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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
Response to Amendment
Applicant has amended claim 8 which was previously objected to; Examiner accordingly withdraws the objection to claim 8.
Claim 1 has been amended. No new matter has been entered. Claims 1, 4-8, 12-19, 25-26, 28-29, and 32 remain pending.
Claim Rejections - 35 USC § 102
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, 4-8, 12-19, 25-26, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haindl et al. (US 20070123831, henceforth Haindl).
Regarding claim 1, Haindl discloses a toggling vascular access port (port 1, fig. 1), comprising: a port body (shallow body 2, insert element 11, and canula 17, fig. 4) coupled with a septum member (membrane 10, fig. 1) covering a cavity defined by the port body (chamber 12, see fig. 3 and see [0031]-[0032]); and at least one port body extension (clamping jaws 19, 20, fig. 2), wherein the port body extension comprises a proximal facing opening (the opening formed by clamping faces 21 and 22 including clamping ridges 40 and 41 is a proximal facing opening where the proximal direction is the direction pointing from canula 17 towards step 13 as shown in fig. 4 and the opening formed by the faces 21 and 22 would be visible in this direction if the port body was removed) configured to slidably receive a distal most portion of the port body (the distal most portion of the port body is canula 17 which is meant to be slidably inserted into the hollow space formed by clamping faces 21 and 22, see at least [0037] and [0038], the sliding is considered to be the lateral closing of the clamping jaws 19 and 20 around the canula 17); wherein the toggling vascular access port is selectively changeable from a delivery configuration (configuration of fig. 1, called out as a second position in [0009]) to a deployed configuration (configuration of fig. 5, called out as a first position in [0009]) by forcing the distal most portion of the port body into the proximally facing opening of the port body extension (if canula 17 is inserted into the proximally facing opening by closing the clamping jaws 19 and 20, the assembly will begin in the delivery configuration as claimed as this would mean that the clamping jaws 19 and 20 are closed) and causing the at least one body port extension to expand laterally (see the difference between figs. 1 and 5, clamping jaws 19 and 20 are expanded laterally in the state of fig. 5) in response to further distally moving the port body relative to the at least one port body extension (see the difference between figs. 1 and 5, shallow body 2 and insert element 11 are moved distally relative to clamping jaws 19 and 20 including at fastening arms 27 and 28, respectively, where the lateral expansion of clamping jaws 19 and 20 about a hinge means that jaws 19 and 20 are moving laterally and proximally relative to shallow body 2 and insert element 22, thus shallow body 2 and insert element 11 move distally to clamping jaws 19 and 20) along at least one defined route (see figs. 1, 4, and 5, clamping jaws 19 and 20 rotate along a path which is a defined route as claimed) extending distal to the proximal facing opening (the distal most ends of clamping jaws 19 and 20 which including the clamping faces 21 and 22 as shown in fig. 5 move along their respective defined routes distally to the proximal facing opening’s location where they extend in the distal direction beyond the point at which the opening is located, which appears to be at the rear end 6 of upper side 3 of housing 1 as shown in fig. 5) on at least one of two opposing sides of the port body (see figs. 1, 4, and 5, since clamping jaws 19 and 20 rotate on respective arced paths on their respective sides of shallow body 2, they work on two opposing sides of the port body), wherein the at least one port body extension and the port body are approximated along a median plane of the port body (see fig. 2, the median plane cuts through catheter 38 and hole 42 at front end 5 and separates jaws 19 and 20 in fig. 2) and laterally opposing portions of the at least one port body extension are parted transversely to the median plane by the lateral expansion (see fig. 2, jaws 19 and 20 are split about the median plane), thereby reducing length-to-width ratio of the toggling vascular access port (see fig. 5, when jaws 19 and 20 are pulled apart, the length as measured from front end 5 to rear end 6 decreases and the width measured between longitudinal sides 7 and 8 increases).
