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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tah et al.( US 20190290435) hereinafter Tah et al.
Tah et al. teaches Insertion devices (e.g., furlow insertion devices) which can be used to facilitate the insertion of a penile prosthesis where an insertion device can include an elongate barrel having an opening defined in a distal end; a lumen defined within the elongate barrel, the lumen being accessible through the opening; and an obturator disposed within the lumen of the elongate barrel. The obturator can be movable within the lumen between a proximal position in the elongate barrel and a distal position in the elongate barrel. The obturator, in its distal position in the elongate barrel, can be configured to receive a needle via the opening. The obturator, in its proximal position in the elongate barrel, can be configured to secure the needle within the elongate barrel.
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Regarding claim 1, Tah et al. teaches an insertion device comprising:
an elongate member defining a lumen extending from a first end of the elongate member to a second end of the elongate member; and
a pusher having a first end portion, the first end portion of the pusher being configured to be disposed within the lumen defined by the elongate member and move from a first position within the lumen defined by the elongate member to a second position within the lumen defined by the elongate member, the first end portion of the pusher defining a slot. Note annotated Figs. 3-4 above and paragraphs [0058] – [0062].
Regarding claim 2, Tah et al. teaches wherein the first end portion of the pusher defines a receiving portion. Note annotated Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 3, Tah et al. teaches wherein the first end portion of the pusher defines a receiving portion configured to receive a portion of a needle. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 4, Tah et al. teaches wherein the pusher has a second end portion opposite the first end portion, the second end portion includes a handle portion. Figs. 3-4 above, element 260 and paragraphs [0058] – [0062].
Regarding claim 5, Tah et al. teaches wherein the pusher has a second end portion opposite the first end portion, the second end portion includes a handle portion, the handle portion being configured to extend from the lumen defined by the elongate member. Note Figs. 3-4 above, element 260 and paragraphs [0058] – [0062].
Regarding claim 6, Tah et al. teaches wherein the pusher has a second end portion opposite the first end portion, the second end portion includes a handle portion, the handle portion being configured to extend from the lumen defined by the elongate member while the first end portion of the pusher is disposed within the lumen defined by the elongate member. Note Figs. 3-4 above, element 260 and paragraphs [0058] – [0062].
Regarding claim 7, Tah et al. teaches wherein the slot defined by the first end portion of the pusher extends in a direction parallel to a longitudinal axis of the pusher. Note Figs. 3-4 above, element 219 and paragraphs [0058] – [0062].
Regarding claim 8, Tah et al. teaches wherein the slot defined by the first end portion of the pusher is a first slot, the first end portion of the pusher defining a second slot. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 9, Tah et al. teaches wherein the slot defined by the first end portion of the pusher is a first slot, the first end portion of the pusher defining a second slot, the first slot extends in a direction parallel to a longitudinal axis of the pusher, and the second slot extends in a direction parallel to the longitudinal axis of the pusher. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 10, Tah et al. teaches wherein the first end portion of the pusher defines a plurality of slots. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 11, Tah et al. teaches wherein the slot defined by the first end portion of the pusher is a first slot, the first end portion of the pusher defining a second slot, a third slot, and a fourth slot. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 12, Tah et al. teaches wherein the first end portion of the pusher is configured to be placed in an expanded configuration and a collapsed configuration. Note Figs. 3-4 above, collet 217 and slots 219 , fig. 5, and paragraphs [0058] – [0062] and [0065].
Regarding claim 13, Tah et al. teaches wherein the first end portion of the pusher is configured to be placed in an expanded configuration and a collapsed configuration, the first end portion of the pusher being configured to be placed in the collapsed configuration in response to the first end portion of the pusher contacting an inner diameter of the elongate member. Note Figs. 3-4 above, collet 217 and slots 219 , fig. 5, and paragraphs [0058] – [0062] and [0065].
Regarding claim 14, Tah et al. teaches wherein the first end portion of the pusher includes a first section disposed on a first side of the slot and a second section disposed on a second side of the slot, the first end portion of the pusher is configured to be placed in an expanded configuration and a collapsed configuration, the first section of the pusher being disposed closer to the second section of the pusher when the first end portion of the pusher is disposed in the collapsed configuration than when the first end portion of the pusher is disposed in the expanded configuration. Note Figs. 3-4 above, collet 217 and slots 219 , fig. 5, and paragraphs [0058] – [0062] and [0065].
Regarding claim 15, Tah et al. teaches wherein the elongate member defines a slot. Note Figs. 3-4 above, element 240, and paragraphs [0058] – [0062] and [0065].
