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 .
Response to Amendment
In the reply filed 3/5/2026, Applicant amended Claims 4, 6, 14, and 16, and added new claims 22-26. Claims 1-26 are currently pending.
Response to Arguments
Applicant's arguments filed 3/25/2026 have been fully considered but they are not persuasive.
Applicant argues that the 103 rejection over Uflacker and Squitieri is improper because Uflacker teaches that a minimum of two septums should be provided to allow healing of adjacent skin and to increase the number of allowable punctures, and therefore teaches away from a single cannulation port (pages 8-9 of the reply filed 3/25/2026).
This argument has not been found persuasive because it mischaracterizes the combination of Uflacker and Squitieri. Contrary to applicant’s arguments, both Uflacker and Squitieri provide motivation to increase the available surface area of the septum.
It is true that Uflacker teaches that multiple septums should be provided in order to increase surface area to increase the number of available punctures and allow healing of adjacent skin (Column 3, Lines 21-24). The examiner agrees that Uflacker does appear to teach away from providing only a single small cannulation port 20 as shown in Figure 1.
However, as noted in the rejection, Squitieri’s septums are disposed in an enlarged oval shape that extends over a major portion of the chamber housing, therefore providing a large surface area that is easy to locate and puncture with a needle (paragraphs [0037-0038]). Accordingly, the proposed modification of Uflacker would increase the surface area available for puncture rather than decreasing it.
Additionally, the examiner notes that Claim 1 was alternatively rejected using an “obvious change in change” rationale (see pages 4 and 5 of the Non-Final Rejection). Applicant has not provided arguments against this rejection.
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.
Claims 1-10, 12-14, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Uflacker et al. (US 6,261,257) in view of Squitieri (US 2007/0123811).
With respect to Claim 1, Uflacker teaches an arteriovenous dialysis graft 10 configured to be implanted in a subject (Abstract; Figures 1-3), comprising:
at least one flexible conduit 18 having first and second end portions, wherein the first portion is configured to connect to an artery 12 of the subject and the second end portion is configured to connect to a vein of the subject such that blood flows through the at least one conduit from the first end portion to the second end portion (conduit 18 includes the portions that connect to the artery and vein; Figure 1; Column 2, Lines 54-60; and
at least one cannulation chamber 16 positioned between the first end portion and the second end portion of the at least one conduit 18 (Figure 1; Column 2 Line 54 through Column 3, Line 11), the chamber comprising:
an elongated housing having an inlet at a first end thereof and an outlet at a second opposing end (see Figures 1-3; inlet and outlet of each chamber are connected to sections of the conduit 18), a posterior wall and a pair of sidewalls (the cannulation chambers have circular cross-sections that comprise a pair of opposing sidewall sections and a posterior wall section) and an open anterior portion defining at least one cannulation port (Figures 1-3; hole 17 surrounding each septum 20; Column 2, Line 61 through Column 3, Line 1), wherein the cannulation ports are disposed along a major portion of the length of the housing (Figures 1-3);
a self-sealing material 20 (a self-sealing septum 20; Column 2, Line 61 through Column 3, Line 27) extending across the cannulation ports, and a longitudinal passageway defined by the housing and the self-sealing material 20 that extends from the inlet to the outlet (Figures 1-3);
wherein the posterior wall and the sidewalls of the housing of the at least one cannulation chamber are configured such that, when a dialysis needle is inserted through the self-sealing material 20 and the cannulation port, the needle is inhibited or prevented from extending through the posterior or sidewalls of the housing (while the self-sealing material is flexible and configured to allow passage of a needle, the posterior and side walls of the housing is made from a rigid plastic or metal material, such that it the needle will be inhibited or prevented from puncturing the housing; see Column 2, Line 51 through Column 3, Line 1).
Uflacker teaches that the chamber housings each have a plurality of cannulation ports 17 that are disposed along a major portion of the length of the housing (Figures 1-3; Column 2, Lines 61-66), but does not specifically teach that the housing comprises a single cannulation port that spans at least a major portion of a length of the housing.
Squitieri teaches a similar arteriovenous dialysis access graft (Abstract) comprising a flexible conduit connecting an artery and a vein, and one or more cannulation chambers disposed along the length of the conduit (Figures 1, 7-9, and 12-13). The cannulation chambers each comprise a rigid shell and a septum that extends across a cannulation port (Abstract; paragraphs [0035-0038]). Specifically, the cannulation ports and self-sealing septums are disposed in an enlarged oval shape that extends over a major portion of the chamber housing, therefore providing a large surface area that is easy to locate and puncture with a needle (paragraphs [0037-0038]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Uflacker’s cannulation chambers to have a cannulation port that has a length that spans at least a major portion of a length of the housing, as suggested by Squitieri, in order to enable ease of puncture of the septum with a dialysis needle.
