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 .
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites “at lest” in line 2. The Examiner believes this is a typographical mistake and that the Applicant meant to recite “at least”
Appropriate correction is required.
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 1-12 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 1 recites the limitation “the length of the catheter” in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the length of the catheter is the same length of the channel recited in line 3.
All remaining claims are rejected as they depend on rejected independent claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(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 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braun et al. (U.S. Publication No. 20090326508), hereinafter Braun.
Regarding claim 1, Braun discloses a catheter system (catheter 100; see FIGS. 1-3; the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated) for implantation through the skin of a patient, the catheter system comprising:
a channel (shaft 105) comprising a length (see length of shaft 105) operable to extend through the skin of the patient;
wherein at least a portion of the length of the catheter is surrounded by a first porous membrane (membrane 110; see FIG. 1)) that is operable to receive tissue in-growth from the patient and enable indwelling of the catheter (see [0159;0220]); and
the first porous membrane comprises pore sizes of between approximately 1 - 50 microns (“pore size of 20-200 microns”, [0121-0123]).
Regarding claim 4, Braun discloses the claimed invention as discussed above concerning the rejection of claim 1, and Braun further discloses wherein the channel (shaft 105) comprises at least one of a silicone, a polymer and a thermoplastic (see polymer tubes, [0156]).
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.
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (U.S. Publication No. 20090326508), hereinafter Braun, in further view of Goffena et al. (U.S. Publication No. 20080021533), hereinafter Goffena.
Regarding claim 2, Braun discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Braun does not expressly state wherein the porous membrane is bonded to an exterior of the channel by at least one of a thermoplastic, silicone, cyanoacrylate and a polymer adhesive.
Goffena teaches a thin-wall PTFE (polytetrafluoroethylene) tube (Abstract) wherein the porous membrane (layers of film 21 and 22; see FIG. 2) is bonded to an exterior of the channel by at least one of a thermoplastic, silicone, cyanoacrylate and a polymer adhesive (see [0077])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the membrane of Braun to be bonded to an exterior of the channel by at least one of a thermoplastic, silicone, cyanoacrylate and a polymer adhesive. Doing so allows for avoidance of shrinkage during heating process of polymer layer, as taught by Goffena (see [0077]).
Regarding claim 13, Braun discloses a catheter system (catheter 100; see FIGS. 1-3; the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated) for implantation through the skin of a patient, the catheter system comprising:
a channel (shaft 105) comprising a length (see length of shaft 105) operable to extend through the skin of the patient;
wherein at least a portion of the length of the catheter is surrounded by a first porous membrane (membrane 110; see FIG. 1)) that is operable to receive tissue in-growth from the patient and enable indwelling of the catheter (see [0159;0220]);
the first porous membrane comprises pore sizes of between approximately 1 - 50 microns (“pore size of 20-200 microns”, [0121-0123]). However, Braun does not expressly state wherein the first porous membrane is thermally bonded to the catheter.
Goffena teaches a thin-wall PTFE (polytetrafluoroethylene) tube (Abstract) wherein the first porous membrane (first layer 21) is thermally bonded to the catheter (“The FEP layer allows for subsequent thermal bonding of the film”, [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the membrane of Braun to be thermally bonded to the catheter. Doing so allows for avoidance of shrinkage during heating process of polymer layer, as taught by Goffena (see [0077]).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (U.S. Publication No. 20090326508), hereinafter Braun, in further view of Thompson et al. (U.S. Publication No. 20210213254), hereinafter Thompson.
Regarding claim 3, Braun discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Braun does not expressly state wherein the first porous membrane is bonded to an exterior of the channel in a manner that is operable to reduce the entry of bacteria and prevent infections associated with the implantation of the catheter.
Thompson improved methods and means for peripheral, intravenous catheterization systems ([0021]) wherein the first porous membrane (see transparent membrane in [0028]) is bonded to an exterior of the channel (see FIG. 2) in a manner that is operable to reduce the entry of bacteria and prevent infections associated with the implantation of the catheter (see [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the membrane of Braun to be bonded to an exterior of the channel in a manner that is operable to reduce the entry of bacteria and prevent infections associated with the implantation of the catheter. Doing so minimizes the adverse consequences of the use of the device on a patient's skin and provides enhanced securement of catheter, as taught by Thompson (see [0021]).
Claims 5-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (U.S. Publication No. 20090326508), hereinafter Braun, in further view of Neuenfeldt et al. (U.S. Publication No. 20210401564), hereinafter Neuenfeldt.
Regarding claim 5, Braun discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Braun does not expressly state comprising a second porous membrane provided between the channel and the first porous membrane.
Neuenfeldt teaches an implantable medical device providing a layered gradient membrane (Abstract, [0009]) comprising a second porous membrane (second layer 14) provided between the channel (“The layers 12, 14 are laminated, adhered, or otherwise connected to one another.”, [0066]) and the first porous membrane (first layer 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Braun to comprise a second porous membrane provided between the channel and the first porous membrane. Doing so provides a vascularization layer, as taught by Neuenfeldt (see [0066]).
