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
The amendment filed December 18th 2025 has been entered. Claims 1 and 3-20 are pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed July 23rd 2025.
Claim Objections
Claim 6 is objected to because of the following informalities: “the first” should be corrected to “a first” for claim language consistency. The Examiner believes all recitations of the word “interior” in claim 6 are understood to be typographical errors and should be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 has been amended to recite “one of the first and second needles to be pushed out of the first one of the one or more septa and into fluid communication with the pump chamber and the other of the first and second needles to be pulled into the first one of the one or more interior septa or a second one of the more or more interior septa.” This combination of limitations is not supported by the original disclosure and is considered as new matter. In the elected embodiment of the invention, one of the first and second needles is pushed out of one of the septa and the other one of the first and second needles is pulled into another one of the septa, not the same septa. One of the first and second needles cannot be pushed out of a first septa and the other one of the first and second needles be pulled into the same, first septa (see Figs. 2A-2B and 3A-3B). As such the amended limitations contradict the originally filed disclosure. Additionally, the Examiner is interpreting all recitations of the word “interior” to be a typographical error. The Examiner suggests the claim to be amended as originally suggested in the prior Office Action.
Claim 7 has been amended to recite “one of the first and second needles to be pushed into a first one of the one or more interior septa and the other of the first and second needles to be pulled out of the first one of the one or more interior septa or a second one of the one or more interior septa.” This combination of limitations is not supported by the original disclosure and is considered as new matter. In the elected embodiment of the invention, one of the first and second needles is pushed into one of the interior septa and the other one of the first and second needles is pulled out of another one of the septa, not the same septa. One of the first and second needles cannot be pushed into a first septa and the other one of the first and second needles be pulled out of the same, first septa (see Figs. 2A-2B and 3A-3B). As such the amended limitations contradict the originally filed disclosure. The Examiner suggests the claim to be amended as originally suggested in the prior Office Action.
Claim 12 has been amended to recite “during a transition between the first and second states, the lumen of one of the first and second needles will be covered by a first one of the one or more septa before the other of the first and second needles is placed in fluid communication with the pump chamber.” This combination of limitations is not supported by the original disclosure and is considered as new matter. In the elected embodiment of the invention, during transition between the first and second states, the lumen of the first and second needles is covered by one of the one or more septa, not by the same first septa. Needle one is covered by its own septa and needle two is covered by another one of the one or more septa, not the same septa. One of the first and second needles cannot both be covered during transition by the same, first septa (see Figs. 2A-2B and 3A-3B). As such the amended limitations contradict the originally filed disclosure. The Examiner suggests the claim to be amended as originally suggested in the prior Office Action.
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.
Claim(s) 1, 3-4, 6-7, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tallarida (US 20190192769 A1), in view of Yacowitz (US 6065371 A).
Regarding claims 1 and 3, Tallarida discloses a valve (medical device 10, [0053] & Fig. 9d) comprising: a pump chamber having one or more openings (pump 46, extraction members 47, and needles 110, [0156] & Fig. 9d-9f; openings at the ends of needles 110 near needle tips 114, [0156] & Fig. 9d); one or more septa covering the one or more openings (self-closing seals 280 being a silicone septum, see [0156] & Fig. 9d); a first needle; and a second needle (two needles 50; [0157] & Fig. 9d). Tallarida further discloses the generic extension of needles 50 together into needles 110 (see [0159] & Fig. 9f).
However, Tallarida fails to explicitly disclose the valve wherein, in a first state, a lumen of the first needle is in fluid communication with the pump chamber and a lumen of the second needle is covered by one of the one or more septa; and wherein, in a second state, the lumen of the second needle is in fluid communication with the pump chamber and the lumen of this first needle is covered by one of the one or more septa, an actuator forming a mechanical coupling between the first and second needles, and the actuator causing movement of the first and second needles in opposite linear directions.
However, Yacowitz teaches a needle actuation system - motor device 20, left needle apparatus 100, and right needles apparatus 200 - in which two needles, needle 101 and needle 201, are mechanically coupled and operable to move in opposite linear directions caused by shafts 28 and 26 and rollers 502 and 602 rotating in clockwise and counterclockwise directions shown by arrows 26a and 28a. The opposing rotation allows for the needles to move translationally about the shafts creating upward and downward movement in opposite linear directions (see Col 2 lines 48-67 and Col 3 lines 1-12 & Fig. 1 and 5 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the needle extension system of Tallarida with Yacowitz to include motor device 20 and apparatuses 100 and 200 since such a modification would allow for the actuation of each needle to be adjustable and yield predictable results pertaining to needle insertion (see Col 5 lines 50-54 and abstract).