In the alternative, it has been held that mere changes in shape do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (MPEP 2144.04.IV.B). in this case, it is unclear why replacing Uflacker’s plurality of ports with a single port that covers the same major surface of the cannulation chamber would have resulted in a non-obvious change in functionality. It would have been an obvious matter of design choice to one having ordinary skill in the art prior to the effective filing date of the instant application to replace Uflacker’s plurality of ports covering a major surface of the chamber with a single port that covers a major portion of the chamber, because a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
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Annotated Figure 1 of Uflacker
With respect to Claim 2, Uflacker teaches that the at least one cannulation chamber 16 comprises first and second cannulation chambers 16 (Figure 1; Column 2, Lines 54-60);
the at least one conduit 18 comprising a middle portion between the first and second end portion, wherein the first chamber 16 is positioned between the first end portion and the middle portion of the at least one conduit, and the second chamber 16 is positioned between the middle portion and the second end portion of the at least one conduit. See annotated Figure 1 of Uflacker above.
With respect to Claim 3, Uflacker teaches that the at least one conduit extends through the longitudinal passageway of each chamber (Figures 1-3). Specifically, the embodiment of Figure 2 shows a configuration wherein the interiors of the chambers are in series with the various portions of the conduit, such that a continuous conduit between the artery and the vein is created. Alternatively, the embodiment of Figure 3 shows a configuration wherein the conduit 18 is a graft that extends through the longitudinal pathway of each chamber (Column 3, Lines 30-34).
With respect to Claim 4, Uflacker teaches that the at least conduit 18 comprises first, second, and third flexible conduits, each conduit having a first and second end (as shown in the annotated figure above, the conduit is broken into a first end portion, a middle portion, and a second end portion). The first end of the first conduit (the first end portion, as shown in the annotated figure) is configured to connect to the artery and the second end of the first conduit is configured to connect to the inlet of the first chamber. The first end of the second conduit (the second end portion, as shown in the annotated figure above) is configured to connect to the vein of the subject and the second end of the second conduit is connected to the second end of the second chamber. The first end of the third conduit (the middle portion, as shown in the annotated figure above) is connected to the outlet of the first chamber and the second end of the third conduit is connected to the inlet of the second chamber. See the annotated version of Figure 1 above.
With respect to Claim 5, Uflacker does not specifically teach that the first and second chambers, the middle portion of the conduit, and at least a portion of the first and second end portions of the conduit are covered by a veneer formed of a biocompatible material.
However, Squitieri further teaches that the materials of the arteriovenous graft may be covered by a thrombus-resistant coating or biologic tissue [0041]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Uflacker’s arteriovenous dialysis access graft to have a coating/veneer of a biocompatible material such as a thrombus-resistant coating or biologic tissue, as suggested by Squitieri, in order to improve the biocompatibility of the implanted device.
With respect to Claim 6, Uflacker teaches that the graft is shaped to form a loop (Column 4, Lines 12-13), and that the chambers are curved and formed along the length of the loop (Figure 1).
In the event that Applicant does not clearly envisage Uflacker’s chambers as being curved, it has been held that mere changes in shape do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (MPEP 2144.04.IV.B.). In this case, it is abundantly clear that Uflacker’s graft assembly forms a loop shape. It would have been an obvious matter of design choice to one having ordinary skill in the art to also form the cannulation chambers such that they follow the same general loop shape. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
With respect to Claims 7 and 8, Uflacker does not specifically teach that the arc angle of the cannulation chambers is 5-45 degrees or 5-60 degrees to accommodate placement in the upper arm, forearm, or lower extremity of the patient. However, it has been held that mere changes in shape do not constitute patentable improvements in the art when said changes do not result in a non-obvious change in functionality (MPEP 2144.04.IV.B.). In this case, it is abundantly clear that the entire graft (including the cannulation chambers should be shaped in a manner such that they fit within the desired area of the body. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Uflacker’s cannulation chambers such that they have an arc angle of 5-45 or 5-60 degrees, or any other shape that was considered desirable for a given application, in order to make the chambers shaped to fit naturally within the body. The examiner notes that a chamber with an arc angle in these ranges would be fully capable of being implanted in the upper arm, forearm, or lower extremity of the patient. .
With respect to Claim 9, Uflacker teaches that the conduit and/or chambers are formed of a biocompatible material (Column 2, Lines 32-47).
With respect to Claim 10, Uflacker teaches that the self-sealing material 20 of the cannulation chambers 16 comprises silicone (Column 2, Line 66 through Column 3, Line 11).
