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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 12/11/2023. Claims 9-20, 22, and 50-52 are currently pending and being examined.
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the other end” in line 7 and 8. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “an other end”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the larger and the smaller ends” in line 8. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a larger end and a smaller end”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Claim 1 recites “said port” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “transcutaneous access port”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites “said access channels” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said one or more access channels”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 15 recites “said access port” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said transcutaneous access port”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Claim 16 recites “said cap” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said extracorporeal protection cap”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: Claim 17 recites “said cap” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said extracorporeal protection cap”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: Claim 17 recites “said access port” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said transcutaneous access port”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: Claim 18 recites “the inner diameter of the inner lumen is smaller at its distal end compared to a larger diameter at its proximal end in order to increase the pressure of the fluid infusion through the connected intracorporeal conduit and whereby the transition between the smaller and the larger diameters”. However, there are multiple antecedent issues. Examiner suggests reciting “an inner diameter of the inner lumen is smaller at its distal end compared to a larger diameter at its proximal end in order to increase a pressure of a fluid infusion through a connected intracorporeal conduit and whereby a transition between the smaller diameter and the larger diameter”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the inner diameter of the inner lumen is larger at its distal end compared to a smaller diameter at its proximal end in order to decrease the pressure of the fluid infusion through the connected intracorporeal conduit and whereby the transition between the smaller and the larger diameters”. However, there are multiple antecedent issues. Examiners suggests reciting “an inner diameter of the inner lumen is larger at its distal end compared to the smaller diameter at its proximal end in order to decrease a pressure of a fluid infusion through a connected intracorporeal conduit and whereby a transition between the smaller diameter and the larger diameter”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: Claim 20 recites “the implantable medical mesh is attached to the outside wall of said device, said mesh”. However, there are multiple antecedent issues. Examiner suggests reciting “an implantable medical mesh is attached to an outside wall of said transcutaneous access port, said implantable medical mesh”. Appropriate correction is required.
Claim 50 is objected to because of the following informalities: Claim 50 recites “the longitudinal axis of the inner lumen of said subcutaneous segment and the longitudinal axis of the inner lumen of said port body can be configured at a variable angle with respect to each other in order to adapt to the anatomy of the access and implant locations”. However, there are multiple antecedent issues. Examiner suggests reciting “a longitudinal axis of the inner lumen of said subcutaneous segment and a longitudinal axis of the inner lumen of said port body can be configured at a variable angle with respect to each other in order to adapt to an anatomy of an access location and an implant location”. `Appropriate correction is required.
Claim 51 is objected to because of the following informalities: Claim 51 recites “the skin and into the inner lumen of said port”. However, there are multiple antecedent issues. Examiner suggests reciting “the patient’s skin and into the inner lumen of said transcutaneous access port”. Appropriate correction is required.
Claim 52 is objected to because of the following informalities: Claim 52 recites “the access channels of removable adaptor that are covered by the skin, can be located by an operator through the skin”. However, there are multiple antecedent issues. Examiner suggests reciting “the one or more access channels of removable adaptor that are covered by the patient’s skin, can be located by an operator through the patient’s skin”. Appropriate correction is required.
Examiner has attempted to find every antecedent issue but applicant is encouraged to fully review their claims for antecedent issues.
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 9, 10, 12, 19, 22, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kramer (USPN 9,174,008).
In reference to independent claim 9, Kramer discloses a transcutaneous access port (fig 4 and 5) for hemodialysis (col 1, lines 38-54 discloses that the port is for a “hemodialysis procedure”) comprising a port body (54) with a subcutaneous segment (40) attachable to an intracorporeal conduit (84, fig 10 and 11), said transcutaneous access port having an inner lumen profile (lumen profile of 40),
characterized in that the said inner lumen has tapering walls with a larger diameter at one end of said inner lumen and a smaller diameter at the other end of said inner lumen (both fig 4 and 5 shows a taper, with fig 4 tapering smoothly outward and fig 5 tapering smoothly inward) and
a smooth transition between the larger and the smaller ends of said inner lumen such as to provide variable blood flow characteristics adapted to either arterial or venous blood flow while minimizing blood flow turbulences (the previous paragraph is functional language that is explicitly met by the structure being present in fig 4).
In reference to dependent claim 10, Kramer discloses the transcutaneous access port according to claim 9, characterized in that the said transcutaneous access port (fig 4) comprises a valve (60).
In reference to dependent claim 12, Kramer discloses the transcutaneous access port according to claim 10, characterized in that the said valve is configured to open when a device (needle 32) is pushed into said port body through said valve (pictured in fig 8 and 9 when needle 32 pierces the access port).
In reference to dependent claim 19, Kramer discloses the transcutaneous access port according to claim 9, characterized in that the inner diameter of the inner lumen is larger at its distal end (52) compared to a smaller diameter at its proximal end (left side of 40, fig 4) in order to decrease the pressure of the fluid infusion through the connected intracorporeal conduit and whereby the transition between the smaller and the larger diameters is smooth in order to minimize fluid flow turbulences (fig 4 shows a smooth transition between the two ends).
