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 Interpretation
Claim 1 is directed toward a cartridge loader wherein both a top loader bay and a bottom loader bay or slidingly engaged to a loader body configured so that the cartridge loader can receive a cartridge having a shield between the top loader bay and bottom loader bay, and wherein the cartridge loader can be manipulated between first and second configurations. While it is acknowledged that the written disclosure defines the context of the invention as being a cartridge loader for a radionuclide preparation, separation, or delivery process, wherein a “shield” is fairly implied to be a material that contains radiation emanating from a radioactive material, it is emphasized that langue of claim 1 does not clearly set forth any such limitations. Also, the cartridge shield with a cartridge provided therein recited in claim 1 is not a positively recited structure of the claimed cartridge loader, although the limitation does require that the cartridge loader have a structure capable of receiving the cartridge shield and cartridge. Accordingly, claim 1 has been interpreted as encompassing a cartridge loader for substantially any type of cartridge wherein the cartridge is provided with an outer protective layer (i.e., a shield), the cartridge loader being characterized by a top loader bay and bottom loader bay which each are slidingly engaged to a body of the cartridge loader and which cooperate to receive a shielded cartridge therebetween.
Claim Rejections - 35 USC § 102
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.
(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.
Claims 1 and 19-20 are rejected under 35 U.S.C. 102(a)(1&2) as being anticipated by Bar-El et al. (US 2018/0154081 A1).
Regarding claim 1, Bar-El teaches an assembly for interfacing between a drug cartridge and a drug delivery device wherein the drug delivery device comprises a compartment and a cartridge bay, the cartridge bay configured to receive a cartridge and to move into the compartment (abstract). Bar-El further contemplates embodiments wherein the cartridge is placed into the bay and the bay slides laterally or longitudinally into the compartment ([0075]-[0076]).
Figs. 4A-D and Figs. 5A-D show related embodiments wherein a bay (423,523) receives a cartridge (420) ([0165]-[0166], [0174]-[0176]) and the bay is pivotally (Figs. 4A-D) or hingedly (Figs. 5A-D) moved between a loading positions in which the bay is outside the body ([0099], Figs. 4A-B,D and Fig. 5A-B,D), and a delivery position in which the bay is positioned within the body ([0109], Figs. 4C, 5C).
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Additionally, Bar-El teaches that an upper portion of the loader body includes a plunger driving assembly including a shaft (410) which dirves a plunger seal (440) of the cartridge to discharge a drug from an opposite end of the cartridge ([0169]-[0171], [0173]).
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The assembly of Bar-El thus fairly comprises a cartridge loader comprising: a loader body (delivery device 422 defining compartment 424—[0165]); a top loader bay (plunger driving assembly located in proximal end of device 422 proximal to opening 441a—[0169]) slidingly engaged to the loader body (plunger driving assembly is fixed in a proximal portion of device 422 proximal to the cartridge compartment 424 and creates linear telescoping motion–[0171]); a bottom loader bay (bay 423) engaged to the loader body (bay 423 rotates about pivot 425 between closed and open position—[0165], Figs. 4A-C); wherein the loader body is configured to receive a cartridge (420) between the top loader bay and the bottom loader bay (see Figs. 4A-D, [0165]; cartridge 420 is received in compartment 424 of device 422 between support 445 of bay 423 and plunger assembly of upper portion of device proximal to compartment 424) and the cartridge loader can be manipulated between a first configuration and a second configuration (bay 423 move between loading and delivery position—[0099], [0109], [0165]; plunger driving assembly moves between extended and retracted configurations—[0184]-[0186]).
Although the particular embodiment (Figs. 4A-D) cited above includes a pivotably mounted lower bay (423), Bar-El explicitly suggests alternative arrangements wherein the bay is slidably engaged to the delivery device (cartridge bay 123 is movably connected to the delivery device by a multi-position mount 125, for example a slider—[0099]; a bay may tilt into the compartment and/or rotate and/or slide laterally or longitudinally into the compartment—[0076]). Thus, Bar-El fairly teaches an embodiments wherein the lower bay is slidably engaged to the loader body.
Also, the outer walls of the cartridge of Bar-El fairly define a shield, and the reservoir of the cartridge of Bar-El fairly defines a cartridge within said shield (consider reservoir 44 within cartridge 420 in Fig. 4D, reservoir 219 within cartridge 220 in Fig. 2B, or the schematic depiction of reservoir 120 within cartridge 153 in Figs. 1A-D). Additionally, the loader of Bar-El would otherwise be capable of receiving a shielded cartridge between the upper and lower bays, the shielded cartridge not being a positively recited feature of the claimed loader (see claim interpretation above).
