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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed May 11, 2026, with respect to the rejection of claims 12, 14-17, 21-22 under 35 U.S.C. 103 as being unpatentable over Nelson in view of U.S. 2009/0187149 to Nelson et al ("Nelson 2"); claims 13 under 35 USC 103 as being unpatentable over Nelson and Nelson 2, and further in view of U.S. 2020/0069871 to Yavorsky et al. ("Yavorsky"); and claim 20 under 35 USC 103 as being unpatentable over Nelson and Nelson 2, and further in view of U.S. 2010/0137695 to Yodfat et al, ("Yodfat") have been fully considered and are persuasive. The rejections of claims 12-17, 20-22 have been withdrawn. It is agreed that claim 12 recites a method and therefore positively recites a receiving cup of a subcutaneous port, and therefore Nelson, Nelson 2, Yavorsky and/or Yodfat do not teach all the steps in the method of claim 12, and its dependent claims 13-22 (see page 10 of Remarks).
In regards to claim 4, applicant’s arguments are persuasive since claim 4 recites a specific structure of an inner surface profile of the port recess that 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. It is agreed that Nelson does not teach an equivalent inner surface profile that would prevent the port from engaging the port recess in a second orientation. The rejection of claim 4 under 35 U.S.C. 102(a)(1) over Nelson is withdrawn.
Applicant's arguments filed May 11, 2026 have been fully considered but they are not persuasive in regards to claim 1 and its dependent claims 2, 5-7, 9-11 under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2014/0276416 to Nelson et al, ("Nelson").
In response to applicant's argument that Nelson does not teach a subcutaneous port, a receiving cup of the port or that the anchor 400 interacts/engages with a subcutaneous port, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With respect to claim 1, the subcutaneous port in the preamble and the receiving cup are claimed functionally and not positively recited in the claim, therefore, Nelson does not have to expressly teach the port, only the capability of interacting with a port. Since Nelson teaches the structure as recited in the claim, and as noted in the rejection has a body (anchor 400) defining a port recess (areas around ball at bottom surface 409, Fig. 14) disposed in a bottom surface, that recess is capable of receiving a portion of a port, 110 of Nelson as shown by the walls of the port 110, and the space between the walls engaging with the bottom 409. Further, the port of Nelson is configured to receive a secondary medical device such as a catheter or lead (102, Fig. 14), and therefore, under the broadest reasonable interpretation, in light of specification, can be considered equivalent to a subcutaneous port as claimed.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., subcutaneous, needle-accessible, medical devices or vascular access ports that may be accessible by needle or in fluid communication with a catheter) are not recited in the rejected claims (See page 6 of Applicant’s remarks). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims do not require a secondary medical device in the form of a needle-accessible port of vascular port that can be accessed by a catheter. For the foregoing reasons, the rejections of claims 1, 2, 5-7, 9-11 are maintained.
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, 5-7, 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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Yavorsky et al, US 2020/0069871 A1.
Regarding claim 2, Nelson discloses the stabilization device according to claim 1 and claim 1 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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Yodfat et al, US 2010/0137695 A1.
Regarding claim 9, Nelson discloses the stabilization device according to claim 1 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, 4, 8 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. (See reasons for allowance for claim 4 above, and also see last non-final dated February 9, 2026)
Claims 12-22 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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