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 .
Status of Claims
Claims 33-56 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/29/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 36 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim 33-35. See MPEP § 608.01(n). Accordingly, the claim 36 has not been further treated on the merits. And is instead evaluated as dependent on claim 33.
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) 33-43, and 46-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aizenberg (US 20180127594 A1) in view of Appling (US 20100191165 A1).
Regarding Claim 33, Aizenberg teaches a tubing (paragraph [0194]) comprising, (ii) an outer wall having an outer surface located on the external face of the tubing (paragraph [0193] discloses a tube with a slippery surface applied an outer surface), and (iii) a fluorinated liquid ((liquid bis described a fluorinated liquid, [0166] [0217]); wherein
(a) the outer wall is comprised of a porous fluoropolymer having pores (paragraph [0194]),
(b) at least a portion of the fluorinated liquid is absorbed into the pores of the outer wall [0166] [0217]);, and a portion of the fluorinated liquid is located on the outer surface of the tubing [0166] [0217]);, and
(c) pores of the outer wall, and on the outer surface are in fluid communication and can flow between the pores and the outer surface (the pores/roughened surface are connected allowing fluid communication, figs.1-2b, 4, 5c, the pores also facilitated wicking, [0204]).
Aizenberg fails to teach at least two lumens separated by septa separating the lumens, the septa are comprised of a porous fluoropolymer having pores, the fluorinated liquid is absorbed into the pores of the septa, and (c) the fluorinated liquid in the pores of the septa.
Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port with a common teach at least two lumens separated by septa separating the lumens. The multiple lumens allowing the tubing to provide more than one function; such as, aspiration and return ([0003]). Furthermore, multilumen catheters are well known in the art of catheters ([0003]). The manner of enhancing a particular device was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement of Appling. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify a catheter, cannula, drain, shunt, port, or totally implantable venous access port of Aizenberg and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have readily recognized providing multiple lumen would have positively provided more than one function; such as, aspiration and return ([0003], Appling), or multiple delivery lumen that are well known in the art of catheters.
As to the limitation of the septa are comprised of a porous fluoropolymer having pores, the fluorinated liquid is absorbed into the pores of the septa, and (c) the fluorinated liquid in the pores of the septa, Aizenberg teaches that the tube has a slippery surface applied to both the inner and outer surface ([0193]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the pores and florinated liquid on the septa of the modified device of Aizenberg/Appling so that the inner surface includes the benefits of repelling biological objects, such as protozoa, bacteria, viruses, fungi, bodily fluids and tissues, proteins and the like ([0133], Aizenberg). It also well known to apply a slippery coating on catheter to reduce friction during insertion.
Regarding Claim 34, Aizenberg teaches a tubing (paragraph [0194]) comprising, (ii) an outer wall having an outer surface located on the external face of the tubing (paragraph [0193] discloses a tube with a slippery surface applied an outer surface), and (iii) a fluorinated liquid ((liquid bis described a fluorinated liquid, [0166] [0217]); wherein
(a) the outer wall is comprised of a porous fluoropolymer having pores (paragraph [0194]),
(b) at least a portion of the fluorinated liquid is absorbed into the pores[0166] [0217] and a portion of the fluorinated liquid is located on the outer surface of the tubing [0166] [0217]), and
(c) the fluorinated liquid in the pores of the outer wall and on the outer surface are in fluid communication and can flow between the pores and the outer surface (the pores/roughened surface are connected allowing fluid communication, figs.1-2b, 4, 5c, the pores also facilitated wicking, [0204]).
Aizenberg fails to teach at least one nonporous liner within and contacting the outer wall, the liner comprising a lumen. Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port with a common teach at least two lumens separated by septa separating the lumens. The multiple lumens allowing the tubing to provide more than one function; such as, aspiration and return ([0003]). Furthermore, multi lumen catheters are well known in the art of catheters (10003]). The manner of enhancing a particular device was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement of Appling Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify catheter, cannula, drain, shunt, port, or totally implantable venous access port of Aizenberg and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have readily recognized providing multiple lumen would have positively provided more than one function; such as, aspiration and return ([0003], Appling), or multiple delivery lumen that are well known in the art of catheters.
Regarding Claim 35, Aizenberg teaches a tubing comprising: (i) an outer wall having an outer surface located on the external face of the tubing ((paragraph [0193]), (ii) a nonporous liner comprising two or more lumens
PNG
media_image1.png
9
8
media_image1.png
Greyscale
and (iii) a fluorinated liquid ((liquid bis described a fluorinated liquid, [0166] [0217]); wherein
(a) the outer wall is comprised of a porous fluoropolymer having pores (paragraph [0194]),
(b) at least a portion of the fluorinated liquid is absorbed into the pores, and a portion of the fluorinated liquid is located (adsorbed) on the outer surface of the tubing [0166] [0217]), and
(c) the fluorinated liquid in the pores of the outer wall and on the outer surface are in fluid communication and can flow between the pores and the outer surface (the pores/roughened surface are connected allowing fluid communication, figs.1-2b, 4, 5c, the pores also facilitated wicking, [0204]).