Regarding claim 16, Tah et al. teaches A kit, including a bodily implant;
a delivery needle configured to be coupled to the bodily implant; and
a delivery device having an elongate member defining a lumen extending from a first end of the elongate member to a second end of the elongate member, and a pusher having a first end portion, the first end portion of the pusher being configured to be disposed within the lumen defined by the elongate member and move from a first position within the lumen defined by the elongate member to a second position within the lumen defined by the elongate member, the first end portion of the pusher defining a slot. Note annotated Figs. 1A-D, 3-4 above and paragraphs [0042], [0058] – [0062]. [0042] FIGS. 1A, 1B and 1C schematically illustrate a furlow insertion device (device) 100 that can be used for insertion (implantation, etc.) of a penile prosthesis in a penis of a patient according to an embodiment. FIG. 1D schematically illustrates a needle 180, a suture 185 and a penile prosthesis 190 that can be used in conjunction with the insertion tool 100 according to an embodiment. In some implementations, the needle 180, the suture 185 and the penile prosthesis 190 can be used in conjunction with other insertion tools, such as those described herein.
Regarding claim 17, Tah et al. teaches wherein the elongate member defines a slot configured to receive at least a portion of the delivery needle. Note annotated Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 18, Tah et al. teaches wherein the slot defined by the first end portion of the pusher extends in a direction parallel to a longitudinal axis of the pusher. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 19, Tah et al. teaches wherein the slot defined by the first end portion of the pusher is a first slot, the first end portion of the pusher defining a second slot. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Regarding claim 20, Tah et al. teaches wherein the slot defined by the first end portion of the pusher is a first slot, the first end portion of the pusher defining a second slot, the first slot extends in a direction parallel to a longitudinal axis of the pusher, and the second slot extends in a direction parallel to the longitudinal axis of the pusher. Note Figs. 3-4 above, collet 217 and slots 219 and paragraphs [0058] – [0062].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanze et al.( US 20230028735) teaches an implant delivery instrument includes a housing with a main body section that defines a passage therethrough from a front end of the main body section to a back end of the main body section. The passage receives an obturator through an opening at the back end, and also receives an implant device. Movement of the obturator through the passage pushes the implant device through a discharge opening at the front end and through an incision into a subdermal pocket of a patient. The housing includes a tab connected to and projecting from the front end of the main body section. The tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision, and the tab is configured to surround the implant device moving through the discharge opening along only one side of the implant device.
RAO et al.( AU 2015301145) teaches a medical device may include a needle member, and a handle coupled to the needle member. The handle may define a track portion. The medical device may also include a pusher member having a sheath disposed around a portion of the needle member, and an extension member being movably coupled to the track portion of the handle such that the pusher member is configured to move from a first position to a second position during a surgical procedure. The pusher member may be removable from the handle. The sheath may define a slot, and the pusher member may be removable from the needle member through the slot.
PINGEL et al.( US 20130296828) teaches an assembly useful for delivering therapeutic material into a void in a tissue or implanted prosthetic device. The assembly includes placing one or more fluid cannulated flow tubes into contact with the plug pusher to form a unitary component; (b2) placing the distal end of assembly in contact with a void comprising in part an opening in patient tissue; (c2) simultaneously displacing the distal end of the fluid tubes into the void and the flowable plug material, where the flowable plug material is introduced at a point proximal to the distal end of the fluid tube in a manner to impede fluid outflow through it.
CHU et al.( US 20050131392) teaches a delivery device for delivering an implant to anatomical site in a body of a patient, the device comprising, a handle, a shaft having proximal and distal ends and attached to the handle at the proximal end, a pusher tube slidably fitted over the shaft and extending from the handle distally along a portion of the shaft, and a pushing mechanism operatively interconnected with the handle for actuating the pusher tube distally along a portion of the shaft to deliver an implant to an anatomical site.
NYGAARD(EP 3001983) teaches a needle handling device (100) engageable to an introducer tool (20) used for implantation of a penile prosthetic insert in a corpora cavernosum of a penis. The needle handling device includes an attachment section (102), a needle capturing section (104) and an intermediate section (106). The attachment section is provided at a first end of the needle handling device and is releasably attached to the introducer tool. The needle capturing section is provided at a second end of the needle handling device and is configured to capture and extract a needle out of the introducer tool. The intermediate section connects the first and the second end of the needle handling device. A method of implanting a penile prosthetic insert in a corpora cavernosum of a penis using a needle handling device is also disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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