Regarding claim 4, Haindl discloses the port wherein the at least one port body extension includes a first arm located to the right of the median plane (clamping jaw 20, see fig. 5, which is to the right of the median plane when viewed from upper side 3 with front end 5 pointed downwards; this convention will be used throughout the remainder of the Office Action unless specified) and a second arm located to the left of the median plane (clamping jaw 19, see fig. 5, which is to the left of the median plane).
Regarding claim 5, Haindl discloses the port wherein, when in the delivery configuration, each one of the first and second arms includes a head portion (see called out head portions in annotated fig. 5 below) and a body portion (see called out body portions in annotated fig. 5 below; these are also referred to as fastening arms 27 and 28, respectively, in fig. 5 and in [0039]), wherein the head portions are in contact with each other along the median plane (see figs. 1 and 5, the wide head portions contact each other along the median plane at end faces 26 and 23 in the delivery configuration of fig. 1) and the body portions surround a distal portion of the port body from both sides of the median plane (see fig. 1, arms 27 and 28 wrap around the radial exterior of housing 2 as shown including about the median plane).
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Annotated fig. 5 from Haindl for the rejection of claims 5-6
Regarding claim 6, Haindl discloses the port configured to separate between the head portions transversely to the median plane when the toggling vascular access port shifts from the delivery configuration (see annotated fig. 5 above, which has been shifted from the delivery configuration of fig. 1 and shows the called out wide head portions as being transversely separated to the median plane).
Regarding claim 7, Haindl discloses the port wherein, when in the deployed configuration, the head portions are in juxtaposition from both sides of the port body (see annotated fig. 5 above calling out the wide head portions; they are considered to be in juxtaposition from both sides of housing 2 where they are placed to the side of the median plane which runs through housing 2) with each one of the head portions forming a gap with a front end of the port body (see fig. 4 which shows a gap between the called out wide head portions and projecting steps 34 and 35 of housing 2, particularly the parts of the called out wide head portions between latching hooks 32 and 33 and holes 42), thereby allowing tissue ingrowth therebetween (if the device of Haindl was to be implanted in the state of fig. 5, which it is structurally capable of doing, tissue would be able to grow between the called out portions of the wide head portions and housing 2; Examiner notes that therebetween is taken to be in reference to being between each of the wide head portions and the front end of the body; Examiner further notes that this allowing of tissue to grow is a functional requirement, and the device only needs to be capable of performing such a function.).
Regarding claim 8, Haindl discloses the port wherein the port body has an inferior portion (housing 2, fig. 1) and a posterior portion (insert 11, fig. 2), wherein the posterior portion is connected to the septum member (see [0034], they are connected where insert 11 is exerting a force on membrane 10 to cause it to curve outwards as disclosed), wherein the inferior portion surrounds the cavity below the septum member ([0032]), wherein the inferior portion includes a first lateral surface (groove 30 on longitudinal side 8, fig. 1) spanning most or all of a right side of the inferior portion (see fig. 1) and a second lateral surface (groove 30 on longitudinal side 7, fig. 1 and [0039]) spanning most or all of a left side of the inferior portion (see fig. 1 and [0039]), and wherein the at least one port body extension comprises a first arm (clamping jaw 20, see fig. 5) slidably connected to the first lateral surface (jaw 20 slides along the bottom surface of groove 30 such as to rotate outwards between the state of fig. 1 and the state of fig. 5) and restrictedly movable along a first defined route (see fig. 5 and fig. 1, jaw 20 can only move along 1 path relative to housing 2, and thus it is considered to be restrictedly moveable along this path which is a defined route) and a second arm (clamping jaw 19, see fig. 5) slidably connected to the second lateral surface (jaw 19 slides along the bottom surface of groove 30 such as to rotate outwards between the state of fig. 1 and the state of fig. 5) and restrictedly movable along a second defined route (see fig. 5 and fig. 1, jaw 19 can only move along 1 path relative to housing 2, and thus it is considered to be restrictedly moveable along this path which is a defined route).
