DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The Amendments filed 04/13/2026 have been entered.
Claims 15 and 19 have thereby been amended.
Claims 15-25 are being examined in this office action.
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 15-25 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 15 recites “a first conduit including….a first[/second] nozzle at a distal end as a component separate from the first[/second] conduit.” The language of the claim defines the nozzle as a component which comprises the first conduit, and subsequently claims that it must be a separate component from the first conduit. These limitations are in direct contradiction with one another. It is unclear if the first and second nozzles are a part of the first and second conduits, or if they are separate components that are attached to the first and second conduits. This claim language also makes it unclear what the structural definition/limits of the first and second conduits are. For the purposes of examination, claim 15 is interpreted to define the first and second nozzles as components initially separate from the first and second conduits.
Claim 16 recites “a stem assembly.” However, claim 16 and its depending claims 17-21 seem to only functionally recite the stem assembly, and fail to positively recite it. Although the depending claims describe the stem assembly in greater detail, claim 16 recites that the outer shell (which is positively recited in claim 15 as “a port assembly comprising….an outer shell”) “includes a distal receiving slot designed to receive a stem assembly,” and fails to explicitly claim that “the port assembly further comprises a stem assembly…” or the like. Because the stem assembly is merely functionally recited, it is unclear what the scope of claim 16 and its depending claims is intended to be.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 15-21 and 23-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marrs (US 6562023) in view of Ensminger (5350360) and in further view of Eliasen (US 20060100592).
Regarding claim 15, Marrs discloses a port assembly (Fig. 1: 20), comprising: a first conduit (see annotated Fig. 6 below) including a first receiving cup at a proximal end (receiving cups 65, see annotated Fig. 6 below) and a first nozzle at a distal end (see annotated Fig. 6 below), a first valve assembly (valve assemblies 66+64, see annotated Fig. 2 below) including a first seal (Fig. 9: seal formed when 66 is compressed between 78 of 64 and 79; col. 5, lines 39-41) and a first valve (Fig. 9: valve 66); a second conduit (see annotated Fig. 6 below) including a second receiving cup at a proximal end (receiving cups 65, see annotated Fig. 6 below) and a second nozzle at a distal end (see annotated Fig. 6 below), a second valve assembly (valve assemblies 66, see annotated Fig. 2 below) including a second seal (Fig. 9: seal formed when 66 is compressed between 78 of 64 and 79; col. 5, lines 39-41) and a second valve (Fig. 9: valve 66); and an outer shell surrounding the first conduit and the second conduit (Fig. 2: outer shell 100), the outer shell including a proximal portion surrounding the first receiving cup and the second receiving cup (Fig. 19: proximal portion of outer shell 104; Fig. 9: 104 surrounds cups 65 when assembled), and the distal portion surrounding the first nozzle and the second nozzle (Fig. 20: distal portion of outer shell 102; Fig. 20: 102 surrounds nozzles at 106), the first conduit, and the second conduit connected via press fit engagement (col. 5, lines 32 and 37-39; Fig. 9: 64 of each the first and second conduits interference/press fit to 62 of each the first and second conduits). However, Marrs discloses the valve assemblies as being located at the top of the receiving cups, and fails to disclose the valve assemblies as being located between each of the receiving cups and their respective nozzles. Additionally, Marrs fails to disclose the proximal and distal 102 portions of the housing being connected via press fit engagement.
Ensminger teaches an analogous port assembly (Ensminger: Fig. 4: analogous dual port assembly), wherein a first valve assembly (Ensminger: Fig. 5: 86, comprising valves 194 and 195 and seal 198, as seen in Fig. 15) is disposed between the first receiving cup and the first nozzle (Ensminger: Fig. 5: valve assembly 86 disposed between receiving cup 74 and nozzle seen in annotated Fig. 5 below) and wherein the first valve assembly is secured to the first conduit by the first nozzle (Ensminger: Fig. 5: valve assembly 86 secured by nozzle seen in annotated Fig. 5 below) and a second valve assembly is disposed between the second receiving cup and the second nozzle (Ensminger: Fig. 5 is a cross-sectional view of the dual port assembly of Fig. 4, depicting both the first and second conduits and associated assemblies) and wherein the second valve assembly is secured to the second conduit by the second nozzle (Ensminger: Fig. 5: valve assembly 86 secured by nozzle seen in annotated Fig. 5 below). It would have been obvious for one of ordinary skill in the art at the time the invention was made to have modified the Marrs valve assembly by incorporating the valve assemblies taught by Ensminger, such that the location of the valve assemblies of Marrs are rearranged to be located between each receiving cup and their respective nozzles, as taught by Ensminger, in order to leave the receiving cups uncovered to allow for easier access when entering them (Ensminger: col. 9, line 66 – col. 10, line 3). However, the Marrs-Ensminger port assembly still fails to disclose the proximal and distal portions of the housing being connected via press fit engagement. As a result of this combination, the first nozzle would be a component separate from the first conduit and the second nozzle would be a component separate from the second conduit, as Ensminger teaches the nozzles as attachable to their respective proximal conduits, rather that the nozzles being a continuous portion of the conduits as originally taught by Marrs. This incorporation by Ensminger allows for the nozzles (and respectively attached stem assembly, see the combined annotated figure below) to be attached to the conduits via snap-fit engagement in order to hold the valves in place at their more distal location.
Eliasen teaches another analogous port assembly with proximal and distal housing portions analogous to Marrs (Eliasen: Fig. 2: distal housing portion 12 and proximal housing portion 2), with the proximal portion (Eliasen: Fig. 2: 2), the distal portion (Eliasen: Fig. 2: 12) connected via press fit engagement (Eliasen: para. [0026], sentences 2-3). It would have been obvious for one of ordinary skill in the art at the time the invention was made to have modified the Marrs-Ensminger housing connections of ultrasonic welding (Marrs: col. 5, lines 50-52) by incorporating, instead, the press fit engagement of the parts taught by Eliasen, in order to create a secure but lower cost and reversible connection of the housing portions.
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Annotated Fig. 6, Marrs
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Annotated Fig. 2, Marrs
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Annotated Fig. 5, Ensminger
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Combined annotated Marrs and Ensminger
Regarding claim 16, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 15, as described above, wherein the distal portion of the outer shell includes a distal receiving slot (Marrs: Fig. 20: slot 106) designed to receive a stem assembly (Marrs: Fig. 6: stems 34 and 36 + 80).
Regarding claim 17, Marrs in view of Ensminger teaches the port assembly according to claim 16, as described above, wherein the stem assembly (Marrs: stems 34 and 36 + 80) includes a housing (Marrs: Figs. 5-6: 80; col. 5, lines 63-64) having a proximal end designed for insertion into the distal receiving slot (Marrs: Figs. 2 and 6: distal end of 80 inserted into/resting on 106), and wherein the stem assembly is connected to the distal portion of the outer shell via press fit engagement (Ensminger: Fig. 5: stem 92 press fit into housing 72, further specified in col. 12, lines 24-25, the exit plug defined as 188 in col. 12, lines 50 and 60-61; Fig. 16: stem 188+190 press fit into chamber 184 of the housing 200).
It would have been obvious for one of ordinary skill in the art at the time the invention was made to have modified the Marrs-Ensminger-Eliasen stem connection to the housing via ultrasonic welding (Marrs: col. 5, lines 63-64) by incorporating, instead, the press fit engagement of the stem to the housing taught by Ensminger, in order to create a secure but lower cost and reversible connection of the stem to the housing.
Regarding claim 18, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 17, as described above, wherein the stem assembly includes a first stem (Marrs: Fig. 6: 34) and a second stem (Marrs: Fig. 6: 36) extending from a distal end of the housing (see annotated Fig. 2 above), the first stem in fluid communication with the first receiving cup (see annotated Fig. 6 above), and the second stem in fluid communication with the second receiving cup (see annotated Fig. 6 above).
Regarding claim 19, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 18, as described above, further comprising a catheter (Marrs: Fig. 6: catheter 24) including a first lumen (Marrs: Fig. 6: 30) designed for insertion over the first stem (see annotated Fig. 6 above), a second lumen (Marrs: Fig. 6: 31) designed for insertion over the second stem (see annotated Fig. 6 above) and an annular collar (Marrs: Fig. 8: annular sealing collar 140 around catheter 24); and a locking member (Marrs: 120) configured to couple the stem assembly to the catheter (Marrs: col. 6, lines 9-10) wherein the locking member includes a catheter receiving channel extending form a proximal end to a distal end and an annular abutment configured to abut against the annular collar to inhibit longitudinal distal movement of the catheter (Marrs: Fig. 8: locking member 120 has a hollow channel/lumen through it, through which the catheter extends through, with an annular abutment contacting 140: see annotated Fig. 8 below).
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Annotated Fig. 8, Marrs
Regarding claim 20, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 19, as described above, wherein the stem assembly and the locking member are connected via protrusions and slots that snap-fit together. However, the Marrs-Ensminger-Eliasen assembly teaches that the stem assembly includes a first protrusion on an upper portion (Marrs: Fig. 4: 88) and a second protrusion on a lower portion (Marrs: Fig. 4: 90), and the locking member includes a first slot (Marrs: Fig. 21: 128) designed to snap-fit in the first protrusion (Marrs: col. 6, lines 40-44), and a second slot (Marrs: Fig. 24: 129) designed to snap-fit in the second protrusion (Marrs: col. 6, lines 40-44).
While the Marrs-Ensminger-Eliasen assembly teaches the reversed configuration of the slots and protrusions for the connection of the stem to the locking member, It would have been obvious for one of ordinary skill in the art at the time the invention was made to have merely reversed the arrangement of the slot and protrusion parts, such that the stem assembly includes a first slot on an upper portion and a second slot on a lower portion, and wherein the locking member includes a first protrusion designed to snap-fit in the first slot, and a second protrusion designed to snap-fit in the second slot, since it has been held that the rearranging of parts of an invention to merely reverse the arrangement of those parts involves only routine skill in the art since the device having the claimed arrangement of the locking features would not perform differently than the prior art device with the reversed arrangement of those same locking features (see MPEP 2144.04 VI A).
Regarding claim 21, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 20, as described above, wherein the outer shell, the housing, and the locking member together provide a smooth continuous outer surface (Marrs: Fig. 1: smooth and continuous surfaces between 120, 80, and 100).
Regarding claim 23, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 15, as described above, wherein the first seal and the first valve are disposed within a first seal valve housing (Marrs: Fig. 9: seal valve housing 76 of 62, which seal via 78 of 64 and valve 66 are disposed within; Ensminger: Figs. 15 and 16: valves 194+195 and seals 198 are disposed in valve housing 184) and the second seal and the second valve are disposed within a second seal valve housing (Marrs: Fig. 9: seal valve housing 62, which seal via 78 of 64 and valve 66 are disposed within; Ensminger: Figs. 15 and 16: valves 194+195 and seals 198 are disposed in valve housing 184).
Regarding claim 24, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 23, as described above, wherein each of the first seal and the second seal include a central hole (Marrs: Fig. 9: central hole 67 at seal 78; col. 5, lines 32-33), however, the valves of Marrs in the Marrs-Ensminger-Eliasen assembly fail to explicitly teach slits in the valves. However, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the slits in the valves taught by Ensminger (Fig. 15: slit 197 in valve 196) into the valves of Marrs, such that each of the first valve and the second valve include at least one slit, in order to allow for easier passage of a needle/device through the valve without having to forcibly pierce the valve 66, while still providing effective sealing (Ensminger: col. 12, lines 31-48).
Regarding claim 25, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 15, as described above, wherein each of the first receiving cup and the second receiving cup are concavely shaped (Marrs: Fig. 9: cups 65 are concavely shaped).
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marrs (US 6562023) in view of Ensminger (5350360) and in further view of Eliasen (US 20060100592) in further view of Lambrecht (US 5741228).
Regarding claim 22, Marrs in view of Ensminger in further view of Eliasen teaches the port assembly according to claim 15, as described above, but fails to explicitly teach grooves defined by the receiving cups.
Lambrecht teaches an analogous port assembly (Lambrecht: Fig. 7), wherein the first receiving cup defines a first groove aligned with the first conduit and the second receiving up defines a second groove aligned with the second conduit (Fig. 7: tapered “V” shaped grooves in the bottom of the receiving cups 14 of each conduit). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the “V” shaped grooves taught by Lambrecht into the bottom of the receiving cups of the Marrs-Ensminger-Eliasen assembly in order to provide better guidance of the entering needle and prevent the need for the needle to be jammed at different angles to find the entry hole/channel.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
Applicant argues that combining the valve/septum placement as taught by Ensminger with the Marrs device would not be obvious and would render the Marrs device unusable. However, the combination as described above, incorporates the structures of the Ensminger port (which are readily found across the art), such that the receiving cups would be open, as taught by Ensminger, and the seal between the needle and the septums would still be formed, but would be formed more distally in the port rather than at the top of the receiving cups, as Ensminger also teaches. These small and obvious rearrangement of structures would not, as Applicant asserts, render the Marrs device useless. Further, Marrs and Ensminger may be combined to incorporate the structures and placements of the Ensminger septums while also keeping the septums across the top of the receiving cups, as taught by Marrs. Rather than being needless and redundant, as Applicant asserts, this combination could be obvious to one of ordinary skill in the art to ensure proper sealing in the port, even if one of the septums were to tear and its seal were to fail during user error of insertion/removal of the needle.
The remainder of Applicant’s arguments are considered moot, as they are based upon the amendments to the claims and have been addressed in the updated rejections recited above.
For these reasons, as they are currently written, claims 15-25 stand rejected as recited above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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