DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 07/27/2026 is acknowledged.
Claims 7-11 and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/27/2026
Claim Rejections - 35 USC § 112
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.
Claims 5, 12-16, and 20 are 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 5 recites the limitation "the diametric center point of the first reservoir" and “the diametric center point of the second reservoir” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the phrase “and a stem” in line 8 renders the claim indefinite because it is unclear whether this is a different stem or the aforementioned stem in line 4 of claim 12. Examiner is interpreting it as the same stem.
Claim 20 recites the limitation "the port body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 13-16, these claims are rejected due to their dependency upon a rejected base claim.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tallarida et al. (U.S Patent Pub. No. 20130218103 A1, “Tallarida”) in view of Evans et al. (U.S Patent Pub. No. 20090156928 A1, “Evans”).
Regarding claim 1, Tallarida discloses the limitations of (Claim 1)
(Original) A subcutaneously implantable access port (10 in Fig. 1A-1D), comprising:
a body (12 in Fig. 1B) defining a first reservoir (22A in Fig. 1B) and a second reservoir (22B in Fig. 1B), a central port axis extending therebetween;
a stem (20 in Fig. 1B) having a base extending from the body (12) along a first stem axis angled relative to the central port axis (see Fig. 1B, para. 0043, and annotated Tallarida drawing 1 below), and a nozzle extending from the base (see annotated Tallarida drawing 1 below, examiner is interpreting the nozzle as the flared tip portion of the stem 20 extending from the base of the stem 20), the base extending from the body (12) between the first reservoir (22A) and the second reservoir (22B, see Fig. 1B and annotated Tallarida drawing 1 below).
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However, Tallarida fails to disclose (Claim 1) a nozzle extending from the base along a second stem axis and angled relative to the first stem axis, and the stem defining a first stem lumen in fluid communication with the first reservoir and a second stem lumen in fluid communication with the second reservoir.
Tallarida discloses an alternative stem embodiment (20’ in Fig. 4) for an alternative cup (14’’ in Fig. 4) which connect to the body (12) of the port (10) in the same manner as those shown in Fig. 1 (see para. 0047). The embodiment of Fig. 4 of Tallarida teaches (Claim 4) a nozzle extending from the base along a second stem axis and angled relative to a first stem axis (see Fig. 4, para. 0047, and annotated Tallarida drawing 2 below).
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Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stem of the embodiment of Fig. 1B of Tallarida with the angled stem of the embodiment of Fig. 4 of Tallarida as Tallarida discloses that the angled stem is preferred so as to provide a low-profile shape and better anatomical fit into the subcutaneous areas around muscle tissue (see para. 0047).
Evans discloses a similar subcutaneous, dual-reservoir port (10 in Fig. 1) having a stem (35 in Fig. 1) extending from the port (10) between the first reservoir (31 in Fig. 1) and the second reservoir (32 in Fig. 1, see para. 0037), wherein Evans teaches (Claim 1) the stem (35 in Fig. 1) defining a first stem lumen (41 in Fig. 1) in fluid communication with the first reservoir (31) and a second stem lumen (42 in Fig. 1) in fluid communication with the second reservoir (32, see para. 0034).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dual-reservoir port of modified Tallarida to explicitly have a first stem lumen and second stem lumen as claimed and taught by Evans according to known methods to yield predictable results. Both Tallarida and Evans disclose subcutaneous, dual reservoir ports having stems extending between a first and second fluid reservoir. Thus, one of ordinary skill in the art would have recognized that modifying the stem of Tallarida to define a first stem lumen and second stem lumen in fluid communication with the first and second reservoirs, respectively, would have yielded results that are predictable. Examiner further notes that separate stem lumens preserve the fluid isolation between the two reservoirs of the port and two lumens of the catheter.
Regarding claim 2, modified Tallarida discloses the port of claim 1, as discussed above. In modified Tallarida, Tallarida discloses (Claim 2) wherein the central port axis extends horizontally through a diametric center point of the first reservoir (22A in Fig. 1B) and through a diametric center point of the second reservoir (22B in Fig. 1B, see annotated Tallarida drawing 1 above – central port axis extends horizontally through the center points of the diameters of both circular reservoirs 22A and 22B).
Regarding claim 3, modified Tallarida discloses the port of claim 1, as discussed above. In modified Tallarida, the embodiment of Fig. 4 of Tallarida discloses (Claim 3) wherein the first stem axis extends perpendicular to the central port axis (see annotated Tallarida drawing 3 below).
Regarding claim 4, modified Tallarida discloses the port of claim 1, as discussed above. In modified Tallarida, the embodiment of Fig. 4 of Tallarida discloses
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(Claim 4) wherein the second stem axis extends parallel to the central port axis (see annotated Tallarida drawing 3 above).