Regarding claim 12, Haindl discloses the port wherein each one of the right and left sides of the inferior portion and/or of the at least one port body extension includes a rail mechanism (steps 36 and 37, respectively, see fig. 4 and see [0041], and latching hooks 33, 32, respectively, see fig. 4 and [0041]) along a length of the respective first or second lateral surface (steps 36 and 37 are along parts 30b of grooves 30, [0041]), defining the first and second defined routes, respectively (the steps 36, 37 facilitate the defined routes where they provide an endpoint which jaws 20 and 19 cannot rotate beyond).
Regarding claim 13, Haindl discloses the port wherein each rail mechanism includes a pair of a geometrically mating curved elongated ridge (latching hooks 33, 32, respectively, see fig. 4 and [0041]) and groove (steps 36 and 37, respectively, see fig. 4 and see [0041]) longitudinally interengaging with each other (see [0041]), wherein one of the ridge and the groove extend along the respective first or second lateral surface (see fig. 4) and the other of the ridge and the groove extend along the respective first or second arm (see fig. 4).
Regarding claim 14, Haindl discloses the port wherein, when in the deployed configuration, the first arm covers the first lateral surface (when viewing the port 1 from the right side in the state of fig. 5, clasping jaw 20 would block a view of groove 30 on the right side, and this is considered to be a covering as it hides from sight which is the definition of covering per Merriam-Webster) and the second arm covers the second lateral surface (when viewing the port 1 from the left side in the state of fig. 5, clasping jaw 19 would block a view of groove 30 on the left side, and this is similarly considered to be a covering).
Regarding claim 15, Haindl discloses the port configured such that an inner surface of each respective first or second arm is in contact with the respective first or second lateral surface with substantially no gap therebetween (see [0042], clamping jaws 19 and 20 fit together well with grooves 30 as they have matching outlines, thus it is understood that there is no substantial gap between the elements).
Regarding claim 16, Haindl discloses the port wherein, when changing from the delivery configuration to the deployed configuration, the at least one port body extension is configured to rotate around an axis of rotation (see figs. 5 and 1, when going from the state of fig. 1 to the state of fig. 5, which the device is physically capable of, clamping jaws 19 and 20 rotate about arcuate central portion 31 of clasp 20 as shown on fig. 5) and configured to slide with an inner surface thereof on at least one of two opposing sides of an inferior portion of the port body (the median plane facing surfaces of arms 28 and 27 of clamping jaws 19 and 20 would slide when moving from the state of fig. 1 to the state of fig. 5 along the bottom surfaces of grooves 30 such as to outwardly release clasping jaws 19 and 20, with the bottom surfaces of grooves 30 being on both of the longitudinal sides of housing 2 which is an inferior portion of the port body as claimed).
Regarding claim 17, Haindl discloses the port wherein the axis of rotation is located farther than and beyond a closer one of the two opposing sides of the inferior portion relative to the inner surface of the port body extension (since the axis of rotation is at arcuate central portion 31 which is longitudinally beyond grooves 30 as shown in fig. 5, this is understood to be true).
Regarding claim 18, Haindl discloses the port wherein the inner surface of the at least one port body extension is configured to cover a front end of the port body (when viewing the port 1 from the front side in the state of fig. 5, clasping jaws 19 and 20 would block a view of at least a portion of front end 5, and this is considered to be a covering as it hides from sight which is the definition of covering per Merriam-Webster) and not cover most of the at least one of the two opposing sides of the inferior portion (when viewing the port 1 from the rear side in the state of fig. 5, clasping jaws 19 and 20 would not block a view of grooves 30), when the toggling vascular access port is in the delivery configuration (see fig. 5).
Regarding claim 19, Haindl discloses the port wherein, when in the deployed configuration, the at least one port body extension covers at least most of the two opposing sides of the port body inferior portion (see state of fig. 1; clasping jaws 19 and 20 and fastening arms 28 and 27 thereof cover all of grooves 30 along longitudinal sides 7 and 8 where they block the grooves from view).