Regarding claim 19, Bar-El teaches the cartridge loader of claim 1. The vial shield with a vial provided therein recited in claim 19 is not a positively recited structure of the claimed cartridge loader, and the bottom loader bay (423) of Bar-El is reasonably capable of holding a shielded vial of an appropriately corresponding size and shape. Thus, the cartridge loader of Bar-El reasonably includes a bottom loader bay configured to hold a vial shield with a vial provided therein.
Regarding claim 20, Bar-El teaches the cartridge loader of claim 1. As discussed with respect to claim 1 above, Bar-El teaches embodiments wherein the bottom bay slides along a slider into the compartment the loader body [(0099], [0076]). Bar-El also teaches providing the bay with a window (447) through which the cartridge can be viewed (Fig. 4A, [0165], [0168]), the window appearing to be an opening that would allow the cartridge to be touched or manipulated while in the bay. Accordingly, Bar-El fairly teaches an embodiment wherein a cartridge (e.g., 420) can be placed into a lower bay (e.g., 423) and slid into the compartment (424) of the loader body by acting on the cartridge through the opening (447) of the bay. Such action on the cartridge would also cause the bay to slide into the compartment due to its engagement with the cartridge. Thus, Bar-El teaches embodiments wherein the bottom loader bay is configured to slide between a first position (outside compartment) and a second position (inside compartment) due to friction caused by the cartridge shield (outer housing of cartridge) as the cartridge loader transitions from the first configuration to the second configuration.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-El et al. (US 2018/0154081 A1) in view of Niziol (US 2021/0057688 A1).
Regarding claim 10,Bar-El teaches the cartridge loader of claim 1. Bar-El does not teach the top loader bay further comprising a magnet for holding the cartridge shield.
However, it is noted that a purpose of invention of Bar-El is to properly align a cartridge with a fluid pathway and a plunger assembly of a drug delivery device ([0016]-[0017], [0074], [0084], [0108], [0169], [0173]).
Furthermore, in the analogous art of cartridge (cassette) housing devices (abstract) with means for facilitating the alignment of cassettes in a holder ([0115]), Niziol teaches a cassette (126) that houses a battery pack, wherein the cassette is received in a bay (122,124) of a receiver assembly (120) ([0112]), and the cassette contacts connectors (146,147) within the bay when fully inserted into the bay ([0113]). Niziol further teaches that magnets are positioned with the bay assemblies and configured to attract a metal plate of the cassette so that the cassette is pulled into place along alignment rails, the magnets thus facilitating alignment of the cassettes with the connectors of the bay ([0115], [0132], [0134], claims 4-5). Niziol thus demonstrates that it is known to provide a magnet within a cartridge receiving bay to facilitate proper alignment and connection of the cartridge (cassette) within the bay. Therefore, it would be obvious to a person having ordinary skill in the art to try including a magnet in the top or bottom bay of Bar-El for the benefit of facilitating the alignment and connection of the cartridge to the bays, as suggested by Niziol ([0115]).
Regarding claim 16, Bar-El teaches the cartridge loader of claim 1. Bar-El does not teach the bottom loader bay further comprising a magnet for holding the cartridge shield. However, as discussed with respect to claim 10 above, it would be obvious to a person having ordinary skill in the art to try including a magnet in the top or bottom bay of Bar-El for the benefit of facilitating the alignment and connection of the cartridge to the bays, as suggested by Niziol ([0115]; see rejection of claim 10 above).
Allowable Subject Matter
Claims 2-9 and 11-15, and 17-18 are objected to as being dependent upon a rejected base claim (claim 1), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 2, Bar-El teaches the cartridge loader of claim 1. Bar-El does not teach a handle track provided on the loader body; and a handle slidingly engaging the handle track such that the handle is configured to move in both a lateral direction and a vertical direction with respect to the loader body.