Regarding claim 6, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 5, and Neuenfeldt further teaches wherein the second porous membrane comprises pore sizes of between approximately 0.01 and 5 microns to allow for delivery of a therapeutic agent to the patient (“second layer 14 comprises an outer membrane of material having pores of about 5.0 to about 10.0 micron”, [0066]).
Regarding claim 7, Braun discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Braun does not expressly state wherein the catheter is in communication with an implantable cellular encapsulation device comprising a lumen for housing at least one of cells and a therapeutic agent.
Neuenfeldt teaches an implantable medical device providing a layered gradient membrane (Abstract, [0009]) wherein the catheter is in communication with an implantable cellular encapsulation device comprising a lumen for housing at least one of cells and a therapeutic agent (“an immuno-isolation implantable medical device is provided that comprises an inner lumen, and the inner lumen comprises a population of live cells or therapeutic agents.”, [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter of Braun to be in communication with an implantable cellular encapsulation device comprising a lumen for housing at least one of cells and a therapeutic agent. Doing so provides uniform diffusion properties and facilitates a more predictable and steady release of therapeutic agents, as taught by Neuenfeldt (see [0032]).
Regarding claim 8, Braun discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Braun does not expressly state wherein the channel is in fluid communication with an oxygen delivery device.
Neuenfeldt teaches an implantable medical device providing a layered gradient membrane (Abstract, [0009]) wherein the channel is in fluid communication (see [0037]) with an oxygen delivery device (pod 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the catheter of Braun wherein the channel is in fluid communication with an oxygen delivery device. Doing so provides uniform diffusion properties and facilitates a more predictable and steady release of therapeutic agents, as taught by Neuenfeldt (see [0032]).
Regarding claim 9, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 7, and Neuenfeldt further teaches wherein at least one of the catheter and the implantable cellular encapsulation device (implantable medical device, see [0013])) comprises an oxygen diffuser (see gradient membrane and oxygen flow in [0013]).
Regarding claim 10, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 9, and Braun further teaches wherein the diffuser comprises a super-hydrophobic membrane (“The porous membrane preferably comprises a hydrophobic material”, [0124]).
Regarding claim 11, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 10, and Braun further teaches wherein the super-hydrophobic membrane comprises at least one of a polytetrafluroethylene, an expanded polytetrafluroethylene, a polymer, a thermoplastic polyurethane, and silicone (“Teflon, polyethylene, polyethylene terephthalate, nylon, silicone, and cellulose acetate, etc. may all be used to form the porous membrane.”, [0124]).
Regarding claim 12, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 5, and Neuenfeldt further teaches comprising an over-pouch (pod 21) operable to retain a fluid and surround the encapsulation device (see [0078]).
Regarding claim 14, Braun discloses a catheter system (catheter 100; see FIGS. 1-3; the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated) for implantation through the skin of a patient, the catheter system comprising:
a channel (shaft 105) comprising a length (see length of shaft 105) operable to extend through the skin of the patient;
wherein at least a portion of the length of the catheter is surrounded by a first porous membrane (membrane 110; see FIG. 1)) that is operable to receive tissue in-growth from the patient and enable indwelling of the catheter (see [0159;0220]); and
the first porous membrane comprises pore sizes of between approximately 1 - 50 microns (“pore size of 20-200 microns”, [0121-0123]). However, Braun does not expressly state a first subcutaneous implantable encapsulation device comprising a lumen and a vascularization membrane, and wherein the lumen is in fluid communication with the channel.
Neuenfeldt teaches an implantable medical device providing a layered gradient membrane (Abstract, [0009]) comprising a first subcutaneous implantable encapsulation device (pod 21) comprising a lumen and a vascularization membrane, and wherein the lumen is in fluid communication with the channel (“a pod 21 comprising a single lumen or interior cavity. The housing or pod 21 comprises an outer layer 30, which preferably comprises a porous material and a vascularizing structure 32 within the outer layer 30 to induce vascularization at the surface and to reduce the immune response by a recipient.”, [0080]; see FIG. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Braun comprising a first subcutaneous implantable encapsulation device comprising a lumen and a vascularization membrane, and wherein the lumen is in fluid communication with the channel. Doing so provides provide both an immuno-protective barrier and a vascularizing structure, as taught by Neuenfeldt (see [0080]).
Regarding claim 15, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 14, and Neuenfeldt further teaches a second subcutaneous implantable encapsulation device comprising a lumen in communication with the channel (see Embodiment of FIG. 7 where pods 51 are a plurality of pods).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to comprise a second subcutaneous implantable encapsulation device comprising a lumen in communication with the channel, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 16, Braun in view of Neuenfeldt teaches the claimed invention as discussed above concerning the rejection of claim 15, and Neuenfeldt further teaches wherein the catheter comprises a bifurcation (hub 52) to deliver fluid to the first and second subcutaneous implantable encapsulation devices (see FIG. 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
06/11/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights