Re. claim 3, Kamrava et al. teaches using a reel with teeth which acts as a spool, however Kamrava fails to explicitly teach using a spool, a motor for rotating said spool in a first rotational direction, and the cable being connected to said spool at a connection point, and rotation of said spool winds said cable onto said spool causing said pulling of said cable. (Re. clm. 5, Kamrava et al. fails to teach a gear mechanism transferring rotation of said motor to said spool.) Laurence et al. discloses winch assembly (520) that controls the movement of the tether (525) which is connected to the plunger. The winch assembly includes a spool (520B) and a motor (101) which control the movement of the tether such that the rotation of the winch assembly controls the pulling and pushing of the tether. Laurence also teaches uses a gear mechanism (see fig. 5C) in the winch assembly and the gear mechanism translates movement from the winch assembly to the plunger (teaches clm. 5 - gear mechanism transferring rotation of said motor to said spool), see figs 2A-2E, 3A-3D, and 5A-5D and para 129-142. At the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to add the teachings of the winch assembly, motor and gear mechanism of Laurence et al. to the device of Kamrava et al. because Laurence et al. provides a small, low cost and light weight delivery mechanism. Furthermore, using a winch assembly with a gear mechanism that includes a motor provides an accurate and efficient drive mechanism that provides specific dosing features. Additionally, it would have been obvious to incorporate the winch assembly with a gear mechanism and motor into the device of Kamrava since the winch assembly would be used to control the movement of the reel element of Kamrava. With regards to claim 5, once the modifications are made to the device of Kamrava as discussed about, the modified device would teach all the limitations of claim 5. With regards to claims 7-8, it would have been obvious to modify the combined device of Kamrava and Laurence et al. to add at least one pulley configured pulley configured between said proximal end of said container and said connection point, wherein said at least one pin and/or pulley contacts said cable to guide said cable between said proximal end of said container and said connection point (clm. 7) such that a configuration of said pulley adjusts tension of said cable (clm. 8) based on the teachings of Kamrava that states the delivery device may use one or more pulleys to direct the tether through opening to allow flexibility with respect to the use of space within the delivery device (Kamrava para. 0040). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add at least one pulley configured pulley configured between said proximal end of said container and said connection point, wherein said at least one pulley contacts said cable to guide said cable between said proximal end of said container and said connection point and wherein a configuration of said pulley adjusts tension of said cable to the combined device of Kamrava and Laurence et al. because adding at least one pulley was taught and suggested in Kamrava and included at least one pulley would allow the winch assembly to be placed in a more desirable location as well as provide a configuration of the pulley in order to control the tension on the tether/cable in order to provide proper engagement with the drive mechanism system (it would be obvious to include additional pulleys to adjust tension or adjust the at least one pulley in order to adjust tension as needed so that the device would work efficiently and accurately). With regards to claims 4 and 6, Kamrava fails to disclose a lead screw; a nut in threaded communication with said lead screw; and a motor for rotating said lead screw, wherein said cable is connected to said nut at a connection point, and rotation of said lead screw axially displaces said nut causing said pulling of said cable in the embodiment of figure 9, however Kamrava does disclose a lead screw (416); a nut (408) in threaded communication with said lead screw, a gear mechanism for transferring rotation of the motor to the lead screw (416) [clm. 6]; and a motor for rotating said lead screw (414) and controlling the movement of the plunger based on the movement of the lead screw, nut and motor. At the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to add the modify the embodiment of figure 9 with the alternative teachings of a different drive mechanism of Kamrava et al. because Kamrava teaches the benefit of using lead screw, drive nut, gears and motor arrangement in order to have a compact drive mechanism and delivery device. Furthermore, Kamrava suggestions combining different embodiments (para. 0069). Therefore, one of ordinary skill in the art would have found it obvious to make the reel -906 of figure 9 the drive nut and incorporate the lead screw, gears and motor into the embodiment of figure 9. Such a modification would only routine skill in the art based on the teachings of Kamrava et al. and the level of skill in the art such as Laurence et al . 07-21-aia AIA Claim s 11-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kamrava et al., US Patent Pub. 2022/0288304 and Laurence et al. US Patent Pub. 2018/0085517 and further in view of Nzike et al. US Patent Pub. 2013/0211370 . Re. clm. 11, the combined device of Kamrava et al. and Laurence et al. fail to teach a fill port in fluid communication with said container at said proximal end of said container. Nzike et al. low-profile delivery device includes a stopper (12), piston (10), a clutch (18) and a refill port (82) that allows the delivery device to be refilled with medicine. Upon refilling the stopper is configured to move backward due to the design of the clutch (see fig. 4, 6, 7, and para. 0073-0084. At the effective filing date of the claimed invention it would have been obvious for one of ordinary skill in the art to modify the combined device of Kamrava et al. and Laurence et al. to include a fill port in fluid communication with said container at said proximal end of said container as taught by Nzike et al. in order to make the device reusable and refill the container. Refillable ports are well-known in the art and would only require routine skill in the art to add a fill port in fluid communication with said container at said proximal end of said container. Re clm. 12, the combined device of Kamrava et al., Laurence et al. and Nzike et al. teach a septum configured at said proximal end of said container, wherein said cable exits said container via said septum, and said septum provides leak proof communication between said fill port and said container as taught by Kamrava et al. as explained above. Furthermore, adding a second passage for the refill port through the septum would be an obvious modification that only requires routine skill and is well known in the medical art. Re clm. 13, 15-17, the combined device of Kamrava et al., Laurence et al. and Nzike et al. teach the claimed invention but fail to teach the spool comprises a clutch mechanism for engaging said spool to rotate in said first rotational direction with said motor, and disengaging said spool from said motor to allow rotation of said spool in a second rotational direction opposite said first rotational direction [clm. 15 and 17] (and wherein said clutch mechanism disengages said spool from said motor, and filling of said container via said fill port causes axial movement of said plunger toward a distal end of said container causing unwinding of said cable off said spool – clm. 13 and 16). Nzike et al. teaches a clutch mechanism (20/22/24/66/68) which engages the piston and allows the piston to retract so that the plunger moves towards a distal end of container when being filled (see fig. 6, 7 and para. 0073-0084). At the effective filing date of the claimed invention it would have been obvious to add a clutch mechanism to the combined device of Kamrava et al. and Laurence et al. because Nzike et al. teaches the benefit of having a clutch mechanism in order to move the piston/plunger back in order to refill the reservoir of the container so that the device does not need to be replaced and can be reused. One of ordinary skill in the art would understand and find it obvious to add a clutch mechanism to the winch assembly and modified device of Kamrava et al. and Laurence et al. which is also further modified with the refill port (as taught by Nzike et al.). Once the clutch mechanism is added, the spool would disengage from the motor/gear transmission and allow the plunger and cable to be retracted back into the container when the device is being refilled because of the pressure from the liquid which is added via the refilled port. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW F DESANTO whose telephone number is (571)272-4957. The examiner can normally be reached M-F 7:30am-4pm(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, ASHLEY BOYER D can be reached at 571-272-4502. 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. Matthew DeSanto /MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
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