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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 21st 2026 has been entered.
Response to Amendment
The amendment filed April 21st 2026 has been entered. Claims 1 and 4-20 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and the 112(a) rejection previously set forth in the Final Office Action mailed February 19th 2026.
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.
Claim 1 is 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.
The limitation of “wherein the actuator causes simultaneous movements of the first and second needles in opposite linear directions” is a positively recited method step of using the apparatus. The Examiner recommends amending the claim language of claim 1 to read “wherein the actuator is configured to cause simultaneous movements of the first and second needles in opposite linear directions”, or similarly.
As per MPEP 2173.05(p)(ll), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
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, 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 claim 1, 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, wherein the actuator causes simultaneous movements 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 simultaneous 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 simultaneous 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-Col 3 lines 1-12, and Col 5 lines 49-60 & Fig. 1 and 5 and abstract). Motors 22 and 24 may operate at the same time, resulting in needles 101 and 201 moving simultaneously. “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...” (Col 5 lines 50-60).
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, could remain in place or be pulled out of needle 110 - 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 can create simultaneous movement of the first and second needles in opposite linear directions. The drive speed may also be adjusted, providing for various extension/retraction configurations.
Regarding claim 4, Tallarida, as modified, discloses all the limitations of claim 1. Tallarida, as modified, further discloses the valve wherein the actuator has a rotational movement that translates to the simultaneous linear movements of the first and second needles in opposite linear 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; “The motors 22 and 24 can be turned on by switches 31 and 32 respectively. The speed of motors 22 and 24 can be adjusted by knobs 34 and 36, respectively.”, Col 2 lines 55-58; both switches may be turned on at the same time and have their speed adjusted, resulting in the motors actuating both needles 101 and 201 simultaneously).
Regarding claim 6, Tallarida, as modified, discloses all the limitations of claim 1. 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 a 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 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 be covered by septum 280; as the shafts rotate needles 50 out of the first and second states as described in claim 1, needle 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 an interior part of the pump chamber (seals 49, being silicone septa, positioned on an inside of extraction member 47, [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 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; alternatively, as modified, considering the drive speed of motors 22 and 24 can be adjusted, one of needles 101 or 201 can be adjusted to move faster/slower than the other one of needles 101 or 201).
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 April 21st 2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the references do not teach or suggest the actuator causing simultaneous movements of the first and second needles in opposite linear directions, the Examiner finds that the needle extension system of Yacowitz is capable of, and can reasonably be interpreted as, simultaneously actuating both needles 101 and 201. Motors 22 and 24 may operate at the same time, resulting in needles 101 and 201 moving simultaneously (see Col 2 lines 48-67-Col 3 lines 1-12, and Col 5 lines 49-60 & Fig. 1 and 5 and abstract of Yacowitz). The claim language does not support Applicant’s argument that “the first and second needles in the amended claim 1 cannot be independently actuated”. Motor device 20, which is being interpreted as the actuator, is capable of moving both needles 101 and 201 simultaneously.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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