As modified, the needle extension mechanism as generically described in Tallarida would operate like the device of Yacowitz. The oppositely rotating shafts 28 and 26 would allow for one of needles 50, for example the left needle as seen in Figure 9f, to extend into fluid communication with needle 110, which is being interpreted as part of the pump chamber, while the other one of needles 50, the right needle, would remain in place - covered by septum 280 in a first state. In a second state, right needle 50 would extend into needle 110 and left needle 50 would retract back into extraction member 47 - covered by septum 280. The extension facilitated by opposing rotating shafts 28 and 26 creates opposite linear movement between the needles.
Regarding claim 4, Tallarida, as modified, discloses all the limitations of claim 3. Tallarida, as modified, further discloses the valve wherein the actuator has a rotational movement that translates to linear movement of the first and second needles in opposite directions (“Activating the switch 31 causes shaft 26 of motor 22 to rotate in a clockwise direction and activating switch 32 causes shaft 28 of motor 24 to rotate in a counter clockwise direction, as shown by direction arrows 26a and 28a. The turning of shaft 26 clockwise causes needle 101 to move up and down in the directions U and D as shown in FIG. 1. Likewise, the turning of shaft 28 counterclockwise causes the needle 201 to move up and down in the directions U and D as shown in FIG. 1.”, Col 4 line 67 and Col 5 lines 1-8).
Regarding claim 6, Tallarida, as modified, discloses all the limitations of claim 3. Tallarida, as modified, further discloses the valve wherein linear movement of the first and second needles in opposite linear directions causes one of the first and second needles to be pushed out of the first one of the one or more septa and into fluid communication with the pump chamber and the other of the first and second needles to be pulled into the first one of the one or more interior septa or a second one of the more or more interior septa (as modified, the oppositely rotating shafts 28 and 26 would allow for one of needles 50, for example the left needle 50 as seen in Figure 9f, to extend into fluid communication with needle 110 while the other one of needles 50, the right needle 50, would remain covered by septum 280; as the shafts rotate needles 50 out of the first and second states as described in claim 1, needles 50 would push through and out of septa 280 into fluid communication with the pump chamber while the other needle 50 is pulled into and out of septa 280).
Regarding claim 7, Tallarida, as modified, discloses all the limitations of claim 4. Tallarida, as modified, further discloses the valve further comprising: one or more interior septa disposed on the interior of the pump chamber (seals 49 being silicone septa, [0157] & Fig. 9d); wherein linear movement of the first and second needles in opposite linear directions causes one of the first and second needles to be pushed into a first one of the one or more interior septa and the other of the first and second needles to be pulled out of the first one of the one or more interior septa or a second one of the one or more interior septa and into fluid communication with the pump chamber (as modified, as the shafts rotate out of the first and second states as described in claim 1, needles 50 would push into and pull out of septa 49 in each one of extraction members 47; needles 50 being fluidly connected with the pump chamber when pulled out of and through septa 49 - moving toward needle 110).
Regarding claim 12, Tallarida, as modified, discloses all the limitations of claim 1. Tallarida, as modified, further discloses the valve wherein, during a transition between the first and second states, the lumen of one of the first and second needles will be covered by a first one of the one or more septa before the other of the first and second needles is placed in fluid communication with the pump chamber (before the extension of needles 50, both needles are covered by septa 280, [0054] & Fig. 9e; this state is being interpreted as synonymous to a transition between the first and second states – before the needle extension system begins opposite linear displacement of needles 50; therefore, before one of needles 50 is placed in fluid communication with the pump chamber, the other one of needles 50 is covered by septa 280).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tallarida (US 20190192769 A1), in view of Yacowitz (US 6065371 A), and further in view of Lanigan (US 20120109062 A1).
Regarding claim 5, Tallarida, as modified, discloses all the limitations of claim 1. However, Tallarida and Yacowitz both fail to explicitly disclose the valve wherein the actuator comprises a shape memory alloy wire. However, Lanigan teaches an actuator 30 similar to the rotating shaft actuator of Yacowitz which includes a rotating crank assembly 300 and linkage assembly 312 to actuate a needle assembly 28 (see [0048], [0075], & Fig. 2 and 9A). Lanigan further teaches that actuator 30 may instead be a shape memory wire-based actuator (see [0046]). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the needle extension mechanism of Tallarida, as modified by Yacowitz, to include a shape memory wire-based actuator since Lanigan teaches shape memory wire-based actuators to be suitable actuation systems for extending and retracting needles (see [0095 of Lanigan).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tallarida (US 20190192769 A1), in view of Yacowitz (US 6065371 A).