Regarding claim 5, modified Tallarida discloses the port of claim 1, as discussed above. In modified Tallarida, Tallarida discloses (Claim 5) wherein the base extends from the body (12) between the diametric center point of the first reservoir (22A) and the diametric center point of the second reservoir (22B, see Fig. 1B).
Examiner notes with the modification of Tallarida to have the stem (20’) in Fig. 4, said stem (20’) and its base as annotated in the drawing 3 above would be attached to the body (12) of the port (10) in the same manner as the stem in Fig. 1B (see para. 0047).
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Regarding claim 6, modified Tallarida discloses the port of claim 1, as discussed above. In modified Tallarida, Tallarida discloses (Claim 6) wherein the body (12) extends along the central port axis between a first end and a second end (see Fig. 1B and annotated Tallarida drawing 4 below), the first reservoir (22A) disposed proximate the first end (see annotated Tallarida drawing 4 below), and the second reservoir (22B) disposed proximate the second end (see annotated Tallarida drawing 4 below), and wherein the base of the stem (20) extends from the body (12) between a first edge of the second reservoir (22B) disposed proximate the first end (see annotated Tallarida drawing 4 below), and a second edge of the first reservoir (22A) disposed proximate the second end (see annotated Tallarida drawing 4 below).
Examiner notes with the modification of Tallarida to have the stem (20’) in Fig. 4, said stem (20’) and its base as annotated in the drawing 3 above would be attached to the body (12) of the port (10) in the same manner as the stem in Fig. 1B (see para. 0047).
Claim(s) 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wadsworth, Jr. et al. (U.S Patent No. 5399168, “Wadsworth”) in view of Tallarida et al. (U.S Patent Pub. No. 20130218103 A1, “Tallarida”) in view of Powers et al. (U.S Patent No. 5833654, “Powers”).
Regarding claim 12, Wadsworth discloses the limitations of (Claim 12) a method of placing a catheter (90 in Fig. 1) and port system (10 in Fig. 1) subcutaneously (see Col.7, lines 40-59), comprising:
forming an incision site (see Col.7, lines 54-55);
coupling the catheter (70) with a stem (20 in Fig. 2) of the port (10, see Col.8, lines 46-49), the stem (20) defining a first stem lumen (67 in Fig. 4) and a second stem lumen (67a in Fig. 4, see Col.10, lines 43-49); and
inserting the port (10) through the incision site (see Col.7, lines 52-59), the port (10) including a first reservoir (40 in Fig. 2) and a second reservoir (42 in Fig. 2) disposed along the central port axis (see Fig. 2, annotated Wadsworth drawing 1 below for central port axis, and Col.9, lines 15-19),
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and a stem (20 in Fig. 2) having a base extending from the port (10) along a first stem axis between the first reservoir (40) and the second reservoir (42, see Fig. 4, annotated Wadsworth drawing 2 below for base and first stem axis – examiner is interpreting the base as the portion of the stem 20 annotated within the box below and extending along the first stem axis), and a nozzle extending from the base (see annotated Wadsworth drawing 2 below – examiner is interpreting the nozzle as the portion of stem 20 constituting the tip which is distal of the barbs 60 and 62).
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However, Wadsworth fails to disclose the limitations of the method (Claim 12) inserting the port through the incision site along a central port axis, and the nozzle extending from the base along a second stem axis angled relative to the first stem axis.
Tallarida discloses a subcutaneous, dual-reservoir port (10 in Fig. 1B) comprising a stem (20 in Fig. 1B) extending from the port between the first reservoir (22A in Fig. 1B) and the second reservoir (22B in Fig. 1B) having a base and nozzle tip both extending along a first stem axis which can be substituted with stem (18’ and 20’ in Fig. 4) having the base extending from the port along a first stem axis and the nozzle extending from the base along a second stem axis angled relative to the fist stem axis (see annotated Tallarida drawing 2 below, see para. 0043 and 0047).
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Since Wadsworth discloses a subcutaneous, dual-reservoir port having a stem extending between the first and second reservoir, and Tallarida discloses a subcutaneous, dual-reservoir port having a stem extending between the first and second reservoir in either a straight configuration (see Fig. 1B) or an angled configuration (see Fig. 4), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stem of Wadsworth extending the straight configuration from the port to have the angled configuration of Tallarida such that the base extends from the port along a first stem axis and the nozzle extends from the base along a second stem axis. Tallarida discloses that the angled stem provides a lower profile shape to better anatomically fit into the subcutaneous areas around muscle tissue and direct fluid sideways away from the port (see para. 0047).
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Powers discloses a subcutaneous, longitudinally aligned, dual-reservoir port (18 in Fig. 1) having a first reservoir (30 in Fig. 3) and a second reservoir (34 in Fig. 3) disposed along a central port axis (see annotated Powers drawing 1 below and Col.5, lines 52-59). Powers teaches (Claim 12) a method of placing a catheter and dual-reservoir port system subcutaneously by forming an incision site and inserting the port through the incision site along the central port axis (see Col.1, line 61 – Col.2, line 13).
Since modified Wadsworth discloses a catheter and dual-reservoir port system and method of insertion thereof where the stem of the port has an angled configuration with its nozzle directed towards a second of the port, and Powers discloses a method for placing a catheter and dual-reservoir port system that teaches the stem of the access port must be received within the incision site last after the rest of the access port to provide access to the outlet of the stem, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of inserting the modified system of Wadsworth such that the port is inserted through the incision site along the central port axis as taught by Powers such that the outlet of the stem in the angled configuration of modified Wadsworth is inserted essentially last after the rest of the port.
Regarding claim 13, modified Wadsworth discloses the method of claim 12, as discussed above.
In modified Wadsworth, Powers discloses (Claim 13) further including inserting a first end (25 in Fig. 2) of the port (18) through the incision site before the second end (27 in Fig. 2) of the port (18), disposed opposite the first end (25, see Fig. 2 and see Col.1, line 61 – Col.2, line 13 – the end 25 opposite of the end 27 with the stem is inserted through the incision site first), the first end (25) disposed proximate the first reservoir (30 in Fig. 3) and the second end (27) disposed proximate the second reservoir (32, see Fig. 2-3).
Thus, in combination, the modified port of Wadsworth comprising the stem in the angled configuration with the outlet of said stem proximate the second of the port would be inserted as taught by Powers such that the stem is essentially inserted last. Thus, the first end is inserted through the incision site first before the second end.
Regarding claim 14, modified Wadsworth discloses the method of claim 12, as discussed above. In modified Wadsworth, Wadsworth discloses (Claim 14) further including the first stem lumen (67 in Fig. 2 and 4) providing fluid communication between the first reservoir (40 in Fig. 2) and a first catheter lumen (72 in Fig. 2 and 4, Col.8, lines 50-54), and the second stem lumen (67a) providing fluid communication between the second reservoir (42) and a second catheter lumen (74 in Fig. 2, see Fig. 2 and 4 and Col.8, lines 50-54).
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Regarding claim 15, modified Wadsworth discloses the method of claim 12, as discussed above. In modified Wadsworth, Tallarida discloses (Claim 15) wherein the first stem axis extends perpendicular to the central port axis, and the second stem axis extends perpendicular to first stem axis (see annotated Tallarida drawing 3 below – examiner notes para. 0047 discloses that the cup 14’ is connected to the housing of the port 10 in the same manner shown as the cup 14 in Fig. 1B).
Regarding claim 16, modified Wadsworth discloses the method of claim 15, as discussed above. In modified Wadsworth, Tallarida discloses (Claim 16) wherein the second stem axis extends parallel to the central port axis (see annotated Tallarida drawing 2 above).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wadsworth in view of Tallarida in view of Powers as applied to claim 12 above, and further in view of Srisathapat et al. (U.S Patent No. 5527307, “Srisathapat”).
Regarding claim 20, modified Wadsworth discloses the method of claim 12, as discussed above. However, modified Wadsworth fails to disclose (Claim 20) further including securing a portion of the catheter within a channel defined within a surface of the port body.
Srisathapat discloses an implantable medication infusion pump (10 in Fig. 1) comprising a side port assembly (28 in Fig. 2-3) having a discharge tube (34 in Fig. 3) extending from the pump (10) along a first axis and a fitting (86 in Fig. 3) extending from the discharge tube (34) along a second axis disposed at an angle from the first axis (see Fig. 3), wherein the fitting (86) is configured to receiving a catheter (18 in Fig. 2, see Col.4, lines 3-10 and lines 56-65). Srisathapat teaches including securing a portion of the catheter (18) within a channel defined within a surface of the body (12, 30, in Fig. 2-3, see annotated Srisathapat drawing 1 below for channel and Col.5, lines 7-20 – examiner is interpreting the body of the pump 10 as the combined structure of the housing 12 and shell 30 of the side port assembly 28, catheter 18 is secured within the fitting 86 which is secured within a channel as annotated below defined in the surface of the shell 30, see Fig. 3 for catheter 18 within said shell 30 and thus within the annotated
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channel).
Since modified Wadsworth discloses the catheter and port system having an angled stem configuration that extends from the port housing and configured to couple to a catheter, and Srisathapat discloses a catheter and implantable infusion pump system having an angled stem configuration that extends from the pump housing and configured to couple to a catheter, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port body of modified Wadsworth to have a channel as taught by Srisathapat for securing the catheter to a surface of the port body. Srisathapat discloses that the connection between the infusion pump and the catheter ensures a quick and easy attachment while being capable of withstanding substantial fluid pressures without leakage (see Col.4, line 66 – Col.5, lines 2 and Col.5, lines 13-20). Thus, modified Wadsworth would be modified to have a side port assembly for housing the stem of the port, and thus the catheter would be received within a channel of the side port assembly for securing to the stem and the port.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