Regarding claim 25, Haindl discloses the port wherein the at least one port body extension is rotatably and slidably connected to the port body (see figs. 1, 4, and 5, clamping jaws 19 and 20 rotate along a path which is a defined route) and is configured to rotate around an axis of rotation (see figs. 5 and 1, when going from the state of fig. 1 to the state of fig. 5, which the device is physically capable of, clamping jaws 19 and 20 rotate about arcuate central portion 31 of clasp 20 as shown on fig. 5) and slide on the at least one of the two opposing sides of the port body when changing from the delivery configuration to the deployed configuration (the median plane facing surfaces of arms 28 and 27 of clamping jaws 19 and 20 would slide when moving from the state of fig. 1 to the state of fig. 5 along the bottom surfaces of grooves 30 such as to outwardly release clamping jaws 19 and 20, with the bottom surfaces of grooves 30 being on both of the longitudinal sides of housing 2 which is an inferior portion of the port body as claimed).
Regarding claim 26, Haindl discloses the port further comprising a toggle anchoring mechanism (clasp 29 and arcuate central portion 31, fig. 5 and [0039]) integrated in the port body and/or the at least one port body extension (see [0039]) and configured to rotate the at least one port body extension around an axis of rotation (see [0039]) and translate the at least one port body extension along the at least one of the opposing sides of the port body when changing from the delivery configuration to the deployed configuration (clamping jaws 19 and 20 translate where the wide head portions as called out in annotated fig. 5 above move longitudinally along the median plane relative to their position in the state of fig. 1).
Regarding claim 28, Haindl discloses the port configured such that the at least one defined route is inclined to a longitudinal axis of the port body so as to gradually increase or decrease distance between a bottom of the port body and a bottom of the at least one port body extension, when changing from the delivery configuration to the deployed configuration (see figs. 1 and 5, when going from the state of fig. 1 to the state of fig. 5 the distance between the bottom 4 of housing 2 and the bottom of clamping jaws 19 and 20 will increase as the jaws get further from the median plane).
Claim 29 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glenn (US 20070161958, henceforth Glenn).
Regarding claim 29, Glenn discloses a method for deploying a toggling vascular access port (port 210, fig. 16; see also [0065] which notes the equivalency of structures between the port of fig. 16 and the port of fig. 1; note also that there appears to be a typographical error in Glenn where [0065] refers to dual wing port 110 but the referenced fig. 16 shows the port with the reference number 210; the embodiment of fig. 16 is relied upon) in a body of a subject (see fig. 14, equivalent port 10 is inserted subcutaneously into the body of a patient), the method comprising: forming a surgical opening through skin tissue layers to a subcutaneous target implantation site in the subject body (see incision I in fig. 14 and see [0003], [0004], and [0038]); through the surgical opening, inserting the toggling vascular access port in a delivery configuration into the target implantation site (see fig. 14 and see the configuration of port 210 in fig. 15, this is the claimed delivery configuration), wherein the toggling vascular access port includes a port body (see port body 20, fig. 14, which is understood to be present in the chosen embodiment in light of [0065]) and at least one port body extension (wings 120 and 130 are port body extensions, see fig. 15); and changing the toggling vascular access port into a deployed configuration (see the configuration of port 210 in fig. 16, this is the claimed deployed configuration) by forcing the at least one port body extension to expand laterally (see the differences between the configurations of figs. 15 and 16, wings 120 and 130 are laterally expanded in fig. 16 where they are further apart) in response to distally moving the port body relative to the at least one port body extension (the side of wings 120 and 130 which is closer to coupling 60 are moved proximally relative to coupling 60 and relative to the portion of port body 20 which is closest to coupling 60, and thus port body 20 in this portion is moved distally relative to wings 120 and 130 as claimed) along at least one defined route (the movement of wings 120 and 130 is a movement along a defined route as called out by the arrows shown in figs. 15 and 16) on at least one of two opposing sides of the port body (see the difference between figs. 15 and 16, the deployed configuration is marked by wings 120 and 130 moving on the sides of the port 210 along directions E and D as shown), thereby approximating the at least one port body extension and the port body along a median plane of the port body (see figs. 15 and 16 where the median plane cuts longitudinally through coupling 60; a section view is provided from the median plane of an alternative embodiment of the claimed port as shown in figs. 4 and 8) and parting laterally opposing portions of the at least one port body extension transversely to the median plane by the lateral expansion (see figs. 15 and 16, laterally opposing portions are wings 120 and 130 which are parted transversely relative to the median plane where they slide along directions E and D), thereby reducing length-to-width ratio of the toggling vascular access port (when changing from the configuration of fig. 15 to the configuration of fig. 16, the length of port 210 as measured along the median plane remains unchanged, while the width of the port 210 as measured perpendicular to the median plane increases where wings 120 and 130 rotate to make the port wider, thus reducing a length-to-width ratio as claimed).