With regard to claim 16, apparatus 42, including pump 46, extraction members 47, and needles 110 may be interpreted as the pump chamber, considering all of the listed components combine to create a space, which can be interpreted as a chamber, configured to facilitate pumping (see [0156] & Fig. 9d-9f). In this configuration, Tallarida, as modified, discloses all the limitations of claim 1.
Tallarida further discloses the valve wherein: the first needle is in fluid communication with a reservoir (an indwelling access port 20, such as indwelling access port 20h, disclosed herein may also be used during a hemodialysis and/or hemofiltration procedure. As shown in FIG. 9c, each of needles 110 may be coupled to fluid infusion and/or extraction apparatus 42 (which may be understood to be part of medical device 10), such as a dialysis apparatus 45, by hollow tubular fluid infusion and/or extraction member 47, such as a cylindrical tubing segment.”, see [0154] & Fig. 9C; “each lumen 48 may contain a pointed tip (hypodermic) needle 50 for delivery of fluid from fluid source 43 to host 58 and/or extraction of fluid from host 58 to fluid receptacle 44.”, see [0157] & Fig. 1c and 9c; the right needle 50 is in fluid communication with fluid source 43, which is being interpreted as a reservoir), and the second needle is in fluid communication with a patient interface (the left needle 50 is in fluid communication with an artery of the host, see [0145] and [0154] & Fig. 9f).
The Examiner notes that in claim 1, the right needle was originally cited as the second needle. However, the original citation was merely an example (see claim 1 above), as the right or left needle in claim 1 could be interpreted as either the first or second needle.
However, Tallarida and Yacowitz both fail to explicitly disclose the valve wherein: the first needle is in fluid communication with a reservoir for containing a liquid drug.
However, the embodiment of indwelling access port 20a of Tallarida teaches a configuration in which fluid source 43, which may be interpreted as a reservoir, is described as capable of comprising a liquid composition to be administered with the aid of pump 46 (see [0151] and [0196]-[0197] and [0201] & Fig. 1c; “a method of injecting a fluid (liquid) composition into a host may be provided using the access port described herein. As alluded to above, a composition may include pharmaceutical products, therapeutic drugs, bodily fluid, nutrients, contrasting agents, dialysis fluid and other fluids.”, [0151]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Fig. 9c-9f of Tallarida, as modified, with the embodiment of Fig. 1c of Tallarida to include fluid source 43 comprising a liquid composition, which may include pharmaceutical products, therapeutic drugs, bodily fluid, nutrients, contrasting agents, dialysis fluid and other fluids, since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. The modification would provide the device with additional therapeutic capabilities (see [0151], [0196], and [0204] of Tallarida).
As modified, fluid source 43 of apparatus 42 would include a liquid composition and be fluidly connected to the right needle, which is fluidly connected to the host through catheter 30h (see [0154] & Fig. 9c). The Examiner additionally notes that, as combined with Yacowitz, the left and right needles are still capable of being inserted together as Yacowitz teaches independent adjustment of each needle (see the citation above in claim 1 to Yacowitz).
In an alternate interpretation, claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tallarida (US 20190192769 A1), in view of Yacowitz (US 6065371 A), and further in view of Parisotto (US 20160199562 A1).
With regard to claim 16, apparatus 42, including pump 46, extraction members 47, and needles 110 may be interpreted as the pump chamber, considering all of the listed components combine to create a space, which can be interpreted as a chamber, configured to facilitate pumping (see [0156] & Fig. 9d-9f). In this configuration, Tallarida, as modified, discloses all the limitations of claim 1.
Tallarida further discloses the valve wherein: the first needle is in fluid communication with a reservoir (an indwelling access port 20, such as indwelling access port 20h, disclosed herein may also be used during a hemodialysis and/or hemofiltration procedure. As shown in FIG. 9c, each of needles 110 may be coupled to fluid infusion and/or extraction apparatus 42 (which may be understood to be part of medical device 10), such as a dialysis apparatus 45, by hollow tubular fluid infusion and/or extraction member 47, such as a cylindrical tubing segment.”, see [0154] & Fig. 9C; “each lumen 48 may contain a pointed tip (hypodermic) needle 50 for delivery of fluid from fluid source 43 to host 58 and/or extraction of fluid from host 58 to fluid receptacle 44.”, see [0157] & Fig. 1c and 9c; the right needle 50 is in fluid communication with fluid source 43, which is being interpreted as a reservoir), and the second needle is in fluid communication with a patient interface (the left needle 50 is in fluid communication with an artery of the host, see [0145] and [0154] & Fig. 9f).
The Examiner notes that in claim 1, the right needle was originally cited as the second needle. However, the original citation was merely an example (see claim 1 above), as the right or left needle in claim 1 could be interpreted as either the first or second needle.
However, Tallarida and Yacowitz both fail to explicitly disclose the valve wherein: the first needle is in fluid communication with a reservoir for containing a liquid drug.
However, Parisotto teaches a valve (disposable blood component set 104, [0064] & Fig. 2; set 104 includes a valve, [0112] & Fig. 5; set 104 is included in hemodialysis machine 102, [0064] & Fig. 1) with a reservoir for containing a liquid drug (drug pump 192, which is a syringe pump, contains a liquid drug, e.g. heparin, vitamin D and iron supplements, such as Venofer®, and Epogen®, [0078] and [0119] & Fig. 1-3 and 5; drug pump 192 is fluidly connected to the blood circuit of the hemodialysis machine, which comprises patient lines 106 and 108, [0064], [0071], and [0012]-[0113]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the reservoir of Tallarida, as modified, with Parisotto to include a liquid drug since such a modification would provide means for injecting heparin, to help prevent blood clots from forming during hemodialysis, or other drugs/supplements to improve patient health and yield predictable results pertaining to effective hemodialysis treatment. As modified, dialysis machine 45 of apparatus 42 would include drug pump 192.
The Examiner additionally notes that, as combined with Yacowitz, the left and right needles are still capable of being inserted together as Yacowitz teaches independent adjustment of each needle (see the citation above in claim 1 to Yacowitz).
Regarding claim 17, Tallarida, as modified, discloses all the limitations of claim 16. Tallarida, as modified, further discloses the valve further comprising: a plunger disposed within the pump chamber (drug pump 192 is a syringe pump which includes a plunger, [0078] & Figs. 1-3 and 5; as modified, the syringe pump is disposed in dialysis machine 45, see Fig. 9c of Tallarida);
wherein movement of the plunger in a first direction causes a suction within the pump chamber; and wherein movement of the plunger in a second direction, opposite the first direction, causes a pressure within the pump chamber (“The drug pump 192 also includes a stepper motor configured to move the plunger of the syringe 178 along the axis of the syringe 178. A shaft of the stepper motor is secured to the plunger in a manner such that when the stepper motor is operated in a first direction, the shaft forces the plunger into the syringe, and when operated in a second direction, the shaft pulls the plunger out of the syringe 178. The drug pump 192 can thus be used to inject a liquid drug (e.g., heparin) from the syringe 178 into the blood circuit via the drug delivery line 174 during use, or to draw liquid from the blood circuit into the syringe 178 via the drug delivery line 174 during use.”, [0078]).
Allowable Subject Matter
Claims 18-19 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.
Response to Arguments
Applicant's arguments filed December 18th 2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that there is no mechanical coupling between the first and second needles, the Examiner finds that the combination of Yacowitz, which modifies Tallarida to include motor device 200 and apparatuses 100 and 200, mechanically joins/links the two needles together. Motor device 200 creates a physical connection between the two needles, mechanically joining or linking the two needles together. The claim does not include language specifying what the coupling is, that the needles cannot be independently actuated, how the actuator forms a mechanical coupling, any structure related to the mechanically coupling. The claim only broadly recites that the actuator forms a mechanical coupling between the needles. Motor 200 and apparatuses 100 and 200 physically join/link, mechanically couple, the needles together.
In response to Applicant’s arguments that one of ordinary skill in the art would not wish to alternate the connections in Tallarida since it would render Tallarida unsatisfactory for its intended purpose, the Examiner finds that the device of Tallarida would function appropriately with the needles moving in opposite directions and being adjustable since the device of Tallarida is used for procedures such as hemodialysis, hemofiltration, peritoneal dialysis, and/or apheresis (see [0013], [0154], and [0197]). The infusion/extraction apparatus 42 is capable of use in procedures that require the extraction and infusion of treated bodily fluid. The device would be capable of functioning as modified considering the procedures in which the device is intended to be used in do not necessarily require simultaneous fluid extraction and infusion. The needles, as modified, would still be capable of working together to facilitate fluid extraction and later infusion.
Additionally, as originally cited, the device of Yacowitz is capable of adjusting each needle as desired (see Col 5 lines 50-54 and abstract of Yacowitz; “The needles can be driven at different speeds, i.e. needle 101 can be driven at one speed while the needle 201 can be driven at another speed. Knobs 34 and 36 can be used to adjust the first motor 22 speed and the second motor 24 speed, respectively.”) The two needles, as modified, would still be capable of being simultaneously inserted.
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783