Handique et al. (US 2007/0292941 A1) teaches a system configured to receive a microfluidic cartridge (abstract), the system (2000—[0172]) including a housing (2002—[0173]) with a moveable lid (2010—[0174]) which is slid between an open (Fig. 2B) and closed position (Fig. 2A) with a handle (2008—[0175]), the handle also being manipulable into a depressed position (Fig. 2C) in which the handle (2008) applies downward pressure on the lid (2002) and a cartridge received in a receiving bay beneath the lid ([0176]). The Figures (especially Fig. 2B) appear to show the handle assembly positioned along ledges above the receiving bay (2014), the ledges fairly defining a handle track. Thus, the system of Handique appears to include a handle track provided on a loader body (ledges above receiving bay 2014), and a handle (2008) slidingly engaging the handle track such that the handle is configured to move in both a lateral direction and a vertical direction with respect to the loader body (housing 2002).
Nonetheless, there is no apparent motivation to combine the structures of Bar-El and Handique (i.e., the teachings of Bar-El and Handique discussed above would not be sufficient to guide a person of ordinary skill in the art to combine the handle of Handique with the device of Bar-El in view of the substantially different designs and purposes of the devices of Bar-El and Handique) to arrive at a cartridge loader defined by a loader body that is slidably engaged to both a top loader bay and a bottom loader bay, and which is provided with a handle track and a handle that slidingly engages with a handle track so as to achieve both lateral and vertical movement, wherein the top and bottom loader bays are configured to receive a shielded cartridge therebetween. No further prior art was found which teaches or fairly suggests the combination of all claimed features. Accordingly, the subject matter of claim 2 is novel and non-obvious over the prior art.
Claims 3-9 and 11-15 contain allowable subject matter at least by virtue of dependency on claim 2.
Regarding claim 17, Bar-El teaches the cartridge loader of claim 1. Bar-El does not teach a cleaning assembly slidingly coupled to the loader body, wherein when the cartridge loader is in the second configuration without receiving the cartridge shield, the cleaning assembly is configured to disinfect the top loader bay and the bottom loader bay.
Farren (US 9687575 B2) teaches UV sterilization systems including devices which fold (Figs. 6-7), retract (Figs. 1-3), and slide (Fig. 13), the sterilization systems intended to be deployed inside a container for sterilization the interior thereof (abstract).
Also, the use of UV LEDs to disinfect items within an enclosed space is well established, as evidenced by Nguyen (US 10064967 B2) teaching a sterilization enclosure (abstract) including ultraviolet LED which emit short wavelength UV light to sterilize items (column 5, lines 13-15).
Nonetheless, no prior art was found which teaches or particularly suggests modifying the device of Bar-El to include a cleaning assembly slidingly coupled to the loader body, wherein when the cartridge loader is in the second configuration without receiving the cartridge shield, the cleaning assembly is configured to disinfect the top loader bay and the bottom loader bay, nor was any prior art found which otherwise teaches combining a cleaning assembly as claimed with all features of independent claim 1. Accordingly, the subject matter of claim 17 is novel and non-obvious over the prior art.
Claims 18 contains allowable subject matter at least by virtue of dependency on claim 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Taylor et al. (US 5,317,554 A) teaches a loader (10) and cartridge loading apparatus (28) wherein cartridges (14) are stored in a magazine (16), the magazine (16) is inserted into a magazine carrier (18), and the magazine carrier (18) moves along a lead screw to position the magazine (16) so that a cartridge (14) is properly aligned with a reader (12) (abstract).
Perry et al. (US 2013/0117488 A1) teaches a docking station for a removable memory cartridge (title, abstract), wherein the docking station (202) includes a receiving compartment (receiving bay 210) into which the memory cartridge (memory element 206) is inserted ([0043]). A pair of alignment features (214) actuate between a retracted positioned inside of the docking station (202) and an extended state (Fig. 2), the alignment features (214) comprising two extension arms which assist in the insertion of the removable memory element (206) ([0043]). The alignment feature couples with a feature of the cartridge, such as a latching alignment receptacle (222) ([0047]), [0050].
Boubeddi et al. (US 20140120223 A1) teaches a beverage maker (title, abstract) which includes a drawer (16) which slides out of a body (12) of the beverage maker (10), the drawer having side rails (20) which run along internal rails (14) of the body (12) (Figs. 1-2, [0018]). A component (24) in the interior space (22) of the drawer ([0019]) may be configured as a hinged body including a capsule receiving portion1 (30) for receiving a particular brand, shape, or type of capsule (Figs. 4-7, [0020]-[0021]). In use, a capsule is loaded into the component (26), positioned in the drawer (16), and slid into the body ([0026]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADY C PILSBURY whose telephone number is (571)272-8054. The examiner can normally be reached M-Th 7:30a-5:00p.
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, MICHAEL MARCHESCHI can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797