Aizenberg fails to teach at least one nonporous liner within and contacting the outer wall, the liner comprising a lumen. Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port with a common teach at least two lumens separated by septa separating the lumens. The multiple lumens allowing the tubing to provide more than one function; such as, aspiration and return ([0003]). Furthermore, multi lumen catheters are well known in the art of catheters (10003]). The manner of enhancing a particular device was made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement of Appling. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify a catheter, cannula, drain, shunt, port, or totally implantable venous access port of Aizenberg and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have readily recognized providing multiple lumen would have positively provided more than one function; such as, aspiration and return ([0003], Appling), or multiple delivery lumen that are well known in the art of catheters.
Regarding Claim 36, Aizenberg in view of Appling teaches a medical device comprising a section of tubing according to any of claims 33 (paragraph [0194].
Regarding Claim 37, Aizenberg in view of Appling teaches the medical device according to claim 36. Aizenberg further teaches wherein the medical device is either fully implantable, or partially implantable or partially insertable, in a patient [0196].
Regarding Claim 38, Aizenberg in view of Appling teaches the medical device according to claim 37. Aizenberg further teaches the medical device is partially implantable or insertable in a patient, and the portion that is partially implantable or insertable in the patient is comprised of a section of tubing (central catheter) of the present disclosure [0196].
Regarding Claim 39, Aizenberg in view of Appling teaches the medical device according to claim 37. Aizenberg further teaches wherein the medical device is selected from the group consisting of catheters, cannulas, drains, shunts, totally implantable venous access ports, and ports (paragraph [0196]).
Regarding Claim 40, Aizenberg in view of Appling teaches the medical device according to claim 37. Aizenberg further teaches wherein the medical device is a catheter ports (paragraph [0196]).
Regarding Claim 41, Aizenberg in view of Appling teaches the catheter of claim 40. Aizenberg teaches wherein the catheter comprises (i) a distal end portion terminating in a tip forming the distalmost end of the catheter for insertion into a patient, and (ii) a proximal end portion (figs. 7c-7e show that the catheter has proximal and distal ends, Aizenberg); wherein: the distal end portion comprises a section of tubing having one two, three, or more lumens (fig. 7c-7e show flow through a lumen), with at least one lumen optionally comprising a nonporous polymer liner, , provided that when the catheter has a single lumen it is lined by a nonporous liner (106, [0019], Bell)the proximal end portion comprises one or more lumens, at least one of which is in fluid communication with at least one of the one, two, three, or more lumens of the distal end portion, and the proximal end portion comprises one or more fittings that form fluid tight seals with the one or more lumens of the proximal end portion (glue can be considered a fitting for sealing, [0192]); and the tip has one or more openings located either in the outer wall and/or at the tip providing fluid communication between one, two, three, or more lumens of the distal end portion and the exterior of the catheter (fig. 7c-7e show flow through a lumen with openings at both ends).
Regarding Claim 42, Aizenberg in view of Appling teaches a method of forming the tubing of claim 33. The combination teaches a tubing comprising an outer wall and two or more lumens separated by septa (Appling, (fig. 3d)), the method comprising extrusion (Appling: tubes are extruded before combining, [0103]) forming the outer wall and at least one septum (Appling: inner surface shown at 45, fig. 3d), wherein the outer wall and the at least one septum separating the lumens is comprised of a porous fluoropolymer ([0133], Aizenberg).
Regarding Claim 43, Aizenberg in view of Appling teaches method of claim 42. The combination further teaches wherein the tubing comprises three or more (e.g., four or more) lumens separated by septa (fig. 3d, Appling).
Regarding Claim 46, Aizenberg in view of Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port comprising a section of tubing according to claim 33 (paragraph [0196]).
Regarding Claim 47, Aizenberg in view of Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port of claim 46, wherein Aizenberg further teaches wherein the porous fluoropolymer comprises a porous per fluoropolymer [0155].
Regarding Claim 48, Aizenberg in view of Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port of claim 46, wherein Aizenberg further teaches the porous fluoropolymer is porous PTFE or porous PVDF (paragraph [0174]).
Regarding Claim 49, Aizenberg in view of Appling teaches a catheter, cannula, drain, shunt, port, or totally implantable venous access port of claim 48, wherein the porous PTFE is expanded PTFE (ePTFE) or electrospun PTFE (paragraph [0174] [0169]).
Regarding Claim 50, Aizenberg in view of Appling teaches the catheter, cannula, drain, shunt, port, or totally implantable venous access port of claim 49. Aizenberg teaches wherein the fluorinated liquid comprises perfluorodecalin or perfluorotributylamine [0267] .
