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.
Claims 1, 4-7, 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al, US 2014/0276416 A1.
Regarding claim 1, Nelson discloses a stabilization device (anchor 400, see embodiment in Figs. 13-23) for a subcutaneous port (400 is capable of being used with port 110 made on the skin, recites an intended use and “port” not positively recited), comprising: a body (402, Figs. 15-17, para [0116]) defining a port recess (recess next to spherical ball on bottom of 402, see annotated Fig. 14 below) disposed in a bottom surface thereof (409, Fig. 14, para [0116]), and configured to receive a portion of the subcutaneous port therein in a first orientation (functional recitation, “subcutaneous port” not positively recited; bottom portion of 402 is capable of receiving port 110); and a guide cylinder (450, Figs. 15, 23, para [0122]) including a needle channel (bore 418, Fig. 23, para [0122]) aligned with a receiving cup of the port when the port is engaged with the body in the first orientation (Fig. 23), the guide cylinder extending from an outer surface of the body to the port recess (Fig. 23) and rotationally coupled to the body between a first position and a second position (450 coupled to body 402 by way of spherical ball 414, which rotates between the three mutually perpendicular axes, Fig. 4, paras [0121]; [0124] and also para [0095], where 414 operates similar to 214), the needle channel aligned with a first insertion site on the skin surface in the first position and a second insertion site on the skin surface in the second position (418 is capable of being aligned with first and second insertions sites through hole 110 by way of first and second positions correspond to at least the first and second axes of the three mutually perpendicular axes, Fig. 4, paras [0121] and [0124]).
Regarding claim 4, Nelson discloses wherein an inner surface profile of the port recess (see annotated Fig. 14 below) is configured to mirror an outer profile of the port to align the guide cylinder with the receiving cup of the port in the first orientation and to prevent the port from engaging the port recess in a second orientation (Fig. 14).
Regarding claims 5-7, Nelson discloses wherein an arc distance between the first position and the second position is between 1° and 180°, or is a non-factorable number of degrees of 360°, or is a prime number (rotates between the three mutually perpendicular axes, which would include between 1 and 360 degrees, Fig. 4, paras [0121]; [0124] and also para [0095], where 414 operates similar to 214).
Regarding claims 10-11, Nelson discloses wherein the needle channel moves in a circular path or a non-circular path between the first position and the second position (rotates between the three mutually perpendicular axes, Fig. 4, paras [0121]; [0124] and also para [0095], where 414 operates similar to 214).
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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 12, 14-17, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Nelson et al, US 2009/0187149 (“Nelson 2”).
Regarding claim 12, Nelson discloses a method of accessing a subcutaneous port (burr hole 110, Figs. 13-23, paras [0114]-[0133]), comprising: engaging a stabilization device (400) with the subcutaneous port to axially align a guide cylinder (450) of the stabilization device with a receiving cup of the port (para [0115]); inserting a medical device such as lead, catheter, cannula, (124, para [0127]) through a needle channel (418) of the guide cylinder to access the receiving cup of the subcutaneous port at a first insertion site (para [0126]-[0127]); removing the medical device from the stabilization device (para [0133] – withdrawing 124); and rotating the guide cylinder of the stabilization device from a first position to a second position to align the needle channel with a second insertion site, different from the first access site (rotates between the three mutually perpendicular axes, Fig. 4, paras [0121]; [0124] and also para [0095], where 414 operates similar to 214, para [0130]; rotation of 414).
Nelson teaches that a medical device such as a lead, catheter can be inserted through the channel of the guide cylinder but does not expressly teach a “needle”.
However, Nelson 2, in the same field of art, teaches a stabilization/anchor (200, para [0049]; also similar embodiments in 300, 400, 500, paras [0118]-[0119]) and method of accessing a subcutaneous port (burr hole) comprising engaging the stabilization device (200) with the subcutaneous port to align a guide cylinder (236, Fig. 4, 6A-B, see paras [0052]-[0055]) with the port, and inserting and/or removing a needle (therapy catheter assembly 102, which is shown at embodiment 600, includes needle 612, paras [1022]-[0124]) through a needle channel of the guide cylinder to access the port at an insertion site (para [0124], Fig. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use and/or substitute the medical device of Nelson 2 that has a needle with the method/device of Nelson in order to provide the stated advantages and benefits of providing a relatively rigid distal catheter to aid in implantation, yet flexible and shear able distal end, and substituting one known type of medical device for another would lead to predictable results and a great expectation of success (see para [0126]).
Regarding claims 14, Nelson discloses wherein an inner surface profile of the port recess (see annotated Fig. 14 above) is configured to mirror an outer profile of the port to align the guide cylinder with the receiving cup of the port in the first orientation and to prevent the port from engaging the port recess in a second orientation (see Fig. 14).
Regarding claims 15-17, Nelson discloses wherein an arc distance between the first position and the second position is between 1° and 180°, or is a non-factorable number of degrees of 360°, or is a prime number (rotates between the three mutually perpendicular axes, which would include between 1 and 360 degrees, Fig. 4, paras [0121]; [0124] and also para [0095], where 414 operates similar to 214).
Regarding claims 21-22, Nelson discloses wherein the needle channel moves in a circular path or a non-circular path between the first position and the second position (rotates between the three mutually perpendicular axes, Fig. 4, paras [0121]; [0124] and also para [0095], where 414 operates similar to 214).
Claims 2, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson and/or Nelson and Nelson 2, and further in view of Yavorsky et al, US 2020/0069871 A1.
Regarding claims 2 and 13, Nelson and/or Nelson as modified by Nelson 2 discloses the stabilization device according to claim 1 and claim 12, but is silent as to wherein a central axis of the needle channel is offset from a central axis of the guide cylinder.
However, Yavorsky, in the same field of art, teaches a stabilization device that is attached to a person’s skin and has a housing/guide (132, Figs. 3-4) with a movable needle mount (136, Fig. 3) having a needle channel/bore (178, Figs. 3-4) where the needle bore/central axis of the needle channel is offset from a central axis of the housing having the guide cylinder (para [0052], Figs. 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the central axis of the needle channel of Nelson offset from a central axis of the guide cylinder as taught by Yavorsky in order to provide the benefit of an adjustable range of motion and change the angle of insertion to the desired insertion site.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson and/or Nelson and Nelson 2, and further in view of Yodfat et al, US 2010/0137695 A1.
Regarding claims 9 and 20, Nelson and/or Nelson as modified by Nelson 2 discloses the stabilization device according to claim 1 and claim 12, but is silent as to further including a ratchet mechanism configured to prevent the guide cylinder from rotating from the second position to the first position.
However, Yodfat, in the same field of art teaches a stabilization device (see Figs. 9a-j, para [0119]) having a base/housing (30) with a guide cylinder/well (37) with a needle channel (angled passageway, para [0119]), where the guide cylinder is rotatable from a first position to a second position (titlable well, para [0119]), and also a ratchet mechanism (tilting mechanism with teeth, gear, cogwheel is equivalent to “ratchet” mechanism, 35, 35’, 39, 39’, 390, 390’, Figs. 9a-i) configured to prevent the guide cylinder from rotating from the second position to the first position (well can be fixed at desired angle or position, para [0119]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the guide cylinder of Nelson being tiltable by way of a ratchet mechanism as taught by Yodfat in order to provide the benefit of fixing the guide/well at the desired angle in position at the treatment site to ensure proper insertion of the needle (para [0119]).
Allowable Subject Matter
Claims 3, 8, 14, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose or render obvious the stabilization device according to claim 1, further including a dial, rotationally coupled with the body and configured to rotate the guide cylinder between the first position and the second position, and the method according to claim 12 further including rotating a dial from a first position to a second position to rotate the guide cylinder from the first position to the second position.
The prior art of record fails to disclose or render obvious the stabilization device and method according to claims 1 and 12, further including wherein the guide cylinder is configured to automatically rotate from the first position to the second position when a needle is removed from the needle channel and/or removing the needle from the needle channel causes the guide cylinder to automatically rotate from the first position to the second position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See additional references cited on PTO-892.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700