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.
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 32 is rejected under 35 U.S.C. 103 as being unpatentable over Glenn (US 20070161958) as applied to claim 29 above, and further in view of Egle et al. (US 20090259187, henceforth Egle).
Regarding claim 32, Glenn discloses the method wherein a rear end of the port body comprising a port clamping portion (the end of port 210 of fig. 15 opposite coupling 60), wherein the inserting includes pushing the toggling vascular access port to the target implantation site (subcutaneous pocket is a target implantation site, see [0004] and see fig. 14 which shows an alternative embodiment being pushed from outside the body to in the subcutaneous pocket at the target implantation site).
Glenn does not disclose the method wherein the inserting includes clamping the port clamping portion with medical forceps and pushing the toggling vascular access port to the target implantation site with the medical forceps. Egle teaches that is beneficial to not touch a vascular access port with a surgeon’s glove (see [0048] and [0049]) as this can cause contamination and infection and risks loss of sterility ([0007]). Egle also teaches the use of medical forceps ([0048]), which is a well known way for a surgeon to touch things without using their glove.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have gripped, or clamped, the port clamping portion of Glenn with medical forceps and to have used these medical forceps to have pushed the toggling vascular access port of Glenn to the target implantation site as this would provide the benefit of preventing loss of sterility and infection which can come with touching the access port with a surgeon’s glove (see Egle [0007]) and would yield the same, predictable result of the vascular access port of Glenn being delivered to the target implantation site for use.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Regarding Haindl, Applicant has argued that Haindl does not disclose the newly claimed proximal facing opening arrangement as claimed. Examiner respectfully disagrees. While the opening of Haindl is different from that of Applicant, the claim does not specify how the opening is meant to face in a proximal direction or provide for which direction within the assembly is meant to be a proximal or distal direction. The opening at the clamping faces of Haindl meets all of the structural and functional limitations required by the amended claim as indicated in the rejection above, and thus Applicant’s arguments are respectfully found unpersuasive.
Regarding Glenn, Applicant argues that the implantation procedure of Glenn relied on for the rejection of claim 29 does not disclose the limitation of “forcing the at least one port body extension to expand laterally in response to distally moving the port body relative to the at least one port body extension” as required by the claim where Glenn relies on a surgeon acting on the wings of the device. Examiner respectfully disagrees. While Glenn does rely on action from a surgeon tightening a suture to change configurations, the suture pulls on both the body and the wing simultaneously, and their respective interactions with the tensioned suture cause distal movement of the body relative to the wings and lateral expansion of the wings as claimed. This is noted in Glenn [0009] where it states “Most preferably, appropriate holes are provided in the body and wing through which sutures can pass. Such a suture line can be drawn tight once the port is implanted to cause the wing to rotate to its deployed position”. This is also shown, for example in fig. 9 and explained in [0045], at tunnel 27 which allows for the interaction of the body, wing, and suture to achieve the deployed configuration. Use of the suture only in the wing and not interacting with the body would cause the entire implanted assembly to shift in the direction of tension as opposed to changing configurations. The interaction of forces as claimed does not prohibit additional elements from being involved in the interaction, it only requires that the distal movement of the body relative to the wings (which is the same as proximal movement of the wings relative to the body) causes lateral expansion of the wings, which occurs with the interaction with the sutures in Glenn.
Thus, Applicant’s arguments are respectfully found unpersuasive and all pending claims are rejected as indicated in the body of the rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783