With respect to Claim 12, Uflacker teaches that each chamber 16 housing comprises at least one of a polymeric material and a titanium. Specifically, Uflacker teaches that the chamber housing may be made of any metal or plastic material that is suitable for implantation in the body (Column 2, Lines 54-65), and plastic materials are polymeric.
In the event that applicant does not clearly envisage this interpretation, the examiner notes that it would have been obvious to one of ordinary skill in the art to try selecting a biocompatible polymer from Uflacker’s generically disclosed “suitable plastic material,” in order to provide a well-known type of material for a body-implanted device.
With respect to Claim 13, Uflacker’s cannulation chambers 16 are fully capable of providing tactile feedback to an operator when an inserted dialysis needle contacts an interior wall of the chamber.
With respect to Claim 14, Uflacker does not specifically teach that the bottom portion of each chamber is squared or flat to inhibit malpositioning and/or twisting of the graft.
However, Squitieri further teaches cannulation chambers that comprise flattened bottom portions (Figures 12-13a). The flat bottom walls of the chambers may further by supplied with suture holes 55 that allow the ports to be fixed in place, thereby preventing movement (Figure 13; paragraph [0051]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Uflacker’s cannulation chambers to have flat bottoms with suture holes that allow them to be fixed in place, as suggested by Squitieri, in order to provide a well-known means for anchoring the chambers to prevent malpositioning once implanted.
With respect to Claim 22, Uflacker teaches that the housing of each cannulation chamber 16 comprises:
a center portion having a center portion outer diameter (see annotated figure below) and a center portion inner diameter (the interior lumen of the housing and tube 100; Figure 3); and
opposing first and second end portions having an end portion outer diameter that is less than the center portion outer diameter and end portion inner diameter that is substantially the same as the center portion inner diameter (see annotated figure below; as seen in Figure 3, the interior lumen has a substantially constant diameter).
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Annotated Figure 3 of Uflacker
With respect to Claim 23, at least a portion of the center portion includes a first material thickness that is greater than a second material thickness of each of the opposed end portions. See the annotated Figure 3 of Uflacker below.
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Annotated figure 3 of Uflacker
With respect to Claim 24, Uflacker does not teach that the opposing first and second end portions of the housings comprise barbed outer surfaces. However, Suiter further teaches in at lease some embodiments that the housings may each comprise barbed outer surfaces (75a, 75b) on the opposing first and second ends (73, 74) thereof (Figure 12; paragraph [0049]). These barbed outer surfaces are configured to engage tubing that is inserted onto the inlet and outlet of each chamber housing [0049]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Uflacker’s cannulation chambers to have barbed outer surfaces on the opposing first and second end portions of the housings, as suggested by Squitieri, in order to provide means for securely engaging tubing with the inlet and outlet of the chambers [0049].
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Uflacker and Squitieri as applied to claims 1 and 2 above, and further in view of Porter (US 2011/0060264).
With respect to Claim 11, Uflacker and Squitieri reasonably suggest the graft of Claims 1 and 2, and Uflacker and Squitieri both suggest that the conduit may be made of PTFE (Column 1, Lines 50-57 of Uflacker; paragraphs [0004] and [0010] of Squitieri). Uflacker and Squitieri, however, do not teach the use of ePTFE as the conduit material.
Porter teaches a dialysis graft system comprising a conduit that is preferably made of ePTFE (paragraphs [0104], [0106], [0109]). This configuration renders the outer surface of the conduit porous, thereby facilitating tissue ingrowth, which can help reduce infection rates [0104]. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Uflacker’s graft system to form the conduit portions from ePTFE, as suggested by Porter, to provide a well-known material for implanted grafts that enhances biocompatibility and reduces infection rates.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,585,998. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an arteriovenous dialysis access graft comprising a flexible conduit and at least one cannulation chamber comprising a self-sealing material and a rigid body. The instant claims are broader than the ‘998 claims at least because they do not require that the chamber(s) comprise an annular inner layer including self-sealing material.
Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,504,461. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an arteriovenous dialysis access graft comprising a flexible conduit and at least one cannulation chamber comprising a self-sealing material and a rigid body. The instant claims are broader than the ‘998 claims at least because they do not require that the chamber(s) comprise an annular inner layer including self-sealing material.
Allowable Subject Matter
Claims 15-21 would be allowable upon filing a terminal disclaimer to overcome the double patenting rejection.
Claims 25-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and upon filing a terminal disclaimer to overcome the double patenting rejection.
The following is an examiner’s statement of reasons for indication of allowable subject matter: The closest prior art (Uflacker and Squitieri, as cited above) does not teach or suggest that the cannulation chambers comprise an elongate shell embedded in the chamber body and extending generally parallel to the longitudinal flow passageway of the conduit, the shell including a posterior wall, a pair of sidewalls, and an open anterior portion facing the cannulation port. This feature is not taught in the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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