Regarding Claim 52, Aizenberg in view of Appling teaches the catheter, cannula, drain, shunt, port, or totally implantable venous access port of claim 50, further comprising a reservoir lumen that is optionally filled with fluorinated liquid (paragraph [0205]).
Regarding Claim 53, Aizenberg in view of Appling teaches the catheter or cannula of claim 50 ([0169]).
Regarding Claim 54, Aizenberg in view of Appling teaches the drain, shunt, port, or totally implantable venous access port of claim 50 ([0169]).
Claim(s) 44, 45, 51, and 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aizenberg (US 20180127594 A1) in view of Appling (US 20100191165 A1) in view of Webler (US 2007/0055142 A1).
Regarding Claim 44, Aizenberg in view of Appling teaches the method of claim 43. Aizenberg fails to teach forming a section of a nonporous polymeric tube into a liner for a corresponding lumen of the tubing by inserting a mandrel within the nonporous tube resulting in a liner substantially conforming to the shape of the corresponding lumen of the tubing; (ii) inserting the tubing and mandrel into the corresponding lumen; and (iii) withdrawing the mandrel. Aizenberg does teach the desire for slippery surface on an inner surface ([0193]).
Webler teaches a tubing with a common liner (232) for providing a lubricous inner surface lumen ([00841). The liner being inserting into the tubing via a mandrel (mandrel removed to form a lumen), forming a lubricious inner surface lumen ([0084]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the slippery surface within the tubing of Aizenberg with the slippery lubricous surface/liner placed by the mandrel of Webler as an obvious alternative for providing a slippery surface on an inner surface.
Regarding Claim 45, Aizenberg in view of Appling teaches the method of claim 44. Aizenberg fails to teach wherein (i) two or more sections of independently selected nonporous polymeric tube are formed into liners for corresponding lumens of the tubing on separate mandrels; (ii) the formed liners and mandrels are inserted into the corresponding lumens of the tubing either simultaneously or sequentially; and (iii) the mandrels are withdrawn either simultaneously or sequentially.
Appling teaches wherein (i) two or more sections of independently selected nonporous polymeric tube are formed into liners for corresponding lumens of the tubing on separate mandrels; (ii) the formed liners and mandrels are inserted into the corresponding lumens of the tubing either simultaneously or sequentially; and (iii) the mandrels are withdrawn either simultaneously or sequentially (Appling comprises three lumen, therefore requiring 33 mandrels with liners, fig. 3d, there is a finite number of ways of inserting and withdrawing; simultaneously or sequentially (different times), therefore the insertion of the mandrels can only be simultaneously or sequentially). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Aizenberg with the separate lumens and Mandrels of Appling to provide multiple functions within the catheter.
Regarding Claim 51, Aizenberg in view of Appling teaches the catheter, cannula, drain, shunt, port, or totally implantable venous access port of claim 50. However Aizenberg in view of Appling fail to teach wherein at least one lumen is lined with a nonporous liner. Webler teaches a tubing with a common liner (232) for providing a lubricous inner surface lumen ([0841). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the slippery surface within the tubing of Aizenberg with the slippery lubricous surface/liner placed by the mandrel of Webler as an obvious alternative for providing a slippery surface on an inner surface.
Regarding Claim 55, Aizenberg in view of Appling teaches method of making the tubing of claim 33, The combination further comprising the steps of:
(i) bringing two or more nonporous polymer tubes having lumens into contact, optionally with an intervening layer of material (Applying, (tubes are extruded before combining, [0103]),
(iii) covering the inner liner assembly with a porous fluoropolymer outer wall ([0133], Aizenberg).
Aizenberg fails to teach bonding the two or more nonporous polymer tubes and any intervening material present together to form an inner liner assembly. Webler teaches a tubing with a common liner (232) for providing a lubricous inner surface lumen ([0841). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the slippery surface within the tubing of Aizenberg with the slippery lubricous surface/liner placed by the mandrel of Webler as an obvious alternative for providing a slippery surface on an inner surface.
Regarding Claim 56, Aizenberg in view of Appling and Webler teach the method of claim 55. Appling teaches wherein the two or more nonporous polymer tubes are formed into a shape substantially conforming to the shape they will have (tubes are extruded before combining, [0103]),.
Aizenberg fails to teach the inner liner assembly prior to bringing the tubes into contact with each other and/or into contact with any intervening material that may be present. Webler teaches they will have in the inner liner assembly prior to bringing the tubes into contact with each other and/or into contact with any intervening material that may be present ([0841). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the slippery surface within the tubing of Aizenberg with the slippery lubricous surface/liner placed by the mandrel of Webler as an obvious alternative for providing a slippery surface on an inner surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20060004325-A1, US-20090247868-A1, and US-20140121590-A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATE ELIZABETH STRACHAN/ Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781