In reference to dependent claim 22, Kramer discloses the transcutaneous access port according to claim 9, characterized in that the said transcutaneous access port comprises an extracorporeal connector (62 in fig 3) to provide needleless connection to a dialyzer (66, fig 3), said extracorporeal connector comprising a conduit (62) with a proximal end (connected to 66) and a distal end (64), wherein said distal end includes a matching connector (64) that can be attached to the device of claim 9 and said proximal end can be attached to a dialyzer (col 4, lines 56-62 discloses “ a neck 61 arranged for being joined with an external delivery tube 62, by means of a coupling 64. As illustrated diagrammatically, external delivery tube 62 is connected to a processing apparatus which, for illustrative purposes, comprises a dialysis apparatus 66 for receiving and processing blood to be delivered through access tube 40”).
In reference to dependent claim 50, Kramer discloses the transcutaneous access port according to claim 9, characterized in that the longitudinal axis of the inner lumen (axis of 40) of said subcutaneous segment and the longitudinal axis of the inner lumen of said port body can be configured at a variable angle with respect to each other in order to adapt to the anatomy of the access and implant locations (col 6, lines 5-10 disclose “a neck 61 arranged for being joined with an external delivery tube 62, by means of a coupling 64. As illustrated diagrammatically, external delivery tube 62 is connected to a processing apparatus which, for illustrative purposes, comprises a dialysis apparatus 66 for receiving and processing blood to be delivered through access tube 40” examiner takes the position that due to the highly flexible nature of the tube allows for the port to be oriented at various angles).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kramer (USPN 9,174,008) in view of Dicarlo (USPAP 2007/0100302).
In reference to dependent claim 11, Kramer discloses the transcutaneous access port according to claim 10, however
Kramer is silent to the valve is configured to open when negative pressure or positive pressure is applied through the inner lumen of said port.
Dicarlo, a similar access port, teaches a valve is configured to open when negative pressure or positive pressure is applied through the inner lumen of said port (para 0022 discloses “When the pressure exerted against the valve membrane 156 is greater than the threshold pressure, the valve membrane 156 opens to permit fluid flow therethrough”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to impart the pressure sensitivity taught in the valve of Dicarlo to the access port of Kramer so that the fluid passes through the valve into the fluid conduit to reach a target site, para 022; DiCarlo.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kramer (USPN 9,174,008) in view of Tennican (USPAP 2018/0243545).
In reference to dependent claim 15, Kramer discloses the transcutaneous access port according to claim 9, however
Kramer does not teach that the said access port comprises an extracorporeal protection cap.
Tennican, a medical device for use with dialysis (para 0075), teaches an extracorporeal protection cap (117 and 118, fig 20 and 21, the cape in this case would be extracorporeal because the access port of Kramer is originally extracorporeal, furthermore the cap is shown in extracorporeal examples such as fig 16), for use with access ports (para 0075 discloses “Device caps in accordance with the invention can be utilized independent of the devices for cleansing and protection of alternative access catheters and ports such as intravascular, peritoneal dialysis, urinary ports and catheters, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cap of Tennican on the access port of Kramer “for cleansing and protection of alternative access catheters and ports” para 0075, Tennican.
In reference to dependent claim 16, Kramer discloses the transcutaneous access port according to claim 15, Tennican further discloses a device characterized in that the said cap is color-coded to allow for easy identification of blood vessel connections (para 0075 discloses “the caps can be packaged independently in pairs (one each of two differing sizes, colors, etc., in groups or in bulk, of one or more colors). FIGS. 20-21 show an example two cap packaging system 115 having a first cap 117 which can be for example a yellow cap and which can be a LEUR-LOK® type cap and a second cap 118 which can be, for example, a green cap and which can also be a LEUR-LOK®. ”).
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kramer (USPN 9,174,008) in view of Mathieu (USPN 5,015,374).
In reference to dependent claim 15, Kramer discloses the transcutaneous access port according to claim 9, however
Kramer is silent to the said access port comprises an extracorporeal protection cap.
Mathieu, a similar device for use with dialysis (title), teaches the port comprises an extracorporeal protection cap (1, fig 7; the cap of Mathieu is meant to be used on an extracorporeal dialysis unit).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cap of Mathieu on the access port of Kramer “so that the
In reference to dependent claim 17, Kramer discloses the transcutaneous access port according to claim 15, Mathieu further discloses a device characterized in that the said cap (1, fig 7) comprises a safety mechanism to prevent accidental opening and a ring-shaped seal (60) for fluid tight connection to the body of said access port (Mathieu is silent to an access port, however Kramer does above).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kramer (USPN 9,174,008) in view of Teitelbaum (USPAP 2010/0274223).
In reference to dependent claim 18, Kramer discloses the transcutaneous access port according to claim 9, however
Kramer does not teach that the inner diameter of the inner lumen is smaller at its distal end compared to a larger diameter at its proximal end in order to increase the pressure of the fluid infusion through the connected intracorporeal conduit and whereby the transition between the smaller and the larger diameters is smooth in order to minimize fluid flow turbulences.
Teitelbaum, a similar vasculature conduit teaches, the inner diameter of the inner lumen (lumen of 100, fig 2) is smaller at its distal end compared to a larger diameter at its proximal end (100, fig 2 shows a smaller distal end and larger proximal end) in order to increase the pressure of the fluid infusion through the connected intracorporeal conduit (the preceding if functional in nature and flows naturally from the disclosed structure which Teitelbaum clearly shows) and whereby the transition between the smaller and the larger diameters is smooth in order to minimize fluid flow turbulences (fig 2 shows a smooth transition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the lumen design taught by Teitelbaum in the access port of Kramer “to provide a sufficient target area for passing a sheathed needle through the patient's skin for access to the blood vessel” para 0029, Teitelbaum. To be clear, by using a tapering design the target area for the needle is increased while keeping the connection to the vessel small.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kramer (USPN 9,174,008) in view of Koarashi (USPAP 2022/0211978).
In reference to dependent claim 20, Kramer discloses the transcutaneous access port according to claim 9, however
Kramer is silent to the implantable medical mesh is attached to the outside wall of said device, said mesh providing additional anchoring means adapted for tissue ingrowth, tissue encapsulation or tissue adhesion and ensures greater stability and additional protection of said implanted device.
Koarashi, a similar access port, teaches the implantable medical mesh (31a, fig 1 & 4) is attached to the outside wall of said device (3), said mesh providing additional anchoring means (functional language met by the presence of medical mesh) adapted for tissue ingrowth, tissue encapsulation or tissue adhesion and ensures greater stability and additional protection of said implanted device (para 0028 discloses “The skin S is fixed to the porous portion 31a by inducing the cells in the thickness direction of the porous portion 31a (in the downward direction in FIG. 5) to pores (air gaps) formed in the porous portion 31a. As long as the cells can invade and grow in the porous portion 31a, the material for the porous portion 31a or the size of the pores is not particularly limited. For the porous portion 31a, a porous material known in the medical field, such as a mesh-shaped titanium fiber may be used”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the medical mesh as taught in Koarashi with the access port of Kramer “to provide a holding mechanism assembly that makes it possible to suppress cells being damaged in a space formed between an outer surface of a driveline and an inner wall of a communicating portion into which an inserting member is inserted” para 0006, Koarashi.
Claims 13, 14, 51, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Kramer (USPN 9,174,008) in view of Bizup (USPN 8,608,712).
In reference to dependent claim 13, Kramer discloses the transcutaneous access port according to claim 9, however
Kramer does not teach that the said transcutaneous access port is configured to be implanted subcutaneously under a patient’s skin.
Bizup, a similar access port, teaches the said transcutaneous access port is configured to be implanted subcutaneously under a patient’s skin (col 1, lines 35-41 discloses “The domed access surface rises upwardly at least as far as the surrounding periphery of the port housing, and conventionally such surface is domed so that a practitioner is easily able to locate the access port and particularly the septum access surface that is subcutaneously placed under the skin of the patient, by palpation.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the subcutaneous structure shown in fig 1 and 3 of Bizup on top of the access port taught in Kramer to “provide a subcutaneous self-sealing septum that defines an access site for multiple needle sticks through the covering skin tissue of the patient, through the septum and into the reservoir” col 1, lines 27-30, Bizup.
In reference to dependent claim 51, Kramer discloses the transcutaneous access port according to claim 13, Bizup further discloses a device characterized in that the said transcutaneous access port comprises a removable adaptor (26 and 14, fig 1-3) with one or more access channels (the access channels are formed by the “X” 40 and the periphery side wall 32, fig 1) that can guide an access needle through the skin and into the inner lumen of said port (col 3, lines 7-13 discloses “septum 14 includes a locator 40 along domed surface 30, that is preferably centered in relationship thereto and preferably is also integral therewith. Locator 40 is of a shape and height that during palpation, the practitioner is particularly able to discern the center of the domed access surface to better identify the access port topography for needle insertion.”).
In reference to dependent claim 14, Kramer discloses the transcutaneous access port according to claim 51, Bizup further discloses a device characterized in that the said access channels (the access channels are formed by the “X” 40 and the periphery side wall 32, fig 1) of said removable adaptor (26 and 14, fig 1-3) and their corresponding access points under the skin are provided in different configurations at different locations under the skin in order for needle punctures to be done at different locations on the skin as to allow the skin to heal from one needle puncture to the next (the different access channels in Bizup are at different locations and are at slightly different angles due to their presence on the dome 14).
In reference to dependent claim 52, Kramer discloses the transcutaneous access port according to claim 51, characterized in that the access channels of removable adaptor that are covered by the skin, can be located by an operator through the skin (col 3, lines 7-13 discloses “a locator 40 along domed surface 30, that is preferably centered in relationship thereto and preferably is also integral therewith. Locator 40 is of a shape and height that during palpation, the practitioner is particularly able to discern the center of the domed access surface to better identify the access port topography for needle insertion.”).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shubayev (USPN 7,223,253) discloses a multichannel access port.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783